case study of intellectual property rights

Ten Famous Intellectual Property Disputes

From Barbie to cereal to a tattoo, a copyright lawsuit can get contentious; some have even reached the Supreme Court

Megan Gambino

Senior Editor

1. S. Victor Whitmill v. Warner Bros. Entertainment Inc. In the recent movie The Hangover Part II , Stu Price, a strait-laced dentist played by actor Ed Helms, wakes up after a night of debauchery in Bangkok to find a tribal tattoo wrapped around his left eye, his skin still painfully pink. Price’s tattoo is identical to the one Mike Tyson has, and it alludes to the boxer’s cameo in the original 2009 movie The Hangover .

Tyson’s tattoo artist S. Victor Whitmill filed a lawsuit against Warner Bros. Entertainment on April 28, just weeks before the movie’s May 26 opening. Since he obtained a copyright for the eight-year-old “artwork on 3-D” on April 19, he claimed that the use of his design in the movie and in advertisements without his consent was copyright infringement. Warner Bros., of course, saw it as a parody falling under “fair use.”

On May 24, 2011 Chief Judge Catherine D. Perry of the United States District Court for the Eastern District of Missouri denied an injunction on the movie’s release, but said Whitmill still had a case. If it meant avoiding a long trial, Warner Bros. said, in early June, that it would be willing to “digitally alter the film to substitute a different tattoo on Ed Helms’s face” when the movie is released on home video. But that ending was avoided on June 17, when Warner Bros. and Whitmill hashed out an agreement of undisclosed terms.

2. Isaac Newton v. Gottfried Wilhelm Leibniz By the early 18th century, many credited the German mathematician and philosopher Gottfried Wilhelm Leibniz with inventing the study of calculus. Leibniz had, after all, been the first to publish papers on the topic in 1684 and 1686. But when Englishman Isaac Newton published a book called Opticks in 1704, in which he asserted himself as the father of calculus, a debate arose. Each of the thinkers’ respective countries wanted to stake a claim in what was one of the biggest advances in mathematics.

Newton claimed to have thought up the “science of fluxions,” as he called it, first. He apparently wrote about the branch of mathematics in 1665 and 1666, but only shared his work with a few colleagues. As the battle between the two intellectuals heated up, Newton accused Leibniz of plagiarizing one of these early circulating drafts. But Leibniz died in 1716 before anything was settled. Today, however, historians accept that Newton and Leibniz were co-inventors, having come to the idea independently of each other.

3. Kellogg Co. v. National Biscuit Co. In 1893, a man named Henry Perky began making a pillow-shaped cereal he called Shredded Whole Wheat. John Harvey Kellogg said that eating the cereal was like “eating a whisk broom,” and critics at the World Fair in Chicago in 1893 called it “shredded doormat.” But the product surprisingly took off. After Perky died in 1908 and his two patents, on the biscuits and the machinery that made them, expired in 1912, the Kellogg Company, then whistling a different tune, began selling a similar cereal. In 1930, the National Biscuit Company, a successor of Perky’s company, filed a lawsuit against the Kellogg Company, arguing that the new shredded wheat was a trademark violation and unfair competition. Kellogg, in turn, viewed the suit as an attempt on National Biscuit Company’s part to monopolize the shredded wheat market. In 1938, the case was brought to the Supreme Court, which ruled in favor of the Kellogg Company on the grounds that the term “shredded wheat” was not trademarkable, and its pillow shape was functional and therefore able to be copied after the patent had expired.

4. Marcantonio Raimondi v. Albrecht Dürer Artist Albrecht Dürer discovered in the early 1500s that a fellow engraver by the name of Marcantonio Raimondi was copying one of his most famous works, a woodcut series of engravings called the Life of the Virgin . To make his prints, Raimondi carved detailed replicas of Dürer’s wood blocks. The prints, with Dürer’s “A” above “D” signature, could pass as Dürer originals, and Raimondi made considerable profits off of them. Dürer took issue and brought his case to the court of Venice. Ultimately, the court ruled that Raimondi could continue making copies, as long as he omitted the monogram.

5. Mattel Inc. v. MGA Entertainment Inc. Barbie was 42 years old when the exotic, puffy-lipped Bratz dolls Cloe, Jade, Sasha and Yasmin strolled onto the scene in 2001. Tensions escalated as the Bratz seized about 40 percent of Barbie’s turf in just five years. The Bratz struck first. In April 2005, their maker MGA Entertainment filed a lawsuit against toy powerhouse Mattel, claiming that the line of “My Scene” Barbies copied the big-headed and slim-bodied physique of Bratz dolls. Mattel then swatted back, accusing Bratz designer Carter Bryant for having designed the doll while on Mattel’s payroll. Bryant worked for Mattel from September 1995 to April 1998 and then again from January 1999 to October 2000, under a contract that stipulated that his designs were the property of Mattel.

In July 2008, a jury ruled in favor of Mattel, forcing MGA to pay Mattel $100 million and to remove Bratz dolls from shelves (an injunction that lasted about a year). But the two toy companies continued to duke it out. This April, in yet another court case, underdog MGA prevailed, proving that Mattel was actually the one to steal trade secrets.

6. Campbell v. Acuff-Rose Music, Inc.

“Weird Al” Yankovic has a policy of writing a parody of a song only if he gets permission from the artist. In the late 1980s, the rap group 2 Live Crew attempted to play by the same rules. Luther Campbell, one of the group members, changed the refrain of Roy Orbison’s hit “Oh, Pretty Woman” from “pretty woman” to “big hairy woman,” “baldheaded woman” and “two-timin’ woman.” 2 Live Crew’s manager sent the bawdy lyrics and a recording of the song to Acuff-Rose Music Inc., which owned the rights to Orbison’s music, and noted that the group would credit the original song and pay a fee for the ability to riff off of it. Acuff-Rose objected, but 2 Live Crew included the parody, titled “Pretty Woman,” on its 1989 album “As Clean as They Wanna Be” anyway.

Acuff-Rose Music Inc. cried copyright infringement. The case went to the Supreme Court, which, in so many words, said, lighten up. “Parody, or in any event its comment, necessarily springs from recognizable allusion to its object through distorted imitation,” wrote Justice David Souter. “Its art lies in the tension between a known original and its parodic twin.”

7. Michael Baigent and Richard Leigh v. The Random House Group Limited Authors Michael Baigent and Richard Leigh surfaced in 2004 with claims that Dan Brown had cribbed the “central theme” and “architecture” of their 1982 book  The Holy Blood and the Holy Grail . Though Baigent and Leigh’s book was nonfiction and Brown’s  The Da Vinci Code  was fiction, they both boldly interpret the Holy Grail as being not a chalice but the bloodline of Jesus and Mary Magdalene, who they alleged had a child together.

Baigent and Leigh accused Random House—ironically, their own publisher, as well as Brown’s—for copyright infringement. A London court ruled, in 2006, that historical research (or “historical conjecture,” as was the case with  The Holy Blood and the Holy Grail ) is fair game for novelists to explore in fiction. “It would be quite wrong if fictional writers were to have their writings pored over in the way  The Da Vinci Code  has been pored over in this case by authors of pretend historical books to make an allegation of infringement of copyright,” wrote Justice Peter Smith in his decision.

8. Lucasfilm Ltd. v. High Frontier and Lucasfilm v. Committee for a Strong, Peaceful America When politicians, journalists and scientists, in the mid-1980s, nicknamed the Reagan administration’s Strategic Defensive Initiative (SDI), the “star wars” program, George Lucas’s production company was miffed. It did not want the public’s positive associations with the term to be marred by the controversial plan to place anti-missile weapons in space.

In 1985, Lucasfilm Ltd. filed a lawsuit against High Frontier and the Committee for a Strong, Peaceful America—two public interest groups that referred to SDI as “star wars” in television messages and literature. Though Lucasfilm Ltd. had a trademark for Star Wars, the federal district court ruled in favor of the interest groups and their legal right to the phrasing so long as they didn’t attach it to a product or service for sale. “Since Jonathan Swift’s time, creators of fictional worlds have seen their vocabulary for fantasy appropriated to describe reality,” read the court decision.

9. A&M Records, Inc. v. Napster Inc. In 1999, to the dismay of musicians around the world looking to sell albums, Shawn Fanning, an 18-year-old whiz kid studying computer science at Northeastern University, created Napster, a peer-to-peer music sharing service that allowed users to download MP3s for free. A&M Records, part of Universal Music Group, a heavy hitter in the music industry, as well as several other record companies affiliated with the Recording Industry Association of America slapped Napster with a lawsuit. The plaintiffs accused Napster of contributory and vicarious copyright infringement. The case went from the United States District Court for the Northern District of California to the United States Court of Appeals for the Ninth Circuit, where Napster was found guilty on both counts. In 2002, Napster was shut down. Grokster, another music-sharing site, surged on for a few more years, but it too stopped operating when the Supreme Court ruled against it in MGM v. Grokster in 2005.

10. Adidas America Inc. v. Payless Shoesource Inc. In 1994, Adidas and Payless got into a scuffle over stripes. Adidas had used its three-stripe mark as a logo of sorts since 1952, and had recently registered it as a trademark. But Payless was selling confusingly similar athletic shoes with two and four parallel stripes. The two companies hashed out a settlement, but by 2001, Payless was again selling the look-alikes. Fearing that the sneakers would dupe buyers and tarnish its name, Adidas America Inc. demanded a jury trial. The trial lasted seven years, during which 268 pairs of Payless shoes were reviewed. In the end, Adidas was awarded $305 million—$100 million for each stripe, as the  Wall Street Journal ’s Law Blog calculated.

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Megan Gambino is a senior web editor for Smithsonian magazine.

5 Interesting IP Cases of 2021

Photo by  Edward Jenner  from  Pexels

What do Quentin Tarantino’s Pulp Fiction NFTs, a $1.2 billion cell therapy patent infringement verdict, and Google’s copying of Java code have in common?

They’ve made it to our list of top 5 intellectual property cases of the past year! Here, we take a look back at cases selected because we find them interesting and hope you do too. These cases should be remembered for their enduring influence, especially as NFTs blow up the inter metanet this year and beyond.

Case Summary: 

1 – Google LLC v. Oracle America, Inc. : Does copyright protection extend to a software interface, and how does fair use of a software interface apply?

2  – Miramax, LLC v. Quentin Tarantino : Who has the rights to develop, market, and sell film-related NFTs?

3 – Belcher v. Hospira: How should inconsistent statements to the FDA and PTO by patent applicants be treated?

4 – Juno v. Kite : How much territory can a patent reasonably stake out, especially with respect to functionally-defined biological compounds?

5 – Biogen v. Mylan : How much disclosure is required to support a patent claim? Or more simply, how little support is too little?

1 – Google LLC v. Oracle America, Inc., 593 S. Ct. ___ (2021)

What’s at stake: Does copyright protection extend to a software interface, and how does fair use of a software interface apply?

We jumped the gun in 2020 and profiled this case in 5 Interesting IP Cases of 2020 when it was still pending. With the verdict in, we think it deserves a spot on this year’s list too.

Background:

At issue is copyright ability of application programming interfaces (APIs) and fair use of Google’s use of Java Standard Edition (SE) (“Java”). The Copyright Act of 1976 enshrined fair use in statutory law (codified at 17 U.S.C. § 107 ), setting four criteria for fair use of copyrighted material in limited circumstances to balance public interest with interests of copyright holders.

This billion-dollar case has a lengthy history from development of Java starting in 1990 to litigation spanning 2010 to present day. Sun Microsystems developed Java, including libraries documented via APIs that allowed for interoperability, and in the mid-2000s a licensing deal could not be reached between Sun and Google for Google to incorporate Java into its Android system.

Google developed its own version of Java libraries instead of licensing Java and incorporated API calls and code central to Java. It’s undisputed that Google copied approximately 11,500 lines of declaring code and organizational structure for 37 packages from Java. Oracle acquired Sun in 2009 and litigation ensued from 2010 – 2015.

Since then, Google won in a District Court jury trial and Oracle appealed to the CAFC , where Oracle won and the case was remanded to the District Court to determine damages Google should pay Oracle. Google’s petition for writ of certiorari to the US Supreme Court was granted and oral arguments were postponed due to COVID-19.

To spice things up a bit, two administrations have backed Oracle ( Obama and Trump ), while Microsoft , Mozilla Corporation , Red Hat , IBM , and many others have backed Google.

The U.S. Supreme Court ruled in April 2021 in favor of Google , reversing the Federal Circuit ruling and remanding for further review. Google’s copying of the Java API was deemed fair use.

As far as copyright ability of computer programs, the Majority (i.e. the champs) took a pass on that question and assumed for argument’s sake that the copyright was valid.

However, the Dissent (i.e. the runners-up who still get a speech) contended that this assumption was a fatal flaw in reasoning .  Congress made no distinction between declaring and implementing code in establishing copyright ability of computer programs. The Dissent argued that the Majority erred in myriad ways, including distinguishing between declaring and implementing code, and thus the Majority eviscerated copyright. In not playing very nicely in the sandbox, Justice Thomas noted that Google “erased 97.5% of the value of Oracle’s partnership with Amazon, made tens of billions of dollars, and established its position as the owner of the largest mobile operating system in the world.” (Could someone get the good Justice an invite to a Larry Ellison yacht party already?)

One important difference in opinion concerned the quantity of code copied. One can view it as a little (the Majority view) or a lot (the Dissenting view). Google copied only 11,500 lines of the 2.86 million lines of code in the API – a little (0.4%). Alternatively, Google copied virtually all the declaring code for hundreds of different tasks – a lot. The dissent contended, “the proper denominator is declaring code , not all code,” finding that Google copied a lot of code.

How this fits with legal precedent:

The Majority maintained that “the application of a copyright doctrine such as fair use has long proved a cooperative effort of Legislatures and courts, and that Congress, in our view, intended that it so continue.” They argued for the judge-made origins of the fair use doctrine (§ 107), and as such its flexibility depending on context. They also put much stock in the fair use doctrine as an “equitable rule of reason” that should not be applied rigidly at risk of stifling “the very creativity which that law is designed to foster.” Stewart v. Abend, 495 U.S. 207, 236 (1990).

The Dissent cut to the chase, concluding, “The majority has used fair use to eviscerate Congress’ considered policy judgement.” (Ouch, virtual glove slaps still sting! Think Justice Thomas carries one of those wallets Samuel L. Jackson favored in Pulp Fiction?)

Favorite quotes from Opinion of the Court and Dissenting Opinion :

Majority: “The doctrine of “fair use” is flexible and takes account of changes in technology.”

Dissent: “Now, we are told, “transformative” simply means…a use that will help others “create new products.”… That new definition eviscerates copyright . A movie studio that converts a book into a film without permission not only creates a new product (the film) but enables others to “create products” – film reviews, merchandise, YouTube highlight reels, late night television interviews, and the like.” (emphasis added)

• Miramax, LLC v. Quantin Tarantino; Visiona Romantica, Inc.; and DOES 1 – 50

What’s at stake: Who has the rights to develop, market, and sell film-related non-fungible tokens (NFTs) when underlying copyright rights are protectable? Specifically, can Quentin Tarantino auction off-scenes from Pulp Fiction in the form of NFTs?

What’s an NFT?

Whether you’re all in on NFTs or giggle at the idea like Keanu Reeves , it looks like they are here to stay.

What is an NFT? Basically, it’s a unique, non-interchangeable, blockchain-stored unit of data. That’s confusing, let’s try again: it’s a way of owning a digital file using a digital ledger to provide public proof of ownership without restricting sharing or copying of the digital file. Still confusing – maybe an analogy would be better? It’s like naming a star so all can search and see that it’s yours while the stars remain visible for all to enjoy. Better?

Coincidentally, stars available for naming on the above-linked Star Register will be backed by NFTs minted in July 2022…

In a November 2, 2021 press release, Secret Network (SCRT Labs) announced the sale of seven “exclusive scenes” form the 1994 film Pulp Fiction in the form of secret NFTs, or NFTs “enhanced with privacy and access control features to create hidden content and experiences.” At the time of this writing, the Tarantino NFT website boasts the sale of “few and rare NFTs” as “the most unique use-case for NFTs ever made” and assures prospective purchasers that they will “get a hold of secrets from the mind and creative process of Quentin Tarantino.”

Miramax was not amused. On November 4, Miramax sent a cease and desist letter, to which Tarantino’s counsel replied on November 5, stating that each NFT will include a “drawing that will be inspired by some element form the scene” and that Tarantino is acting within his “Reserved Rights” to “print publication” as detailed in the Original Rights Agreement effective June 23, 1993.

Miramax then seemed personally offended. In a suit filed on November 16, 2021, Miramax lamented that Tarantino kept his NFT plans secret from his “long-time financier and collaborator” on Pulp Fiction and other films. The suit details the terms of the Original Rights Agreement and the Tarantino-Miramax Assignment executed July 15, 1993 and recorded with the U.S. copyright Office on August 6, 1993. The suit alleges Breach of Contract, Copyright Infringement under 17 U.S.C. § 501, Trademark Infringement under 15 U.S.C. § 1114, and Unfair Competition under 15 U.S.C. § 1125(a).

This one is hot off the presses, so we have no definitive answer here . It is telling, however, that the lawsuit included screenshots from the Tarantino NFT website depicting images of characters played in the film by Samuel L. Jackson, John Travolta, and Uma Thurman, and those images are no longer in use. The website now includes less recognizable images evocative of Pulp Fiction. Perhaps use of the original set of images was a bit of a gamble?

Favorite quotes from the lawsuit:

“Defendants’ infringing acts have caused and are likely to cause confusion, mistake, and deception among the relevant consuming public as to the source of the Pulp Fiction NFTs.” “Tarantino’s conduct may mislead other creators into believing they have rights to exploit Miramax films through NFTs and other emerging technologies, when in fact Miramax holds those rights for its films.”

• Belcher Pharmaceuticals, LLC v. Hospira, Inc. (Fed. Cir. 2021)

What’s at stake: How should inconsistent statements to the FDA and PTO by patent applicants be treated?

Drug development is a winding road, from scientific decisions made very early in the discovery process and PTO filings to clinical trial design and submissions to the FDA seeking regulatory approval. Mistakes along the way can be quite costly. One such mistake, providing different information to different government agencies, is at issue here and is not unlike a child playing each parent independently of the other to get her way.

Belcher Pharmaceuticals, LLC (“Belcher”) sought to develop an injectable l-epinephrine formulation with improved characteristics, and toward that end sought (i) patent protection in the form of issued U.S. Patent No. 9,283,197 (the “ ‘197 patent”) and (ii) regulatory approval in the form of New Drug Application (“NDA”) No. 205029. The NDA was based entirely on the literature and neither pre-clinical nor clinical studies supported the submission.

Belcher asserted the ‘197 patent against Hospira, Inc. (“Hospira”) in an infringement suit, the U.S. District Court ruled the ‘197 patent unenforceable due to inequitable conduct , and Belcher appealed to the U.S. Court of Appeals for the Federal Circuit (“CAFC”).

Much of the case hinges upon the conduct and intent of Mr. Darren Rubin, Belcher’s Chief Science Officer. Mr. Rubin was considered the head of IP (though he was not a registered patent agent or attorney), and oversaw both IP matters and matters pertaining to regulatory approval. Mr. Rubin was a key player in drafting and prosecution of the ‘197 patent as well as drafting of the NDA. Thus, Mr. Rubin was involved in communicating information to both the PTO and the FDA.

To expedite regulatory approval , the NDA (submitted on November 30, 2012) referred to the 2.8 to 3.3 pH range of the formulation as “old” since a pre-existing product made by Swiss company Sintetica SA (“Sintetica”) already exhibited a similar range and could be relied upon in lieu of new data. To expedite patent issuance , a response to an Office Action rejecting claims as obvious argued against obviousness based on the criticality of the 2.8 to 3.3 pH range. The Examiner allowed the claim, reasoning that nothing in the prior art would teach or suggest the criticality of the pH range.

Statements in the NDA submitted to the FDA directly conflicted with statements later submitted to the PTO. The NDA was submitted on November 30, 2012 , and the response to the Office Action was filed on November 5, 2015 . To quote Scooby-Doo: ruh roh.

The CAFC on September 1, 2021 affirmed the District Court’s ruling, finding that the District Court did not clearly err or abuse its discretion in deciding that the ‘197 patent is unenforceable.

The court rejected Belcher’s rationales for Mr. Rubin withholding relevant prior art from the PTO. Belcher argued that Mr. Rubin genuinely believed the prior art references were irrelevant. The court didn’t buy it since Mr. Rubin knew of several relevant references before and during prosecution of the ‘197 patent and he played a central role in both FDA submissions and PTO filings.

Eight days after this ruling on September 9, 2021, Senators Patrick Leahy (D-VT) and Thom Tillis (R-NC) sent a letter (PDF) to acting Director of the USPTO Drew Hirshfeld asking that the PTO take steps to “enforce patent applicants’ obligations to disclose statements made to other government agencies.” The letter takes direct aim at the inequitable conduct of Belcher v. Hospira and imagines a world where information flows from other federal agencies (i.e., the FDA) to the PTO.

Time will tell what becomes of the request, i.e. hahahahahahaha.

Inequitable conduct in patent law is a breach of the applicant’s duty of candor by omitting material information or misrepresenting with intent to deceive in dealings with the PTO. Section 2016 of the Manual of Patent Examining Procedure (MPEP) states that a finding of inequitable conduct “with respect to any claim in an application or patent, renders all the claims thereof unpatentable or invalid.” Thus, inequitable conduct is not limited to certain claims, but is all or nothing.

A ruling in Therasense, Inc. v. Becton, Dickinson and Co. , 649 F.3d 1276 (Fed. Cir. 2011) strengthened the standards for finding materiality and intent and prompted the PTO to rewrite the definition of materiality, enshrining it in 37 CFR § 1.56 . In Belcher v. Hospira , the court pointed to Aventis Pharma S.A. v. Hospira, Inc. , 675 F.3d 1324, 1334 (Fed. Cir. 2012) in which the court rejected post hoc rationales akin to Belcher’s argument that Mr. Rubin genuinely believed the references were immaterial.

Favorite quotes from Opinion of the Court:

“…prior art is but-for material information if the PTO would not have allowed a claim had it been aware of the undisclosed prior art.” “…the district court found that [Mr. Rubin’s criticality] argument was “false” and a “fiction” because Mr. Rubin knew about the prior art’s teachings of that pH range.” (emphasis added)

Note: We offer due diligence services for investors that examine patent portfolios in light of FDA composition and manufacture disclosures. Nothing about this selection of a Top 5 IP case has anything to do with those services. And Matrix Resurrections is hands-down the best Matrix movie of all time.

• Juno Therapeutics, Inc. v. Kite Pharma, Inc. (Fed. Cir. 2021)

What’s at stake: How much territory can a patent reasonably stake out, especially with respect to functionally-defined biological compounds?

In particular, the biological compound at the center of this case is YESCARTA®, an FDA-approved cell therapy for large B-cell lymphoma. The stakes are huge, with a whopping ~$1.2 billion on the line after a U.S. District Court judgement against Kite Pharma, Inc. for willful infringement.

Juno Therapeutics and the Sloan Kettering Institute for Cancer Research (“Juno”) sued Kite Pharma, Inc. (“Kite”) and won in a jury verdict, so Kite appealed to the Federal Circuit, challenging the validity of claims of the patent Juno asserted against Kite’s YESCARTA®, U.S. Patent No. 7,446,190 (the “ ‘190 patent”).

The jury in the District Court found that the ‘190 patent contained adequate written description supporting the asserted claims and found that Kite’s infringement of the ‘190 patent was willful, leading to the massive ~$1.2 billion judgement. Naturally, Kite appealed.

The ‘190 patent claims cover chimeric T-cell receptors, which are important components of chimeric antigen receptor (CAR) T-cell therapies. In CAR T-cell therapies, cells of the body’s natural immune system are re-engineered to attack cancer cells. This is done by modifying a patient’s own T cells with a CAR targeted to specific proteins, called antigens, present in tumors.

CARs are proteins composed of several domains, including a binding domain that interacts with an antigen (see our blog post on patenting antibody therapeutics for more on antibody-based binding domains).

Juno’s patent claimed, among other things, receptors with “a binding element that specifically interacts with a selected target.” The patent disclosed by name (and not nucleic acid or amino acid sequence) two binding elements, also known as single chain variable fragments (scFVs). By claiming these biological compounds functionally (i.e., by binding ability) instead of structurally (i.e., by 3D structure determined by amino acid sequence), Juno claimed quite broadly. Kite sought to invalidate the ‘190 patent based on lack of written description supporting these broad claims.

The CAFC agreed with Kite, and on August 26, 2021 reversed the District Court’s ruling, finding inadequate written description in the ‘190 patent to support the claims.

The court was not convinced by Juno’s expert and inventor testimony that scFvs were generally known in the field, and that other claimed elements were the heart of the invention. Instead, the court focused on the “ millions of billions ” of possible scFv sequences claimed in the ‘190 patent, leading the court to conclude that these claims are generic and the patent lacks support for the functionally-defined genus (see MPEP 806.04 for more on generic claims).

In this ruling, the court cited Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co. , 598 F.3d 1336 (Fed. Cir. 2010)   in which the court held that sufficient description of a genus requires “either a representative number of species falling within the scope of the genus or structural features common to the members of the genus…” Since claims of the ‘190 patent cover “any scFv for binding any target” and are thus generic, the written description must include either representative species or structural features. The court found it lacked both.

“The problem with the ‘190 patent is that, although there were some scFvs known to bind some targets, the claims cover a vast number of possible scFvs and an undetermined number of targets about which much was not known in the prior art.” “ It is not fatal that the amino acid sequences of these two scFvs were not disclosed as long as the patent provided other means of identifying which scFvs would bind to which targets, such as common structural characteristics or shared traits.” (emphasis added).

“A ‘mere wish or plan’ for obtaining the claimed invention is not adequate written description.” (quoted from Centocor Ortho Biotech, Inc. v. Abbott Labs. , 636 F.3d 1341, 1348 (Fed. Cir. 2011).

• Biogen Int’l GmbH v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2021)

What’s at stake: How much disclosure is required to support a patent claim? Or more simply, how little support is too little?

As we described above, drug development is a winding road, and twists and turns during the regulatory approval process may drive similar twists and turns during patent prosecution. Patent practitioners strive to anticipate the nature of a drug product when it hits the market and draft a patent application accordingly. However, the clinical pathway to approval may result in a product that requires claim amendments lacking sufficient support in the original filing.

Biogen International GmbH and Biogen MA, Inc. (“Biogen”) sued Mylan Pharmaceuticals, Inc. (“Mylan”) for patent infringement in U.S. District Court. Biogen asserted 6 patents purportedly covering Tecfidera® and alleged that Mylan’s proposed generic dimethyl fumarate (DMF) product for treating multiple sclerosis (MS) was infringing.

In a bench trial, the District Court ruled in favor of Mylan, finding patents invalid for lack of written description. Biogen appealed to the Federal Circuit, narrowing the scope of the suit to only U.S. Patent No. 8,399,514 (the “ ‘514 patent”).

Biogen markets DMF at a dose of 480 mg/day (DMF480) under the brand name Tecfidera® for treatment of MS. Notably, the ‘514 patent mentions this dose only once in the specification at the lower end of a 480 – 720 mg/day range. Biogen had not included the 480 mg/day dose in its clinical trials, but the FDA recommended testing this dose in a Phase III clinical trial.

The 480 mg/day dose showed efficacy, and much of this case centered on whether Biogen’s February 8, 2007 patent filing supports claims of the ‘514 patent that ultimately issued in 2011.

On November 30, 2021 the Majority (think: Pats) affirmed the District Court’s ruling, finding inadequate written description in the ‘514 patent to support the claims and thus holding Biogen’s ‘514 patent invalid.

The Dissent (think: Jets) vociferously disagreed, taking issue with both the District Court and the Majority’s unwillingness to allow Biogen to draw a distinction between therapeutic and clinical effects . The Dissent argued that this is a fundamental error, and that a proper distinction between the two would impact the written description requirement analysis and change the outcome of the case.

As the Majority explained, “whether a claim meets the written-description requirement is a question of fact.” As in Juno v. Kite , the Majority cites Ariad to explain that “the term “possession” in the context of written-description jurisprudence entails an “objective inquiry into the four corners of the specification…” and that mere theoretical research cannot result in an awarded patent.

The Majority further points to Novozymes v. DuPont Nutrition Biosciences APS , 723 F.3d 1336 (Fed. Cir. 2013) (“ Novozymes ”) and In re Ruschig , 379 F.2d 990, 994–95 (CCPA 1967) to elucidate written description requirements when a broad genus is disclosed and a particular species is claimed.

For laundry list-type disclosures, Novozymes and In re Ruschig require ‘blaze marks’ to guide a reader toward the claimed compound, similar to blaze marks on trees marking trails through an otherwise unmarked forest.

Anyone who has lost their way in the backcountry knows the relief that comes from sighting a blaze mark, and the pure joy of leap frogging from mark to mark to relocate a clearly delineated trail. The Majority finds that a reader would lose their way in the wilderness of patent ‘514 laundry list disclosures, and that the one reference to a 480 mg/day dose is an insufficient blaze mark to point to the claimed invention. 

Majority: “The DMF480 dose is listed only once in the entire specification….That is in stark contrast to DMF720, which is referenced independently as one dose and was known to be effective as of the February 2007 priority date.” “The district court, as the finder of fact, did not find it necessary or appropriate to distinguish between therapeutic effects and clinical efficacy based on the specification’s definition of “therapeutically effective dose”…”

Dissent: “Clinical efficacy involves the type of scientific rigor associated with Phase III clinical trials…Therapeutic effects, by contrast, “do not require efficacy on clinical endpoints or superior efficacy to existing drugs.”” “…the district court’s refusal to acknowledge the difference between therapeutic and clinical effects evinces a fundamental misunderstanding of what is claimed…” “How much brighter need a disclosure blaze?”

About Andrew Lerner

Andrew Lerner  joined RVL® as a registered patent agent upon completing his PhD in Biochemistry and Biophysics at the University of North Carolina, Chapel Hill. His practice areas include clearance & patentability analyses, patent prosecution, and due diligence; strategic IP portfolio development; and IP diligence for life science venture funds.

Andrew has supported faculty, researchers, and staff involved in innovation and commercialization across broad disciplines at top tier universities, and has led IP and market diligence activities for life science, biotechnology, and medical device seed funding. He serves as a reviewer for several seed stage funding mechanisms and regularly advises entrepreneurs as a mentor through Veterati, a platform that connects veterans/mentors with Service Members, Veterans, and Military Spouses.

Rockridge Venture Law®  is a certified B Corp law firm embracing the mantra of technology lawyers for good.  Rockridge® services  include corporate, intellectual property, litigation, M&A, privacy, technology, and venture capital law. Rockridge has been recognized as a  B Corp Best for the World  and  Real Leaders Top 150 Impact Company , and has been featured by Conscious Company Magazine, Forbes, and other top media focused on industry leaders in impact and innovation.

The Rockridge team has worked with Grammy winners, Nobel Prize winners, and world champion athletes to create and monetize distinctive intellectual property assets. Rockridge clients include founders, investors, and multinationals scaling disruptive technologies and iconic brands. Rockridge is headquartered in Tennessee, with satellite offices in Durham and New York.

We’re Building Today’s Company for Tomorrow’s Economy® by leading clients through the dizzying array of information controls, by helping them to develop and monetize proprietary assets, and by enabling their impactful products, programs, and principles.

See case studies on how we’ve helped transformative companies at  Rockridge  Case Studies.

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Author Andrew Lerner

Patent Lead at Rockridge Venture Law // Innovation Fellow at UNC School of Pharmacy // Ph.D., UNC - Chapel Hill, Biochem/Biophysics // B.S. University of California, Berkeley // Veteran U.S.M.C. Russian cryptologist

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Case Study on Intellectual Property Rights: Everything You Need to Know

IP rights is an example of a real-world legal case involving IP rights that can give you an idea of a how a court may rule in a particular legal scenario. 4 min read updated on January 01, 2024

What Is an Intellectual Property Rights Case Study?

A case study on intellectual property rights is an example of a real-world legal case involving intellectual property rights that can give you an idea of a how a court may rule in a particular legal scenario. Examining such studies can be valuable as it will give you some idea if your actions involving intellectual property will be deemed legal by a court of law.

Intellectual Property Rights Case Study Examples

The following are five examples of intellectual property rights cases that are illustrative of how intellectual property law may work:

• S. Victor Whitmill v. Warner Bros. Entertainment Inc. In this case, S. Victor Whitmill, a tattoo artist, filed suit against Warner Bros. for copyright infringement due to their use of a tattoo he created for Mike Tyson, which was subsequently depicted on a fictional character in the Warner Bros. film The Hangover, Part II . Warner Bros., on the other hand, argued that their use of the tattoo was in the spirit of parody and thus was covered by Fair Use . Ultimately, Whitmill’s desire for an injunction against the release of the film was denied, and an agreement between the two parties was made out of court for undisclosed terms.
• National Biscuit Co. v. Kellogg Co. In this case, National Biscuit Co. filed suit against Kellogg Co. over their sale of shredded wheat cereal. According to National Biscuit Co., Kellogg’s manufacture and sale of this product constituted unfair competition and trademark violation, since the previous iteration of their company had been owned by the inventor of shredded wheat and the machinery used to make it, although the patents on both inventions had been allowed to expire. Kellogg Co. countered with the argument that National Biscuit’s suit amounted to an attempt to monopolize the market on shredded wheat. Ultimately, the US Supreme Court ruled that “shredded wheat” was not a trademarkable term and its design was a functional one, and thus free for copying since the trademark had expired.
• MGA Entertainment Inc. v. Mattel Inc. In this case, toymaker MGA Entertainment filed suit against Mattel, arguing that their line of “My Scene” Barbie dolls infringed upon the design of MGA’s line of "Bratz" dolls, which had a similar appearance. Mattel then countersued, claiming Carter Bryant, a designer for MGA, had designed the dolls while working for Mattel and subject to a contract that stated that all designs made while under contract would be Mattel’s property. A jury eventually ruled in Mattel’s favor, hitting MGA with a $100 million reparation to Mattel as well as an injunction (which lasted a year) to cease selling the dolls in question. However, in a later case over the same issue, the ruling went in favor of MGA, and Mattel was considered to be the one that stole trade secrets .
• A&M Records, Inc. v. Napster Inc. In this case, A&M Records sued the file-sharing business Napster over its website, wherein users could download music files free of charge. A&M Records claimed that this was vicarious and contributory copyright infringement , and before the US 9th Circuit Court of Appeals, Napster was ruled to be guilty of both counts. As a result, it was forced to shut down, as was Grokster, a file-sharing site that operated under a similar model, a few years later.
• Lucasfilm Ltd. v. High Frontier and Lucasfilm v. Committee for a Strong, Peaceful America . In these cases, Lucasfilm Ltd. filed suits against the public interest groups High Frontier and the Committee for a Strong, Peaceful America over their use of the term “star wars” to describe President Reagan’s Strategic Defensive Initiative, which involved space-bound missile defense. The term was born out of the popularity of the Star Wars movie franchise, and Lucasfilm did not want their product associated with a controversial, politically divisive defense policy. The court ruled that the term “star wars” could be used as long as it was not used to sell a product or service, further observing that creators of fiction had long seen their invented terms used to describe reality.

Considering these five cases as well as others may give you some idea of how courts interpret IP law . That said, each case is different, and there are many factors that go into determining a ruling, including the facts of the case, the jurisdiction of the case, and the judge or jury hearing the case, all of which could potentially yield a different result.

If you need more than a case study on intellectual property rights to help you in understanding intellectual property law, you can post your legal need on UpCounsel’s marketplace. UpCounsel accepts only the top 5 percent of lawyers. Lawyers on UpCounsel come from law schools such as Harvard Law and Yale and average 14 years of legal experience, including work with or on behalf of companies like Google, Menlo Ventures, and Airbnb.

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With the continuing advancements of cutting-edge technologies — such as genome editing (CRISPR) and Non-Fungible Tokens (NFTs) — U.S. courts will have a full docket of challenging IP cases throughout 2023. Below are some of the most significant issues we are watching:

Keep an Eye on the US Supreme Court for New IP Law in 2023

Andy Warhol Found. for Visual Arts, Inc. v. Goldsmith , 11 F.4th 26 (2d. Cir. 2021),  cert.   granted , 142 S. Ct. 1412 (Mar. 28, 2022) (No. 21-869). The Supreme Court heard arguments on October 12, 2022 whether a work of art which “recognizably deriv[es] from” its source material but conveys a different meaning or message is sufficiently “transformative” to render the accused work a fair use, or whether further justification must be shown to qualify as a fair use.

Amgen Inc. v. Sanofi, Aventisub LLC , 987 F.3d 1080 (Fed. Cir. 2021),  cert.   granted in part sub nom. Amgen Inc. v. Sanofi , 143 S. Ct. 399 (Nov. 4, 2022) (No. 21-757). In  Amgen , the Supreme Court will address the issue of whether a patent specification must disclose “the full scope of claimed embodiments” without undue experimentation.

Hetronic Int'l, Inc. v. Hetronic Ger. GmbH , 10 F.4th 1016 (10th Cir. 2021),  cert.   granted sub nom.   Abitron Austria GmbH v. Hetronic Int'l, Inc. , 143 S. Ct. 398 (Nov. 4, 2022) (No. 21-1043). The question presented here is whether the Tenth Circuit erred in applying the Lanham Act extraterritorially to petitioners’ foreign sales, including purely foreign sales that never reached the United States or confused consumers in the United States.

VIP Prods. LLC v. Jack Daniel’s Props., Inc. , 2022 WL 1654040 (9th Cir. Mar. 18, 2022),  cert.   granted , 2022 WL 17087471 (U.S. Nov. 21, 2022) (No. 22-148). The Supreme Court granted certiorari on two questions: (1) Whether humorous use of another’s trademark as one’s own on a commercial product is subject to the Lanham Act’s traditional likelihood-of-confusion analysis, or instead receives heightened First Amendment protection from trademark-infringement claims? and (2) Whether humorous use of another’s mark as one’s own on a commercial product is “noncommercial” under 15 U.S.C. § 1125(c)(3)(C), thus barring as a matter of law a claim of dilution by tarnishment under the Trademark Dilution Revision Act?

The Thorny Issue of Patent Eligibility: Still Under Consideration at the High Court

Interactive Wearables, LLC v. Polar Electro Oy et al. , 2021 WL 4783803 (Fed. Cir. Oct. 14, 2021),  petition for cert. filed , 2022 WL 864210 (U.S. Mar. 18, 2022) (No. 21‑1281). The petition for certiorari presents the questions of: (1) What is the standard for determining when a claim is “directed to” a patent-ineligible concept under  Alice ? (2) Is patent eligibility (at each step of the  Alice  inquiry) a question of law or fact? and (3) Whether § 112 considerations can inform the analysis in determining patent eligibility under § 101?

Tropp v. Travel Sentry, Inc. , 2022 U.S. App. LEXIS 3906 (Fed. Cir. Feb. 14, 2022),  petition for cert. filed , 2022 U.S. S. Ct. Briefs LEXIS 2127 (U.S. July 5, 2022) (No. 22-22). The petition for certiorari presents the question of whether claims covering TSA master-key compliant locks used for travel that recite physical steps, rather than computer-processing steps, are patent-eligible under 35 U.S.C. § 101.

In Trademarks, the Standard for Expressive Use Is in Flux

VIP Prods. LLC v. Jack Daniel's Props., Inc. , 2022 WL 1654040 (9th Cir. Mar. 18, 2022),  cert.   granted , 2022 WL 17087471 (U.S. Nov. 21, 2022) (No. 22-148). See discussion above on upcoming Supreme Court cases.

Non-Fungible Token (NFT) Cases

Nike, Inc. v. StockX LLC , 1:22-cv-00983 (S.D.N.Y. Feb, 3, 2022). Nike alleges trademark infringement where its registered marks are used in NFTs sold by StockX. These NFTs are used as part of an effort to authenticate resold shoes.

Hermès Int'l v. Rothschild , 1:22-cv-00384, 2022 WL 1564597 (S.D.N.Y. May 18, 2022). In a case of first impression, Judge Rakoff denied dismissal of trademark infringement claims where an artist sold NFTs depicting Hermès’ registered mark for handbags.

Yuga Labs, Inc. v. Ryder Ripps et al. , 2:22-cv-04355 (C.D. Cal. June 24, 2022). Yuga has alleged trademark infringement of its marks where the individual defendant sold NFTs intentionally depicting Yuga’s mark in an effort to highlight Yuga’s alleged racism. Ripps filed a motion to dismiss claiming his First Amendment right to free speech trumps any claims of trademark infringement. The motion to dismiss is currently pending.

Large Damages Awarded in Patent Cases Are Being Challenged With Success

Inst. of Tech. v. Broadcom Ltd. , 25 F.4th 976 (Fed. Cir. 2022). The Federal Circuit vacated a $1.1 billion jury award on account of an unsupported two-tier reasonable royalty model and lack of apportionment.

Roche Diagnostics Corp. v. Meso Scale Diagnostics, LLC , 30 F.4th 1109 (Fed. Cir. 2022). The Federal Circuit vacated a $137 million damage award, noting that apportionment must be considered on remand.

VLSI Tech. LLC v. Intel Corp. , 6:21-cv-00057, 2022 WL 1477725 (W.D. Tex. May 10, 2022),  appeal filed , No. 22-1906 (Fed. Cir. June 15, 2022);  VLSI Tech. LLC v. Intel Corp. , 6:19‑cv‑00256 (W.D. Tex. Nov. 15, 2022). VLSI defeated Intel in two out of three patent infringement trials relating to computer chip-making technologies, with VLSI awarded over $3.1 billion in total damages. Intel has appealed the earliest award of $2.1 billion at the Federal Circuit, arguing that VLSI introduced non-comparable licenses and its methodology violates principles of apportionment. An appeal of the recently awarded $949 million is expected in due course.

USPTO Director Will Step in When IPR Parties Act Inappropriately

OpenSky Indus., LLC, Intel Corp., v. VLSI Tech. LLC , IPR2021-01064, 2022 WL 5240856 (P.T.A.B. Oct. 4, 2022). USPTO Director found that OpenSky abused the IPR process and took remedial measures by removing OpenSky from further participation in the IPR proceeding.

Appeal of CRISPR Interference Puts Sufficiency of Conception into Question

Regents of the Univ. of Cal., Univ. of Vienna, and Emmanuelle Charpentier (“CVC”) v. The Broad Inst. (“Broad”) et al. , Patent Interference No. 106,115, 2022 WL 1664030 (P.T.A.B. Feb. 28, 2022),  appeal filed , No. 22-1594 (Fed. Cir. Apr. 4, 2022). This appeal of an Interference decision contests the requirements of conception in determining inventorship of CRISPR gene editing technology as between CVC and Broad.

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Intellectual Property

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The Case of the Medical Stent

5 Leading Cases of Intellectual Property Rights

In this article, the author has discussed 5 leading case laws under patent law, copyright law, and trademarks law..

5 Leading Cases of Intellectual Property Rights | Overview

• Bayer Corporation v. Union of India
• Diamond v. Chakrabarty
• Yahoo! Inc. vs. Akash Arora & Anr
• The Coca-Cola Company v. Bisleri International Pvt. Ltd. and Ors
• D.C. Comics v. Towle

Introduction

Intellectual Property Rights has proved itself to be invaluable in all senses in the socio-economic fields in the world. It has gained immense popularity in the recent past. It is what motivates people to create and innovate. Things which are governed by Intellectual property laws are creations of the mind. In this article, the author has have discussed 5 leading case laws under Patent Law, Copyright Law, and Trademarks Law.

1. Bayer Corporation v. Union of India [1]

This landmark judgment is the first-ever case in India dealing with the granting of a compulsory license under an application made under Section 84 of the Patents Act, 1970.

The petitioner, Bayer Corporation Ltd incorporated in the USA invented and developed a drug named ‘Nexavar (Sorafenib Tosylate)’ used in the treatment of persons suffering from Kidney Cancer (RCC). The drug was granted an international patent in 45 countries including India. Under normal circumstances, a third party can manufacture and sell the patented drug only with the permission or license granted by the patent holder.

Natco, a drug manufacturer had approached Bayer for a grant of a voluntary license to manufacture and sell the drug at a much lower price of Rs. 10,000/- per month of therapy as against the price of Rs. 2, 80,428/- per month of therapy charged by the petitioner.

The request was denied and hence they made an application to the Controller under section 84 of the Act for a compulsory license on the ground that the petitioner had not met the reasonable requirement of the public in respect of the patented drug. It was granted on the condition that the applicant had to sell the drug at Rs 8,800/- per month and was directed to pay 6% of the total sale as royalty to the petitioner. [2] Natco was also directed to sell the drug only in India and to make the drug available to at least 600 needy patients each year free of charge.

Aggrieved by the order, the petitioner approached the Intellectual Property Appellate Board (IPAB) contending that the order passed was contrary to the provisions of the Act since the drug was made available at a lower price by Cipla. The board, however, rejected the contention by holding that the drug was not made available at a cheaper price by the petitioner and that the petitioner’s stance was detrimental to the public at large who are in need of the drug. Hence, the petitioner preferred an appeal in the High Court. [3]

Issues Involved

The major issues for consideration by the High Court were:

• Has the requirements under Section 84(1) been satisfied for granting a compulsory license?
• Whether supplies by infringers of a patented drug to be considered/taken into account to determine the satisfaction of reasonable requirement test?

With regard to Issue No.1, the Court held that all the three requirements under clauses (a), (b) and (c) of Section 84(1) for granting compulsory license has been satisfied in this case.

The court opined that the question of whether the reasonable requirement of the public has been satisfied under Section 84(1) (a) is to be determined after examining the evidence produced by both parties.

In the present case, after examining the figures given by the Petitioner in affidavits it is clear that the requirements haven’t been met by the petitioner. It was held that the dual pricing system under the Patient Assistance Programme would not satisfy the conditions of Section 84(1) (b) and hence the drug was not considered to be available at a reasonable price to the public. [4]

On the question of whether the patented drug has been worked in the territory of India, the Court held that when a patent holder is faced with an application for a Compulsory License , it is for a patent holder to show that, the patented invention/drug is worked in the territory of India by the manufacturer or otherwise. It is not compulsory that “ Worked in India ” should include “ manufacture ” if the patent holder can furnish valid reasons before the authorities for not manufacturing in India keeping Section 83 of the Act in mind.

• On Issue No. 2, the Court answered the question negatively and held that the supply by the infringers, Cipla and Natco could not be taken into account since their supply could stop any day. It is only when the patent holder grants a de facto license could infringer’s supplies be taken into account. The obligation to meet a reasonable requirement of the public is of a patent holder alone either by itself or through its licensees.
• Section 84(7) of the Act, provides a deeming fiction which provides that the reasonable requirement of the public is not satisfied, if the demand for a patented article is not met to an adequate extent in which regard the patent holder has failed in the present case.

The decision, in this case, will go a long way to ensure that the interests of the public are drowned by reason of the personal interests of the patent holder in necessary circumstances.

2. Diamond v. Chakrabarty [5]

This was the historical decision in which the US Supreme Court considered the patentability of a living micro-organism. The decision is one which will have a huge impact in the field of Biotechnology.

Ananda Chakrabarty, a microbiologist filed patent claims for human-made, genetically engineered bacterium that was capable of breaking down multiple components of crude oil. A patent examiner rejected the patent because it was outside of the scope of the patentable subject matter under 35 U.S.C. §101 .

The Patent Office Board of Appeals affirmed and ruled that living things are not patentable subject matter under Section 101. The Court of Customs and Patent Appeals reversed this decision holding that the fact that micro-organisms are alive is insignificant for the purpose of patent law. [6] Diamond, the Commissioner of Patents, petitioned the United States Supreme Court for certiorari against the decision of the Court of Appeals.

Issue Involved

The main issue before the Court was whether the respondent’s micro-organism plainly qualifies as patentable subject matter.

Arguments Raised by the Appellant

Diamond raised the argument that with the enactment of the Plant Patent Act, 1930 and Plant Variety Protection Act, 1970 Congress implicitly understood that living organisms were not within the scope of 35 U.S.C. §101. He also relied upon the judgment in Parker v. Flook [7] wherein it was held that courts should show restraint before expanding protection under 35 U.S.C. §101 into new, unforeseen areas. [8]

Section 101 of Title 35 U.S.C. provides for the issuance of a patent to a person who invents or discovers “any” new and useful “manufacture” or “composition of matter.” The court held that a live, human-made micro-organism is a patentable subject matter under Section 101 and that the respondent’s microorganism constituted a “manufacture” or “composition of matter under the statute. The court opined that the organism was a product of human ingenuity “having a distinctive name, character, and use”. [9]

Moreover, the Court rejected the appellant’s argument by holding that the patent protection afforded under the Plant Patent Act, 1930 and Plant Variety Protection Act, 1970 was not evidence of Congress’ intention to exclude living things from being patented. The court pointed out that genetic technology was not foreseen by Congress do not make it non-patentable unless expressly provided. The Court held that the language of the Act was wide enough to embrace the respondent’s invention. [10]

3 . Yahoo ! Inc. vs. Akash Arora & Anr [11]

This landmark judgment is the first case relating to cybersquatting in India. Cybersquatting has been defined as the registration, trafficking in, or use of a domain name that is either identical or confusingly similar to a distinctive trademark or is confusingly similar to or dilutive of a famous trademark. [12]

The plaintiff is a global internet media who is the owner of the trademark ‘Yahoo!’ and the domain name ‘Yahoo.Com’ , which are very well-known and render services under its domain name. While the application of the plaintiff for registration of the trademark was pending in India, the defendant Akash Arora started providing similar services under the name ‘Yahoo India’ .

The present case is brought out by the plaintiff for passing off the services and goods of the defendants as that of the plaintiff by using a name which is identical to or deceptively similar to the plaintiff’s trademark ‘Yahoo! ‘ and prayed for a permanent injunction to prevent the defendant from continuing to use the name.

• Whether an action for passing off could be maintained against services rendered?
• Whether a domain name is protected under the Trade and Merchandise Marks Act, of 1958?
• Whether the use of a disclaimer by the defendant will eliminate the problem?

The Delhi High Court extensively examined the issues and rejected the defendant’s contention that an action for passing off could only be brought against goods and not services rendered by virtue of Section 2(5), Sections 27, 29 and Section 30 of the Act. It was held that the passing off action could be maintained against the service, as the service rendered could be recognized for the action of passing off.

The law relating to passing off is well-settled and clear. The principle behind the same is that no man can carry on his business in a way that can lead to believing that he is carrying on the business of another man or has some connection with another man for the business. [14] The plaintiff is entitled to relief under Section 27(2) and Section 106 of the Act which is governed by principles of Common law.

The Court relied upon the landmark judgment of Monetary Overseas v. Montari Industries Ltd. and reiterated that “When a defendant does business under a name which is sufficiently close to the name under which the plaintiff is trading and that name has acquired a reputation and the public at large is likely to be misled that the defendant’s business is the business of the plaintiff, or is a branch or department of the plaintiff, the defendant is liable for an action in passing off.” [15]

• With regard to Issue No. 2, the Hon’ble Court relied on the US case Card Service International Inc. vs. McGee [16] , and held that the domain name serves the same function as a trademark and is hence entitled to the same protection.
• While discussing the impact of the disclaimer issued by the defendant, the Court held that it would not eliminate the problem because of the nature of Internet use. [17] The users might not be sophisticated enough to understand the slight difference in the domain name to distinguish between the two.

The Court addressed each of these issues and came to the conclusion that Yahoo Inc. had a good reputation in the market and that the name adopted by the defendants were deceptive and misleading causing damage to the reputation of the plaintiff and undue gain for the defendants. In consequence, the court granted an injunction in favour of the plaintiff under Rules 1 and 2 of Order 39 of CPC, 1908.

4. The Coca-Cola Company v. Bisleri International Pvt. Ltd. and Ors. [18]

This case is better known as the " MAAZA War case ". This was decided by the Delhi Court.

The plaintiff (Coca-Cola) is the largest brand of soft drinks operating in 200 countries whereas Defendant No1 earlier known as Acqua Minerals Pvt. Ltd. used to be a part of the Parle Group of Industries. The owners of Bisleri had sold the trademarks, formulation rights, know-how, intellectual property rights, and goodwill etc. of their product MAAZA amongst others to the plaintiff by a master agreement.

In March 2008, when the plaintiff filed for registration of the MAAZA trademark in Turkey, the defendant sent a legal notice repudiating the Licensing Agreement thereby ceasing the plaintiff from manufacturing MAAZA and using its trademarks etc. directly or indirectly, by itself or through its affiliates. In consequence, the plaintiff claimed permanent injunction and damages for infringement of trademark and passing off. The plaintiff also alleged that the defendant had unauthorisedly permitted the manufacture of certain ingredients of the beverage bases of MAAZA to be manufactured by a third party in India. [19]

• Does the Delhi High Court have jurisdiction in the present case?
• Is there any infringement of the trademark or passing off?
• Is the plaintiff entitled to get a permanent injunction?

It was held that the Court had jurisdiction to decide the case if a threat of infringement exists. It was pointed out that an intention to use the trademark besides direct or indirect use of the trademark was sufficient to give jurisdiction to the court to decide on the issue. [20]

The court held that it is a well-settled position of law that exporting products from a country is to be considered as a sale within the country wherefrom the goods are exported and it amounts to infringement of the trademark.

The Court granted an interim injunction against the defendant from using the mark in India as well as in the export market to prevent the plaintiff from irreparable loss and injury and quashed the appeal by the defendant. [21]

5. D.C. Comics v. Towle [22]

This very interesting case is a recent landmark judgment in the field of copyright law.

Facts of the Case

DC Comics (DC) is the publisher and copyright owner of comic books featuring the story of the world-famous character, Batman. Originally introduced in the Batman comic books in 1941, the Batmobile is a fictional, high-tech automobile that Batman employs as his primary mode of transportation. The Batmobile has varied in appearance over the years, but its name and key characteristics as Batman’s personal crime-fighting vehicle have remained consistent.

Since its creation in the comic books, the Batmobile has also been depicted in numerous television programs and motion pictures. Two of these depictions are relevant to this case: the 1966 television series Batman, starring Adam West, and the 1989 motion picture Batman, starring Michael Keaton.

Defendant Mark Towle produces replicas of the Batmobile as it appeared in both the 1966 television show and 1989 motion picture as part of his business at Gotham Garage, where he manufactures and sells replicas of automobiles featured in motion pictures or television programs for approximately “avid car collectors” who “know the entire history of the Batmobile .” Towle also sells kits that allow customers to modify their cars to look like the Batmobile , as it appeared in the 1966 television show and the 1989 motion picture.

DC filed this action against Towle, alleging, among other things, causes of action for copyright infringement, trademark infringement, and unfair competition arising from Towle’s manufacture and sale of the Batmobile replicas. The district court passed a summary judgment in favour of DC.

Summary of Judgment

The main question for consideration is whether BATMOBILE is entitled to copyright protection. The Court of Appeal relied on a number of historical decisions in deciding this case. The court held that copyright protection extends not only to the original work as a whole but also to “sufficiently distinctive” elements, like comic book characters, contained within the work. [23]

Although comic book characters are not listed in the Copyright Act, courts have long held that, as distinguished from purely “literary” characters, comic book characters, which have “physical as well as conceptual qualities”, are copyrightable. [24] The court relied on the judgment in Hachiki’s case [25] where it was held that automotive character can be copyrightable. Moreover, it has been held that copyright protection can apply for a character even if the character’s appearance changes over time. [26]

The U.S. Court of Appeals for the Ninth Circuit, in this case, developed a three-part test for determining protection of a character appearing in comic books, television programs or films under the 1976 Copyright Act, independent of any specific work in which it has appeared and irrespective of whether it “lacks sentient attributes and does not speak” as explained above. [27]

The court held that the present case satisfied the three-part test DC had the right to bring suit because it had reserved all merchandising rights when it granted licenses for the creation of the 1966 Batman television series and the 1989 Batman film.

It was held that the 1966 program and 1989 film were derivative works of the original Batman comics and that any infringement of those derivative works also gave rise to a claim for DC, the copyright owner of the underlying works.

It was found that Towle’s replicas infringed upon DC’s rights hence the Court also upheld the District Court’s refusal to allow Towle to assert a laches defense on DC’s trademark claims because the infringement was found to be willful. [28]

The law relating to intellectual property is constantly evolving all around the world. Being a relatively new concept, there are many areas which still need development and protection of the laws. All the above-mentioned case laws have a wide impact on society. They have brought about major breakthroughs in IP law.

Originally Published: May 26, 2019

[1] AIR 2014 Bom 178

[2] www.manupatra.com

[3] LANDMARK JUDGEMENTS IN PATENT LAW, Available at http://www.talwaradvocates.com/landmark-judgements-patent-law/

[4] BAYER CORP. V. UNION OF INDIA, Available at http://www.indialaw.in/blog/blog/intellectual-property-rights/bayer-corp-v-union-of-india/

[5] 447 U.S. 303, 100 S. Ct. 2204 (1980)

[6] DIAMOND v. CHAKRABARTY (1980), Available at https://caselaw.findlaw.com/us-supreme-court/447/303.html

[7] 437 U.S. 584 (1978)

[8] Diamond v. Chakrabarty, Available at https://www.quimbee.com/cases/diamond-v-chakrabarty

[9] Hartranft v. Wiegmann, 121 U.S. 609, 615

[10] https://www.lexisnexis.com/lawschool/resources/p/casebrief-diamond-v-chakrabarty.aspx

[11] 1999(19) PTC 201 (Del)

[12] Anti-cybersquatting Consumer Protection Act (15 U.S.C. 1125(d))

[13] Hereinafter referred to as the ‘Act’.

[14] MANU/DE/0120/1999

[15] 1996 PTC 142

[16] 42 USPQ 2d 1850

[17] Jesus Vs. Brodsky, 46 USPQ 2d 1652

[18] MANU/DE/2698/2009

[19] www.lexquest.com

[20] Case analysis: Coca-Cola Co. Vs. Bisleri International Pvt. Ltd, Available at https://brandsandfakes.com/case-analysis-coca-cola-co-vs-bisleri-international-pvt-ltd/135/

[21] LANDMARK JUDGEMENTS IN TRADEMARKS LAW, Available at http://www.talwaradvocates.com/5-landmark-judgements-trademarks-law/

[22] MANU/FENT/2518/2015

[23] Halicki Films, LLC v. Sanderson Sales & Mktg, 547 F.3d 1213, 1224 (9th Cir. 2008)

[24] Walt Disney Productions v. Air Pirates, 581 F.2d 751 (9th Cir. 1978).

[25] Halicki Films, LLC v Sanderson Sales & Marketing, 547 F.3d 1213 (9th Cir. 2008).

[26] Toho Co., Ltd. v. William Morrow & Co., Inc., 33 F.Supp.2d 1206 (C.D. Cal. 1998)

[27] http://www.frosszelnick.com/dc-comics-v-towle

• Five Landmark Decisions in Indian Tort Law – by Tanishka Goswami (Opens in a new browser tab)
• Intellectual Property Rights

Fathima Mehendi

5th Year law student at National University of Advanced Legal Studies (NUALS), Kochi

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Case Studies

Collegiate Licensing

Follow on Biologics

InnoCentive

Museum Licensing

Smartphones

University Licensing

1. Collegiate Licensing

Intellectual property accounts for about 40% of the net asset value of all corporations in America. 1 One clear method of extracting value from these assets is by entering the licensing market for trademarks and copyrights which, globally, involves $100 billion per year. But the potential of this market is not limited to traditional firms and for-profit enterprises. Companies specializing in collegiate-sports licensing have been helping colleges and universities maximize revenue through licensing deals. Given that they are institutions that specialize in the creation and cultivation of knowledge and expression, colleges and universities should naturally be attuned to the potential that exists in these intellectual property-related activities. 

2. Follow-on Biologics

The rise of generic pharmaceuticals has resulted in large price reductions and numerous opportunities for large and small drug companies. Now, provisions in the new comprehensive health care law combined with a wave of patent expirations on major biologics are opening the door to companies interested in pursuing generic versions of brand-name biologics, known as follow-on biologics or biosimilars. Perhaps the best example is the case of Merck’s investment in and creation of a follow-on biologics unit, Merck BioVentures.

3. InnoCentive

Whether you call it “crowdsourcing,” 2 “open innovation,” 3 or “the wisdom of crowds,” 4 the collaborative approach to innovation is becoming a force. It is an increasingly common tactic employed by businesses, individual inventors, and government bodies. After having set aside any sense of paranoia about protecting their intellectual property rights, these leaders are turning to customers, competitors, and even the public at large for inspiration in solving a host of technological and design problems.

More often, firms turn to companies like IdeaWicket , NineSigma , and Napkin Labs , all of whom act as innovation “middlemen” by connecting seekers with solvers. The best-known of these entities is InnoCentive , a company founded within Eli Lilly in 2001 that became independent in 2005. InnoCentive strives to “help companies innovate better, to find the fastest path to solutions.” 5 Firms that want to take advantage of InnoCentive’s services first post a project by constructing a detailed list of their goals. Then, InnoCentive’s community selects projects to “solve” from among those listed. The result can be hundreds of ideas for the firm’s technological or design problems. 6 Prize money for the best ideas, which serves as an inducement for the problem solvers, ranges from $5,000 to $1 million. 7 The solvers come from 175 countries. More than one third have doctorates. 8

Dwayne Spradlin, president and chief executive of InnoCentive, says that, for many companies, embracing open innovation requires a large cultural shift. 9 Two particular concerns are that companies that post information about their problems risk giving valuable information to competitors, or that a solver will devise a useful solution but refuse to hand it over to the organization that initially sought it. 10 So far, neither concern has materialized. 11 In fact, InnoCentive appears to have been remarkably successful. Giants like Procter & Gamble and even the United States government have turned to the InnoCentive community for help in solving their problems.

4. Museum Licensing

Given that intellectual property accounts for about 40% of the net asset value of all corporations in America, 12 for-profit entities have frequently had to contend with intellectual property-related issues. However, non-profits with a connection to knowledge and ideas, such as museums, can also benefit tremendously from seriously considering their approach to intellectual property. These institutions are akin to the media companies, software firms, and biotechnology entities that have such strong interests in intellectual property in the for-profit context. Though it may seem counter-intuitive, an open intellectual property strategy may be more beneficial to museums than to for-profits in the information business, because the mission of cultural heritage organizations extends beyond revenue creation to include preserving and disseminating ideas, expression, and knowledge. The examples in this case study demonstrate how licensing and branding can benefit museums, licensees, and the public at large.

5. Smartphones

The stories of Research in Motion and Apple provide examples of the benefits of a smart intellectual property strategy, as well as the litigious nature of the smartphone industry. An increasingly crowded smartphone market is also raising the attractiveness of the patent-licensing business model employed by firms like Qualcomm and InterDigital.

6. Starbucks

Each year, the world produces about 7 million tons of coffee. 13 Together, we drink 500 billion cups of coffee annually. 14 The potential for profits to be derived from this massive coffee trade are obvious. The money to be gained (or lost) as a result of the intellectual property strategies employed by the multi-national coffee purchasers, and the coffee-producing countries that supply, them is less obvious. This case study examines the dispute over the right to use the term “Sidamo” in describing coffee products between the Government of Ethiopia and the coffee giant Starbucks.

7. University Licensing

The patenting of university research can be big business. In 2007, technology licensing revenues generated by the top ten universities alone accounted for nearly $1.5 billion. 15 These impressive revenues were built upon a strong foundation of university-based research and development. The National Science Board reported that US academic institutions spent $48 billion on research and development in 2006, accounting for 33% of total research nationally. 16 As the licensing-revenue numbers indicate, this laboratory research can resonate powerfully in our everyday lives. Large corporations like Google, Cirrus Logic, and Genentech have all based their products on university-licensed intellectual property. 17

The Cohen-Boyer patents for recombinant DNA rank among the most revered and lucrative academic licenses in U.S. history. These licenses were issued on a non-exclusive, rather than the conventional exclusive, basis. Despite the impressive returns that it has generated, the Cohen-Boyer IP strategy of non-exclusive licensing pursued by Stanford and the University of California at San Francisco (UCSF) in the 1980s and 90s has generally not been replicated in large part by universities throughout the United States. Instead, exclusive licensing has become the norm throughout US research universities. 18 This case study explores the incentive structures that characterize university settings through the lens of the Cohen-Boyer Patents.

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10 Landmark Cases on Intellectual Property Rights

Introduction.

Sir John Salmond has defined ‘Right’ as an interest recognized and protected by a rule of justice. It is an interest in respect of which there is a duty and the disregard of which is ‘Wrong’. 1

He further has explained that a ‘Legal right’ is an interest recognized and protected by rule of law and violation of which would be a ‘Legal Wrong’.

Now coming to Intellectual property rights; these are those ‘Legally Protected Exclusive Rights’ awarded to the creators for their intellectual creations. When these rights are violated then cases are filed to get legal remedy. In this article, have tried to gather 10 landmark judgments where intellectual property rights were infringed.

Types of Intellectual Property

Before diving any deeper we first need to know what does intellectual property means and what its types are. The World Intellectual Property Organization (U.N.) defines ‘Intellectual Property as the Creation of the mind, such as inventions; literary and artistic works; designs; and symbols, names, and images used in commerce. 2

The above definition gives an overall idea that intellectual properties are more than one and have different rights associated with them. Generally, there are 7 kinds of Intellectual property rights. They are patents, Copyright, Trademarks, Industrial Designs, Geographical Indications, Plant Varieties, and Semiconductor Integrated Circuits. For example, patents are issued for inventions while copyrights are given for literary and artistic works.

Landmark Cases on Intellectual Property Rights

Below is a list of landmark judgments on Intellectual property rights passed by the courts in India.

• Bajaj Auto Ltd. v.TVS Motors Comp. Ltd. (2010) Madras HC 3

This case relates to a controversy that had arisen over the unauthorized use of patented DTS-i technology. In this case, the plaintiff Bajaj Auto prayed for issuing a permanent injunction for stopping the defendant’s TVS Motors from using its patented technology in any form and had also sought damages from them. The issue here was related to using of twin spark plug technology inside the internal combustion engine by the defendant.

In this case doctrine of pith and marrow also known as the doctrine of equivalents was applied. The doctrine applies to situations where despite there is no apparent literal infringement been committed still, an infringement occurs due to the product or process infringing the patent has a structure or performs a function that is very similar and analogous to an element already been claimed in the patented invention and thereby performs same things in the same way as the patented element and achieves the same results.

A purposive construction was given to understand if the ‘novel feature’ constitutes ‘pith and marrow’ or not i.e. if the new feature constitutes claimed by the plaintiff in their patent is an essential feature of the invention or not.

This case is also important because in this case the apex court has made several observations and made certain directions regarding the speedy disposal of cases related to intellectual property. The Supreme Court has directed to hear intellectual property cases on a day-to-day basis and to decide the cases within 4 months from the date on which they were filed.

2. Novartis v. Union of India (2013) SC 4

In this case, Novartis Pharmaceutical Company has applied for patenting a drug ‘Gleevec’ which was rejected by the Indian patents office. Novartis challenged all the rejections in the apex court.

It was held by the Supreme court that the substance that was sought to be patented by Novartis was a modification of an already known drug that was in the public domain since 1993 thus it lacks novelty requirement under patent law. As well Novartis has also not shown any evidence of any therapeutic efficacy of its modified medicine over the already existing drug which is a mandatory condition under section 3 (d) of Patents Act, 1970.

The court thus held that there was no invention done and a mere discovery of an already existing drug does not amount to invention. The application was accordingly dismissed by the court.

3. F. Hoffman-La Roche Ltd. v. Cipla Ltd. (2012) Delhi HC 5

This case has arisen over a dispute where Cipla has filed a patent application for a generic drug ‘Erlopic’ which was manufactured using a polymorphic compound of Erlotinib Hydrochloride. While patent for Erlotinib Hydrochloride was already been given to another company Roche. Therefore, Roche has filed an infringement application against Cipla. But Cipla claimed that it had not used Erlotinib Hydrochloride in its medicine ‘Erlopic’ but had only used a polymorphic compound of Erlotinib Hydrochloride.

It was finally held that Cipla has infringed the patent of Erlotinib Hydrochloride granted to Roche as any preparation of a polymorphic compound of Erlonitibactually first does involve the manufacturing of Erlotinib Hydrochloride. The patent application of Erlotinib Hydrochloride also has stated that its compound form can exist in different polymorphic forms and any such forms will be covered by its patent.

4. Bayer Corporation vs Union of India (2014) Bombay HC 6

Bayer Corporation patented a cancer medicine ‘Nexavar’. Indian patent office exercised its rights and granted a compulsory license of Nexavar to Natco Pharma. Ltd. for producing a generic version of it. The patent office has also directed Natco to pay royalties to Bayer, to donate 6000 free medicine to the public, to manufacture the medicine locally, and to sell the medicine only in India and not to assign manufacturing of it to others.

Meanwhile, Bayer was manufacturing the same medicine for a comparatively higher price than what Natco offered to the public. Aggrieved by the patents controller’s decision Bayer moved to IPAB (Intellectual property appellate board) and filed an application which got rejected. Bayer now filed an appeal before the board which was also rejected.

Bayer Corp. then filed an appeal before The Bombay High Court which held that compulsory licensing of life-saving drugs falls within the right of the Indian patents office as well as the rule of making available of patented drugs at an affordable price for the general public should be maintained as per section 82(1)(b) under The Patents Act, 1970. The judgment passed by The Bombay High Court was later upheld by The Supreme Court.

5. Yahoo! Inc. v. Akash Arora &Anr(1999) Delhi HC 7

This case relates to unauthorized registration and use of internet domain names that are similar and identical to registered trademarks and service marks also known as ‘Cyber Squatting’.

In this case, the defendant was using a domain name ‘Yahoo India’ which was extremely identical to that of the plaintiff’s ‘Yahoo!’. It was held that the defendant’s ‘Yahoo India’ has the potential to confuse and deceive internet users into believing that both are the same and belong to the same ‘Yahoo!’. The court explained that a disclaimer in this regard by the defendant to make people aware is not sufficient and it is immaterial if the term ‘Yahoo’ has a dictionary meaning as over the years Yahoo! has already acquired ‘distinctiveness’ and ‘uniqueness’ as required under the trademark law. The High Court has also held that domain names on the internet are used by business groups for the same purpose as any trademark or service mark.

6. Clinique Laboratories LLC &Anr v. Gufic Ltd. &Anr. (2009) Delhi HC 8

This case relates to the infringement of trademark and passing off i.e. selling goods by falsely misrepresenting the goods to belong to some other.

In this case, Plaintiff had a registered trademark ‘Clinique’ and it came to know about a similar trademark ‘Derma Cliniq’ registered by the defendant. The plaintiff then filed a petition for cancellation/rectification before the Registrar of Trademarks. The plaintiff later filed an application before the court for an injunction regarding infringement of its trademark by the defendant and for restraining the defendant from passing off its goods as that of the plaintiff’s.

However, under section 124 (1) of The Trademarks Act, 1994 any suit for infringement should be stayed by the court till the cancellation/rectification petition is finally decided and disposed of by the Registrar of Trademarks. The plaintiff thus filed for a stay of the present suit and had sought permission to apply for removal of the trademark from the trademarks register which was registered by the defendant.

But, at the same time section 124 (5) of The Trademarks Act, 1994 makes a provision where the court has the authority to pass an interlocutory order. Thus, the court exercising this power held that it has the authority to pass interlocutory orders in the form of injunction, attachment of property, the appointment of a receiver, order for account keeping, etc. if is prima facie convinced of invalidity of a registered trademark.

The court held that identical and similar trademarks, though registered later; can be challenged by the owner of an earlier registered trademark. The court further held that pending rectification/cancellation petition or infringement suit the court is allowed to pass such interim orders as it deems necessary and proper. The court therefore upon being primarily convinced about the invalidity of the registration of the defendant’s trademark restrained the defendant from using its registered trademark till the disposal of a rectification/cancellation petition by the Registrar of Trademarks.

7. Star India Pvt. Ltd. v. Moviestrunk.com &Ors. (2020) Delhi HC 9

In this case, Plaintiff Star India was a film production and distribution company while the defendant owned online streaming websites. The case relates to unauthorized streaming of the plaintiff’s film on the defendant’s streaming website. The plaintiff filed a suit for infringement of copyright.

The Delhi High Court held the defendant liable for infringement of copyright of plaintiff work for streaming its copyrighted content without the knowledge and consent of the plaintiff. The Court granted injunction and damages and thus Plaintiff’s exclusive right to exploitation was re-ensured.

8. Marico Limited v. AbhijeetBhansali(2020) Bombay HC 10

In this case, the defendant who is a YouTuber and a social media influencer has made objectionable and disparaging comments on ‘Parachute hair oil’ in one of his videos and has used the parachute hair oil bottle in his video.

The plaintiff Marico Ltd. who is the owner of Parachute Oil Brand has applied for the removal of the video on the grounds that the YouTuber through his video has harmed the goodwill of the company and has also violated its trademark ‘Parachute’.

The court while interpreting Section 29 of The Trademarks Act, 1999 held that defendant has violated the exclusive trademark rights of the plaintiff by not seeking prior permission or consent of the plaintiff, and thus, the court ordered the removal of video.

9. Bajaj Electricals Ltd. v. Gourav Bajaj &Anr.(2020) Bombay HC 11

In this case, the plaintiff was a duly incorporated company and a part of Bajaj Group conglomerates of businesses and industries. The defendant was a person who had the word ‘Bajaj’ as title in his name. The defendant in his 2 electrical stores and website had used the name ‘Bajaj’. He has also used the expression ‘Powered by: Bajaj’ on his product labels.

The plaintiffs proved that their name has become a well-known mark over several decades and therefore only they are now entitled to use it and not the defendant or anybody else. The defendant claimed legitimate use of his name but, the plaintiffs also proved the malafide intention of the defendant over the use of the name on the labels of his products where he has tried to deceive people by using the name ‘Bajaj’ in such a way that made people believe as if his products are endorsed by The Bajaj Group.

The court agreed with the grounds raised by the plaintiffs and thus passed an interim injunction against the use of the trademark by the defendant on their products as well as in their domain name.

10. ISKON v. Iskon Apparel Pvt. Ltd. (2020) Bombay HC 12

The plaintiff ISKON has filed the case on infringement of its trademark by the defendant, where the defendant has used the word ‘ISKON’ on its products and has also passed off his brand. The plaintiff has also sought to get their trademark declared as a well-known mark.

It was held that the defendant has clearly infringed the trademark of the plaintiff and has also passed off his brand by deceiving people and giving them a false belief that its products are associated with the plaintiff. The court also held that plaintiff’s trademark has satisfied all the criteria to become a well-known mark.

• Page 281 Book: Studies in Jurisprudence and Legal Theory by Dr. N. V. Paranjape
• https://www.wipo.int/about-ip/en/
• https://indiankanoon.org/doc/248352/
• https://indiankanoon.org/doc/165776436/
• https://indiankanoon.org/doc/123231822/
• https://indiankanoon.org/doc/28519340/
• https://indiankanoon.org/doc/1741869/
• https://indiankanoon.org/doc/99626708/
• https://www.casemine.com/judgement/in/5e55cdc49fca193984fd7305
• https://indiankanoon.org/doc/79649288/
• https://indiankanoon.org/doc/101671569/
• https://indiankanoon.org/doc/83405343/

Written by  Naman  Practising Advocate at Patna High Court and student at Gujarat National Law University.

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Global Dimensions of Intellectual Property Rights in Science and Technology (1993)

Chapter: 13 biotechnology case study, 13 biotechnology case study.

GEORGE B. RATHMANN

I want to describe a bit of the history of the biotechnology field to give you a strong sense of the importance of this field, not just in itself but as a prelude to a new technology as it develops over the next century. I then relate that history to some questions that have been raised and finally relate my conclusions with respect to biotechnology to the objectives of the conference.

As rocky as the road for biotechnology was in the United States, what we see coming up on the world scene is much more difficult, much more serious. We desperately need a legal system to solve the problems, and it is our hope that there are ways of dealing with these issues.

The biotech era really dawned when Watson and Crick defined the structure of deoxyribonucleic acid (DNA). As with many world-shattering discoveries, this was simple and concise—a publication of one page outlining the structure of DNA ( Nature, April 25, 1953, p. 737). They also had the vision to say it would affect not only how we looked at deoxyribonucleic acid, but how we looked at life itself and our ability to understand living systems. There would be products, there would be opportunities, and there would be new insights that would be most important. All that was recognized in a one-page article.

As important and earth shaking as that was, from the standpoint of the commercialization of biotechnology, something nearly as important occurred on June 17, 1980, when the Supreme Court ruled that live organisms could be patented. It was well recognized as important at the time, but I think few

people realized how important it was for launching the commercialization of biotechnology.

In that patent, Dr. Ananda Chakrabarty, who was at G.E. at the time, claimed an organism that would digest oil. The invention was never commercialized, but it told the world that this field was going to be important and there were going to be commercial opportunities. An investment in trying to understand the biochemistry of life would pay off in the sense that the intellectual property could be protected. Within four months (October 14, 1980), the biotechnology company Genentech went public and jolted Wall Street with a rise in its stock price from $35 to $71 1/4. So it is clear that as of that date, biotechnology assumed increasing commercial importance.

At that time, in October 1980, I was looking at the opportunity to start a biotech company called Amgen and we were putting out a document that we hoped would raise $15 million. Partly because of Genentech's success, we were able to raise $19 million—with only a scientific advisory board, one employee, and promises for two future hires. So it certainly had a profound effect on whether Amgen would ever be. As a matter of fact, within a year, Amgen, Genetics Institute, Immunex, Genetics Systems, Chiron, and many others companies were formed. Within two years, more than 100 companies were formed as this era was launched.

Now, the Chakrabarty decision made it look simple: life forms were patentable. Genentech, Cetus and many others afterwards launched public offerings, recognizing the commercial potential that biotechnology would lead to new discoveries of valuable intellectual property, which could be protected by patents. In reality, it was not quite that simple and the launchings were not that consistent.

Venture capital funds vacillated quite a bit, although after 1980 there was a very substantial influx of venture capital ( Figure 13-1 ). There were periods when it went down, and periods when it went up. Although these look like gigantic numbers, remember it takes about a quarter of a billion dollars to bring a pharmaceutical product to market. It probably takes more than that to commercialize something important in agriculture, food, or other areas. So this flow of venture capital was actually inadequate to keep it going. Of course, the public made the difference, but it can be seen that this was not exactly a consistent, reliable source of funds, either.

If we smooth everything out, the market value of biotechnology stocks moved dramatically from 1980, when it was literally zero, to 1991, when it was more than $35 billion ( Figure 13-2 ). Those of us in the industry saw some very serious bumps in that curve. In 1987 some biotech companies lost 30-40 percent of the value of the company in a matter of a few days. When you finally smooth everything out, it looks a lot simpler and surer than it felt.

FIGURE 13-1 Venture Capital Disbursements in Biotechnology

Source: Venture Economics and Ernst and Young

Figure 13-3 shows the amount of capital raised through public stock offerings. In 1991, more money was raised in six months than for many years, and as a matter of fact, when the total figures came in for the year they exceeded $4 billion—equal to all the money that had been raised in the previous years since the launching of commercial biotechnology. Of course, the big news is $550 million in initial public offerings. Those are new companies whose survival may mean wonderful improvements to our lives around the world. At the same time they will be facing some of the rocky roads that the earlier companies faced. So we can see that it is not a steady, easy trip.

Product sales in the industry today have reached about $8 billion and are expected to reach $20 billion by the year 2000. That may be a very conservative figure. The drug industry worldwide by that time will be well over $200 billion, and biotechnology is contributing roughly half of the most important products today. By the time the year 2000 comes around, biotechnology-derived products could be even more important. Of course there should be many other parts of the biotech industry that are commercially interesting by that time.

FIGURE 13-2 Market Value of Biotechnology Stocks

FIGURE 13-3 Amount of Capital Raised Through Initial Public Offerings and Other Public Offerings

Source: Paine Webber and Ernst and Young

So we are looking at something of great importance to the economy of the country and to international trade, which is discussed below.

I was asked by the National Research Council to address several questions. The first was, What adjustments in intellectual property rights have been made? Well, of course, the first is the allowance of claims to living organisms. The United States certainly led the way there. It was a very important opportunity that organisms that produced a pharmaceutical material could be claimed in patents. We had something tangible to claim even if the product being produced was already known or already had been defined.

One of the things that has been evolving over the last few years, and certainly in 1987 had a pretty dismal outlook, is referred to as In re Durden . This case implied that just because you have a novel starting material on which you carry out a process to produce another material, the process is not automatically patentable. That case was often interpreted much more severely to mean that unless the process is highly inventive, mere novelty because of novel starting materials does not make it patentable. So it was not possible in 1987 to get claims to the process that was going to produce, for example, in Amgen's case, erythropoietin by using a novel organism.

Because inventors could not claim the process, they had a very serious problem. They could not invoke any rights at all against companies who used their organism overseas, produced the product, and brought it in. They did not have a final product claim; they did not have a process claim; and there was no mechanism for protecting against the direct theft of the organism overseas—copying it, or following the teachings of the patent, and then just shipping the product to the United States.

However, an evolution has occurred since then. Certainly, a lot of process claims have now been granted. There is a bill authored by Congressman Boucher that would give guidance to the Patent Office to make sure it issues those claims. Without those claims, the organism patent is meaningless with respect to overseas competition. What if the overseas country does not issue the organism patent? The organism has only one purpose—to produce the protein, so the inventor is left with no protection against importation. Amazingly enough, the inventor is protected from infringement in the United States by U.S. companies but is unable to stop foreign infringement and U.S. importation. The trade implications are clear.

This has been a very serious problem that is now being addressed. Yet there are still concerns from people who wonder if it is really "fair" to keep foreign companies from bringing their products into the United States. They ask, "Isn't that protectionism?" This a very strange interpretation of fairness. I think these inventions are clearly being copied and misappropriated by foreign companies. Changes may or may not move smoothly, but these issues should be resolved in the next few years, and more and more compa-

nies are availing themselves of the process protection, though some opportunities have been abandoned after In re Durden objections.

There have been great differences in the interpretation of the scope of claims. My initial discussion is limited to the United States because global issues have really only come into play in the least five years. Even in the United States, the scope of claims has been quite a difficult issue with which to deal. The questions stated are, If the claims are too broad, doesn't it mean we are inhibiting the diffusion of technology? If the claims are too narrow, doesn't it mean that the inventor really is disadvantaged? I could say a lot about that, but in actual fact I will cite the record. A Boston court in the United States leaned toward a pretty narrow interpretation of the claims. In a Delaware court, a jury decided that the Genentech case should be very broadly interpreted and cover structures quite different from the ones that were defined in the patent simply because all the rest were straightforward once the patent teachings were available. So these are still issues, but I think we will move toward a pretty clear understanding over the next few years.

The effect on biotechnology advancement has not been smooth even in this country. Patent uncertainty has encouraged second entrants, who then plead that since they made such a significant investment, believing they were not going to be prevented from manufacturing the product, the terms of the claims of the patents should be relaxed. This has certainly been an expensive mistake in many cases.

Major delays in issuance of patents have prevented some innovators from pushing their products as rapidly as they could, because they feared that they might never have coverage and once they proved the success of the product, it could be duplicated relatively readily. I think many of us in the business got a lot of encouragement from the Orphan Drug Act, because that act suggested that we at least could get six years of protection if we were the first to have a product approved for an orphan indication. If we never received adequate patent protection, we still might be able to recoup our investments, which was very comforting. There has been a lot of controversy about the Orphan Drug Act and whether it should serve as a kind of substitute for the Patent Act. Nevertheless, it helped an embryonic biotechnology industry raise money and sustain its early critical momentum.

Finally, patents played a key role in attracting pharmaceutical companies' investments. These were very important for some companies in the early days. Even though the pharmaceutical companies were not the innovators, they certainly helped support many new biotechnology companies and they clearly needed the confidence of patent exclusivity.

As stated in congressional testimony by Dr. P. Roy Vagelos, Chairman of Merck & Co., "To sustain their ability to discover and develop products which form the basis of American competitiveness, U.S. pharmaceutical

companies count on renewed government support ... in strengthening international protection of intellectual property rights." We can illustrate that perhaps even more significantly in the biotech industry.

For example, in 1986 a pharmaceutical product would cost about $94 million and take somewhere between 10 and 20 years before entering the market. Some kind of protection is certainly required before that kind of investment is made. The figure today is $240 million. That number has been challenged by Congress and looked at many ways by the Office of Technology Assessment (OTA); the latest OTA study says that costs may often be that high, although sometimes they may be lower. However, it does not require a lot of arithmetic to figure this out. The pharmaceutical industry in this country alone spends about $10 billion on R&D per year, and about 30 new products—30 new molecular entities—are approved each year. That comes out to be more than $300 million invested for each success.

In fact, there are at most only four or five new therapeutic products approved each year that are important and if you divide by that, you arrive at astronomical figures for important new therapeutics. Also, all this investment is required years before you can enter the market and start to get a return. So this certainly fits the pattern of something that requires protection, and patents look like the way to do it.

In 1986 the average development time of a new pharmaceutical product was 10 years. The interesting thing is that biotechnology has compressed that time. Because of the rational design of these products, their remarkable efficiency and safety profile, and the understanding and cooperation of the U.S. Food and Drug Administration, the average development time is about four to seven years today for biotechnology products, which is a big help. However, it is still a long time and a large investment.

So let us review how biotechnology was commercialized. What happened is not particularly logical, not what anyone would have deduced sitting around a table trying to decide what was going to happen. When a biotech company decided it wanted to launch a product, it had to build a company to launch the product. All the different stages and structures had to be built—the vectors and expression systems, purifications, scale-up, manufacturing, clinical testing, regulatory submissions, and marketing. Surprisingly enough, almost all of these things were in place in major pharmaceutical companies, yet almost every single important invention was done by independent biotechnology companies. That is the fact; that is what we have to deal with. How were they able to do all this, why would they be the first to do it, and was it effective? Is it not terribly inefficient to have to create a company for each new product? That is what was done.

Small, start-up biotechnology companies were responsible for many miracle drugs. For example, Amgen developed erythropoietin, and we now know that 10 milligrams per year, one-fiftieth of an aspirin tablet, will

prevent 20 or more transfusions for people that are deficient in erythropoietin—and there are many more. Chiron produced the answer to hepatitis C, which is something that has plagued society and challenged scientists for more than 30 years—a well-defined disease about which nothing could be done. Cetus discovered ways of amplifying genes. Individual inventors, individual small companies, are pioneering and finding important new molecules and insights that are changing the way medicine is practiced today. This was done in a way that perhaps was hardly predictable—small, independent companies got started and did this all on their own—but this is exactly what happened. Sometimes it occurred with the support of large companies, but none of the key innovations and developments throughout the field were made by the large companies.

As I said, it was a fairly rocky road. I think that is important. The fragility of a new technology and the need for immediate action are more critical than making long-range plans to do wonderful things over long periods of time. These companies are fragile and their viability is always in question. Their survival is in jeopardy at all times. Take 1989 as an example. Headlines blared, "Clouds gather over the biotech field." Interestingly enough, firms were stumbling on regulation and patent problems. The patent situation looked very confused at that time. It was very difficult again to get financing, and the feeling was that many companies would go out of business and some did.

If we look at the number of financings, we see what has faced this emerging technology—and will probably apply to every new technology—big financing surges, dry spells, big surges. The dry spell in 1984 and 1985 seemed to last forever. We learned it can take eight quarters before you see another chance to raise money. When 1987 came along, the stock market wilted, and 1988, 1989, and 1990—one after another—were all very bad years. Of course, 1991 salvaged a lot of companies, but those were dangerous times for fragile, embryonic businesses.

So some protection is required. There is no question that patent protection fits the need in terms of the large investment required over a long period of time. The question is always asked, however, whether keeping the inventions secret would work. Well, it doesn't. Once the gene has been described, it is trivial to produce the product. Even if the gene is not described anywhere, once the structure is out, once the product is available even in clinical trials, the structure can be determined and often easily duplicated at a much lower cost. The cost is even lower because the copier only has to copy winners. He does not have to duplicate the losers. The copier avoids the major investments that the innovator had to make.

So international protection becomes the issue today. The problems in obtaining worldwide protection are difficult. There are many countries that do not honor the patent system. Surprisingly, countries that do not have

strong patent systems (e.g., China, India, Argentina, Brazil) are not troublesome to the biotech field, although the pharmaceutical industry has expressed concern. However, international trade competition with countries that purport to have a patent system is a very serious issue.

For example, Japan is a strong competitor. In Japan, patent flooding surrounds innovator's patents. The Japanese patent office grants narrow patents instead of broad ones. I think it is pretty obvious to those in this industry that small companies need broad patents. If you are going to try to compete in the marketplace with giants, you had better know that you have some reasonable protection against obvious duplication or partial duplication. The Japanese system has not produced many biotechnology innovations and has not produced biotechnology companies. Our problems with the Japanese system are narrow patents, sometimes taking 10 or more years to issue, and patent flooding, which surrounds the inventor's contribution and forces him to join up with a large, entrenched Japanese company to survive.

To summarize, developing countries have concerned some industries, but they have not been competitive in biotechnology. Europe has awarded strong patents that afford U.S. innovators reasonable protection. Japan has been a very serious issue. Today we see two companies in Japan enjoying the products of Amgen—two products approaching a billion dollars in sales, at prices two to four times that of the products in this country, guaranteeing high profits. It is very easy to see what is going to happen over the long term. Those companies are going to be able to invade other countries in the field of biotechnology and be very active participants in trade.

The question then is, Can the United States dictate or influence international patent practices? Well, somehow it has to. This sounds unfair to some, but it is equally unfair to have misappropriation of intellectual property.

We know the history of what happened: Japan behind, Japan even, Japan ahead. The outlook is very serious. If we think back about that 20year period around the 1960s when U.S. patents were not being upheld, that may have been why it was easy for the Japanese to move in and take over the territory.

Now, for future challenges: The federal government's patenting of the genome was a hypothetical question until a short time ago. Would this be serious? It has now become a very practical question. The U.S. Patent Office is currently examining the NIH's application for patents on certain gene sequences. In the meantime, the Industrial Biotechnology Association has held discussions with Reid Adler of the National Institutes of Health (NIH), biotech executives and administration officials who are examining this issue. What should the NIH do with respect to all of these gene patents? A good start is to provide a forum between industry, NIH and other inter-

ested parties to see if we can understand whether these patents should be applied for, whether they should be issued, and if issued, how they should be handled.

Finally, can patents be issued faster? The U.S. Patent and Trademark Office's numbers on the average time of application pendency are very strange and not helpful. The Patent Office has always figured out ways to say it is doing things in two years when, in fact, there has not been a useful biotech patent that has taken less than four years, and usually five. If we cannot get meaningful numbers, I don't think the problem can be solved. I think the Patent Office is misleading all of us.

In terms of the conference objectives, I would like to close with these thoughts concerning a few final issues: First, with respect to international perception of the importance of intellectual property rights, the world acknowledges that the United States was the pioneer in biotechnology, and that it was done by risk capital, as well as federal support of R&D, originally. The positive contribution to human welfare is acknowledged worldwide. That does not mean that all the countries in the world want to give strong patent protection for biotechnology, which is a very difficult issue.

Second, with respect to biotechnology patents, in the United States, the road has been rocky but reasonably satisfactory. Worldwide protection will ultimately be critical. It is sad that this did not occur long ago. Because of this lack, we are seeing companies in foreign countries appropriating U.S. technology to get started.

Finally, with respect to conflict resolution, the most precious resource of a budding new industry or budding new technology is time. The solutions have to be time sensitive. Grandiose solutions that involve 60 or 70 countries, and take years and years, will mean that a lot of the companies will fail before the solutions are in place. I think people should be aware of that.

I would remind you of one last thing. This is an industry of small companies. If you look at the profile of public biotechnology companies, only 13 percent have more than 300 employees, and none have more than 2,000 employees. If we look at all biotech companies (publicly and privately held), there are only 3 percent with more than 300 employees. We are dealing with a very, very broad-based, small-company business and my remarks apply as well to my firm, ICOS, which we started within the last year, as well as to the largest biotech companies, which are still relatively small. These are the companies seeking patent protection. Strong protection can hardly ''disadvantage small companies" as some critics suggest.

As technological developments multiply around the globe—even as the patenting of human genes comes under serious discussion—nations, companies, and researchers find themselves in conflict over intellectual property rights (IPRs). Now, an international group of experts presents the first multidisciplinary look at IPRs in an age of explosive growth in science and technology.

This thought-provoking volume offers an update on current international IPR negotiations and includes case studies on software, computer chips, optoelectronics, and biotechnology—areas characterized by high development cost and easy reproducibility. The volume covers these and other issues:

• Modern economic theory as a basis for approaching international IPRs.
• U.S. intellectual property practices versus those in Japan, India, the European Community, and the developing and newly industrializing countries.
• Trends in science and technology and how they affect IPRs.
• Pros and cons of a uniform international IPRs regime versus a system reflecting national differences.

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A Casebook on the Enforcement of Intellectual Property Rights

4th edition.

Author: LTC Harms

Publication year: 2018

DOI: English

The fourth edition of this popular casebook is a valuable tool for judges, lawyers and law enforcement officials in the handling of intellectual property cases. It compiles case law related to IP enforcement from a wide range of courts and tribunals, providing a thorough analysis of common and civil law jurisprudence, underscoring similarities and, where appropriate, highlighting differences. It covers the most recent decisions on topical issues in common and civil law, and emphasizes the jurisprudence in the area of copyright and trademark rights.

Buy a paper copy

Other editions.

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عربي (2013)

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• L'application des droits de propriété intellectuelle - Recueil de jurisprudence [2ème édition - 2014]
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Corporate Kaijus Clash: 15 Famous Copyright Infringement Cases

What is Copyright Infringement

Infringement of copyright occurs when an individual unlawfully violates the exclusive rights bestowed upon a copyright proprietor, sans their authorization. These exclusive rights entail the freedom to duplicate, circulate, execute, showcase, and engender derivative works from a unique work of authorship.

Ideas are a nebulous concept, and legally protecting something intangible can result in an interesting chain of events, especially when big names and corporations are thrown into the mix. We'll delve into some historic courtroom battles over alleged copyright violations and look at some of the most high-profile cases ever brought by well-known plaintiffs.

Here are the 15 most famous instances of copyright infringement:

1. Whitmill vs Warner Brothers

Despite Hangover 2's success, its publisher, Warner Brothers, was sued by tattoo artist S. Victor Whitmill for using Whitmill's uncredited tattoo design without permission in the film and its promotional materials.

Despite Warner Brothers' claims that their use of the design was protected by the "fair use" policy, Whitmill pursued the case and sought a preliminary injunction that would have prevented the film from hitting theaters on schedule.

While the judge did rule against Whitmill's injunction request, he did agree that Whitmill still had a solid case and could pursue the lawsuit on other grounds.

An agreement was reached behind closed doors, and the film was released on schedule, thereby creating comedic history.

2.  Katy Perry vs Marcus Gray

Copyright infringement and the music industry go together like peanut butter and jelly, so it stands to reason that this sector accounts for the lion's share of high-profile cases.

Dark Horse, Katy Perry's 2013 smash single, was one of the year's biggest hits. Earning recognition for achievements like selling over 13 million copies worldwide, attracting billions of Youtube views, having the song performed live during the Super Bowl, and winning MTV's music awards for best female video music in 2014.

In spite of this, Marcus Gray, a rapper, sued Perry the same year, claiming that she had stolen the riff and beat from his song "Joyful Noise''. Legal representation for Katy Perry argued that Gray's statement is preposterous and that he is trying to hold "the basic blocks of music," which could harm all composers.

Damages for Gray's case were estimated at $2.78 million and were awarded to him by the court in 2019. The judge would overturn the initial decision, however, in 2020 after an appeal was submitted, claiming that there was simply insufficient evidence to support the case.

3. The Music Industry vs Napster

A young technical genius named Shawn Fanning developed a piece of software called Napster in 1999 when the internet was still in its infancy. It is a peer-to-peer file-sharing application that allows users to freely share and download music.

Suffice it to say, Napster caught the attention of the music Industry. Metallica's drummer Lars Ulrich filed a lawsuit against the developer of the software in 2000, alleging copyright infringement, unauthorized use of a digital audio interface device, and racketeering.

This is believed to be the first case in which a well-known artist has directly sued a peer-to-peer file-sharing software company. This caused a domino effect in which major record labels like A&M and others began suing Napster. The plaintiffs accused the software company of vicarious copyright infringement and were eventually found guilty in 2002.

To the public's chagrin, Napster was forced to close that year, apologized publicly, and paid up to $26 million in damages.

This incident served as the catalyst for some people's animosity toward Metallica.

Legal protection of something intangible such as an Idea can result in an interesting chain of events.

4. Vanilla Ice vs David Bowie & Queen

As the first hip-hop single to reach number one on the Billboard Hot 100, Vanilla Ice's "Ice Ice Baby" left an indelible mark on popular culture. However, one of its worst qualities is that it sampled the bass lines from Under Pressure, a hit song by Queen and David Bowie.

Vanilla Ice tried to defend himself from the lawsuit brought against him by Queen and David Bowie for the unauthorized use of their song by claiming that he had added a single note to the end of the riff to make it more unique, but this was deemed insufficient.

The case was eventually settled out of court for an undisclosed amount of money, with both Queen and Bowie receiving songwriting credit.

5. Apple vs Microsoft

There was once a time when the two tech giants squared off in court.

Apple filed a lawsuit against Microsoft in 1988, shortly after the release of Windows 2.0 , a significant upgrade to the original version. At the time, Apple accused Microsoft of plagiarizing the graphical user interface found on the Macintosh system without permission or a license.

This is where the case becomes interesting, as Apple did in fact grant Microsoft permission to use Macintosh's design elements in Windows. The mystery surrounding this part is that, for some reason, Apple's legal department did not receive the memo, after the release of Windows 2.0,

Apple was so taken aback by the suddenness of the legal proceedings that it skipped sending any sort of preemptive warning or threat.

As a result of this misunderstanding, the court ruled in favor of Microsoft in 1989, and although Apple attempted to appeal the decision multiple times, all of its efforts were unsuccessful.

6. Gucci vs Guess

In 2009, two of the fashion industry's most recognizable names squared off when Gucci sued Guess, alleging that the latter had violated several of Gucci's trademarks. Gucci had originally asked for $221 million in damages but settled for $4.1 million.

So why did that happen? The judge reasoned that Gucci's claim that it has repeatedly sent cease-and-desist letters to various parties over the years was a fatal flaw in the company's case.

These entities ranged from national corporations to small-time counterfeiters and infringers. With budgetary concerns and the fact that most of their evidence was speculative, Gucci's defense department has been stretched thin.

7. Starbucks vs Obsidian Group

Starbucks sued rival coffee chain Obsidian Group in 2016 for promoting its newest drink, the Freddoccino. Starbucks claimed that the name's similarity violates the copyright of their own popular iced coffee, the Frappuccino.

Despite Obsidian's efforts to assuage concerns by renaming their drink "the Freddo," Starbucks remained steadfast in their pursuit of the case, and the case has yet to be resolved as of mid-late 2022.

8. Art Buchwald vs Paramount Studios

In 1990, writer and comedian Art Buchwald sued Paramount, claiming that the studio stole his ideas from an abandoned project and turned them into the film's screenplay.

According to Paramount's defense, at the time, they paid their authors through the "Hollywood account," which means the screenwriters are paid based on how much profit the film made.

They stood firm in their claim that, despite gross revenue of $288 million dollars, the film produced no net profit, and thus they were not required to pay Buchwald. If this statement struck you as perplexing, the judge felt the same way.

He called Paramount's payment method "blatantly unethical and unconscionable" and ruled in Buchwald's favor, awarding him 900,000 dollars in damages.

9.  Star Wars vs Battlestar Galactica

For science fiction fans, 1977 was an interesting year. Twentieth Century Fox sued Universal Studios for infringement the same year that A New Hope was released and defined a generation.

Fox asserted that Battlestar Galactica, a science fiction series produced by Universal, was "too similar" to one of their flagship intellectual properties.

Universal Studio did not take this lightly and filed a lawsuit of its own, claiming that Star Wars stole ideas from older media, such as the 1972 film Silent Running.

Two years later, the case was resolved in favor of Battlestar Galactica. The franchise as a whole was not doing so well at the time, despite the positive publicity surrounding the movie. The original show had been canceled, and fans were flocking to see The Empire Strikes Back.

10. Apple vs Google

In 2010, as smartphones became increasingly important in our daily lives, Apple and Samsung went to court over Samsung's alleged violations of Apple's patents on several of its smartphone designs. Apple's main competitor was not Samsung per se, but rather the Android operating system developed by Google and used by Samsung and other manufacturers.

Partially because of a "Mobile Application Distribution Agreement," Google's legal team had to intervene to help Samsung.

Concurrently, Motorola filed one of the most publicized lawsuits in technology history, accusing Apple of intellectual property infringement. Motorola claimed that Apple violated their patents on 3G phone technology and other aspects of smartphone design, while Apple fired back by claiming that Motorola had infringed on their patents on a number of features.

The court was so frustrated by the fight that the judges threw out the case three times in 2012, on the grounds that neither party had enough implicated evidence and were told to settle out of court. 2012 was the year that Google bought Motorola.

Although Apple has never directly attacked Google, they appear to focus on third-party companies that sell Google's software products; nonetheless, Google appears to be adamant in defending its popular mobile software.

11. Bratz vs Barbie

Carter Bryant, the creator of Bratz, was previously employed by Mattel, the manufacturer of Barbie. During his time working at Barbie, he came up with the idea for Bratz, which he later sold to one of Mattel's biggest competitors, MGA Entertainment.

The new doll franchise debuted in 2001 and quickly became the plastic bombshell's biggest competitor.

Mattel sued both Bryant and MGA in 2008, claiming that Bryant's idea was stolen intellectual property. MGA countersued, resulting in the two doll manufacturers locking horns.

MGA accused Mattel of corporate espionage by having its employees trained in spying on its competitors and resorting to clandestine underhanded tactics, such as having its employees print fake business cards and use them to enter the private showrooms of its competitor.

The lawsuit concluded in 2013 with a verdict in favor of MGA and an award of $170 million in damages, but Mattel would file an appeal to overturn the verdict, causing both parties to walk away empty-handed.

12. Naruto vs Slater

Photographer David Slater left his camera unattended while photographing wildlife in a foreign reserve, leading to a court case involving copyright infringements involving both humans and animals.

A crested macaque named Naruto discovered the camera and started taking the now-famous "Monkey Selfies" that have been making the rounds online. Slater, after discovering the images in his camera, published the image and its context on the website Blurb.

People for the Ethical Treatment of Animals (PETA) took notice of the photo after it went viral and sued Slater, Wildlife Personalities Ltd., and Blurb for copyright infringement, arguing that the selfies violated Naruto's authorship rights. In response, Slater filed a motion to dismiss, and the judge quickly sided with Slater, finding that Naruto lacked standing under the Copyright Act.

13. Lana Del Ray vs Radiohead

Lana Del Rey once claimed that Radiohead sued her for allegedly plagiarizing the hit song "Creep" in her 2017 single Get Free. Warner/Chappell, Radiohead's publisher, denied suing Del Ray or taking legal action against her, but admitted requesting that she attribute Creep to "all writers."

In 2018, during a Lollapalooza performance in Brazil, Del Ray appeared to confirm that the alleged lawsuit is over by telling her audience, "Now that my lawsuit is over, I guess I can sing that song whenever I want, right?"

14. John Fogerty vs John Fogerty

In one of the strangest copyright cases ever litigated, a record label once sued an artist for sounding like himself in a song he had written and performed decades earlier. John Fogerty is a musician and songwriter who was a member of the band Creedence Clearwater Revival (CCR). He eventually left the group to pursue a solo career, and his efforts paid off during the 1980s.

However, that all changed when he released a song titled "The Old Man Down the Road," which was later sued by CCR's record label, Fantasy Records, for allegedly plagiarizing CCR's "Run Through the Jungle." That's right; John Fogerty was sued over a tune he composed himself.

The judge sided with Fogerty in the end, saying, "you can't plagiarize yourself," effectively ending any further discussion as to whether or not he plagiarized himself.

After Fogarty's victory, he filed a countersuit against Fantasy Labels to recover the money he had spent on the case. The case went all the way to the Supreme Court of the United States, where it was ultimately decided in favor of the plaintiff. The judge ruled that the circumstances of the case ran counter to the original intent of the copyright law, which was to safeguard creative endeavors and promote new ideas.

15. Youtube vs Viacom

Viacom sued YouTube for $1 billion in 2007 for "Brazen" copyright infringement for allegedly hosting over 150,000 clips of Viacom's television shows and owned properties on their website.

YouTube argued that it is not legally responsible for content that infringes on third-party copyrights because it is merely an online service provider. This side issue could become the case's deciding factor.

The judge issued an order requiring YouTube to turn over its internal communications logs and transcripts to Viacom for review. If not for one small detail, this evidence would be considered indisputable and Viacom would have won without a doubt. As part of a guerilla marketing campaign, Viacom hired 18 advertising firms to create "unofficial accounts" and upload them as random users before the trial began, an action that can be described as nothing less than a blunder.

Worse yet, Viacom had no idea which accounts belong to them, so they ended up suing the third party to remove content that they had uploaded themselves.

This gave YouTube new life, and they argued that it was unreasonable to remove any account without knowing whether or not it belonged to Viacom.

Since YouTube had no way of telling which accounts were infringing on copyrights, it had no way of stopping them. Viacom's case collapsed due to this minor oversight, and the judge ultimately sided with YouTube, potentially sparing the media conglomerate.

To take full advantage of your brand and to maintain its goodwill, businesses should keep an eye out for counterfeiters and monitor if someone else is engaged in copyright infringement and reaping the benefits from their brand, If you own a business and come across a situation where a 3rd party is infringing on your brand image for their own products, get in touch with us at [email protected] for a complimentary consultation on how we can protect you from such thefts.

Also read our article on Copyright Guide for Freelance Writers to learn how you can avoid infringing copyrighted material.

Click on the link for more information on UAE Copyright Law .

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National Research Council (US). Intellectual Property Rights and the Dissemination of Research Tools in Molecular Biology: Summary of a Workshop Held at the National Academy of Sciences, February 15–16, 1996. Washington (DC): National Academies Press (US); 1997.

Intellectual Property Rights and the Dissemination of Research Tools in Molecular Biology: Summary of a Workshop Held at the National Academy of Sciences, February 15–16, 1996.

• Hardcopy Version at National Academies Press

5 Case Studies

• Introduction

Each of the following cases involves an important research tool in molecular biology, and each was chosen to illustrate a form of protection of intellectual property and a pattern of development involving both the public and the private sector. For each case, we present background material and a summary of the discussion that raised issues peculiar to the case.

The ideal strategies for the handling of intellectual property in molecular biology are not always immediately obvious, as these case studies illustrate. For most, final decisions have not been made about how access to these research tools will be controlled. Such decisions might be modified in response to both scientific and legal developments.

• Recombinant DNA: A Patented Research Tool, Nonexclusively Licensed With Low Fees

The Cohen-Boyer technology for recombinant DNA, often cited as the most-successful patent in university licensing, is actually three patents. One is a process patent for making molecular chimeras and two are product patents—one for proteins produced using recombinant prokaryote DNA and another for proteins from recombinant eukaryote DNA. Recombinant DNA, arguably the defining technique of modern molecular biology, is the founding technology of the biotechnology industry (Beardsley 1994). In 1976, Genentech became the first company to be based on this new technology and the first of the wave of biotechnology companies, which in fifteen years has grown from one to over 2000.

The first patent application was filed by Stanford University in November 1974 in the midst of much soul-searching on the part of the scientific community. Stanley Cohen and Herbert Boyer, who developed the technique together at Stanford and the University of California, San Francisco (UCSF), respectively, were initially hesitant to file the patent (Beardsley 1994). Several years of discussion involving the National Institutes of Health (NIH) and Congress followed. By 1978, NIH decided to support the patenting of recombinant DNA inventions by universities; in December 1980, the process patent for making molecular chimeras was issued. The product patent for prokaryotic DNA was issued in 1984. The patents were jointly awarded to Stanford and UCSF and shared with Herbert Boyer and Stanley Cohen. The first licensee signed agreements with Stanford on December 15, 1981. As of February 13, 1995, licensing agreements had generated $139 million in royalties, which have shown an exponential increase in value since their beginning. In 1990–1995 alone, the licensing fees earned $102 million.

This case has three key elements. First, the technology was inexpensive and easy to use; from a purely technical standpoint, there were only minimal impediments to widespread dissemination. Second, there were no alternative technologies. Third, the technology was critical and of broad importance to research in molecular biology.

The technology was developed in universities through publicly funded research. The strategy used to protect the value of the intellectual property was to make licenses inexpensive and attach minimal riders. The tremendous volume of sales made the patent very lucrative. Every molecular biologist uses this technology. However, not all inventions are as universally critical. Only a few university patents in the life sciences, such as warfarin and Vitamin D, have been even nearly as profitable as the Cohen-Boyer patent. Clearly, had this technology not been so pivotal for molecular biology or had an equally useful technology been available, the licenses would not have been sold so widely and the decision to license the technology might have met with more resistance.

The Cohen-Boyer patent is considered by many to be the classic model of technology transfer envisaged by supporters of the Bayh-Dole Act, which was intended to stimulate transfer of university-developed technology into the commercial sector. Ironically, it presents a different model of technology than that presumed by advocates of the Bayh-Dole act (for discussion, see chapter 3 ). Lita Nelsen, director of the Technology Licensing Office at the Massachusetts Institute of Technology (MIT), noted that the premise of the Bayh-Dole Act is that exclusivity is used to induce development and that universities should protect their intellectual property because without that protection, if everybody owns it, nobody invests in it. ''The most-successful patent in university licensing, in the entire history of university licensing, is the Cohen-Boyer pattern which is just the reverse. It is a nonexclusive license. It provides no incentive, just a small tax in the form of royalties on the exploitation of the technology.''

The biotechnology boom that followed the widespread dissemination of recombinant DNA techniques transformed the way universities manage intellectual property. It also fundamentally changed the financial environment and culture of biological research.

Nelsen described two ways in which this patent was so successful in fostering the aims of the Bayh-Dole Act. First, it got the attention of biologists by showing the advantages of protecting intellectual property. Stanford earned respectability for the venture by involving NIH and discussing in a public forum how this technology could be disseminated in a way that would not impede research. Second, it got the attention of university chancellors. They began to see that licensing, patenting, and technology transfer might have some financial benefits for the university. Nelsen commented that "that went a little too far. Everybody was waiting for $100 million per year out of their technology transfer offices. Most of them did not get it, and most of them are never going to get it." In the meantime, technology transfer managers developed more experience and became professionalized. They began to learn how to decide what to patent, how to market technology, and how to close deals at reasonable prices and with reasonable expectations. And industry learned how to negotiate licenses with universities.

Nelsen concluded that the whole biotechnology industry came out of the Cohen-Boyer patent, not only because Cohen-Boyer developed gene splicing, but because universities learned how to do biotechnology and early technology licensing—even if the first example was paradoxical.

The decision to negotiate nonexclusive, rather than exclusive, licenses was critical to the industry. If the technology had been licensed exclusively to one company and the entire recombinant DNA industry had been controlled by one company, the industry might never have developed. Alternatively, major pharmaceutical firms might have been motivated to commit their resources to challenging the validity of the patent.

Nelsen noted that at most major universities, it has become standard in industry-sponsored research agreements that the university will retain ownership of any resulting patents but almost without exception will grant the sponsor a first option to an exclusive license. With the increase in university-industry partnerships this applies to more research than in past years. Moreover, the Bayh-Dole Act encourages universities to grant exclusive licenses to companies even if the research was publically sponsored. But as the next case study shows, even when a company holds exclusive rights to a fundamental technology, it might choose to disseminate the technology broadly.

• PCR and TAQ Polymerase: A Patented Research Tool for Which Licensing Arrangements Were Controversial

Polymerase chain reaction (PCR) technology presents an interesting counterpoint to the Cohen-Boyer technology. Both are widely used innovations seen by many as critical for research in molecular biology. However, the licensing strategies for the two technologies have been quite different, and they were developed in different contexts.

PCR allows the specific and rapid amplification of targeted DNA or RNA sequences. Taq polymerase is the heat-stable DNA polymerase enzyme used in the amplification. PCR technology has had a profound impact on basic research not only because it makes many research tasks more efficient, in time and direct cost, but also because it has made feasible some experimental approaches that were not possible before the development of PCR. PCR allows the previously impossible analysis of genes in biological samples, such as assays of gene expression in individual cells, in specimens from ancient organisms, or in minute quantities of blood in forensic analysis.

In less than a decade, PCR has become a standard technique in almost every molecular biology laboratory, and its versatility as a research tool continues to expand. In 1989, Science chose Taq polymerase for its first "Molecule of The Year" award. Kary Mullis was the primary inventor of PCR, which he did when he worked at the Cetus Corporation. He won a Nobel Prize for his contributions merely 8 years after the first paper was published in 1985, which attests to its immediate and widely recognized impact. Tom Caskey, senior vice-president for research at Merck Research Laboratories and past-president of the Human Genome Organization, attributes much of the success of the Human Genome Project to PCR: "The fact is that, if we did not have free access to PCR as a research tool, the genome project really would be undoable. . . Rather than bragging about being ahead, we would be apologizing about being behind."

Whereas recombinant DNA technology resulted from a collaboration between university researchers whose immediate goal was to insert foreign genes into bacteria to study basic processes of gene replication, PCR was invented in a corporate environment with a specific application in mind—to improve diagnostics for human genetics. No one anticipated that it would so quickly become such a critical tool with such broad utility for basic research.

Molecular biology underwent considerable change during the decade between the development of recombinant DNA and PCR technologies (Blumenthal and others, 1986). The biotechnology industry emerged, laws governing intellectual property changed, there was a substantial increase in university-industry-government alliances, and university patenting in the life sciences increased tenfold (Blumenthal and others 1986, Henderson and others). There was virtually no controversy over whether such an important research tool should be patented and no quarrel with the principle of charging licensing fees to researchers. The controversy has been primarily over the amount of the royalty fees.

Cetus Corporation sold the PCR patent to Hoffman-LaRoche for $300 million in 1991. In setting the licensing terms for research use of PCR, Roche found itself in a very different position from Stanford with respect to the Cohen-Boyer patent. First, it was a business, selling products for use in the technology. That made it possible to provide rights to use the technology with the purchase of the products, rather than under direct license agreements, such as Stanford's. This product-license policy was instituted by Cetus, the original owner of the PCR patents. An initial proposal to the scientific community by the president of Cetus for reach-through royalties—royalties on second-generation products derived through use of PCR—was met with strong criticism. Ellen Daniell, director of licensing at Roche Molecular Systems, noted that the dismay caused by the proposal has continued to influence the scientific community's impression of Roche's policy.

Roche's licensing fees have met with cries of foul play from some scientists who claim that public welfare is jeopardized by Roche's goals. Nevertheless, most scientists recognize that Roche has the right to make business decisions about licensing its patents. The fact that Roche had paid Cetus $300 million for the portfolio of PCR patents led some observers to think that Roche intended to recoup its investment through licensing revenues, a point that Daniell disputed. She pointed out that Roche's business is the sale of products and that licensing revenues are far less than what would be needed to recoup the $300 million over a time period that would be relevant from a business viewpoint. Daniell listed Roche's three primary objectives in licensing technology:

• Expand and encourage the use of the technology.
• Derive financial return from use of the technology by others.
• Preserve the value of the intellectual property and the patents that were issued on it.

Roche has established different categories of licenses related to PCR, depending on the application and the users. They include research applications, such as the Human Genome Project, the discovery of new genes, and studies of gene expression; diagnostic applications, such as human in vitro diagnostics and the detection of disease-linked mutations; the production of large quantities of DNA; and the most extensive PCR licensing program, human diagnostic testing services. Licenses in the last-named category are very broad; there are no upfront fees or annual minimum royalties, and the licensees have options to obtain reagents outside Roche.

Discussion about access to PCR technology centered on the costs of Taq polymerase, rather than on the distribution of intellectual property rights. Tom Caskey's view was that "the company has behaved fantastically" with regard to allowing access to PCR technology for research purposes. Bernard Poiesz, professor of medicine at the State University of New York in Syracuse and director of the Central New York Regional Oncology Center, agreed that he knew of no other company that had done as well as Roche in making material available for research purposes. But he also argued that the price of Taq polymerase is too high and has slowed the progress of PCR products from the research laboratory to the marketplace. Poiesz stated that the diagnostic service licenses "are some of the highest royalty rates I have personally experienced." He cited the example of highly sensitive diagnostic tests for HIV RNA, which he said are too expensive for widespread use, largely because of the licensing fees charged by Roche. 1 Caskey felt that Roche should have expanded the market by licensing more companies to sell PCR-based diagnostic products and profited from the expansion of the market, rather than from the semiexclusivity that it has maintained.

Nor are all university researchers satisfied with their access to Taq polymerase. Ron Sederoff commented that—in contrast to the human genomics field, in which funding levels are much higher than for other fields of molecular biology—many academic researchers do not find easy access to the technology. Several workshop participants noted that the high cost Taq polymerase made many experiments impossible for them.

What is the effect of the Cetus-Roche licensing policy on small companies? Tom Gallegos, intellectual property counsel for Oncorpharm, a small biotechnology company, stated that most small companies cannot afford the fees charged by Roche. He noted that the entry fee for a company that wants to sell PCR-based products for certain fields other than diagnostics ranges from $100,000 to $500,000, with a royalty rate of 15%. By comparison, a company pays about $10,000 per year and a royalty fee of 0.5–10% for the Cohen-Boyer license. The effect is an inhibition of the development of PCR-related research tools, with consequent reductions or delays in the total royalty stream and possibly litigation.

Sidney Winter, professor of economics at the Wharton School of Business, suggested that in asking whether the price of some technology is too expensive, one should consider "compared with what?" Compared with licensing and royalty fees for Cohen-Boyer, PCR might seem excessive. If one imagines that the cost of the PCR patent were financed by a tax on the annual US health-care expenditure which was about $1 trillion in 1995 (Source: Congressional Budget Office), that tax would be roughly equal to 0.03% and might be a price worth paying for the advances made possible by PCR technology.

During the workshop, several people distinguished between research tools that are commercial products and tools that have little market value but are important tools for discovery. In the case of PCR, the research tool is both a commercial product and a discovery tool. As such, it raises questions. Are the PCR patents an example of valuable property that would have been widely disseminated in the absence of patent rights? Is PCR an example of a technology that has been more fully developed because of the existence of patent rights? Daniell stated that Roche has added considerable value to the technology, in part through the mechanism of patent rights. There was vigorous discussion and disagreement as to whether the licensing fees justify the value added by Roche.

• Protein and DNA Sequencing Instruments: Research Tools to Which Strong Patent Protection Promoted Broad Access

This case study was selected because it provides a clear example of how patent protection promoted the development and dissemination of research tools. By most standards, this would be considered a successful transfer of technology. The possibility of automated, highly sensitive DNA and protein sequencers was developed in the public sector by Leroy Hood's group at California Institute of Technology (Cal Tech). However, it was only with the help of substantial private investment that these research tools were widely disseminated.

The ability to synthesize and sequence proteins and DNA revolutionized molecular biology; automating these tasks promised to consolidate the revolution. Indeed much of the achievement of the Human Genome Project is attributable to the development of automated sequencing instruments, which greatly reduced the time and cost needed to sequence DNA. Because the effects of genes depend on the proteins that they encode, protein sequencing has been a key step in deciphering gene function. Until automated sequencing instruments were widely available, only a few laboratories had access to this technology.

The prototypes for these instruments were developed in Hood's laboratory during the years 1970–1986. Over a period of six or seven years, the team of scientists assembled by Hood increased the sensitivity of protein sequencing instruments by a factor of about 100. That transformed a difficult and uncertain task into one that could be reliably accomplished with the minute quantities of purified proteins that so often limited the scope of the analysis. Hood's laboratory was the first to sequence lymphokines, platelet-derived growth factor, and interferons. After those successes, he was approached by many scientists who asked why the technology could not be made available to the whole research community. Since the middle 1990s, the technology has become widely available.

The broad availability of sequencing technology is due, in no small part, to Hood's perseverance in the face of widespread skepticism. His 1980 manuscript that described, for the first time, automated DNA sequencing was delayed by the journal Nature on the grounds that this technology sounded like "idle speculation." Hood wrote three or four proposals to NIH and the National Science Foundation but was unable to obtain funding for his instrumentation work. The bulk of the support for this technology came from the private sector, and even then companies were reluctant to invest in developing the sequencing instrumentation. He approached nineteen companies, all of which declined to support the development of the sequencers. Eventually, he obtained funding from Applied Biosystems (ABI), but even this support required difficult negotiations between Cal Tech and ABI. ABI insisted on, and received, an exclusive license. As Hood told it, the argument that convinced Cal Tech to support the arrangement was that "if the scientific community wants these instruments, it is our moral obligation to make them commercially available."

At the time of this workshop, ABI had sold more than 3,000 DNA sequencers and more than 1,000 protein sequencers worldwide (although some elements of the technology, such as peptide synthesis, were not protected by patents, most of the instrumentation was patented by ABI). Sequencing facilities that serve multiple investigators are now standard features at research universities. That is not to say that licensing of this technology has been without controversy. Cal Tech licensed the technology to ABI with the stipulation that ABI would sublicense it under what Cal Tech considered reasonable terms. A number of companies have argued that ABI's terms are not reasonable. As with PCR, the situation is complicated in that the primary licensee claims that its license fees reflect what it needs to charge to earn a reasonable return on its investment in developing the technology.

ABI is clearly the leader in the world market for DNA sequencers. But other companies, such as Pharmacia and LI-COR, have important market shares. LI-COR has established a niche in the market with its infrared fluorescence DNA sequencer; infrared light has low background fluorescence, which allows for the development of more robust, solid-state instrumentation than is possible with other DNA sequencing technology. LI-COR is typical of many small biotechnology companies in its reliance on its patent portfolio. Harry Osterman, director of molecular biology at LI-COR, noted that "DNA sequencing is more than just an instrument, it is a system. To make a viable product, all the disparate pieces need to be integrated. That makes for a challenging intellectual property and licensing exercise, unless you have the internal funds to do everything. You require instrumentation, software, chemistry, and microbiology." Patent protection allows a small company to negotiate cross-licenses, which are critical in systems technologies, such as sequencing instrumentation. It can provide an opportunity that a small company would not otherwise have to compete in a market.

One might argue that patent protection served both the large company (ABI) and the small company (LI-COR) in bringing their sequencing technology to the market. In the case of ABI, patent protection afforded them the opportunity to develop a complex system of technology in an orderly and efficient manner, as proposed by the prospect development theory presented by Richard Nelson in chapter 3 . In the case of LI-COR, patent protection of sequencing systems enabled it to negotiate the cross-licenses needed to develop its product fully. In both cases, private support has driven the development and dissemination of a research tool. The public and private sectors seem to have gained equally.

• Research Tools in Drug Discovery: Intellectual Property Protection for Complex Biological Systems

Research tools in drug discovery present an example of the difficulties in protecting intellectual property when technologies involve complex biological systems that lack discrete borders. The information is often broad and refers to general categories of matter, such as a class of neural receptors, rather than finite entities, such as the human genome, or specific techniques, such as PCR or recombinant DNA techniques. Controversies have emerged over broad patents, which some see as stifling research on and development of useful drugs and others see as critical to the translation of research knowledge into useful products. The focus of the discussion in the workshop was the tension between the dependence of small biotechnology companies on patents and the difficulties created when research on complex biological systems is restricted by a thicket of patents on individual components of the systems.

When research on a complex system—for example, receptor biology or immunology—requires obtaining multiple licenses on individual components of the system, the potential for paying substantial royalty fees on any useful application derived from that product can be daunting. "Royalty stacking" can swamp the development costs of some therapies to the point where development is not economically feasible. That is a problem particularly in gene therapy, where the most promising advances now are related to rare genetic diseases that present small markets.

Bennett Shapiro, vice-president for worldwide basic research at Merck Research Laboratories, argued that the central issue is not about patenting, but about access, about encouraging the progress of biomedical research. Problems can arise when access to related components of biological systems is blocked. For example, schizophrenia is often treated with compounds that suppress dopaminergic neurotransmission. Many such compounds, for example haloperidol, act nonspecificially and suppress the entire family of dopamine receptors. People who take those compounds for schizophrenia often develop other disorders some of which resemble Parkinson's disease, another disease involving the dopamine system. A rational approach to discovery of improved schizophrenia drugs would be to target specific dopamine receptors. But if different companies hold patents on different receptors, the first step on the path to an important and much needed therapeutic advance can be blocked.

Shapiro commented that when only one company starts along the path of discovering a particular type of drug, its chance of discovering it is very low. Merck supports only a tiny fraction of total biomedical research, and it benefits enormously from research going on elsewhere in the world. It is in Merck's interest to share the results of its research with the understanding that they can be even more useful if placed in the pool of worldwide research resources.

It is interesting to compare that perspective on drug discovery with the early history of radio and television, other examples of complex systems of which many components were patented individually. In chapter 3 , Richard Nelson noted that it was not until cross-licensing practices became widespread in the early development of radio and television that important advances that enabled broad access to the technology took place. When the intellectual property was sequestered in the hands of a few companies, the entire electronics industry remained sluggish. Of course, the progress of the industry overall must be balanced by the financial needs of individual companies. Shapiro noted that Merck has felt the need to become more energetic about patenting than it was years ago. For example, carrageenan footpad assays were used to develop non-steroidal anti-inflammatory drugs. The assays were in the public domain, and many companies used them to develop new drugs. Today, Merck would patent such an assay and use its patent position to trade with other companies for access to other research tools.

James Wilson, director of the Institute for Human Gene Therapy at the University of Pennsylvania, described his experience with the different ways in which patents on research tools are used. One is to block others from using the tools—to protect one's proprietary use—which he did not see as economical. Genetic therapy patents might not generate enough financial return to offset the investment costs. Wilson also suggested that genetic therapy patent files are only going to waste money in lawsuits brought against those patents. Second is to generate revenues for universities to support their infrastructures, although, as Lita Nelsen noted, most universities are not likely to earn much from patent revenues. The third is to barter so as to continue development without creating an economic disadvantage.

Like previous panelists, Larry Respess of Ligand Pharmaceuticals, argued that the chances of survival of a small biotechnology company would be slight without patents. He noted that the biotechnology industry is composed of small companies that have grown through venture capital and public offerings and that finance research through equity, not product revenues. The goal is to develop products and then evolve into an independent company.

Wilson also pointed to a dramatic increase over the last two to three years in the difficulty in transferring material between universities. Nelsen emphasized that university technology transfer managers are still learning. And many decisions of the US Patent and Trademark Office (PTO) are controversial and under close scrutiny by those charged with managing intellectual property.

In commenting that "it is hard to know what the proprietary landscape is going to be, but it will be complex, whatever it is," Wilson summarized many of the workshop participants' comments.

Changes in Biotechnology Strategies

Respess discussed how R & D strategies for biotechnology have changed over the last twenty years. The biotechnology industry was born in about 1975 by Genentech, and most of the companies that followed Genentech pursued a similar strategy. Their objective was to produce and sell therapeutically-active large protein molecules, which was made possible by the availability of the Cohen-Boyer technology. The strategy was to discover and try to patent a gene for such a protein; it was hoped that the gene could be used to express abundant quantities of the protein. Some of the early examples are insulin, growth hormone, erythropoietin, and the interferons.

The advantages of that approach were that everyone knew that the products would be useful and that recombinant techniques were efficient for production, compared with earlier techniques of extraction from cadavers and tissue. Another advantage—albeit not from a scientific viewpoint—is that it is easy to sell to the investment community; it was a simple, easily understood model. Respess described the raising of capital in the early days of biotechnology as "unbelievable. You could found a company and, within a relatively short time, go public and raise many millions of dollars." However, those days are now past, in part because of the intrinsic limitation of large protein molecules: they are expensive to produce and to deliver to patients (they must be delivered by injection). The drug targets that are easy to identify have already been exploited.

A newer biopharmaceutical strategy emerged—not to discover large proteins or other large-molecule drugs, but to find other therapeutically active small molecules. These are the traditional targets of pharmaceutical research, but a biopharmaceutical company uses modern biotechnology and insights from molecular biology to get to the ultimate target product more quickly and efficiently. This approach has several advantages. The drugs are conventional and can typically be given orally, as well as by injection; they are relatively easy to manufacture; and the Food and Drug Administration is very familiar with such drugs, which makes it easier to get a new drug approved. The problem from a small company's perspective, however, is that it takes a very expensive infrastructure. Ultimately, synthesizing small molecules means making many molecules, and medicinal chemistry is very expensive. You have a tool, but you do not have any products in hand.

• Expressed-Sequence Tags (ESTs): Three Models for Disseminating Unpatented Research Tools

An expressed-sequence tag (EST) is part of a sequence from a cDNA clone that corresponds to an mRNA (Adams and others 1991). It can be used to identify an expressed gene and as a sequence-tagged site marker to locate that gene on a physical map of the genome. In 1991 and 1992, NIH filed patent applications for 6,800 ESTs and for the rapid sequencing method developed by Craig Venter, who was a scientist at NIH. The PTO rejected NIH's application and when Harold Varmus became director of NIH, he decided not to appeal. But controversy caused by the initial patent application continued. In 1992, Venter left NIH to form The Institute for Genome Research (TIGR), a nonprofit company, and William Haseltine joined the newly established private company, Human Genome Sciences (HGS), a for-profit company that initially provided almost all of TIGR's funding. The focus of the controversy then moved from the public to the private sector, and it changed from an issue about patenting research tools to an issue of access to unpatented research tools. Like many other research tools, ESTs fill different roles and some of the controversy has involved disputes of the relative importance of ESTs for uses other than research.

Two factors have contributed to the controversy over intellectual property issues in this particular setting. First is the perception that some of the participants have been staking out intellectual property claims that extend beyond their actual achievements to include discoveries yet to be made by others. There is no question that ESTs constitute a powerful research tool. Questions about the patenting of ESTs have focused on the criteria of utility. ESTs are of limited value without substantial and nonobvious development. Initially a public institution, NIH, proposed to patent discoveries that both scientists and some representatives of industry felt belonged in the public domain. More recently a private institution, Merck, has assumed the quasigovernment task of sponsoring a university-based effort to place information into the public domain. While other private companies have provided funds for public sector research, such as in the Sandoz-Scripps agreement, these efforts have not been with the expressed purpose of putting information into the public domain.

This is a particularly interesting case study, in part because it began as a controversy over patents—over what could be patented, what should be patented and what would be the effect of patenting. It has evolved into a controversy over the dissemination of unpatented information and the terms on which that information will be made available.

Different firms have taken different approaches to the dissemination of these unpatented research tools, thus providing a natural experiment with which to study three models for disseminating the same sort of information. The models all arose in the private sector, and we can assume that although each firm adopted a different strategy, they had the same ultimate goal of maximizing the value that they could obtain from the information. Merck has put the information in the public domain, Human Genome Sciences (HGS) initially adopted an exclusive-licensing model, and Incyte adopted a broad licensing approach of offering nonexclusive licenses to its database to as many firms as would sign up. Putting information in the public domain limits opportunities to exploit it as a trade secret by controlling access to it. Patents, or the patent applications of private database owners, potentially limit the ability to use the information that is in the public domain if any patent rights are ultimately obtained.

• HGS. The strategy of HGS has been to form a major partnership with the pharmaceutical firm SmithKline Beecham (SKB) 2 , with which it agreed to provide a three year exclusive license to its EST database. SKB has sublicensed its rights to a major Japanese pharmaceutical company, Takeda Chemical, Ltd., and HGS also has 200 restricted-licensing arrangements with university researchers. The TIGR database contains a limited portion of the data created by HGS and all of the data created by TIGR before April 1, 1994 which is when TIGR stopped work on human cDNAs. TIGR provides two levels of access to its EST databases. At the first level, an investigator is allowed access to sequences that are owned by HGS that overlap or are identical with sequences already in the public domain and for which public databases are available. At the second level, investigators are allowed access to about 70,000 sequences that are not listed in the publicly available databases (Genbank or the European databases). To obtain the second level, an investigator must agree to disclose any invention that is made at any time after access is gained. Furthermore, HGS or the Institute for Genome Research (TIGR) must be allowed at least six months to negotiate a licensing agreement. 3 The public does not have access to the much larger HGS cDNA database.
• Merck. Merck is interested in using the information from ESTs for furthering its research efforts. The Merck Gene Index was established to fill a public-access gap and was developed in partnership with established genome centers. Sequencing is carried out at Washington University, and the data are handled at the Los Alamos Laboratories. The international databases are a direct source of the information. A biotechnology company has taken all the clones into its distribution system and will freely distribute its materials. Other institutions, such as TIGR and Genethon, have entered sequences into this public database.
• Incyte. Incyte's strategy has been to offer nonexclusive licenses to its database. As of the time of the workshop, six companies (Pfizer, Upjohn, Novo Nordisk, Hoechst, Abbott Laboratories, and Johnson & Johnson) have contributed in the aggregate, around $100 million, exclusive of contingency payments and royalty payments for access to this database. Even as the Merck data continue to be placed in the public domain, Incyte continues to sign up new subscribers; there seems to be continuing value for the subscribing firms to obtain access to one of the private databases. This strategy is interesting not only for what it says about the nonexclusive-licensing strategy but because this is the most current information as to the relative values of the private databases versus the public-domain database.

The Informational Value of ESTs Is Rudimentary

None of the participants disputed the value of ESTs as research information, but several commented on the rudimentary nature of the information. Having an EST in hand does not guarantee a practical strategy for obtaining the identity of the gene of which the EST is but a fragment. Furthermore, if the gene identified is unknown, there remains substantial investment in understanding its function. It has been successfully accomplished in many cases, and many specific strategies have been developed over the years for approaching this task. Nonetheless, it remains fraught with uncertainty. In 1995 the Human Genome Organization (HUGO) issued a statement on ''Patenting of DNA sequences'' arguing that the nature of sequence information is so rudimentary that to limit access to it is to impede development of medical advances.

Several uses have been suggested for genes and gene fragments to claim utility requirement for patent protections. They include the use of genes or gene fragments for categorizing, mapping, tissue typing, forensic identification, antibody production, or locating gene regions associated with genetic disease. However, each of those suggested uses may not be carried out without considerable further effort and additional biological information that is not inherent in the sequence alone. Many of the workshop participants concurred with the HUGO statement that without databases to provide further information, the informational value of ESTs themselves is very limited.

William Haseltine, CEO of HGS, noted that patent applications filed by HGS for ESTs involve considerably more than simply identification of the gene fragments and involve information about the stage of development and tissue type in which those genes are expressed. He further commented that the importance of the EST database is not simply that the fragments are identified, but that the database itself provides a high level of information.

The Value of ESTs Could Be Reduced by Limiting Access

Many of the workshop participants echoed the HUGO statement of concern that "the patenting of partial and uncharacterized cDNA sequences will reward those who make routine discoveries but penalize those who determine biological function or application. Such an outcome would impede the development of diagnostics and therapeutics." Both Harold Varmus and Gerald Rubin suggested that some researchers are likely to be discouraged from working on patented ESTs for fear that the patent holders would lay claim to their future discoveries, particularly discoveries about gene function, which are clearly of far greater biological utility than the identification of anonymous fragments and are more likely to have useful applications for human health.

Several previous reports have stated that research-tool claims should not be so broad as to block the discoveries outside of the patent (House of Commons Science and Technology Committee 1995, National Academies Policy Advisory Group 1995). No one at the workshop argued otherwise.

Fragile X syndrome, which is the most-common form of mental retardation, provides an example of how ESTs can contribute to human disease. The name refers to the fact that the X chromosome is easily broken. Caskey described how he, Steve Warren, and Ed Benustra used an EST to discover that the genetic defect involves multiple repeats of the nucleotide triple CGG. They went on to characterize the gene, and that provided the information necessary to develop what is now the most widely used diagnostic test for fragile X syndrome. When they made their discovery, the sequence information on the gene involved gave no information on function. It was investigators like Bob Nussbaum, and Dreyfus, at Philadelphia, who went on to identify the gene's function.

Caskey suggested that if speculative claims were permitted among a certain set of ESTs the rights of investigation to discover that gene would be denied.

James Sikella cited the example of the HIV patent, which is jointly held by the US and French governments. The patent has not been tightly restricted for investigational use. At the time of its filing, its sequence and functions were not described. Many discoveries about HIV have evolved from that sequence information, and Sikella noted that it would have been a disservice to the public if the sequence information had not been available as a general research tool.

The Human Genome Is Finite

As of this workshop, some 27,000–5,000 human genes were represented in the database. Humans are estimated to have about 80,000–100,000 genes, so that represents about one-fourth to almost half of the total. Tom Caskey predicted that as the database begins to be flooded with sequence information, there will be a higher stringency on patents and patent claims will be directed more toward functional aspects of the genes, rather than being primarily descriptive.

Caskey also described how the usefulness of the gene index has improved with the addition of more sequences. When the general location of a disease gene is known from genetic mapping, limited sequencing is an important strategy for finding the gene. By sampling the critical region, the small bits of sequences can be used to search for homologies in the gene sequence database. In this way, a previously sequenced gene or gene fragment can be identified as being located in a critical region. Such a gene is then a prime suspect for more detailed studies in those individuals carrying the disease. Initially, the success rate for this technique of finding disease genes in positionally cloned regions was only about 40%. As the size of the gene database increases, so does the success rate. This is, therefore, becoming a fast and facile method for identifying a disease gene in a critical region identified by genetic mapping.

Sikella suggested that the success of the Human Genome Project may be measured, in part, by how the knowledge that it generates benefits society. He emphasized the importance of making these benefits available in a cost-effective way.

The Advent of DNA Sequencing Presents Important Questions about Patentability

Leon Rosenberg commented that "although the debate seems to have cooled a bit, the issues surely have not been resolved." Tom Caskey of Merck and William Haseltine of HGS both commented that they have no quarrel with the current criteria for patents, but they express different views as how those criteria should be interpreted. Since the workshop, HGS has received patents on a number of ESTs with broader claims of utility than the initial EST patent applications filed by NIH in 1974. Whether this will influence the debate over ESTs is an open question. Caskey noted that after one has an EST, identifying the full length sequence cDNA is the obvious next step. And yet this rarely leads to precise knowledge of that gene's function. He predicted that the complete cDNA sequences might become the 1997 version of ESTs—that is, research tools which many people do not believe meets the full potential criteria of novelty, nonobviousness, and utility. Rosenberg suggested that "the biomedical research community has not yet truly grappled with the possibility that a large number of genes could be controlled by the rights of a relatively small number of parties who could not possibly hope to fully exploit their potential value." He suggested that if research tools are not made available to the scientific community and others, we will have to confront this issue directly, whether that requires changes in patent law or other equally drastic directions.

• Adams MD, Kelley JM, Gocayne JD, Dubnick M, Polymeropoulos MH, Xiao H, Merril CR, Wu A, Olde B, Moreno RF, Kerlavage AR, McCombie WR, Venter JC. 1991. Complementary DNA sequencing: expressed sequence tags and human genome project . Science 252(5013): 1651–1656. [ PubMed : 2047873 ]
• Beardsley T. 1994. Big time biology . Sci Amer. November: 90–97. [ PubMed : 7997867 ]
• House of Commons Science and Technology Committee. 1995. Human genetics: the science and its consequences , Vol.1. London, UK: House of Commons;
• National Academies Policy Advisory Group. 1995. Intellectual property and the academic community . London: The Royal Society. 65p.

Royalty rates refer to a charge based on the revenues earned by the licensee and are different from the up-front fees and annual minimum royalties referred to earlier. As a member of a not-for-profit institution, Poiesz was offered the choice between a 9% or 12% royalty rate, with the lower rate available to those who agreed to use Roche-manufactured DNA polymerase for their testing.

Takeda Chemical, Ltd., the largest Japanese pharmaceutical firm, is another partner. Since the workshop, HGS has directly licensed three other companies: Schering-Plough, Merck KGAA (a German company, not affiliated with US Merck), and Synthelabo (a French company).

After April 1, 1997, all of the original EST sequences in the HGS-TIGR databases completed by April 1994 will be publicly available with no restrictions.

• Cite this Page National Research Council (US). Intellectual Property Rights and the Dissemination of Research Tools in Molecular Biology: Summary of a Workshop Held at the National Academy of Sciences, February 15–16, 1996. Washington (DC): National Academies Press (US); 1997. 5, Case Studies.
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