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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 intermetanet 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.
Outcome:
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…
Background:
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).
Outcome:
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.
Background:
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.
Outcome:
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.
How this fits with legal precedent:
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.
Background:
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.
Outcome:
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).
How this fits with legal precedent:
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.
Favorite quotes from Opinion of the Court:
“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.
Background:
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.
Outcome:
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.
How this fits with legal precedent:
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.
Favorite quotes from Opinion of the Court and Dissenting Opinion:
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.
About RVL®
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.
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