Law Commons^™

Is The Chemical Genus Claim Really “Dead” At The Federal Circuit?: Part Ii, Christopher M. Holman

Faculty Works

A 2020 law review article entitled The Death of the Genus Claim (“Death”) purports to document a dramatic shift in the Federal Circuit’s interpretation of 35 U.S.C. 112(a)’s enablement and written description requirements, particularly as applied to chemical genus claims. According to the authors of Death, it has become nearly impossible to obtain a chemical genus claim that will be upheld as valid in the face of a challenge for overbreadth under Section 112(a). Death was cited extensively in Amgens’s successful petition for certiorari in Amgen v. Sanofi, a case asking the Supreme Court to overturn the Federal Circuit’s decision …

Competition And Innovation: The Breakup Of Ig Farben, Felix Poege

Faculty Scholarship

The relationship between competition and innovation is difficult to disentangle, as exogenous variation in market structure is rare. The 1952 breakup of Germany’s leading chemical company, IG Farben, represents such a disruption. After the Second World War, the Allies occupying Germany imposed the breakup because of IG Farben’s importance for the German war economy instead of standard antitrust concerns. In technology areas where the breakup reduced concentration, patenting increased strongly, driven by domestic firms unrelated to IG Farben. An analysis of patent texts shows that an increased propensity to patent does not drive the effect. Descriptively, IG Farben’s successors increased …

Color Of Creatorship - Author's Response, Anjali Vats

Articles

This essay is the author's response to three reviews of The Color of Creatorship written by notable intellectual property scholars and published in the IP Law Book Review.

Sy-Stem-Ic Bias: An Exploration Of Gender And Race Representation On University Patents, Jordana Goodman

Faculty Scholarship

People of color and women are underrepresented in science, technology, engineering and math (“STEM”) fields in the United States. Through both intentional and unintentional structural barriers, universities continue to lose valuable intellectual resources by perpetuating a lack of gender, racial, and ethnic diversity as people climb the academic ladder. Identifying racial and gender disparities between university campus populations and their patent representation quantifies the qualitatively observed systemic racism and sexism plaguing STEM. Although many have written about racial and gender underrepresentation in STEM, no author has ever endeavored to simultaneously quantify the racial and gender gap at universities in the …

Homography Of Inventorship: Dabus And Valuing Inventors, Jordana Goodman

Faculty Scholarship

On July 28, 2021, the Device for the Autonomous Bootstrapping of Unified Sentience ("DAB US") became the first computer to be recognized as a patent inventor. Due to the advocacy of DAB US's inventor, Dr. Stephen Thaler, the world's definition of "inventor" has finally fractured - dividing patent regimes between recognition of machine inventorship and lack thereof This division has sparked many scholarly conversations about inventorship contribution, but none have discussed the implications of a homographic inventorship.

This Article addresses the implications of international homographic inventorship - where countries have different notions and rules concerning patent inventorship - and the …

Who Benefits?: How The Aia Hurt Deceptively Non-Joined Inventors, Jordana Goodman

Faculty Scholarship

Congress enacted the America Invents Act (“AIA”) to bolster economic development, sustain American innovation, and protect American jobs. This pro-business legislation, however, overlooked one actor critical to any successful innovation endeavor: the inventor. The AIA created access barriers, preventing inventors from efficiently and effectively seeking the entire remedy spectrum to which they are entitled. Paul Morinville and others have opined that the new first-to-file system put small inventors out of business, naming the AIA the single worst disaster in the history of the U.S. patent system. Beyond the filing and subject matter changes, the AIA created fundamental access to justice …

Reviewing Inter Partes Review Five Years In: The View From University Technology Transfer Offices, Cynthia L. Dahl

All Faculty Scholarship

With the implementation of the inter partes review (IPR) proceeding under the America Invents Act in 2012, university technology transfer offices (TTOS) were worried that the value of their patents might be irreparably harmed. With IPR proceedings making patent challenges easy, relatively inexpensive, and a threat extending over the lifetime of a patent, TTOs wondered if IPRs might do nothing short of undermining their licensing business model.

However, although IPRs have irreparably changed the patent infringement landscape outside of the university setting, the effect on university patents has not been nearly as severe. This chapter explores why that might be …

Frand And Antitrust, Herbert J. Hovenkamp

All Faculty Scholarship

This paper considers when a patentee’s violation of a FRAND commitment also violates the antitrust laws. It warns against two extremes. First, is thinking that any violation of a FRAND obligation is an antitrust violation as well. FRAND obligations are contractual, and most breaches of contract do not violate antitrust law. The other extreme is thinking that, because a FRAND violation is a breach of contract, it cannot also be an antitrust violation.

Every antitrust case must consider the market environment in which conduct is to be evaluated. SSOs operated by multiple firms are joint ventures. Antitrust’s role is to …

Diffusing New Technology Without Dissipating Rents: Some Historical Case Studies Of Knowledge Sharing, James Bessen, Alessandro Nuvolari

Faculty Scholarship

The diffusion of innovations is supposed to dissipate inventors’ rents. Yet in many documented cases, inventors freely shared knowledge with their competitors. Using a model and case studies, this article explores why sharing did not eliminate inventors’ incentives. Each new technology coexisted with an alternative for one or more decades. This allowed inventors to earn rents while sharing knowledge, attaining major productivity gains. The technology diffusion literature suggests that such circumstances are common during the early stages of a new technology.

The "Evergreening" Metaphor In Intellectual Property Scholarship, Erika Lietzan

Faculty Publications

This article is a plea for changes in the scholarly dialogue about "evergreening" by drug companies. Allegations that drug companies engage in "evergreening" are pervasive in legal scholarship, economic scholarship, medical and health policy scholarship, and policy writing, and they have prompted significant policymaking proposals. This Article was motivated by concern that the metaphor has not been fully explained and that policymaking in response might therefore be premature. It canvasses and assesses the scholarly literature-more than 300 articles discussing or mentioning "evergreening." It catalogues the definitions, the examples, and the empirical studies. Scholars use the term when describing certain actions …

Automation And Predictive Analytics In Patent Prosecution: Uspto Implications And Policy, Tabrez Y. Ebrahim

Faculty Scholarship

Artificial-intelligence technological advancements bring automation and predictive analytics into patent prosecution. The information asymmetry between inventors and patent examiners is expanded by artificial intelligence, which transforms the inventor-examiner interaction to machine-human interactions. In response to automated patent drafting, automated office-action responses, "cloems" (computer-generated word permutations) for defensive patenting, and machine-learning guidance (based on constantly updated patent-prosecution big data), the United States Patent and Trademark Office (USPTO) should reevaluate patent-examination policy from economic, fairness, time, and transparency perspectives. By conceptualizing the inventor-examiner relationship as a "patenting market," economic principles suggest stronger efficiencies if both inventors and the USPTO have better information …

Ignorance Over Innovation: Why Misunderstanding Standard Setting Organizations Will Hinder Technological Progress, Kristen Osenga

Law Faculty Publications

On January 17, 2017, the Federal Trade Commission (FTC) sued Qualcomm Inc. in federal district court, alleging antitrust violations in the company's licensing of semiconductor chips used in cell phones and more. The suit alleges, in part, that Qualcomm refuses to license its patents that cover innovations incorporated in technology standards (standard-essential patents, or SEPs), in contradiction of the company's promise to license this intellectual property on fair, reasonable, and nondiscriminatory (FRAND) terms. According to the FTC, Qualcomm's behavior reduces competitors' ability to participate in the market, raises prices paid by consumers for products incorporating the standardized technology, and at …

The Supreme Court’S Devaluation Of U.S. Patents, Christopher M. Holman

Faculty Works

In a span of three weeks during the spring of 2017, the U.S. Supreme Court issued three patent decisions, bringing the total number of patent decisions for the 2016-2017 term to six. This means that the October 2016 term ties the previous record of six patent decisions in the October 2014 term. This represents a tremendous increase in the number of patent decisions compared to earlier times, and particularly the early days of the Federal Circuit. For reference, during the first quarter of a century the Federal Circuit was in existence, the Supreme Court heard on average less than one …

In Defense Of Secondary Pharmaceutical Patents: Response To The Un's Guidelines For Pharmaceutical Patent Examination, Christopher M. Holman

Faculty Works

In 2015 the United Nations Development Programme issued a document entitled Guidelines for Pharmaceutical Patent Examination: Examining Pharmaceutical Patents from a Public Health Perspective (the “Guidelines”). The heart of the Guidelines is a category-by-category examination of eight types of “secondary” pharmaceutical patent claims: Markush claims; selection patents; polymorphs; enantiomers; salts; ethers and esters; compositions; doses; combinations; prodrugs; metabolites; and new medical uses. The Guidelines advise patent offices to apply heightened patentability requirements to these claims in a manner that would effectively deny patent protection to important pharmaceutical innovations currently afforded patent protection. In particular, the Guidelines postulate that many forms …

Manufacturing Barriers To Biologics Competition And Innovation, W. Nicholson Price Ii., Arti K. Rai

Articles

As finding breakthrough small-molecule drugs becomes more difficult, drug companies are increasingly turning to "large molecule" biologics. Although biologics represent many of the most promising new therapies for previously intractable diseases, they are extremely expensive. Moreover, the pathway for generic-type competition set up by Congress in 2010 is unlikely to yield significant cost savings. This Article provides a fresh diagnosis of and prescription for this major public policy problem. It argues that the key cause is pervasive trade secrecy in the complex area of biologics manufacturing. Under the current regime, this trade secrecy, combined with certain features of Food and …

Protecting Products Versus Platforms, Jacob S. Sherkow

Articles & Chapters

Patents have long been the most important legal assets of biotech companies. Increasingly, however, biotech firms find themselves on one side of a divide: as either traditional product companies or platform companies. Given the differences between these two types of business models, the merits of intellectual property (IP) protection vary between them. This article explores how those differences relate to biotech startups and entrepreneurs seeking to protect their inventions.

Describing Drugs: A Response To Professors Allison And Ouellette, Jacob S. Sherkow

Articles & Chapters

Profs. Allison and Ouellette’s Article, How Courts Adjudicate Patent Definiteness and Disclosure, 65 Duke L.J.609 (2015), on courts’ adjudication of certain patent disputes presents some surprising data: pharmaceutical patents litigated to judgment fare substantially worse on written-description analyses if they are not part of traditional pioneer-generic litigation. This Response engages in several hypotheses for this disparity and examines the cases that make up Allison and Ouellette’s dataset. An analysis of these cases finds that the disparity can be best explained by technological and judicial idiosyncrasies in each case, rather than larger differences among pharmaceutical patent cases. This finding contextualizes …

The Changing Life Science Patent Landscape, Arti K. Rai, Jacob S. Sherkow

Articles & Chapters

Over the past two decades, patent law in the life sciences has been buffeted by numerous controversies. With courts, legislatures and patent offices all responding, one could be forgiven for believing that the main constant has been change. In the following article, we look back at some of the major events in life science intellectual property (IP) law and business practice over the past 20 years and then suggest where IP practice in the life sciences may be heading in the coming years.

Stem Cell Patents After The America Invents Act, Jacob S. Sherkow, Christopher Scott

Articles & Chapters

Under the newly passed Leahy-Smith America Invents Act (AIA), the U.S. Patent and Trademark Office may hear new challenges to stem cell patents. Here, we explore how the new law affects challenges to stem cell patents, focusing on two recent cases, and discuss the future of stem cell patent disputes.

The History Of Patenting Genetic Material, Jacob S. Sherkow, Henry T. Greely

Articles & Chapters

The US Supreme Court’s recent decision in Association for Molecular Pathology v. Myriad Genetics, Inc. declared, for the first time, that isolated human genes cannot be patented. Many have wondered how genes were ever the subjects of patents. The answer lies in a nuanced understanding of both legal and scientific history. Since the early twentieth century, “products of nature” were not eligible to be patented unless they were “isolated and purified” from their surrounding environment. As molecular biology advanced, and the capability to isolate genes both physically and by sequence came to fruition, researchers (and patent offices) began to apply …

Researching The Early History Of The Patent Policy: Getting Started, Robert Berry

Librarian Publications

There are a lot of reasons to research the early history of American patent policy. It is an inherently interesting history that provides a framework making contemporary patent policy more comprehensible and a foundation for interpreting historic patent records. For students it provides an opportunity to become familiar with some of basic primary sources that are a staple of research into American history. Also, of course, questions may arise from time to time that can only be authoritatively answered by researching this history.

The approach described below seeks to balance comprehensiveness with feasibility, and emphasizes the importance of creating a …

Brief Of Amici Curiae Law, Business, And Economics Scholars In Alice Corp. V. Cls Bank, No. 13-298, Jason Schultz, Brian Love, James Bessen, Michael J. Meurer

Faculty Scholarship

The Federal Circuit’s expansion of patentable subject matter in the 1990s led to a threefold increase in software patents, many of which contain abstract ideas merely tethered to a general-purpose computer. There is little evidence, however, to suggest this expansion has produced an increase in software innovation. The software industry was highly innovative in the decade immediately prior to this expansion, when the viability of software patentability was unclear and software patents were few. When surveyed, most software developers oppose software patenting, and, in practice, software innovators tend to rely on other tools to capture market share such as first-mover …

Preliminary Injunctions Post-Mayo And Myriad, Jacob S. Sherkow

Articles & Chapters

The Supreme Court's recent interest in patentable subject matter has had several, unexpected downstream effects on preliminary injunctions in patent disputes.

The Supreme Court has recently expressed increased interest in patent eligibility, or patentable subject matter, the doctrine that limits the types of inventions eligible for patenting. Its two decisions, Mayo Collaborative Services v. Prometheus Laboratories, Inc., in 2012, and Association for Molecular Pathology v. Myriad Genetics, Inc., in 2013, represented the first broad restrictions on patentable subject matter in over thirty years. And later this term, the Court will decide yet another patent eligibility case: Alice Corp. v. CLS …

Toward A Closer Integration Of Law And Computer Science, Christopher S. Yoo

All Faculty Scholarship

Legal issues increasingly arise in increasingly complex technological contexts. Prominent recent examples include the Stop Online Piracy Act (SOPA) and the Protect Intellectual Property Act (PIPA), network neutrality, the increasing availability of location information, and the NSA’s surveillance program. Other emerging issues include data privacy, online video distribution, patent policy, and spectrum policy. In short, the rapid rate of technological change has increasingly shown that law and engineering can no longer remain compartmentalized into separate spheres. The logical response would be to embed the interaction between law and policy deeper into the fabric of both fields. An essential step would …

Competition For Innovation, Herbert J. Hovenkamp

All Faculty Scholarship

Both antitrust and IP law are limited and imperfect instruments for regulating innovation. The problems include high information costs and lack of sufficient knowledge, special interest capture, and the jury trial system, to name a few. More fundamentally, antitrust law and intellectual property law have looked at markets in very different ways. Further, over the last three decades antitrust law has undergone a reformation process that has made it extremely self conscious about its goals. While the need for such reform is at least as apparent in patent and copyright law, very little true reform has actually occurred.

Antitrust has …

Patent Value And Citations: Creative Destruction Or Strategic Disruption?, David S. Abrams, Ufuk Akcigit, Jillian Popadak

All Faculty Scholarship

Prior work suggests that more valuable patents are cited more and this view has become standard in the empirical innovation literature. Using an NPE-derived dataset with patent-specific revenues we find that the relationship of citations to value in fact forms an inverted-U, with fewer citations at the high end of value than in the middle. Since the value of patents is concentrated in those at the high end, this is a challenge to both the empirical literature and the intuition behind it. We attempt to explain this relationship with a simple model of innovation, allowing for both productive and strategic …

Exclusivity Without Patents: The New Frontier Of Fda Regulation For Genetic Materials, Gregory Dolin

All Faculty Scholarship

Over the last twenty years, the legal and scientific academic communities have been embroiled in a debate about the patent eligibility of genetic materials. The stakes for both sides could not be higher. On one hand are the potential multi-billion dollar profits on the fruits of research (from newly discovered genes), and on the other is scientists' ability to continue and expand research into the human genome to improve patients' access to affordable diagnostic and therapeutic modalities. This debate is currently pending before the Supreme Court, which is considering a petition for certiorari in Ass'n for Molecular Pathology v. U.S. …

Intellectual Property Misuse, Herbert J. Hovenkamp

All Faculty Scholarship

This book of CASES AND MATERIALS ON INNOVATION AND COMPETITION POLICY is intended for educational use. The book is free for all to use subject to an open source license agreement. It differs from IP/antitrust casebooks in that it considers numerous sources of competition policy in addition to antitrust, including those that emanate from the intellectual property laws themselves, and also related issues such as the relationship between market structure and innovation, the competitive consequences of regulatory rules governing technology competition such as net neutrality and interconnection, misuse, the first sale doctrine, and the Digital Millennium Copyright Act (DMCA). Chapters …

Competition In Information Technologies: Standards-Essential Patents, Non-Practicing Entities And Frand Bidding, Herbert J. Hovenkamp

All Faculty Scholarship

Standard Setting is omnipresent in networked information technologies. Virtually every cellular phone, computer, digital camera or similar device contains technologies governed by a collaboratively developed standard. If these technologies are to perform competitively, the processes by which standards are developed and implemented must be competitive. In this case attaining competitive results requires a mixture of antitrust and non-antitrust legal tools.

FRAND refers to a firm’s ex ante commitment to make its technology available at a “fair, reasonable and nondiscriminatory royalty.” The FRAND commitment results from bidding to have one’s own technology selected as a standard. Typically the FRAND commitment is …

Using Valuation-Based Decision Making To Increase The Efficiency Of China's Patent Subsidy Strategies, William Murphy, John L. Orcutt

Law Faculty Scholarship

[Excerpt] “The Chinese government has grown concerned that its patent fee subsidy programs have not funded the most deserving patents, and thus they no longer wish to spend public resources to promote low-value patents. Instead, the government would prefer subsidy programs that encourage the most deserving patents. The Patent Strategy reflects this desire, as the fourth strategic focus of the Patent Strategy recognizes the need to “[o]ptimize [China’s] patent subsidy policy and further define the orientation to enhance patent quality.”19 This Article explains how a disciplined and transparent valuation-based decision making process can help the Chinese government design patent fee …