Intellectual Property Law Commons^™

Unveiling The Patent Landscape Of Biologic Drugs, Michael D. Frakes, Melissa F. Wasserman

Northwestern University Law Review

It is undeniable that the escalating price of biopharmaceuticals is a critical issue, as high prices limit patients’ access to life-saving medications and strain our healthcare system. Biologics, or large-molecule drugs, which are revolutionizing modern healthcare, are significantly contributing to the escalating cost of prescription drugs. While biologic drugs represent only 2% of all U.S. prescriptions, they comprise close to 50% of net drug spending.

Policymakers have proposed a series of interventions to decrease drug prices that target the patent practices of pharmaceutical firms. Yet due to differences in law, we have a robust source of patenting information for small-molecule …

Reprioritizing International Patent Law, John R. Thomas

Georgetown Law Faculty Publications and Other Works

Over the past half-century, rapid technological change and globalization have reshaped innovation and intellectual property, yet the foundational international agreements anchoring the global patent system have remained essentially unchanged. The drafters of the Paris Convention for the Protection of Industrial Property and the Patent Cooperation Treaty (PCT) viewed these agreements as dynamic instruments that, through procedural coordination, would rationalize international patent administration. The Paris Convention has resisted reform for decades, however, while the PCT has failed to achieve its goals of reducing examination workloads and fostering worksharing among national patent offices. It now exacerbates the very inefficiencies it sought to …

Patent Pending: How The Current Patent Utility Requirement Hinders Biotechnological Innovation, Madison Drlik

Journal of Law and Health

The legal system is always playing catch up to adapt to new legal landscapes, doctrines, and technology; however, patent law needs help to compete with biotechnological research in the race towards innovation. Biotechnological research in the realm of human health and medicine often involves the use of therapeutic drugs. The field of healthcare biotechnology takes biological systems and processes and generates novel, creative solutions to a number of human health conditions. However, the translation process for a new drug, therapy, or process is long and expensive which requires investors to help the researchers and scientists move their creations from inception …

Assessing Patent Pledges: A Case Study In The Vaccine And Biopharma Space, Ana Santos Rutschman

Akron Law Review

No abstract provided.

Inconsistencies At The International Trade Commission And The United States Federal District Courts, Christine Dedoulis

Catholic University Journal of Law and Technology

This article will analyze Section 337 of the Tariff Act of 1930, under which the International Trade Commission (Commission) conducts unfair import investigations, as it applies to patent infringement cases. Further, this article will explore different outcomes regarding parallel litigation at the Commission and District Courts, including what remedies are available and the effect of duplicative and inconsistent determinations on the patentee. In light of these comparisons, this article will provide suggestions on how to minimize inconsistencies between the Commission and District Courts, with particular emphasis on determining if some middle ground exists and if a classification system could be …

The Invisible String: How Litigation Funders In Patent Suits Pose A National Security Risk, Cosette Mclaughlin

Fordham Intellectual Property, Media and Entertainment Law Journal

This Note will address why the Supreme Court should modify Rule 7.1 of the Federal Rules of Civil Procedure to require third-party litigation funding (TPLF) funders and agreements to be disclosed to the judge and the opposing party. This amendment would mitigate the national security risk posed by foreign adversaries acting through TPLF in patent suits by eliminating the veil of secrecy. The semiconductor industry acts as an illustration of the benefits of this modification.19 In addition, if TPLF funding were required to be disclosed to all involved, conflict identification would become significantly easier. Full transparency in patent litigation TPLF …

Design Patent Law's Three Little Words, Mark D. Janis

Indiana Law Journal

U.S. design patent law protects the visual characteristics of articles of manufacture. For many years, major manufacturers of athletic footwear have protected their visually iconic designs with design patents, fueling a global market valued at nearly $100 billion. Today, however, shoe design has arrived in the digital universe. Digital sneakers such as Gucci’s Virtual 25 and Nike’s “Our Force Ones” can be “worn” only in virtual worlds but have substantial real world economic value. Yet U.S. design patent law makes it difficult—some would say impossible—to protect those designs, on the ground that they do not satisfy the statutory requirement for …

Design Patent Infringement As Unfair Competition, Mark D. Janis

William & Mary Law Review

The rule for determining design patent infringement requires an assessment of substantial similarity through the eyes of an ordinary observer—similarity sufficient to induce the observer to purchase the infringing design supposing it to be the patented design. That test, which originates in the Supreme Court’s 1871 Gorham Manufacturing Co. v. White decision, is an anomaly. It is a patent infringement test framed in language that would be more at home in a trademark infringement or unfair competition case. Yet the Federal Circuit has insisted that design patent infringement is unlike trademark infringement or unfair competition, dismissing any kinship as superficial. …

Brief Of 30 Scholars Of Law, Economics, And Medicine As Amici Curiae In Support Of The Petition, Charles Duan

Amicus Briefs & Court Filings

Amici curiae are scholars of law, economics, and medicine, listed in the Appendix. Their interest is in the proper development of patent law in ways that best promote the interests of innovation access and the public interest.

Second-Guessing The Jury: The Federal Circuit's Flawed Take On Enhanced Damages In Halo V. Pulse, Dennis D. Crouch

Faculty Publications

This article critically examines the Federal Circuit's February 2025 decision in Halo v. Pulse, focusing on the court's approach to enhanced damages in patent infringement cases. The analysis identifies a fundamental tension between jury findings of willful infringement under a clear and convincing evidence standard and the district court's subsequent discretion to deny enhanced damages by essentially reconsidering the same evidence. The article argues that the Federal Circuit's affirmation of this approach undermines the Supreme Court's 2016 Halo decision, which sought to make enhanced damages more accessible in cases of egregious misconduct. By creating an artificial distinction between "willful infringement" …

Million-Dollar Mysteries: Recent Complex Patent Cases Lost To Rule 36, Dennis D. Crouch

Faculty Publications

This article examines the Federal Circuit's continued use of Rule 36 summary affirmances to dispose of complex patent cases without written opinions. Through analysis of eight recent Rule 36 cases decided in early 2025, the author demonstrates that sophisticated legal issues involving millions of dollars are being summarily affirmed despite presenting novel and important questions of patent law. The cases discussed involve design patent evidentiary standards, jury trial rights for hybrid legal-equitable claims, analogous art determinations, claim construction, written description requirements, and PTAB procedural issues. The author argues that while the court may be avoiding difficult cases with complex factual …

Patent Textualism, David O. Taylor

Faculty Journal Articles and Book Chapters

The Supreme Court today embraces textualism—the practice of interpreting legal text by reference to how an ordinary person would have understood that text at the time it was promulgated. Yet, when it comes to patent cases at the Court interpreting the statutory provision governing patent eligibility, textualism has rarely been used as an interpretive tool. This Article, besides highlighting this contradiction, will consider how textualism’s application to this foundational aspect of the patent statute would change patent law.

This Article will analyze the Supreme Court’s adoption of textualist principles in other fields and then evaluates the application of textualism to …

On Snow's Intellectual Property And Immorality, David O. Taylor

Faculty Journal Articles and Book Chapters

In this Essay, I consider the “why” and “how” of Professor Snow’s controversial, countercultural, important, and relevant position that immorality may result in the denial of intellectual property protection. First, I highlight how surprising it is that Professor Snow’s argument springs from the theories underlying intellectual property protection, rather than the theories underlying the morality and ethics he believes ought to be considered in determining intellectual property protection. No one (that I know, at least) goes to the Environmental Protection Agency seeking better regulations to protect the environment and uses the labor desert theory of property rights as an argument. …

The Timing Of Claim Construction: An Analysis Of Claim Construction Procedure And A Proposed Rule To Ensure Cost Effective And Timely Relief In Patent Infringement Cases, Timothy A. Richard

Catholic University Journal of Law and Technology

The federal government issues patents to encourage inventors to produce new and useful works and advance the state of the art.[1] The patent process is simple: in exchange for the right to exclude all others from making and using an invention for an established period, the inventor provides the government — and ultimately the public — with a full disclosure of how to make and use the invention.[2] Despite this full disclosure, the terms used in patent claims are subject to judicial interpretation during litigation.[3] Both the Supreme Court of the United States (“Supreme Court”) and the …

Expertise, Ideology, And Dissent, Paul R. Gugliuzza, Jonathan R. Nash, Jason Rantanen

American University Law Review

No abstract provided.

A Patent System For Temple Grandin, Andrew Chin

Touro Law Review

This article explores the intersection of neurodiversity and innovation through the lens of Temple Grandin’s contributions to livestock handling systems and her philosophical alignment with the U.S. patent system. Drawing on cognitive research by Simon Baron-Cohen, archaeological insights from Penny Spikins, and personal reflections, I argue that autistic cognitive styles—characterized by heightened “folk physics” aptitudes and visual thinking—have historically driven technological progress. Grandin’s patented inventions, motivated by sensory-based empathy for animals, exemplify how neurodivergent inventors seek to embed their conceptions of ethical utility into the nation’s technological infrastructure. The article critiques modern patent litigation trends, advocating instead for a system …

Patenting The Taboo: Sex, Drugs, And Abortion, Andrew Gilden, Sarah R. Wasserman Rajec

Faculty Publications

The patent system provides a surprisingly rich archive of the interplay between social norms and technological change. Patent law requires applicants to publicly disclose the novelty and usefulness of their inventions, thereby bringing to light areas of innovation that may have previously lived in the shadows. In other words, patent law encourages public disclosure of technologies that are taboo—developed and practiced in secret, for reasons such as social approbation, illegality, or religious sanctity. To obtain a patent for a taboo technology, patentees must establish their legitimacy as innovators while navigating cultural norms that are hostile to their fields of innovation. …

Patent Law: An Open-Access Casebook, Sarah Fackrell, Sarah R. Wasserman Rajec, Andres Sawicki

Faculty Publications

No abstract provided.

Design Problems, Mark P. Mckenna, Jessica Silbey

Faculty Scholarship

This Essay draws on our empirical research into designers and their work to investigate the limits of intellectual property law for achieving its goal of progress in the design context. We focus on two related aspects of our research and also address a pressing doctrinal question in design patent law. The two research questions we discuss are: (1) How do designers conceive of and solve design problems through innovative design practice?; and (2) How do designers incorporate human values of coherence, inclusivity, and sustainability in their process, imbuing their practice with a kind of politics? The related doctrinal question concerns …

Certainly Uncertain: An Analysis Of The Patent Eligibility Restoration Act Of 2023, Charles Duan

American University Business Law Review

Patentable subject matter eligibility has been a topic of major policy debate over many years, culminating in the recent introduction of a bill that would entirely overhaul current law. This article reviews the proposed legislation in view of its historical context, the purported need to reduce uncertainty, and the likely effects of the bill. Based on this analysis, the article concludes that the legislation is unnecessary, ill conceived, and likely to be harmful to scientific research, a variety of industries, and the public good.

Brief Of Law Scholars As Amicus Curiae In Support Of Appellees And Affirmance, Charles Duan

Amicus Briefs & Court Filings

Amici are law professors and scholars who focus their scholarship and teaching on intellectual property law, property law, regulatory law, and health law.2 They write to address the plaintiff’s, Novo Nordisk Inc., et al. (Novo), overarching contention that the Medicare drug price negotiation program constitutes an unconstitutional price control. Amici submit this brief to provide the Court with the historical and legal background regarding the constitutionality of government price negotiations and price regulations. The amici explain how Courts have historically ruled on these questions, as well as the far-reaching consequences that a ruling in Novo’s favor would have on the …

Formulating Public Pharma, Shweta Kumar

IPIPC Papers & Reports

In 2022, prices for both brand-name and generic drugs in the U.S. were nearly three times as high as prices in comparably industrialized nations, with the cost of insulin products in particular being nearly ten times as high. As a result, 3 out of 10 American adults cannot afford to take their medication as prescribed. Furthermore, in 2024 the U.S. experienced its worst drug shortage in over a decade, with more than 300 drugs in short supply. Generic drugs are particularly vulnerable to shortage, as manufacturers have poor economic incentives to produce drugs with slim profit margins. While the Biden …

Patent Your Passenger Pigeons: De-Extinction Technologies & Ramifications Of The Product Of Nature Doctrine, Tyler Brooks

William & Mary Environmental Law and Policy Review

Part I of this Note will provide a brief overview of the current methods and scientific breakthroughs that are actively being pursued by private actors (particularly the bioengineering company Colossal Biosciences) to make de-extinct creatures, establishing the crucial point that any technique used to create such an animal will inherently fall short of being able to replicate an extinct species with any one hundred percent accuracy. This section will then briefly speak as to why private actors are looking to invest in de-extinction technologies in the first place, setting out how de-extinction technologies might one day prove incredibly profitable for …

Brief Of 15 Scholars Of Law And Medicine As Amici Curiae In Support Of The Petition For Rehearing En Banc, Charles Duan

Amicus Briefs & Court Filings

The panel decision announces an over-expansive, ill-defned doctrine of inducement, in which well-pled allegations may be based on nothing more than ordinary marketing materials and mandatory labeling--even when those materials never recite or describe the claimed invention. This unprecedented and erroneous expansion of inducement liability leaves the law uncertain. It is now unclear, among other things, what statements a generic frm may make about its own product's equivalence and how much of the generic product's labeling information must be revised--assuming that such revisions are even regulatorily allowed--in order to avoid the risk of an inducement lawsuit.

Patent Law's Role In Protecting Public Health, Sean B. Seymore

Vanderbilt Law School Faculty Publications

Innumerable inventions implicate public health-including drugs, vac- cines, dietary supplements, and sewage treatment plants. Over the past cen- tury, the Patent Office and the courts have modulated the ability to obtain or enforce patents for these inventions-whether in response to a public health crisis or to protect the credulous public from unscrupulous inventors. While normative and policy-based arguments can justify these interventions, they've disrupted the delicate balance of two competing policy objectives in patent law- enhancing public welfare and promoting innovation. This Article offers a new approach for courts to protect public health in patent cases-by making public health an …

A New Approach To Patent Reform, Janet Freilich, Michael J. Meurer, Mark Schankerman, Florian Schuett

Faculty Scholarship

Scholars and policy makers have tried for years to solve the tenacious and harmful crisis of low quality, erroneously granted patents. Far from resolving the problem, these determined efforts have resulted in hundreds of conflicting policy proposals, failed Congressional bills, and no way to evaluate the policies’ value or impact or to decide between the overwhelming multiplicity of policies.

This Article provides not only new solutions, but a new approach for designing and assessing policies both in patent law and legal systems more generally. We introduce a formal economic model of the patent system that differs from existing scholarship because …

Remembering Dr. Dmitry Karshtedt As A Scholar And Friend, Jonas Anderson, Sean Seymore, Timothy R. Holbrook

Sturm College of Law: Faculty Scholarship

Professor Dmitry Karshtedt was one of the preeminent patent law scholars of the past decade. Professor Karshtedt’s scholarship influenced the way that the Supreme Court thinks about patent law’s enablement doctrine. His work exploring the boundaries between patent law and tort law led to significant change in various areas of patent law. His work on nonobviousness changed the conversation about patent law’s most important doctrinal area. This article pays homage to Professor Karshtedt’s influential scholarship, illuminating his profound impact on the field while offering a glimpse into the enduring friendship shared by the authors and Professor Karshtedt.

Access To Justice For Black Inventors, Jordana R. Goodman, Khamal Patterson

Vanderbilt Law Review

To receive a patent, an inventor must meet certain inventive and procedural standards. Their invention must be novel, nonobvious, and written in such a way that any person skilled in the inventive subject can make and use the invention without undue experimentation. This process is far from objective.

An inventor is not always communicating within their own social circle. An inventor is required to communicate their invention so that a patent examiner believes a person having ordinary skill in the art ("PHOSITA") would recognize the invention as nonobvious. Moreover, a fictitious skilled person must be able to make and use …

Remembering Dr. Dmitry Karshtedt As A Scholar And Friend Remembering Dr. Dmitry Karshtedt As A Scholar And Friend, Jonas Anderson, Sean Seymore, Tim Holbrook

Utah Law Faculty Scholarship

Professor Dmitry Karshtedt was one of the preeminent patent law scholars of the past decade. Professor Karshtedt’s scholarship influenced the way that the Supreme Court thinks about patent law’s enablement doctrine. His work exploring the boundaries between patent law and tort law led to significant change in various areas of patent law. His work on nonobviousness changed the conversation about patent law’s most important doctrinal area. This article pays homage to Professor Karshtedt’s influential scholarship, illuminating his profound impact on the field while offering a glimpse into the enduring friendship shared by the authors and Professor Karshtedt.

Seed Patents: Enabling Innovation Beyond Biological Deposits, Ellaina Sanders

American University Law Review

In J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred International, Inc., the Supreme Court held that new sexually reproducing plant varieties are patentable subject matter. This allowed breeders and seed companies to protect their intellectual property in new seeds by obtaining utility patents so long as they meet the other statutory requirements, such as enablement. Unlike other intellectual property protection for new plant varieties, utility patents require the patent disclosure to include enough information that a person of ordinary skill in the art could make and use the invention without undue experimentation. In In re Wands, the Federal Circuit …