Intellectual Property Law Commons^™

The Impact Of Uncertainty Regarding Patent Eligible Subject Matter For Investment In U.S. Medical Diagnostic Technologies, A. Sasha Hoyt

Washington and Lee Law Review

Historically, 35 U.S.C. § 101, the statute governing patent eligible subject matter, has been construed broadly—with its legislative history indicating that it should cover “anything under the sun that is made by man.” The Supreme Court crafted three exceptions to § 101: (1) abstract ideas, (2) laws of nature, and (3) natural phenomena. In recent years, the Supreme Court’s eligibility jurisprudence has further narrowed § 101 to effectively exclude meritorious medical diagnostic methods. Indeed, since the Court’s decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., the Federal Circuit has held every single diagnostic method claim brought before it …

Cannabis Derivatives And Trademark Registration: The Case Of Delta-8-Thc, W. Michael Schuster

Indiana Law Journal

The legal environment surrounding the cannabis industry is ambiguous and constantly changing. While cannabis is prohibited under federal law, a 2018 statute legalized a variant of the cannabis plant (“hemp”) that is low in its most common intoxicating agents. Recognizing this, entrepreneurs began to process hemp to extract and sell chemicals contained therein. Included in this trend is the extraction of Delta-8 Tetrahydrocannabinol (Δ8-THC)—a psychoactive drug with an increasing market presence in states where most cannabis (e.g., “marijuana”) is illegal.

As competition in the Δ8-THC field emerged, firms sought to distinguish their wares through brand recognition and federal trademark registration. …

Beyond Compulsory Licensing: Pfizer Shares Its Covid-19 Medicines With The Patent Pool, Chenglin Liu

Faculty Articles

On March 15, 2022, the United States, European Union, India, and South Africa reached an agreement on the waiver of intellectual property rights (IP rights) for COVID-19 vaccines. The waiver agreement has rekindled the debate on the balance between IP rights protection and equitable access to medicines during a public health crisis. India, South Africa, and other developing countries maintain that a waiver was the only way to make vaccines affordable and accessible. Leading pharmaceutical companies argue that the waiver will stifle innovation and make lifesaving medicines less accessible. Both sides have seemingly overlooked Pfizer's voluntary agreement with the Medicines …

Comment: On Patents And Appropriations—And Tragedies, David O. Taylor

Washington and Lee Law Review

I write to provide a few remarks concerning Sasha Hoyt’s illuminating work published in the pages of this journal. In it, Hoyt addresses the impact of the Supreme Court’s patent eligibility decisions on private investment in the development of medical diagnostic technologies. As an initial matter, I want to congratulate Hoyt for tackling an important topic. As Hoyt discusses, medical diagnostic technologies enable the diagnosis of diseases and other medical conditions such as genetic disorders, and early and accurate diagnosis may lead to early treatments and, ultimately, at least in some cases, saved lives. But the creation of medical diagnostic …

Patent Eligibility And Cancer Therapy, Christopher B. Seaman

Washington and Lee Law Review

As an empirical legal scholar, I am pleased to report that Sasha Hoyt has done what very few law students—and even many law professors—could achieve. She successfully conducted a novel empirical study to assess the real-world impact of a U.S. Supreme Court decision, Mayo Collaborative Services v. Prometheus Laboratories, Inc., on venture capital (VC) investment in startups and other companies that develop medical diagnostic technology.

As Ms. Hoyt notes, patent protection is particularly important for startup companies, as it can help protect their innovations from unauthorized use, attract funding and other investments, and foster collaboration with third parties. In …

Antibody Claims And The Evolution Of The Written Description/Enablement Requirement, S Sean Tu, Christopher M. Holman

Faculty Works

No abstract provided.

Table Of Contents, Seattle University Law Review

Seattle University Law Review

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Post-Grant Adjudication Of Drug Patents: Agency And/Or Court?, Arti K. Rai, Saurabh Vishnubhakat, Jorge Lemus, Erik Hovenkamp

Articles

The America Invents Act of 2011 (AIA) created a robust administrative system-the Patent Trial and Appeal Board (PTAB)-that provides a route for challenging the validity of granted patents outside of district courts. Congress determined that administrative adjudication of the validity of initial patent grants could be cheaper and more scientifically accurate than district court adjudication of such validity.

For private economic value per patent, few areas of technology can match the biopharmaceutical industry. This is particularly true for small-molecule drugs. A billion-dollar drug monopoly may be protected from competition by a relatively small number of patents. Accordingly, the social cost …

Autumn Is Coming: A Novel Liability Theory That May Kill Pharmaceutical Evergreening, Uri Y. Hacohen

Cardozo Arts & Entertainment Law Journal

Pharmaceutical evergreening-attempts by brand-name manufacturers to leverage patent rights to artificially extend legal protection for drugs-is among the most pressing and unresolved public policy challenges of our time. On July 14, 2021, in Sanofi et al. vs. Unipharm Ltd., the Israeli Supreme Court adopted a novel and internationally unprecedented legal policy to combat the evergreening pandemic. By using its equitable powers, the Israeli court empowered a generic manufacturer, Unipharm, to claim on behalf of the public interest the wrongly obtained monopoly profits that a brand-name manufacturer, Sanofi, obtained by improperly leveraging its improvement patent to impair generic market entry. This …

Eviscerating Patent Scope, Shahrokh Falati

Articles & Chapters

The scope of patent claims directed to inventions in the field of pharmaceuticals and biotechnology has been stumped by the Court of Appeals for the Federal Circuit’s recent jurisprudence on 35 U.S.C. § 112. Specifically, the application of a heightened test for enablement of claims to a genus of compounds with functional limitations or a genus of therapeutic antibodies, coupled with an increasingly broader application of the written description doctrine, has resulted in considerable uncertainty in the biopharmaceutical industry. The Federal Circuit’s shift in interpreting 35 U.S.C. § 112 contravenes the statute and Supreme Court precedent by splitting the singular …

Trick Or Treat? How A U.S. Patent Over A Method For Processing Sugarcane Wrongly Alarmed The Colombian Panela Industry, Carter Ostrowski

University of Cincinnati Law Review

No abstract provided.

France's Organisme De Défense Et De Gestion: A Model For Farmer Collective Action Through Standard Development And Brand Management, Christopher J. Bardenhagen, Philip H. Howard, Marie-Odile Noziéres-Petit

Journal of Food Law & Policy

Quality-based food production, often with a regional dimension, can provide farmers with new, value added markets. It can also provide consumers with access to place based high-quality products, and may benefit local economies through increased commerce. French Organismes de Défense et de Gestion (ODGs) illustrate a mode of quality-based agri-food business organization. ODGs focus on the development of production standards, as well as management of the intellectual property related to those standards. This mode, which is commonly used in Europe, has not often been used in the United States, despite its potential for regional food system development. The ODG mode …

Copying Copyright: Adopting A Fair Use Defense In Patent Law In Times Of Public Health Crisis, Kellie C. Van Beck

Brooklyn Law Review

Epidemics have devastated humankind for centuries. Given the simultaneous rise of advanced disease prevention and treatment and the great potential for mass public uptake, it is unsurprising that the U.S. pharmaceutical industry has grown to $775 billion in annual sales revenue. It is clear that the commercialization of important public health measures is not without controversy. Of particular debate is that vaccine and other drug manufacturers monopolize their products and control them through patent laws. Yet there is a strong dichotomy between the importance of patents and the need for public access to innovations. This is not to say that …

An Analysis Of The Patent Linkage System And Development Of The Biosimilar Industry In Taiwan, Jerry I-H Hsiao

Brooklyn Journal of International Law

In 2019, as an effort to join the Trans-Pacific Partnership (TPP) Agreement (now Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP)), Taiwan has implemented the patent linkage system which covers both small molecule generic drugs and large molecule biosimilar into the Pharmaceutical Affair Act. The system modeled after the U.S.’s patent linkage system designed for small molecule drugs under the Hatch Waxman Act (HWA). Based on the experience of the patent linkage system under the HWA, biosimilar industry representatives in Taiwan contended that the adoption of the patent linkage system will be detrimental to the development of local industry. By …

Intellectual Property Exhaustion And Parallel Imports Of Pharmaceuticals: A Comparative And Critical Review, Irene Calboli

Faculty Scholarship

This Chapter addresses the topic of intellectual property (IP) exhaustion in the context of the parallel trade of pharmaceuticals. These imports, which are controversial in general, are more complex with respect to pharmaceuticals, which require additional marketing and import authorizations. Nevertheless, individual countries remain free to accept these imports under the flexibility of Article 6 of the Agreement on Trade Related Aspects to Intellectual Property Rights (TRIPS Agreement). This Chapter reviews several national approaches—in developed, developing, and least developed countries (LDCs)—from the perspective of the exhaustion of patent rights as well as other IP rights. Through this review, it highlights …

Food For Thought: Intellectual Property Protection For Recipes And Food Designs, Kurt M. Saunders, Valerie Flugge

Duke Law & Technology Review

As any chef will tell you, cooking and food preparation is a creative, sometimes innovative, endeavor. Much thought and time is invested in selecting ingredients, developing the process for preparing the dish, and designing an interesting or appealing look and feel for a food item. If this is true, then it should come as no surprise that recipes, food designs, and other culinary creations can be protected by various forms of intellectual property, namely: trade secrets, design and utility patents, trade dress, but usually not copyright. This article considers how intellectual property law has been applied to protect recipes and …

Mitigating The Effects Of Intellectual Property Colonialism On Budding Cannabis Markets, Hughie Kellner

Indiana Journal of Global Legal Studies

Globalization has reduced barriers to trade, communication, and understanding, opening opportunities that extend far beyond national borders. However, in this bounty of opportunity lie obligations, and often those obligations tie a nation's hands when trying to deal with a problem that arises. One obligation nations face is upholding the United Nations' (UN) decision to prevent the illicit use of cannabis. Another is supporting and following the World Trade Organization's (WTO) near elimination of barriers for companies to bring patent and trademark protection with them into any country they do business with. In a modern globalized economy, if a nation fails …

Trademark Issues In The Cannabis Industry Under U.S. Law (Cannabis, Recreational Use), Christine Farley, Erik Ponce, Rachel Santarlas, Zara Snapp

Presentations

By Mexican Group of the International Association for the Protection of Intellectual Property (Association Internationale pour la Protection de la Propriété Intellectuelle, AIPPI)

Table Of Contents, Seattle University Law Review

Seattle University Law Review

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Medical Device Artificial Intelligence: The New Tort Frontier, Charlotte A. Tschider

Faculty Publications & Other Works

The medical device industry and new technology start-ups have dramatically increased investment in artificial intelligence (AI) applications, including diagnostic tools and AI-enabled devices. These technologies have been positioned to reduce climbing health costs while simultaneously improving health outcomes. Technologies like AI-enabled surgical robots, AI-enabled insulin pumps, and cancer detection applications hold tremendous promise, yet without appropriate oversight, they will likely pose major safety issues. While preventative safety measures may reduce risk to patients using these technologies, effective regulatory-tort regimes also permit recovery when preventative solutions are insufficient.

The Food and Drug Administration (FDA), the administrative agency responsible for overseeing the …

Avoiding The Trips Trap: A Path To Domestic Disclosure Of Clinical Drug Data Consistent With International Norms, Cynthia M. Ho

Faculty Publications & Other Works

No abstract provided.

Table Of Contents, Seattle University Law Review

Seattle University Law Review

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Trademark Enforcement And Statutory Incentives, Leah Chan Grinvald

Cardozo Arts & Entertainment Law Journal

The combination of the recent U.S. Supreme Court case, Romag Fasteners v. Fossil Group, Inc., and the diamond anniversary of the Lanham Act provides good grounds to reflect on how trademark enforcement and statutory incentives have evolved through the years. Although enforcement of one's trademarks through the use of the courts can be traced back to England in the 1790s, trademark litigation and other enforcement activities have exploded, in relative terms, since the enactment of the Lanham Act in 1946. Although not subject to an easy empirical correlation, this trend suggests that the statute has had an impact on increasing …

Drugs, Patents, And Well-Being, Christopher Buccafusco, Jonathan S. Masur

Faculty Scholarship

The ultimate end of patent law should be to spur innovations that improve human welfare-innovations that make people better off. But firms will only invest resources in developing patentable inventions that will allow them to make money-that is, inventions that people will want to use and buy. This can gravely distort the types of incentives that firms face and the types of inventions they pursue. Nowhere is this truer than in the pharmaceutical field There is by now substantial evidence that treatments for diseases that primarily afflict poorer people-including the citizens of developing nations-are dramatically underproduced, compared with drugs that …

Commercializing Cannabis: Confronting The Challenges And Uncertainty Of Trademark And Trade Secret Protection For Cannabis-Related Businesses, John Mixon

Washington Journal of Law, Technology & Arts

Over the last couple of decades, society has become more accepting of recreational cannabis and an ever-growing number of states have passed pro-cannabis legislation. With this change, the cannabis industry has, to some extent, exploded into a booming enterprise in states that have legalized marijuana. Nonetheless, cannabis' status as a Schedule I banned substance under the Controlled Substances Act of 1970 remains unchanged. As a result, businesses in the cannabis industry face the unique challenge of having to toe the line between "legally" operating under state law and violating federal law, which trumps state law. One particular situation in which …

The Double-Edged Sword Of Medical Patents: How Monopolies On Healthcare Products Disparately Impact Certain American Populations, Sarah Mcgraw

The University of Cincinnati Intellectual Property and Computer Law Journal

No abstract provided.

Dispute Settlement Under The African Continental Free Trade Area Agreement: A Preliminary Assessment, Olabisi D. Akinkugbe

Articles, Book Chapters, & Popular Press

The African Continental Free Trade Area Agreement (AfCFTA) will add a new dispute settlement system to the plethora of judicial mechanisms designed to resolve trade disputes in Africa. Against the discontent of Member States and limited impact the existing highly legalized trade dispute settlement mechanisms have had on regional economic integration in Africa, this paper undertakes a preliminary assessment of the AfCFTA Dispute Settlement Mechanism (DSM). In particular, the paper situates the AfCFTA-DSM in the overall discontent and unsupportive practices of African States with highly legalized dispute settlement systems and similar WTO-Styled DSMs among other shortcomings. Notwithstanding the transplantation of …

Enough Is As Good As A Feast, Noah C. Chauvin

Seattle University Law Review

Ipse Dixit, the podcast on legal scholarship, provides a valuable service to the legal community and particularly to the legal academy. The podcast’s hosts skillfully interview guests about their legal and law-related scholarship, helping those guests communicate their ideas clearly and concisely. In this review essay, I argue that Ipse Dixit has made a major contribution to legal scholarship by demonstrating in its interview episodes that law review articles are neither the only nor the best way of communicating scholarly ideas. This contribution should be considered “scholarship,” because one of the primary goals of scholarship is to communicate new ideas.

Biosimilars: The Quest For A Rational Regulatory And Intellectual Property Approach In Canada, Elizabeth S. Dipchand

LLM Theses

Biologics and biosimilars represent the promise for more effective treatments of many diseases. International treaty obligations influenced heavily by the biopharmaceutical industry and advanced through the international trade agenda may lead to an imbalance between incentivizing innovation and the public interest. Canada’s implementation of its obligations into national patent and regulatory laws encourages aggressive biologic patent protection strategies that, coupled with linked regulatory assessments, may establish compounding layers of exclusion that disproportionately disincentivizes both the biologics innovation and biosimilar development. This comparative analysis addresses the progression of international obligations and the way in which they have been implemented into Canada’s …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

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