Intellectual Property Law | Open Access Articles

Next Verse, Same As The First: Inadequacies In The Government's Legal Approach Toward Biotechnology, Kimberly Righter

Sustainable Development Law & Policy

No abstract provided.

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Implementing Kyoto, Glenn Wiser

Sustainable Development Law & Policy

No abstract provided.

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Can International Patent Law Help Mitigate Cancer Inequity In Lmics?, Srividhya Ragavan, Amaka Vanni

Faculty Scholarship

Although low- and middle-income countries (LMICs) bear 75% of the cancer burden globally, their available resources to treat cancer constitute less than 5% of global health resources. This inequity makes it imperative to take appropriate measures to treat and prevent cancer in LMICs, which should include consideration of trade and patent policies. This article highlights some impediments to effective use of existing policies to promote access to treatment and prevention measures in LMICs and offers recommendations about next steps.

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The Intellectual Property Of Vaccines: Takeaways From Recent Infectious Disease Outbreaks, Ana Santos Rutschman

All Faculty Scholarship

This Essay examines the ways in which intellectual property regimes influence incentives for the development of new vaccines for infectious diseases. Charting the tension between market forces and public health imperatives, the Essay considers an emerging solution to the long-standing problem of insufficient incentives for vaccine research and development: the rise of public-private partnerships in the health space. The Essay provides a short case study on CEPI, a large-scale public-private partnership dedicated exclusively to funding research on vaccines for infectious diseases. In exploring how the interaction between intellectual property rules and practices affect vaccine innovation, the Essay offers illustrations from …

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Nonexcludable Surgical Method Patents, Jonas Anderson

Utah Law Faculty Scholarship

A patent consists of only one right: the right to exclude others from practicing the patented invention. However, one class of patents statutorily lacks the right to exclude direct infringers: surgical method patents are not enforceable against medical practitioners or health care facilities, which are the only realistic potential direct infringers of such patents. Despite this, inventors regularly file for (and receive) surgical method patents. Why would anyone incur the expense (more than $20,000 on average) of acquiring a patent on a surgical method if that patent cannot be used to keep people from using the patent?

The traditional answer …

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The Survival Of Critical Infrastructure: How Do We Stop Ransomware Attacks On Hospitals?, Helena Roland

Catholic University Journal of Law and Technology

Our nation’s infrastructure is under an emerging new threat: ransomware attacks. These attacks can cause anything from individual laptops, to entire cities to shut down for a period of time until the victim pays a ransom to the attacker. Unfortunately, these attacks are on the rise and the attackers have a new target: hospitals. Ransomware attacks on hospitals can temporarily shut down operating room technology and limit physician access to patient files, ultimately threatening the safety of hospital patients and the surrounding community. This paper examines how the threat of ransomware attacks on hospitals is on the rise and what …

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Geographical Indications Of Origin, Economic Development, And Cultural Heritage: Good Match Or Mismatch?, Irene Calboli

Faculty Scholarship

In this article, I propose that geographical indications (GIs) carry important economic benefits. First, GIs are essential instruments to facilitate investments in high-quality products and niche markets, and promote local trade and development. Second, GIs offer an additional layer of information for consumers about the geographical origin and quality of the products they identify, in turn reducing the information asymmetries between producers and consumers. Third, because of this information function, GIs can assist in rewarding or holding producers accountable for their products based on the additional information they convey to the market. Yet, GIs can also protect culture-related interests and …

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The U.S. Posture On Global Access To Medication & The Case For Change, Michael Palmedo, Srividhya Ragavan

Faculty Scholarship

The year 2020 marks the 25th anniversary of including intellectual property rights within the larger agenda of trade. While the marriage between trade and intellectual property was always uncomfortable, COVID-19 exposed the flaws, failures and the inadequacy of the trade agenda to harmonise intellectual property rights, particularly for patents in pharmaceuticals. Typically, the United States through its questionable United States Trade Representative (USTR) process exposed the vulnerabilities of the intellectual property systems of the rest of the world. COVID-19 exposed the manner in which the so-called ‘superior’ intellectual property regime of the US left the country with a weak health-care …

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Who’S Afraid Of Section 1498? A Case For Government Patent Use In Pandemics And Other National Crises, Christopher J. Morten, Charles Duan

Faculty Scholarship

COVID-19 has created pressing and widespread needs for vaccines, medical treatments, PPE, and other medical technologies, needs that may conflict – indeed, have already begun to conflict – with the exclusive rights conferred by United States patents. The U.S. government has a legal mechanism to overcome this conflict: government use of patented technologies at the cost of government-paid compensation under 28 U.S.C. § 1498. But while many have recognized the theoretical possibility of government patent use under that statute, there is today a conventional wisdom that § 1498 is too exceptional, unpredictable, and dramatic for practical use, to the point …

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From Discovery To Delivery: Public Sector Development Of The Rvsv-Zebov Ebola Vaccine, Matthew Herder, Janice Graham, Richard Gold

Articles, Book Chapters, & Popular Press

The discovery and development of the Ebola rVSV-ZEBOV vaccine challenge the common assumption that the research and development for innovative therapeutic products and vaccines is best carried out by the private sector. Using internal government documents obtained through an access to information request, we analyze the development of rVSV-ZEBOV by researchers at Canada’s National Microbiology Laboratory beyond its patenting and licensing to a biotech company in the United States in 2010. According to government documentation, the company failed to make any progress toward a phase 1 clinical trial until after the WHO Public Health Emergency of International Concern freed substantial …

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Editorial, Lucie Guibault

Articles, Book Chapters, & Popular Press

1 This issue marks the tenth month into the COVID-19 pandemic. Since March 2020, we have learned to live with the more or less strict public health measures put in place to ‘flatten the curve’ of infection from the virus. Words like ‘social distancing’, ‘mask wearing’, and ‘lockdowns’ have taken an entirely new meaning. In spite of these measures, the human toll is huge, most clearly among frontline workers and vulnerable people. While the curve is far from flat in most countries, the pandemic has brought to light the long time unacknowledged persistence of systemic inequalities: figures show that poorer, …

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Accountability, Secrecy, And Innovation In Ai-Enabled Clinical Decision Software, Arti K. Rai, Isha Sharma, Christina Silcox

Faculty Scholarship

This article employs analytical and empirical tools to dissect the complex relationship between secrecy, accountability, and innovation incentives in clinical decision software enabled by machine learning (ML-CD). Although secrecy can provide incentives for innovation, it can also diminish the ability of third parties to adjudicate risk and benefit responsibly. Our first aim is descriptive. We address how the interrelated regimes of intellectual property law, Food and Drug Administration (FDA) regulation, and tort liability are currently shaping information flow and innovation incentives. We find that developers regard secrecy over training data and details of the trained model as central to competitive …

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In Memory Of Professor James E. Bond, Janet Ainsworth

Seattle University Law Review

Janet Ainsworth, Professor of Law at Seattle University School of Law: In Memory of Professor James E. Bond.

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Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

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Potential Liability For Physicians Using Artificial Intelligence, W. Nicholson Price Ii, Sara Gerke, I Glenn Cohen

Articles

Artificial intelligence (AI) is quickly making inroads into medical practice, especially in forms that rely on machine learning, with a mix of hope and hype. Multiple AI-based products have now been approved or cleared by the US Food and Drug Administration (FDA), and health systems and hospitals are increasingly deploying AI-based systems. For example, medical AI can support clinical decisions, such as recommending drugs or dosages or interpreting radiological images.2 One key difference from most traditional clinical decision support software is that some medical AI may communicate results or recommendations to the care team without being able to communicate the …

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The Internet Of Bodies, Andrea M. Matwyshyn

William & Mary Law Review

This Article introduces the ongoing progression of the Internet of Things (IoT) into the Internet of Bodies (IoB)—a network of human bodies whose integrity and functionality rely at least in part on the Internet and related technologies, such as artificial intelligence. IoB devices will evidence the same categories of legacy security flaws that have plagued IoT devices. However, unlike most IoT, IoB technologies will directly, physically harm human bodies—a set of harms courts, legislators, and regulators will deem worthy of legal redress. As such, IoB will herald the arrival of (some forms of) corporate software liability and a new legal …

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Table Of Contents, Seattle University Law Review

Seattle University Law Review

No abstract provided.

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Helsinn Healthcare S.A. V. Teva Pharmaceuticals Usa, Inc.: “Sale” Keeps Its Old Meaning Under The Leahy–Smith America Invents Act, Sherrie Holdman

Minnesota Journal of Law, Science & Technology

No abstract provided.

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Money That Costs Too Much: Regulating Financial Incentives, Kristen Underhill

Indiana Law Journal

Money may not corrupt. But should we worry if it corrodes? Legal scholars in a range of fields have expressed concern about “motivational crowding-out,” a process by which offering financial rewards for good behavior may undermine laudable social motivations, like professionalism or civic duty. Disquiet about the motivational impacts of incentives has now extended to health law, employment law, tax, torts, contracts, criminal law, property, and beyond. In some cases, the fear of crowding-out has inspired concrete opposition to innovative policies that marshal incentives to change individual behavior. But to date, our fears about crowding-out have been unfocused and amorphous; …

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That Is Northern Lights Cannabis Indica . . . No, It's Marijuana: Navigating Through The Haze Of Cannabis And Patents, Dawson Hahn

Concordia Law Review

By their very nature, patents are exclusionary. A patent grants the right to exclude others from making use of an invention or process. But patents are also tools to promote innovation. However, when an invalid patent is granted, the patent becomes an exclusionary tool that also chills innovation. Invalid cannabis patents may be chilling innovation in the cannabis market, but they may not be the only thing. While the Controlled Substances Act continues to prohibit cannabis at a federal level, researchers and medical professionals will be unsure of the legality of their actions. This naturally leads to another chilling effect …

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A Brand-Name Drug Company May Violate Section Two Of The Sherman Act By Mislabeling A Submitted Patent In The Orange Book: An Implication From In Re Actos End-Payor Antitrust Litigation, 848 F.3d 89 (2d Cir. 2017), Ping-Hsun Chen

Brooklyn Journal of Corporate, Financial & Commercial Law

The Hatch-Waxman Act encourages generic drug companies to submit an abbreviated new drug application (“ANDA”) for a generic version of a drug approved by the U.S. Food and Drug Administration (“FDA”). Nevertheless, a mechanism exists for a brand-name drug company to adjudicate a patent infringement dispute before the FDA approves an ANDA. The mechanism includes the regulatory scheme of patent information submission implemented by the FDA. 21 U.S.C. § 355(b)(1) requires that patent information be correct. False patent information destroys the objectives of the Hatch-Waxman Act. In re Actos End-Payor Antitrust Litigation, 848 F.3d 89 (2d Cir. 2017), may demonstrate …

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Biobanks As Innovation Infrastructure For Translational Medicine, W. Nicholson Price Ii

Book Chapters

Biobanks represent an opportunity for the use of big data to drive translational medicine. Precision medicine demands data to shape treatments to individual patient characteristics; large datasets can also suggest new uses for old drugs or relationships between previously unlinked conditions. But these tasks can be stymied when data are siloed in different datasets, smaller biobanks, or completely proprietary private resources. This hampers not only analysis of the data themselves, but also efforts to translate data-based insights into actionable recommendations and to transfer the discovered technology into a commercialization pipeline. Cross-project technological innovation, development, and validation are all more difficult …

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The Cost Of Novelty, W. Nicholson Price Ii

Law & Economics Working Papers

Patent law tries to spur the development of new, better, innovative technology. But it focuses much more on “new” than “better” — and it turns out that “new” carries real social costs. I argue that patent law promotes innovation that diverges from existing technology, either a little (what I call “differentiating innovation”) or a lot (“exploring innovation”), at the expense of innovation that tells us more about existing technology (“deepening innovation”). Patent law’s focus on newness is unsurprising, and fits within a well-told narrative of innovative diversity accompanied by market selection of the best technologies. Unfortunately, innovative diversity brings not …

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Table Of Contents, Seattle University Law Review

Seattle University Law Review

No abstract provided.

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A Mathematical Solution To The Sine Of Madness That Is Pharmaceutical Compulsory Licensing Under The Trips Agreement And The Doha Declaration, Ashley E. Sperbeck

Marquette Intellectual Property Law Review

A viable economic solution is necessary to address the shortcomings, textual ambiguities, and deficiencies engulfing international patent protection, leading to the inability of LDCs facing public health crises or national emergencies and lacking pharmaceutical manufacturing facilities to obtain generic pharmaceuticals. This Note poses a solution to this problem via another Amendment to the TRIPS Agreement and the Doha Declaration, which provides a mathematical framework to determine when and under what circumstances a compulsory license should be granted. Furthermore, this Note contemplates establishment of a WTO subcommittee to oversee this proposed solution and to ensure compliance with this Amendment. This concrete …

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Tribal Sovereign Immunity As A Defense At The Patent Trial And Appeal Board? Or A Violation Of U.S. Antitrust Laws?, Samantha Roth

Marquette Intellectual Property Law Review

This Comment will address two primary issues. First, it will analyze the basis of sovereign immunity rights of tribes, with a focus on the relationship between intellectual property rights and sovereignty. Second, it will discuss whether this arrangement violates the antitrust laws of the United States. This Comment concludes that even if a claim of tribal sovereign immunity is legitimate, it is likely that such an arrangement still violates the relevant antitrust claims.

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Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg

Marquette Intellectual Property Law Review

This article examines the intersection of patent law, FDA regulation, and Medicare coverage in a particularly promising field of biomedical innovation: genetic diagnostic testing. First, I will discuss current clinical uses of genetic testing and directions for further research, with a focus on cancer, the field in which genetic testing has had the greatest impact to date. Second, I will turn to patent law and address two recent Supreme Court decisions that called into question the patentability of many of the most important advances in genetic testing. Third, I will step outside patent law to take a broader view of …

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Finding A Forest Through The Trees: Georgia-Pacific As Guidance For Arbitration Of International Compulsory Licensing Disputes, Karen Mckenzie

Marquette Intellectual Property Law Review

This paper will examine the challenges of international compulsory licensing by examining the issue historically and legally as well as offer possible solutions. Thus, this paper will explore the challenge of balancing corporate interests against the affordability and availability of pharmaceuticals by focusing on discrete situations in developing countries, the history of compulsory licensing, and how the World Health Organization (the “WHO”) and the WTO have attempted to tackle these challenges through compulsory licensing, and it will suggest a possible framework for use in arbitration, which balances equities through a Georgia-Pacific analysis.

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Patents And The Pharmaceutical Industry: Curbing The Abusive Practices Employed By Blockbuster Drug Companies To Prolong Market Exclusivity, Kelley Chandler

Cornell Journal of Law and Public Policy

Patent law in the pharmaceutical space presents unique challenges. Interactions between patent terms, the FDA, the drug development process, and the need for quality medical solutions create a complex dynamic which leads to uncertainty. This uncertainty makes it difficult to discern between solutions which might be effective, and solutions which will spawn new challenges where they so intently sought to eliminate old ones. Although Hatch-Waxman was a success in many ways, in other ways it has proven to frustrate the purposes behind its enactment. The suggestions presented here are a sound starting point for alleviating some of the burden plaguing …

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The Patent Ability Of Genetic Therapies: Car-T And Medical Treatment Exclusions Around The World, Luis Gil Abinader, Jorge L. Contreras

American University International Law Review

No abstract provided.

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Full-Text Articles in Intellectual Property Law

Next Verse, Same As The First: Inadequacies In The Government's Legal Approach Toward Biotechnology, Kimberly Righter

Sustainable Development Law & Policy

Implementing Kyoto, Glenn Wiser

Sustainable Development Law & Policy

Can International Patent Law Help Mitigate Cancer Inequity In Lmics?, Srividhya Ragavan, Amaka Vanni

Faculty Scholarship

The Intellectual Property Of Vaccines: Takeaways From Recent Infectious Disease Outbreaks, Ana Santos Rutschman

All Faculty Scholarship

Nonexcludable Surgical Method Patents, Jonas Anderson

Utah Law Faculty Scholarship

The Survival Of Critical Infrastructure: How Do We Stop Ransomware Attacks On Hospitals?, Helena Roland

Catholic University Journal of Law and Technology

Geographical Indications Of Origin, Economic Development, And Cultural Heritage: Good Match Or Mismatch?, Irene Calboli

Faculty Scholarship

The U.S. Posture On Global Access To Medication & The Case For Change, Michael Palmedo, Srividhya Ragavan

Faculty Scholarship

Who’S Afraid Of Section 1498? A Case For Government Patent Use In Pandemics And Other National Crises, Christopher J. Morten, Charles Duan

Faculty Scholarship

From Discovery To Delivery: Public Sector Development Of The Rvsv-Zebov Ebola Vaccine, Matthew Herder, Janice Graham, Richard Gold

Articles, Book Chapters, & Popular Press

Editorial, Lucie Guibault

Articles, Book Chapters, & Popular Press

Accountability, Secrecy, And Innovation In Ai-Enabled Clinical Decision Software, Arti K. Rai, Isha Sharma, Christina Silcox

Faculty Scholarship

In Memory Of Professor James E. Bond, Janet Ainsworth

Seattle University Law Review

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Potential Liability For Physicians Using Artificial Intelligence, W. Nicholson Price Ii, Sara Gerke, I Glenn Cohen

Articles

The Internet Of Bodies, Andrea M. Matwyshyn

William & Mary Law Review

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Helsinn Healthcare S.A. V. Teva Pharmaceuticals Usa, Inc.: “Sale” Keeps Its Old Meaning Under The Leahy–Smith America Invents Act, Sherrie Holdman

Minnesota Journal of Law, Science & Technology

Money That Costs Too Much: Regulating Financial Incentives, Kristen Underhill

Indiana Law Journal

That Is Northern Lights Cannabis Indica . . . No, It's Marijuana: Navigating Through The Haze Of Cannabis And Patents, Dawson Hahn

Concordia Law Review

A Brand-Name Drug Company May Violate Section Two Of The Sherman Act By Mislabeling A Submitted Patent In The Orange Book: An Implication From In Re Actos End-Payor Antitrust Litigation, 848 F.3d 89 (2d Cir. 2017), Ping-Hsun Chen

Brooklyn Journal of Corporate, Financial & Commercial Law

Biobanks As Innovation Infrastructure For Translational Medicine, W. Nicholson Price Ii

Book Chapters

The Cost Of Novelty, W. Nicholson Price Ii

Law & Economics Working Papers

Table Of Contents, Seattle University Law Review

Seattle University Law Review

A Mathematical Solution To The Sine Of Madness That Is Pharmaceutical Compulsory Licensing Under The Trips Agreement And The Doha Declaration, Ashley E. Sperbeck

Marquette Intellectual Property Law Review

Tribal Sovereign Immunity As A Defense At The Patent Trial And Appeal Board? Or A Violation Of U.S. Antitrust Laws?, Samantha Roth

Marquette Intellectual Property Law Review

Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg

Marquette Intellectual Property Law Review

Finding A Forest Through The Trees: Georgia-Pacific As Guidance For Arbitration Of International Compulsory Licensing Disputes, Karen Mckenzie

Marquette Intellectual Property Law Review

Patents And The Pharmaceutical Industry: Curbing The Abusive Practices Employed By Blockbuster Drug Companies To Prolong Market Exclusivity, Kelley Chandler

Cornell Journal of Law and Public Policy

The Patent Ability Of Genetic Therapies: Car-T And Medical Treatment Exclusions Around The World, Luis Gil Abinader, Jorge L. Contreras

American University International Law Review