Law Commons^™

Intellectual Property As A Determinant Of Health, Ana Santos Rutschman

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Public health literature has long recognized the existence of determinants of health, a set of socio-economic conditions that affect health risks and health outcomes across the world. The World Health Organization defines these determinants as “forces and systems” consisting of “factors combin[ing] together to affect the health of individuals and communities.” Frameworks relying on determinants of health have been widely adopted by countries in the global South and North alike, as well as international institutional players, several of which are direct or indirect players in transnational intellectual property (IP) policymaking. Issues raised by the implementation of IP policies, however, are …

Regulatory Malfunctions In The Drug Patent Ecosystem, Ana Santos Rutschman

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Patent protection for several of the world’s best-selling and most promising drugs — biologics — has begun waning. Over the next few years, many other drugs in this category will lose critical patent protection. In principle, this should open the United States market to competition, as more manufacturers are now able to produce relatively cheaper versions of these expensive drugs, known as biosimilars. That, however, has not been the case. This Article examines this problem in the context of the articulation between anticompetitive behaviors and regulatory interventions in the biopharmaceutical arena, and argues for a novel solution: a timelier response …

The Mosaic Of Coronavirus Vaccine Development: Systemic Failures In Vaccine Innovation, Ana Santos Rutschman

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Scientists are racing to develop vaccines against the novel coronavirus. While some vaccine candidates may enter the market in record time, the current vaccine innovation ecosystem exposes governance lacunas at both the international and domestic levels.

Brief Of Intellectual Property Law Scholars As Amici Curiae In Support Of Neither Party, Westerngeco Llc V. Ion Geophysical Corp., No. 16-1011, Us Supreme Court, Timothy R. Holbrook, Ann Bartow, Dan L. Burk, Donald P. Harris, David C. Hricik, Amy L. Landers, Yvette Joy Liebesman, Lee Ann W. Lockridge, Jason Rantanen

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This amici curiae brief was filed on behalf of Intellectual Property Law Scholars in WesternGeco LLC v. Ion Geophysical Corp. in the U.S. Supreme Court. The question presented is:

"Whether the U.S. Court of Appeals for the Federal Circuit erred in holding that lost profits arising from prohibited combinations occurring outside of the United States are categorically unavailable in cases in which patent infringement is proven under 35 U.S.C. § 271(f)."

In RJR Nabisco, Inc. v. European Community, 136 S. Ct. 2090 (2016), the Supreme Court articulated a two-step method for assessing the extraterritorial reach of a US statute:

1. …

Ip Preparedness For Outbreak Diseases, Ana Santos Rutschman

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Outbreaks of infectious diseases will worsen, as illustrated by the recent back-to-back Ebola and Zika epidemics. The development of innovative drugs, especially in the form of vaccines, is key to minimizing future outbreaks, yet current intellectual property (IP) regimes are ineffective in supporting this goal.

IP scholarship has not adequately addressed the role of IP in the development of vaccines for outbreak diseases. This Article fills that void. Through case studies on the recent Ebola and Zika outbreaks, it provides the first descriptive analysis of the role of IP from the pre- to the post-outbreak stages, specifically identifying IP inefficiencies. …

Brief Amici Curiae Of Intellectual Property Professors In Support Of Petitioner, No. 18-600, Texas Advanced Optoelectronic Solutions, Inc. V. Renesas Electronics America, Inc., Timothy R. Holbrook, Ann Bartow, Andrew Chin, David C. Hricik, Yvette Joy Liebesman, Lucas Osborn

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To comply with the obligations of the Uruguay Round Agreements, particularly the Agreement on the Trade Related Aspects of Intellectual Property (TRIPS), Congress amended 35 U.S.C. § 271(a) to make it an act of infringement to “offer to sell” a patented invention within the United States. See Uruguay Round Agreements Act, Pub. L. No. 103-465, §§ 531-533, 108 Stat. 4809 (1994).

The Federal Circuit has interpreted this provision in a manner contrary to the presumption against the extraterritorial reach of United States laws. The Federal Circuit has held that location of the ultimate sale contemplated in the offer controls the …