Intellectual Property Law Commons^™

Table Of Contents, Vol. 22:1, Journal Of Intellectual Property Law

Georgia Journal of Law & Technology

No abstract provided.

When Biopharma Meets Software: Bioinformatics At The Patent Office, Saurabh Vishnubhakat, Arti K. Rai

Faculty Scholarship

Scholars have spilled much ink questioning patent quality. Complaints encompass concern about incoming applications, examination by the U.S. Patent and Trademark Office (“USPTO”), and the USPTO’s ultimate output. The literature and some empirical data also suggest, however, that applications, examination, and output may differ considerably based on technology. Most notably, although definitions of patent quality are contested, quality in the biopharmaceutical industry is often considered substantially higher than that in information and communications technology (ICT) industries.

This Article presents the first empirical examination of what happens when the two fields are combined. Specifically, it analyzes the creation and early history …

Diagnostics Need Not Apply, Rebecca S. Eisenberg

Articles

Diagnostic testing helps caregivers and patients understand a patient's condition, predict future outcomes, select appropriate treatments, and determine whether treatment is working. Improvements in diagnostic testing are essential to bringing about the long-heralded promise of personalized medicine. Yet it seems increasingly clear that most important advances in this type of medical technology lie outside the boundaries of patent-eligible subject matter. The clarity of this conclusion has been obscured by ambiguity in the recent decisions of the Supreme Court concerning patent eligibility. Since its 2010 decision in Bilski v. Kappos, the Court has followed a discipline of limiting judicial exclusions from …

Keeping The Gates Open For Human Embryonic Stem Cell Research, Ren-How Harn

Cardozo Public Law, Policy & Ethics Journal

Human embryonic stem cell research represents an area of scientific progress that promises to deliver on the wonders mankind has thus far only seen in science fiction movies. However, ethical and legal concerns threaten to stifle research in an area often regarded as the holy grail of regenerative medicine. This Note analyzes the question in patent law of whether human embryonic stem cells constitute patentable subject matter under 35 U.S.C. §101 from a legal and policy perspective after the 2013 Supreme Court decision in Association for Molecular Pathology v. Myriad. The issue has generated recent interest and debate with …

New Forms Of Dialects Between Intellectual Property And Public Health: Pharmaceutical Patent-Related Investment Disputes, Valentina Vadi

The International Lawyer

No abstract provided.

Pharmaceutical Patents And The Human Right To Health: The Contested Evolution Of The Transnational Legal Order On Access To Medicines, Laurence R. Helfer

Faculty Scholarship

Disputes over the regulation of access to medicines are occurring in multiple transnational, national, and local venues. Competing groups of states and non-state actors shift horizontally and vertically among these forums in an effort to develop competing legal rules over the propriety of granting intellectual property (IP) protection to newly developed life-saving drugs. This chapter applies the framework of Transnational Legal Orders (Terence C. Halliday & Gregory Shaffer, eds. 2015) to explain the origins of these controversies and their consequences. The chapter argues that the current state of affairs arose from a clash between two previously discrete TLOs—one relating to …

Denaturalizing Transparency In Drug Regulation, Matthew Herder

Articles, Book Chapters, & Popular Press

In the arena of pharmaceutical drug regulation, transparency is the favoured focus of many current policy initiatives. Transparency is predominantly understood in terms of information disclosure. Requirements to register clinical trials, publish summary results, share clinical trial data, and disclose physician-industry relationships as well as rationales behind regulatory decision making are each predicated upon this idea that imparting information will both inform and deter unwanted behaviours. In this paper, I argue that understanding transparency qua disclosure has clear limitations and suggest transparency can and should serve an additional function - namely, of enabling standard setting through a more participatory, public …

Non-Price Competition In “Substitute" Drugs: The Ftc's Blind Spot, Gregory Dolin

All Faculty Scholarship

As the recent case of United States v. Lundbeck illustrates, the Federal Trade Commission’s lack of knowledge in medical and pharmacological sciences affects its evaluation of transactions between medical and pharmaceutical companies that involve transfers of rights to manufacture or sell drugs, causing the agency to object to such transactions without solid basis for doing so. This article argues that in order to properly define a pharmaceutical market, one must not just consider the condition that competing drugs are meant to treat, but also take into account whether there are “off-label” drugs that are used to treat a relevant condition, …

Who's Virus Is It Anyway? How The World Health Organization Can Protect Against Claims Of "Viral Sovereignty", Jason Carter

Georgia Journal of International & Comparative Law

No abstract provided.

Multipolarity, Intellectual Property And The Internationalization Of Public Health Law, Sam F. Halabi

Faculty Publications

This Article critically examines the proliferation of international legal agreements addressing global health threats like the outbreak of infectious diseases, tobacco use and lack of access to affordable medicines. The conventional wisdom behind this trend is that a global normative shift has occurred which has caused states to regard health as “special” and less subject to the normal rules of international law making because health threats endanger all of humanity. This Article challenges that thesis, arguing that at the same time the number and scope of international health law treaties has grown, developed states have subordinated health law to intellectual …

Generic Entry Jujitsu: Innovation And Quality In Drug Manufacturing, W. Nicholson Price Ii

IP Theory

The manufacturing side of the pharmaceutical industry has been neglected in innovation theory and policy, with the unfortunate result of stagnant manufacturing techniques driving major problems for the healthcare system. This innovation failure has roots in ineffective intellectual property incentives and high regulatory hurdles to innovative change. Changes in pure regulation or intellectual property incentives have significant potential to help the innovation deficit, but are not the only possibility for change. A relatively minor regulatory change could harness the powerful dynamics of pioneer/generic competition surrounding generic drug market entry. If pioneer firms were permitted to make label claims committing to …

Multipolarity, Intellectual Property, And The Internationalization Of Public Health Law, Sam F. Halabi

Michigan Journal of International Law

The cause of global health today is arguably the most influential human rights movement ever seen, mobilizing vast flows of direct and indirect aid to the developing world to fight disease and build health care infrastructure; prompting the establishment of international organizations like UNAIDS and the Global Fund to fight AIDS, Tuberculosis and Malaria (Global Fund); including global health as a priority in major diplomatic summits; and driving the formation and implementation of international agreements to address global health threats. Champions of this movement claim that the diverse and influential state and non-state actors participating in the development of the …

Making Do In Making Drugs: Innovation Policy And Pharmaceutical Manufacturing, W. Nicholson Price Ii

Law Faculty Scholarship

Despite increasing recalls, contamination events, and shortages, drug companies continue to rely on outdated manufacturing plants and processes. Drug manufacturing’s inefficiency and lack of innovation stand in stark contrast to drug discovery, which is the focus of a calibrated innovation policy that combines patents and FDA regulation. Pharmaceutical manufacturing lags far behind the innovative techniques found in other industries due to high regulatory barriers and ineffective intellectual property incentives. Among other challenges, although manufacturers tend to rely on trade secrecy because of the difficulty in enforcing patents on manufacturing processes, trade secrecy provides limited incentives for innovation. To increase those …

Pacific Nortwest Perspective: The Impact Of The America Invents Act On Nonprofit Global Health Organizations, John Morgan, Veronica Sandoval

Washington Journal of Law, Technology & Arts

The Leahy-Smith America Invents Act of 2011 (AIA) makes fundamental changes to the legislative landscape governing patent law in the United States and will bring about corresponding changes in the manner in which inventors and attorneys address patent issues. While the law is newly implemented, inventors in all sectors of the economy are eager to formulate reactions to it. In this Article, we explore the effects of the AIA on nonprofit research organizations dedicated to global health and life sciences. We report the perspectives of counsel representing such organizations throughout the Pacific Northwest. We also consider the patent system, and …

The Case For Flexible Intellectual Property Protections In The Trans-Pacific Partnership , Matthew E. Silverman

Journal of Law and Health

The United States and eleven other countries are currently in the end stages of negotiating the Trans-Pacific Partnership (TPP)—the largest free trade agreement (FTA) in U.S. history—which incorporates a range of trade topics, including the protection and enforcement of intellectual property rights (IPRs). Although the negotiations have been highly secretive, negotiating texts of the agreement leaked as recently as November 2013 have suggested that the United States is proposing IPR provisions, specifically relating to patent protection, that are stronger and less flexible than IPR provisions included within three of the four most recent U.S. FTAs. This paper addresses and analyzes …

Pinwheel Of Fortune, 13 J. Marshall Rev. Intell. Prop. L. 761 (2014), James Ming Chen

UIC Review of Intellectual Property Law

This paper examines public health law in the context of prospect theory, the leading behavioral account of risk aversion and risk-seeking. The paper first demonstrates how international environmental law can be mapped along prospect theory’s risk-seeking axis. It then completes this picture of prospect theory by examining National Federation of Independent Business v. Sebelius, which upheld the constitutionality of the Patient Protection and Affordable Care Act (“PPACA”). Although Sebelius upheld the PPACA as an exercise of the federal government’s taxing authority, it reasoned that a directive aimed at uninsured individuals to buy health insurance lay beyond the power of Congress …

A Scientific Approach To Intellectual Property And Health: Innovation, Access, And A Forgotten Corner Of The Universal Declaration Of Human Rights, 13 J. Marshall Rev. Intell. Prop. L. 794 (2014), Adam Houston

UIC Review of Intellectual Property Law

For years, there has been vigorous debate over the relationship between intellectual property and health, especially in the context of pharmaceutical patents. Despite numerous attempts to strike a balance between innovation and access, however, few have looked to Article 27 of the Universal Declaration of Human Rights for guidance. Article 27, and its further elaboration and codification under Article 15 of the International Covenant on Economic, Social, and Cultural Rights, explicitly address this balance by pairing the right of everyone “to share in scientific advancement and its benefits” with a similarly universal right of authors to “material interests resulting” from …

Should All Drugs Be Patentable?: A Comparative Perspective, Cynthia M. Ho

Faculty Publications & Other Works

Although there has been substantial discussion of the proper scope of patentable subject matter in recent years, drugs have been overlooked. This Article begins to address that gap with a comparative perspective. In particular, this Article considers what is permissible under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), as well as how India and Canada have utilized TRIPS flexibilities in different ways to properly reward developers of valuable new drugs, while also considering the social harm of higher prices beyond an initial patent term on drugs.

This Article brings valuable insight into this area at a critical …

Drugged Out: How Cognitive Bias Hurts Drug Innovation, Cynthia M. Ho

Faculty Publications & Other Works

No abstract provided.

Toward A Jurisprudence Of Drug Regulation, Matthew Herder

Articles, Book Chapters, & Popular Press

Efforts to foster transparency in biopharmaceutical regulation are well underway: drug manufacturers are, for example, legally required to register clinical trials and share research results in the United States and Europe. Recently, the policy conversation has shifted toward the disclosure of clinical trial data, not just trial designs and basic results. Here, I argue that clinical trial registration and disclosure of clinical trial data are necessary but insufficient. There is also a need to ensure that regulatory decisions that flow from clinical trials — whether positive (i.e. product approvals) or negative (i.e. abandoned products, product refusals, and withdrawals) — are …

Table Of Contents

Seattle Journal for Social Justice

No abstract provided.

Fifty Years After Gideon: It Is Long Past Time To Provide Lawyers For Misdemeanor Defendants Who Cannot Afford To Hire Their Own, Robert C. Boruchowitz

Seattle Journal for Social Justice

No abstract provided.

Legal Financial Obligations: Fulfilling The Promise Of Gideon By Reducing The Burden, Travis Stearns

Seattle Journal for Social Justice

No abstract provided.

Does The Right To Counsel On Appeal End As You Exit The Court Of Appeals?, Nancy P. Collins

Seattle Journal for Social Justice

No abstract provided.

The Undersigned Attorney Hereby Certifies -- The Washington Supreme Court Rule On Standards And Its Implications, Justice Sheryl Gordon Mccloud, Justice Susan Owens, Marc Boman, Joanne Moore

Seattle Journal for Social Justice

No abstract provided.

G Forces: Gideon V. Wainwright And Matthew Adler's Move Beyond Cost-Benefit Analysis, Janet Moore

Seattle Journal for Social Justice

No abstract provided.

Dark Medicine: How The National Research Act Has Failed To Address Racist Practices In Biomedical Experiments Targeting The African-American Community, Anietie Maureen-Ann Akpan

Seattle Journal for Social Justice

No abstract provided.

Congress' Encroachment On The President's Power In Indian Law And Its Effect On Executive-Order Reservations, Mark R. Carter Jd, Phd

Seattle Journal for Social Justice

No abstract provided.

Do We Have It Right This Time? An Analysis Of The Accomplishments And Shortcomings Of Washington's Indian Child Welfare Act, Karen Gray Young

Seattle Journal for Social Justice

No abstract provided.

Securing Food Justice, Sovereignty & Sustainability In The Face Of The Food Safety Modernization Act (Fsma), Eve Kerber

Seattle Journal for Social Justice

No abstract provided.