Intellectual Property Law Commons^™

The Impact Of The Biosimilars Provision Of The Health Care Reform Bill On Innovation Investments, 10 J. Marshall Rev. Intell. Prop. L. 553 (2011), Katherine N. Addison

UIC Review of Intellectual Property Law

The Biologics Price Competition and Innovation Act of 2009 provides an abbreviated FDA approval pathway for biosimilars. The passage of this biosimilar legislation is a positive step toward retaining a robust biotechnology industry in the United States while also protecting innovators. The Act’s increased FDA exclusivity is welcome, but FDA exclusivity alone is insufficient to encourage and protect innovation and investment in biosimilars. Instead, the exclusivity provided by a patent term, together with the ability to adjust this term to compensate an applicant for U.S. Patent and Trademark Office and FDA delays, is necessary to ensure development of highly specialized …

Improving Antibiotic Markets For Long Term Sustainability, Aaron S. Kesselheim, Kevin Outterson

Faculty Scholarship

The world faces a worsening public health crisis: A growing number of bacteria are resistant to available antibiotics. Yet there are few new antibiotics in the development pipeline to take the place of these increasingly ineffective drugs. We review a number of proposals intended to bolster drug development, including such financial incentives for pharmaceutical manufacturers as extending the effective patent life for new antibiotics. However, such strategies directly conflict with the clear need to reduce unnecessary antibiotic prescriptions and could actually increase prescription use. As an alternative, we recommend a two-prong, “integrated” strategy based on prizes administered through the insurance …

Patent Office As Biosecurity Gatekeeper: Fostering Responsible Science And Building Public Trust In Diy Science, 10 J. Marshall Rev. Intell. Prop. L. 423 (2011), Brian J. Gorman

UIC Review of Intellectual Property Law

When the fields of intellectual property law and biotechnology intersect, most analysis is driven byeconomic and ethical issues. This article examines these factors, but in relation to the emerging security threat posed by biohackers, or do-it-yourself (“DIY”) scientists, who operate free from oversight and industry norms at the fringes of the biotechnology community. Public health risks are poised to grow as these citizen-scientists race for lucrative discoveries in the new frontier of syntheticbiology. This article proposes that the existing paradigm adjust accordingly to leverage regulatory compliance from the most ambitious biohackers looking to benefit from patent protection. The U.S. government …

The Human Right To Health And Hiv/Aids: South Africa And South-South Cooperation To Reframe Global Intellectual Property Principles And Promote Access To Essential Medicines, Erika George

Faculty Scholarship

The HIV/AIDS pandemic has had a devastating and disproportionate impact in countries of the Global South. The experience of an individual infected with HIV in Africa is very different than that of an individual infected with HIV in America. Life expectancy varies sharply. The ability or inability to access medicines essential for treatment accounts for much of the variance. This article examines how the rhetoric of human rights used in the context of South Africa's AIDS crisis resonated across the Global South, resulted in a powerful social movement for access to medicines, and contributed to important changes in international intellectual …

Bayer Schering Pharma Ag V. Barr Laboratories, Inc., Joshua Zarabi

NYLS Law Review

No abstract provided.

Three Statutory Regimes At Impasse: Reverse Payments In Pay-For-Delay Settlement Agreements Between Brand-Name And Generic Drug Companies, Rudolph J.R. Peritz

Articles & Chapters

No abstract provided.

Approval Of New Pharmacogenomic Tests: Is The Canadian Regulatory Process Adequate?, Yann Joly, Emma Ramos-Paque

Canadian Journal of Law and Technology

In the first part of our analysis, we will examine the impact which pharmacogenomics is expected to have on drug research and development, on the drug approval process and on post-marketing surveillance and clinical practice. This will allow us to show how pharmacogenomic testing could be beneficial to drug companies, regulatory bodies, and patients. The second part of our analysis will focus on the regulatory framework applicable to the approval of pharmacoge- nomic tests in Canada, although we are aware of the fact that most manufacturers decide to approve their tests outside of Canada. As mentioned, the applicable regu- lations …

Pharmaceutical Patent Bargains: The Brazilian Experience, Bruno Salama, Daniel Benoliel

Cardozo Journal of International and Comparative Law

In the backdrop of the strict patent regime flatly adopted by the World Trade Organization (WTO) for all countries, a few countries constantly challenge this system through aggressive patent bargains. Within the pharmaceutical sector, noticeably, some countries now threaten to issue or otherwise actually issue compulsory licenses that may sway large pharmaceutical companies into selling drugs with large discounts or into granting voluntary licenses domestically. That is conspicuously the negotiation strategy adopted by Brazil in its negotiations with big international pharmaceutical companies.

This paper explains Brazil's aggressive bargaining approach based on an analysis of two aspects of its political economy. …

Canadian Personal Data Protection Legislation And Electronic Health Records: Transfers Of Personal Health Information In It Outsourcing Agreements, Dara Lambie

Canadian Journal of Law and Technology

Personal data protection and privacy of personal health information in the electronic era is a broad topic that includes consent, security measures and access considerations. The focus of this article is on one component of the larger picture: data transfers of personal health information that occur in the context of informa- tion technology (“IT”) outsourcing. If the societal good envisioned by an inter-jurisdictional EHR is to be fully realized, then the necessity of outsourcing is a reality that must be addressed.

The Eminence Of Imminence And The Myopia Of Markets, Teneille R. Brown

Utah Law Faculty Scholarship

This article questions the privileging of disaster, or imminent threat, over more distant threats to public health. In many cases, this privileging makes sense as we do not have time to evaluate the threat under traditional frameworks. But in some cases, we privilege disaster in ways that may be ethically and legally unsound. Here I am interested in a particular type of public health threat – the negative consequences that stem from climate change. In this article I view the climate change discussion through the lens of distributive justice. I analyze the ethical as well as legal arguments for encouraging …

Pharmaceutical Patent Litigation Settlements: Implications For Competition And Innovation, John R. Thomas

Georgetown Law Faculty Publications and Other Works

Although brand-name pharmaceutical companies routinely procure patents on their innovative medications, such rights are not self-enforcing. Brand-name firms that wish to enforce their patents against generic competitors must commence litigation in the federal courts. Such litigation ordinarily terminates in either a judgment of infringement, which typically blocks generic competition until such time as the patent expires, or a judgment that the patent is invalid or not infringed, which typically opens the market to generic entry. As with other sorts of commercial litigation, however, the parties to pharmaceutical patent litigation may choose to settle their case. Certain of these settlements have …

Recent Development: The Anti-Counterfeiting Trade Agreement, Emily Ayoob

Cardozo Arts & Entertainment Law Journal

No abstract provided.

Special 301 And Access To Medicine In The Obama Administration, Sean Flynn

Scholarly Articles in Law Reviews & Journals

I. Introduction

This article examines the history and current use of the Special 301 program to restrict access to generic medicines in developing countries, specifically the 2009 and 2010 reports released under the Obama Administration. The news for access to medicines advocates is not good overall. Both reports continue the previous Administration’s policies of using Special 301 to promote Trade-Related Aspects of Intellectual Property Rights (“TRIPS”) policies (“TRIPS-plus”) endangering access to medicines for millions of people worldwide. These policies violate not only the Obama Administration’s pledges to promote access to affordable medications in developing countries, but also U.S. commitments under …

Death From The Public Domain?, Kevin Outterson

Faculty Scholarship

In his recent article in the Texas Law Review, Ben Roin advances the claim that pharmaceutical innovation and the public’s health are harmed by the doctrines of non-obviousness and novelty. He does not mince words, labeling the nonobvious requirement as “perversity” with a “pernicious” effect on drug development. In his view, these standards pose an insurmountable barrier for drug companies seeking to commercialize inventions already in the public domain. He claims that valuable, life-saving drug ideas languish in the public domain because the companies face high barriers to entry from the FDA, but potential free riders are encouraged through the …

A Discourse On The Public Nature Of Research In Contemporary Life Science: A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski

Journal Articles

This article addresses the impact of integration of academia, industry, and government on the public nature of research. The article concludes that, while the integration has benefited science immensely, regulatory measures should be taken to restore the public nature of research in an age of integration.

An Economic Justification For Open Access To Essential Medicine Patents In Developing Countries, Sean Flynn, Aidan Hollis, Mike Palmedo

Scholarly Articles in Law Reviews & Journals

This paper offers an economic rationale for compulsory licensing of needed medicines in developing countries. The patent system is based on a trade-off between the “deadweight losses” caused by market power and the incentive to innovate created by increased profits from monopoly pricing during the period of the patent. However, markets for essential medicines under patent in developing countries with high income inequality are characterized by highly convex demand curves, producing large deadweight losses relative to potential profits when monopoly firms exercise profit-maximizing pricing strategies. As a result, these markets are systematically ill-suited to exclusive marketing rights, a problem which …

Demythologizing Phosita: Applying The Non-Obviousness Requirement Under Canadian Patent Law To Keep Knowledge In The Public Domain & Foster Innovation, Matthew Herder

Articles, Book Chapters, & Popular Press

The Supreme Court of Canada recently revised the doctrine of non-obviousness in a pharmaceutical “selection patent” case, Apotex Inc. v. Sanofi-Synthelabo Canada Inc. Although cognizant of changes to the same doctrine in the United States and the United Kingdom, a critical flaw in how the doctrine is being applied in Canada escaped the Court’s attention. Using content analysis methodology, this article shows that Canadian courts frequently fail to characterize the “person having ordinary skill in the art” (PHOSITA) for the purpose of the obviousness inquiry. The article argues that this surprisingly common analytical mistake betrays a deep misunderstanding of innovation, …

A Kernel For Open Source Drug Discovery In Tropical Diseases, Leticia Ortı, Rodrigo J. Carbajo, Ursula Pieper, Narayanan Eswar, Stephen M. Maurer, Arti K. Rai, Ginger Taylor, Matthew H. Todd, Antonio Pineda-Lucena, Andrej Sali, Marc A. Marti-Renom

Faculty Scholarship

Open source drug discovery, a promising alternative avenue to conventional patent-based drug development, has so far remained elusive with few exceptions. A major stumbling block has been the absence of a critical mass of preexisting work that volunteers can improve through a series of granular contributions. This paper introduces the results from a newly assembled computational pipeline for identifying protein targets for drug discovery in ten organisms that cause tropical diseases. We have also experimentally tested two promising targets for their binding to commercially available drugs, validating one and invalidating the other. The resulting kernel provides a base of drug …

Patients Without Borders: The Emerging Global Market For Patients And The Evolution Of Modern Health Care, Nathan Cortez

Indiana Law Journal

No abstract provided.

Mary Doe’S Destiny: How The United States Has Banned Human Embryonic Stem Cell Research In The Absence Of A Direct Prohibition, Yi-Chen Su, Albert Wai-Kit Chan

Richmond Journal of Law & Technology

Mary Doe is a human embryo preserved in liquid nitrogen, in an unnamed in vitro fertilization clinic. Mary Doe’s name was given by an organization dedicated to advocating for equal humanity and personhood of pre-born children, including “children in vitro.” In response to President Clinton’s policy favoring embryonic stem cell [hereinafter ES- cell] research, the organization filed suit on behalf of Mary Doe, and all other frozen human embryos similarly situated, seeking a permanent injunction against any and all plans to undertake human ES-cell experimentation.

On The Importance Of Intellectual Property Rights For E-Science And The Integrated Health Record, Giuseppina D'Agostino, Chris Hinds, Marina Jirotka, Charles Meyer

Articles & Book Chapters

An integrated health record (IHR) that enables clinical data to be shared at a national level has profound implications for medical research. Data that have been useful primarily within a single clinic will instead be free to move rapidly around a national network infrastructure. This raises challenges for technologists, clinical practice, and for the governance of these data. This article considers one specific issue that is currently poorly understood: how intellectual property (IP) relates to the sharing of medical data for research on large-scale electronic networks. Based on an understanding of current practices, this article presents recommendations for the governance …

The "Public Health" Of The Conventional International Patent Régime And The Ethics Of "Ethicals:" Access To Patented Medicines, Amir H. Khoury

Cardozo Arts & Entertainment Law Journal

No abstract provided.

Asking For Money Back - Chilling Commercialization Or Recouping Public Trust In The Context Of Stem Cell Research?, Matthew Herder

Articles, Book Chapters, & Popular Press

As publicly funded institutions have increasingly embraced the goal of commercializing scientific research, concerns about private appropriation have become familiar refrain. One commonly suggested remedy is to create some kind of 'recoupment' provision whereby the State, on behalf of the public, receives a certain percentage of profits realized. The Bayh-Dole Act originally included a recoupment provision but it was deleted by a legislative committee. Countries around the globe attempting to emulate Bayh-Dole have, whether by design or default, reinforced the underlying logic against recoupment, which is essentially as follows: obligations to provide direct financial returns undermine the commercialization process and …

Symposium: Molecules And Conflict: Cancer, Petents, And Women's Health, Eileen M. Kane

American University Journal of Gender, Social Policy & the Law

No abstract provided.

Symposium: Comments On Panel 2, Peter Jaszi

American University Journal of Gender, Social Policy & the Law

No abstract provided.

Is An Accrued Cause Of Action For Copyright Infringement More Like A Kidney Or A Contract?, Bryanne J. Schmitt

Cardozo Arts & Entertainment Law Journal

No abstract provided.

Patent Political Economy - Indian Lessons On Pharmaceutical Patent, Julien L. Chaisse, Samira Guennif

ExpressO

The Intellectual Property Rights (IPR) regime adopted by any country is essentially a tool that strives to ensure both the growth of the domestic pharmaceutical industry and people’s access to medicines. But, contrary to the very easily advanced theory, there is no paradox between the two. From this perspective, the Indian experience has shown that it is precisely the relaxation of its national IPR regime that promoted the growth of its domestic industry, thereby ensuring a better patient access to medicines. However, the globalisation process does not overlook any sector, which means that medicines too are submitted to the new …

A Complete Property Right Amendment, John H. Ryskamp

ExpressO

The trend of the eminent domain reform and "Kelo plus" initiatives is toward a comprehensive Constitutional property right incorporating the elements of level of review, nature of government action, and extent of compensation. This article contains a draft amendment which reflects these concerns.

Why It Is Time To Eliminate Genomic Patents, Together With Natural Extracts Doctrine That Have Supported Such Patents, Allen K. Yu

ExpressO

The constitutional purpose of intellectual property is to “promote the progress of science and useful arts.” Given the utilitarian basis of patents, it is critical that policies and laws must be continually adjusted to reflect the needs of new technologies. When the law tries to shield itself from rather than confront the realities of underlying technologies, patents end up actually subverting rather than promote technological progress. This paper explores why the natural extracts doctrine belongs to the class of doctrines that subvert progress. The doctrine, established over a century ago to enable the patenting of purified compounds for use as …

Bond Repudiation, Tax Codes, The Appropriations Process And Restitution Post-Eminent Domain Reform, John H. Ryskamp

ExpressO

This brief comment suggests where the anti-eminent domain movement might be heading next.