Law Commons^™

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 …

Much Ado About The Tpp's Effect On Pharmaceuticals, Emily M. Morris

Faculty Publications

The Trans-Pacific Partnership Agreement’s many provisions that were beneficial to the pharmaceutical industry have caused a good deal of controversy. Specifically, critics allege that the TPP’s provisions requiring that member states expand patentable subject matter, adjust pharmaceutical patent terms, and link regulatory marketing approval to a drug's patent status would have raised drug prices and hindered access to medicines, particularly in developing countries. Closer examination of these provisions as well as the various ways in which member states can modify or ameliorate the effects of these provisions suggests that their potential effect on drug prices and access to health care …

Corporate Power Unbound: Investorstate Arbitration Of Ip Monopolies On Medicines—Eli Lilly V. Canada And The Trans-Pacific Partnership Agreement, Brook K. Baker, Katrina Geddes

Journal of Intellectual Property Law

No abstract provided.

Biosimilar Naming: A Call For Uniformity In A Complex Field, Jacqueline Genovese

Brooklyn Journal of International Law

Recombinant technology has opened a pathway for a means of producing a variety of therapeutic proteins and generating the growth of the biopharmaceutical industry. Further, due the patent expirations of a number of biologics in the coming years, there has been an increased interest in the development of generic biologics, also known as biosimilars, and a widespread push for biosimilar FDA approval in the United States. While the pressure for the expansion of biosimilar approval is warranted, the FDA must be cautious when implementing regulatory guidelines. Since biologics differ greatly from small-molecule drugs, biologics have a distinct approval process. The …

Get The Balance Right!: Squaring Access With Patent Protection, Kristen Jakobsen Osenga

Law Faculty Publications

Professor Osenga discusses the tensions between the interests of patent holders and patients worldwide in need of pharmaceutical treatments. Explaining the combination of exclusive patent and compulsory license approaches that govern access to intellectual property by statute and treaty, she urges that a carefully conceived balancing of these approaches will best serve both interests.

Intellectual Property As An ‘Investment’ In International Law: A Question Of Access To Medicines Vs Access To Justice, Christopher Wadlow

Christopher Wadlow

No abstract provided.

The Great Pharmaceutical Patent Robbery, And The Curious Case Of The Chemical Foundation, Christopher Wadlow

Christopher Wadlow

In 1918, the United States confiscated virtually all German-owned intellectual property assets within its jurisdiction. Out of 6,000 patents in the chemical field, 4,500 were assigned for a very modest consideration to an newly-established entity, the Chemical Foundation, which was incorporated with the objective of licensing and managing them for the benefit of the United States chemical industry. This article describes the origins and activities of the Chemical Foundation, and considers whether it provides a useful model, or at least useful lessons, for the collective management of patents today.

Ensuring Effective Pain Treatment: A National And Global Perspective, Allyn L. Taylor, Lawrence O. Gostin, Katrina A. Pagonis

O'Neill Institute Papers

Medical availability of effective pain medication is vitally important domestically and globally. Medical advances have substantially improved the technical capacity to control pain and diminish its consequences. Worldwide, millions of persons with chronic, acute, and terminal conditions have found relief from excruciating pain through medical intervention. However, richer countries have disproportionately benefited from improvements in access to and use of pain medication. The tragedy is that for most of the world's population, particularly persons in poorer countries, effective pain control is entirely unavailable.

Regulatory Data Protection Under Trips Article 39(3) And Article 10bis Of The Paris Convention: Is There A Doctor In The House?, Christopher Wadlow

Christopher Wadlow

Article 39 of the WTO TRIPs Agreement has attracted much attention for the protection its final paragraph affords for regulatory data in the pharmaceutical and agrochemical industries, but the literature has tended to treat Article 39(3) in individual isolation. This is to ignore one of the most striking features of Article 39, which is that in contrast to every other substantive provision of TRIPs, it expressly defines its entire scope of application by reference to a pre-existing treaty, the Paris Convention for the Protection of Industrial Property, and specifically Article 10bis of the latter, dealing with unfair competition. This article …

Regulatory Marketing Approval For Pharmaceuticals As A Non-Tariff Barrier To Trade: Analysis Under The Wto's Agreement On Technical Barriers To Trade, Mary Hess Eliason

San Diego International Law Journal

At a fundamental level, pharmaceuticals serve two roles: both as a cure for disease and as a product. As a cure for disease, a drug's value cannot be quantified because it saves lives. As a product, profit analysis shapes every step of a drug's progression to market. In least developed nations the barriers to drug access are not solely economic. National regulatory systems for market approval are being used to prevent external pharmaceutical manufacturers from participating in a national market. This article will address how the regulatory framework of pharmaceutical registration may serve as a barrier to trade in drugs, …

Global Responses: The Search For Cures In The Development Of Pharmaceuticals, Stuart R. Walker

Indiana Journal of Global Legal Studies

In this article, Professor Stuart Walker examines several challenges that

will be faced by the global pharmaceutical industry in the near future. These

involve the question of improving the overall quality of life and care for

millions in an era of cost containment. In order to respond to the increasing

demands for advances in medicine while simultaneously retaining an

industrially strong, innovative, and resilient economy, responsibility for the

necessary changes will need to be shared among governments, the

pharmaceutical industry, and health care professionals.

In particular, four challenges faced by the global pharmaceutical industry

and their responses to each are …