Law Commons^™

Public Non-Commercial Use' Compulsory Licensing For Pharmaceutical Drugs In Government Health Care Programs, Pier Deroo

Michigan Journal of International Law

Suppose a relatively prosperous nation with universal public health coverage faces an HIV/AIDS crisis. It refuses to negotiate with the patent-holding manufacturers of the best antiretrovirals (ARVs) available, instead issuing compulsory licenses. Compulsory licenses permit the generic drug manufacturers designated in the compulsory licenses to make, use, import, and sell the patented ARVs without the permission of the patent owners, increasing competition and lowering prices. Realizing that drugs are much cheaper without patents, the nation decides to issue another round of compulsory licenses for an extensive list of patented drugs for its universal health care program. While improving public access …

Hatch-Waxmanizing Copyright, Michal Shur-Ofry

Michigan Telecommunications & Technology Law Review

This Essay presents a novel proposal for counter balancing "copyright overspills." In the background of the discussion is the common reality of users succumbing to rights holders' attempts to license uses which are most likely fair uses or completely free of copyright protection. These practices have attracted considerable attention in recent literature. Most scholarly proposals in this context emphasize the need to clarify the contours of the fair use doctrine and to remove doctrinal ambiguities. Yet these initiatives are probably insufficient to overcome users' risk aversion in copyright markets due to an inherent structural imbalance within copyright law. While the …

Pharmaceutical Patent Litigation Settlements: Balancing Patent & Antitrust Policy Through Institutional Choice, Timothy A. Cook

Michigan Telecommunications & Technology Law Review

Should a branded pharmaceutical company be allowed to pay a generic competitor to stay out of the market for a drug? Antitrust policy implies that such a deal should be prohibited, but the answer becomes less clear when the transaction is packaged as a patent-litigation settlement. Since Congress passed the Hatch-Waxman Act, which encourages generic manufacturers to challenge pharmaceutical patent validity, settlements of this kind have been on the rise. Congress, the Department of Justice, and the Federal Trade Commission have condemned these agreements as anticompetitive and costly to American consumers, but none of these bodies has been able to …

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.

Exhausted Or Unlicensed: Can Field-Of-Use Restrictions In Biotech License Agreements Still Prevent Off-Label Use Promotion After Quanta Computer?, Kristal M. Wicks

The University of New Hampshire Law Review

[Excerpt] “In the biotechnology (biotech) industry, companies must be increasingly aware of their intellectual property and how their licensing strategies can impact their rights. When licensing patented technology, it is common practice for biotech companies to include restricted field-of-use provisions in their license agreements. Such provisions permit a licensee to only use licensed technology in a defined field and restrict use or development in another field. This licensing strategy plays an important role within the biotech industry because it allows companies to more effectively control their intellectual property and to more efficiently research and develop pharmaceutical products.

A problem that …

The 2009 H1n1 Swine Flu Pandemic: Reconciling Goals Of Patents And Public Health Initiatives, Michelle Kaplan

Fordham Intellectual Property, Media and Entertainment Law Journal

No abstract provided.

How Many Patents Does It Take To Make A Drug - Follow-On Pharmaceutical Patents And University Licensing, Lisa Larrimore Ouellette

Michigan Telecommunications & Technology Law Review

As described by Professors Dan Burk and Mark Lemley, drugs are[...] special because of the low number of patents per product: "In some industries, such as chemistry and pharmaceuticals, a single patent normally covers a single product. Much conventional wisdom in the patent system is built on the unstated assumption of such a one-to-one correspondence." Although many have repeated this one-patent, one-drug assumption, there has been little empirical analysis of how many patents actually protect each drug. In fact, most small-molecule drugs are protected by multiple patents. The average was nearly 3.5 patents per drug in 2005, with over five …

It Is Time: Why The Fda Should Start Disclosing Drug Trial Data, Mustafa Ünlü

Michigan Telecommunications & Technology Law Review

Although [drug] manufacturers bear the cost of research data generation, it is oftentimes a worthwhile investment that also confers significant commercial advantages. Consequently, they have argued that research data should be considered a trade secret and kept confidential. The FDA's longstanding position has been to accept this proposition. Even when Congress appeared to mandate disclosure or weaken the underlying rationale for secrecy, the FDA has continued to treat research data as confidential. A strong argument against a default posture of confidentiality is that research data disclosure would promote broad public interests by eliminating the societal costs brought about by keeping …

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.

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

Bruno Meyerhof Salama

Unsettling Drug Patent Settlements: A Framework For Presumptive Illegality, Michael A. Carrier

Michigan Law Review

A tidal wave of high drug prices has recently crashed across the U.S. economy. One of the primary culprits has been the increase in agreements by which brand-name drug manufacturers and generic firms have settled patent litigation. The framework for such agreements has been the Hatch-Waxman Act, which Congress enacted in 1984. One of the Act's goals was to provide incentives for generics to challenge brand-name patents. But brand firms have recently paid generics millions of dollars to drop their lawsuits and refrain from entering the market. These reverse-payment settlements threaten significant harm. Courts nonetheless have recently blessed them, explaining …

The Politics Of Patents And Drugs In Brazil And Mexico: The Industrial Bases Of Health Policies, Kenneth C. Shadlen

Ken Shadlen

After introducing pharmaceutical patents in the 1990s, Brazil subsequently adjusted the patent system to ameliorate its effects on drug prices while Mexico introduced measures that reinforce and intensify these effects. The different trajectories are due to the nature of the actors pushing for reform and subsequent patterns of coalitional formation and political mobilization. In Brazil, government demand for expensive, patented drugs made health-oriented patent reform a priority, and the existence of an autonomous local pharmaceutical sector allowed the Ministry of Health to build a supportive coalition. In Mexico, government demand made reforms less urgent, and transformations of the pharmaceutical sector …

Why Fdca Section 505(U) Should Not Concern Us Greatly, Kyle Faget

Michigan Telecommunications & Technology Law Review

Among the many amendments found in the Food and Drug Administration Amendment Act of 2007 (FDAAA) is a provision at the end of the act, Section 505(u), which grants chiral switches five years of market exclusivity under certain circumstances. Prior to Congressional enactment of the FDAAA, the Food and Drug Administration (FDA) refused to award new chemical entity (NCE) status to enantiomers of previously approved racemic mixtures. The FDA defines a new chemical entity ("NCE") as a drug that contains no active moiety that has been approved by the FDA in any other application submitted under Section 505(b) of the …

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 …

Pharma's Nonobvious Problem, Rebecca S. Eisenberg

Articles

This Article considers the effect of the recent decision of the U.S. Supreme Court in KSR International Co. v. Teleflex, Inc. on the nonobviousness standard for patentability as applied to pharmaceutical patents. By calling for an expansive and flexible analysis and disapproving of the use of rigid formulas in evaluating an invention for obviousness, KSR may appear to make it easier for generic competitors to challenge the validity of drug patents. But an examination of the Federal Circuit's nonobviousness jurisprudence in the context of such challenges reveals that the Federal Circuit has been employing all along the sort of flexible …

Pharmaceutical Lemons: Innovation And Regulation In The Drug Industry, Ariel Katz

Michigan Telecommunications & Technology Law Review

Before a new drug can be marketed, the Food and Drug Administration must be satisfied that it is safe and effective. According to conventional wisdom, the cost and delay involved in this process diminish the incentives to invest in the development of new drugs. Accordingly, several reforms aimed at restoring such incentives have been implemented or advocated. This Article challenges the central argument that drug regulation and drug innovation are necessarily at odds with one another. Although intuitively appealing, the argument that drug regulation negatively affects the incentives to innovate does not fully capture the role that regulation plays in …

Restoring The Genetic Commons: A Common Sense Approach To Biotechnology Patents In The Wake Of Ksr V. Teleflex , Anna Bartow Laakmann

Michigan Telecommunications & Technology Law Review

In this Article, I argue that a new approach to biotechnology patenting is necessary to fully realize the tremendous potential of recent advances in our understanding of the human genome. Part I places the gene patenting debate in context by highlighting the key landmarks that have shaped the biotechnology industry and outlining the products and stakeholders that comprise the industry. Part II describes the current state of the law on biotechnology patents, summarizing the Federal Circuit's application of the various doctrines that collectively define the patent landscape's parameters. In this Part, I explain how the Federal Circuit's jurisprudence is tied …

Diversifying Without Discriminating: Complying With The Mandates Of The Trips Agreement, Graeme B. Dinwoodie, Rochelle C. Dreyfuss

Michigan Telecommunications & Technology Law Review

Since the Patent Act was revised in 1952, patent law has expanded to cover an array of novel endeavors--new fields of technology (notably computer science and business methods) as well as the activities of researchers engaged in fundamental scientific discovery. These changes have been accompanied by shifts in the organizational structure of the technological community, with smaller firms and universities emerging as important players in the patent system, and by new marketplace expectations arising from consumer demand for interoperable technology and converging functionality. As a result of these developments, structural flaws in the legal order have become evident. Although the …

The Patent End Game: Evaluating Generic Entry Into A Blockbuster Pharmaceutical Market In The Absence Of Fda Incentives, Jeremiah Helm

Michigan Telecommunications & Technology Law Review

Generic drugs play an important role in the American system of health care. Most anticipate that the entry of these drugs into the market will lower prices and thereby increase treatment options for consumers. To stimulate generic entry, the Food and Drug Administration currently offers a period of marketing exclusivity to the first firm that gains approval for a generic version of a branded drug. During this 180-day period, only two firms can sell versions of the drug: the original, branded drug maker and the first approved generic firm. After the period of exclusivity expires, other generic firms are free …

Pharmaceutical Lemons: Innovation And Regulation In The Drug Industry, Ariel Katz

Ariel Katz

Before a new drug can be marketed the Food and Drug Administration must be satisfied that it is safe and effective. According to conventional wisdom, the cost and delay involved in this process diminish the incentives to invest in the development of new drugs. Accordingly, several reforms aimed at restoring such incentives have been implemented and others have been advocated. This paper challenges the central argument in the debate on the topic, namely that drug regulation and drug innovation are necessarily at odds with each other. Although intuitively appealing, the argument that drug regulation negatively affects the incentives to innovate …

The Emerging Bric Economies: Lessons From Intellectual Property Negotiation And Enforcement, Robert C. Bird, Daniel R. Cahoy

Northwestern Journal of Technology and Intellectual Property

No abstract provided.

The Role Of The Fda In Innovation Policy, Rebecca S. Eisenberg

Michigan Telecommunications & Technology Law Review

This Article reexamines the role of FDA regulation in motivating investment in biopharmaceutical innovation. I begin by challenging the standard story that it is the patent system that makes drug development profitable, and drug regulation that makes it costly, by showing how patents add to costs and how drug regulation works in tandem with patents to protect profits. I then compare FDA-administered exclusive rights to patents as a means of fortifying drug development incentives, suggesting ways that FDA-administered rights might be preferable both from the perspective of policy makers and from the perspective of firms. In the remainder of the …

Why Pharmaceutical Firms Support Patent Trolls: The Disparate Impact Of Ebay V. Mercexchange On Innovation, Jeremiah S. Helm

Michigan Telecommunications & Technology Law Review

Before the unanimous decision in eBay v. MercExchange, patent holders were almost always granted an injunction against an infringer. In fact, the Federal Circuit, in deciding eBay, noted that, upon a finding of infringement, an injunction would issue unless there were extraordinary circumstances. The Court, in a brief opinion, disagreed with the Federal Circuit and explained that the injunction issue in a patent case must be analyzed under the traditional four-factor test.[...] Is the four-factor test fairer or better than the Federal Circuit's near-automatic injunction rule? It is certainly more difficult to administer a factor test as compared to a …

The Trademark Dilution Revision Act - A Consumer Perspective, Paul Alan Levy

Fordham Intellectual Property, Media and Entertainment Law Journal

No abstract provided.

Paper Dragon: Inadequate Protection Of Intellectual Property Rights In China, Omario Kanji

Michigan Journal of International Law

This Note will explore the extent to which China is in violation of its obligations under TRIPs. Section I surveys the current state of IPR infringement in China. Section II analyzes relevant TRIPs provisions, case law, and treaties that supplement TRIPs provisions. Section III analyzes Chinese criminal law, the December 2004 Judicial Interpretation of Chinese criminal law, and Chinese IP law as they pertain to IPR infringement. Section IV outlines enforcement efforts in China against the backdrop of the law analyzed in the previous section. Section V evaluates these enforcement efforts given China's capabilities and obligations, and Section VI concludes …

Supporting Innovation In Targeted Treatments: Licenses Of Right To Nih-Funded Research Tools, Tanuja V. Garde

Michigan Telecommunications & Technology Law Review

Support for new drug development has taken some interesting turns in current patent law jurisprudence. Beginning with the severe curtailment of scope of the common law experimental use doctrine in Madey v. Duke University, and culminating with the recent Supreme Court decision in Merck KGaA v. Integra Lifesciences I, Ltd., broadening the scope of the statutory research exemption, the freedom to conduct experimental research using another's patented inventions becomes dependent in part on the purpose of the research. That the patent at issue in Merck was characterized by the Federal Circuit as being directed to a research tool raised the …

Staying Within The Negotiated Framework: Abiding By The Non-Discrimination Clause In Trips Article 27, Kevin J. Nowak

Michigan Journal of International Law

This Note argues that the Panel in Canada-Generic Medicines correctly decided that the non-discrimination clause in Article 27 applies to the exceptions of Articles 30 and 31. Because Article 27 is the guiding force of Section 5, any exceptions to the rights granted under Section 5 must comply with the requirements set forth in Article 27. Although extreme applications of the non-discrimination clause could be limiting upon some exceptions, Articles 30 and 31 were not placed into TRIPs as complete escape clauses from the framework of Section 5. Additionally, the application of the non-discrimination clause to Articles 30 and 31 …

The Problem Of New Uses, Rebecca S. Eisenberg

Articles

Discovering new uses for drugs that are already on the market seems like it ought to be the low-lying fruit of biopharmaceutical research and development (R&D). Firms have already made significant investments in developing these drugs and bringing them to market, including testing them in clinical trials, shepherding them through the FDA regulatory approval process, building production facilities, and training sales staff to market them to physicians. By this point, the drugs have begun to enjoy goodwill among patients and physicians and casual observations in the course of clinical experience may point to potential new uses. One might expect that …

The Experimental Purpose Doctrine And Biomedical Research, Tao Huang

Michigan Telecommunications & Technology Law Review

The experimental use doctrine is a common law rule in patent law that until a few years ago excused accused infringers who made and used patented products or processes on the basis of an experimental, educational, or nonprofit purpose when there was de minimis economic injury to the patent owner and de minimis economic gain to the infringer. While the application of the experimental purpose doctrine was always narrow, two recent Federal Circuit decisions indicate that there is not much left under its aegis. In Madey v. Duke University, the Federal Circuit strictly limited the application of the experimental purpose …

An Examination Of Patents, Licensing, Research Tools, And The Tragedy Of The Anticommons In Biotechnology Innovation, Michael S. Mireles

University of Michigan Journal of Law Reform

The continued development of and affordable access to potentially life saving pharmaceuticals, gene therapies and diagnostics is unquestionably a socially important issue. However, crafting government policy to encourage the development of and allowing affordable access to those services and products is difficult. On one hand, the development of those services and products requires a large investment of funds because of the complexity, collaborative nature, and uncertainty of the development of those products and services. Accordingly, investors require the safety of strong and stable patent rights to ensure a return on their investment in the development of a commercial end-product or …