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Patents, Product Exclusivity, And Information Dissemination: How Law Directs Biopharmaceutical Research And Development, Rebecca S. Eisenberg

Fordham Law Review

No abstract provided.

Pharmacogenomics, Genetic Tests, And Patent-Based Incentives, Michael J. Meurer

Faculty Scholarship

Pharmacogenomics promises to revolutionize medicine by using genetic information to guide drug therapy. Genetic tests will help doctors improve drug safety and efficacy by better matching patients and drugs. This Article evaluates the effectiveness of patent-based incentives to create genetic tests, and the optimal mix of public and private sector pharmacogenomic R&D. Drug patent owners have a strong incentive to develop genetic tests that predict adverse drug reactions and allow them to market drugs that otherwise would be shelved. Incentives are also strong for genetic tests that are created as part of the drug development process. Incentives tend to be …

Patents, Product Exclusivity, And Information Dissemination: How Law Directs Biopharmaceutical Research And Development, Rebecca S. Eisenberg

Other Publications

It's a great honor for me to be invited to deliver the Levine Distinguished Lecture at Fordham, and a great opportunity to try out some new ideas before this audience. As some of you know, I've been studying the role of patents in biomedical research and product development ("R&D") for close to twenty years now, with a particular focus on how patents work in "upstream" research in universities and biotechnology companies that are working on research problems that arise prior to "downstream" product development. But, of course, the patent strategies of these institutions are designed around the profits that everyone …

Walking The Talk Of Trust In Human Subjects Research: The Challenge Of Regulating Financial Conflicts Of Interest, Robert Gatter

All Faculty Scholarship

There has been a call for more stringent regulation of financial conflicts of interest in human subjects research following the deaths of several individuals who volunteered to participate in human subjects research, which deaths were linked to the financial conflicts of interest of participating researchers and research institutions. Each proposal argues that regulation is necessary to restore trust in medical research. This Article examines whether proposed strategies for regulating financial conflicts of interest are likely to achieve the goal of a trustworthy human research enterprise. It does not question whether enhancing trustworthiness is an appropriate goal; rather, it assumes that …

Reaching Through The Genome, Rebecca S. Eisenberg

Book Chapters

The past two decades have been a period of rapid evolution in the science of biotechnology and therefore in patent strategies, if not in patent law itself. Patent law takes a long time to catch up with science, and commentators take a long time to catch up with the law, but patent lawyers don’t have that luxury. They have to keep ahead of the game, figuring out claiming strategies that allow their clients to capture the value of future discoveries. I want to discuss some of these strategies today.

Bayh-Dole Reform And The Progress Of Biomedicine, Arti K. Rai, Rebecca S. Eisenberg

Articles

Advances in fundamental biomedical research play an important and growing role in the development of new therapeutic and diagnostic products. Although the development of pharmaceutical end products has long been a proprietary enterprise, biomedical research comes from a very different tradition of open science. Within this tradition, long-standing norms call for relatively unfettered access to fundamental knowledge developed by prior researchers. The tradition of open science has eroded considerably over the past quarter century as proprietary claims have reached farther upstream from end products to cover fundamental discoveries that provide the knowledge base for future product development.

An Overview Of Progress In The International Regulation Of The Pharmaceutical Industry, Joan Costa-Font, Aaron Burakoff Harvard University; University Of Barcelona

The University of New Hampshire Law Review

[Excerpt] “The pharmaceutical industry, a significant source of healthcare throughout the world, has several features that distinguish it from the rest of the health industry. In the last half-century, new technology, better technological know-how, and overall economic growth have led to widespread and rapid growth in the pharmaceutical sector. Advancements in pharmaceutical research and development have led to the production of drugs that can routinely combat afflictions that, only years ago, were untreatable or even fatal. Since 1970, the average share of Gross Domestic Product (GDP) on pharmaceutical goods has increased in most Organization for Economic Cooperation and Development (OECD) …

Key Disclosure Issues For Life Sciences Companies: Fda Product Approval, Clinical Test Results, And Government Inspections, William O. Fisher

Michigan Telecommunications & Technology Law Review

The government, particularly the Food and Drug Administration ("FDA"), heavily regulates the life sciences industry. FDA actions can have an extraordinary influence on the fortunes of biotechnology companies. Timely FDA approval of a drug or medical device can permit a company to exploit an inviting market window. FDA product approval is, in turn, tied to clinical test results which demonstrate "efficacy" and safety. Delayed approval, unfavorable test results, or the denial of an FDA application may ruin a company. Beyond the FDA product approval process and related testing lie FDA inspections and the possibility that the government will investigate charges …

International Intellectual Property, Access To Health Care, And Human Rights: South Africa V. United States, Winston P. Nagan

UF Law Faculty Publications

This Article examines the question of access to patented medicines in international law. It analyzes the extent to which international agreements may lawfully limit affordable versions of these medicines that may be available through parallel imports or compulsory licensing procedures. It considers the concept of intellectual property rights from a national and international perspective to determine how these rights must be sensitive to matters of national sovereignty when extraordinary, life-threatening diseases afflict societies in catastrophic ways. This Article suggests that viewing property (including intellectual property) as a human right requires that its scope be delimited and understood in the context …

The Role Of Patents In Exploiting The Genome, Rebecca S. Eisenberg

Book Chapters

The sequencing of the human genome is a great scientific accomplishment that opens the door to further scientific inquiry of a sort that would otherwise be impossible. In addition to being passionately interested in the patent issues this research presents, as a legal scholar I have a long-standing interest in the role of intellectual property in interactions between the public and private senators and between universities and private firms in research science, with a focus on biomedial research. However, although the Human Genome Project has provided a rich terrain for exploring these issues, I am puzzled that intellectual property issues …

International Governance Through Trade Agreements: Patent Protection For Essential Medicines, Judy Rein

Northwestern Journal of International Law & Business

This paper examines the current conflicts surrounding the implementation of patent protection for pharmaceuticals. Part II outlines the specifics of trade agreements shaping the global intellectual property regime and the consequences for governments seeking to devise an essential drugs policy. Part III analyzes the process of obtaining consensus and compliance with patent protection rules through the negotiation and implementation of trade agreements, and the utilization of dispute settlement mechanisms. This section also examines the aggressive application of unilateral measures to induce adherence to levels of protection beyond those established at the multilateral and regional level. Part IV considers alternative approaches …

Parallel Trade In The Pharmaceutical Industry: Implications For Innovation, Consumer Welfare, And Health Policy Article, Clause E. Barfield, Mark A. Groombridge

Fordham Intellectual Property, Media and Entertainment Law Journal

No abstract provided.

Statutory Compliance And Tort Liability: Examining The Strongest Case, Michael D. Green

University of Michigan Journal of Law Reform

Professor Green addresses the matter of the proper balance between the tort system and regulation in the context of prescription drugs and the FDA's vigorous oversight of the industry. He articulates several reasons why a regulatory compliance defense, in which tort law would defer to FDA regulation, is quite attractive. Despite the superior expertise of the FDA in assessing the benefits and risks of a drug, a regulatory compliance defense is considerably more problematical than might appear at first glance. Ascertaining compliance with FDA requirements could be a lengthy and complicated inquiry that would either replace or supplement the issues …

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 …

Pharmaceuticals: Test Bed For European Themes On Trademarks And The Free Movement Of Goods, Ian S. Forrester, Anne N. Nielson

Fordham Intellectual Property, Media and Entertainment Law Journal

No abstract provided.

Book Review Of Michael D. Green, Bendectin And Birth Defects: The Challenges Of Mass Toxic Substance Litigation, Stefan Oglevee

RISK: Health, Safety & Environment (1990-2002)

Review of Michael D. Green, Bendectin and Birth Defects: The Challenges of Mass Toxic Substances Litigation (University of Pennsylvania Press 1996). Acknowledgements, index, preface, selected bibliography. LC 95-42306; ISBN 0-8122-3257-7 [368 pp. $29.95 Cloth. 1300 Blockley Hall, 418 Service Drive, Philadelphia PA 19104-6097.]

Decision Analysis And Fda Drug Review: A Proposal For Shadow Advisory Committees, John M. Mendeloff

RISK: Health, Safety & Environment (1990-2002)

The FDA seems to acknowledge that sometimes different standards of proof for assessing drug efficacy should be used. Dr. Mendeloff thus proposes a methodology that might illuminate the FDA's decision-making and help better to assess its decisions.

Worms, Mice, Cows And Pigs: The Importance Of Animal Patents In Developing Countries, Elisabeth T. Jozwiak

Northwestern Journal of International Law & Business

Transgenic animals play a large role in several critical industries: the pharmaceutical industry, the agricultural industry, farming, and medical research. As these biotechnology-oriented industries have grown, the United States and other industrialized nations have realized the importance of patent protection for genetically-engineered animals. Unfortunately, lesser-developed countries (LDCs), which can benefit the most from such industries, do not provide adequate patent protection for transgenic animals, even though patent protection for transgenic animals could ultimately lead to reduction in starvation and disease, two of the biggest problems facing many LDCs. The United States should pursue bilateral negotiations with developing countries in the …

The Proposed Products Liability Restatement: A Misguided Revision, Jerry Phillips

Touro Law Review

No abstract provided.

Pharmaceuticals And Intellectual Property: Meeting Needs Throughout The World, Thomas G. Field Jr.

Law Faculty Scholarship

To the extent that most people think about patents and other forms of intellectual property at all, they tend to be aware that the owners of such property may have the legal capacity to limit market entry--without fully appreciating the extent to which products or processes that can be easily copied might otherwise be unavailable. Focusing on their function in recouping risk capital, this article will survey the types and functions of intellectual property. Then it will attend to the situation in developing countries, particularly the role of intellectual property in meeting their needs for medical products.

Unavoidably Unsafe Products And Strict Products Liability: What Liability Rule Should Be Applied To The Sellers Of Pharmaceutical Products?, Richard C. Ausness

Law Faculty Scholarly Articles

Injuries from adverse drug reactions have increased dramatically in recent years. This increase is largely attributable to the changing nature of pharmaceutical products. First of all, more pharmaceutical products are currently available to physicians than ever in history. Presently, there are more than ten thousand prescription drugs on the market, and each year four hundred to five hundred new ones are introduced. Second, modern drugs often are more potent than their older counterparts, thus increasing the likelihood of adverse reactions.

It should come as no surprise that this rise in the number of drug-related injuries has led to a comparable …

The Application Of A Due Diligence Requirement To Market Share Theory In Des Litigation, Thomas C. Willcox

University of Michigan Journal of Law Reform

This Note argues that courts should impose a due diligence requirement on plaintiffs as a prerequisite to the use of market share theory. Part I examines traditional products liability theories along with alternative theories and explains the relationship of due diligence to market share theory. Part II argues that due diligence should be a prerequisite to market share liability. Part III discusses the nature of due diligence in this context. Finally, Part IV considers various objections to a due diligence requirement and argues that they are essentially without merit.

Contract Law In Modern Commercial Transactions, An Artifact Of Twentieth Century Business Life?, James J. White

Articles

Diligent first year law students study contract law with a passion previously reserved for romantic objects and religious idols. Their professors lead them in extensive and difficult intellectual explorations of the wilds of contract law. There are careful analyses of why damage recovery X will stimulate performance Y, why recovery A is appropriate to encourage the aggrieved party to return to the market, and so on and so forth. Lurking behind this year long analysis are several inarticulate hypotheses: that they make rational evaluations of the threat of legal sanctions; that they respond in other varied and subtle ways to …

The Supreme Court's Opinion In The Inwood Case: Declination Of Duty, Kenneth B. Germain

Kentucky Law Journal

No abstract provided.

Legislative Notes: The Fda's Over-The Counter Drug Review: Expeditious Enforcement By Rulemaking, David Selmer

University of Michigan Journal of Law Reform

This article attempts to show that the OTC drug review has distinct advantages over traditional drug regulation. Part I outlines briefly the traditional case-by-case approach to drug licensing and describes FDA enforcement efforts prior to the OTC drug review. Part II sets forth the new rulemaking approach and considers the use of advisory panels. Part III examines several procedural questions associated with the review and concludes that the use of monographs as regulatory standards will afford the FDA an expeditious enforcement mechanism by resolving complex scientific issues at the administrative rather than the judicial level. Judicial review should be available, …

The Ftc's Injunctive Authority Against False Advertising Of Food And Drugs, Michigan Law Review

Michigan Law Review

Two judicial decisions in the early 1950s construing the FTC's section 13 (a) power produced a conflict that has not been resolved either by later courts or by the amendments to section 13 enacted in 1973. The dispute basically concerns the depth of the courts' inquiry into whether an advertisement violates- section 12 and the applicability of traditional equitable concepts in the context of the statutory injunction procedure. This Note contends that the legislative history of pertinent provisions of the Act suggests an appropriate resolution of the conflict through a two-step approach that would relax the scrutiny ordinarily accorded petitions …

Improving Michigan's Generic Drug Law, Phyllis Greenwood Rozof

University of Michigan Journal of Law Reform

This note will describe the conditions which existed prior to enactment of the Michigan drug substitution law, will discuss the history and provisions of that legislation, and will identify certain problems which the law fails to correct.

The Prosubstitution Trend In Modern Pharmacy Law, Sidney H. Willig

University of Michigan Journal of Law Reform

This article explores the legal problems presented to the practicing pharmacist by drug substitution. It delineates the practical and economic realities bearing on substitution and the arguments both in favor of and against limited legal substitution. After describing the current status of the law on the subject and the various resultant liabilities of the pharmacist, the article then suggests means by which substitution might be made an acceptable practice in certain circumstances.

Governmental Regulation Of The Drug Industry, J. Mark Hiebert

Cleveland State Law Review

In today's world of increased government participation in business, certain industries are frequently spotlighted for particular attention. The communications industry is one, the drug industry is another. In both cases the special attention is fitting, for the communications industry, like the drug industry, each in its own way, reaches the very fiber of American life. Each has the inherent capability of changing our political and social order. At any rate two points are basic: first, the drug industry directly affects the foundations of our society and therefore is a reasonable concern of government. Secondly, the drug industry has a legitimate …