Law Commons^™

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 …

Settlements Between Brand And Generic Pharmaceutical Companies: A Reasonable Antitrust Analysis Of Reverse Payments, Anne-Marie C. Yvon, Ph.D.

Fordham Law Review

No abstract provided.

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 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 …

Sell V. United States: Involuntary Administration Of Antipsychotic Medication To Criminal Defendants, Brandy M. Rapp

University of Richmond Law Review

No abstract provided.

Economic Analyses Of Patent Settlement Agreements: The Implementation Of Specific Economic Tests, The Evaluation Of Dynamic Efficiency, And The Scope Of Patent Rights, James Langenfeld, Wenqing Li

University of San Francisco Law Review

No abstract provided.

Drug Regulations And The Constitution After Western States, Margaret Gilhooley

University of Richmond Law Review

No abstract provided.

The Psychological Manipulation Of The Consumer-Patient Population Through Direct-To-Consumer Prescription Drug Advertising., Elizabeth C. Melby

The Scholar: St. Mary's Law Review on Race and Social Justice

Drug direct-to-consumer advertisements manipulates the public through the manufacturer’s marketing practices. The goal of pharmaceutical companies is to create consumer demand for their products, and they achieve this goal by showing advertisements that portray their products as life-enhancing. This leads to an exponential increase in demand for and spending on these pharmaceutical drugs. This increased promotion of direct-to-consumer advertising affects the physician-patient relationship, while drug companies face little, if any, liability. Drug companies expend significant efforts to obtain patents to keep their products competitive on the market, and to prevent customers from switching to an inexpensive generic drug. The author …

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

Fordham Law Review

No abstract provided.

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 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.

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.

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 …