Intellectual Property Law Commons^™

Breaking The Bank: Revisiting Central Bank Of Denver After Enron And Sarbanes-Oxley, Celia Taylor

ExpressO

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 …

Regulating The Regulators: The Impact Of Fda Regulation On Corporations' First Amendment Rights, 39 J. Marshall L. Rev. 95 (2005), Lisa M. Fealk-Stickler

UIC Law Review

No abstract provided.

Public Use Or Experimental Use: Are Clinical Trials Susceptible To Another Attack Similar To That In Smithkline Beecham Corp. V. Apotex Corp., 39 J. Marshall L. Rev. 149 (2005), Nimalka Wickramasekera

UIC Law Review

No abstract provided.

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 …

"As The Federal Circuit Turns": The Supreme Court's Consideration Of Merck V. Integra And The Safe Harbor Provision, 4 J. Marshall Rev. Intell. Prop. L. 368 (2005), Blair M. Jacobs, Christina A. Ondrick

UIC Review of Intellectual Property Law

The Hatch-Waxman Act was enacted to balance the competing interests in the pharmaceutical marketplace between brand name and generic drug manufacturers. In the twenty years since its inception, the safe harbor provision contained in § 271(e)(1), has been interpreted to provide broad protection to those involved in research activities. However, in 2003, the Federal Circuit narrowly interpreted the safe harbor provision in a move that could potentially frustrate future research and improvements on patented technologies. Merck v. Integra is currently before the United States Supreme Court, who has the challenge of unraveling the competing interests involved. In order to encourage …

Note: Exclusive Licensing Of Dna Diagnostics: Is There A Negative Effect On Quantity And Quality Of Healthcare Delivery That Compels Nih Rulemaking?, Edward Weck

William Mitchell Law Review

This comment surveys the costs of deoxyribonucleic acid (DNA) diagnostic tests and argues in favor of non-exclusive licensing as a means to provide broad access to affordable DNA diagnostic testing. Part II provides background information on genetic testing, patenting genes as applied to genetic testing, the Bayh-Dole Act, and technology transfer. In addition, Part II summarizes academic commentary regarding the implications of exclusive licensing for biotechnology. Scholars propose a number of solutions, including expanding the experimental use exception. Part III details proposed rulemaking for DNA diagnostics. Part IV reviews anecdotal examples of genetic testing for breast cancer, hereditary hemochromatosis, and …

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 …

Modern Bootlegging And The Prohibition On Fair Prices: Last Call For The Repeal Of Pharmaceutical Price Gouging, Luke W. Cleland

ExpressO

This article discusses the recent passage of the Medicare Prescription Drug, Modernization and Improvement Act of 2003, and the executive and judicial decisions affecting the ability of the general public to access foreign pharmaceutical markets. The article examines the recent actions taken by the U.S. government, explore various state movements within the United States aimed at reducing pharmaceutical drug prices, outline the process of pharmaceutical drug prices in foreign countries, and advocate for a workable integration of all available mechanisms to feasibly reduce prescription drug prices for the benefit of both U.S. consumers and U.S. drug companies. As avenues to …

Global Intellectual Property Protection As Viewed Through The European Community's Treatment Of Geographical Indications: What Lessons Can Trips Learn?, Jacqueline Nanci Land

Cardozo Journal of International and Comparative Law

The note examines the European Community's (EC) approach to geographical indications (GIs) and its implications for the TRIPS Agreement, highlighting the EC as a potential model for harmonizing intellectual property (IP) laws globally. It argues that while TRIPS has made significant strides in creating an international IP framework, challenges such as differing national priorities and the influence of industrialized nations hinder full harmonization. The EC's integrated system, particularly its handling of GIs, offers valuable lessons for addressing these challenges and achieving more effective global IP protection.

Will The European Union Prove To Be Lactose Intolerant? The European Union's Attempt To Strike A Delicate Balance Between Protecting Appellation Of Origin For Cheese And The Promotion Of Free Movement Of Goods Between Member States, Danielle B. Shalov

Cardozo Journal of International and Comparative Law

The note examines the tension within the European Union between protecting traditional cheese-making methods through designations of origin and ensuring the free movement of goods. It highlights how the EU has navigated this balance through regulations and judicial decisions, ultimately favoring free trade while attempting to preserve cultural and geographical heritage tied to food production.

The Effectiveness Of International Enforcement Of Intellectual Property Rights, 37 J. Marshall L. Rev. 985 (2004), Allison Cychosz

UIC Law Review

No abstract provided.

2004 Update - 180-Day Exclusivity Under The Hatch-Waxman Amendments To The Federal Food, Drug, And Cosmetic Act, Erika Lietzan

Faculty Publications

This article updates the author's previously published article on the topic, provides some insight into recent events in this area of the law, and specifies a few minor items that were noted incorrectly in the earlier work.

The Implementation Of Fda Determinations In Litigation - Why Do We Defer To The Pto But Not To The Fda?, William G. Childs

Faculty Scholarship

This Article examines the possible inequity of the treatment of licensees' rights in tort litigation in comparison to patent rights in patent litigation. In particular, this Article presents the presumptions afforded from issued patents as a valid model for the proper treatment of FDA approval in litigation. Presently, most academic discussion proposes either preclusion of tort claims or leaving the system more or less as it stands. This Article, on the other hand, proposes a middle ground.

This Article begins by examining the differences between the USPTO and the FDA. In particular, the quantity and quality of the review provided …

Ethnopharmacology, Patents And The Politics Of Plants' Genetic Resources, Remigius N. Nwabueze

Cardozo Journal of International and Comparative Law

The article critiques the exploitation of the South's biodiversity and genetic resources by the North, driven by self-interest and pharmaceutical needs, while highlighting the inequities perpetuated by international frameworks like TRIPS and the CBD. It argues that current legal systems, rooted in Western intellectual property principles, fail to protect indigenous knowledge and traditional practices adequately. The analysis proposes alternative approaches, such as compensation regimes and collective rights organizations, to address these disparities and ensure fair benefit-sharing.

Traditional Medical Knowledge, Intellectual Property Rights & Benefit Sharing, Gerard Bodeker

Cardozo Journal of International and Comparative Law

The article argues that there is a significant conflict between the exploitation of traditional medical knowledge (TMK) by commercial entities and the efforts of indigenous communities to protect their knowledge. This conflict stems from the clash between the intellectual property (IP) system, which often favors corporate interests, and the rights of indigenous peoples to their traditional knowledge. The article highlights the need for equitable legal frameworks to address issues of ownership, benefit sharing, and prior informed consent, particularly in the context of international agreements like TRIPS and the CBD.

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

Allowing universities to patent the results of government-sponsored research sometimes works against the public interest.

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.

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 …

Industry Strategies For Intellectual Property And Trade: The Quest For Trips, And Post-Trips Strategies, Susan K. Sell

Cardozo Journal of International and Comparative Law

The article examines the origins, negotiation, and post-implementation strategies of the TRIPS Agreement, emphasizing the significant role of U.S. corporate interests in shaping this global intellectual property regime. It highlights how industries leveraged political and legal mechanisms to enforce TRIPS, while also addressing emerging challenges and opposition, particularly concerning public health and biotechnology.

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 …

Sustainable Agriculture, Patent Rights, And Plant Innovation, Mark D. Janis

Indiana Journal of Global Legal Studies

No abstract provided.

Computer-Aided Drug Design Using Patented Compounds: Infringement In Cyberspace?, 34 J. Marshall L. Rev. 1001 (2001), Ted L. Field

UIC Law Review

No abstract provided.

Pharmaceutical Patent Protection: More Generic Favored Legislation May Cause Pioneer Drug Companies To Pull The Plug On Innovation, Mandy Wilson

Kentucky Law Journal

No abstract provided.

Deleting The Bolar Amendment To The Hatch-Waxman Act: Harmonizing Pharmaceutical Patent Protection In A Global Village, 32 J. Marshall L. Rev. 751 (1999), Ned Milenkovich

UIC Law Review

No abstract provided.

Licensed To Steal: Has Sovereign Immunity Gone Too Far, 32 J. Marshall L. Rev. 779 (1999), Sulaiman M. Qazi

UIC Law Review

No abstract provided.

It's A Wonderful Genome: The Written-Description Requirement Protects The Human Genome From Overly-Broad Patents, 32 J. Marshall L. Rev. 805 (1999), Emanuel Vacchiano

UIC Law Review

No abstract provided.

Patents: Help Or Hindrance To Technology Transfer?, Rebecca S. Eisenberg

Book Chapters

Intellectual property is a broad heading used to refer to a wide variety of rights associated with inventions, discoveries, writings, artistic works, product designs, and designations of the source of goods and services. Patents and trade secrets are the most important of these sorts of intellectual properties in the field of biotechnology. One aspect of intellectual property that distinguishes it sharply from other forms of property-and for some people makes it harder to justify-is that intellectual properties may be possessed and used by many people simultaneously. This is not so for tangible property. If someone borrows my car, I cannot …