Law Commons^™

The Uneasy Case For Patent Law, Rachel E. Sachs

Michigan Law Review

A central tenet of patent law scholarship holds that if any scientific field truly needs patents to stimulate progress, it is pharmaceuticals. Patents are thought to be critical in encouraging pharmaceutical companies to develop and commercialize new therapies, due to the high costs of researching diseases, developing treatments, and bringing drugs through the complex, expensive approval process. Scholars and policymakers often point to patent law’s apparent success in the pharmaceutical industry to justify broader calls for more expansive patent rights.

This Article challenges this conventional wisdom about the centrality of patents to drug development by presenting a case study of …

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 …

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 …

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 …

The New Codex Alimentarius Commission Standards For Food Created With Modern Biotechnology: Implications For The Ec Gmo Framework's Compliance With The Sps Agreement, Aaron A. Ostrovsky

Michigan Journal of International Law

This Note makes two assertions. First, despite the fact that the Codex guidelines do not specifically invoke the Precautionary Principle in name, it can indeed be read into the guidelines in the amount of deference given to states in how they assess risk. This in turn means that the E.C.'s Deliberate Release Directive should be enjoy a presumption of compliance with both the SPS Agreement and the GATT. The second assertion is that even if the adjudicating body of the WTO finds that the Deliberate Release Directive, in relying on the Precautionary Principle, prescribes a higher level of protection than …

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 …

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.

Seeds Of Distrust: Federal Regulation Of Genetically Modified Foods, Thomas O. Mcgarity

University of Michigan Journal of Law Reform

This Article describes and evaluates the existing federal regulatory regime for protecting public health from risks posed by foods derived from GM plants. Part I briefly describes the technology involved in genetically modifying plants and relates the ongoing debates over the risks and benefits of GM food plants. Part II examines in detail the regulatory regime that has evolved in the United States to regulate the safety of GM foods, focusing in particular upon the pervasive role that the substantial equivalence doctrine has played in that regime. Finally, Part III suggests a more precautionary approach toward regulating GM foods that …

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 …