Law Commons^™

Is The Eli Lilly Written Description Requirement A Paper Tiger?: A Comprehensive Assessment Of The Impact Of Eli Lilly And Its Progeny In The Courts And Pto, Christopher M. Holman

ExpressO

In University of California v. Eli Lilly, decided by the Federal Circuit in 1997, the court established for the first time a new form of patent law’s written description requirement, apparently targeted specifically at biotechnology. To this day, the conventional wisdom is that the so-called Lilly written description requirement (“LWD”) exists as a biotechnology-specific “super-enablement” requirement, substantially more stringent than the enablement requirement (the conventional standard for patentability), and standing as an impediment to effective patent protection for biotechnology inventions. My objective in writing this article was to test this conventional wisdom, by conducting a comprehensive search for all LWD …

Stealing What's Free: Exploring Compensation To Body Parts Sources For Their Contribution To Profitable Biomedical Research, Jo-Anne Yau

ExpressO

It is undisputed in the biotechnology industry that human body parts play a vital role in research. The body parts donors, referred to as "Sources" in this article, are subjected to physical and financial exploitation. Forbidding the explosion of profits from trickling down to the Source presents an irrational inequity. Despite established law, it is evident from case analysis, prevailing social practices, and constitutional interpretation that Source compensation is a plausible solution.

This article proposes a model of compensation for Sources, whereby Sources are compensated based on a proportionate share of the research profits set aside for the Source as …

Biopiracy And Beyond: A Consideration Of Socio-Cultural Conflicts With Global Patent Policies, Cynthia M. Ho

University of Michigan Journal of Law Reform

This Article provides afresh and multi-dimensioned approach to a long-standing claim of biopiracy patents made by developing countries and communities. The basic principles of patent law and policy are first established to provide a foundation from which to evaluate the claim that genetic resources and traditional knowledge from developing countries are being misappropriated in a variety of ways that are loosely referred to as biopiracy. The Article distinguishes rhetoric from reality in examining biopiracy allegations from the perspective of national patent laws, as well as international agreements. In addition, the Article explains the underlying conflicts, misconceptions, and historical biases that …

Biotechnology Entrepreneurship And Ethics: Principles, Paradigms, And Products, Patricia C. Kuszler

Articles

Biotechnology, whether in the context of new drugs derived from DNA and genetic technology, genetically modified food, or biologics making use of living cells, raises ethical concerns at a variety of different levels. At the research level, there is concern that the very nature of research is being subverted, rather than enhanced, by entrepreneurship. This area of ethical concern has intensified in the United States as a result of the conflicts of interests resulting from the growing alliance between University academia and private industry in the research enterprise. As we travel down the research path into development of a drug …

A Realist Approach To Merck Kgaa V. Integra, Daniel A. Lev

Northwestern Journal of Technology and Intellectual Property

No abstract provided.

Artful Prior Art And The Quality Of Dna Patents, Andrew Chin

Faculty Publications

No abstract provided.

Biotechnology's Prescription For Patent Reform, Christopher M. Holman

Faculty Works

On June 8, 2005, Congressman Lamar Smith introduced H.R. 2795, the Patent Reform Act of 2005, aimed at improving the quality and certainty of issued patents, simplifying the patent procurement process, harmonizing U.S. law with international practice, and reining in abusive patent enforcement practices. Congress has set the legislation aside for the time being, but will likely revisit the issue again shortly. The biotechnology industry, one of the fastest growing sectors in the United States economy, strongly opposes many of the proposed reforms. This paper considers the Congressional testimonies of the Biotechnology Industry Organization ("BIO") and other representatives of biotechnology's …

The Story Of Diamond V. Chakrabarty: Technological Change And The Subject Matter Boundaries Of The Patent System, Rebecca S. Eisenberg

Book Chapters

Technological change often exposes unstated assumptions lurking in the law and makes them problematic, and patent law is no exception. Although the core mission of the patent system is to promote technological progress, path-breaking new technologies have not always been easily assimilated within its boundaries. The first wave of patent applications on advances in biotechnology in the 1970s illustrate some of the difficulties. Before that time, living organisms had generally been assumed to fall outside the range of patent-eligible subject matter under a timehonored exclusion for "products of nature." But genetically engineered organisms, although derived from naturally occurring life forms, …

Rules V. Standards For Patent Law In The Plant Sciences, Mark D. Janis

Articles by Maurer Faculty

This article argues that US patent jurisprudence as applied to the plant sciences is moving to a second stage that will be characterized by more by incremental calibration than by spectacular change. The article discusses two doctrines of patent scope that are likely to be implicated in calibrating the utility patent system for the plant sciences: enablement and experimental use. It considers how those doctrines may be refined to serve as calibration tools in the application of patent law to the plant sciences.

Share And Share Alike: Increasing Access To Government-Funded Inventions Under The Bayh-Dole Act, Gary Pulsinelli

Scholarly Works

The Bayh-Dole Act attempts to utilize the incentives of the patent system to persuade companies to develop inventions arising from government-funded research, allowing recipients of government funding to patent their inventions and then sell or license those patents as they see fit. The Act has, in many respects, succeeded in its goal of getting the results of government-funded research into the hands of industry, but sometimes at the cost of limiting or taxing future research. Thus, commentators have proposed changes to the Act that will help avoid these costs without destroying the benefits. One such proposal would require the National …