Law Commons^™

The "Reasonable Plant" Test: When Progress Outruns The Constitution, Max Oppenheimer

All Faculty Scholarship

No abstract provided.

Maintaining Competition In Copying: Narrowing The Scope Of Gene Patents, Oskar Liivak

Cornell Law Faculty Publications

In supporting gene patents, the patent office, the courts and other supporters have assumed that gene discoveries are identical to traditional inventions and therefore the patent system should treat them as identical. In other words, they have assumed that the relatively broad claims that are used for traditional inventions are also appropriate for encouraging gene discovery. This article examines this assumption and finds that gene discoveries are critically different from traditional inventions and concludes that the patent system cannot treat them as identical.

As a doctrinal matter, this article applies the generally overlooked constitutional requirements of inventorship and originality and …

Intellectual Property Management In Health And Agricultural Innovation: A Handbook Of Best Practices, Vol. 2, Anatole Krattiger, Richard T. Mahoney, Lita Nelsen, Jennifer A. Thomson, Alan B. Bennett, Kanikaram Satyanarayana, Gregory D. Graff, Carlos Fernandez, Stanley Kowalski

Law Faculty Scholarship

Prepared by and for policy-makers, leaders of public sector research establishments, technology transfer professionals, licensing executives, and scientists, this online resource offers up-to-date information and strategies for utilizing the power of both intellectual property and the public domain. Emphasis is placed on advancing innovation in health and agriculture, though many of the principles outlined here are broadly applicable across technology fields. Eschewing ideological debates and general proclamations, the authors always keep their eye on the practical side of IP management. The site is based on a comprehensive Handbook and Executive Guide that provide substantive discussions and analysis of the opportunities …

Intellectual Property Management In Health And Agricultural Innovation: Executive Guide, Anatole Krattiger, Richard T. Mahoney, Lita Nelsen, Jennifer A. Thomson, Alan B. Bennett, Kanikaram Satyanarayana, Gregory D. Graff, Carlos Fernandez, Stanley Kowalski

Law Faculty Scholarship

Prepared by and for policy-makers, leaders of public sector research establishments, technology transfer professionals, licensing executives, and scientists, this online resource offers up-to-date information and strategies for utilizing the power of both intellectual property and the public domain. Emphasis is placed on advancing innovation in health and agriculture, though many of the principles outlined here are broadly applicable across technology fields. Eschewing ideological debates and general proclamations, the authors always keep their eye on the practical side of IP management. The site is based on a comprehensive Handbook and Executive Guide that provide substantive discussions and analysis of the opportunities …

Intellectual Property Management In Health And Agricultural Innovation: A Handbook Of Best Practices, Vol. 1, Anatole Krattiger, Richard T. Mahoney, Lita Nelsen, Jennifer A. Thomson, Alan B. Bennett, Kanikaram Satyanarayana, Gregory D. Graff, Carlos Fernandez, Stanley Kowalski

Law Faculty Scholarship

Prepared by and for policy-makers, leaders of public sector research establishments, technology transfer professionals, licensing executives, and scientists, this online resource offers up-to-date information and strategies for utilizing the power of both intellectual property and the public domain. Emphasis is placed on advancing innovation in health and agriculture, though many of the principles outlined here are broadly applicable across technology fields. Eschewing ideological debates and general proclamations, the authors always keep their eye on the practical side of IP management. The site is based on a comprehensive Handbook and Executive Guide that provide substantive discussions and analysis of the opportunities …

Rational Risk/Benefit Analysis Of Genetically Modified Crops, Stanley P. Kowalski

Law Faculty Scholarship

Safety concerns over the use of molecular biotechnology in the improvement of crops has generated substantial, heated and confusing debates, often driven by ideology and hysterics. Modification of crops is not new, and biotechnology (in its broadest sense) has been used for over a century to accelerate the development of new crops for food, feed and fibre, so as to meet the demands of a growing global community. The introduction of crops developed via molecular biotechnology [Genetically Modified Crops (GMCs)] represents the latest step in this inexorable innovative progression of technology. However, misinformed concern has led to a broad embrace …

Knowledge Commons: The Case Of The Biopharmaceutical Industry, Arti K. Rai

Faculty Scholarship

No abstract provided.

The Impact Of Human Gene Patents On Innovation And Access: Survey Of Human Gene Patent Litigation, Christopher M. Holman

Faculty Works

In 2005, an article in the highly influential journal Science reported that roughly 20% of human genes are patented. This figure has been widely cited and at times over-interpreted. For example, a popular science fiction author warns the public that their bodies are "owned" by someone else. A bill was introduced in Congress in 2007 that would essentially seek to ban the patenting of DNA. The bill appears motivated in part by a perception that one-fifth of our genes are owned by somebody else, that these owners can do whatever they want with these genes, and that there is "nothing …

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

Faculty Works

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 …

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 …

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 …

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 …

Preparing The Groundwork For A Responsible Debate On Stem Cell Research And Human Cloning, O. Carter Snead

Journal Articles

The debate over both cloning and stem cell research has been intense and polarizing. It played a significant role in the recently completed presidential campaign, mentioned by both candidates on the stump, at both parties' conventions, and was even taken up directly during one of the presidential debates. The topic has been discussed and debated almost continuously by the members of the legal, scientific, medical, and public policy commentariat. I believe that it is a heartening tribute to our national polity that such a complex moral, ethical, and scientific issue has become a central focus of our political discourse. But, …

Treaty Governance, Intellectual Property And Biodiversity, John Linarelli

Scholarly Works

When resources become valuable, various social and institutional pressures come to bear to enclose them in a property rights regime. Given the substantial progress of biotechnology and the life sciences, genetic resources found in biological diversity are experiencing such pressures. The question of how much commodification or commercialization of genetic resources is appropriate is of global concern; it affects the distribution of wealth in and among societies and countries. This article explores the emerging treaty law on intellectual property and biodiversity. It inquires What is biodiversity? and Why is biodiversity preservation important? It then focuses on the United Nations Framework …

Protein Similarity Score: Simplified Version Of The Blast Score As Superior Alternative To Percent Identity For Claiming Genuses Of Related Protein Sequences, Christopher M. Holman

Faculty Works

Recombinant proteins form the basis for most of the products of biotechnology, including drugs, diagnostics, research reagents, genetically modified organisms and industrial enzymes. However, the nature of proteins and the rules of patentability conspire to make it difficult to achieve adequate patent protection for novel proteins and the polynucleotides that encode them. Narrow patent claims limited to protein sequences sharing a high degree of structural identity can generally be designed around by introducing structural changes in the claimed protein, thereby avoiding the patent without substantially altering the protein's function. However, inventors are generally restricted in their ability to broadly claim …

Nanotechnology And Regulatory Policy: Three Futures, Glenn Harlan Reynolds

Scholarly Works

This Article outlines the basic characteristics of nanotechnology as it is currently understood and will briefly describe some of the technical - and social - consequences likely to arise as nanotechnology matures. Next, it examines three potential approaches for regulating nanotechnology and the likely consequences of each. The Article concludes with suggestions for further study, as well as a list of "dos" and "don'ts" for regulating nanotechnology.

Day 1. Monday, August 11, 2003: National Renewable Energy Lab, National Energy Renewable Laboratory

Energy Field Tour 2003 (August 11-16)

8 pages (includes illustrations).

Contains references.

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.

Golden Rice: A Case Study In Intellectual Property Management And International Capacity Building, Stanley P. Kowalski, R. David Kryder

Law Faculty Scholarship

In order for agricultural biotechnology (agri-biotech) to play a larger role in the development of sustainable agricultural systems, intellectual property (IP) rights management must be addressed. These issues are not limited to developing countries. With increased globalization, the management of agri-biotech IP rights affects both developing and industrialized countries. In industrialized countries, for example, IP rights risk management entails protection of inventions via strong patent portfolios. For developing countries, IP rights risk management includes the acquisition of rights requisite for the use of inventions essential to the basic welfare of the population. Strategies are needed to bridge these disparate IP …

Foreword: The Promise And Peril Of Biotechnology, Joan H. Krause

Faculty Publications

No abstract provided.

Stranger In A Strange Land: Biotechnology And The Federal Circuit, Lawrence M. Sung

Faculty Scholarship

No abstract provided.

Biotechnology And The Legal Constitution Of The Self: Managing Identity In Science, The Market, And Society, Jonathan Kahn

Faculty Scholarship

This article considers how certain ideas underlying the tort of appropriation may enable use more effectively to deal with the problems presented by a case such Moore v. Regents of the University of California which dealt with property rights of Moore’s spleen cells. First, the author explores how the tort of appropriation of identity opens up new approaches to inform and perhaps supplement principles of property law as a guide to managing genetic information or other materials that seem intimately bound up with a particular human subject. Secondly, the author analyzes how the various opinions produced by the Supreme Court …

The Intellectual And Technical Property Components Of Pro-Vitamin A Rice (Goldenricetm): A Preliminary Freedom-To-Operate Review, R. David Kryder, Stanley P. Kowalski, Anatole F. Krattiger

Law Faculty Scholarship

Rice is a staple food for millions of people, predominantly in Asia, but lacks essential nutritional components such as Vitamin A. This is very important for over 180 million children and women of child bearing age who suffer from Vitamin A deficiency in Asia alone. For this reason, an improvement was made under an effort led by Profs. Ingo Potrykus and Peter Beyer by inserting several genes into rice to produce an improved product called GoldenRice. Because GoldenRice has the potential to be easily integrated into the farming systems of the world's poorer regions, the advent of GoldenRice promises to …

Symposium: Patent Rights And Licensing, Michael S. Baram, Ashley Stevens, Thomas Meyers, Michael J. Meurer

Faculty Scholarship

This panel will discuss intellectual property - the patent incentive, patentability issues, licensing, and litigation-related matters. It will be moderated by Dr. Ashley Stevens, the Director of the Office of Technology Transfer at Boston University. Ashley has multiple degrees, including a doctorate in physical chemistry from Oxford University. He has worked in the biotech industry for a number of years, mostly with startup companies and academic research organizations such as the Dana Farber Cancer Institute, where he was also Director of Technology Transfer. Ashley was instrumental in the startup and operations of firms such as Biotechnica International, and started his …

From Jeans To Genes: The Evolving Nature Of Property Of The Estate, A. Mechele Dickerson

Faculty Publications

No abstract provided.