Law Commons^™

Nudging The Fda, W. Nicholson Price Ii, I. Glenn Cohen

Law Faculty Scholarship

[Excerpt] "The FDA’s regulation of drugs is frequently the subject of policy debate, with arguments falling into two camps. On the one hand, a libertarian view of patients and the health care system holds high the value of consumer choice. Patients should get all the information and the drugs they want; the FDA should do what it can to enforce some basic standards but should otherwise get out of the way. On the other hand, a paternalist view values the FDA’s role as an expert agency standing between patients and a set of potentially dangerous drugs and potentially unscrupulous or …

Intellectual Property And Opportunities For Food Security In The Philippines, Jane Payumo, Howard Grimes, Antonio Alfonso, Stanley P. Kowalski, Keith Jones, Karim Maredia, Rodolfo Estigoy

Law Faculty Scholarship

By 2050, the Philippine population is projected to increase by as much as 41 percent, from 99.9 million to nearly 153 million people. Producing enough food for such an expanding population and achieving food security remain a challenge for the Philippine government. This paper argued that intellectual property rights (IPR) can play a key role in achieving the nation’s current goal to be food-secure and provided examples to illustrate that the presence of sound intellectual property (IP) helps foster research, development, and deployment of agricultural innovations. This paper also offered key recommendations about how the IP system can be further …

Exhausted Or Unlicensed: Can Field-Of-Use Restrictions In Biotech License Agreements Still Prevent Off-Label Use Promotion After Quanta Computer?, Kristal M. Wicks

The University of New Hampshire Law Review

[Excerpt] “In the biotechnology (biotech) industry, companies must be increasingly aware of their intellectual property and how their licensing strategies can impact their rights. When licensing patented technology, it is common practice for biotech companies to include restricted field-of-use provisions in their license agreements. Such provisions permit a licensee to only use licensed technology in a defined field and restrict use or development in another field. This licensing strategy plays an important role within the biotech industry because it allows companies to more effectively control their intellectual property and to more efficiently research and develop pharmaceutical products.

A problem that …

Normalizing Novelty: Regulating Biotechnological Risk At The U.S. Epa, Les Levidow, Susan Carr

RISK: Health, Safety & Environment (1990-2002)

Drs. Levidow and Carr examine EPA's regulation of biotechnology in the field of genetically modified organisms.

Genome Research And Traditional Intellectual Property Protection -- A Bad Fit?, Kate H. Murashige

RISK: Health, Safety & Environment (1990-2002)

Dr. Murashige addresses the need for a patent system more closely tailored to the needs of biotechnology. For example, the obviousness requirement may interfere with using patents to recoup high costs of work when it could arguably be done by researchers of ordinary skill.

Maximizing The Return From Genome Research: Introduction, Thomas G. Field Jr.

RISK: Health, Safety & Environment (1990-2002)

Professor Field introduces and explains the origins of the symposium.

Biotechnology Process Patents: Is Special Legislation Needed?, Timothy P. Linkkila, Timothy E. Tracy

RISK: Health, Safety & Environment (1990-2002)

The authors review administrative and court decisions prompting proposed changes to the patent law. After reviewing pros and cons, they argue that, on balance, pending bills can easily cause more problems than they solve.

Origins Of The Human Genome Project, Robert Mullan Cook-Deegan

RISK: Health, Safety & Environment (1990-2002)

Dr. Cook-Deegan recounts some of the scientific and political history leading to controversy about the proper mix of private and public roles in pursuing genome research and bringing its fruits to bear, e.g., in preventing and curing disease.

Overview Of Potential Intellectual Property Protection For Biotechnology, Kate H. Murashige

RISK: Health, Safety & Environment (1990-2002)

Dr. Murashige compares the function and value of copyright, patent and trade secret laws in recovering investments in developing genome-related biotechnology.

Book Review, Allan M. Wheatcraft

RISK: Health, Safety & Environment (1990-2002)

Review of the following book: SHELDON KRIMSKY, BIOTECHNICS AND SOCIETY: THE RISE OF INDUSTRIAL GENETICS. (Praeger 1991) [280 pp.] Bibliography, figures, index, list of acronyms used, tables. LC: 90-23214, ISBN: 0-275-93860-3. [Paper $17.95. P.O.B. 5007, Westport CT 06881.]