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Manufacturing Barriers To Biologics Competition And Innovation, W. Nicholson Price Ii, Arti K. Rai

Faculty Scholarship

As finding breakthrough small-molecule drugs gets harder, drug companies are increasingly turning to “large molecule” biologics. Although biologics represent many of the most promising new therapies for previously intractable diseases, they are extremely expensive. Moreover, the pathway for generic-type competition set up by Congress in 2010 is unlikely to yield significant cost savings.

In this Article, we provide a fresh diagnosis of, and prescription for, this major public policy problem. We argue that the key cause is pervasive trade secrecy in the complex area of biologics manufacturing. Under the current regime, this trade secrecy, combined with certain features of FDA …

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 …

Supplemental Forms Of Intellectual Property Protection For Plants, Mark D. Janis

Articles by Maurer Faculty

A new hierarchy of intellectual property protection for plant innovation is emerging. Utility patent protection is poised to become the dominant intellectual property mechanism for plants in the U.S. and perhaps elsewhere. Plant breeder's rights systems continue to garner a dedicated following, especially in developing countries, as a means for complying with international intellectual property treaty obligations. But while utility patent and plant breeder's rights regimes have come to occupy the first tier of the intellectual property hierarchy for plants, other forms of intellectual property protection remain important, albeit in a supplemental role. This article surveys supplemental intellectual property strategies …

Alternative Dispute Resolution In Patent Controversies, Norman L. Balmer

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

Mr. Balmer relates how ADR allows attorneys to tailor rules to resolve disputes in light of, e.g., party relationships and internal dynamics. He notes that, for life to go on, having resolution is itself an important goal.