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Manufacturing Barriers To Biologics Competition And Innovation, W. Nicholson Price Ii, Arti K. Rai
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 …
Director Confidentiality, Cyril Moscow
Director Confidentiality, Cyril Moscow
Law and Contemporary Problems
The Corporate Directors Guidebook contains the bare proposition that a director must keep confidential all matters involving the corporation that have not been disclosed to the public. Moscow explores the need to modify the flat recitation of a rule of director confidentiality in light of the limited authority for a blanket restriction, and the necessary exceptions in the business contexts in which the issue arises. In particular, many situations do not involve damage to the corporation, or there is express or implied consent to the sharing of information.
How Trade Secrecy Law Generates A Natural Semicommons Of Innovative Know-How, Jerome H. Reichman
How Trade Secrecy Law Generates A Natural Semicommons Of Innovative Know-How, Jerome H. Reichman
Faculty Scholarship
No abstract provided.
Reforming The Law Of Proprietary Information, Chris Montville
Reforming The Law Of Proprietary Information, Chris Montville
Duke Law Journal
No abstract provided.
“An Ingenious Man Enabled By Contract”: Entrepreneurship And The Rise Of Contract, Catherine Fisk
“An Ingenious Man Enabled By Contract”: Entrepreneurship And The Rise Of Contract, Catherine Fisk
Faculty Scholarship
A legal ideology emerged in the 1870s that celebrated contract as the body of law with the particular purpose of facilitating the formation of productive exchanges that would enrich the parties to the contract and, therefore, society as a whole. Across the spectrum of intellectual property, courts used the legal fiction of implied contract, and a version of it particularly emphasizing liberty of contract, to shift control of workplace knowledge from skilled employees to firms while suggesting that the emergence of hierarchical control and loss of entrepreneurial opportunity for creative workers was consistent with the free labor ideology that dominated …
Antitrust Restrictions On Trade Secret Licensing: A Legal Review And Economic Analysis, Elizabeth Miller
Antitrust Restrictions On Trade Secret Licensing: A Legal Review And Economic Analysis, Elizabeth Miller
Law and Contemporary Problems
No abstract provided.
Developments Under The Freedom Of Information Act—1982, Steven J. Lepper
Developments Under The Freedom Of Information Act—1982, Steven J. Lepper
Duke Law Journal
No abstract provided.
Protecting Trade Secrets Through Copyright, Stephen M. Dorvee
Protecting Trade Secrets Through Copyright, Stephen M. Dorvee
Duke Law Journal
No abstract provided.