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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
Articles
As finding breakthrough small-molecule drugs becomes more difficult, 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. This Article provides a fresh diagnosis of and prescription for this major public policy problem. It argues 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 Food and …
Bargaining Over The Transfer Of Proprietary Research Tools: Is This Market Failing Or Emerging?, Rebecca S. Eisenberg
Bargaining Over The Transfer Of Proprietary Research Tools: Is This Market Failing Or Emerging?, Rebecca S. Eisenberg
Book Chapters
This analysis highlights the importance of transactions between prior and subsequent innovators to permit valuable research to go forward across the boundaries of prior patent claims. In a recent article focusing on biomedical research,4 Michael Heller and I argue that too many patent rights on 'upstream' discoveries can stifle 'downstream' research and product development by increasing transaction costs and magnifying the risk of bargaining failures. Just as too few property rights leave communally held resources prone to overuse in a 'tragedy of the commons', too many property rights can leave resources prone to underuse in what Heller calls a 'tragedy …
Opinion Letter As To The Patentability Of Certain Inventions Associated With The Identification Of Partial Cdna Sequences, Rebecca S. Eisenberg, Robert P. Merges
Opinion Letter As To The Patentability Of Certain Inventions Associated With The Identification Of Partial Cdna Sequences, Rebecca S. Eisenberg, Robert P. Merges
Articles
You have asked for our legal opinion on the patentability of inventions claimed in U.S. patent applications 07/716,831, filed June 21, 1991 (the '831 application, or .'831"), 07/837,195, filed September 25, 1992 ("'195"), and 07/952,911, filed February 12, 1993 (."911"), all filed in the name of Craig Venter and others and assigned to the National Institutes of Health "(NIH)." We understand that NIH has abandoned these patent applications and has no present intention of filing similar applications in the future, but that NIH remains interested in the patenting of human DNA sequences from a broader public policy perspective. We have …
Reply To Comments On The Patentability Of Certain Inventions Associated With The Identification Of Partial Cdna Sequences, Rebecca S. Eisenberg, Robert P. Merges
Reply To Comments On The Patentability Of Certain Inventions Associated With The Identification Of Partial Cdna Sequences, Rebecca S. Eisenberg, Robert P. Merges
Articles
A brief reply is in order to clarify our position on the patenting of research tools. We stand by the statement that "there are reasons to be wary of patents on research tools," but that statement should not be understood as a broad condemnation of patents on research tools in all contexts. Indeed, immediately after the cited language our opinion letter acknowledges that withholding patent protection from research tools could undermine private incentives to develop research tools and to make them available to investigators or lead to greater reliance on trade secrecy. Unlike the government, which purports to pursue patent …