Abstract

http://ssrn.com/abstract=303619
 
 

Footnotes (207)



 


 



Biotechnology's Uncertainty Principle


Mark A. Lemley


Stanford Law School

Dan L. Burk


University of California, Irvine School of Law


Case Western Reserve Law Review, Vol. 54, p. 691, 2004
Minnesota Public Law Research Paper No. 03-4
UC Berkeley Public Law and Legal Theory Research Paper No. 125

Abstract:     
In theory, we have a unified patent system that provides technology-neutral protection to all kinds of technologies. However, we have recently noticed an increasing divergence between the rules actually applied to different industries. Biotechnology provides one of the best examples. In biotechnology cases, the Federal Circuit has repeatedly held that uncertainty in predicting the structural features of biotechnological inventions renders them nonobvious, even if the prior art demonstrates a clear plan for producing the invention. At the same time, the court claims that the uncertain nature of the technology requires imposition of stringent patent enablement and written description requirements that are not applied to patents in other disciplines. Thus, as a practical matter it appears that although patent law is technology-neutral in theory, it is technology-specific in application. Much of the variance in patent standards is attributable to the use of a legal construct, the "person having ordinary skill in the art" (PHOSITA), to determine obviousness and enablement. We do not challenge the idea that the standards in each industry should vary with the level of skill in that industry. We think the use of the PHOSITA provides needed flexibility for patent law, permitting it to adapt to new technologies without losing its essential character. We fear, however, that the Federal Circuit has not applied that standard properly in biotechnology. The court has a static perception of the field that was set in its initial analyses of biotechnology inventions, but which does not reflect the realities of the industry. In the final part of the paper, we offer a very preliminary policy assessment of these industry-specific patent cases. We suggest that the special rules the Federal Circuit has constructed for biotech cases are rather poorly matched to the specific needs of the industry. Indeed, in some ways the Federal Circuit cases have it exactly backwards. We offer a few suggestions as to what a consciously designed biotechnology patent policy may look like.

Number of Pages in PDF File: 70

Keywords: patents, biotechnology, law and economics, obviousness, PHOSITA

Accepted Paper Series





Download This Paper

Date posted: June 4, 2003  

Suggested Citation

Lemley, Mark A. and Burk, Dan L., Biotechnology's Uncertainty Principle. Case Western Reserve Law Review, Vol. 54, p. 691, 2004; Minnesota Public Law Research Paper No. 03-4; UC Berkeley Public Law and Legal Theory Research Paper No. 125. Available at SSRN: http://ssrn.com/abstract=303619 or http://dx.doi.org/10.2139/ssrn.303619

Contact Information

Mark A. Lemley (Contact Author)
Stanford Law School ( email )
559 Nathan Abbott Way
Stanford, CA 94305-8610
United States
Dan L. Burk
University of California, Irvine School of Law ( email )
4500 Berkeley Place
Irvine, CA 92697-1000
United States
949-824-9325 (Phone)
Feedback to SSRN


Paper statistics
Abstract Views: 9,041
Downloads: 1,126
Download Rank: 9,678
Footnotes:  207
People who downloaded this paper also downloaded:
1. Policy Levers in Patent Law
By Mark Lemley and Dan Burk

2. Is Patent Law Technology-Specific?
By Dan Burk and Mark Lemley

© 2014 Social Science Electronic Publishing, Inc. All Rights Reserved.  FAQ   Terms of Use   Privacy Policy   Copyright   Contact Us
This page was processed by apollo7 in 0.297 seconds