Unblocked Future: Why Gene Patents Won’t Hinder Whole-Genome Sequencing and Personalized Medicine

W. Nicholson Price II

University of New Hampshire School of Law (formerly Franklin Pierce Law Center)

August 7, 2011

Cardozo Law Review, Vol. 33, No. 4, 2012

Whole-genome sequencing has been hailed as the crucial next step in personalized medicine. It has also been described as likely violating hundreds if not thousands of pre-existing patents on individual genes. These claims of patent infringement, however, are usually made without detailed analysis. Instead of stating that infringement definitely occurs, or in what circumstances, the discussion of whole-genome sequencing mentions that some claims may be typically infringed, but some may be invalid, and leaves the matter there. This paper seeks to provide a detailed analysis of the ways that whole-genome sequencing may infringe extant gene patents, focusing on the common basic structure of most such patents. In particular, the sequencing step itself may infringe the composition of matter claims of isolated DNA molecules in only a very few gene patents, with novel nanopore sequencing technology appearing to bypass infringement altogether. Gene patents often also include methods claims for comparing the personal sequence with a reference sequence for diagnostic purposes; these claims are much more likely infringed by any plausible whole-genome sequencing effort, but appear to fall into a two-class trap where comparison-only methods claims are vulnerable to § 101 patentable subject matter challenges and determination-and-comparison methods can be relatively easily avoided by having different entities perform the sequencing and analysis steps. The paper concludes with a brief analysis of policy considerations for whole-genome sequencing and suggestions for moving forward.

Number of Pages in PDF File: 37

Keywords: gene patents, whole-genome sequencing, personalized medicine

JEL Classification: O33

Accepted Paper Series

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Date posted: August 23, 2011  

Suggested Citation

Price, W. Nicholson, Unblocked Future: Why Gene Patents Won’t Hinder Whole-Genome Sequencing and Personalized Medicine (August 7, 2011). Cardozo Law Review, Vol. 33, No. 4, 2012. Available at SSRN: http://ssrn.com/abstract=1914560

Contact Information

William Nicholson Price II (Contact Author)
University of New Hampshire School of Law ( email )
Two White Street
Concord, NH 03301
United States
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