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

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 it occurs, 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 Article 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 to be infringed by any plausible whole-genome sequencing effort, but appear to fall into a twoclass trap whereby comparison-only methods claims are vulnerable to section 101 patentable subject matter challenges and determination-andcomparison methods can be relatively easily avoided by having different entities perform the sequencing and analysis steps. The Article concludes with a brief analysis of policy considerations for whole-genome sequencing and suggestions for moving forward. ∗ Visiting Scholar, UCSF/UC Hastings Consortium on Law, Science and Health Policy, UC Hastings College of the Law. Columbia Law School, J.D. 2011. Columbia Graduate School of Arts and Sciences, Department of Biology, Ph.D. 2010. The author wishes to thank Hal Edgar, Bob Cook-Deegan, Jaime King, Henry Lebowitz, Jerry Sobel, and Ana Bračič for their very helpful comments and feedback. PRICE.33-4 4/2/2012 3:56 PM 1602 C ARD O Z O L A W R E V IE W [Vol. 33:4