Download this Paper Open PDF in Browser

Will Gene Patents Derail the Next-Generation of Genetic Technologies?: A Reassessment of the Evidence Suggests Not

80 UMKC L. REV. 563 (2012).

44 Pages Posted: 8 Feb 2012 Last revised: 5 Apr 2013

Christopher M. Holman

University of Missouri - Kansas City School of Law

Date Written: February 8, 2012

Abstract

Judge Bryson recently asserted in Association for Molecular Pathology v. US Patent and Trademark Office (dissenting-in-part) that human gene patents "present a significant obstacle to the next generation of innovation in genetic medicine — multiplex tests and whole-genome sequencing." His concern over the impact of gene patents on genetic testing, which coincides with his position that certain gene patents should be declared patent ineligible, reflects a widely held misperception that 20% of human genes are patented in a manner that would necessarily result in infringement by whole genome sequencing and other forms of genetic testing. In fact, the myth that 20% of human genes are patented is based on a gross misreading of a single "Policy Perspective" article published in Science in 2005, and an unfortunate tendency among many commentators to consider gene patents in abstract terms that disregard the critical role of patent claims in limiting the scope of a patent owner's right to exclude. Analysis of the claims of 533 of the of the patents identified in the Science article as "covering" human genes reveals that most do not include a single claim that would be infringed by whole genome sequencing and other forms of genetic testing. In fact, it seems quite likely that, were they to be litigated, few if any of these gene patents would be found to cover genetic testing or whole genome sequencing. Furthermore, a variety of practical limitations on enforcement and remedies appear to render it unlikely that the owners of these patents would be motivated to assert them against providers of whole genome sequencing and other next-generation diagnostic technologies in a manner that would impede progress in this area. There have been numerous instances in which fears that patents would harm biomedical research and medicine have proven in retrospect to have been greatly exaggerated, and history counsels against overreacting to the current controversy over gene patents. Ironically, it might be the case that the next generation of genetic diagnostic testing innovation will be adversely impacted not by too many patents, but by a lack of adequate patent protection.

Keywords: gene patents, genetic technology, genome sequencing, genetic testing, human genes, biotechnology, patents, patent law, gene patents, DNA patents, biotechnology, genetic testing, diagnostic testing, whole genome sequencing, patent thicket

JEL Classification: I10, I11, I12, I18, K20, K23, K32, O31, O32, O33, O34, O38

Suggested Citation

Holman, Christopher M., Will Gene Patents Derail the Next-Generation of Genetic Technologies?: A Reassessment of the Evidence Suggests Not (February 8, 2012). 80 UMKC L. REV. 563 (2012).. Available at SSRN: https://ssrn.com/abstract=2001574 or http://dx.doi.org/10.2139/ssrn.2001574

Christopher M. Holman (Contact Author)

University of Missouri - Kansas City School of Law ( email )

5100 Rockhill Road
Kansas City, MO 64110-2499
United States

Paper statistics

Downloads
375
Rank
64,757
Abstract Views
2,212