On June 23, 2011, the United States House of Representatives passed the “Leahy-Smith America Invents Act” (H.R. 1249) to amend title 35 of the United States Code, to provide for patent reform.  Within the numerous provisions related to the examination, administration and enforcement of U.S. patents is a proposed amendment that may affect the value of genetic testing patents.  Under Section 27 of H.R. 1249 the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent Office (Director) shall report to Committee of the Judiciary of the Senate and the Committee on the Judiciary of the House of Representatives on effective ways to conduct independent confirmatory genetic tests (second opinions) of genetic diagnostic tests covered by patents that are exclusively licensed. 

The Director’s report must include at least 4 items:

1. The impact of the current lack of independent second opinion testing on the ability to provide the highest level of medical care and on inhibiting innovation to existing testing and on inhibiting innovation to existing testing and diagnosis;

2. The effect that providing independent second opinion testing would have on the existing patent and license holders of the exclusive genetic test;

3. The impact that current exclusive licensing and patents on genetic testing activity has on the practice of medicine, such as the interpretation of testing results and performance of testing procedures;

4. The role that cost and insurance coverage have on access to and provision of genetic diagnostic tests.

One wonders if this is an unusual request to ask of the Director.  What resources in the Patent Office would he or she draw upon to provide an opinion on: the “highest level” of medical care, impediments to innovation, the effect of independent second opinions on patent holders, the impact that current licensing has on the practice of medicine, interpretation of testing results and performance of testing procedures, as well as the “role” that cost and insurance coverage have on access to and provision of genetic diagnostic tests?  Even with appropriate and unlimited resources, what is the standard for “highest level of medical care” and does “independent second opinion” intend repeating the genetic test itself, or only the review and interpretation of the results? 

Section 27 of H.R. 1249 appears directly responsive to policy concerns raised in several court challenges to the patenting of isolated genes and their use in medical diagnostics, for example the U.S. Supreme Court’s pending review of Prometheus v. Mayo, 628 F.3d 1347 (Fed. Cir. 2010) and several challenges before the Federal Circuit (see Jackie Wright Bonilla’s posts of June 1 and 20, 2011).  Most certainly, the Director’s report would address the 2010 report by the Secretary’s Advisory Committee on Genetics, Health and Society, which has been cited by opponents to the patenting of isolated genes and genetic diagnostic tests who contend that such patents are unnecessary for innovation or to stimulate research and development of medical diagnostic methods.

While many in the biotechnology and pharmaceutical industry are focused on the recent court challenges to the patent-eligibility of genes and medical diagnostic tests pending either in the U.S. Supreme Court or the Federal Circuit, patent reform legislative efforts, almost through the back door, have introduced yet another ball to watch in this continuing saga.