By Timothy J. O'Leary, MD, PhD
The AMP position on gene patents and the legal position it has taken with regard to these patents has polarized the membership more, perhaps, than any other issue in this organization’s history. Although it is possibly true that members representing “for-profit” commercial organizations favoring the patentability of gene sequence information are disproportionately represented, there are members from industry who stand to gain if gene patents are disallowed and from academic institutions who will lose revenue if gene sequences are found to be non-patentable. Although it may be several years before we know the answer, on April 4, 2011 the Court of Appeals for the Federal Circuit (CAFC) heard oral arguments on Myriad Genetics’ appeal of the decision invalidating its BRCA1 and BRCA2 sequence patents.
Appellate court hearings involving private companies are by no means unusual here in Washington, DC. This hearing, however, was unusual because Acting US Solicitor General Neal Katyal argued for the United States government in favor of AMP’s position, as stated by attorneys for the American Civil Liberties Union. Most of us were unable to attend the hearing in person. Through the miracle of modern technology AMP members worldwide can hear the oral arguments at
http://oralarguments.cafc.uscourts.gov/default.aspx?fl=2010-1406.mp3 (search Argument Date 2011-04-04).
The recordings show the intense interest of the three-judge panel on the issue, and reflect, in my opinion, the care that federal court judges typically exercise in attempting to render judgments in complex cases in which they do not personally have strong scientific and technical expertise. Although some observers have suggested that the CAFC decision is irrelevant since the loser will most certainly appeal to the Supreme Court, I personally believe that the decision, when rendered, will reflect thoughtful legal opinion, and likely will stand for the simple reason that the Supreme Court decides not to hear the vast majority of cases that are sent to it for consideration.
Whether or not any of us personally supports AMP’s position in this case, the organization remains committed to engage in advocacy that is intended to promote improved patient care through the use of molecular diagnostics. I believe that all of us believe that the use of molecular techniques can improve medical care and regardless of our various personal differences on specific issues, AMP advocacy will ultimately lead to improved health for people both in the United States and abroad.