Breast Cancer Gene Case Has Another Day in Court

A three-judge federal appeals court heard arguments on Monday in a case that could decide the future of human gene patents.  The high-profile lawsuit was filed by the American Civil Liberties Union and the Public Patent Foundation on behalf of a number of researchers, patients, women’s health organizations and scientific organizations against Myriad Genetics and the University of Utah Research Foundation, holders of patents on genes known as BRCA1 and BRCA2 that are associated with elevated risk of breast cancer. The plaintiffs argue that the US Patent and Trade Office erred in granting these patents because genes are products of nature, not human inventions.

The panel heard Myriad’s appeal of a decision strongly favoring the plaintiffs that was issued in March 2010 by Federal District Court Judge Robert Sweet. Whatever is decided by the appeals court, many observers expect the case to continue on to the Supreme Court.

A few things stood out in Monday’s hearing. First, the judges were very interested in whether all the plaintiffs actually have standing in the case – that is, in whether they have actually been harmed by Myriad’s control of the genes. For example, University of Pennsylvania researchers whom Myriad stopped from conducting BRCA1/2 testing are now saying that if the patents on those genes are ruled invalid, they are unsure whether they will continue to screen for them. The judges focused on this account to the exclusion of statements filed by more than 150 other labs attesting to work that had been halted by the Myriad patents or by “cease and desist” letters from the company. The ACLU argued that University of Pennsylvania will, of course, screen for those two genes since their molecular pathologists screen for almost every other medically relevant gene on a daily basis. They asserted that these researchers’ reluctance to say so outright is due to past threats by Myriad.  

Read More . . .