The US Court of Appeals for the Federal Circuit (CAFC) [official website] on Thursday ruled [opinion, PDF] for the second time in Association for Molecular Pathology v. US Patent and Trademark Office (AMP) that a Utah company does have valid patents on two genes associated with breast and ovarian cancers. AMP concerned Myriad Genetics [official website] patents on BRCA1 and BRCA2 [NCI backgrounder], isolated human genes that differ from native genes in that the process of extracting them results in changes in their molecular structure, although not in their genetic code. Arguing that the process of isolating genetic material from a human DNA molecule does not make the isolated genetic material (cDNA) a patentable invention, the American Civil Liberties Union (ACLU) and the Public Patent Foundation (PUBPAT) [advocacy websites; press release] in 2009 filed a lawsuit [JURIST report] in the US District Court for the Southern District of New York (SDNY) [official website], which then invalidated all of Myriad's patents [JURIST report]. Last year in a 2-1 ruling the Federal Circuit reversed in part [opinion, PDF; JURIST report], rejecting Myriad's method patent but holding the gene patents themselves valid as "the difference between knowledge of nature and reducing a portion of nature to concrete form, the latter activity being what the patent laws seek to encourage and protect." This year the same CAFC three-judge panel reheard the case on remand from the US Supreme Court [official website] based on the Court's March decision in Mayo Collaborative Services v. Prometheus Laboratories [opinion, PDF; JURIST report], in which it ruled that in order for something to be patentable it must add enough to a natural phenomena to make it different than anything found in nature. The ACLU and PUBPAT argued that Mayo "gave new vigor" to the principles used in determining whether a product of nature has been "transformed" enough to make it patentable, and that it supports the conclusion that cDNA is not patentable material. The CAFC, however, again ruled against the advocacy groups [ACLU press release], renewing its decision to "reverse the district court's decision that Myriad's composition claims to 'isolated' DNA molecules cover patent-ineligible products of nature under §101 because each of the claimed molecules represents a nonnaturally occurring composition of matter." The CAFC also again rejected one of Myriad's method patents for analyzing DNA sequences but upheld its patent for cancer screening.
The ACLU and PUPAT were concerned that these types of patents limit the amount of research that can be done and the availability of diagnostic tests associated with these genes to women in need. They filed a petition for certiorari [JURIST report] in the Supreme Court in 2011 after the Federal Circuit ruling that the patents were valid. The CAFC decisions run contrary to the position of the Obama administration, which in 2010 filed an amicus curiae brief [JURIST report] in support of the ACLU and PUBPAT. JURIST Guest Columnist Doreen Hogle [official profile] argued that the Mayo decision raised questions as to what innovations are subject to patent law protection and may result in stifled investment in technology [JURIST comment].