The American Civil Liberties Union (ACLU) and the Public Patent Foundation (PUBPAT) filed a brief [text, PDF] with the US Court of Appeals for the Federal Circuit [official website] on Friday in Association for Molecular Pathology v. US Patent and Trademark Office, an ongoing case challenging a Utah company's patent on genes [press release] associated with breast and ovarian cancers. Myriad Genetics [official website] currently owns the patent to BRCA1 and BRCA2 [NCI backgrounder]. The ACLU and PUBPAT argued in the filing that they are concerned that this patent limits the amount of research that can be done and the availability of diagnostic tests associated with these genes to women in need.
[T]he contested claims (and similar claims) have already inhibited research. Over half of all labs surveyed as part of an NHGRI-funded study reported "deciding not to develop a new clinical [BRCA] test because of a gene patent or license." A similar study found that 46% felt that gene patents had "delayed or limited their research." Another researcher looking closely at patenting genes found that it had "persistent negative effects on subsequent scientific research." The claims curtail the ability of scientists to examine human genes. Because scientific work relies on using DNA after it has been isolated, and because the patents do not specify a single BRCA molecule or a single use of the DNA but instead cover all of them, the patents give exclusivity over the BRCA1 and BRCA2 DNA itself, and their preemptive effect mandates a finding of invalidity.In March 2012, the Supreme Court decided the case Mayo Collaborative Services v. Prometheus Laboratories [opinion text, PDF; JURIST report] and 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, and that industry reliance upon a patent cannot be a consideration as to whether something is patentable. The Supreme Court then vacated the US Court of Appeals for the Federal Circuit's 2011 decision [JURIST report] in Association for Molecular Pathology and remanded [press release] it back to that court to make a decision consistent with Mayo. The ACLU and PUBPAT argued in the brief that the decision in 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 these genes cannot be patented. Oral arguments will be held on July 20.
The ACLU and PUBPAT filed a petition for certiorari [JURIST report] in the Supreme Court in 2011 after the Court of Appeals for the Federal Circuit held that some of the patents were valid. This decision was contrary to the position of the Obama administration, which filed an amicus curiae brief [PDF; JURIST report] in support of the ACLU and PUBPAT. A federal district court in 2009 originally held [opinion, PDF] that all of the patents were invalid. 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].