The Court of Appeals for the Federal Circuit [official website] on Friday ruled 2-1 [opinion, PDF] that patents held on two genes linked to hereditary ovarian and breast cancer are valid. The American Civil Liberties Union (ACLU) and the Public Patent Foundation (PUBPAT) [advocacy websites] originally filed [JURIST report] the suit on behalf of patients and scientists challenging patents held by Myriad Genetics [corporate website] on the BRCA genes [NCI backgrounder]. Myriad Genetics appealed the lower court decision that found the patents to be invalid [JURIST report]. Federal Appeals Judge Alan Lourie [official profile] wrote in the majority opinion:
The ability to visualize a DNA molecule through a microscope, or by any other means, when it is bonded to other genetic material, is worlds apart from possessing an isolated DNA molecule that is in hand and usable. It is 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.The majority, however, ruled that Myriad Genetics may not patent its method of determining whether a gene had mutations because the analysis consists of non-patentable "abstract mental steps." The case may appear before the Supreme Court if appealed.
The court's decision countered the position held by the Obama administration, which submitted an amicus curie brief [text, PDF] in support of the ACLU and PUBPAT. Nevertheless, the US Patent and Trademark Office [official website] has issued patents for genes for decades. Such patents cover nearly 2,000 human genes and genetic research companies hold patents to approximately 20 percent of the human genetic code. Many of the patented genes are associated with diseases such as Alzheimer's and cancer. Supporters of the decision argue that restricting patents on human genes would decrease the amount of genetic research performed by the public sector because it would no longer be profitable for companies to study human genes. Currently, the holder of a gene patent can prevent others from studying the gene and can also develop testing for specific genetic mutations, which they can then market without direct competition.