Last week, the DOJ submitted a court filing that proposed to substantially limit the ability of genes to be patented at the USPTO. The submission was made in response to the dispute between Myriad Genetics who is defending their patents on isolated DNA sequences in the BRCA1 and BRCA2 genes. The ACLU and others are attempting to invalidate the patents, arguing that genes should not be patentable subject matter. The matter is now pending at the Court of Appeals for the Federal Circuit (CAFC), and will likely be decided later this year or early next year.
Other major patent offices such as the EPO severely limit what can be claimed regarding genes and genetic treatments, so the USPTO is the office currently taking the contrarian approach to gene patents. Myriad argues that the ability to patent genes in the United States contributed to the growth in biotechnology sector over the past twenty years and that growth could be hindered if gene patents are no longer permissible. Myriad also states that gene patents are necessary because they help protect the multi-million dollar investments into their biotechnology innovations. In spite of the recent DOJ court filing, the USPTO states that for the time being they do not have any plans at this time to change their rules on gene patents.
We’ve already talked in detail about the Myriad decision at the District Court level here. The brief recently submitted by the DOJ coming out against Myriad’s position shines some light on the current administration’s view on the patentability of genes. You can bet that whoever loses at the CAFC level will appeal the case to the Supreme Court. Although the submission by the DOJ is the latest salvo in the battle into whether gene sequences are patentable subject matter, there will be much more to come as the case is eventually decided by the Supreme Court.