The Myriad Genetics case decided by Judge Robert W. Sweet of the Southern District of New York in March of 2010 shocked the biotech and patent field by reversing decades of policy and case law supporting the patenting of genetic material.
In the opinion, Judge Sweet ruled that the claimed genes involved a “law of nature” and therefore did not qualify as patentable subject matter. At risk now are the thousands of patents granted by the USPTO for genes from humans and other organisms.
Being such a departure from long-standing policy, many anticipate the reversal of the Sweet ruling on appeal. However, a new ally has emerged in favor of invalidating these gene patents: the United States Department of Justice.
In an amicus curiae brief submitted on October 29, 2010, the Department of Justice stated its position that human and other genes should not be eligible for patents because they are a part of nature, and therefore not inventions.
Specifically, they argue that genes that have been isolated, but without a material change to their naturally occurring chemical structure and function, should be ineligible for patent.
When filing this brief, the Department of Justice acknowledged that “this conclusion is contrary to the longstanding practice of the Patent and Trademark Office, as well as the practice of the National Institutes of Health and other government agencies that have in the past sought and obtained patents for isolated genomic DNA”.
Currently, most countries have patentability rules for genetic material that are similar to those of the U.S. (pre-Myriad). Following the Myriad outcome, foreign parties have begun to challenge the validity of gene patents in their jurisdictions. Already, plaintiffs in Australia have sued Myriad to invalidate their patents there. Other lawsuits in other countries can’t be too far behind.
Although some gene patent proponents argue that this patent litigation is about legal precedent and reliance, I honestly think that this is one of those issues that is largely about one’s politics and policy. Whether or not human genes are legally patentable is a question rather like the “if a tree falls in the forest” hypo. I’ve noticed that most biotech proponents, in particular, base their pro-patenting contentions on policy arguments, rather than on legal ones — perhaps because there is no real legal answer. That being the case, although I’d like to read a Supreme Court opinion deciding this issue, perhaps this is really one for Congress to deal with.