This is a surprise: The U.S. federal government's position now opposes gene patents:
The new position was declared in a brief filed late Friday by the Justice Department in relation to a lawsuit challenging the validity of patents held on two genes that are used to judge whether a woman has an unusually high risk of breast cancer.
“We acknowledge 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,” the brief said.
This is a natural consequence of technological advance. Today there's little novelty in isolating a gene sequence. It is still work to associate a gene with a disease, but it has become very easy to add a genotype to a chip that contains hundreds of thousands of other genotypes. It's pretty hard to argue that anything having to do with testing genotypes today is deserving of patent protection. In fact, a group of geneticists have published a do-it-yourself workaround to the Myriad patents on BRCA1 and BRCA2.
The story is brief and does not discuss whether the administration still considers some other applications of genetic information to be patent eligible. The new position is based on the idea that gene sequences are "products of nature". Since the BRCA1 and BRCA2 patents are at issue, the "natural products" idea must be construed to include rare mutational variants and tests that include combinations of rare natural variants. These have been aspects of the testing procedure that the government formerly held to be worthy of protection.
If personalized genomic medicine has much hope, it will be because systematic relations are discovered between common diseases and combinations of variants at many genes. Could there by any combinatorial test sufficiently novel for patent protection?
And to what extent would RNA silencing and other methods that may use natural sequences be patentable?
The area may now be wide open.