Just when you thought it was safe to begin testing your own genes, you need to think again...
On 13 June 2013 the Supreme Court of the United States of America issued their long awaited ruling on the patentability of "isolated" nucleic acid sequences (AMP v. Myriad Genetics).
The Court held that isolated naturally occurring DNA is not patent eligible subject matter under 35 U.S.C 101. In their ruling, the Court found 5 of Myriad's patent claims directed to naturally occurring DNA sequences to be invalid. The particular DNA sequences at issue were the DNA sequences of naturally occurring mutants of the human BRCA1/BRCA2 genes. No method claims were considered by the Court in this case.
On the day the Supreme Court decision issued, a rival diagnostics company (Ambry Genetics) announced that it would offer a competing genetic test for the BRCA1/BRCA2 mutations recited in the invalidated Myriad claims. The new test would be offered at much lower cost than Myriad's existing tests. As one might imagine, this announcement by Ambry was not well-received by Myriad.
On 9 July 2013, in what was perhaps a well anticipated counter-move, Myriad sued Ambry for patent infringement of 10 different patents (University of Utah Research Foundation v. Ambry Genetics, 13-640, U.S. District Court for the District of Utah). The 10 patents are either held by, or under exclusive licence to Myriad. Not surprisingly, Myriad asserts in their action that Ambry is infringing a number of their patent claims that relate to methods of genetic diagnostic testing for BRCA1/BRCA2 mutations. The asserted methods are largely PCR based methods of detecting mutations. In addition, several asserted claims relate to particular short DNA sequences that are used in genetic diagnostic methods of BRCA1/BRCA2 testing (oligonucleotides and/or PCR primers). None of the asserted claims were considered by the Court in their decision.
In their action, Myriad is seeking a preliminary injunction, injunctive relief, damages for wilful infringement and lost profit, and delivery for destruction of all "products" that infringe any asserted claim. Perhaps the surprising aspect of these events is Ambry's decision to offer genetic diagnostic testing for BRCA1/BRCA2 at all. After all, even after the Court found Myriad's 5 DNA claims invalid, Myriad's patent portfolio relating to BRCA1/BRCA2 testing still contains 24 patents containing 515 distinct method and product claims.