Remember, I am not a lawyer (IANAL), and I am not a compensated judicial prognosticator. I was wrong in my last post about the Myriad Genetics case. The appeals court issued a order today, which is hardly the fall.
Quick refresher – the Myriad Genetics case concerns the patents connected to two genes that have strong connections with breast cancer – BRCA1 and BRCA2. Myriad Genetics holds patents on those genes and on genetic tests connected to those genes. The case was previously awaiting argument before the Supreme Court when a separate case, Mayo v. Prometheus, was decided by the Court. Because the decision in that case was closely related to Myriad Genetics, the Supreme Court asked the lower court to reconsider the matter in light of the Mayo v. Prometheus decision.
The order does not come down clearly on one side or the other with respect to the parties in the case. The order affirms the district court decision invalidating the patent claims on testing methods (it considers the methods to cover only patent-ineligible abstract steps). It reverses the lower court’s decision invalidating the patent claims on the isolated sequences of DNA that comprise the breast cancer genes.
Further analysis of the order emphasizes that I am not a lawyer. It also suggests that the Mayo case had little to do with this decision, independent of useful background. From page 42:
“While Mayo and earlier decisions concerning method claim patentability provide valuable insights and illuminate broad, foundational principles, the Supreme Court’s decisions in Chakrabarty and Funk Brothers set out the primary framework for deciding the patent eligibility of compositions of matter, including isolated DNA molecules.”
A fair amount of the debate over patentability of the BRCA genes in this case has resolved around the interpretation of Section 101 of federal patent law (35 USC Section 101). The court in this case argues that the isolated strands of DNA are sufficiently distinct from the same sequences in their natural state to make them patentable. Other courts have disagreed on this point. I’m also not a biologist, so I would point you towards legal blogs to dive deeper into the law (I’ll likely re-tweet relevant links on the blog’s Twitter feed).
My read of the appellate court decision is that they consider the District Court decision to invalidate the claims over DNA sequences an overreach. That court essentially created new law that they were not entitled to do. But the appellate court considers the test claims invalid because they are little more than a simple comparison.
The order includes two separate decisions, a concurring opinion from one judge (essentially taking a different angle, and incorporating more of the Mayo case, to arrive at a comparably similar decision), and a partial dissent from another.
I think the dissent could be important, as it makes a claim concerning genome sequencing that, if accurate, is worth following. In the dissent, the judge considers the extraction of gene sequences to be insufficient to make them new genes, and therefore patentable (FWIW, I’m of the same opinion). The dissent outlines an interpretation of the patent claim for these sequences that could cover a multitude of different molecules created by filling in the gaps listed in the patent claim.
I am assuming that at least one of the two sides in the case will appeal. Whether the Supreme Court will hear it is unclear to me. Once it enlightens us, I’ll post it here.