The Supreme Court finally published its decision in the case of Association for Molecular Pathology v. Myriad Genetics, a case that seemed to hover over the landscape of life science patents for an eternity. We might be tempted to think the decision shuts the door on a very contentious area of patent law. After all, we now know isolated DNA is not patentable, but complementary DNA is. So that’s it, right?
Wrong. In fact, at least one observer believes the decision may collapse at some point.
Richard Gilly with the law firm of Akerman (Washington) told me in an interview “there will be some challenges to existing patents” because of the ruling, but he also noted that the proteins used in proteomics might be next up for this kind of scrutiny. Jim Crowne, director of legal affairs at the American Intellectual Property Law Association in Arlington, Virginia, also chimed in for the coverage at Medical Device Daily, stating that the ruling is something of a 40,000-foot document. Crowne said, “the main question [going forward] is how marked the difference is between what occurs naturally and what you have described in your application.”
The range of opinions doesn’t stop there, however. In an entry at the blog at patentlyo.com, Dennis Crouch writes that John Duffy, a professor of law at the University of Virginia, described the outcome as “a half-loss to inventors, a half-loss to advocates for a broader public domain but, unfortunately, a full victory for patent lawyers, who will have lots of business opining on and litigating the complexities of this decision.”
In other words, it’s nowhere near over if this decision is going to keep the patent bar busy.
Crouch’s posting at patentlyo indicates that Brenda Simon of the Thomas Jefferson School of Law said Myriad “does not impact one of the most valuable aspects made possible through Myriad's patent protection: a private biobank of patient data containing information about additional mutations that Myriad can maintain as a trade secret.”
I would point out that Simon’s remarks echo a lot of comments I’ve heard about the Myriad patent. Interested parties I’ve talked to off the record have asserted the real value of the patent for the BRCA 1 and 2 genes is not for use as a diagnostic, but for development of therapeutics for treatment of BRCA-related breast cancer.
But one of the most interesting comments I’ve seen on this was offered by Andrew Chin of the University of North Carolina School of Law, who said the decision means that patents on DNA probes “are problematic” where the section 101 test (subject matter eligibility) is concerned. Chin said the problem extends to DNA research “regardless of whether the probes are produced by isolation or synthesis,” adding that the distinction “will distort scientific and medical progress and ultimately prove to be doctrinally unstable.”
So, patent geeks and wonks, there’s no need to despair. The SCOTUS decision merely closed chapter one of the Myriad story. Chapter two is just beginning.