Supreme Court Urged to Reconsider Patent Eligibility Approach—Just Not This Time
Encouraging the Supreme Court to reconsider its patent subject matter eligibility framework in a brief filed Friday, the US Department of Justice and the US Patent and Trademark Office nonetheless nudged the high court not to hear the case of Hikma Pharmaceuticals USA Inc. v. Vanda Pharmaceuticals Inc.
The patent at issue claims a schizophrenia treatment, with drug dosages adjusted depending on differing genetic abilities to metabolize the given drug. Earlier in this case, this method stood as a patent-eligible, practically-applied human activity, and not merely an all-encompassing preemption of the principles of drug metabolism. Both the District of Delaware and the Court of Appeals for the Federal Circuit found this subject matter to be eligible for patenting. The accused infringer has now asked the Supreme Court to strike the patent down as drawn essentially only to the natural law of genetically-affected drug metabolism.
“The confusion created by this Court’s recent Section 101 precedents warrants review in an appropriate case. This case, however, is not an optimal vehicle for bringing greater clarity because the court of appeals majority arrived at the correct result. ”
Notably, the US Patent and Trademark Office ran with the Federal Circuit’s patent-favorable decision, issuing a memorandum to the examining corps in favor of considering methods of treatment as patent-eligible subject matter.
At the Supreme Court, the justices have asked for the government’s views on whether the case should receive their full consideration. Nearly nine months after this request, the Solicitor General, together with the USPTO, has filed Friday’s brief discouraging review of the Vanda case.
The brief states that medical treatment methods generally qualify as eligible inventions for patent coverage, consistent with every indication from Congress and the USPTO over the course of decades. Therefore, it agrees with the Federal Circuit’s ruling and asks the Supreme Court to allow the decision in Vanda to stand.
However, the brief also pointedly criticizes the current step-wise approach for determining whether subject matter is patent-eligible, particularly in the wake of the Supreme Court’s decision in Mayo v. Prometheus. As described in the brief, the framework post-Mayo suffers from ambiguity in the abstract and wreaks havoc particularly on patent coverage for medical diagnostics, like that in the Athena Diagnostics case, about which we have previously reported.
With uncertain and shifting terrain, patent applicants and stakeholders in medical and software-based fields should join us in keeping an eye on the latest developments in patent subject matter eligibility.