By: Katie Rubino
Recently at the end of April, the Supreme Court denied a petition for certiorari in the case of Saint Regis Mohawk Tribe. V. Mylan Pharm. Inc. The case centers around whether tribal sovereign immunity applies in inter partes review (IPR) proceedings before the Patent Trial and Appeal Board (PTAB).
The case first began in 2017, when Allergan transferred a set of patents relating to its cyclosporine eye product Restasis™ to the Saint Regis Mohawk Tribe. Restasis™ (cyclosporine) works by decreasing the function of lymphocytes, primarily by forming a complex with cyclophilin to block phosphatase activity of calcineurin, which decreases the production of inflammatory cytokines produced by T-lymphocytes. Terms of the agreement for the transfer included that even though Allergan transferred ownership of the patents to the Saint Regis Mohawk Tribe, an exclusive and perpetual license to the patents was retained by Allergan.
Before transfer of the Restasis™ patents to the Saint Regis Mohawk Tribe, Mylan and Teva filed an IPR on Allergan’s patents for Restasis™ at the PTAB. The Saint Regis Mohawk Tribe then responded to the IPR proceeding by claiming they had tribal sovereign immunity, and as such were immune from suit. Tribal sovereign immunity is a legal doctrine that allows for inherent authority of indigenous tribes to govern themselves, and as such as recognizes them as domestic dependent nations. The PTAB denied the motion to terminate the IPR based on a claim of tribal sovereign immunity. The PTAB reasoned that Saint Regis Mohawk Tribe had not shown that it was entitled to tribal sovereign immunity. Further the PTAB reasoned that because of the licensing arrangement between the Saint Regis Mohawk Tribe and Allergan, even in the absence of the Saint Regis Mohawk Tribe, Allergan could represent the Tribe’s rights. The Saint Regis Mohawk Tribe then appealed the PTAB’s decision to the Court of Appeals of the Federal Circuit (CAFC).
The CAFC affirmed the decision of the PTAB, denying the motion to terminate the IPR based on a claim of tribal sovereign immunity. The CAFC reasoned that an IPR is like an agency enforcement action rather than a civil suit so sovereign immunity is not implicated. The CAFC reasoned that an IPR is more like an agency enforcement because the director of the Patent and Trademark Office (PTO) has discretion in deciding whether or not to institute an IPR. If the director fails to institute an IPR, there is no subsequent review.
Upon appeal to the Supreme Court, the case was denied certiorari, and as such the decision by the CAFC stands. Presently, another case pending before the CAFC, Regents of Univ. of Minn. V. LSI Corp. seeks to examine whether state sovereign immunity applies in IPR. The appeal in that case was argued in March 2019, and a decision is expected in the near future.
Caldwell Intellectual Property Law