The Supreme Court on Monday declined to hear a case regarding the U.S. Patent Trial and Appeal Board's (PTAB) authority to determine the validity of patents Allergan transferred to the Saint Regis Mohawk Tribe.
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The high court's decision not to hear the case leaves in place an appeals court's ruling that permits challenges to Allergan's patents for Restasis to continue through the U.S. Patent and Trademark Office's inter partes review (IPR) process without the Tribe's involvement.
The IPR process, which PTAB oversees, was created about six years ago as a faster, lower-cost alternative to determining patent validity through the federal courts. Several generic drugmakers—including Akorn, Mylan, and Teva Pharmaceuticals—have sought to use the process to challenge Allergan's patents for Restasis so they can develop generic versions of the drug.
However, Allergan in September 2017 announced the company had transferred its patents for Restasis to the Saint Regis Mohawk Tribe. Under the arrangement, Allergan agreed to pay the tribe $13.75 million, and the tribe agreed to claim sovereign immunity as grounds to dismiss the IPR challenges—a move that some legal experts said could give pharmaceutical companies a new avenue to block patent disputes from generic drug companies. There was legal precedent for claiming sovereign immunity in IPR cases.
But PTAB in February 2018 ruled that it had the authority to determine the validity of the transferred patents and denied the Tribe's motion to dismiss an IPR challenge filed by Mylan. PTAB ruled that tribal immunity does not apply to IPR cases and that Allergan retains an ownership interest in the IPR case. As such, PTAB said the IPR challenge could continue without the tribe's participation in the case.
Allergan appealed the ruling to the U.S. Court of Appeals for the Federal Circuit, and a three-judge panel for the appeals court in July 2018 upheld PTAB's authority to review the transferred patents.
Allergan then appealed the panel's ruling to the Supreme Court.
The Supreme Court on Monday denied Allergan's request to hear the case, leaving the lower court's ruling in place.
An Allergan spokesperson declined to comment on the Supreme Court's decision (Hurley, Reuters, 4/15; Sagonowsky, FiercePharma, 4/15).
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