SCOTUS rejects case concerning Allergan patents transferred to Native American tribe

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.

Your cheat sheets for understanding health care's legal landscape

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.

Background: Allergan transfers Restasis patent to Saint Regis Mohawk Tribe

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 AkornMylan, 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.

SCOTUS declines to hear case

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).

Your cheat sheets for understanding health care's legal landscape

book

To help you keep up with the ever-changing regulatory environment, we recently updated our cheat sheets on some of the most important—and complicated—legal landmarks to include a brand new one-pager on the new tax law.

Check out the cheat sheets now for everything you need to know about MACRA, the Affordable Care Act, antitrust laws, fraud and abuse prevention measures, HIPAA, and the two-midnight rule.

Get the Cheat Sheets


Next in the Daily Briefing

CDC: Prescribing guidelines shouldn’t be used to deny opioids to cancer patients

Read now