BioPharma, Policy

Allergan, Saint Regis Mohawk Tribe ask SCOTUS to hear Restasis patent case

A federal court last year put the kibosh on a deal whereby Allergan transferred to the tribe the Restasis patents, which the tribe then licensed back to Allergan, asserting tribal sovereign immunity to have generic companies’ challenge to the patents dismissed.

A Native American tribe and a drugmaker that partnered to try and block generic competition to one of the latter’s eye drugs are now hoping the nation’s highest court will hear their case.

In a petition filed with the Supreme Court on Dec. 20 and docketed Friday, the Saint Regis Mohawk Tribe and drugmaker Allergan have asked the court to hear their case. Attorneys for the tribe did not respond to requests for comment. Allergan declined to comment.

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On Sept. 8, 2017, Dublin-headquartered Allergan announced that it had transferred all the Orange Book-listed patents covering the dry-eye drug Restasis (cyclosorine) to the Saint Regis Mohawk Tribe, whose reservation is located in upstate New York and neighbors a corresponding reserve in Canada. In return for upfront payments and royalties, the tribe would then exclusively license the patents back to the drugmaker. The upfront payment to the tribe was $13.75 million, and it would be eligible for up to $15 million in royalties. Ahead of last week’s J.P. Morgan Healthcare Conference, JPM posed the question in a conference primer about updates on potential competition against Restasis.

At the time of its announcement, the deal was touted as a valuable source of revenue for the tribe. “We realize that we cannot depend solely on casino revenues and, in order for us to be self-reliant, we must enter into diverse business sectors to address the chronically unmet needs of the Akwesasne community, such as housing, employment, education, healthcare, cultural and language preservation,” a statement from the tribe read. Akwesasne is the traditional name of the Mohawk’s territory and coincides with the reservation.

The thinking was that because federally recognized tribes are sovereign entities, the Saint Regis Mohawk could invoke sovereign immunity to petition the Patent Trial and Review Board to dismiss an Inter Partes Review challenging the patents filed by generic drugmakers Mylan and Akorn, named as respondents in the Supreme Court petition. The PTAB denied the tribe’s motion to dismiss the IPR, and the US Court of Appeals for the Federal Circuit upheld the PTAB’s decision.

In its opinion, the Federal Circuit court agreed with the generic drugmakers’ view that a federally recognized tribe that owned a patent could not assert sovereign immunity in an IPR proceeding because the proceeding bore more similarity to an agency enforcement action than a civil suit by a private party. In their appeal to the Supreme Court, the tribe and the drugmaker hope to resolve the question of whether an IPR before the PTAB is the type in which tribal sovereign immunity can be asserted.

Photo: Allergan