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Monday, August 27, 2018

Allergan, Mohawk Tribe ask rehearing in sovereign immunity patent case


Allergan plc (NYSE:AGN) and the Saint Regis Mohawk Tribe filed a petition on Aug. 20for an en banc rehearing of their patent case in front of the full U.S. Court of Appeals for the Federal Circuit (CAFC). A three-judge panel ruled in July that the tribe cannot assert sovereign immunity in an inter partes review challenging patents on Restasis cyclosporine, affirming a February decision from the Patent Trial and Appeal Board (PTAB) (see “Court Denies Appeal in Mohawk Case, Clarifies IPR’s Role”).
Allergan transferred six patents on the dry eye treatment to the tribe in September 2017in a bid to shield the patents from the IPR process. The tribe in turn filed a motion requesting that PTAB, an administrative body within the U.S. Patent and Trademark Office, dismiss petitions from three generic drug companies that are trying to use IPRs to invalidate the patents (see “More on Sovereign Immunity”).
CAFC ruled in July that tribal sovereign immunity cannot be asserted in IPR because the proceedings “are both functionally and procedurally different from district court litigation,” and thus more like an agency enforcement action — a situation where tribal immunity does not apply — “than a civil suit brought by a private party.”
In the petition, Allergan and the tribe objected to that classification of IPR, calling it contrary to precedent. The parties wrote that the panel’s decision is inconsistent with the Supreme Court’s decision in SAS Institute Inc. v. Iancu, which held that “IPR is a ‘procedure allow[ing] private parties to challenge previously issued patent claims in an adversarial process before the Patent Office that mimics civil litigation.'”
While the ruling was specific to tribal immunity, the appellants also argue that the precedent could be applied to all cases regarding sovereign immunity because “the panel’s holding turns entirely on the inherent attributes of the IPR proceeding itself,” which are the same for all IPRs.
According to petition, the decision “effectively bars” states and federal agencies such as NASA, HHS, and the U.S. Army and Navy from asserting sovereign immunity in IPRs brought against them as patent owners.
“The panel’s reasoning effectively forecloses IPR immunity claims by any sovereign entity,” the two parties wrote.
Separately on Friday, Mylan N.V. (NASDAQ:MYL), Teva Pharmaceutical Industries Ltd.(NYSE:TEVA; Tel Aviv:TEVA) and Akorn Inc. (NASDAQ:AKRX) filed to extend to Sept. 18 a deadline to provide their response to the en banc petition. The three companies filed suit in the U.S. District Court for the Eastern District of Texas challenging the Restasis patents to launch generic versions of the dry eye drug (see “Conferred Immunity in IPR”).

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