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Allergan’s Restasis to Face Impending Generic Competition After Patent License Play Fails

Allergan transfered Restasis patents to the Saint Regis Mohawk Tribe in an effort to take advantage of their sovereign immunity status, however this approach has failed to protect the company's market exclusivity for the drug.

Allergan’s Restasis to Face Impending Generic Competition After Patent License Play Fails

By: Sarah Hand, M.Sc.

Posted on: in News | Videos | Life Science Videos | Pharmaceutical News

Since Allergan’s blockbuster dry eye disease drug Restasis lost patent protection last year, the company has been implementing some unorthodox strategies in order to delay generic competition. Among these tactics was the decision to transfer Restasis patents to the Saint Regis Mohawk Tribe in an effort to take advantage of their sovereign immunity status, however this approach has failed to protect Allergan’s market exclusivity for the drug.

According to a press release issued by generic competitor Mylan, the US Patent Trial and Appeal Board (PTAB) dismissed the tribe’s motion to interfere with the challenge to six of Allergan’s patents for Restasis on the basis of their sovereign immunity. The board found that the tribe did not provide sufficient proof that their immunity relates to inter partes review, and since Allergan licenses the rights to manufacture and sell Restasis from the tribe, the patent review will be allowed to proceed.


RELATED: Allergan’s Restasis Will Soon be Open to Generic Copycats After Ruling in Patent Case


“Mylan has always been vocal in its efforts to challenge and break down barriers to access,” said Mylan CEO Heather Bresch. “The PTAB’s ruling reinforces our belief that Allergan’s maneuvers to engage the St. Regis Mohawk Tribe for patent protection were a sham. We will continue to be steadfast in our efforts on both the legal and regulatory fronts to bring a generic version of Restasis to patients as quickly as possible.”

Though Allergan’s patents for Restasis aren’t set to expire for another six years, the impending patent review coupled with last year’s federal court ruling mean the drugmaker will likely see generic copycats sooner rather than later.

“We are disappointed by the Federal District Court’s decision on the Restasis patents,” said Robert D. Bailey, Chief Legal Officer, Allergan, at the time of the 2017 ruling. “We are carefully reviewing the decision and are considering all options.”

According to Mylan, the PTAB review has been tentatively scheduled for April 3rd of this year, with a final decision on the challenged patents to be handed down by June 6th.


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