Mylan Allowed to Proceed with Patent Challenge Against Allergan for Blockbuster Drug Restasis

Mylan has received a favorable ruling from the US Patent Trial and Appeal Board (PTAB), which denied a motion by the St. Regis Mohawk Tribe to terminate Mylan’s patent challenge regarding six patents related to Allergan’s Restasis (cyclosporine ophthalmic emulsion), a drug to treat dry eyes and one of Allergan’s top-selling drugs with 2017 sales of $1.47 billion. Mylan is seeking to market a generic of Restasis.

In September 2017, Allergan entered into an agreement with the Saint Regis Mohawk Tribe, a recognized sovereign tribal government, under which the Saint Regis Mohawk Tribe obtained the rights to Orange Book-listed patents covering Restasis and Allergan was granted exclusive licenses under the patents related to the product. The patents are listed in the Orange Book, which publishes all US Food and Drug Administration-approved drug products with therapeutic equivalence, and are set to expire on August 27, 2024 and relate to methods of providing therapeutic effects using cyclosporin components.

The tribe then filed a motion to dismiss an ongoing inter partes review (IPR) of the Restasis patents based on its sovereign immunity from IPR challenges. Now, in February 2018, the PTAB denied the tribe’s motion on multiple grounds, according to information for Mylan.The PTAB held that the tribe did not establish that the doctrine of tribal sovereign immunity applied to IPR proceedings. The PTAB held that even if tribal sovereign immunity did apply, the IPR proceedings could continue without the tribe because Allergan retained ownership interests in the patents.

The PTAB has tentatively scheduled an oral hearing on the merits for April 3, 2018, and stated that it would render a final written decision on the patentability of the challenged patents by June 6, 2018, according to Mylan.

Allergan has been involved in patent litigation for Restasis with several generic-drug companies, including Mylan. In October 2017, the US District Court for the Eastern District of Texas ruled four asserted patents covering Restasis invalid based on obviousness. The case is currently on appeal before the US Court of Appeals for the Federal Circuit. Separately, Allergan reached a settlement with InnoPharma, a subsidiary of Pfizer, for an authorized generic of Restasis.

Source: Mylan

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