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17 Oct 2017

Mylan invalidates Allergan's patents on Restasis

US District Court for the Eastern District of Texas decides all asserted claims of the patents relating to Restasis invalid based on obviousness.

Mylan has announced that the US District Court for the Eastern District of Texas has issued a 135-page decision finding all asserted claims of the patents relating to Restasis invalid based on obviousness. The Court, recognizing that Allergan's patent protection for Restasis ended in 2014, concluded that "Allergan is not entitled to renewed patent rights for Restasis in the form of a second wave of patent protection". The invalidated patents are US Patent Numbers 8,629,111; 8,648,048; 8,685,930 and 9,248,191. Mylan received a covenant not to sue on the remaining two Orange Book patents, US Patent Numbers 8,633,162 and 8,642,556, shortly before the trial began.

The Court's decision also will be binding against the Saint Regis Mohawk Tribe, which the Court added to the lawsuit. In ultimately allowing the Tribe to join the lawsuit, the Court expressed its concerns that "sovereign immunity should not be treated as a monetizable commodity that can be purchased by private entities as part of a scheme to evade their legal responsibilities. It is not an inexhaustible asset that can be sold to any party that might find it convenient to purchase immunity from suit. Because that is in essence is [sic] what the agreement between Allergan and the Tribe does, the Court has serious reservations about whether the contract between Allergan and the Tribe should be recognized as valid, rather than being held void as being contrary to public policy."

Mylan CEO Heather Bresch commented: "We couldn't be more pleased with today's federal court ruling invalidating the Restasis patents. For decades, our investments and perseverance continue to pay off as we have led the charge in challenging the unnecessary roadblocks often put up by brand pharmaceutical companies, whether it's through the regulatory pathway or around its intellectual property, which often delay access to affordable generic medicines to patients.

Bresch continued: "We look forward to continuing to work with the FDA to expeditiously bring our more affordable, generic Restasis product to patients."

The admitted purpose of the Allergan/Saint Regis Mohawk Tribe transaction was to employ Native American sovereign immunity to cut-off pending IPR proceedings before the Patent Trial and Appeal Board (PTAB) and to prevent the PTAB from canceling Allergan's invalid patents. The Court's decision emphasized the duplicitousness of Allergan's changing course with respect to the Patent Office, explaining that the company "invoked the benefits of the patent system" but now seeks "the right to continue to enjoy the considerable benefits of the US patent system without accepting the limits that Congress has placed on those benefits."

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