Supreme Court Declines to Hear Allergan’s Arguments Around Protecting Patents on Restasis

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WASHINGTON— The U.S. Supreme Court earlier this week declined to hear arguments in a matter initiated by Allergan to protect patents on its dry eye treatment Restasis, which related to the transfer of the patents to the Native American Saint Regis Mohawk tribe of New York. The patent transfer was intended to protect the patents from a federal administrative court’s review of their validity.The Supreme Court included the Restasis matter in a long list of cases that the court earlier this week declined to review.

The decision by the justices of the Supreme Court, however, keeps in place a federal appeals court ruling that upheld the U.S. Patent and Trademark Office’s authority to decide the validity of patents covering Restasis.

In transferring the Restasis patents to the Native American tribe in 2017 Allergan had stated that the tribe’s sovereign status under federal law made the patents immune from administrative review by the agency.

Mylan, one of the defendants in the court case, is one of the firms seeking to sell a lower-cost generic version of Restasis, but the Food and Drug Administration has yet to give its approval to a generic version of the popular eye drop.

Allergan could not be reached for comment on the court’s decision this week.

Late last year, a U.S. Court of Appeals declined to restore Allergan’s invalidated patent claims for Restasis, as VMAIL reported.  The decision by the appeals court came without the court issuing a formal opinion. Restasis accounted for about $1.5 billion in sales for Allergan in 2017, and is one of the leading products in the company’s portfolio.