When Allergan transferred six Restasis patents to the Saint Regis Mohawk tribe in 2017 in a bid to shield the dry-eye treatment from generic competition, it was widely maligned by everyone from industry insiders to tech giants like Microsoft. And in July, the U.S. Court of Appeals for the Federal Circuit ruled that Allergan’s effort to shield its patents by declaring tribal immunity is a no-go tactic.
Now, Allergan and the tribe want the U.S. Supreme Court to weigh in.
On its website, SCOTUS posted (PDF) a writ of certiorari that Allergan and the Mohawk filed in late December. The court will decide by Feb. 11 whether to hear the case.
The dispute over Allergan’s partnership with the Mohawk tribe dates back to early last year, when would-be Restasis generics maker Mylan challenged the six patents. The tribe tried to get Mylan's bid thrown out on the grounds that sovereign immunity should shield it from patent challenges. But the Patent Trial and Appeal Board struck down the tribe’s motion.
The U.S. appeals court upheld that decision on the grounds that inter partes reviews by the U.S. Patent and Trademark office constitute an agency enforcement action, not a civil suit where tribal immunity might be relevant. Allergan and the Mohawk tribe disagree with that assessment and are asking SCOTUS to decide whether inter partes reviews that are presented to the Patent Trial and Appeal Board should be protected by tribal sovereign immunity.
Allergan has good reason to pursue out-of-the-box ideas for protecting Restasis. The drug, which brought in $1.4 billion in sales in 2017, continued to drive much of the company’s sales growth last year. But concerns that the product could be facing generic competition soon have driven some disgruntled shareholders to press CEO Brent Saunders to come up with a new strategy for the company. Those calls may get louder as Allergan’s top-selling Botox faces pressure in the migraine market from a new class of CGRP inhibitors.
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Even though Allergan appealed to SCOTUS for a review of the Mohawk tribe partnership, the company doesn’t seem all that optimistic about keeping Restasis generics off the market. In November, Allergan nixed a planned $200 million expansion of its manufacturing site in Waco, Texas, deciding instead to spread $180 million in investments across all of its manufacturing sites.
The expected loss of Restasis exclusivity, a spokeswoman told FiercePharma at the time, “has shifted our priority from expanding the Waco site to investing significantly in our existing operations.”
Mylan is not the only generics maker looking to steal Restasis market share from Allergan. InnoPharma, Akorn and Teva have also filed generics applications for the drug, and Teva is already marketing its version in Canada.