The U.S. Supreme Court declined to hear Allergan's appeal defending its effort to shield its patents from review by selling them to a Native American tribe, according to STAT. The rebuff leaves a lower court ruling in place.
In 2017, Allergan transferred six patents of its best-selling eye medication, Restasis, to St. Regis Mohawk tribe in an effort to keep generic competition from the market. At the same time, Allergan was facing a patent challenge from several generic manufacturers, including Mylan, Teva Pharmaceuticals and Akorn. The three generic drugmakers petitioned for what is known as an inter partes review, a separate legal process overseen by a unit of the U.S. Patent Office.
The controversial deal struck with the Mohawk tribe sought to protect the Restasis deal from legal review, as the drugmaker believed the sovereign tribal government had immunity from inter partes review.
Allergan paid the tribe $14 million and agreed to pay another $15 million in annual royalties. The Mohawk tribe then worked to get the challenges dismissed before the patent board.
But in February 2018, the patent board decided that tribal immunity doesn't apply to inter partes review cases. In July 2018, the decision was upheld by a federal appeals court, which ruled a Native American tribe can't claim sovereign immunity to sidestep an inter partes review.
Allergan and the Mohawk tribe then asked the Supreme Court to reverse the appeals court ruling. In its argument to the Supreme Court, Allergan and the Mohawk tribe argued that the federal appeals court "fundamentally misconstrued" an earlier case that informed its decision.
However, the Supreme Court declined to hear the case, leaving the lower court ruling in place.
An Allergan spokesperson declined STAT's request for comment.
Read the full report here.