Declaring its objection to patent reviews by administrative law tribunals from the U.S. Patent and Trademark Office (USPTO), Allergan Plc adopted a surprising strategy for protecting the patents to its dry eye drug Restasis. The Dublin-based drugmaker transferred the relevant patents to the Saint Regis Mohawk Tribe of New York in exchange for ongoing licensing fees.
The move was intended to insert a question of tribal sovereignty into the heart of a dispute over whether generic versions of Restasis can be sold. Mylan NV and Teva Pharmaceutical Industries Ltd have asked regulators to allow them to sell generic versions of the drug.
The competitors have a strong case, as a federal judge in Texas invalidated Allergan’s Restasis patents in 2017. According to Reuters, the judge invalidated those patents without waiting for a ruling from the patent board, and his decision was upheld on appeal.
Yet Allergan took issue with the administrative tribunals of the USPTO, which it called biased and a flawed forum. Its maneuver to transfer the Restasis patents to the Mohawk was done in an effort to shield the patents from review by such tribunals. Allergan says it does not object to federal judges ruling on patent validity.
Last year, a USPTO tribunal ruled that the patents were still reviewable despite being the property of a sovereign tribe. Sovereign immunity did not, after all, put the Restasis patents beyond the reach of its proceedings.
Lawmakers from both parties called Allergan’s maneuver a sham, and the U.S. Court of Appeals for the Federal Circuit, which reviews cases from the USPTO, apparently agreed. The appeals court affirmed the tribunal’s decision.
Allergan appealed the Federal Circuit’s decision to the U.S. Supreme Court, which recently refused to hear it. That leaves the USPTO and federal rulings in place.
The tribal sovereignty maneuver having failed to protect the patents, Restasis appears ripe for generic treatment.