Intellectual Property Practice Group Co-Leader Imron Aly spoke with The Center for Biosimilars on key takeaways from the long-running case Saint Regis Mohawk Tribe, Allergan v. Mylan, in which Allergan transferred its patents for the brand-name drug Restasis to the Saint Regis Mohawk Tribe. Allegan promised the tribe annual royalties in exchange for the tribe invoking sovereign immunity from inter partes review (IPR) that would protect the drug from generic competition.
Imron said this case has important lessons for innovator product sponsors and generic and biosimilar developers as they consider IPR proceedings and the patent landscape as a whole.
When facing IPR proceedings, innovator product sponsors should “be prepared to challenge the IPR on the merits. From a patent owner's point of view, the numbers are shifting,” Imron said. “It’s not so unfavorable to the brand or favorable to the generic…maybe going forward in the [Patent Trial and Appeal Board] proceeding it is worthwhile even for the brand company to try to leverage something early in terms of merits arguments.”
Imron added another takeaway that brands should become more creative in terms of thinking about settlements to end litigation rather than avoiding patent challenges altogether.
“If a brand company is showing that they’re willing to pay a tribe to take on a patent and then pay them to license it going forward, maybe there are ways to sublicense to generics…and still make it a money-making machine, but come up with alternatives.”
Royalty payment settlements, Imron said, could keep brand companies “with a finger in the market” even after competitors enter with their products. “If I were a brand company,” he said, “if [an IPR] is instituted, [I'd] maybe reach a settlement that has a launch date in the future plus a royalty provision.”
Imron’s interview reflects his continued creativity in resolving disputes that biosimilar generics can employ.
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