On Monday, June 4, the Federal Circuit will hear arguments in Saint Regis Mohawk Tribe v. Mylan Pharmaceuticals Inc., a case that may have substantial impact on the future of Inter Partes Reviews (IPRs) due to the central issue of tribal immunity. Metro Detroit patent litigator Glenn Forbis spoke to Law360 in anticipation of the upcoming arguments, discussing both the background of the case and the impact it may have.
The Saint Regis Mohawk Tribe previously partnered with Allergan PLC to shield the latter’s Restatsis drug from review at the Patent Trial and Appeal Board (PTAB). In 2016, Allergan reportedly paid the tribe more than $13 million, plus additional ongoing royalties, to take ownership of the patent for Restatsis and license it back to the company. That same year, Restatsis allegedly generated $1.5 billion in revenue.
At stake is whether tribal sovereign immunity applies in IPRs. The PTAB determined in February that it does not. They also found that Mylan had proven that the patents in question were likely invalid.
The PTAB’s decision was immediately appealed, but not before it could find support from several big players, including the U.S. Department of Justice and Senior U.S. Circuit Judge William Bryson, who oversaw the matter in district court. Judge Bryson has stated that he has “serious concerns” about the agreement between the St. Regis Mohawk Tribe and Allergan as well as the effect it could have on Inter Partes Reviews.
Although many expect Mylan to prevail, the wildcard nature of Allergan’s defense strategy has some patent owners considering the alternative. “If tribal immunity were to pass muster,” Forbis said, “there would be a gaping loophole that would be attractive for many patent owners, depending on the size of their litigation and the value of their patents.”
With oral arguments scheduled to take place Monday, June 4, expect patent owners and other interested parties to be watching very closely.