Judge Rules Restasis Patents Invalid, Also Questions Validity of Patent Transfer

On Monday, a Federal Circuit judge invalidated Allergan’s patents for its dry-eye drug, Restasis, on the basis of obviousness. He also ordered the joinder of the Saint Regis Mohawk Tribe with Allergan as a co-plaintiff in the action against drug maker Teva, which seeks to develop a follow-on version of the drug.

Judge William C. Bryson said that the yet-to-be-addressed validity of assignments of Allergan’s assignment of its Restasis patents to the Tribe did not impact the court’s ability to hear the Hatch-Waxman case at hand, but he raised the question of whether immunity from inter partes review (IPR) proceedings is “the kind of transaction to which the Tribe’s sovereign immunity was meant to extend.” Bryson also suggested the possibility that Allergan could be considered the true patent holder for Restasis if the Tribe’s substantial rights to the drug only include the right to receive a stream of revenue through royalties.

It remains to be seen how the courts will address Allergan’s approach to patent protection. Ha Kung Wong, JD, partner at Fitzpatrick, Cella, Harper and Scinto, recently told The Center for Biosimilars^® in an interview that Allergan’s patent transfer raises questions about pharmaceutical patent litigation in general. Wong said that “Experts on sovereign immunity so far seem to be in agreement that what was done was perfectly legal…so there is no reason to believe that Allergan’s motion to dismiss these IPRs won’t be granted.” However, he noted, “The fact that it is evidently preferable to lease one’s patents to another entity, which are presumptively valid upon issuance, [rather] than to risk continuous challenges…raises questions about the current post-grant trial process.”

Wong also noted the potential for the legislative and judicial branches to weigh in sovereign immunity: “Challengers’ concerns are perhaps rooted more in the perception that Allergan violated the purpose of sovereign immunity rather than the actual law of sovereign immunity. Generally, sovereign immunity with respect to patents is usually thought of as protecting state-run research institutions like state universities, but the law itself is not so limited. It remains to be seen whether Congress or the Supreme Court, both of which have been deferential to the concept of sovereign immunity in the past, would be willing to curtail it here.”