Big Molecule Watch
October 16, 2017

Court Permits St. Regis Mohawk Tribe to Join Restasis® Litigation, but Nixes Allergan’s Patents

Today, Judge Bryson, a Federal Circuit judge sitting by designation in the U.S. District Court for the Eastern District of Texas, Marshall Division, issued an Opinion and Order granting Allergan’s motion to join the St. Regis Mohawk Tribe (“the Tribe”) as a party to this litigation regarding the drug Restasis®.  As background, Allergan had previously assigned its rights to Restasis® patents to the Tribe and received an exclusive license to the patents from the Tribe.  Mylan, in opposing Allergan’s motion to join the Tribe, stated that Allergan “has admitted in other forums that the intent is to employ Native American sovereign immunity and attempt to cut-off pending validity challenges with the Patent Office.”  The referenced validity challenges at the Patent Office are:  IPR2016-01127, -01128, -01129, -01130, -01131 and -01132.  The oral hearing in these IPRs has been indefinitely postponed pending the PTAB’s decision on the Tribe’s motion to dismiss (based on its sovereign immunity).

Judge Bryson stated that “the Court has serious doubts that the transaction in which Allergan has sought to obtain immunity from inter partes review by the PTO in exchange for payments to the Tribe is the kind of transaction to which the Tribe’s sovereign immunity was meant to extend.”  Judge Bryson noted that while issues of sovereign immunity “may be dispositive in the IPR proceedings … those issues do not bear on this Court’s power to hear this case.”  Judge Bryson granted Allergan’s motion to join, without ruling on the validity of the assignment to the Tribe, because defendants had not argued that they would be prejudiced by joinder of the Tribe and joinder would not interfere with the timing of the Court’s judgment in the case, and to ensure that the Court’s judgment could not be challenged on the ground that the owner of the patents was not a party to the action.

Patent owners and petitioners alike are closely watching the impact of the Allergan/Tribe transaction on the pending IPRs.  It remains to be seen whether Allergan’s efforts to use tribal immunity to shield the Restasis® patents from PTAB review will be successful.

Judge Bryson also issued an Opinion finding Allergan’s Restasis® patents invalid.

The post Court Permits St. Regis Mohawk Tribe to Join Restasis® Litigation, but Nixes Allergan’s Patents appeared first on Goodwin Procter BioSimilars Blog.