In an interesting turn of events, the Board is now permitting amicus briefs in the hotly disputed case between Allergan, Inc. and generic drug makers relating to patents for Allergan’s dry eye drug, Restasis. This appears to be the first time that the Board has allowed amicus briefs in a post-grant challenge.
In 2015, Allergan sued several generic drug makers, including Mylan Pharmaceuticals Inc., Teva Pharmaceuticals USA, Inc., and Akorn Inc., for infringement of six of its dry eye drug patents. Subsequently thereafter, the generic drug makers filed Petitions for IPR against the six patents, which the Board instituted.
With the oral hearing in the IPRs just a week away, Allergan assigned the dry eye drug patents to the Saint Regis Mohawk Tribe on September 8, 2017, and then licensed them back for reportedly $13.75M with $15M in annual royalties. The Tribe then filed an updated mandatory notice in the IPRs notifying the Board that the Tribe has been assigned all six dry eye drug patents. Thereafter, the Tribe obtained leave from the Board and filed a Motion to Dismiss the IPRs of the dry eye drug patents on the grounds of sovereign immunity.
Despite having previously denied a request by the Association for Accessible Medicines to file an amicus brief in the Allergan IPRs, the Board recently issued an Order on November 3, 2017 permitting the High Tech Inventors Alliance (HTIA) —and any other amici curiae—leave to file an amicus brief as to whether the Tribe’s Motion to Dismiss should be granted for sovereign immunity. The Order suggested that amicus briefs are not permitted in a typical case, but given this is an issue of first impression, the Board has allowed them.
The Board directs any interested party who wishes to present similar arguments to coordinate their efforts in a joint amicus brief. Amicus briefs are due December 1, 2017.