PTAB Denies Tribe's Request for Sovereign Immunity From IPRs on Restasis Patents

The US Patent Trial and Appeal Board (PTAB) has decided that the Saint Regis Mohawk Tribe cannot claim sovereign immunity from inter partes review (IPR) of Allergan’s patents covering Restasis, and that the IPR proceedings on those patents can continue with Allergan as the patent owner.

The decision stems from Allergan’s 2017 transfer of patents covering its dry-eye drug to the Tribe in exchange for invoking sovereign immunity from IPRs. The move came less than 1 week before a scheduled oral hearing for several instituted IPRs of patents covering Restasis. The Tribe then moved to dismiss the scheduled proceedings for lack of jurisdiction.

After considering numerous amicus briefs (and the supplemental briefs of both the petitioners and the patent owners), the PTAB determined that “…the Tribe has not established that the doctrine of tribal sovereign immunity should be applied to these proceedings. Furthermore, we determine that these proceedings can continue even without the Tribe’s participation in view of Allergan’s retained ownership interests in the challenged patents.”

Among the reasons for its decision, says the PTAB, is that tribal sovereignty is subject to the superior control of Congress, and that acts of Congress apply to tribes. Thus, since Congress has enacted a statute that stipulates that any patent is subject to the requirements of law, including IPRs, tribal ownership of a patent does not shield the owner from an IPR proceeding.

Furthermore, the PTAB agreed with the petitioners in their claim that Allergan is the true owner of the patents in question, regardless of how Allergan and the Tribe characterized their arrangement. The PTAB addresses the following among its reasons for the decision:

• The licensing agreement between the parties limits the Tribe’s right to sue for infringement over the patents
• The Tribe’s freedom to practice the patents is limited
• Allergan’s field of use for the patents extends to all FDA-approved uses
• Rights granted to Allergan in the patent are “perpetual"
• The financial interest of the Tribe does not itself constitute a “substantial right” to the patents
• The license agreement itself allows for the possibility that Allergan has the primary right to defend challenged patents
• The Tribe cannot freely assign its interests in the patents under the agreement

However, the PTAB did not address the question of whether the arrangement between the Tribe and Allergan was proper; in October 2017, Judge William C. Bryson, who presided over an unrelated Hatch-Waxman litigation concerning Restasis, called for briefs addressing “…whether the assignment of the patents to the Tribe should be disregarded as a sham.” Bryson later invalidated the patents in question in this case.

In its decision, the PTAB wrote that, “In reaching this conclusion, we do not comment on whether the License and the other agreements between the Tribe and Allergan constitute a ‘sham’ transaction, nor do we need to decide whether the agreements are otherwise improper under the law.”