On September 8, 2017, Allergan PLC (“Allergan”), a global pharmaceutical company, publicly announced the assignment of all Orange Book-listed patents for its dry-eye drug RESTASIS® to the Saint Regis Mohawk Tribe (“Tribe”) in upstate New York. In a unified statement about the transaction, the Tribe Council stated, “This is a viable and sound opportunity for the Saint Regis Mohawk Tribe to enter into the patent, technology and research sector as part of our overall economic diversification strategy.” Under the terms of the agreement, Allergan retains an exclusive license in the patents related to the product, while the Tribe receives an initial payment of $13.75 million and up to $15 million in annual royalties for the life of the patents. The patents are set to expire on August 27, 2024.

Allergan’s Chief Legal Officer, Bob Bailey, stated, “The Saint Regis Mohawk Tribe and its counsel approached Allergan with a sophisticated opportunity to strengthen the defense of our RESTASIS® intellectual property…” With the unorthodox transfer of ownership, Allergan aims to shield the RESTASIS patents from invalidity challenges at the Patent Trial and Appeals Board (“PTAB”) by asserting the Tribe’s sovereign immunity. In fact, on September 22, 2017, the Tribe did just that – filing a Motion to Dismiss the IPR proceedings for lack of jurisdiction based on tribal sovereign immunity.

Inter Partes review (“IPR”) is an adjudicatory proceeding conducted by the Patent Trial and Appeals Board (“PTAB”) in which a petitioner can challenge the validity of any issued patent.[1] The proceeding became an available vehicle for post-grant opposition of patents one year after the enactment of the Leahy-Smith America Invents Act in 2011. An IPR proceeding is initiated by the filing of a petition requesting to cancel as unpatentable one or more claims of the patent in dispute.[2] While there is no time limit for requesting an IPR during the life of a patent, certain limitations may bar a party from utilizing the process. For instance, under 35 USC §315 (b), a party cannot file a petition more than one year after the date on which “the petitioner is served with a complaint alleging infringement of the patent.”[3] Furthermore, a party is barred from filing a petition if “before the date on which the petition for such a review is filed, the petitioner or real party in interest filed a civil action challenging the validity of a claim of the patent.”[4] Congress implemented both of these statutory bars to avoid the redundant and costly expenses of parallel USPTO and district court proceedings.[5]

On June 3, 2016, Mylan Pharmaceuticals Inc. petitioned for an IPR of U.S. Patent 8,685,930, then owned by Allergan, Inc., covering RESTASIS. The PTAB rendered a Decision to institute IPR on December 8, 2016. Mylan was later joined by Teva Pharmaceuticals USA, Inc. and Akorn Inc. (additional competitor generic drug manufacturers) in the IPR proceeding.

On September 8, 2017, Allergan filed a Patent Owner’s Updated Mandatory Notices to inform the PTAB that the Saint Regis Mohawk Tribe (“Tribe”) had become a real party-in-interest based on an Assignment. In the Patent Owner’s Updated Mandatory Notices, the Tribe made a special appearance to request the PTAB to stay all proceedings in the IPR pending resolution of the Tribe’s motion to dismiss the IPR based on sovereign immunity.

As a federally recognized, sovereign Indian Tribe, the Tribe asserts inherent sovereign immunity.[6]  Sovereign immunity is codified in the Eleventh Amendment to the U.S. Constitution, providing “Judicial power of the United States shall not be construed to extend to any suit in law or equity, commenced or prosecuted against one of the United States by Citizens of another State, or by Citizens or Subjects of any Foreign State.” The broad doctrine prohibits actions against foreign states in federal courts and administrative tribunals. Legal precedent also favors a successful defense.[7]

On September 19, 2017, the PTAB rendered an Order concluding that “briefing on the issue of Tribe’s alleged tribal sovereign immunity from these proceedings is warranted.” The Order authorized the Tribe to file a motion to terminate the IPR on the basis of sovereign immunity and the petitioners to file an opposition to the motion.

---

[1] See 35 U.S.C. §311.

[2] Id. Patentability of claims may only be contested on grounds under 35 U.S.C. §102 or §103, and only on the basis of prior art consisting of patents or printed publications. Id. Additionally, a petition may only be filed after the later of either nine months after the grant of the patent or the termination of a post-grant review proceeding. Id.

[3] 35 USC §315 (b)

[4] 35 USC 315(a)(1). Notice, however, that this provision does not bar a petitioner from filing both an IPR and a declaratory judgment action in federal court on the same day.

[5] See Rules of Practice for Trials Before the Patent Trial and Appeal Board, 77 Fed. Reg. 48,663 (Aug. 14, 2012).

[6] See Motion to Dismiss

[7] See Covidien LP v. University of Florida Research Foundation Incorporated; Neochord, Inc. v. University of Maryland Baltimore; Reactive Surfaces Ltd., LLP v. Toyota Motor Corporation