University of Miami Law Review


Nicholas Dilts


The United States Congress passed the Leahy Smith America Invents Act in 2011 in an effort to streamline the patent system and reduce patent litigation, allowing the United States to continue to be competitive globally. The Act enabled the U.S. Patent Office to facilitate patent challenges through an administrative process called inter partes review, an adversarial proceeding before the newly established Patent Trial and Appeal Board that was designed to be a cheaper and more efficient alternative for post-grant patent review than litigation in front of the federal district courts. In the years that followed, the Patent Trail and Appeal Board has earned a reputation for being notoriously trigger-happy in its invalidation of patents. This reputation has encouraged patent holders to seek out ways to circumvent inter partes review in an effort to have their patents reviewed in front of the federal district courts, where they might stand a better chance. One such attempt was initiated by the global pharmaceutical company, Allergan, Inc., when it sold the rights to its Restasis eye drug to the Saint Regis Mohawk Tribe. The main components of the deal focused on a transfer of the Restasis ownership rights along with a yearly sum to the Tribe. In return, the Tribe licensed back the drug’s production rights to Allergan and agreed to assert a tribal sovereign immunity defense in response to any inter partes review challenge, which would force the dispute into the federal district court forum.

The Allergan-Saint Regis deal threatened to have major impacts on the intellectual property world, the livelihoods of the federally recognized tribes, and the U.S. economy overall. The issues it presented involved an intersection of multiple types of law and begged a review of the patent review process, the state of the tribes today, and the scope of tribal sovereign immunity in today’s day and age. Whether tribal sovereign immunity could be applied to an administrative action in post-grant patent review evolved into a battle at multiple forums. When the dust settled, the Patent Trial and Review Board had issued a decision that tribal sovereign immunity was not applicable and invalidated the Restasis patent—a decision that was affirmed by the United States Court of Appeals and the Supreme Court of the United States. This Comment discusses all of the angles in this case before advocating that the Supreme Court ultimately did not go far enough when it simply chose not to review the lower court’s decision. Instead, the Court should have used this opportunity to limit tribal sovereign immunity in a way that implies a waiver of sovereign immunity for economic activities that take place off of tribal lands. This solution would simultaneously help to promote overall systemic and economic efficiency, as well as allow the tribes a better opportunity to participate in today’s marketplaces—providing them with a more positive outlook for the future.