Patent, Pharmaceutical, American Indian, Native American, dry eye, drug, PTAB, Allegran, economic oppression, Restasis, ANDA, bioequivalent, tribe, mohawk, saint regis, sovereign immunity, sale, Sioux, consumer welfare


Last year, a Fortune 500 pharmaceutical company attempted to rent the sovereign immunity of an American Indian tribe in order to shield its patents on a dry-eye drug from invalidation by generic competitors in inter partes review. Pharmaceutical firms are notorious for pursuing unconventional methods to extend the duration of their patents and, in this sense, the maneuver is unsurprising. The exploitation, however, of an historically disenfranchised community with limited economic opportunities is particularly unsettling. This Article will provide, firstly, a factual summary of the legal background of this case; secondly, a review of the February 2018 decision of the Patent Trial and Appeal Board (“PTAB”) to deny the application of tribal sovereign immunity in this case; thirdly, a review of the July 2018 decision of the U.S. Court of Appeals for the Federal Circuit, affirming the PTAB’s decision; fourthly, a discussion of the ways in which the precedent set by Allergan’s maneuver may adversely affect consumer welfare by undermining the process of inter partes review; fifthly, an analysis of the history of tribal sovereign immunity and how its exploitation in this case reflects the historic oppression of American Indians; and finally, strategies to deter such transactions from recurring in the future.