Specifically, anticompetitive practices justified by sovereign immunity will crush biotechnology development and science leadership.

Alanna Marie Spero, “Sovereign Immunity, Intellectual Property, and the Life Sciences: Investigation and Analysis of the Preserving Access to Cost Effective Drugs Act,” Harvard University, 03-xx-2019, https://dash.harvard.edu/bitstream/handle/1/42004073/SPEROESQ-DOCUMENT-2019.pdf?sequence=1&isAllowed=y

Patent filings in the life sciences are one of the most significant influencers of modern technology as well as the most significant contributor to the advancement and availability of scientific knowledge for use of public benefit. However, over the past twenty-five years, changes have been made to patent law that have complicated an already competitive and at times cutthroat area of law, and as a result this valued intersection of science and law has been further muddled with discourse, patent challenges, and industry leaders seeking every legal avenue or “loophole” to improve their position in the patenting arena. Most recently, this has included the attempt of pharmaceutical company Allergan to circumvent a patent challenge through capitalizing on the sovereign immunity of a Native American Tribe. (Allergan, Inc. and the Saint Regis Mohawk Tribe v. Teva Pharmaceuticals USA, Inc., No. 2:15-cv-1455-WCB (Fed. Cir. Oct. 16, 2017). In July of 2018, a three-justice panel of the U.S. Court of Appeals for the Federal circuit (“CAFC”) issued a scathing decision against Allergan, though Allergan and the Saint Regis Mohawk Tribe have since filed for an en banc rehearing before the CAFC, a rarely granted review in which the full CAFC would preside over the rehearing, but which has yet to be granted. Presuming that the decision of the CAFC is affirmed, sovereign immunity would be rendered be inapplicable to patent law proceedings and, sovereign entities actually participating in invention and development within biotechnology and the life sciences may be penalized for the bad acts of Allergan and the tribe in their attempt to “rent out” sovereign status. The hypervigilant response to the Allergan case is likely to provide unwarranted deprivation of sovereign rights to deserving entities.

Throughout its lengthy history, sovereign immunity (“SI”) has been valiantly upheld and rarely restricted by the federal courts of the United States. The origin of SI includes its granting to the states in exchange for their agreement to join the union and establish the entity of the United States in itself. SI has faced significant legal challenges; however, the vast majority of cases have upheld this immunity with very little exception. When SI was limited in its scope or application, foregoing rulings were not necessarily consistent, with justices overturning or ruling contrary to precedent case law decisions.

In the history of lawsuits involving a question of sovereign immunity, no such area of law has faced the volume, or the intensity of challenges then patent law and licensing. Within the last 20 years alone, patent law and its sovereign actors have been affected by the America Invents Act (2012), the Bayh Dole Act (1980), the Patent and Plant Variety Protection Remedy Clarification Act (“PRCA”, 1992), the Copyright Remedy Clarification Act (“CRCA”, 1990), the Trademark Remedy Clarification Act (“TRCA”, 1992), and the Intellectual Property Jurisdiction Clarification Act (2011). These changes to patent law still respected the boundaries of sovereign status for state-entity patent actors, though, and include carved out provisions dictating how such should be applied to non-profit academics and state actors.

In the life science patent area, a valuable and mutually beneficial relationship exists between private and public entities. Information and inventions flow from academic partnerships (often public actors) to the private sector by way of Sponsored Research Agreements and Licenses, through which a private corporation financially supports the research of an academic with the anticipatory return of a license offer to practice any inventions or innovations that may result from the researcher’s work. This benefits the academic not only financially, but in furthering their objective to disseminate information and foster more innovation, benefitting the greater public good and contributing to society in the process. The private entity is able to access and collaborate with the research that a faculty member has invested years or even decades of work to, without which the company would likely not be able to establish on its own.