AAM White Paper: Renting Tribal Immunity to Evade IPR Review of Pharmaceutical Patents

For more than four decades, U.S. Patent and Trademark Office (PTO) review of issued patents has been considered a vital component of a healthy patent system, and Congress has worked to improve that review system to systematically eliminate invalid, competition-killing patents. The rental of Native American sovereign immunity by brand name drug companies is a transparent attempt to thwart this process. If successful, these transactions would bring back the very same abuses: a proliferation of weak patents, a lack of public confidence in patents, a lack of certainty in the validity of issued patents, and a lack of competition. The Patent and Trial Appeal Board (PTAB) of the PTO’s hands are far from tied, however. By concluding that sovereign immunity does not apply in inter partes review proceedings under the Supreme Court’s Federal Maritime Commission and Cuozzo decisions, or by concluding that it can finish its “second look” at the Restasis patents given the equities of the tribal immunity rental transactions, the PTAB can ensure that big pharma schemes do not keep patients from affordable, FDA-approved medicines.

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Association for Accessible Medicines


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