Tribal Sovereign Immunity as a Defense in Overcoming IPR Challenges of Brand Name Pharmaceutical Patent Validity at PTAB – Effects on the Industry

Elana Williams


Tribal sovereignty has been recognized by the American government since the establishment of the United States and tribal sovereign immunity has been a part of American jurisprudence for over a century. Tribal sovereign immunity continues to play an important role in modern times, especially in the last few years with the rise of inter partes review (IPR) proceedings stemming from the America Invents Act of 2011. IPR proceedings are filed with the United States Patent and Trademark Office (USPTO) and heard by the Patent Trial and Appeal Board (PTAB) as an alternative to or in conjunction with traditional patent litigation in the U.S. Court of Appeals for the Federal Circuit. Therefore, patent owners may have to defend their patents both at PTAB and in federal court.

PTAB has recently granted its first motion to consider the issue of tribal sovereign immunity as it relates to patents covering the branded drug Restasis®. This case involves two giants of the pharmaceutical industry: Allergan PLC (Allergan), a brand name drug manufacturer who holds the Restasis® patents, and Mylan N.V. (Mylan), a generic pharmaceutical company.

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