On July 20, the United States Court of Appeals for the Federal Circuit ruled in the case of the St Regis Mohawk Tribe v Mylan Pharmaceuticals that sovereign immunity does not extend to inter partes review (IPR) proceedings.
On July 20, the United States Court of Appeals for the Federal Circuit ruled in the case of the St Regis Mohawk Tribe v Mylan Pharmaceuticals that sovereign immunity does not extend to inter partes review (IPR) proceedings.
The ruling arose from a dispute in which drug maker Allergan, seeking to shield its patents for the dry-eye drug Restasis from IPR challenges from rival drug makers who hoped to develop generic products, transferred its patents covering Restasis to the Saint Regis Mohawk Tribe. The tribe agreed to invoke sovereign immunity against IPRs in exchange for a bulk payment of $13.75 million and an additional $15 million per year in royalties on drug sales.
The gambit drew wide criticism, with representatives of the generics industry calling it “bad-faith behavior,” and United States senators calling for investigations into the matter and introducing a legislative solution to prohibit such patent transfers in the future.
While the United States Patent Trial and Appeal Board previously decided that the tribe could not claim sovereign immunity in this case, Allergan and the tribe appealed that ruling.
In its newly issued decision in the appeal, affirming the prior ruling, the court explained that, while the Tribe argued that its immunity extended to IPRs because they are proceedings between private parties, the court holds that IPRs are more similar to agency enforcement actions—to which sovereign immunity does not apply—than they are to civil suits.
The decision cited recent Supreme Court ruling in the Oil States case, in which the court emphasized the government’s “central role” in IPR proceedings. The appellate court also emphasizes the fact that IPR proceedings have substantial differences from civil proceedings, and once an IPR has been instituted, the Patent Trial and Appeal Board may continue a review even if a petitioner chooses not to participate; “this reinforces the view that IPR is an act by the agency in reconsidering its own grant of a public franchise,” wrote the court.
Finally, “the Director’s important role as a gatekeeper and the Board’s authority to proceed in the absence of the parties convinces us that the [United States Patent and Trademark Office] is acting as the United States in its role as a superior sovereign to reconsider a prior administrative grant and protect the public interest in keeping patent monopolies ‘within their legitimate scope,’” according to the decision.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Rising Biosimilar Adoption for an Italian Payer Will Benefit National Health Care System, Patients
April 9th 2024Data from 2021 and 2022 indicates increasing biosimilar use in an Italian health care company, with potential for full adoption in the future, benefiting both the National Health System and citizens through efficient and sustainable health care policies.
Review Highlights Most Popular European Policies to Boost Biosimilar Uptake
April 3rd 2024Although tender systems are a common strategy to encourage biosimilar utilization across Europe, policies like automatic substitution are rarely utilized, according to a systematic review of European policies and biosimilar uptake.