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USPTO Director Issues Interim Guidance on Discretionary Denials of PTAB Petitions

On June 21, 2022, U.S. Patent and Trademark Office (USPTO) Director Katherine K. Vidal issued new, binding interim guidance addressing the Patent Trial and Appeal Board’s (PTAB) approach to discretionary denials of PTAB petitions.

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Can They Really Do That? The Specter of Government-Authorized Infringement of Pharmaceutical Patents

Practices: Intellectual Property

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The perception that pharmaceuticals in the United States are overpriced, and that patent rights are why, has been a recurrent political theme over the last several years. This view, along with the ongoing novel coronavirus pandemic, has caused some to consider whether the U.S. government should act to ensure affordable access to potentially life-saving medicines.

But under what authority could the U.S. government take action on patents in an attempt to lower drug prices or make a lifesaving product more widely accessible? A team of Ropes & Gray intellectual property litigators, led by partner Matt Rizzolo, has authored a white paper exploring the topic in depth. The paper – titled Can They Really Do That? The Specter of Government-Authorized Infringement of Pharmaceutical Patents – offers a detailed look into two possible statutory levers that the federal government could pull. The authors also discuss the important roles that the Food, Drug, & Cosmetic Act and the fragmented nature of the U.S. health care system may play in any government-authorized infringement or compulsory licensing efforts. Finally, they discuss a variety of legal and policy avenues that patent holders may employ if their patent rights are threatened by the government, up to and including constitutional claims.

Click here to read the full Whitepaper.

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