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Inter Partes Patent Challenges Are Constitutional, US Supreme Court Rules

 
• By Sue Sutter

But Patent Trial and Appeals Board must issue final written decision on all claims raised by challenger – not just some of them, court says; rulings in two closely watched cases mean that IPR proceedings can continue unabated, but generic drug and biosimilar sponsors may need to rethink how they go about challenging innovator patent claims.

Facade of US Supreme court in Washington DC on sunny day

Two US Supreme Court decisions handed down April 24 keep alive the ability of generic drug and biosimilar sponsors to administratively challenge innovator patents but could affect their strategies for initiating such challenges through the Patent Trial and Appeals Board.

In a 7-2 decision in Oil States Energy Services v Greene's Energy Group, the high court ruled that the inter partes review (IPR) process is constitutional, violating neither Article...

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How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

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US FDA’s ‘Good Reputation’ For Science May Mean Loper Bright Not ‘Cataclysmic,’ Attorney Says

 
• By Malcolm Spicer

Bridget Dooling, a law school professor who reviewed draft regulations from the FDA and other agencies as an OMB attorney, said prior federal court decisions suggest judges typically defer to agency decisions based in science.

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Life After Loper: Vaping Case Shows US FDA Retains Considerable Deference

 
• By Craig Bleifer, Royce DuBiner, Max Bogost, Michael Brody, and Allyson Maur

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‘The Question Is, What’s Going To Happen Next?’ – The Future For Biosimilars In Europe

 
• By Dave Wallace

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US FDA’s ‘Good Reputation’ For Science May Mean Loper Bright Not ‘Cataclysmic,’ Attorney Says

 
• By Malcolm Spicer

Bridget Dooling, a law school professor who reviewed draft regulations from the FDA and other agencies as an OMB attorney, said prior federal court decisions suggest judges typically defer to agency decisions based in science.