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Reversal In CAR-T Patent Battle Shows Federal Circuit’s Preference For Narrow Claims

 
• By Brenda Sandburg

Appeals court finds that Juno/BMS patent is invalid, overturning $1.2bn jury verdict against Kite/Gilead. Ruling illustrates court does not like functionally-defined patent claims, attorneys say. Decision could impact future CAR-T patents and disputes.

CAR T-cell immunotherapy
Gilead wins reversal in CAR T-cell immunotherapy patent battle • Source: Alamy

In a significant upset, the US Court of Appeals for the Federal Circuit reversed a jury verdict that Kite Pharma, Inc.’s Yescarta infringed Juno Therapeutics Inc.’s chimeric antigen receptor (CAR) T-cell therapy patent. The decision shows the difficulty in pursuing broad patents claiming the backbone of the technology and the need to describe all elements of claims.

Juno, now Bristol Myers Squibb Company, sued Kite, now a subsidiary of Gilead Sciences, Inc., claiming its use...

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More from Cell & Gene Therapies

‘We Need To Move With The Times’: Cell & Gene Therapy Catapult CEO On UK’s Regulatory Overhaul

 
• By Eliza Slawther

The UK drug regulator has introduced several changes in recent months, such as the introduction of a decentralized manufacturing regulation. Matthew Durdy, CEO of the Cell and Gene Therapy Catapult, explains what these changes mean for the cell and gene industry.

Prasad’s Return Shelves Center Consolidation, But Maybe An Opening For OCE 2.0?

 
• By Kate Rawson

Vinay Prasad’s exit from the US FDA reignited conversations about integrating its drugs and biologics centers under George Tidmarsh. Those plans appear to be shelved, but the leadership transition could be an opportunity to fully realize the vision for the Oncology Center of Excellence.

Ultragenyx Says CRL Discussions ‘Productive’ Despite US FDA Leadership Upheaval

 
• By Jessica Merrill

Ultragenyx said talks with the FDA about a path forward after receiving a CRL for UX111 have been productive despite the recent upheaval at the agency.

Prasad 2.0 Brings New Instability Concerns, Questions About Changed Regulatory Philosophy

 
• By Sarah Karlin-Smith

Many agency stakeholders believe Vinay Prasad may be forced to change his regulatory approach at least somewhat after receiving a second chance to lead the US FDA's biologics center.

More from Advanced Technologies

Plans For EU Biotech Act Shift Up A Gear

 
• By Eliza Slawther

Companies have until early November to respond to a public consultation from the European Commission on its planned Biotech Act, which it hopes will help unleash the potential of small and midsize enterprises in the bloc.

AI In Clinical Research: Benefits Across The Board, But ‘Nirvana’ Still Out Of Reach

 
• By Vibha Sharma

Generative artificial intelligence tools, such as ChatGPT, have “democratized” AI, and contract research organizations are wholeheartedly embracing these tools, given their focus on efficiency, says Stephen Pyke, who chairs the AI committee at the Association of Clinical Research Organizations.

Generic Drugs And AI: Maximum Daily Dose Tool Could Help US FDA Be ‘At The Forefront’

 
• By Michael McCaughan

The FDA is testing a new artificial intelligence tool to help generic drug developers automate maximum daily dose calculations.