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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

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.

Double Duty At US FDA: Tidmarsh Will Temporarily Lead Both CDER And CBER

 
• By Sarah Karlin-Smith

Just a week and a half into his tenure at the agency, the new CDER Director George Tidmarsh was also tapped to serve as acting head of CBER. Prasad’s swift ouster at CBER may point to a softening in cell and gene therapy regulation but could also portend even more scrutiny on vaccines.

Vinay Prasad Out At US FDA

 
• By Sarah Karlin-Smith

The removal of CBER Director Prasad comes after a wave of right-wing backlash to his appointment over the past few days that was also critical of his decision to ask Sarepta to suspend all sales of the DMD gene therapy Elevidys. FDA reversed its decision the day before Parsad's departure.

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