Cipla Defeated In US Kyprolis Patent Tussle

Three Key US Patents Not Obvious, Court Finds

Indian firm Cipla went it alone against Amgen and its Onyx Therapeutics subsidiary to obtain a judgment that would allow for market entry in the US for the firm’s generic to the Kyprolis oncology brand. However, a district court has ruled in the main against the firm.

Gavel
Cipla has received a mainly negative verdict on three US Kyprolis patents • Source: Shutterstock

Cipla has suffered defeat in US patent-litigation proceedings with Amgen and its Onyx Therapeutics subsidiary over their Kyprolis (carfilzomib) injectable brand that is set to bar it from generic market entry until December 2027.

A US district court ruled against the Indian firm, finding that it had failed to prove by “clear and convincing...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Legal & IP

UK Decision Opens Up Competition On Forxiga

 
• By 

Generic dapagliflozin rivals to AstraZeneca’s Forxiga are now free to hit the UK market after the country’s Supreme Court lifted the final barrier preventing launch, allowing off-patent firms access to a market worth hundreds of millions of pounds annually.

Sandoz Rushes To Fill Gap After German Court Revokes Xarelto Patent

 
• By 

Germany’s Federal Patent Court has invalidated Bayer’s key patent covering once-daily use of Xarelto (rivaroxaban), paving the way for Sandoz to launch a generic version. Bayer is considering an appeal.

Dr Reddy’s On Semaglutide Prospects, Capacity And There’s An IP Hearing To Watch

 

Dr Reddy’s CEO discusses the growth opportunity for semaglutide, including production capacity and ‘crazy’ demand indications, and a potential 20-plus product GLP-1 portfolio. All eyes are also on an upcoming hearing in India pertaining to Novo Nordisk’s semaglutide patent in the country.

US Court Agrees To Throw Out Viatris Wegovy Infringement Case

 
• By 

Viatris’ Mylan has won a key patent case against Novo Nordisk over generic Wegovy, with a US federal district judge ruling Mylan’s label did not encourage use that infringed Novo’s method-of-treatment patent.

More from Generics Bulletin

Iron Sucrose Competition Expands With Viatris and Amphastar FDA Approvals

 
• By 

Viatris and Amphastar are expanding their complex generic portfolios with the planned launches of FDA-approved versions of Vifor Pharma/Daiichi Sankyo’s Venofer (iron sucrose). The FDA’s database also show Sandoz holds an approval for generic Venofer, though it has not disclosed launch plans.

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

 

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

Amgen Welcomes Evolving Biosimilar Guidelines As Competitive Advantage

 
• By 

Amgen sees potential regulatory shifts toward streamlined biosimilar approvals as favorable, citing its strength in developing high-quality products.