Apotex Loses Again On Alternate Salt Alimta In US

Federal Circuit Affirms Finding Of Infringement Under Doctrine Of Equivalents

Apotex’ 505(b)(2) new drug application rival to Alimta will stay off the US market after the Federal Circuit found that a lower court had correctly concluded that prosecution history estoppel did not bar Lilly’s infringement claims against the Canadian firm under the doctrine of equivalents.

Gavel
The Federal Circuit did not need to consider an argument of tangentiality raised by Lilly • Source: Shutterstock

Competition for Eli Lilly’s Alimta (pemetrexed) blockbuster continues to elude the US market after the US Court of Appeals for the Federal Circuit ruled that a lower court was correct to grant the originator’s motion for summary judgment of infringement against 505(b)(2) new drug application sponsor Apotex under the doctrine of equivalents.

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

J&J Denied Injunction Over Private-Label Ustekinumab In US

 
• By 

Stelara originator J&J has been denied in its initial attempt to prevent Samsung Bioepis and ustekinumab biosimilar partner Sandoz from selling a private-label version of the product through a PBM in the US.

UK Forxiga SPCs Wiped Out As Trio Succeed With Plausibility Attack

 
• By 

Generic competition to AstraZeneca’s blockbuster SGLT2 inhibitor Forxiga (dapagliflozin) treatment for diabetes may hit England and Wales earlier than 2028 after a pair of SPCs were invalidated following proceedings initiated by a trio of generics manufacturers.

Glenmark’s UK Dapagliflozin Blocked On Appeal After Teva Readied Launch

 
• By 

Glenmark’s advantage for its UK generic version of AstraZeneca’s Forxiga (dapagliflozin) has quickly been snuffed out, after the originator won on appeal its request for injunctive relief.

Sandoz Admits To Widescale Infringement In Resolving US Rinvoq Patent Tussle

 
• By 

Sandoz has reached an agreement with AbbVie to dismiss without prejudice patent-infringement litigation involving more than 20 patents shielding the originator’s blockbuster JAK inhibitor Rinvoq.

More from Generics Bulletin

J&J Denied Injunction Over Private-Label Ustekinumab In US

 
• By 

Stelara originator J&J has been denied in its initial attempt to prevent Samsung Bioepis and ustekinumab biosimilar partner Sandoz from selling a private-label version of the product through a PBM in the US.

UK Forxiga SPCs Wiped Out As Trio Succeed With Plausibility Attack

 
• By 

Generic competition to AstraZeneca’s blockbuster SGLT2 inhibitor Forxiga (dapagliflozin) treatment for diabetes may hit England and Wales earlier than 2028 after a pair of SPCs were invalidated following proceedings initiated by a trio of generics manufacturers.

What’s Next? Five Things To Look Out For In May

 
• By 

Generics Bulletin previews the most noteworthy and anticipated events for May 2025.