Legal Notebook: Catalyst’s Suit vs. FDA Is Tossed, Avonex Patent Invalidity Verdict Is Reinstated

 
• By Brenda Sandburg
  
Generate a summary of this article
Listen to this article
Beta

Court finds US FDA did not impede Catalyst orphan exclusivity for Firdapse as it approved different indication for competing product. Biogen loses 10-year patent battle against competing multiple sclerosis drug makers.

Courthouse Pillars & Stairs
District court dismisses suit agaisnt FDA while appeals court reverses Biogen win in multiple sclerosis drug patent dispute • Source: Shutterstock

Courts issued two notable decisions this week in pharma cases. In one dispute, the US Food and Drug Administrative prevails in its administrative split of a new drug application to meet Orphan Drug Act requirements. In the other, an appeals court appears to sink Biogen chances of winning royalties from a fellow innovator company marketing a competing multiple sclerosis drug.

A district court dismissed Catalyst Pharmaceuticals, Inc.’s complaint against the US Food and Drug Administration, finding that the agency...

Pink Sheet Podcast

Learn what's happening at the US FDA. On the go.

Derrick Gingery and the team bring you a weekly "Drug Fix".

SpotifyApple PodcastsWebsite

More from US FDA

PS-AgencyLeadership (Premium-1): Study Reveals How Immune System of Astronauts Breaks Down

Recent studies show that spaceflight can significantly weaken astronauts’ immune systems, making them more susceptible to infections and health complications during and after missions. Understanding these changes is crucial for ensuring the safety of future long-duration space travelers.

Nancy Test Circulable Section Geography

 
• By Brian Bossetta

This is a short description

New US FDA Adcomm Trend: Approved Cancer Meds Get Another Look When Competitors Coming

 
• By Sarah Karlin-Smith

Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.

Califf: Not Wise To Create Problems Related to Chinese Pharma Supply Chain Dependence

 
• By Sarah Karlin-Smith

The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.

More from Agency Leadership

New US FDA Adcomm Trend: Approved Cancer Meds Get Another Look When Competitors Coming

 
• By Sarah Karlin-Smith

Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.

Califf: Not Wise To Create Problems Related to Chinese Pharma Supply Chain Dependence

 
• By Sarah Karlin-Smith

The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.