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

 
• By Brenda Sandburg

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...

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More from US FDA

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.

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 Telework, More Staff, US FDA’s Tidmarsh Plans To Alleviate Workforce Challenges

 
• By Sarah Karlin-Smith

The new CDER director focused on plans to improve morale during an Aug. 8 townhall, but staff comments indicate that may be a challenge.

New US FDA CDER Director Pledges No Politics In Approvals, Adds Higher Ups Can Overturn

 
• By Sarah Karlin-Smith

New CDER Director George Tidmarsh promised to keep politics out of drug approvals, but suggested during a meeting with staff that he could not insulate the drug center from political pressures coming from those above him.

More from Agency Leadership

New US FDA CDER Director Pledges No Politics In Approvals, Adds Higher Ups Can Overturn

 
• By Sarah Karlin-Smith

New CDER Director George Tidmarsh promised to keep politics out of drug approvals, but suggested during a meeting with staff that he could not insulate the drug center from political pressures coming from those above him.

US FDA Requires Opioid Class Labeling Changes Despite Adcomm Advice

 
• By Kate Rawson

Quantitative estimates of the safety risks with opioid pain medication, including the risk of addiction and misuse, must be added to labeling.

US FDA Skips User Fee Increase For More Staff Amid Exodus, Hiring Difficulties

 
• By Derrick Gingery

A calculation used to determine whether the FDA has the staff to handle its workload also was not included in the description of prescription drug user fee calculations.