Legal Notebook: Catalyst’s Suit vs. FDA Is Tossed, Avonex Patent Invalidity Verdict Is Reinstated
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.
You may also be interested in...
In rare loss for FDA, appeals court reverses district court decision tossing Catalyst’s suit over Orphan Drug Act, saying deference should not have been granted to agency’s interpretation. District court finds it is too early to rule on one Pfizer charity co-pay program but backs broad reading of Anti-Kickback Statute.
Suit against agency reveals internal discussions to approve Jacobus' Ruzurgi despite Catalyst's orphan exclusivity for the same drug; Sen. Bernie Sanders urged FDA to address price of Catalyst's Firdapse (amifampridine).
Lawsuit seeking invalidation of rare disease treatment's approval in Lambert-Eaton myasthenic syndrome encompasses policy trifecta of exclusivity, drug pricing, and expanded access issues.