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

Executive Summary

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.

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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.

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