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Legal Briefs: Courts On Exclusivity; Namenda ‘Hard Switch’ Deemed Coercive; Acorda Fights Bass Patent Petition

 
• By Brenda Sandburg

FDA’s active moiety rationale for denying Vascepa five years exclusivity is rejected by district court; Actavis strategy to protect Namenda franchise meets another hurdle; Acorda challenges ‘improper purpose’ of Bass IPR petition.

A district court spotlighted FDA’s apparently inconsistent definitions of what constitutes an “active ingredient” in rejecting the agency’s rationale for denying Amarin Pharmaceuticals Inc.’s fish oil pill Vascepa (icosapent) five years of market exclusivity as a new chemical entity. The court ordered the agency to reconsider its decision.

The agency found that the active moiety in Vascepa, the omega-3 fatty acid eicosapentaenoic acid (EPA), is one component of the active moiety in GlaxoSmithKline PLC’s previously approved Lovaza (omega-3-acid ethyl esters)

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