Sarepta Wins Exon 51 Composition Patent Rights Over BioMarin
Patent Trial and Appeal Board rules against BioMarin in proceeding to determine who has rights to a composition of matter patent for eteplirsen; last year the board ruled in BioMarin's favor on method of use patent.
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A legal settlement with BioMarin means that Sarepta doesn't have to worry anymore about the potential to infringe patents related to exon-skipping DMD therapies. Meanwhile, BioMarin gains some compensation for its ill-fated Prosensa buy.
Circumstances of FDA's approval of Sarepta's Exondys 51 approval may give BioMarin reason to appeal the complete response for its Duchenne muscular dystrophy treatment drisapersen – but its high-quality data could preclude success.
What CDER Director Woodcock saw as a flexible and reasonable approach to approval of Sarepta's muscular dystrophy drug, ODE I Director Unger viewed as a threat to the substantial evidence standard.