Proposed CREATES Amendment Could Impede the Availability of Affordable Generic Drugs

Last month, legislation intended to help remove barriers for generic drugmakers to bring affordable medicines to market cleared an important hurdle when the Senate Judiciary Committee passed the CREATES (Creating and Restoring Equal Access to Equivalent Samples) Act. But during consideration, Sen. Orrin Hatch (R-Utah) offered an amendment that would inhibit generic drug manufacturers from challenging the validity of brand-name manufacturers’ patents through an administrative remedy known as inter partes review.

       

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