четверг, 19 января 2017 г.

Supreme Court to Consider Biologics Price Competition and Innovation Act

Supreme Court to Consider Biologics Price Competition and Innovation Act


On Friday, Jan. 13, the Supreme Court granted the appellant's petition and the respondent's cross-petition for a writ of certiorari in Sandoz Inc. v. Amgen Inc. This is the first time the Court will construe the Biologics Price Competition and Innovation Act of 2009 , the law that established a regulatory pathway for approval of "biosimilar" drugs and set forth a complex scheme for resolving patent disputes between the biosimilar applicant and the sponsor of the reference product.



from Biotech News