Search Results for: "amgen v sandoz"

Summary of Sandoz's Opening Brief in Sandoz v. Amgen

  Sandoz filed its opening brief to the Supreme Court on Friday, February 10, 2017. The dispute focuses on the notice marketing provision and the information exchange or “patent dance” procedures of the Biologics Price Competition and Innovation Act (BPCIA). Sandoz’s opening brief addressed: Whether notice of commercial marketing given…

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Supreme Court Announces Briefing Schedule in Amgen v. Sandoz

The Supreme Court has ordered a briefing schedule in Amgen v. Sandoz. Because the Court granted and consolidated Sandoz’s petition and Amgen’s conditional cross-petition, the Court has adopted a four-brief schedule, comparable to the procedure used in the courts of appeals. According to the order, the briefing schedule will be as…

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Year in Review: The Top-Five Legal Developments of 2016

Here are our picks for the top-five most significant legal developments in the world of biosimilars in 2016: 5) Congress passed and President Obama signed the 21st Century Cures Act.  Among other things, the Act modifies the standards and review processes for FDA evaluation of applications to market new drugs,…

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AMGEN FILES SUPPLEMENTAL BRIEF IN SANDOZ V. AMGEN

On Tuesday, Amgen filed its supplemental brief opposing Sandoz’s petition for writ and responding to the Solicitor General’s brief, which we discussed here. In sum, the Solicitor General sided with Sandoz, stating that: notice of commercial marketing before FDA approval is consistent with § 262(l)(8)(A); injunctive relief is not available…

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Analysis of Solicitor General's Brief in Sandoz v. Amgen

As we posted earlier this week, the Acting Solicitor General (“SG”), on December 7th,  filed an amicus brief in which it (a) recommended that the Supreme Court grant Sandoz’s cert petition and Amgen’s conditional cross-cert petition regarding how to interpret important provisions of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), and…

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