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Results: 1-10 of 1,285

Supreme Court Interprets BPCIA Provisions Relating to the ‘Patent Dance’
  • McGuireWoods LLP
  • USA
  • June 15 2017

On June 12, 2017, the U.S. Supreme Court interpreted two provisions of the Biologics Price Competition & Innovation Act (BPCIA) relating to patent


Recent Supreme Court Ruling Favors Biosimilar Applicants
  • Hunton & Williams LLP
  • USA
  • June 15 2017

In a highly anticipated decision, the US Supreme Court on Monday reversed the Federal Circuit in a case involving the Biologics Price Competition and


SCOTUS Ruling Gives a Boost to Biosimilars; FDA Continues to Advance Products Through AdComs
  • Mintz Levin Cohn Ferris Glovsky and Popeo PC
  • USA
  • June 14 2017

On a sweltering hot D.C. morning, those of us anxiously awaiting the Supreme Court’s opinion in its first case involving biosimilar biological


U.S. Supreme Court Finds that Dancing with Biosimilars is NOT Mandatory
  • Kilpatrick Townsend & Stockton LLP
  • USA
  • June 14 2017

The U.S. Supreme Court had a busy day on Monday (June 12, 2017) issuing four unanimous decisions in recently argued cases. Of particular note is the


Supreme Court Paves Way for Faster Marketing of Biosimilars
  • Buchanan Ingersoll & Rooney PC
  • USA
  • June 14 2017

The Supreme Court in Sandoz Inc. v. Amgen, Inc., 15-1039, reversed the Federal Circuit on some of the most basic provisions of the Biologics Price


SCOTUS Unravels Some of the BPCIA Enigma But Questions Remain
  • Fish & Richardson PC
  • USA
  • June 13 2017

Reference product sponsors (RPSs) and biosimilar manufacturers were hoping the Supreme Court of the United States would clarify two aspects of the


Supreme Court Biosimilar Patent Dance Decision Largely Favors Biosimilars
  • Foley & Lardner LLP
  • USA
  • June 13 2017

On June 12, 2017, the Supreme Court issued a unanimous decision in Sandoz Inc. v. Amgen Inc. (No. 15-1039), deciding that 42 U.S.C. 262(l)(9)(C


Supreme Court Dictates How Long Biosimilar Applicants Must Wait Before Bringing Approved Products to Market
  • Wolf Greenfield & Sacks PC
  • USA
  • June 13 2017

Over seven years after the Biologics Price Competition and Innovation Act (BPCIA) was signed into law, the Supreme Court has answered two


Supreme Court Interprets BPCIA Disclosure and Notice Provisions
  • Haug Partners LLP
  • USA
  • June 13 2017

On June 12, 2017, in a unanimous decision, the Supreme Court of the United States decided Sandoz Inc. v. Amgen Inc., which concerned certain


Supreme Court Issues First Interpretation of the BPCIA
  • Haug Partners LLP
  • USA
  • June 13 2017

The Supreme Court yesterday issued its first opinion interpreting the Biologics Price Competition and Innovation Act ("the BPCIA"), the statute which