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Results: 1-10 of 905

Food & Beverage Litigation Update - Issue 649
  • Shook Hardy & Bacon LLP
  • USA
  • October 9 2017

A report from the Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services has concluded that the Food and Drug


Food & Beverage Litigation Update - Issue 647
  • Shook Hardy & Bacon LLP
  • USA
  • September 11 2017

Implementing an Executive Order titled "Reducing Regulation and Controlling Regulatory Costs," the U.S. Food and Drug Administration (FDA) has opened


Biosimilar Notice May Be Given Prior to FDA Approval
  • McDermott Will & Emery
  • USA
  • June 26 2017

In a unanimous decision, the Supreme Court of the United States explained that under the Biologics Price Competition and Innovation Act of 2009


Supreme Court Affords Greater Leeway to Biosimilars in the 'Patent Dance'
  • Pepper Hamilton LLP
  • USA
  • June 22 2017

In a recent ruling, the U.S. Supreme Court clarified what happens when biosimilar applicants do not follow the regulatory framework for disputes with


Sandoz Inc. v. Amgen Inc.
  • Merchant & Gould
  • USA
  • June 16 2017

In a unanimous decision in Sandoz Inc. v. Amgen Inc., the U.S. Supreme Court held that injunctive relief was not available under federal law to


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 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


To Dance or Not to Dance: Supreme Court Held Patent Dance Under BPCIA Not Enforceable By Injunction Under Federal Law
  • Vinson & Elkins LLP
  • USA
  • June 13 2017

On June 12, 2017, the Supreme Court held that a biosimilar applicant cannot be enjoined under federal law to provide its application and manufacturing


Supreme Court Issues Highly Anticipated Decision Interpreting the Biologics Price Competition and Innovation Act
  • Kramer Levin Naftalis & Frankel LLP
  • USA
  • June 12 2017

On June 12, the Supreme Court decided Sandoz Inc. v. Amgen Inc., the first case under the Biologics Price Competition and Innovation Act of 2009