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Results:1-10 of 27

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


Pharmaceutical Antitrust Update: Courts Address How and When Product Hopping May Violate the Antirust Laws
  • Haug Partners LLP
  • USA
  • March 29 2017

For many companies that compete in competitive markets, innovation and product improvement fuels competitive success: create a better product than


FDA Publishes Updated Patent Information Forms
  • Haug Partners LLP
  • USA
  • December 7 2016

For those parties required to submit patent information to the U.S. Food and Drug Administration, the Agency has published updated forms: Form 3542


FDA Publishes Biosimilar Biological Product Reauthorization Performance Goals and Procedures Fiscal Years 2018 Through 2022
  • Haug Partners LLP
  • USA
  • September 23 2016

Last week, the U.S. Food and Drug Administration published the Biosimilar Biological Product Reauthorization Performance Goals and Procedures Fiscal


President Obama Signs GMO Labeling Bill into Law
  • Haug Partners LLP
  • USA
  • August 17 2016

On July 29, 2016, President Barack Obama signed S.764 into law. The law amends the Agricultural Marketing Act of 1946 to require that the U.S


CREATES Act of 2016: Bipartisan Bill Aimed at Curbing REMS Abuses
  • Haug Partners LLP
  • USA
  • July 19 2016

Congress passed the Food and Drug Administration Amendments Act of 2007 (“FDAAA”) to give the U.S. Food and Drug Administration (“FDA”) new authority


FLH defends brand pharmaceutical client’s blockbuster product and secures affirmance from the Federal Circuit of summary judgment of no invalidity for four patents
  • Haug Partners LLP
  • USA
  • September 24 2015

On September 24, 2015, the U.S. Court of Appeals for the Federal Circuit affirmed summary judgment of non-obviousness of 18 claims from four patents


New York Federal Court allows truthful and non-misleading off-label promotion
  • Haug Partners LLP
  • USA
  • August 10 2015

The U.S. District Court for the Southern District of New York recently granted Amarin Pharma, Inc. preliminary relief against the U.S. Food and Drug


Significant PTAB decisions regarding Chiesi's drug CARDENE
  • Haug Partners LLP
  • USA
  • April 24 2015

Ready-to-use CARDENE I.V. Premixed Injection is indicated for the short-term treatment of hypertension and is the only available FDA-approved