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Results:1-10 of 41

Ready to Release a New Pharmaceutical? What to Think About When Selecting Your Drug Name
  • Foley & Lardner LLP
  • USA
  • November 8 2017

Pharmaceutical name clearance in the United States can be complicated. This post aims to provide insight into the regulatory safety review process and


Federal Circuit Finds Velcade Patent Not Obvious Under Lead Compound Analysis
  • Foley & Lardner LLP
  • USA
  • July 25 2017

In Millennium Pharmaceuticals, Inc. v. Sandoz, the Federal Circuit reversed the district court decision that invalidated one of the Orange


USPTO Extends Cancer Immunotherapy Pilot Program
  • Foley & Lardner LLP
  • USA
  • June 26 2017

On June 29th, 2016, the USPTO announced the Cancer Immunotherapy Pilot Program to allow expedited examination of patent applications that pertain 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 Decision Largely Favors Biosimilar Applicants
  • Foley & Lardner LLP
  • USA
  • June 12 2017

The U.S. Supreme Court rendered its first interpretations of the biosimilar patent dispute resolution procedures of the Biologics Price Competition


Conflict Between Granting a Preliminary Injunction and Staying the Case Pending Appeal of the Injunction
  • Foley & Lardner LLP
  • USA
  • June 5 2017

In Fresenius Kabi USA, LLC v. Fera Pharmaceuticals, LLC, et al., Case No. 15-3654 (D.N.J.) the district court recently denied Fresenius’s motion to


Recent Guidance from the Federal Circuit on the Doctrine of Equivalents in Cases Involving Chemical Compositions
  • Foley & Lardner LLP
  • USA
  • May 30 2017

In Mylan Institutional LLC, et al. V. Aurobindo Pharma Ltd., et al., Case No. 2017-1645, the Federal Circuit affirmed the district court’s grant of a


CAFC Finds ANDA Infringement Despite Differences Between FDA Labeling And Claim Language
  • Foley & Lardner LLP
  • USA
  • May 23 2017

In a non-precedential decision issued in Braintree Labs., Inc. v. Breckenridge Pharmaceutical, Inc., the Federal Circuit reversed the district


Federal Circuit’s Primer on Equivalence Infringement of Chemical Process Patents
  • Foley & Lardner LLP
  • USA
  • May 21 2017

In an appeal characterized as “unusual,” the Federal Circuit affirmed the grant of a preliminary injunction, holding it likely that plaintiff patent


Are Secret Sales Prior Art Under The AIA?
  • Foley & Lardner LLP
  • USA
  • May 9 2017

In Helsinn Healthcare S.A. V. Teva Pharmaceuticals USA, Inc., the Federal Circuit found that a publicly-announced “Supply and Purchase” agreement