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Results: 1-10 of 91

Summary of FDA Guidance on Determining Whether to Submit an ANDA or a 505(b)(2) Application
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • October 24 2017

On October 13, 2017, the U.S. Food and Drug Administration (FDA) released for comment, by December 12, 2017, draft guidance for industry entitled


Frequent Participation in Hatch-Waxman Litigation in a Forum May Be Relevant to Whether a Defendant Can Be Sued in That Forum for Patent Infringement
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • October 19 2017

Submitting an Abbreviated New Drug Application (ANDA) and subsequent prospective infringement can be sufficient to show an act of infringement under


Summary of FDA Guidance on Statistical Approaches to Evaluate Analytical Similarity
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • October 5 2017

On September 21, 2017, the U.S. Food and Drug Administration released a nonbinding draft guidance for industry, Statistical Approaches to Evaluate


Sandoz v. Amgen Supreme Court Decision
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • June 14 2017

On June 12, 2017, the U.S. Supreme Court issued a unanimous decision in Sandoz Inc. v. Amgen Inc., Nos. 15-1039, 15-1195,1 interpreting two provisions


Sandoz v. Amgen Supreme Court Oral Argument
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • April 27 2017

On April 26, 2017, the U.S. Supreme Court heard oral arguments in Sandoz Inc. v. Amgen Inc., Nos. 15-1039, 15-1195, concerning Sandoz’s petition and


Combination Products: Regulatory and Patent Issues You Should Consider Now
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • February 23 2017

Products involving combinations of drugs, biological products, and medical devices are becoming increasingly prominent. Combination products can


FDA Request for Justification Found to Provide a Mere Research SuggestionNot Conception of Claimed Formulation
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • February 13 2017

In Cumberland Pharmaceuticals Inc. v. Mylan Institutional LLC, Nos. 16-1115, -1259 (Fed. Cir. Jan. 26, 2017), the Federal Circuit affirmed the lower


No Trade Dress Protection For Pink Ceramic Hip Implant Components
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • February 6 2017

The U.S. District Court for the District of Colorado recently denied a manufacturer of ceramic medical products trade dress protection for the color


Summary of Guidance on Interchangeability of Biosimilars With Reference Products
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • January 24 2017

On January 17, 2017, the U.S. Food and Drug Administration released a nonbinding draft Guidance for Industry, Considerations in Demonstrating


Summary of FDA Guidance on the Nonproprietary Naming of Biological Products
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • January 18 2017

On January 12, 2017, the U.S. Food and Drug Administration (“FDA”) released a final Guidance for Industry, Nonproprietary Naming of Biological