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Results:1-10 of 10

Safe Harbor Provision of 35 U.S.C. 271(e)(1) - Implications of Intent and Continued Use
  • Kilpatrick Townsend & Stockton LLP
  • USA
  • September 7 2018

The safe harbor defense has been of issue in two recent cases in which the bounds of the protection has been analyzed. Section 271(e)(1) carves out an


FDA Proposes a New Risk-Based Enforcement Approach for Certain Categories of Homeopathic Drug Products
  • Kilpatrick Townsend & Stockton LLP
  • USA
  • December 22 2017

More than 2 years after the Food and Drug Administration (FDA or agency) held a public hearing to obtain input from both the public and industry


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


FDA’s Hatch-Waxman Regulations Get a Long Overdue Update
  • Kilpatrick Townsend & Stockton LLP
  • USA
  • October 13 2016

On December 5, 2016, twenty-two (22) pages of new Hatch-Waxman regulations will be codified in the Code of Federal Register. These new regulations


Sandoz Wins FDA Approval for First Biosimilar of Amgen’s Enbrel
  • Kilpatrick Townsend & Stockton LLP
  • USA
  • September 6 2016

On August 30, 2016, the Food and Drug Administration (FDA) approved the third U.S. biosimilar product - Sandoz Inc.’s (Sandoz) biosimilar of Amgen Inc



Alyson L. Wooten
  • Kilpatrick Townsend & Stockton LLP

Jennifer Giordano-Coltart Ph.D.
  • Kilpatrick Townsend & Stockton LLP

Alyson L. Wooten PharmD
  • Kilpatrick Townsend & Stockton LLP

Carolina M. Wirth
  • Kilpatrick Townsend & Stockton LLP