Deciphering the Business Implications of the On-Sale Bar

April 23, 2018 1:55pm

Jonathan Bachand
Partner
Knobbe Martens (Washington, DC)

Colleen James
Partner
Mayer Brown LLP (New York, NY)

Liane M. Peterson
Partner
Foley & Lardner LLP (Washington, DC)

Pearl Siew
Senior Vice President
Eagle Pharmaceuticals, Inc. (Woodcliff Lake, NJ)

  • Assessing the on-sale bar provision of the Patent Act as amended by the AIA
  • Evaluating the impact of the Helsinn and Medicines Co. decisions
  • Exploring matters of due diligence for brand companies for manufacturing contracts, clinical trials and purchase and distribution agreements
  • Developing best practices and devising time tables to keep track of such agreements in order to avoid an on-sale bar situation
  • Determining opportunities and evaluating monetary consequences and circumstances in which the generic may invoke the on-sale bar provision