Saturday, July 4, 2020

August 13: The Impact of Patent Term Extension on Litigation Under the Hatch-Waxman Act: A Look at the Federal Circuit’s Recent Decision in Biogen v. Banner Life Scis.

Section 156 of the Patent Act provides for a patent term extension for FDA-regulated products to compensate for delays in obtaining approval. But what constitutes a “product” under this regulatory scheme? In a recent decision, the Federal Circuit relied on the definition of Section 156, holding that a ‘product’ means the ‘active ingredient… including any salt or ester of the active ingredient’ without expanding the definition and does not include any metabolite of the active ingredient of the product or its de-esterfied form.
On Thursday, August 13, Fish attorneys Robert Oakes and Kelly Allenspach Del Dotto will review the case and its implications for Hatch-Waxman litigation. Among other topics, our speakers will discuss:
  • The purpose behind the patent term extension provision of 35 U.S.C. § 156
  • Section 156’s restrictions on patent term extension and what the statute defines as a “product”
  • The Biogen Int’l GmbH. v. Banner Life Scis. LLC decision, and the impact it could have on Hatch-Waxman litigation.
Title:
The Impact of Patent Term Extension on Litigation Under the Hatch-Waxman Act: A Look at the Federal Circuit’s Recent Decision in Biogen v. Banner Life Scis.
Webinar Date+Time:
Thursday, August 13th, 2020
1:30 pm EDT
Register Now!
Speakers:
  • Robert Oakes 
  • Kelly Allenspach Del Dotto. 
By:
Fish & Richardson, P.C.
Credit:
Fish & Richardson is an accredited CLE provider by the California, New York, and Texas State Continuing Legal Education Boards. (California Provider Number 4933). Fish & Richardson will apply for 1.0 hour of CLE credit in some additional states. Credit will be awarded only to attorneys who report their required CLE states during their registration process and who log in and complete the webinar in its entirety. Note that Fish is unable to grant CLE credit to attendees who listen to the audio portion only.

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