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.

In this webinar, Fish attorneys Robert Oakes and Kelly Allenspach Del Dotto review the case and its implications for Hatch-Waxman litigation. Among other topics, they 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

Presenters: Kelly Allenspach Del Dotto, Robert Oakes

To access a recording of this webinar or receive a copy of the slides, please contact [email protected].