Oral Arguments Preview: Teva v. Amneal Tests Scope of Orange Book Device Patent Listings
Patent – Patently-O 2024-11-08
Summary:
by Dennis Crouch
Today at 2pm Eastern, the Federal Circuit will hear arguments in a case that could significantly shape pharmaceutical patent listing practices under the Hatch-Waxman Act. In Teva v. Amneal (No. 24-1936), the court will consider whether device patents that don't explicitly recite active drug ingredients can be properly listed in FDA's Orange Book. William Jay of Goodwin Procter will argue for Teva; Steven Maddox of Procopio will represent Amneal. The judges are not yet listed for the case, but I expect it will be three judges picked from these six: Chief Judge Moore, Judge Dyk, Judge Prost, Judge Chen, Judge Hughes, or Judge Stark.
- Listen on YouTube at 2:00 PM on 11/8.
- Dennis Crouch, Orange Book Listing Requirements Under Scrutiny, Patently-O (Sept. 17, 2024).
- David Taylor, Argument Preview - Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC, Fed. Cir. Blog (Nov 1, 2024).
The case centers on several Teva patents related to its ProAir HFA inhaler device and dose counter. After Amneal filed an ANDA for a generic version, it counterclaimed--seeking delisting of these patents from the Orange Book.