Posts Tagged: Biologics Price Competition and Innovation Act


Did the Federal Circuit doom Amgen’s Enbrel® monopoly?

In the case, Amgen v. Sanofi, the Court vacated an injunction Amgen obtained against a competing drug to its new PCSK9-inhibitor.  The Court’s decision turned …
By Zachary Silbersher
1 month ago 1

CAFC denies Amgen discovery in biosimilar patent dispute

In a patent infringement case governed by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), the Federal Circuit found that it lacked jurisdiction to compel discovery …

SCOTUS says OK to give notice of commercial marketing before FDA license under Biologics Price Competition and Innovation Act

42 U.S.C. § 262(l) of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) regulates “biosimilars,” biological products that are highly similar to FDA-approved biological products. Section 262(…

Industry Reaction to SCOTUS decision in Sandoz v. Amgen

The Court’s Sandoz v. Amgen decision gutted a statute that had been carefully crafted to facilitate timely resolution of patent disputes and avoid delaying market entry …
By Gene Quinn
6 months ago 2

Understanding the BPCIA Litigation Pathway to Avoid Expensive, Incurable Mistakes

Modeled after the Hatch-Waxman Act, the BPCIA seeks not only to encourage competition in the field of biologics but also to promote innovation by, among other things, …

Courts Answer Key Questions Over the Reach of the BPCIA

Two recent Federal Circuit opinions provide some answers to the issues presented by complaints alleging non-compliance with the BPCIA. In Amgen Inc. v. Sandoz Inc., the Federal …

The Amgen Quagmire: Federal Circuit Rules Patent Dance Does Not Excuse Biosimilar Applicants from Providing Notice of Intent to Market

The Supreme Court is currently considering whether to review Amgen Inc. v. Sandoz Inc., the Federal Circuit’s first decision regarding the Biologics Price Competition and Innovation …

Biosimilars at the Federal Circuit – Will this be the Last Dance?

This statute tried to mirror the Hatch-Waxman statute for small molecules, including both an abbreviated drug approval process and a mechanism to address any patent claims during …