BPCIA Dance is Optional

Date: 8/18/2015
 Amgen Inc. v. Sandoz Inc.
 BPCIA Dance is Optional

In 2009, Congress passed the Biologics Price Competition and Innovation Act ("BPCIA") that provides a framework under which manufacturers can receive approval to market and sell a biosimilar of an existing biologic. The BPCIA framework is similar, but not identical to, the process pharmaceutical companies use when filing an abbreviated new drug application ("ANDA"). Although the BPCIA was passed in 2009, there have been few cases interpreting how the BPCIA should be applied.

In Amgen Inc. v. Sandoz Inc., (Fed. Cir. July 21, 2015), Amgen sued Sandoz alleging that Sandoz violated the BPCIA by failing to disclose required information. Sandoz had provided notice to Amgen that it was seeking approval from the FDA of a biosimilar of an Amgen biologic product and intended to market it immediately upon approval from the FDA. Sandoz, however, "opted not to provide Amgen with Sandoz's biosimilar application within 20 days of the FDA's notification of acceptance" as provided for by the BPCIA. The FDA eventually approved Sandoz's application. Amgen then sued Sandoz, for among other reasons, violating the BPCIA for not providing the required information and for failing to give proper notice before the date of first commercial marketing of the biosimilar.

The district court dismissed the claim because it found that Sandoz did not have to provide the required information and that Sandoz did give proper notice. On appeal, the Federal Circuit affirmed it was optional for an applicant to provide the technical informational to the biologic owner required by the BPCIA. If an applicant does not provide the required information, the biologic owner can sue for patent infringement (also bypassing the BPCIA). The Federal Circuit, however, reversed the district court holding regarding notice of marketing. Sandoz argued that waiting 180 days from its notice to Amgen was sufficient to comply with the BPCIA's notice requirement. The Federal Circuit disagreed. Per the BPCIA, Sandoz cannot give "proper" notice until it receives approval from the FDA. That is, Sandoz needs to wait at least 180 days after receiving approval from the FDA before marketing it products.

This ruling provides clarification on two points regarding the BPCIA. First, information required to be exchanged under the BPCIA, i.e., "patent dance" is optional, and, if a party chooses not to participate or stop participating in the exchange, the biologic holder can immediately sue for patent infringement. Second, the 180 day notice that the applicant needs to provide the patent holder before beginning commercial marketing cannot start until the applicant has received a license from the FDA for its biosimilar.

For more information about this article, contact Joseph A. Saltiel, Vice Chair of the Intellectual Property & Technology Group, at 312.245.7500 or via e-mail at jsaltiel@masudafunai.com.