The first biosimilars cases are making their way through the Biologics Price Competition and Innovation Act and are testing their patent litigation provisions along the way. Congress enacted the BPCIA in 2010 to provide a regulatory pathway for the introduction of biosimilar and interchangeable biologic drugs into the U.S. market. Similar to the Hatch-Waxman Act which regulates generic entry of small molecule drugs, the BPCIA provides a framework for the abbreviated approval of protein-based drugs shown to be highly similar with no clinically meaningful differences to previously FDA-approved drugs.
Last week, the Federal Circuit issued its first order related to biosimilars (specifically Sandoz’s FDA-approved ZARXIO® biosimilar) in Amgen v. Sandoz, Case No. 2015-1499. At the heart of the dispute is whether or not biosimilar manufacturers are required to disclose their FDA application and manufacturing processes to the branded company under § 262(l)(2)-(8) of the Act, the first step in what has been dubbed the “patent dance.” In March of this year, a U.S. District Court in the Northern District of California ruled in favor of Sandoz, viewing this “patent dance” as optional. Amgen filed an expedited appeal to the Federal Circuit, which will be heard on June 3, and filed a motion for injunctive relief. Last Tuesday, the Federal Circuit granted Amgen’s motion, preventing Sandoz’s launch (for now). In what could be interpreted as a sign that the Federal Circuit may disagree with the district court’s ruling, both Sandoz and Amgen were ordered to brief “what amount of bond should be posted” while the appeal is pending. Indeed, the Federal Circuit expressly stated that “[t]he bond amount will be determined by subsequent order.”
Companies deciding to dance or not to dance, or more generally those considering whether or not to engage with the provisions of the BPCIA need to recognize the BPCIA framework is still in its infancy as compared to the Hatch-Waxman provisions which have been clarified by thirty years of litigation. While the courts begin to refine any rough edges in the BPCIA, in the meantime, there are a things both innovators and biosimilar manufacturers should be thinking about.
For example, branded companies/innovators should review their BLAs and create a list of all possibly relevant patents for each product. In addition, branded companies should identify who will be receiving confidential information under the BPCIA provisions and ensure they familiarize themselves with the statutory framework and the case law interpreting that framework. For any products a biosimilar company is considering, the biosimilar manufacturer should analyze their freedom to operate in that space and consider strategies for each identified patent, which may include design around, awaiting expiration, asserting invalidity, etc.