The Biologics Price Competition and Innovation Act (BPCIA)*, signed into law in 2010, created a pathway for the Food and Drug Administration (FDA) to approve generic versions of brand name biological products or “biologics.” The resulting pathway is completely different from the ANDA approval process with which the “small molecule” industry has become so familiar. The legislation includes numerous provisions, including patent related provisions, which are complex and highly specific to biosimilar stakeholders. For example, the BPCIA provides innovators with 12 years of market exclusivity for their biologic. The BPCIA also establishes a mandatory patent arbitration process for applicants seeking abbreviated approval of their biosimilar.
We stand ready to assist clients — both generic and innovator companies — navigate the new and complex biologic/biosimilar pathway. The firm has been counseling biotech clients with an eye to BPCIA, and firm members will soon be lecturing on the topic. As experts in both pharmaceutical and patent matters, we draw upon the extensive experience of our numerous professionals to provide practical advice on addressing the new intersection of patent reform and biosimilar pathway rules. For example, our Biosimilars team can assist in design-around (biobetter) strategies, coordination and timing of patent application filing, as well as post-FDA filing patent litigation/arbitration matters.