Why Primary Patents Covering Biologics Should be Unenforceable Against Generic Applicants under the Biologics Price Competition and Innovation Act

This article is an abridged and shortened version of the article “Patents vs. Statutory Exclusivities in Biological Pharmaceuticals — Do We Really Need Both?” (18 Michigan Telecommunication & Technology Law Review 419). This version of the article briefly reviews the framework for the approval of generic biologics established under the Biologics Price Competition and Innovation Act (BPCIA) and focuses on the interplay of the exclusivity regime established by BPCIA for FDA approved bio-pharmaceutical products with the protection afforded them under patent law. The BPCIA exclusivities are intended to run in parallel and in addition to any patents that may apply to such approved bio-pharmaceutical products. This seeming “double dipping” is not only unnecessary but might also be hazardous from a public policy perspective. Thus, this article calls for limiting the potentially negative consequences of this “double dipping” by making certain patents covering FDA approved biologics unenforceable against generic manufacturers filing applications under BPCIA. Finally, this article explains why and when it would still be necessary to make patent protection available for owners and developers of biological pharmaceuticals