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Patent dispute resolution under the Biologics Price Competition and Innovation Act

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) creates a pathway for expedited FDA approval of follow-on biologic drugs. As part of this pathway, the BPCIA includes special procedures to resolve patent disputes between the brand, or reference product sponsor, and the follow-on drug manufacturer. This article outlines the basics of the BPCIA and details procedures that reference product sponsors and follow-on applicants will follow to resolve patent issues under the Act. Finally, the article notes that the BPCIA patent dispute mechanism may lead to several unintended consequences: (1) it may be unlikely to provide patent certainty to the parties because it may not address the full portfolio of patents covering a biologic product; (2) it may also be unlikely to raise and resolve all pertinent patent issues prior to FDA approval; and (3) it is unclear whether there is a manner in which parties can enforce the rules of the patent dispute mechanism. At this time, no drug has been approved under the BPCIA, and no litigation has begun under the BPCIA's patent resolution procedures. While this article identifies potential outcomes, it will be important to monitor real-world experiences over the next several years.