Enforcement of biologic patents at the United States International Trade Commission under Section 337 provides certainty and tactical advantages to patent holders that are unavailable in district court under the BPCIA. For example, broad domestic and international discovery obligations commence immediately upon institution, a greater selection of patents may be enforced, equitable remedies prohibiting importation and sales are mandatory, and the accelerated schedule will not be derailed by IPRs, counterclaims, or process patent defenses under Section 271(g). Based upon these benefits (and others discussed below), Section 337 is a valuable biologic enforcement mechanism for therapeutic companies who have historically underutilized the tactical advantages offered by this forum.

Background regarding the BPCIA -

The Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) was enacted on March 23, 2010, as part of the Patient Protection and Affordable Care Act. It provides that the submission of a biosimilar application can be an act of infringement of patents that are or could be identified through the BPCIA’s patent dispute process (the “Patent Dance”).