Patent, Dance, BPCIA, Mandatory, Enigma, Biosimilar, Price, Competition, Innovation


Recently, the nature of one of the aspects of the Biosimilar, Price, Competition, and Innovation Act of 2009 (“BPCIA”) has been called into question: Is the “patent dance,” the structured patent dispute resolution process of the BPCIA, mandatory or optional? A mandatory patent dance requires a biosimilar applicant to comply with all its requirements, while an optional patent dance allows the biosimilar applicant to opt out of the entire dance if it so chooses. This question is important because it has the potential to affect that delicate balance of the BPCIA. This Note focuses on some of the consequential implications of deciding whether the patent dance of the BPCIA is optional or mandatory. This Note ultimately argues that the patent dance of the BPCIA should be mandatory.