The Riddle of the Mysterious Patent Dance Wrapped in an Enigma: Is the Patent Dance of the BPCIA Optional or Mandatory?Dov Hirsch*Note - Fordham Intellectual Property, Media & Entertainment Law Journal
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The Riddle of the Mysterious Patent Dance Wrapped in an Enigma: Is the Patent Dance of the BPCIA Optional or Mandatory?
Dov Hirsch*
Note

  The full text of this Article may be found here.

27 Fordham Intell. Prop. Media & Ent. L.J. 645
Note by Dov Hirsch*

ABSTRACT

[R]

ecently, 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.


*Staff Member, Fordham Intellectual Property, Media & Entertainment Law Journal, Volume XXVII; J.D. Candidate, Fordham University School of Law, 2018; B.A., Biology, Brooklyn College, 2015. I would like to thank Professor Janet Freilich for her constant and indispensable help and the IPLJ Editorial Board and staff for their efforts throughout the editorial process. I would also like to express my special appreciation to my wife, Adina, and daughter, Sophia, for their unwavering support and encouragement.