Should A Biosimilar Sponsor Do The 'Patent Dance?' It Depends On Many Things

22 Aug 2017

The amount of exclusivity remaining for a reference product, strength of an innovator's patents and risk of a preliminary injunction are factors that biosimilar sponsors should consider in deciding whether to follow the BPCIA's patent information and exchange procedures, one legal expert suggests.

Biosimilar developers should weigh a host of factors in deciding whether to follow the Biologics Price Competition and Innovation Act's patent information and exchange procedures now that the US Supreme Court has ruled the federal law does not require 351(k) applicants to engage in the "patent dance."

Factors for consideration include the amount of marketing exclusivity remaining on a reference product, the strength of the patents at...