A decision in favour of Sandoz could lead to a new definition of the patent dance procedures contained in the Biologics Price Competition and Innovation Act (BPCIA).
Amgen asked the Supreme Court whether biosimilar applicants must adhere to the BPCIA’s two-stage process that requires applicants to file an Abbreviated Biologics License Application along with providing the patent owner with information about the applicant’s manufacturing process, otherwise known as the ‘patent dance’.
Applicants then have 180 days to provide the patent owner with notice of Food and Drug Administration (FDA) approval.
Brendan O’Malley, partner at Fitzpatrick, Cella, Harper & Scinto, commented: “Reference product sponsors believe a reversal on this question would lead to chaos, in part because they would have no way to predict when a launch might be imminent, making it difficult to obtain a preliminary injunction before the biosimilars enter the market.”
The Supreme Court also faces a separate question from Sandoz, which asks whether the notice of commercial marketing can be effective in general.
O’Malley said that an affirmation on this question could be a reference sponsor’s sole mechanism for patent enforcement if the biosimilar applicant declines to engage in the patent dance.
“A reversal on this question could help to restore reference product sponsors’ expectation that an early and orderly pathway would exist for enforcing their patent rights.”