In June 2017, the Supreme Court handed down its decision in Sandoz v. Amgenthe first lawsuit brought under the Biologics Price Competition and Innovation Act (BPCIA).
The decision prompted a host of speculation about its effect on the BPCIA's regulatory frameworkoften called the Patent Danceincluding predictions that the decision would gut key features of the 2012 legislation. Three years later the practical impact of Sandoz has been more muted.
While the decision has resulted in numerous attempts to circumvent the pre-suit exchange, cases filed after June 2017 have actually seen a slight uptick in overall compliance with the Patent Dance.
The decision has led to several creative attempts to bypass the Act's pre-suit exchange, but the more common strategy appears to be compliance. Opting out of the Patent Dance has potential advantages, but doing so also cedes power to the reference product sponsor (RPS)allowing the sponsor to bring their full patent estates to bear in a single action.
Two Provisions of BCPIA
Sandoz dealt with two provisions of the BCPIA: 42 U.S.C. Section 262(l)(2)(A) and (l)(8).
The former provides that, within 20 days of the FDA accepting the biosimilar application, the applicant shall disclose its abbreviated biologics license application (aBLA) and such other information to the RPS. On this issue, the court held that injunctive relief is not available to compel compliance with Section 262(l)(2)(A)leaving the BPCIA as the sole remedy where an applicant fails to abide by (2)(A).
The second issue addressed, Section 262(l)(8), requires that the biosimilar manufacturer notice the RPS 180 days prior to commercial marketing of the applicant's biosimilar. There, Sandoz held that an applicant can give notice to the sponsor either before or after gaining FDA approval.
Disclosure of the aBLA and 'Such Other Information'
Sandoz's ruling has emboldened some biosimilar applicants to test the boundaries of minimum disclosure under (2)(A). Applicants have provided limited portions of their aBLAs, given cumbersome access to the documents, and/or delayed production of their materials. Additionally, in crafting their initial productions, applicants have continued to all but ignore 2(A)'s such other information clause.
On the other hand, it is clear that applicants do not view Sandoz as carte blanche to skip aBLA disclosure altogether. In all but one post-Sandoz case, the aBLA has been provided to the sponsor during the...