In June 2017, the Supreme Court handed down its decision in Sandoz v. Amgen—the 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 framework—often called the “Patent Dance”—including 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
Sandozdealt 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 pre-suit exchange, and some applicants have provided further information following requests by the RPS.
RPS recourse in these situations may be limited. The BPCIA’s (l)(9)(C) allows the sponsor to bring an action for declaratory judgement if the applicant fails to provide the “information required” by paragraph (2)(A), but what constitutes “failure” has yet to be clearly defined. (One case where a RPS brought suit for failure to comply was dismissed outright).
As such, sponsors have generally responded by documenting alleged deficiencies in their pleadings, but for the most part have forgone early DJ actions. Instead, RPSs have broadened their initial 3(A) lists, likely in an effort to preserve their rights in subsequent phases.
Notice of Commercial Marketing
In contrast to the somewhat uniform approach to aBLA disclosure, post-Sandozcases have seen widely disparate approaches to the BPCIA’s commercial marketing provision. Consistent with early projections, several biosimilar applicants have attempted to short circuit the Act via early NCM.
For instance, Adello gave notice on the same day that it submitted its aBLA to the FDA. Sandoz omitted notice under (l)(8) entirely, instead stating it “would not participate” in the BPCIA. And in a pair of Genentech cases, the biosimilar applicant gave its NCM prior to approval and then filed a DJ action the same day.
Despite these examples, however, the overall impact has been a slight trend towards later notice. In the majority of post-Sandoz filings, the biosimilar applicant has waited to give notice until after gaining FDA approval, and in general parties have completed the BPCIA’s pre-suit exchange regardless of when NCM is given. In at least two cases, the first phase of the Dance was completed, and the biosimilar launched, all without any mention of NCM in the pleadings.
One explanation for increased compliance is that attempts to sidestep the Dance have not been well received at the district court level. Both Genetech cases were summarily dismissed. Just prior to Sandoz, the court in Janssen v. Celltrion found the applicant did not “properly complete” the prescribed steps and thus could not “obtain the limitation of damages to a reasonable royalty.”