Last week the Office of the Solicitor General (“SG”) filed an amicus brief on behalf of the United States in support of Sandoz’s position with respect to the BPCIA’s notice of commercial marketing requirement and patent dance provisions. You may recall that the SG also filed a brief in support of Sandoz at the cert stage, which we covered here.
The SG’s most recent brief, like its prior brief, takes the position that the information-disclosure requirement in 42 U.S.C. § 262(l)(2)(A) is mandatory but that the only consequence for an applicant’s failure to provide its confidential business information to a reference product sponsor articulated in the BPCIA is the sponsor’s right to bring an artificial-infringement action. It also once again takes the position that a biosimilar applicant can provide an effective notice of commercial marketing prior to FDA approval. The SG’s brief further contends that neither the information-disclosure requirement nor the commercial marketing notice requirement can be enforced by an injunctive remedy because no cause of action exists for direct judicial enforcement of either provision. The SG’s brief newly argues that no notice of commercial marketing is required at all where the biosimilar applicant declines to engage in the patent dance. The brief contends that the sole statutory function of the notice requirement is to authorize litigation on Round 2 patents that sponsors were prevented from pursuing during the patent dance; thus, if no patent dance occurs, “the notice under Section 262(l)(8)(A) that triggers those provisions would serve no ongoing statutory function.”
Stay tuned to Big Molecule Watch for more coverage of the amicus briefs filed in Sandoz v. Amgen last week.