Responding to the Supreme Court’s request for its views, see prior post, the Solicitor General recently recommended granting certiorari and reversing some of the Federal Circuit’s key holdings in Amgen v. Sandoz (Nos. 15-1039 & 15-1195).
The case involves issues central to the application of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), the statutory scheme establishing an abbreviated pathway for regulatory approval of follow-on biologic products. The Federal Circuit held, first, that a biosimilar applicant cannot provide the statutory 180-day notice of commercial marketing until after the biosimilar’s approval by the FDA and, second, that a biosimilar applicant is not required to engage in the so-called “patent dance” and disclose information—such as its aBLA and manufacturing information—to the original biologic manufacturer. More information on the Federal Circuit’s decision can be found here and here. The Supreme Court deferred its decision on the parties’ certiorari petitions in order to consider the Solicitor General’s views.
Regarding the 180-day notice of commercial marketing, the Solicitor General opined that, contrary to the Federal Circuit’s holding, the governing statute should be construed to allow the provision of such notice before FDA approval of the biosimilar product. According to the Solicitor General, if a biosimilar applicant cannot provide notice until after FDA approval, this effectively extends the statutory exclusivity period of the original biologic beyond what Congress intended. The Solicitor General also expressed the view that the BPCIA does not provide for injunctive relief in the event that a biosimilar applicant fails to give the statutory notice of commercial marketing.
Regarding the BPCIA’s information exchange provisions, the Solicitor General indicated that “the Federal Circuit misconceived the relevant inquiry” in concluding that a biosimilar applicant is not required to engage in the patent dance. The Solicitor General otherwise agreed with the appellate court, however, that a violation of this requirement would not entitle an original biologic manufacturer to injunctive relief, only to earlier filing of a patent infringement action.
In recommending that both issues be reviewed by the Supreme Court, the Solicitor General observed the growing importance and expense of biologic medicines, the “carefully calibrated legislative effort” underlying the BPCIA, and the increasing prevalence of BPCIA litigation. The Solicitor General’s recommendation increases the odds that certiorari will be granted in Amgen v. Sandoz; the Supreme Court is expected to revisit the case at its conference on January 6, 2017.
The Solicitor General’s briefing was filed just days before the Supreme Court denied review of another case involving the BPCIA’s 180-day notice period, Apotex Inc. v. Amgen Inc. (No. 16-332). The question presented in Apotex was whether the 180-day pre-marketing notice is mandatory even for those biosimilar companies that engage in the patent dance, as explained in our prior post. If it grants certiorari in Amgen v. Sandoz, the Supreme Court could still opt to address this related issue as well.