On Monday, June 20, 2016, the Supreme Court deferred a decision on the certiorari petitions filed by both parties from the Federal Circuit’s decision in Amgen v. Sandoz, 794 F.3d 1347 (2015), and instead called for the views of the Solicitor General (CVSG).
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. More information on the Federal Circuit’s decision can be found here.
Sandoz in its petition (No. 2015-1039) challenges the Federal Circuit’s finding that a biosimilar applicant cannot provide the required 180-day notice of commercial marketing prior to FDA approval of the biosimilar product. Sandoz contends that this holding effectively extends the statutory exclusivity period of the original biologic (i.e., the reference product) beyond what Congress intended. Amgen responded by both opposing Sandoz’s petition and filing a conditional cross-petition (No. 2015-1195). In the event that Sandoz’s petition is granted, Amgen requests that the Court also review the Federal Circuit’s finding that a biosimilar applicant is not required to participate in the BPCIA’s “patent dance”—i.e., the provisions requiring that the biosimilar company disclose various information to the reference product sponsor, including its abbreviated biologics license application (aBLA) and details of its manufacturing process.
A CVSG order is generally viewed as increasing the odds that certiorari will be granted, with those odds being further increased if the Solicitor General supports a grant of certiorari. No deadline applies, and the Solicitor General generally takes several months to respond. Moreover, as the Supreme Court will soon be on summer recess, there will not be movement in this case before the new term begins in early October. Whether or not certiorari is ultimately granted, Amgen v. Sandoz will have a profound impact on both biologic and biosimilar companies alike as they plot a course through the intricacies of the BPCIA.