As we have discussed before (here and here), the first generation of biosimilar litigation under the Biologics Price Control and Innovation Act (BPCIA) addresses whether the BPCIA’s patent dispute resolution procedures – the “patent dance” – are mandatory.  Last week FDA declined to weigh in on the issue, preferring to let the courts decide.

One of the leading BPCIA cases is Amgen’s suit against Sandoz for failing to participate in the “patent dance.”  A California federal district court recently ruled for Sandoz and Amgen is pursuing an expedited appeal.  In parallel with its federal lawsuit, Amgen filed a Citizen Petition asking the FDA to require biosimilar applicants to certify compliance with the information disclosure provisions of the BPCIA before formally accepting the biosimilar application for review.  On March 25, 2015, the FDA denied Amgen’s petition.  Unlike the district court, however, FDA did not take a position on the meaning of the BPCIA, instead deferring to the ongoing federal court litigation on the issue.

The BPCIA provides that, within 20 days of its application being accepted for review, the biosimilar applicant:

  1. shall provide to the reference product sponsor a copy of the application submitted to the Secretary under subsection (k), and such other information that describes the process or processes used to manufacture the biological product that is the subject of such application; and
  2. may provide to the reference product sponsor additional information requested by or on behalf of the reference product sponsor.

42 U.S.C. § 262(l)(2).

In support of the argument that subsection (A) is mandatory, Amgen’s petition relied on the same reasoning as in its motions to Judge Seeborg in the Northern District of California – namely that this provision contrasts the mandatory language (“shall”) in paragraph (A) with non-mandatory language (“may”) in paragraph (B).  Judge Seeborg last week rejected this argument, finding the BPCIA’s information disclosure requirements – including those with the mandatory “shall” – to be optional.  Choosing not to comply, according to Judge Seeborg, means only the biosimilar applicant giving up the “temporary safe harbor from litigation” provided by 42 U.S.C. § 262(l)(9)(B).  Amgen is appealing Judge Seeborg’s ruling to the Federal Circuit.

In its decision denying Amgen’s Citizen Petition, the FDA first concluded that the BPCIA did not require it to impose the requested certification requirement, contrasting the BPCIA with the patent certification provisions in the Hatch-Waxman act relating to 505(b)(2) applications (so-called “paper NDAs”) and ANDAs, which expressly require applicants to certify compliance to FDA.  FDA noted that Amgen’s petition had only said that it “should” – rather than must – require certification, which FDA considered to be an “implicit[] acknowledge[ment]” that certification is a “matter of regulatory discretion and not compelled” by the BPCIA.

FDA declined to exercise its discretion to establish a certification requirement.  In doing so, FDA noted that the Amgen case and a recent case filed by Janssen Biotech “may clarify how [42 U.S.C. § 262(l)] should be interpreted.”  In other words, FDA is deferring to the courts as to how to interpret the information disclosure provisions of the BPCIA.

FDA stated that it was denying the petition “at this time,” leaving open the possibility that it might revisit the issue after a final federal court determination.  But of course, if the courts find that the patent dance is mandatory and enforceable as Amgen contends, the presence or absence of an FDA certification requirement may not be very significant.  Conversely, if they find for Sandoz, FDA is unlikely to require certification of requirements the courts have determined to be optional.  In that sense, FDA’s decision on Amgen’s petition may turn out to be the agency’s final word on the issue for all practical purposes.