Near the end of last month, the U.S. Food and Drug Administration ("FDA") denied a citizen petition filed by Amgen in which it requested that action be taken to ensure that biosimilar applicants comply with the disclosure and exchange provisions described in the Biologics Price Competition and Innovation Act (“BPCIA”).  Amgen had filed its petition on October 29, 2014, after Sandoz refused to disclose a copy of its biosimilar application related to Amgen’s NEUPOGEN^® (filgrastrim) biologic drug product.  More precisely, Sandoz had alleged that the disclosure provision of the BPCIA was not mandatory.  Instead, as noted in the petition, Sandoz had independently offered to provide Amgen with the information, but with conditions and restrictions not found in the statute.  Amgen requested in the petition that the FDA require all new biosimilar applicants to certify that they would comply with the disclosure provisions (in a manner similar to how an ANDA filer must provide a certification in the Hatch-Waxman context).  However, the FDA denied this request because the provisions of the BPCIA do not in fact impose such a certification requirement, which stands in opposition to the explicit certification requirement for ANDA filers as found in the Hatch-Waxman statute.

Of course, this comes on the heels of the Northern District of California’s denial of Amgen’s motion for a preliminary injunction and partial judgement on the pleadings in the Amgen v. Sandoz case.  As previously reported here, the Court in that case sided with Sandoz in determining that the disclosure provisions were not mandatory.  In large part, the Court based its decision on the fact that, even though the BPCIA states that the biosimilar applicant “shall provide to the reference product sponsor a copy of the application,” and other information related to the manufacturing process, the statute also provides the “penalty” for not so disclosing.  Essentially, Sandoz was just opting for the penalty – being subject to “an action under section 2201 of Title 28, for a declaration of infringement, validity, or enforceability of any patent that claims the biological product or a use of the biological product.”  42 U.S.C. § 262(l)(9)(C).  The obvious problem, however, is that a product sponsor will likely not be aware of which patents it can assert in the absence of such a disclosure.

In its citizen petition to the FDA, Amgen again alleged that the disclosure provisions and patent exchanges dictated by the BPCIA – the so-called biosimilar “patent dance” – were mandatory, not optional or discretionary.  Amgen pointed to the text and the history of the statute for the support.  In fact, without the initial disclosure by the biosimilar applicant, the “patent dance” cannot even begin.  “All of these provisions quickly become nullities if biosimilar applicants are free to simply ignore the requirements of § 351(l)(2)(A),” Amgen asserted.  This can become an even more serious issue when considering “interchangeable” biosimilar products.  Such products earn a period of exclusivity tied in part to any potential litigation.  As such, it would behoove a biosimilar applicant to delay, or even eliminate, any litigation by not disclosing its application or manufacturing information.  Indeed, if a biosimilar applicant were not required to disclosure that it had, in fact, filed an application, it could maintain the fact that it had filed an application secret.  This could not have been what Congress intended, Amgen contended.

Momenta Pharmaceuticals also submitted a paper to the FDA in response to Amgen’s citizen petition on November 25, 2014.  This paper echoed Momenta’s comments that it submitted to the FDA in May 2012, expressing concern that the “patent dance” provisions of the BPCIA would be converted to an FDA regulated regime.  Instead, Momenta alleged that granting Amgen’s petition would be contrary to the intent of Congress.  Specifically, Momenta asserted that Congress intended:

• to separate the FDA from the patent resolution process;
• to allow applicants to choose to engage in the patent exchange process at the time a 351(k) Application is filed when appropriate;
• to provide reference biologic sponsors with procedural patent exchange protections should applicants elect to seek patent resolution early; and
• to allow for specific remedies should applicants elect not to seek patent resolution prior to commercial launch.

In the end, the FDA sided with Momenta and denied Amgen’s petition.  “Neither section 351(k) nor section 351(l) requires the FDA to impose certification requirements as part of the biosimilar review process.”  This is, again, in contrast to the Hatch-Waxman statute, which requires ANDA filers to certify regarding each patent listed in the FDA’s Orange Book.  “Viewed against the explicit requirements under the FD&C Act, the Petition’s contention that FDA ‘should’ require a certification for biosimilar applications implicitly acknowledges that imposing such a requirement is a matter of regulatory discretion and not compelled under the PHS Act.”  With regard to that discretion, the FDA noted that the issue about whether the disclosure provisions were mandatory was being resolved in the Federal courts.  Nevertheless, the FDA did provide Amgen with a glimmer of hope, if not for now than for the future: “In light of the ongoing litigation regarding interpretation of section 351(l) of the PHS Act, at this time, the Agency denies the request to exercise its discretion to require biosimilar applications to include a certification to FDA that the applicant will timely comply with section 351(l)(2)(A) of the PHS Act.” (emphasis added).  Of course, this likely provides little solace to Amgen, because if it does receive a favorable ruling on appeal in the Amgen v. Sandoz case, such FDA action will not be necessary.