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FDA Denies Request to Make “Patent Dance” a Prerequisite for Biosimilar Approval

In a decision released on March 25, 2015, FDA denied a Citizen’s Petition that would have effectively made the information and patent exchange described in § 262 of the Biologics Price Competition and Innovation Act (“BPCIA”) a precondition for approval.  The Petition, which had been filed by Amgen, requested that FDA require biosimilar applicants to certify to FDA that they had provided the reference product sponsor a copy of their biosimilar application as well as “information that describes the process(es) used to manufacture the biosimilar product that is the subject of that application.”  FDA Response at 1.  FDA denied the Petition, finding that the language of the BPCIA did not require FDA to act and explaining that that FDA would not exercise its discretion to force biosimilar applicants to comply with a provision the interpretation of which is currently the subject of ongoing litigation.

The BPCIA states that a biosimilar applicant “shall” provide the “reference product sponsor” with a copy of its biosimilar application “and such other information that describes the process or processes used to manufacture the biological product that is the subject of such application” within 20 days after FDA informs the applicant that its BLA has been accepted for review. 42 USC § 262(l)(2)(A).  Providing this information triggers a series of information exchanges and negotiations – the so called “patent dance” – where the biosimilar applicant and reference drug product sponsor exchange contentions regarding patent infringement and validity and identify the patents that may be the subject of litigation.

In its Petition, Amgen argued that Congress intended the information exchange and patent dance to be mandatory.  Amgen argued that failure to comply with these provisions “vitiates the entire scheme that Congress created” and “substantially undermines the ability of the reference product sponsor to determine which patents may be implicated by the commercial manufacture, use, sale or import of the biosimilar product.”  Amgen Petition at 2, 14.  It then argued that FDA should require biosimilar applicants to certify compliance because “[i]n the absence of action by FDA … the risk of non-compliance is real and substantial.”  Id. at 4.

As an example of biosimilar applicant non-compliance, Amgen cited Sandoz’s refusal to provide information regarding its manufacturing process in connection with its Zarxio® application.  Id.  Zarxio® is a biosimilar to Amgen’s Neupogen®.  Sandoz’s Zarxio® application is currently the subject of litigation in which Amgen has alleged that Sandoz violated the terms of the BPCIA by failing to provide information regarding its application and manufacturing process.  U.S. District Court Judge Richard Seeborg of the Northern District of California recently denied Amgen’s motion for judgment on the pleadings as well as its request for a preliminary injunction based on Sandoz’s alleged non-compliance with the BPCIA.

After considering Amgen’s arguments, and arguments submitted by third-party commenter Momenta, FDA denied Amgen’s petition.  FDA determined that, in contrast to the Hatch-Waxman Act, which requires FDA to publish a list of patents covering approved drugs (the “Orange Book”), and which requires ANDA applicants to submit certifications to the FDA with respect to listed patents, the BPCIA “generally does not describe any FDA involvement in monitoring or enforcing the information exchange by creating a certification process or otherwise.”  FDA Response at 3-4.  Accordingly, FDA determined that its decision on whether to impose a certification requirement was a matter of “regulatory discretion”.  Id. at 4.  FDA then declined to exercise its discretion to require certification, “in light of the ongoing litigation” between Sandoz and Amgen regarding the correct interpretation of the information exchange provisions of the BPCIA.  Id.

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Dave Cotta