In parallel with the district court case where Amgen is asserting that Sandoz has not complied with the BPCIA because they have not provided Amgen with a copy of their biosimilar application, in October 2014 Amgen filed a Citizens Petition requesting FDA require such disclosure. On March 25, 2015 FDA denied Amgen’s Petition.
In their Petition, Amgen requested that before accepting an application for review under section 351(k) of the Public Health Service Act, FDA should require the application to include a certification that the applicant will timely comply with section 351(1)(2)(A) “by providing the reference product sponsor with a copy of the biosimilar application and information that describes the process(es) used to manufacture the biosimilar product that is the subject of that application.” One month after Amgen filed their Petition, Momenta opposed it arguing that the patent exchange provisions in section 351(1) are not mandatory and that “there is no statutory basis for the requested FDA role via certification or enforcement with respect to the private patent exchange process under Section 351 (1).” According to Momenta, granting the Petition would be contrary to congressional intent, specifically to separate FDA from the patent resolution process.
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