Recent Court Decision Clarifies Some 505(b)(2) NDA Issues and What It Might Mean for Industry

In January 2015, the United States District Court of the District of Columbia issued an opinion, supporting the Food and Drug Administration’s (FDA) position on a 505(b)(2) new drug application (NDA) approval. The decision reaffirms FDA’s interpretation of the statutory provision (section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FDC Act)), which allows an applicant to rely on clinical studies that were previously submitted to the agency in support of another drug and not conducted or licensed by the 505(b)(2) applicant.

The court decision is instructive, because it clarifies certain issues relating to the frequently-litigated 505(b)(2) NDA regulatory pathway and patent certification requirements. This Bulletin summarizes the court’s decision. We will not describe in detail the facts and history of the case, except to offer some background and context. Furthermore, in the interest of brevity, this Bulletin will not detail the 505(b)(2) NDA and patent certification process requirements.


  • In September 2014, FDA approved Hikma Pharmaceuticals PLC/West-Ward Pharmaceuticals Corp.’s 505(b)(2) NDA for its Mitigare (colchicine capsule) product, indicated for the treatment of gout.
  • The next month, Takeda Pharmaceuticals, U.S.A., Inc. (acquirer of Mutual Pharmaceutical Company, Inc.) sued FDA, contending that the agency erred in approving West-Ward’s NDA (Takeda owns Colerys tablets, another approved colchicine drug product).
  • Takeda argued that West-Ward’s failure to cite to Colerys and to certify as to Takeda’s patents resulted in Takeda not having the opportunity to sue for patent infringement and delay FDA approval of the competitor product for 30 months.

Highlights of Court Decision

  • The court ruled West-Ward was not required to reference Colerys if it did not rely on Colerys data to support its own 505(b)(2) NDA for Mitigare.
  • There is no FDA policy that, if the agency relied on the Colerys’ data to approve West-Ward’s Mitigare’s NDA, the agency should have required West-Ward to certify as to the Colerys patents:

    • “put bluntly, their [plaintiffs’] argument hinges on the existence of an FDA drug reference policy that does not exist”;
    • in this case, while the court said FDA’s reliance on data is not relevant, it found that FDA did not, in fact, rely on Colerys’ data to approve Mitigare;
    • the statutory language of “right of reference or use” (in 21 U.S.C. § 355(b)(2)) applies only to the applicant and only to what application materials the applicant is required to submit to FDA.
  • The court reiterated that West-Ward, the applicant, has the right to choose the “most appropriate” or “most similar” reference listed drug, i.e., the drug for which the borrowed studies were conducted, for its 505(b)(2) NDA.
  • FDA explained, and the court accepted, the applicant has the right to make the reference determination for the following reason:

because, under the Section 505(b)(2) scheme, the applicant uses the reference listed drug to supply safety and effectiveness data in total or partial fulfillment of the applicant’s obligation to prove that its drug is safe and effective – meaning that there is a direct correlation between the drug the applicant chooses to reference and the applicant’s burden of proof.

  • The FDC Act requires a 505(b)(2) NDA applicant to certify only to patents associated with the reference listed drug; the applicant is not required to certify to other patents.
  • The court supported FDA’s decision to approve Mitigare with a label that contains safety information different from Colerys.
  • The case has been appealed to the D.C. Circuit Court of Appeals; while we believe the decision is clear in analysis and reasoning, we believe the saga of 505(b)(2) NDA litigation will continue for some time.

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