Monday, November 30, 2015

ANDA Applicant’s Communications With FDA Concerning REMS Discoverable Under D.N.J. Local Patent Rules

The court granted plaintiff's motion to compel defendants to produce communications with the FDA regarding defendants' negotiation of a joint Risk Evaluation and Mitigation Strategy program. "This dispute centers on whether the documents in question 'pertain' to Defendants' ANDAs pursuant to L. Pat. R. 3.6(j) . . . The plain language of L. Pat. R. 3.6(j) requires an ANDA applicant to produce 'a copy of all correspondence between itself and the FDA pertaining to the ANDA application to each party asserting infringement, or set forth the basis of any claim of privilege for such correspondence. . . .' The parties have not submitted any case law interpreting that clause and the Court has not located any through its independent research. . . . All parties agree that the product at the center of this case . . . will be not be sold to the public without a REMS, which is required by the FDA. . . . While those communications do not appear to be directly relevant to the questions of infringement or validity, they certainly pertain to and concern the central issue in these cases: Defendants' ANDAs."

Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC, 2-13-cv-00391 (NJD November 23, 2015, Order) (Dickson, M.J.)

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