House Passes MMA Amendment Requiring FTC and DOJ Review of Biosimilar Patent Litigation Settlements

On September 25, 2018, the House of Representative passed the “Patient Right to Know Drug Prices Act” (S.2554).  As we previously reported, the Senate passed the bill on September 19, 2018.  The bill includes amendments to the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (“MMA”) that require patent litigation settlements between a Reference Product Sponsor and a biosimilar applicant under section 351(k) to be submitted for review by the Federal Trade Commission (“FTC”) and the U.S. Department of Justice (“DOJ”).  The proposed legislation would impose on biosimilar-related patent litigation settlements and agreements the same FTC and DOJ disclosure requirements currently in place for ANDA litigation settlements under the MMA.  The bill also bans the practice of so-called “pharmacy gag clauses,” which prevent pharmacists from informing customers the price of a product using insurance versus paying out of pocket.  The bill will now be considered by the President, who has expressed support for such legislation.

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