In a press release today, the Federal Trade Commission announced that it "has notified Sanofi-Aventis U.S. LLC, Watson Pharmaceuticals, Inc., and Synthon Holding B.V., that it believes the companies violated federal law by failing to inform antitrust authorities about drug patent agreements involving Sanofi's insomnia drug Ambien CR." According to the release, "the FTC staff told the companies that it decided not to recommend enforcement action for several reasons, including its finding that the violation does not appear to have harmed consumers or competition, nor benefitted the companies." Instead, the FTC apparently decided this is a "teachable moment," and published advisory letters that it mailed to Sanofi, Watson and Synthon.
The press release quotes FTC Bureau of Competition Director Richard Feinstein as stating, "The Bureau of Competition recognizes the importance of clear guidance concerning the types of agreements that are subject to the MMA filing requirement. We expect that these companies, and the pharmaceutical industry more broadly, will closely consider the contents of these advisory letters in connection with future agreements that may be subject to the MMA."
According to the advisory letters, Section 1112(a)(2) of the Medicare Modernization Act requires an agreement to be filed if it concerns:
(A) the manufacture, marketing, or sale of the brand name drug that is the listed drug in the ANDA involved;
(B) the manufacture, marketing, or sale of the generic drug for which the ANDA was submitted; or
(C) the Hatch-Waxman 180-day exclusivity period as it applies to an ANDA based on the same brand name drug.
In addition, "companies must also file the text or a written description of any agreements between them that are contingent upon, provide a contingent condition for, or are otherwise related to an agreement that is required to be filed under the provisions set forth above." The letters further state that "the only exclusion from the Act's filing requirement is an exception for agreements that solely concern: (A) purchase orders for raw material supplies; (B) equipment and facility contracts; (C) employment or consulting contracts; or (D) packaging and labeling contracts."
It appears that the FTC is monitoring activity in specific ANDA litigations--either in the press or perhaps through PACER--as the Ambien CR agreements were publicly available. The FTC reminds industry that "in case of doubt about whether filing [of a specific agreement] is required, companies can contact Commission staff for guidance."