Clarifying Obligation To Report Drug Patent Agreements

Law360, New York (June 7, 2011, 12:12 PM EDT) -- On May 9, 2011, the Federal Trade Commission's Bureau of Competition notified Sanofi-Aventis U.S. LLC, Watson Pharmaceuticals Inc. and Synthon Holding BV that the companies' failure to inform the FTC and the U.S. Department of Justice about patent agreements concerning Sanofi's insomnia drug, Ambien CR, violated the reporting requirements of the Medicare Prescription Drug, Improvement and Modernization Act of 2003. The notifications came in the form of "advisory letters," which purported to clarify the patent agreement filing requirements under the MMA.

While the decision not to initiate enforcement proceedings may reflect the ambiguity of the statute — or the fact that...

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