Synthon Pharmaceuticals, Inc. v. Sanofi-Aventis U.S. L.L.C.

Synthon Pharmaceuticals, Inc. v. Sanofi-Aventis U.S. L.L.C.

B.P.A.I. (2013)

Fitzpatrick Successfully Defends Ambien CR® Patent in Inter Partes Reexamination.

On March 27, 2013, a three judge panel of the Patent Trial and Appeal Board (“PTAB”) issued a decision in favor of Fitzpatrick client, Sanofi, upholding the validity of Sanofi’s United States Patent No. 6,514,531. The ’531 Patent claims controlled-release zolpidem dosage forms having a biphasic in vitro profile of dissolution when measured under specified test conditions. Sanofi markets a controlled-release zolpidem dosage form covered by the ’531 Patent under the trade name Ambien CR®.

After the U.S.P.T.O. instituted the inter partes reexamination at the request of Third Party Requester, Synthon Pharmaceuticals, the Patent Examiner rejected all of the claims of the ’531 Patent as obvious over a prior art disclosure of a controlled-release dosage form. On appeal, the PTAB reversed all of the Patent Examiner’s obviousness rejections, noting that the prior art failed to specify any dissolution test conditions.

The Fitzpatrick team included Margaret A. Scoolidge, Natalie D. Lieber and Dennis J. McMahon.