By Memorandum Opinion entered by The Honorable Sue L. Robinson in Merck Sharp & Dohme Corp. v. Teva Pharmaceuticals USA, Inc., Civil Action No. 14-874-SLR (D.Del., November 16, 2016), the Court found the asserted claims of U.S. Patent No. 6,127,353 ("the '353 patent") are valid but that defendant does not infringe the asserted claims of the '353 patent with its ANDA product.[1] Specifically, the Court found in favor of plaintiff Merck and against defendant as to defendant's asserted affirmative defenses of invalidity of the '353 patent based on obviousness-type double patenting and alleged lack of an adequate written description of the invention as required by 35 U.S.C. § 112, ¶ 1. Id. at *2-7. The Court found in favor of defendant and against plaintiff Merck as to the infringement of the '353 patent after finding that plaintiff had not established, by a preponderance of the evidence, the presence of mometasone furoate monohydrate ("MFM") in defendant's ANDA product during its two-year shelf life. Id. at *8-24.
A copy of the Memorandum Opinion is attached.
[1] The '353 patent is listed in the Food and Drug Administration's publication titled Approved Drug Products with Therapeutic Equivalence Evaluations, which is known as the "Orange Book", for the nasal spray, Nasonex®. This action arose out of the filing of an Abbreviated New Drug Application ("ANDA") by defendant Teva seeking to produce and market a generic mometasone furoate nasal spray.
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