Merck Sharp & Dohme Corp. v. Sandoz Inc.

Filing a paragraph IV certification is not required for a District Court to have subject matter jurisdiction over a claim of patent infringement; all that is required is the allegation of patent infringement.

April 16, 2013

GENERICally Speaking

Case Name: Merck Sharp & Dohme Corp. v. Sandoz Inc., Civ. No. 12-3289 (PGS), 2013 U.S. Dist. LEXIS 19933 (D.N.J. Feb. 14, 2013) (Sheridan, J.)

Drug Product and Patent(s)-in-Suit: Emend® (aprepitant); U.S. Pat. Nos. 5,591,336 (“the ‘336 patent”) and 5,716,942 (“the ’942 patent”)

Nature of the Case and Issue(s) Presented: A pharmaceutical company is required to submit an NDA to the FDA before introducing a new drug into interstate commerce. The NDA must identify any patents for “which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug.” 21 U.S.C. § 355(b)(1). When the NDA is approved, this information is published in the FDA’s Orange Book. When a generic manufacturer files an ANDA including a “paragraph IV certification” that generic manufacturer certifies that the patent listed by the NDA holder in the Orange Book is invalid or will not be infringed by the drug that is the subject of the ANDA.

Before the Court were two motions to dismiss, asserted by two separate sets of defendants in two separate patent litigations initiated by Merck. Merck’s NDA includes two dosage strengths, 115 mg and 150 mg. For the 115 mg strength, Merck submitted information concerning both patents, and once approved, the Orange Book listed both patents. For the 150 mg strength supplemental NDA, Merck submitted similar patent information, however, on approval, only the ’336 patent was listed in the Orange Book. The Orange Book was corrected, but after the submission of Defendants’ ANDAs, which did not include paragraph IV certifications against the ’942 patent. The Defendants moved to dismiss only with respect to the ’942 patent. The central question before the Court was whether a paragraph IV certification was necessary in order for a District Court to assert jurisdiction over a claim pursuant to 35 U.S.C. § 271(a). The Court denied both motions.

Why Merck Prevailed:  The Court found that it had subject matter jurisdiction over Merck’s claim with respect to the ’942 patent because 28 U.S.C. § 1338 grants federal courts “original jurisdiction of any civil action arising under any Act of Congress relating to patents.” Because the complaint alleges jurisdiction under that section and causes of action for patent infringement under 35 U.S.C. § 271(e)(2), which is an Act of Congress related to patents, the Court has jurisdiction. Additionally, nothing in the language of the Hatch-Waxman Act suggests that infringement actions against ANDA filers must be based only on Orange Book-listed patents. Finally, common sense and judicial efficiency also weighed in favor of trying the two infringement claims together.

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