Merck Sharp & Dohme Corp. v. Sandoz Inc., No. 12-3289 (D.N.J. 2013)
In an opinion issued earlier this month, Defendants moved to dismiss for lack of subject matter jurisdiction with respect to one of two asserted patents in a lawsuit involving generic versions of EMEND (fosaprepitant dimeglumine) for injection.
Merck filed a supplement to its NDA to add a 150 mg dosage strength, listing two patents, U.S. Patent Nos. 5,591,336 and 5,716,942. Upon approval, however, only the '336 patent was listed in the Orange Book. Both patents were listed in the Orange Book for the previously approved 115 mg dosage strength. Defendants filed ANDAs for the 150 mg dosage strength only and made paragraph IV certifications for the '336 patent and not the '942 patent. Merck's complaint alleges infringement of both patents.
Judge Sheridan, relying on judicial efficiency and common sense, held that subject matter jurisdiction existed despite the fact that the '942 patent was not listed in the Orange Book. Defendants alleged the same defenses for both patents and could not dispute that the '942 patent claims the use of drugs that their ANDAs concern.The court stated that 35 USC § 271(e)(2) does not suggest that "infringement actions against ANDA filers must be based only on Orange Book listed patents." Rather, the jurisdiction standard applied by Judge Sheridan (from AstraZeneca Pharm. LP v. Apotex Corp., 669 F.3d 1370, 1377 (Fed. Cir. 2012)) was that jurisdiction exists where "a patent owner alleges that another’s filing of an ANDA infringes its patent under § 271(e)(2)."