Ortho-McNeil Pharmaceutical, Inc. v. Mylan Laboratories, Inc.

Citations: 267 F. Supp. 2d 545; 2003 U.S. Dist. LEXIS 9591; 2003 WL 21313363Docket: CIV.A. 102CV32

Court: District Court, N.D. West Virginia; March 31, 2003; Federal District Court

SummaryOriginalCytator Case TreatmentBackward CitatorAnalysis

EnglishEspañolSimplified EnglishEspañol Fácil

Plaintiffs Ortho-McNeil Pharmaceutical, Inc., Johnson & Johnson Pharmaceutical Research & Development, LLC, and Daiichi Pharmaceutical Co. Ltd. filed a motion to amend their complaint in a patent infringement case involving the '407 patent for the drug levofloxacin. They seek to add a claim against Quimica Sintetica, S.A. and its U.S. agent, Betachem, Inc., for inducement of patent infringement under 35 U.S.C. § 271(b). Defendants Mylan Laboratories, Inc. and Mylan Pharmaceuticals, Inc. oppose this motion. The court, referencing Federal Rule of Civil Procedure 15(a) and the precedent set in Foman v. Davis, emphasizes that leave to amend should be granted when justice requires it. However, the court ultimately denies the plaintiffs' motion to amend.

Leave to amend a complaint should be granted freely unless there is a clear reason for denial, such as undue delay, bad faith, failure to cure deficiencies, undue prejudice, or futility. The District Court has discretion in granting amendments, but a refusal without justification constitutes an abuse of discretion. Plaintiffs assert they have adequately stated a claim of inducement of patent infringement against Quimica and Betachem, alleging their participation in the submission of an ANDA for levofloxacin tablets before the '407 patent's expiration. They claim that Quimica and Betachem encouraged Mylan to file the ANDA, thereby inducing infringement. The plaintiffs reference case law, including Water Technologies Corp. v. Calco, Ltd., which holds that a party induces infringement by knowingly assisting another's infringement, and Smithkline Beecham Corp. v. Pentech Pharm. Inc., where similar allegations led to a granted amendment motion. The standard for assessing futility of an amendment is whether it states a claim for which relief can be granted. Plaintiffs seek a judgment declaring Quimica and Betachem liable for inducing infringement under 35 U.S.C. § 271(b), a declaration that their actions infringe the '407 patent under various subsections of § 271, and a permanent injunction against their manufacturing and selling activities related to bulk levofloxacin in the U.S.

Under 35 U.S.C. § 271(e)(4), the court must set the effective date for FDA approval of a drug involved in infringement as no earlier than the patent's expiration if the infringement falls under specified provisions. Injunctive relief may be granted against an infringer to prevent actions related to the approved drug, and monetary relief is contingent on commercial activity concerning that drug. The remedies outlined are exclusive, though courts may award attorney fees per section 285. 

In this case, the plaintiffs do not seek to delay FDA approval against Quimica and Betachem, which would be redundant since similar relief is sought against Mylan. The plaintiffs request an injunction against Quimica and Betachem from selling bulk levofloxacin, but this is problematic for two reasons: first, bulk levofloxacin is not the drug associated with Mylan's ANDA; second, Quimica and Betachem are not accused of conducting commercial sales, only of providing raw materials for Mylan's ANDA, which is exempt from infringement under 35 U.S.C. § 271(e)(1). The court cannot issue a narrower injunction due to 35 U.S.C. § 271(e)(3), and since no commercial sales of the infringing product have occurred, the remedy under § 271(e)(4)(C) is not applicable. 

Consequently, the plaintiffs' amended complaint fails to establish a basis for relief against Quimica Sintetica, S.A. and Betachem, Inc. as inducers of infringement, leading to a denial of their motion to amend. The court ordered that copies of this decision be transmitted to counsel of record.