The opinion of the court was delivered by: Hon. Dennis M. Cavanaugh
DENNIS M. CAVANAUGH, U.S.D.J.
This matter comes before the Court upon motion by Defendants Glenmark Pharmaceuticals, Inc., USA and Glenmark Pharmaceuticals, Ltd. (collectively, "Defendants") to dismiss Abbott Laboratories ("Abbott Laboratories") and Abbott Laboratories, Inc. ("ALI") (collectively, "Plaintiffs") pursuant to Fed. R. Civ. P. 12(b)(1). Defendants also move for summary judgment pursuant to Fed. R. Civ. P. 56 that Abbott GmBH & Co. KG, Abbott Laboratories, and ALI are not entitled to lost profits. Pursuant to Fed. R. Civ. P. 78, no oral argument was heard. After considering the submissions of all parties, it is the decision of this Court for the reasons herein expressed that Defendants' motions are denied.
The '244 patent, titled "Combination of Angiotensin-Converting Enzyme Inhibitors with Calcium Antagonists as well as their Use in Drugs[,]" issued on February 24, 1998, with a filing date of June 7, 1995 and a foreign application priority date of October 2, 1986. The '244 patent discloses and claims a "pharmaceutical composition" used to treat hypertension. The pharmaceutical composition contains an angiotensin-converting enzyme inhibitor ("ACE inhibitor") having certain bicyclic or tricyclic ring systems and a calcium antagonist (also known as a calcium channel blocker or "CCB") in "amounts effective for treating hypertension."
The '244 patent issued on February 24, 1998 to inventors Reinhard Becker, et al. The patent was initially assigned to Hoechst Aktiengesellschaft who subsequently assigned ownership rights to Aventis Pharma Deutschland GmbH, renamed Sanofi-Aventis Deutschland GmbH. Aventis Pharma S.A. was granted an exclusive license to manufacture, use and sell pharmaceutical products containing trandolapril and verapamil hydrochloride. Aventis Pharma S.A. granted Abbott Germany an exclusive license to manufacture, use and sell pharmaceutical products containing trandolapril and verapamil hydrochloride. Abbott Germany in turn granted Abbott Laboratories an exclusive license to manufacture, use and sell pharmaceutical products containing trandolapril and verapamil hydrochloride. Abbott Laboratories granted ALI an exclusive sublicense to use and sell pharmaceutical products containing trandolapril and verapamil.
Abbott Laboratories is the owner of the New Drug Application ("NDA") No. 20-591. Pursuant to the NDA approval, Abbott Laboratories, through ALI, sells drug products containing the trandolapril/verapamil hydrochloride combination in the United States under the trademark Tarka®.
The '244 patent is listed in FDA publication titled "Approved Drug Products with Therapeutic Equivalence Evaluation" ("Orange Book") as being applicable to Abbott Laboratories' aforementioned NDA for its Tarka® tablets.
On July 24, 2007, Glenmark filed an Abbreviated New Drug Application ("ANDA") No. 79-135 with the FDA for approval to market a generic version of the drug Tarka®. On October 24, 2007, Glenmark notified Plaintiffs that it had made a "Paragraph IV"certification asserting that the '244 patent is invalid. On December 7, 2007, consistent with the provisions of the Hatch-Waxman Act, Plaintiffs initiated suit before this Court against Defendants for patent infringement.
1. Standard of Review for Motion to Dismiss Pursuant to Rule 12(b)(1) Standing is a threshold requirement in any federal lawsuit, and the party must have standing at the time it brings the suit. Sicom Sys., Ltd. V. Agilent Techs., Inc., 427 F.3d 971, 975-76 (Fed. Cir. 2005). "The party bringing the action bears the burden of establishing that it has standing." Id. at 976. The district court must accept the complaint's allegations as true and "'general factual allegations of injury resulting from the defendant's conduct may suffice, for on a motion to dismiss [it is] presume[d] that general allegations embrace those specific facts that are necessary to support the claim.'" Wiav Solutions LLC v. Motorola, Inc., 631 F.3d 1257, 1264 (Fed. Cir. Dec. 22, 2010) (quoting Lujan v. Defenders of Wildlife, 504 U.S. 555, 561 (1992)). However, "consideration of a Rule 12(b)(1) jurisdiction-type motion need not be limited; conflicting written and oral evidence may be considered and a court may 'decide for itself the factual issues which determine jurisdiction.'" Id. (citing Williamson v. Tucker, 645 F.2d 404, 413 (5th Cir.) Cert. denied, 454 U.S. 897 (1981)). "When ...