The opinion of the court was delivered by: Mary Cooper, District Judge.
This matter comes before the Court on motion by plaintiffs, Pharmacia & Upjohn Co. ("Pharmacia"), Sankyo Company Ltd. ("Sankyo"), and Takeda Chemical Industries, Ltd. ("Takeda") (collectively "plaintiffs"), seeking preliminary injunctive relief to prevent defendants, Ranbaxy Pharmaceuticals, Inc. and Ranbaxy Laboratories Ltd. (collectively "Ranbaxy") from marketing in the United States an FDA-approved generic copy of a prescription antibiotic product sold in the U.S. by Pharmacia under the trade name VANTIN®.
The parties approach this case recognizing that Ranbaxy admits that its FDAapproved generic product will be an exact chemical copy of Pharmacia's VANTIN® product. Ranbaxy defends the injunction motion on two grounds. First, Ranbaxy contends that the '783 patent does not cover either the accused Ranbaxy product or VANTIN®, and therefore the Ranbaxy product does not infringe that patent. Alternatively, Ranbaxy contends that if the '783 patent does cover the Ranbaxy product, that patent should have expired long ago in 1995, when several related patents expired. Thus, Ranbaxy should now be free to market its product. This argument is based upon a theory of invalidity due to "obviousness-type double patenting," discussed below.
The Court has analyzed this motion based upon the written materials and the oral arguments presented by the parties.*fn1
We conclude that plaintiffs have met their burden to demonstrate a right to the injunctive relief sought. Therefore, upon posting of an appropriate bond the motion will be granted pursuant to Federal Rule of Civil Procedure 65.
I. BACKGROUND AND PROCEDURAL HISTORY
Plaintiff Takeda, a Japanese corporation, is the owner-assignee of the '783 patent, which was issued on May 26, 1987. (Confoy Decl., Ex. 1: U.S. Patent No. 4,668,783.)*fn2 Plaintiff Sankyo, a Japanese corporation, is the exclusive licensee of Takeda under the '783 patent. Plaintiff Pharmacia, a U.S. corporation, is an exclusive sub-licensee of Sankyo under the '783 patent, with the right to enforce it in cooperation with Sankyo. (Compl.¶ 10.) The '783 patent is directed to a class of antibiotic pharmaceutical products known in the industry as "cefpodoxime proxetil."*fn3 (Id. ¶ 9.) It will expire in May, 2004. (Wilp Decl. ¶ 4.)
Defendant Ranbaxy Pharmaceuticals, Inc. is a U.S. corporation, and defendant Ranbaxy Laboratories Ltd. is its parent company, headquartered in India. (Def. Br. at 2.) Both defendants are referred to as "Ranbaxy" for purposes of this motion. On December 19, 2000, Ranbaxy filed two Abbreviated New Drug Applications ("the ANDAs") with the U.S. Food and Drug Administration ("FDA"), seeking approval to market antibiotics containing cefpodoxime proxetil in the U.S. (Chattaraj Decl. ¶¶ 3-4; id., Exs. 21, 23.) In this opinion, the Ranbaxy products that will be marketed in the U.S. pursuant to the ANDAs are referred to as "the Ranbaxy product." The ANDAs refer to the New Drug Application previously approved by the FDA for Pharmacia, which sells its cefpodoxime proxetil products under the trade name VANTIN®. (Charraraj Decl. ¶ 5.) On May 31, 2002, one of Ranbaxy's ANDAs received FDA approval.*fn4
This action was commenced by plaintiffs on November 15, 2001, seeking declaratory judgment of infringement and injunctive relief based upon Ranbaxy's filing of the ANDAs and Ranbaxy's declared intention to market its product when approved. (Compl. at 1-6.) The Court entered a stipulated order on December 10, 2001 which provided, inter alia, for expedited discovery on the injunctive issues. (Docket entry #18 ("12-10-01 Order").) The 12-10-01 Order provided that Ranbaxy would inform the Court of developments with its pending ANDAs, and would not market its product in the U.S. without giving 15-day notice to plaintiffs, in which case plaintiffs could seek an emergency temporary restraining order. (Id. at 4.) Thereafter discovery was conducted on issues relating to injunctive relief, the pleadings were amended several times, and plaintiffs filed the present motion for preliminary injunction on May 3, 2002. The Court conducted oral argument on this and other pending motions on July 19, 2002.*fn5 (Oral Arg. Tr.) Ranbaxy has not commenced marketing its product as yet, pending the outcome of this motion.
A. Jurisdiction, Standard for Preliminary Injunction
This Court has subject matter jurisdiction in this patent dispute pursuant to 28 U.S.C. § 1331 and 1338(a). Jurisdiction is also proper under the Federal Declaratory Judgment Act, 28 U.S.C. § 2201 and 2202.
A party seeking a preliminary injunction against an alleged infringer bears the burden of proving entitlement to relief based upon: (1) a reasonable likelihood of success on the merits; (2) irreparable harm if the injunction is not granted; (3) the balance of hardships tipping in its favor; and (4) a tolerable effect on the public interest. See, e.g., Sofamor Danek Group, Inc. v. DePuy-Motech, Inc., 74 F.3d 1216, 1219 (Fed. Cir. 1996); Reebok Int'l Ltd. v. J. Baker, Inc., 32 F.3d 1552, 1555 (Fed. Cir. 1994). The Court must balance these factors against one another and against the extent of the relief sought. Hybritech Inc. v. Abbott Lab., 849 F.2d 1446, 1451 (Fed. Cir. 1988).
The necessary showing of a likelihood of success must include evidence by the movant that there are no genuine grounds to challenge the "validity" of the patent or the "infringement" of the patent by the accused product. Id. However, a patent is statutorily presumed valid, 35 U.S.C. § 282, and this presumption places the burden of going forward, as well as the burden of persuasion, upon the party attacking validity — even at the preliminary injunction stage of the case. Canon Computer Sys., Inc. v. Nu-Kote Intern., Inc., 134 F.3d 1085, 1088 (Fed. Cir. 1998). The alleged infringer must at least identify some persuasive evidence of invalidity at the preliminary injunction stage to overcome the presumption of validity. Id.
As relevant to this motion, Ranbaxy here challenges plaintiffs' claim of infiingement, and also asserts that the '783 patent is invalid due to obviousness-type double patenting. (See Def. Br.; Oral Arg. Tr. at 38.) Each of these issues presents the Court with the threshold task of making a preliminary claim construction.
B. Likelihood of Success — Infringement Issue
An infringement inquiry is a twostep process. First, the court must determine the scope and meaning of the patent claim as a matter of law. Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). Second, the properly construed claim is compared to the accused product to determine whether it contains every limitation of the claim or a substantial equivalent of any limitation not literally present. Laitram Corp. v. Rexnord, Inc., 939 F.2d 1533, 1535 (Fed. Cir. 1991). In their motion, plaintiffs allege that Ranbaxy's product infringes at least Claims 1 and 2 of the '783 patent. (Pl. Br. at 6.) However, since Claim 1 is independent and the other five claims of the '783 patent are dependent, the attention of the parties and of the Court on this motion has been focused upon construction of Claim 1. (Def. Br. at 5; Pl. Reply Br. at 2.)
There is a "`heavy presumption' that a claim term carries its ordinary and customary meaning." CCS Fitness Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002). A claim term should generally be given its ordinary meaning unless the patentees "clearly set forth a definition of the disputed claim term in either the specification or prosecution history." Id. Thus, words in a claim are generally given their ordinary and customary meaning in the absence of a contrary indication in the patent specification or file history. Wolverine World Wide, Inc. v. Nike, Inc., 38 F.3d 1192, 1196 (Fed. Cir. 1994).
When interpreting an asserted patent claim, the court should look first to the intrinsic evidence of record, which is the patent itself, including the claims, the specification, and the complete prosecution history. Markman, 52 F.3d at 979. Such intrinsic evidence is the most significant source of the legally operative meaning of disputed claim language. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1583 (Fed. Cir. 1996). Dictionaries, encyclopedias and treatises "are always available to the court to aid in the task of determining meanings that would have been attributed by those of skill in the relevant art to any disputed terms used by the inventor in the claims. . . . Thus, categorizing them as `extrinsic evidence' or even a `special form of extrinsic evidence' is misplaced and does not inform the analysis." Tex. Digital Sys., Inc. v. Telegenix, Inc., 308 F.3d 1193, 1202-03 (Fed. Cir. 2002). The Court has considered all of the parties' submissions on this motion, including the extrinsic expert declaration evidence provided by Dr. Sloan for plaintiffs and Dr. Remmel for Ranbaxy, in light of these principles.
2. Construction of the '783 Patent Claims
Claim 1 of the '783 patent recites a compound having the following formula:
1. A compound of the formula:
('783 patent, Col. 39:25 to 40:10-14 ("Claim 1").)
Plaintiffs allege that Ranbaxy's product literally infringes the R4 limitation of Claim 1 of the '783 patent ("R4", or "the R4 limitation"). (Pl. Br. at 7-11.) Ranbaxy agrees that in both Pharmacia's VANTIN® products and Ranbaxy's product, the chemical structure of the R4 component is identical. (Def. Br. at 6.) However, Ranbaxy contends that the R4 limitation, properly construed, covers neither the Ranbaxy product nor VANTIN[R].*fn6 (Id. at 6-12.) The central inquiry on the infringement issues, therefore, concerns the proper claim construction of the R4 limitation of Claim 1.*fn7
We begin with basic undisputed concepts in organic chemistry. According to standard convention, the compound molecule shown in Claim 1 is made up of atoms in which "H" designates hydrogen, "C" designates carbon, "N" designates nitrogen, "S" designates sulfur, "COOH" designates a carboxylic acid, and the term "R" designates groups of atoms (radicals) identified by class in the claim. (Pl. Br. at 7.) A "residue" is a collection of atoms that are in a definite shape, but a "residue" is smaller than a molecule. (Oral Arg. Tr. at 53.)
One of the known types of "residue of a nucleophilic compound" is a "hydroxyl" group. A hydroxyl group is also known as "-OH." (Sloan Decl. ¶ 14; Remmel Decl. ¶ 12, Table 1.) This signifies one oxygen and ...