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®.
Plaintiffs possess the exclusive rights to U.S. Patent No.
4,668,783 ("the '783 patent"), which is due to expire on May 26,
2004. Plaintiffs contend that marketing of the Ranbaxy product in
the U.S., prior to expiration of the '783 patent in May, 2004
will constitute patent infringement and that a preliminary
injunction should be entered against Ranbaxy until that time.
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,
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
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
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
1. A compound of the formula:
[EDITORS' NOTE: GRAPH IS ELECTRONICALLY NON TRANSFERRABLE.]
('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