The opinion of the court was delivered by: Gettleman, District Judge.
MEMORANDUM OPINION AND ORDER
Plaintiffs Glaxo Group Ltd. and Glaxo Wellcome Inc.
("plaintiff") have brought a two count anticipatory patent
infringement complaint against defendant Apotex, Inc. In Count I,
plaintiff requests a declaratory judgment, seeking to enjoin a
future patent infringement. Count II alleges patent infringement
pursuant to 35 U.S.C. § 271(e)(2)(A). Defendant has moved to
dismiss both counts, arguing that the court lacks jurisdiction
over the first, and that the second fails to state a claim. For
the reasons set forth below, the motion is denied.
Plaintiff is the owner of U.S. Patent No. 4,562,181 (the "181
patent") entitled "Amorphous Form of Cefuroxime Ester," which
covers amorphous cefuroxime axetil. Plaintiff is also the holder
of a new drug application ("NDA") for the antibiotic sulfur
cefuroxime axetil tablets, which is covered by the 181 patent and
is sold by plaintiff under the brand name Ceftin. Ceftin is a
broad spectrum medicine used to combat graham positive and graham
negative bacterial infections, and is the most often prescribed,
largest selling branded cephalosporin pharmaceutical in this
country. The 181 patent was awarded on December 3, 1985, but
filed on July 28, 1983. Pursuant to 35 U.S.C. § 154(c)(1), the
patent expires on July 28, 2003, twenty years from the earliest
United States filing date.*fn1
Defendant is a Canadian company that engages in the manufacture
of generic versions of prescription drugs which it markets
throughout the world. On April 5, 2000, defendant filed an
abbreviated new drug application ("ANDA") for permission to
market a generic version of Ceftin, which was deemed acceptable
for filing by the Food and Drug Administration ("FDA") on June 2,
2000.*fn2 Defendant's ANDA is currently under review by the
Office of Generic Drugs at the FDA. The parties disagree on the
length of the FDA's ANDA approval process. Defendant, relying on
the affidavit of its Chairman and Chief Executive Officer, states
that it expects the process to take no less than two years.
According to plaintiff, the FDA has averaged 18 months for
approvals. Under either scenario, the ANDA should be approved
prior to expiration of the patent.*fn3
Finally, on July 28, 2000, plaintiff again wrote to defendant,
specifically requesting information regarding: 1) whether
defendant intends to market a cefuroxime axetil product in the
United States and has applied to the FDA for approval of a
generic form; 2) whether defendant believes that any generic
product it will market would not infringe plaintiff's patents and
why; and 3) whether defendant believes any of plaintiff's patents
to be invalid. Receiving no response, plaintiff filed the instant
lawsuit on September 20, 2000.
In Count I, brought pursuant to the Declaratory Judgment Act,
28 U.S.C. § 2201, plaintiff seeks a declaration adjudicating that
defendant will infringe the 181 patent by its threatened acts of
manufacture, importation and sale of products covered by the
patent, and ordering that the effective date of any approval of
defendant's ANDA for cefuroxime axetil tablets and their use be
no earlier than the expiration date of the 181 patent. Defendant
has moved to dismiss Count I pursuant to Fed.R.Civ.P. 12(b)(1),
for lack of a justiciable controversy.
It is axiomatic that by enacting the Declaratory Judgment Act,
"Congress enlarged the range of remedies available in the federal
courts but did not extend their jurisdiction." Skelly Oil Co. v.
Phillips Petroleum Co., 339 U.S. 667, 671-72, 70 S.Ct. 876, 94
L.Ed. 1194 (1950). The Act authorizes a court to declare the
rights of an interested party in a case of actual controversy
within its jurisdiction. 28 U.S.C. § 2201. In the instant case,
there is no question that jurisdiction over patent matters rests
exclusively in the federal court. See 28 U.S.C. § 1338(a).
Therefore, the sole requirement for jurisdiction under the Act is
that there be an actual controversy, or a conflict that is "real
and immediate" in that there is a "true actual controversy"
between the parties. Lang v. Pacific Marine and Supply Co.
Ltd., 895 F.2d 761, 764 (Fed.Cir. 1990).
A patentee may seek a declaration that a person will infringe a
patent in the future. Glaxo, Inc. v. Novopharm, Ltd.,
110 F.3d 1562, 1569 (Fed.Cir. 1997) (citing Lang, 895 F.2d at 763). When
a patentee sues for a declaration of future infringement the
actual controversy requirement "is met by a sufficient allegation
of immediacy and reality." Lang, 895 F.2d at 764. To meet this
actual controversy requirement, the patentee must demonstrate
that: 1) the defendant is engaged in activity directed toward
making, selling or using subject to an infringement charge, or be
making meaningful preparation for such activity; and 2) the
defendant's actions indicate a refusal to change the course of
its actions in the face of acts by the patentee sufficient to
create a reasonable apprehension that suit will be forthcoming.
Id. at 764. The first prong examines the accused infringer's
conduct and ensures that the controversy is real and substantial.
Id. The second prong requires conduct by both the accused
infringer and the patentee, and ensures that the controversy is
definite and concrete between the parties having adverse legal
In the instant case, the facts alleged in the complaint, and
presented in the parties' moving papers pursuant to Fed.R.Civ.P.
12(b)(1), convince the court that both prongs have been met.
First, defendant has filed and the FDA has accepted for filing
the ANDA, which, as both parties recognize, means that defendant
is ready or has at least made meaningful preparations to be ready
to market the allegedly infringing product. See Novopharm, 110
F.3d at 1570-71. Second, even
accepting defendant's timetable, the ANDA is likely to be
approved by June 2002, over a year before the patent expires.
Obviously, the threat of defendant entering the market is not
"years away," see Telectronics Pacing Systems, Inc. v.
Ventritex, Inc., 982 F.2d 1520, 1527 (Fed. Cir. 1992), nor, in
light of defendant's steadfast refusal to reply to plaintiff's
demand letters, is there any real doubt that defendant plans to
sell some form of cefuroxime axetil once the ANDA is approved.
Defendant argues that there is no evidence that it has decided
whether and when to market the product. Defendant argues that it
may decide to wait until plaintiff's patent expires. It is
indisputable, however, that defendant has submitted the ANDA,
"accompanied by data sufficient to make FDA approval eminent."
Defendant's refusal to respond to plaintiff's letters inquiring
about defendant's plans, coupled with defendant's same refusal at
oral argument, along with the enormous amount of money at stake,
leads to the inescapable conclusion that defendant plans to enter
the market as soon as possible. Although it is true that there is
no actual written threat of infringement as there was in
Novopharm, 110 F.3d at 1571, defendant cannot defeat
jurisdiction simply by refusing to put in writing what is
Based on these facts, the court concludes that the complaint
alleges sufficiently that defendant is engaged in meaningful
preparation of activity directed toward making, selling or using
subject to an infringement charge, and that defendant has refused
to change the course of its actions in the face of plaintiff's
acts to preserve its patent rights. Accordingly, the court
concludes that there is an actual controversy between the parties
sufficient to support declaratory judgment jurisdiction. To hold
otherwise, as defendant requests, would be to close one's eyes to
the economic realities of the situation. Plaintiff's cefuroxime
axetil sales last year ...