The opinion of the court was delivered by: JOAN H. LEFKOW, District Judge
MEMORANDUM OPINION AND ORDER
Plaintiff, Teva Pharmaceuticals USA, Inc. ("Teva"), filed this
action seeking a declaratory judgment that United States Patent
Nos. 5,844,105 ("the '105 patent"), 5,945,405 ("the '405
patent"), 5,858,986 ("the '986 patent"), 6,010,718 ("the '718
patent"), and 6,551,616 ("the '616 patent") held by defendant,
Abbott Laboratories ("Abbott"), are invalid and would not be
infringed if Teva commercially marketed a generic version of
Abbott's extended release clarithromycin product, BIAXIN XL.
Before the court is Abbott's Motion to Dismiss for Lack of
Subject Matter Jurisdiction, claiming that no case or controversy
existed at the time Teva filed its suit. For the reasons stated
below, Abbott's motion is granted.
I. Factual and Procedural Background
Abbott is the exclusive licensee of United States Patent No.
4,331,803 ("the '803 patent"), a compound patent relating to
clarithromycin, the active ingredient in both BIAXIN IR, Abbott's
immediate release clarithromycin product, and BIAXIN XL,'s
extended release clarithromycin product. The '803 patent expires
on May 23, 2005. In addition to the compound patent, Abbott is the current holder of the '105 patent, the '405
patent, and the '986 patent, all of which relate to different
crystal forms of clarithromycin. Abbott is also the current
holder of the '718 and '616 patents, which relate to extended
release formulations of clarithromycin.
On December 17, 2002, Teva, a developer, manufacturer, and
marketer of generic pharmaceutical products, filed an abbreviated
new drug application ("ANDA") seeking approval from the Food and
Drug Administration ("FDA") to release a generic version of
Abbott's immediate release clarithromycin product, BIAXIN IR. On
the same day, Teva filed an ANDA seeking approval to release a
generic version of Abbott's extended release clarithromycin
product, BIAXIN XL.
On August 6, 2003, Teva filed suit in this court seeking a
declaratory judgment that (1) the '105 patent, the '405 patent,
and the '986 patent ("the Teva I patents") are invalid under
35 U.S.C. § 101, and (2) Teva's generic version of Abbott's
immediate release clarithromycin product would not infringe those
patents. See Teva Pharmaceuticals USA, Inc. v. Abbott
Laboratories, 301 F. Supp. 2d 819 (N.D. Ill. 2004) ("Teva I").
Teva I did not involve, indeed did not mention, Teva's attempt
to gain approval to release an extended release clarithromycin
product, and Abbott did not learn of Teva's attempt to do so
until filing of the instant suit.
Abbott filed a motion to dismiss Teva I for lack of
jurisdiction, claiming that no case or controversy existed at the
time the suit was filed, which the court denied. On March 15,
2004, Abbott filed an answer and asserted compulsory
counterclaims for infringement of the Teva I patents. Teva
filed a reply to Abbott's counterclaims on April 5, 2004.
On August 6, 2003, the same day Teva filed Teva I, Teva sent
a letter informing Abbott of the lawsuit and asking Abbott to
provide a covenant not to enforce the Teva I patents against Teva's immediate release clarithromycin product. Abbott has
refused to provide Teva with a covenant not to sue.
On three other occasions, Abbott has sued or maintained suit
against Teva or its Canadian affiliate Novopharm Limited
("Novopharm") for patent infringement relating to other drugs for
which Teva has filed ANDAs: (1) Abbott Laboratories v.
Novopharm Ltd., 00 CV 2141, 00 CV 5094, and 01 CV 1914 (N.D.
Ill.), concerning fenofibrate; (2) Abbott Laboratories, Fournier
Industrie at Sante & Laboratories Fournier SA v. Teva
Pharmaceutical Co., Inc., C.A. 02-1512 (D. Del.), concerning
fenofibrate; and (3) Knoll Pharmaceutical Co., Inc. and The John
and Lois Arnold Family Ltd. Liab. P'Ship v. Teva
Pharmaceuticals USA, Inc., 01 CV 1646 (N.D. Ill.), concerning
In addition, on June 18, 2002, Novopharm served a "Notice of
Allegation"*fn1 on Abbott and its Canadian Subsidiary,
Abbott Laboratories Limited,*fn2 pertaining to an
Abbreviated New Drug Submission ("ANDS") filed by Novopharm
seeking regulatory approval to market a generic version of BIAXIN
IR in Canada. In the Notice of Allegation, Novopharm asserted
that the Canadian counterpart of the Teva I patents ("the
Canadian patent") was invalid and that Novopharm's immediate
release clarithromycin product would not infringe the Canadian
patent. In response to the Notice of Allegation, Abbott filed a
"Regulatory Application" in the Federal Court of Canada seeking
an order prohibiting the Canadian Minister of Health from issuing
a Notice of Compliance ("NOC") to Novopharm until the Canadian
patent expires.*fn3 Abbott has also filed Regulatory
Applications against four other generic manufacturers who have
challenged the Canadian patent. On October 14, 2003, Novopharm
agreed to withdraw its Notice of Allegation, and Abbott in turn
agreed to discontinue its Regulatory Application.
II. Requirements for Jurisdiction Under the Declaratory
The Declaratory Judgment Act limits issuance of a declaratory
judgment to cases of "actual controversy." 28 U.S.C. § 2201(a).
If no actual controversy exists between the parties regarding the
subject on which declaratory judgment is sought, the court lacks
subject matter jurisdiction. Aetna Life Ins. Co. v. Haworth,
300 U.S. 227, 239-40 (1937); Spectronics Corp. v. H.B. Fuller
Co., 940 F.2d 631, 634 (Fed. Cir. 1991). A declaratory judgment
"may not be a medium for securing an advisory opinion in a
controversy which has not arisen." Coffman v. Breeze Corp.,
323 U.S. 316, 324 (1945). Furthermore, even if a justiciable
controversy has been shown to exist, federal courts have
discretion to decline to exercise their jurisdiction.
International Harvester Co. v. Deere & Co., 623 F.2d 1207,
1217 (7th Cir. 1980).
In declaratory judgment actions involving allegations of patent
noninfringement, invalidity, or unenforceability, an "actual
controversy" exists where there is both (1) an explicit threat or
other action by the patentee, which creates a reasonable
apprehension on the part of the declaratory plaintiff that it
will face an infringement suit, and (2) present activity by the
declaratory plaintiff which could constitute infringement or
concrete steps taken with the intent to conduct such activity.
Fina Research, S.A. v. Baroid Ltd., 141 F.3d 1479, 1481 (Fed.
Cir. 1998). The declaratory plaintiff bears the burden to establish,
by a preponderance of the evidence, that the two-part test for an
actual controversy has been met. See McNutt v. General Motors
Acceptance Corp., 298 U.S. 178, 189 (1936) ("[T]he court may
demand that the party alleging jurisdiction justify his
allegations by a preponderance of evidence.").
In Teva I, the court held that Teva's submission of an ANDA
under 35 U.S.C. § 355(j) for its immediate release clarithromycin
product constituted an act of infringement sufficient to satisfy
the second prong of the "actual controversy" test.
301 F. Supp. 2d at 830. Teva also submitted an ANDA for its extended release
clarithromycin product. Thus, for the reasons set ...