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TEVA PHARMACEUTICALS USA, INC. v. ABBOTT LABORATORIES

October 7, 2004.

TEVA PHARMACEUTICALS USA, INC., Plaintiff,
v.
ABBOTT LABORATORIES, Defendant.



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 vicoprofen.

  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 Judgment Act

  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 ...


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