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ABBOTT LABORATORIES v. ANDRX PHARMACEUTICALS

June 3, 2005.

ABBOTT LABORATORIES Plaintiff,
v.
ANDRX PHARMACEUTICALS, INC., TEVA PHARMACEUTICALS USA, INC., and ROXANE LABORATORIES, INC. Defendants.



The opinion of the court was delivered by: DAVID COAR, District Judge

MEMORANDUM OPINION AND ORDER

This matter comes before the court on plaintiff Abbott Laboratories, Inc.'s ("Abbott") motion for a preliminary injunction against defendant Teva Pharmaceuticals USA, Inc. ("Teva"). Plaintiff seeks to enjoin Defendant Teva from marketing a generic version of the antibiotic drug, clarithromycin, in an extended release formulation. Abbott is the patent holder on a series of patents relating to clarithromycin, which Abbott markets under the brand name "BIAXIN" and, in its extended release formulation, "BIAXIN XL." Abbott alleges that Teva's generic product infringes Plaintiff's U.S. Patent Nos. 4,680,386 ("the `386 patent"); 6,010,718 ("the `718 patent"); and 6,551,616 ("the `616 patent"), relating to its BIAXIN XL product.

I. BACKGROUND

  Abbott Laboratories filed a complaint against Andrx Pharmaceuticals, Inc. ("Andrx"), Teva Pharmaceuticals USA, Inc., and Roxane Laboratories, Inc. ("Roxane"), alleging patent infringement. Andrx, Teva, and Roxane manufacture and market generic versions of branded pharmaceuticals in the United States. Abbott sought a declaratory judgment that these defendants would infringe the `386 patent. In addition, Abbott sought a declaratory judgment against both Teva and Andrx of infringement of Abbott's United States Patent Nos. 6,551,616 ("the `616 patent"), 6,010,718 ("the `718 patent"), and 6,872,407 ("the `407 patent"). Each of these patents pertains to Abbott's branded antibiotic product, BIAXIN XL, which is an extended release formulation of clarithromycin, an erythromycin derivative.

  Clarithromycin is a macrolide antibiotic used to treat bacterial infections, particularly those of the skin and upper respiratory system. Abbott held a patent on the immediate release version of clarithromycin, marketed as BIAXIN, until the patent expired on May 23, 2005. Abbott began marketing BIAXIN in the United States in approximately 1991. In 2000, Abbott was issued two formulation patents (the `616 and the `718 patents) on an extended release formulation of clarithromycin. Abbott began marketing this extended release formulation under the name BIAXIN XL in 2000. As of May 2005, Abbott estimated that BIAXIN XL accounted for approximately 70% of the sales in the BIAXIN market. Generic competitors entered the market for immediate release clarithromycin on May 24, 2005.

  Abbott brought an application for a temporary restraining order against Andrx and Teva in this court. Andrx and Abbott entered a stipulated temporary restraining order on May 20, 2005. This court held a hearing and entered a temporary restraining order against Teva on May 20, 2005.*fn1 This court then held a hearing on Abbott's motion for a preliminary injunction against Teva. Teva does not dispute that its generic clarithromycin extended release formulation infringes Abbott's `718 and `616 patents. Rather, Teva asserts that those patents, along with the `386 patent, are invalid for obviousness under 35 U.S.C. § 103 (2004). In addition, Teva asserts that it does not infringe the `386 patent.

  II. PRELIMINARY INJUNCTION STANDARD

  A party seeking a preliminary injunction must make a four-part threshold showing that (1) the movant has some likelihood of success on the merits of the underlying litigation; (2) immediate irreparable harm will result if the relief is not granted; (3) the balance of hardships to the parties weighs in the movant's favor; and (4) the public interest is best served by granting the injunctive relief. Polymer Techs., Inc. v. Bridwell, 103 F.3d 970, 973 (Fed. Cir. 1996).

  III. ANALYSIS

  A. Likelihood of Success on the Merits

  In order to show that it has a likelihood of success on the merits, in light of the burdens and presumptions that will be present at trial, the movant must first prove that the non-movant infringes the patents in suit, and also that the movant's infringement claim will likely survive the non-movant's challenges on the basis of patent invalidity and unenforceability. Genentech, Inc. v. Novo Nordisk, A/S, 108 F.3d 1361, 1364 (Fed. Cir. 1997). A patent is presumed to be valid, 35 U.S.C. § 282 (2002), and at trial, the party raising a validity challenge must prove invalidity by clear and convincing evidence. This presumption does not relieve a patentee who moves for a preliminary injunction from carrying its normal burden of demonstrating a likelihood of success on all disputed liability issues at trial, including validity. Id. at 1364, n. 2. A validity challenge at the preliminary injunction stage can succeed on evidence that would not support a judgment of validity at trial. Amazon.com, Inc. v. Barnesandnoble.com, Inc., 239 F.3d 1343, 1359 (Fed. Cir. 2001). "Vulnerability is the issue at the preliminary injunction stage, while validity is the issue at trial." Id. The alleged infringer must identify at least some persuasive evidence of invalidity at this early stage to overcome the presumption of validity. Pharmacia & Upjohn Co. v. Ranbaxy Pharmaceuticals, Inc., 274 F. Supp. 2d 597, 601 (N.D. Ill. 2003). The patentee also is held to a less stringent standard and must only present a "clear case supporting the validity of the patent in suit." Id. A patentee can make such a case by showing, for example, that the patent in suit has withstood previous validity challenges in other proceedings or benefitted from a long period of industry acquiescence in its validity.

  Abbott asserts that it is likely to succeed on the merits because it will likely prove infringement at trial of one or more of the claims of the patents-in-suit. Plaintiff also contends that it likely will demonstrate that Defendant's challenges to the validity of the patents in suit lack substantial merit. Amazon.com, Inc. v. Barnesandnoble.com, Inc., 239 F.3d 1343, 1351 (Fed. Cir. 2001).

  1. Infringement Analysis

  An infringement inquiry proceeds in two steps. Pharmacia, 274 F. Supp. 2d at 601. First, the court must determine, as a matter or law, the correct scope and meaning of the disputed claim term. Then, the court must compare the properly construed claim to the accused device and ascertain whether that device contains every limitation of the claim or a substantial equivalent thereof. Id.

  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). Claim terms should therefore be accorded their ordinary meaning unless the patentees "clearly set forth a definition of the disputed claim term in either the specification or prosecution history." Id. When interpreting an asserted patent claim, the court should look first to the intrinsic evidence of record, which is the patent itself, including its claims, specification, and complete prosecution history. Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed. Cir. 1995) (en banc), aff'd 517 U.S. 370 (1996). This intrinsic evidence is the primary and most significant source of the legally operative meaning of any claim language that is in dispute. Vitronics Corp. v. Conceptronic, Inc. 90 F.3d 1576, 1583 (Fed. Cir. 1996). The court may also consider extrinsic evidence such as expert declaration evidence provided for the parties. Pharmacia, 274 F. Supp. 2d at 602.

  Abbott is the exclusive U.S. licensee of the `386 patent which discloses a compound (and the salts thereof) formed during the most commonly used process for the synthesis of 6-0-methylerythromycin, commonly known as clarithromycin. This compound is referred to in the patent as an "intermediate" for the preparation of clarithromycin. The compound itself is referred to as 6-0-methylerythromycin A 9-oxime ("9-oxime") and, according to the patent, "is useful in the preparation of clarithromycin and useful as an antibacterial agent." U.S. Pat. No. 4,680,386 at 1:5-10.

  Abbott claims that 9-oxime is present in trace amounts in Teva's extended release clarithromycin product. Teva denies that 9-oxime is present in its product, but asserts that if it is present, the quantities are insignificant and cause no harm to Abbott (or benefit to Teva) and, finally, that the `386 patent is invalid because of obviousness. At this early stage of the proceedings, the parties have raised no issue as to claim construction.

  Teva resists Abbott's claim that its product infringes the `386 patent. Abbott's expert, Alexander Schilling, tested Teva's bulk product and found 9-oxime in the amount of one part per million (ppm). Teva's expert, George Gokel, disputes this finding and criticizes Schilling's methodology. The Court is not persuaded that Schilling's methodolology and finding are unreliable, especially in light of exhibit A to the Declaration of Jennifer L. Polse in Support of Abbott's Motion for a Preliminary Injunction against Teva. That exhibit appears to be a letter (on Teva letterhead) from Michaela Rapaport of the Regulatory Affairs Department, Teva, API Division to Mr. Moshe Nulman. The reference is: "RE: Impurity. Clarithromycin 9-oxime (CLM oxime)." In substance, the letter reads:
Please be informed that the impurity Clarithromycin 9-oxime (CLM oxime) will no longer be listed on the Certificate of Analysis. Furthermore, it will not be included in the official Drug Master File as a potential impurity. However, due to different regulatory considerations, the levels of this impurity will be monitored continually but will not officially be reported.
  This letter appears to represent an acknowledgment by Teva that 9-oxime is present in minute (impurity) amounts in Teva's product and the Court will so find.

  As this court noted in a prior decision regarding a temporary restraining order, Teva apparently concedes that if the `718 and `616 patents are valid, it will be infringing them. For that reason, this court will turn directly to a validity analysis of those two patents.

  2. Invalidity Defense-Obviousness

  Only a valid patent gives the patent owner the right to exclude others; an invalid patent cannot be infringed. For this reason, accused patent infringers often seek to demonstrate that the patentee's patent is invalid and that they cannot be held liable for infringement. One of the requirements for patentability is that a new and useful product or process be "nonobvious." 35 U.S.C. § 103 (2004). Section 103 denies patents to those devices where "the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains." The "person . . . of ordinary skill" is not the inventor but rather someone "who . . . is not one who undertakes to innovate, whether by patient, and often expensive, systematic research or by extraordinary insights. . . ." Standard Oil Co. v. Am. Cyanamid Co., 774 F.2d 448, 454 (Fed. Cir. 1985). Obviousness must be evaluated not by reference to each individual part claimed, but rather by reference to the invention as a whole. Gillette Co. v. S.C. Johnson & Son, Inc., 919 ...


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