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DAIICHI PHARMACEUTICAL CO., LTD. v. APOTEX

August 5, 2005.

DAIICHI PHARMACEUTICAL CO., LTD. and DAIICHI PHARMACEUTICAL CORPORATION, Plaintiffs,
v.
APOTEX, INC. and APOTEX CORP., Defendants.



The opinion of the court was delivered by: WILLIAM BASSLER, District Judge

OPINION

Plaintiffs are Daiichi Pharmaceutical Co. Ltd., a Japanese drug manufacturer, and its New Jersey-based subsidiary, Daiichi Pharmaceutical Corporation (collectively, "Daiichi"). This lawsuit concerns Daiichi's U.S. Patent No. 5,401,741 (the "`741 patent"), entitled a "Topical Preparation for Treating Otopathy."

  Daiichi brings this action against Apotex Inc., a Canadian-based generic drug manufacturer, and its subsidiary, Apotex Corp. (collectively, "Apotex") for willful patent infringement under the Hatch-Waxman Act, 35 U.S.C. § 271(e)(2), and the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202, and 35 U.S.C. § 271(a), (b) and/or (c).

  Jurisdiction and venue in this district are proper pursuant to 28 U.S.C. §§ 1331, 1338(a), 1391(b), and 1400(b).

  This Opinion addresses the proper interpretation of the `741 patent claims.

  I. BACKGROUND

  Daiichi owns the `741 patent, which was issued by the U.S. Patent and Trademark Office ("PTO") in March 1995.*fn1 The `741 patent discloses a "Topical Method for the Treatment of Otopathy," and sets forth the following seven claims:*fn2 Claim 1: A method for treating otopathy which comprises the topical otic administration of an amount of ofloxacin or a salt thereof effective to treat otopathy in a pharmaceutically acceptable carrier to the area affected with otopathy.

 
Claim 2: The method of claim 1 wherein the said otopathy is otitis media.
Claim 3: The method of claim 2 wherein the said otopathy is otitis externa.
Claim 4: The method of claim 2 wherein the concentration of ofloxacin in the pharmaceutically acceptable carrier is about 0.05 to about 2% w/v.
Claim 5: The method as claimed in claim 4, wherein the dosage form of ofloxacin is an aqueous solution.
Claim 6: The method as claimed in claim 5, wherein the aqueous solution of ofloxacin is applied to the external auditory canal by instillation.
Claim 7: The method as claimed in claim 6, wherein the aqueous solution of ofloxacin is intratympanically injected through a puncture in the tympanic membrane.
(Declaration of Michael A. Krol in Support of Apotex' Claim Construction Brief ("Krol Decl."), Exh. A.) The `741 patent is not due to expire until March 2012. (Daiichi Brief in Support of Claim Construction ("Daiichi Br."), at 1.)

  At the time that Daiichi's researchers began working on the `741 patent, a number of antibiotics were available for the treatment of bacterial ear infections. Unfortunately, these antibiotics, whether administered to patients systemically (by ingestion or injection), or topically (by application to the surface of the infected area), were associated with certain adverse side effects. For example, patients given oral antibiotics, such as amoxicillan, were known to develop bacterial resistance, thereby reducing or eliminating the effectiveness of the antibiotic. (Id. at 7.)

  Topical administration of antibiotics, while an improvement over systemic administration, presented its own risks.*fn3 Specifically, when certain antibiotic compounds were applied to the surface of the middle ear they could "migrate" into the inner ear, causing structural damage and resulting in permanent hearing loss and/or impairment of balance — side-effects referred to in the field as "ototoxicity." (Id., at 8-9.)

  The risk of ototoxicity is not limited to topical administration of antibiotic compounds directly to the middle ear. Rather, if the compound is applied to the surface of the external auditory canal of patients whose tympanic membranes are ruptured — a condition which can develop in patients with middle ear infections — the drug may migrate first to the middle ear, and then to the inner ear, thereby presenting the same risks of ototoxicity. (Id. at 8.)

  There are therefore at least two situations which present the risk of ototoxicity. First, when a patient suffers from otitis media, a bacterial infection of the middle ear. Second, when a patient suffers from otitis externa, a bacterial infection of the external auditory canal, with a ruptured tympanic membrane.*fn4 This latter situation is particularly troublesome for treating physicians because in many cases of otitis externa, the swelling of the external auditory canal makes it difficult, if not impossible, to know if the tympanic membrane is intact prior to initiating antibiotic therapy. (Id. 4-5.)

  The method described in the `741 patent was intended to overcome these risks, by setting forth a method for the topical administration of ofloxacin — a previously known antibiotic compound — to both the external auditory canal and the middle ear, while significantly reducing the risk of ototoxicity and antibacterial resistance. (Krol Decl., Exh. A; Daiichi Br. 8-11.) In 1997, two years after the issuance of the `741 patent, the Food and Drug Administration ("FDA") approved Daiichi's FLOXIN® Otic product, which is covered by the terms of the `741 patent and is the first antibiotic ear drop approved by the FDA for use in both the external auditory canal and the middle ear. (Id., at 6.)

  In early 2003, Daiichi received notice that Apotex, a Canadian-based generic drug manufacturer, had filed with the Food and Drug Administration ("FDA") an Abbreviated New Drug Application ("ANDA") for Ofloxacin Otic Solution. Arguing that Apotex' Ofloxacin Otic Solution is a generic "copy" of its FLOXIN® Otic product, Daiichi filed this suit in March 2003. The amended complaint (the "Amended Complaint"), filed in May 2004, alleges willful infringement of all seven claims of the `741 patent.

  Apotex denies Daiichi's allegations and raises the following defenses: (1) patent invalidity; (2) anticipation; (3) obviousness; (4) unenforceability; (5) noninfringement; (6) noninfringement of claim 7; and (7) misuse. In addition, Apotex has filed a counterclaim against Daiichi, which has since been severed from the main action and stayed pending trial on the issue of infringement.

  In accordance with Magistrate Judge Madeline Cox Arleo's October 9, 2003 pretrial scheduling order, the parties have now substantially completed discovery, including depositions.

  The sole issue currently before the Court is the proper interpretation of the `741 patent claims. The parties have fully briefed the issue and, on July 22, 2005, the Court conducted a Markman proceeding. This Opinion sets forth the Court's conclusions with respect to claim construction.

  II. LEGAL FRAMEWORK

  There are two steps in a patent infringement action. First, the claims must be properly construed in order to determine their scope and meaning. Second, the claims as properly construed must be compared to the accused device or process. CVI/Beta Ventures, Inc. v. Tura LP, 112 F.3d 1146, 1152 (Fed. Cir. 1997), cert. denied, 522 U.S. 1109 (1998). As previously mentioned, this Opinion addresses only the first step, which is a threshold issue of law for ...


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