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