United States District Court, D. New Jersey
August 5, 2005.
DAIICHI PHARMACEUTICAL CO., LTD. and DAIICHI PHARMACEUTICAL CORPORATION, Plaintiffs,
APOTEX, INC. and APOTEX CORP., Defendants.
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.
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 the court to decide. Markman v. Westview Instr.,
52 F.3d 967 (Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370
A. Analytical Framework
"It is a bedrock principle of patent law that the claims of a
patent define the invention to which the patentee is entitled the
right to exclude." Phillips v. AWH Corp., No. 03-1269, 031-286,
2005 WL 1620331, at *4 (Fed. Cir. July 12, 2005) (internal
quotation marks omitted). Accordingly, a court, in construing the
terms of a patent, should look first to the language of the claim
itself. Vitronics Corp. v. Conceptronics, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996).
The words of a claim "are generally given their ordinary and
customary meaning." Phillips, 2005 WL 1620331, at *5 (internal
quotation marks omitted). "[T]he ordinary and customary meaning
of a claim term is the meaning that the term would have to a
person of ordinary skill in the art in question at the time of
the invention, i.e., as of the effective filing date of the
patent application." Id.
The ordinary meaning of a term cannot, however, be construed in
a vacuum; rather, a court must "must look at the ordinary meaning
in the context of the written description and the prosecution
history." Medrad, Inc. v. MRI Devices Corp., 401 F.3d 1313,
1319 (Fed. Cir. 2005). The court does so to "determine whether
the inventor used any terms in a manner inconsistent with their
ordinary meaning." Vitronics, 90 F.3d at 1582.
For example, "the specification acts as a dictionary when it
expressly defines terms used in the claims or when it defines
terms by implication." Phillips, 2005 WL 1620331, at *13
(internal quotation marks omitted). Similarly, a patent's
prosecution history may clarify the meaning of a claim,
particularly in light of exchanges between the patent applicant
and the PTO. See Northern Telecom, Ltd. v. Samsung Elec. Co.,
215 F.3d 1281 (Fed. Cir. 2000). Thus, the claim language, the specification, and the patent prosecution history collectively
referred to in patent law as the "intrinsic record" are the
foundation of claim construction analysis and will, in most
instances, resolve any ambiguity in a disputed claim term.
Vitronics, 90 F.3d at 1582-83 ("Such intrinsic evidence is the
most significant source of the legally operative meaning of
disputed claim language.")
Only in the rare circumstance in which there is still doubt as
to the meaning of a claim after the court has examined the
intrinsic record, should a court look to extrinsic evidence such
as treatises, technical references, and expert testimony, to
resolve any doubts or ambiguities. Id., at 1583.
With these principles in mind, the Court turns first to a
discussion of the "ordinary person skilled in the art," and then
to an analysis of each disputed claim term.
A. Ordinary Person Skilled in the Art
The person having ordinary skill in the art is a hypothetical
person who is presumed to know all of the relevant art within the
field of invention and any analogous technical fields. See
Standard Oil Co. v. Am. Cyanamid Co., 774 F.2d 448, 454 (Fed.
Cir. 1995). The purpose of this standard is to "provide? an
objective basis from which to begin claim interpretation."*fn5 Phillips, 2005 WL 1620331, at * 5.
The Court of Appeals for the Federal Circuit instructs that the
ordinary person is not a judge, a layman, a person skilled in
remote arts, or the inventor. Envtl. Designs, Ltd. v. Union Oil
Co., 713 F.2d 693, 697 (Fed. Cir. 1983). Rather, "[a] person of
ordinary skill in the art is . . . presumed to be one who thinks
along the line of conventional wisdom in the art and is not one
who undertakes to innovate, whether by patient, and often
expensive, systematic research, or by extraordinary insights
. . ." Standard Oil, 774 F.2d at 454.
In Envtl. Designs, the Court of Appeals for the Federal
Circuit set forth the following non-exhaustive list of factors
for a court to use in ascertaining the level of ordinary skill in
the art: (1) the inventor's educational background; (2) the kinds
of problems confronted in the art; (3) solutions found
previously; (4) the level of sophistication of the technology;
(5) the speed of innovation in the art; and (6) the educational
level of active workers in the field. 713 F.2d at 696. At the
same time, the Court of Appeals noted that these factors may or
may not apply to the facts of a given case.*fn6 Id. ("Not
all such factors may be present in every case, and one or more of
these factors may predominate in a particular case.").
Here, Daiichi argues that the ordinary person skilled in the
art is "a general practitioner or pediatrician of modest
experience." (Daiichi Br., at 13.) By contrast, Apotex argues
that it is "a physician with detailed understanding of ear
diseases, e.g., an otolaryngologist, and a pharmaceutical
scientist, such as a pharmacist with an advanced degree (Pharm.
D. or Ph.D.), or another worker in the field with expertise in
medicinal chemistry and pharmaceutical formulation." (Apotex
Moving Brief on Claim Construction ("Apotex Br."), at 11.) Noting
that the parties offer little more than conclusory arguments
concerning this issue in their briefs, the Court finds that two
prior decisions, one issued by the Court of Appeals for the
Federal Circuit and one by an Indiana district court, are
The first case, Merck and Co., Inc. v. Teva Pharm. USA, Inc.,
347 F.3d 1367 (Fed. Cir. 2003), cited by Daiichi, involved a
patented method for treating osteoporosis, through the
administration of a bisphosphonic acid. At the center of the
claim construction dispute was whether the term used to refer to the acid in the patent should be read to encompass the active
agent contained in the accused product.
Rejecting the testimony of the defendant's expert witness, a
chemist, the Court of Appeals affirmed the district court's
conclusion that, in this case, a person skilled in the art would
have: (1) a medical degree; (2) experience treating patients with
osteoporosis; (3) and knowledge of the pharmacology and usage of
bisphosphonates. Id. at 1371.
In the second case, Eli Lilly & Co. v. Teva Pharmaceuticals,
2004 WL 1724632 (S.D.Ind. July 29, 2004) (unpublished decision),
an Indiana district court used similar reasoning. The case
involved several patents for the use of fluoxetine, more commonly
known as Prozac®, for the treatment of depression and anxiety.
Plaintiff sued for patent infringement when the defendant, a
generic drug manufacturer, sought FDA approval to sell a generic
version of fluexotine for the treatment of premenstrual syndrome
In analyzing the defendant's obviousness defense,*fn7 the
district court stated that, "to limit `one of ordinary skill in
the art' to clinical researchers would be too restrictive." Id. The district court went on to conclude that the ordinary person
skilled in the art would be a "medical doctor (an OB/GYN, a
family practice physician, or a psychiatrist) who: (1) regularly
sees and treats patients suffering from PMS; and (2) is familiar
with the prior art." Id. at *33.
The Court sees no reason why the logic employed in Merck and
Eli Lilly & Co. should not apply to the facts of this case.
Here, the ordinary person skilled in the art would have a medical
degree, experience treating patients with ear infections, and
knowledge of the pharmacology and use of antibiotics. This person
would be, as Daiichi argues, a pediatrician or general
practitioner those doctors who are often the "first line of
defense" in treating ear infections and who, by virtue of their
medical training, possess basic pharmacological knowledge.
B. Disputed Terms
Having determined that the ordinary person skilled in the art
is a person with a medical degree, experience treating patients
with ear infections, and knowledge of the pharmacology and use of
antibiotics, the Court now turns to the disputed claim terms
In their briefs filed with the Court, each party submitted a
chart setting forth its proposed claim language. After reviewing
the charts and observing that the parties disagreed as to almost
every term used in the patent, the Court asked the parties to submit a jointly prepared claim construction chart, so as to
identify the material terms in dispute. The jointly prepared
chart was of limited usefulness and the parties were asked, at
the Markman proceeding, to identify exactly which terms the
Court was being asked to interpret. The parties agreed that the
Court need only address the following three terms: (1)
"otopathy"; (2) "effective to treat;" and (3) "intratympanically
injected through a puncture of the tympanic membrane." The Court
addresses each of these three terms in order.
The parties disagree as to the proper interpretation of
"otopathy," a term used in Claims 1, 2, and 3 of the patent.
Daiichi argues that it should be construed to mean "otitis
externa and/or otitis media." By contrast, Apotex argues that
it should be construed as "any disease of the ear." The Court
does not find either argument persuasive.
The doctrine of claim differentiation requires each claim to
have a different scope. As the Court of Appeals for the Federal
There is presumed to be a difference in meaning and
scope when different words or phrases are used in
separate claims. To the extent that the absence of
such difference in meaning and scope would make a
claim superfluous, the doctrine of claim
differentiation states the presumption that the
difference between claims is significant.
Comark Comms., Inc. v. Harris Corp., 156 F.3d 1182
, 1187 (Fed. Cir. 1998).
Daiichi's proposed construction plainly violates the principle
of claim differentiation. Claims 1, with Daiichi's proposed
language italicized, reads as follows:
A method for treating otitis externa and/or otitis
media which comprises the topical otic
administration of an amount of ofloxacin or a salt
thereof effective to treat otitis externa and/or
otitis media in a pharmaceutically acceptable
carrier to the area affected with otitis externa
and/or otitis media.
Such a construction would clearly render Claims 2 and 3
The method of claim 1 wherein the said otopathy is
The method of claim 2 wherein the said otopathy is
The Court declines Daiichi's invitation to cast aside well-settled
principles of claim construction analysis in construing the
Rather, the proper course is to adhere to the rule that "[t]he
presence of a dependent claim that adds a particular limitation
raises the presumption that the limitation in question is not
found in the independent claim." Liebel-Flarsheim Co. v. Medrad,
Inc., 358 F.3d 898, 910 (Fed. Cir. 2004); see also Sunrace
Roots Enter. Co. v. SRAM Corp., 336 F.3d 1298, 1302-03 (Fed. Cir. 2003). Accordingly, the fact that Claim 2 is limited
to otitis media and Claim 3 to otitis media and otitis
externa persuades this Court that Claim 1 is not limited to
otitis media and/or otitis externa.
The Court notes that, at the Markman proceeding, Daiichi
raised one argument, not previously presented in its briefs,
concerning the issue of claim differentiation. The argument is
that all of the claims are in fact different under its proposed
interpretation because: (1) Claim 2 relates to otitis media;
(2) Claim 3 relates to otitis externa; and (3) Claim 1 refers
to otitis media and otitis externa. Daiichi's argument
simply does not work.
It is well-established that "[c]laims in dependent form shall
be construed to include all limitations of the claim incorporated
by reference into the dependant claim." See 37 C.F.R. § 75(c).
Therefore, Claim 3 must be read to include all of the limitations
contained in Claim 2, which would mean that the "otopathy"
referred to in Claim 3 is both otitis externa and otitis
media, rendering Daiichi's proposed interpretation of Claim 1
Daiichi's proposed construction is not only contradicted by the
language of the claims themselves, it is also inconsistent with
the patent specification as whole. Several sections of the
specification explicitly state that otitis externa and otitis media are among the types of otopathy, not the only types
of otopathy, to which the `741 patent is directed. For example,
the specification states:
The otopathy on which the preparation of the present
invention is effective includes inflammatory
otopathy, such as otitis media and otitis externa
. . .
(Krol Decl., Exh. A (emphasis added).) Another section of the
The preparation according to the present invention
exhibits marked improvements over the conventional
drugs in terms of not only ototoxicity but also
tissue distribution and excellent therapeutic effects
on otopathy, particularly otitis media and otitis
(Id. (emphasis added).)*fn8
In light of the claim language
and the specification, the Court fails to see a principled basis
for adopting Daiichi's proposed construction.
Unfortunately, Apotex' proposed construction is no more
persuasive. Apotex argues that the "plain and ordinary meaning"
of the term "otopathy," and the one which the Court should adopt,
is "any disease of the ear." In support of its argument, Apotex points out that during the patent prosecution process, Daiichi
submitted to the PTO an excerpt from Dorland's Medical
Dictionary, 26th edition, which defines "otopathy" as "any
disease of the ear." (Krol Decl., Exh. I.) Apotex' argument is
unconvincing for two reasons.
First, Daiichi represents to the Court that it submitted
Dorland's Medical Dictionary definition of "otopathy" to the PTO
only because Daiichi was required to do so pursuant to Patent
Office Rule 56, 35 C.F.R. § 1.56. Specifically, the Dorland's
Medical Dictionary definition had been submitted during the
prosecution of the foreign counterpart to the `741 patent and,
therefore, was required to be disclosed to the PTO pursuant to
Daiichi's duty of good faith and candor. (Daiichi Brief in
Response to Apotex' Brief on Claim Construction ("Daiichi
Reply"), at 5.) In fact, the record shows that the Patent
Examiner crossed the definition off of Daiichi's Form PTO-1449,
indicating, as the Form PTO-1449 itself instructs, that the
Patent Examiner did not rely on Dorland's Medical Dictionary in
its consideration of the `741 patent application. Apotex offers
nothing to rebut these facts.
The second, and perhaps more important, reason why the Court
rejects Apotex' proposed construction is the recent and
much-anticipated Phillips decision, in which the Court of
Appeals for the Federal Circuit, sitting en banc, issued a
strongly worded caution against the blind use of dictionary definitions in claim
construction analysis. As stated in Phillips:
The main problem with elevating the dictionary to
such prominence is that it focuses the inquiry on the
abstract meaning of words rather than on the meaning
of claim terms within the context of the patent . . .
heavy reliance on the dictionary divorced from the
intrinsic evidence risks transforming the meaning of
the claim term to the artisan into the meaning of the
term in the abstract, out of its particular context,
which is its specification.
Phillips, at *14 (emphasis added). The Court of Appeals further
elaborated, "there may be a disconnect between the patentee's
responsibility to describe and claim his invention, and the
dictionary editors' objective of aggregating all possible
definitions for particular words." Id. This Court finds the
Court of Appeals' warning in Phillips especially pertinent
Neither the Court, nor Daiichi, dispute that the term
"otopathy" may be literally translated into "a disorder of the
ear." That does not, however, mean that this is how the term
should be construed in the context of the `741 patent. Rather,
viewing the disputed term from the perspective of the ordinary
person skilled in the art, as this Court is required to do,
precludes such an intepretation.
A pediatrician or general practitioner, let alone an
otolaryngologist, would know that ofloxacin is an anti-bacterial
agent whose only therapeutic purpose is to kill or eradicate
bacteria. The pediatrician or general practitioner would therefore assume that the otopathy to which the `741 patent is
directed must be amenable to antibiotic treatment that is,
infections caused by the presence of bacteria.*fn9
Accordingly, the Court concludes that the most sensible
construction of the term otopathy, as used in the `741 patent, is
"bacterial ear infection."
2. "effective to treat"
Daiichi argues that the phrase "effective to treat" otopathy
means "safe and efficacious to treat." (Daiichi Br., at 21.)
Apotex disagrees, and argues that the term "safe" should not be
read into the patent claim. The Court agrees with Daiichi.
It is proper to interpret terms and phrases appearing in the
claim in light of the fundamental purpose and significance of the
invention. Minnesota Mining & Mfg. Co. v. Johnson & Johnson
Ortopaedics, Inc., 976 F.2d 1559 (Fed. Cir. 1992); In re
Research Corp. Techs., Inc., No. 97-2836, 1998 U.S. Dist. LEXIS
23150 at *12 (D.N.J. Oct. 16, 1998). Doing so in this case amply
supports Daiichi's argument that "[s]afety was a paramount
concern of the inventors" of the `741 patent. (Daiichi Br., at
In describing the background to the invention, the patent
specification recites the following: Conventionally employed topical preparations for
treating otopathy . . . have ototoxicity as side
effects or therapeutic effects thereof tend to be
decreased due to emergence of resistant
* * *
In order to overcome the above-described problems,
the inventors have conducted extensive investigations
and, as a result, have reached the present invention.
* * *
Ofloxacin is of high safety. Acute toxicity (LD) of
ofloxacin was found to be 5450 mg/kg (p.o.) in mice,
200 mg/kg or more (p.o.) in dogs, and from 500 to
1,000 mg/kg (p.o.) in monkeys.
* * *
The preparation according to the present invention
exhibits marked improvements over the conventional
drugs in terms of not only otoxicity but also tissue
distribution and excellent therapeutic effects on
otopathy . . .
(Krol Decl., Exh. A.) In addition, the specification describes a
number of animal studies involving the ototoxic effects of
topically applied ofloxacin and data concerning the drug's
In light of the extensive discussion of side-effects and safety
in the patent specification, the Court concludes that it is
proper to construe the disputed term "effective to treat" as
"efficacious and safe."*fn10 3. "intratympanically injected through a puncture of the
Apotex argues that term "intratympanically injected through a
puncture of the tympanic membrane," as used in Claim 7 of the
patent, means "introduced into the middle ear with an instrument
such as a syringe." (Apotex Br., at 25.) Daiichi urges a broader
interpretation, in which the term means "forced into the middle
ear through a puncture of, or a tympanostomy tube within, the
tympanic membrane." (Daiichi Br., at 30.) The Court agrees with
Apotex' interpretation of the disputed term.
Daiichi argues that Claim 7 should be read to include, but
should not to be limited to, the use of a syringe. The basis for
this argument is that since the `741 patent is directed to the
treatment of otitis media with a perforated tympanic membrane,
there would be no need to use a syringe to force the antibiotic
into the middle ear cavity. According to Daiichi, Claim 7 should
be construed to include the instillation of of loxacin drops into
the external auditory canal, as set forth in Claim 6, which are
then forced, i.e. "injected," through the ruptured tympanic
membrane using a method referred to as "pumping the tragus."*fn11
Noting that the language of Claims 6 and 7 does nothing to
support this interpretation, the Court finds that a close reading of the patent specification precludes this Court from adopting
Daiichi's proposed construction. Specifically, in several
sections of the specification, "intratympanic injections" are
distinguished from the instillation of ear drops. The
Dose forms of the topical preparation of the present
invention include sprays, otic solutions, e.g.
intratympanic injections and ear drops, ointments
and the like.
* * *
In administration of the ofloxacin solution, several
0.5 ml-doses per day are applied to the external
auditory canal by spreading, spraying or
instillation, or intratympically injected through a
puncture of the tympanic membrane.
(Krol Decl., Exh. A. (emphasis added).) Indeed, even Daiichi's
own expert, Dr. Angelo Agro, testified at her deposition, that an
ordinary person skilled in the art would not have known at the
time the `741 patent was issued that "intratympanically injected"
meant "pumping the tragus." As Agro testified:
Q: At the time of the invention, were any ototopical
preparations being intratympanically injected in the
fashion you are describing [pumping the tragus]?
(Krol Decl., Exh. M, Transcript of Deposition of Angelo Agro,
Had Daiichi intended the act as its own lexicographer and
defined the term "intratympically injected" to mean "pumping the
tragus," it was certainly free to do so by clearly defining the term in the patent specification. Having failed to do so, the
Court finds that the most sensible construction of the term is,
as Apotex argues, "introduced into the middle ear with an
instrument such as a syringe," an interpretation that is
consistent with the generally known meaning of the word
For the reasons set forth in this Opinion, the Court declares
(1) the term "otopathy" as used in the claims of U.S.
Patent No. 5,401,741 is properly construed to mean
"bacterial ear infection;"
(2) the term "effective to treat" as used in the
claims of U.S. Patent No. 5,401,741 is properly
construed to mean "safe and efficacious to treat;"
(3) the term "intratympanically injected through a
puncture of the tympanic membrane" as used in the
claims of U.S. Patent No. 5,401,741 is properly
construed to mean "introduced into the middle ear
with an instrument such as a syringe."
An appropriate Order follows.