ALCON PHARMACEUTICALS LTD. et al v. DR. REDDYS LABORATORIES, INC. et al

Filing 135

MEMORANDUM AND ORDER re: Joint Claim Construction regarding U.S. Patent Nos. 6,284,804, 6,359,016 and 9,402,805. Signed by Judge Peter G. Sheridan on 6/27/2017. (mmh)

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW JERSEY

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Civil Action No:
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15-cv-5756 (PGS)(DEA)
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IN RE: CIPRODEX
MEMORANDUM
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AND
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ORDER
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SHERIDAN, U.S.D.J.
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This matter comes before the Court on a Second Amended Joint Claim Construction and
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Prehearing Statement (hereinafter “Joint Claim Construction”) regarding U.S. Patent Nos.
6,284,804 (“the ’804 patent”), 6,359,016 (“the ’016 patent”) and 9,402,805 (“the ’805 patent”)
(collectively “Patents-in-Suit”). The Joint Claim Construction is submitted by Plaintiffs Alcon
Pharmaceuticals Ltd., Alcon Laboratories, Inc., and Alcon Research, Ltd. (collectively “Alcon” or
“Plaintiffs”) and Defendants Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd.
(collectively, “DRL”), Par Pharmaceutical Inc. (“Par”), and Watson Laboratories, Inc. (“Watson”)
(DRL, Par, and Watson are collectively referred to as “Defendants”), pursuant to L. Pat. R. 4.3.
(See D.I. 84)
The ’804 and the ’016 patents are directed towards topical suspension formulations
containing ciprofloxacin and dexamethasone. Whereas, the ’805 patent is directed towards
methods of treating middle ear infections using aqueous suspension formulations containing
ciprofloxacin and dexamethasone. Ciprodex®, a brand name pharmaceutical drug for treating
middle ear infections (otitis media) in children with ear tubes, as well as outer ear infections (otitis
externa) in children and adults, includes ciprofloxacin and dexamethasone as the active
ingredients.

In order to market and sell Ciprodex®, Alcon listed the Patents-in-Suit in the Food and
Drug Association’s (“FDA”) Approved Drug Products with Therapeutic Equivalence
Applications, commonly known as the Orange Book. See 21 U.S.C. § 355(B)(1). Thereafter,
Defendants filed an Abbreviated New Drug Application (“ANDA”) with the FDA in order to seek
approval to market a generic version of Ciprodex®. See 21 U.S.C. § 355(j)(1). Accordingly,
pursuant to 21 U.S.C. § 355(j)(5)(B)(iii), Alcon initiated this suit against Defendants because
Defendants’ request to market the generic version of Ciprodex® is done prior to the expiration of
the Patents-in-Suit.
On February 23, 2017, a stipulation and order staying the litigation between Plaintiffs and
Defendant Watson was entered on the record. (See D.I. 100) Thereafter, on April 3, 2017, another
stipulation and order was entered on the record between Plaintiffs and Defendant Par regarding
Par’s ANDA filings constituting an act of infringement of the ’805 patent, and that Par will not
assert any defense of non-infringement as to the ’805 patent in this suit. (See D.I. 114)
As such, the remaining disputed claim terms between Plaintiffs and Defendant DRL
include—“A topically administrable suspension composition intended for application to the eye,
ear or nose,” as recited in claim 1 of the ’804 patent; “A topically administrable aqueous
suspension composition intended for application to the eye, ear or nose,” as recited in claims 1, 2
and 3 of the ’016 patent; and “Treating a Human Patient,” as recited in claim 1 of the ’805 patent.
On May 8, 2017, pursuant to L. Pat. R. 4.6, a Markman hearing was conducted before the
Court for the aforementioned terms. These terms are construed below.

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BACKGROUND
Ciprodex® is an FDA approved pharmaceutical product that includes two active
ingredients—ciproflaxcin and dexamethasone. Ciprofloxacin is an antibiotic that treats infections
caused by bacteria. And, dexamethasone is a steroid that reduces the actions of chemicals in the
body that cause inflammation.
I.

The Patent Family
The Patents-In-Suit include the ’804 patent, the ’016 patent and the ’805 patent. The ’016

patent is a continuation1 of the ’804 patent, and as such shares the same specification and inventive
entity as the ’804 patent. Both, the ’804 and the ’016 patents, are directed towards suspension
formulations containing dexamethasone and ciprofloxacin. The formulation contains a nonionic
polymer, a nonionic surfactant and an ionic tonicity agent. The formulations are physically stable
and easily re-suspended, and are intended for topical application to the eye, ear or nose. (See
Abstract of the ’804 patent and the ’016 patent).
The only difference between the ’804 patent and the ’016 patent is the claimed subject
matter. The ’804 patent includes one (1) claim directed to a composition that is intended for
application to the eye, ear or nose. Whereas, the ’016 patent includes five (5) claims, wherein
claims 1, 2 and 3 are in independent form, and claims 4 and 5 depend from claim 3.
The ’804 and the ’016 patents disclose a formulation that comprises two active agents—
corticosteroids (dexamethasone) and antibiotic (ciprofloxacin). (See the ’804 patent2, col. 2, ll. 1-

See Manual of Patent Examining Procedure (“MPEP”) 201.07. (“A continuation application is an application for the
invention(s) disclosed in a prior-filed co-pending non-provisional application […]. The disclosure presented in the
continuation must not include any subject matter which would constitute new matter if submitted as an amendment to
the parent application.”).
1

Hereinafter, when referring to the specification of the ’804 patent, it is understood that the ’016 patent recites the
same disclosure because the disclosures of the two patents are identical. The Court will differentiate the citations
between the ’804 patent and the ’016 patent where necessary.
2

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5) Dexmathasone can be present in any ophthalmic or optically acceptable form having poor water
solubility such that the resulting formulation is a suspension formulation. Whereas, ciprofloxacin
can also be present in any ophthalmic or optically acceptable form such that the ciprofloxacin
ingredient is in solution in the final formulation. (See Id. at col. 2, ll. 10-20) In addition to these
aforementioned active ingredients, the suspension formulations also contain—sodium chloride as
an ionic tonicity agent, a nonionic polymer, a nonionic surfactant, a quaternary ammonium halide
as a preservative, a chelating agent, and boric acid. (See Id. at col. 2, ll. 30—col. 3, ll. 11) The
resultant suspension formulation has a desired pH of 4.5 and an average particle (mean volume
basis) of the dexamethasone ingredient to be less than 10 µm (micro-meters) to avoid irritation or
discomfort to the user. (See Id. at col. 3, ll. 10-25)
The ’804 patent discloses the different methods of forming this suspension formulation;
and the different formulations A-E that were tested for resuspension time in accelerated and realtime settling studies. (See Id. at col. 4) The result of these studies illustrated that the suspension
formulation can be preserved such that it meets both the United States Pharmacopeia (USP) and
the European Pharmacopia (Ph. Eur.) minimum preservative requirements for ophthalmic and otic
formulations. (See Id. at col. 6, ll. 25-30)
With respect to the ’805 patent, issued on August 2, 2016, it is a separate and distinct patent
from the ’804 patent and the ’016 patent because the ’805 patent is not a continuation, divisional
or a continuation-in-part application of either the ’804 patent or the ’016 patent. As such, the ’805
patent does not share the same disclosure as the ’804 and the ’016 patents. The earliest priority
date of the ’805 patent potentially dates back to September 21, 2001, from provisional application
number 60/323,951. (See Front Cover of the ’805 patent)

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The ’805 patent is directed towards method of treating middle ear infections in humans
having an open tympanic membrane3 by using aqueous suspension formulations, which contain
dexamethasone and ciprofloxacin. (See Abstract of the ’805 patent)
The method of treatment includes topical application of a fixed combination of
ciprofloxacin and dexamethasone as an adequate suspension product. Generally, the dosage
regimen includes applying the suspension product twice a day. Each application involving
administering three or four drops into the ear canal, and preferably pumping the tragus 4 to force
product through the opening in the tympanic membrane, and in effect to the site of the
infection/inflammation in the middle ear. (See the ’805 patent, col. 2, ll. 20-30)
The ’805 patent discloses that in addition to the active agents—ciprofloxacin and
dexamethasone—the suspension formulations include a tonicity agent. The tonicity agent may be
ionic (e.g., NaCl) or nonionic (e.g., mannitol); however, NaCl is preferred as the tonicity agent.
(Id. at col. 3, ll. 25-33)
Studies of Ciprodex® were conducted on pediatric patients with acute otitis media with
tympanostomy tubes. The studies indicated that this drug, which was administered twice a day in
pediatric patients, was safe and tolerated well. (Id. at col. 15, ll. 15-20) The ’805 patent includes
twenty-two (22) claims, wherein claim 1 is an independent claim. Claim 1 is a method claim for
treating a human patient, which includes the steps of—(i) diagnosing the patient having otitis

See Body Maps, “Tympanic membrane” (“The tympanic membrane is a vital component of the human ear, and is
more commonly known as the eardrum. It is a thin, circular layer of tissue that marks the point between the middle
ear and the external ear. It is approximately 0.1 mm [millimeter] thick, 8 to 10 mm in diameter, and has a mass weight
of around 14 mg [milligram]. Despite this diminutive size and mass, the tympanic membrane is extremely tough and
flexible, and difficult to damage beyond repair.”), available at http://www.healthline.com/human-bodymaps/tympanic-membrane (last visited May 22, 2017).
3

See Merriam-Webster Dictionary, “Tragus” (“the prominence in front of the external opening of the outer ear”),
available at https://www.merriam-webster.com/dictionary/tragus (last visited May 22, 2017).
4

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media and an open tympanic membrane, and (ii) topically applying into the ear canal of the patients
ear an aqueous suspension composition. (Id. at col. 15, ll. 50-62)
II.

Declaration of Dr. Michael Crowley, Dr. M. Jayne Lawrence and Dr. Soham Roy
Dr. Crowley, on behalf of Alcon, has provided opinion concerning the meaning of certain

claim terms in the Patents-in-Suit. (See Declaration of Crowley (“Decl. of Crowley”) at ¶ 1; D.I.
54-9). Dr. Crowley notes that the preamble5 of the ’804 patent, a term in dispute, which includes
the term “suspension composition” means a liquid formulation in which one or more active
ingredients are in suspension. (Id. at ¶ 44). That is, without the active ingredients being in
suspension, no person skilled in the art would refer to a formulation as a “suspension composition.”
(Id.)
With regards to “suspension”, Dr. Crowley notes that in chemistry, a suspension is defined
as a two-phase system in which an un-dissolved compound is dispersed in a solid, liquid or a gas
vehicle. In pharmaceuticals, Dr. Crowley notes, this term refers to solid particles that are dispersed
within a liquid vehicle, which is generally water. (Id. at ¶ 13) Dr. Crowley notes that the suspension
formulation must meet chemical and physical stability requirements sufficient to justify shelf life.
Stability being defined as “the extent to which a product retains, within specified limits, and
throughout its period of storage and use (i.e., its shelf life) […].” (Id. at ¶ 14, citing United States
Pharmacopeia (23rd edition 1995) (“1995 USP”)) Most pharmaceutical products have a shelf life
of at least two (2) years. (Id. at ¶ 15)
A physical stability of a suspension formulation refers to the stability of the physical
aspects of the composition, including—appearance, pH, viscosity, dissolution and particle size
distribution for undissolved components. The size distribution of undissolved particles must

See Claim 1 of the ’804 patent at col. 8, ll. 17-18 (“A topically administrable suspension composition intended for
application to the eye, ear or nose).
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remain the same for the shelf life of the suspension. (Id. at ¶ 16) A pharmaceutical suspension is
acceptable even if it settles during its shelf life, so long as it is easily re-suspendible and
homogeneous for a long duration to administer a uniform dose. (Id. at ¶ 17)
Conversely, the composition would be unacceptable if over time, the particles start to
clump together and settle in a loose structure, or form a dense sediment on the bottom of the
container, known as “caking.” (Id. at ¶ 18) Dr. Crowley notes that this is unacceptable as it prevents
an administration of a uniform dose of the active ingredient and reduces the potential shelf-life of
the suspension formulation. (Id. at ¶ 19) As such, absent such physical stability and easily redispersibility, the FDA would not have approved this drug. (Id. at ¶ 21)
Dr. Lawrence, on behalf of Defendant Watson Laboratories, Inc., has also provided opinion
concerning the meaning of certain claim terms in the Patents-in-Suit. (See Declaration of M. Jayne
Lawrence (“Decl. of Lawrence”) at ¶ 12; D.I. 55-1)
Regarding the preamble of the ’804, Dr. Lawrence notes that one skilled in the art would
recognize that the asserted claims recite a list of specific ingredients with specific proportions,
which includes pharmaceutical ingredients with pharmaceutical excipients. (See Decl. of
Lawrence at ¶ 70) Further, Dr. Lawrence notes that the preamble of the’804—does not give
additional meaning to the pharmaceutical compositions, does not add any structure to the claimed
invention, and one could omit reading the preamble and still have the same complete understanding
of the pharmaceutical compositions. (Id. at ¶ 72) Dr. Lawrence cautions that Actavis’ proposed
addition of “with at least one active ingredient in suspension” to the preamble is redundant and
misleading because one skilled in the art would recognize that the particular claimed compositions
are directed to two specific drugs—dexamethasone and ciprofloxacin—and not at least one active
ingredient in suspension. (Id. at ¶ 77)

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Lastly, Dr. Soham Roy, on behalf of Alcon, provides his opinion on the disputed claim
term “treating a human patient” as recited in the preamble of claim 1 of the ’805 patent.
(Declaration of Dr. Soham Roy (“Decl. of Roy”) at ¶ 1; D.I. 94) Dr. Roy notes that the term
“treating” in the aforementioned claim term includes an intent requirement, such that the
composition must be administered or the procedure must be performed with an intent to cause a
therapeutic benefit in the subject. (See Decl. of Roy at ¶ 21) In other words, “treating a human
patient” is directed towards a procedure that the composition must be performed ‘for the purpose’
of effecting a therapeutic improvement in the patient. (Id. at ¶ 25) Dr. Roy further states, “a
treatment is always administered with the intent to cause a therapeutic effect in a human patient.”
(Id. at ¶ 29) As such, intent being a ‘critical component’ of this term. (Id. at ¶ 26)
STANDARD OF REVIEW
“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., 415 F.3d 1303, 1312
(Fed. Cir. 2005) (en banc) (quoting Innova/Pure Water Inc. v. Safari Water Filtration Sys., Inc.,
381 F.3d 1111, 1115 (Fed. Cir. 2004)). Claim construction determines the correct claim scope,
and is a determination exclusively for the court as a matter of law. Markman v. Westview
Instruments, Inc., 52 F.3d 967, 978-79 (Fed. Cir. 1995) (en banc), aff’d, 517 U.S. 370 (1996). The
focus in construing disputed terms in claim language “is on the objective test of what one of
ordinary skill in the art at the time of the invention would have understood the term[s] to mean.”
Id. at 986.
To determine the meaning of the claims, courts start by considering the intrinsic evidence.
Phillips, 415 F.3d at 1313; C.R. Bard, Inc. v. U.S. Surgical Corp., 388 F.3d 858, 861 (Fed. Cir.
2004); Bell Atl. Network Servs., Inc. v. Covad Comms. Group, Inc., 262 F.3d 1258, 1267 (Fed. Cir.

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2001).

The intrinsic evidence includes the claims themselves, the specification, and the

prosecution history. Phillips, 415 F.3d at 1314; C.R. Bard, Inc., 388 F.3d at 861.
The claims themselves provide substantial guidance in determining the meaning of
particular claim terms. Phillips, 415 F.3d at 1314. First, the context in which a term is used in the
asserted claim can be very instructive. Id. Other asserted or non-asserted claims can aid in
determining the claim’s meaning because claim terms are normally used consistently throughout
a patent. Id. Differences among claims can also assist in understanding a term’s meaning. Id.
For example, when a dependent claim adds a limitation, there is a presumption that the independent
claim does not include that limitation. Id. at 1314-15.
“[C]laims ‘must be read in view of the specification of which they are a part.’” Id. at 1315
(quoting Markman, 52 F.3d at 979). “[T]he specification ‘is always highly relevant to the claim
construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of a
disputed term.’” Id. (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir.
1996)). This is true because a patentee may define his own terms, give a claim term a different
meaning than the term would otherwise possess, or disclaim or disavow the claim scope. Id. at
1316. In these circumstances, the inventor’s lexicography governs. Id. The specification may
also resolve the meaning of ambiguous claim terms “where the ordinary and accustomed meaning
of the words used in the claims lack sufficient clarity to permit the scope of the claim to be
ascertained from the words alone.” Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1325
(Fed. Cir. 2002). But, “[a]lthough the specification may aid the court in interpreting the meaning
of disputed claim language, particular embodiments and examples appearing in the specification
will not generally be read into the claims.” Comark Commc’ns, Inc. v. Harris Corp., 156 F.3d
1182, 1187 (Fed. Cir. 1998) (quoting Constant v. Advanced Micro-Devices, Inc., 848 F.2d 1560,

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1571 (Fed. Cir. 1988)); also see Phillips, 415 F.3d at 1323 (“although the specification often
describes very specific embodiments of the invention, we have repeatedly warned against
confining the claims to those embodiments.”).
The prosecution history is another tool to supply the proper context for claim construction.
It “can often inform the meaning of the claim language by demonstrating how the inventor
understood the invention and whether the inventor limited the invention in the course of
prosecution, making the claim scope narrower than it would otherwise be.” Phillips, 415 F.3d at
1317.
“Extrinsic evidence consists of all evidence external to the patent and prosecution history,
including expert and inventor testimony, dictionaries, and learned treatises.” Markman, 52 F.3d
at 980. Although extrinsic evidence can be useful, it is “less significant than the intrinsic record
in determining ‘the legally operative meaning of claim language.’” Phillips, 415 F.3d at 1317
(quoting C.R. Bard, Inc., 388 F.3d at 862).
Dictionaries and treatises may aid a court in understanding the underlying technology and
the manner in which one skilled in the art might use claim terms, but dictionaries and treatises may
provide definitions that are too broad or may not be indicative of how the term is used in the patent.
Id. at 1318.

Similarly, expert testimony may aid a court in understanding the underlying

technology and determining the particular meaning of a term in the pertinent field, but an expert’s
conclusory, unsupported assertions as to a term’s definition are entirely unhelpful to a court. Id.
Generally, extrinsic evidence is “less reliable than the patent and its prosecution history in
determining how to read claim terms.” Id. The Supreme Court recently explained the role of
extrinsic evidence in claim construction:

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In some cases, however, the district court will need to look beyond
the patent’s intrinsic evidence and to consult extrinsic evidence in
order to understand, for example, the background science or the
meaning of a term in the relevant art during the relevant time period.
. . . In cases where those subsidiary facts are in dispute, courts will
need to make subsidiary factual findings about that extrinsic
evidence. These are the “evidentiary underpinnings” of claim
construction that we discussed in Markman, and this subsidiary fact
finding must be reviewed for clear error on appeal.
Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831, 841 (2015).
Overall, in construing the claims, “[t]he judge’s task is not to decide which of the
adversaries is correct. Instead, the judge must independently assess the claims, the specification,
and if necessary the prosecution history and relevant extrinsic evidence, and declare the meaning
of the claims.” Exxon Chem. Patents, Inc. v. Lubrizol Corp., 64 F.3d 1553, 1556 (Fed. Cir. 1995).
ANALYSIS
The Court will now construe the disputed claim terms as listed in the Patents-in-Suit.
A. “A topically administrable [aqueous]6 suspension composition intended for application to
the eye, ear or nose,” as recited claim 1 of the ’804 patent and in claims 1, 2 and 3 of the
’016 patent.
Claim Term
“A topically administrable
[aqueous] suspension
composition intended for
application to the eye, ear or
nose”

Plaintiffs’ Proposed
Construction
“A pharmaceutical
composition, with at least one
active ingredient in
suspension, suitable for
topical administration to the
eye, ear or nose, including
that the composition is
physically stable and easily
re-suspended.”

Defendants’ Proposed
Construction
The preamble is not limiting and
does not require construction.
To the extent the preamble is
determined to require
construction, it should be given
its plain and ordinary meaning,
“a topically administrable
aqueous suspension composition
intended for application to the
eye, ear or nose.”

The term “aqueous” only appears in preamble of claims 1, 2 and 3 of the ’016 patent. The parties do not dispute that
the term “aqueous” alters their proposed construction of the disputed claim term. (See Pl.’s Opening Br. at 5; D.I. 54;
Def.’s Opening Br. at 16; D.I. 55).
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Representative Claim 1 of the ’804 patent recites,
1. A topically administrable suspension composition intended for application
to the eye, ear or nose consisting essentially of
a) 0.1% (wt.) dexamethasone alcohol;
b) 0.35% (wt.) ciprofloxacin hydrochloride, monohydrate;
c) NaCI in an amount sufficient to cause the composition to have an osmolality of
about 250-350 mOsm;
d) 0.2% (wt.) hydroxyethyl cellulose;
e) 0.05% (wt.) tyloxapol;
f) a buffer comprising sodium acetate and acetic acid;
g) 0.01% (wt.) benzalkonium chloride;
h) 0.01% (wt.) edetate disodium;
i) 0.6% (wt.) boric acid; and
wherein the composition has a pH of 4.5±0.2.
Defendant DRL essentially argues that this Court should not construe the aforementioned
preamble of the ’804 patent because—(i) it does not carry any patentable weight; (ii) the terms in
the preamble are not construed as claim limitations; and (iii) the preamble is merely an introductory
statements of purpose and intended result. (See Def.’s Opening Br. at 17-20; D.I. 55) In addition,
DRL asserts that Alcon’s proposed construction should not be adopted because it avoids ‘chemical
stability’ and ‘microbiological stability’ requirements, something which Alcon’s expert, Dr.
Crowley, indicated is required for the suspension composition to be able to be re-suspended. (See
Def.’s Responsive Br. at 22; D.I. 73 (internal citations omitted)).
Additionally, in a letter dated June 13, 2017, DRL indicated that pursuant to the amended
L. Pat. R. 4.2(a), the proposed plain and ordinary meaning of the disputed claim term provides “no
confusion, uncertainty or lack of clarity about DRL’s claim construction.” (See Def. DRL’s Letter,
dated June 13, 2017). DRL further indicates that it “will not later seek to define any claim terms
differently, and rests on its submissions.” (Id.; emphasis in original).
The “preamble” of a claim is the introductory portion of the claim that describes the
invention in more general terms and typically appears before the transition term “comprising”.

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Nexans Inc. v. General Cable Technologies Corp., 630 F.Supp.2d 499, 506 (E.D. Pa. 2008). The
determination of whether a preamble limits a claim is made on a case-by-case basis in light of the
facts in each case. As such, there is no standard that determines when a preamble should be
construed as a claim limitation. Corning Glass Works v. Sumitomo Elec., U.S.A. Inc., 868 F.2d
1251, 1257 (Fed. Cir. 1989). Generally, there is a presumption against reading preamble language
as a claim limitation because after the transition “a patentee defines a structurally complete
invention in the claim body and uses the preamble only to state a purpose or intended use of the
invention” or “to give context for what is being described in the body of the claim.” Symantec
Corp. v. Computer Assocs. Int’l, Inc., 522 F.3d 1279, 1288 (Fed. Cir. 2008).
There are some exceptions which negate the above presumption. For instance, “[i]f the
claim preamble, when read in the context of the entire claim, recites limitation of the claim, or, if
the claim preamble is ‘necessary to give life, meaning, and vitality’ to the claim, then the claim
preamble should be construed as if in the balance of the claim.” Pitney Bowes, Inc. v. HewlettPackard Co., 182 F.3d 1298, 1305-1306 (Fed. Cir. 1999); also see In re: Cruciferous Sprout
Litigation, 301 F.3d 1343, 1347 (Fed. Cir. 2002). Additionally, a “[c]lear reliance on the preamble
during prosecution to distinguish the claimed invention from the prior art may indicate that the
preamble is a claim limitation because the preamble is used to define the claimed invention.” In
re: Cruciferous Sprout Litigation, 301 F.3d at 1347; also see Metabolite Labs., Inc. v. Corp. of
Am. Holdings, 370 F.3d 1354, 1358-62 (Fed. Cir. 2004).
Further, one way for a preamble to “give meaning” to a claim is provide an antecedent
basis for a term in the body of the claim. Sanofi v. Lupin Atlantis Holdings S.A., 2016 WL 5842327,
*2 (D. Del. 2016) (citing Bicon, Inc. v. Straumann Co., 441 F.3d 945, 952 (Fed. Cir. 2006).
“[W]hen the limitations in the body of the claim rely upon and derive antecedent basis from the

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preamble, then the preamble may act as a necessary component of the claimed invention.” Id.
(internal quotation marks omitted). “[D]ependence on a particular disputed preamble phrase for
antecedent basis may limit claim scope because it indicates a reliance on both the preamble and
claim body to define the claimed invention.” Catalina Marketing Int’l, Inc. v. Coolsavings.coms,
Inc., 289 F.3d 801, 808 (citing Bell Communications Research, Inc. v. Vitalink Communications
Corp., 55 F.3d 615, 620 (Fed. Cir. 1995). “[W]hen the claim drafter chooses to use both the
preamble and the body to define the subject matter of the claimed invention, the invention so
defined, and not some other, is the one the patent protects.” Bell Comms., 55 F.3d at 620. Likewise,
when the preamble is essential to understand limitations or terms in the claim body, the preamble
limits claim scope. Pitney Bowes, 182 F.3d at 1306.
Here, the Court finds that the preamble carries patentable weight and should be construed
as a claim limitation. The preamble recites in-part, “suspension composition.” The word
“composition” is recited twice in the body of the claim as “the composition.” (See the ’804 patent,
col. 8, ll. 24, 33) In patent law, it is widely understood that the recitation of the term “the” or “said”
before a feature indicates to a reader that the feature following these terms has been introduced
prior in the claim language. And, as such, recitation of “the” or “said” feature simply indicates that
a new feature is not being introduced in the claim. Instead, reference to an earlier recited feature
is being made in order to avoid any indefiniteness rejection by the patent examiner under pre-AIA
(“America Invents Act”) 35 U.S.C. § 112, second paragraph, or AIA 35 U.S.C. § 112, ¶ 2.7

See MPEP 2173.06(e) “Lack of Antecedent Basis” (“A claim is indefinite when it contains words or phrases whose
meaning is unclear. In re Packard, 751 F.3d 1307, 1314 (Fed. Cir. 2014). The lack of clarity could arise where a claim
refers to “said lever” or “the lever,” where the claim contains no earlier recitation or limitation of a lever and where it
would be unclear as to what element the limitation was making reference. Similarly, if two different levers are recited
earlier in the claim, the recitation of “said lever” in the same or subsequent claim would be unclear where it is uncertain
which of the two levers was intended. A claim which refers to “said aluminum lever,” but recites only “a lever” earlier
in the claim, is indefinite because it is uncertain as to the lever to which reference is made.”).
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Accordingly, by reciting “the composition” in the body of the claim, it is evident that it is
referring to the “suspension composition,” recited in the preamble of the claim. Granted, the drafter
could have been more precise reciting “the suspension composition” or even “the topically
administrable suspension composition,” in the body of the claim, to avoid any ambiguity;
nevertheless, the Court finds that “the composition” in the body of the claim depends on the
preamble phrase (suspension composition) as an antecedent basis. See Catalina, 289 F.3d at 808.
Same analysis applies to claims 1, 2 and 3 of the ’016 patent.
As such, the Court finds that preamble of claim 1 of the ’804 patent and the preamble of
claims 1, 2 and 3 of the ’016 patent are ‘necessary to give life, meaning, and vitality’ to the
aforementioned claims, and thereby carry patentable weight that are to be construed as claim
limitations.
Next, the Court considers the proposed construction of the aforementioned claim term.
Generally, claim terms are “given their ordinary and customary meaning,” which 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.” See Phillips, 415 F.3d at 1303. In reading the aforementioned claim term, the Court
finds that one skilled in the art would understand the meaning of the term at the time of the
invention.
With respect to “suspension composition” in particular, the Court notes that Dr. Crowley,
in his declaration, indicated that the composition needs to be physically and chemically stable such
that even if solid particles settle during the shelf life of the composition, the composition is easily
re-suspendible and homogeneous for a long duration in order to administer a uniform dose. (See
Decl. of Crowley at ¶¶ 13, 17)

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The Court notes that including features such as “physically stable and easily resuspendible,” as suggested by Alcon, in construing the aforementioned claim term, is unnecessary
as one skilled in the art, in light of the specification, would understand the ordinary and customary
meaning. See Markman, 52 F.3d at 979 (“[C]laims ‘must be read in view of the specification of
which they are a part.’”) Moreover, if the Court adopted Alcon’s proposed construction, or
included characteristics such as physical stability and re-suspension to define the disputed claim
term, then the Court would be committing the cardinal sin of incorporating limitations from the
specification into the claim. See Phillips, 415 F.3d at 1323 (“although the specification often
describes very specific embodiments of the invention, we have repeatedly warned against
confining the claims to those embodiments.”)
In AstraZeneca LP v. Breath Ltd., the court found that the term “'suspension' requires no
construction and should be accorded its plain meaning, 'a liquid in which solid particles are
dispersed but undissolved.'” 2013 U.S. Dist. LEXIS 49375, 21-22. In addition, the court in Glaxo
Wellcome v. Genentech, Inc., found that “composition” was a common enough word entitled to
ordinary comprehension. See 136 F. Supp. 2d 316, 334-35 (D. Del. 2001). The court found in
Genentech the construction for “composition” to mean “a combination of two or more substances.”
Id.
Accordingly, the Court determines that the term, “topically administrable [aqueous]
suspension composition intended for application to the eye, ear or nose,” as recited claim 1 of the
’804 patent and preamble of claims 1, 2 and 3 of the ’016 patent is to be given its plain, ordinary
and customary meaning, which is—“topically administering a combination of two or more
substances in which solid particles are dispersed, but undissolved, which is intended for application
to the eye, ear or nose.”

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B. “Treating a Human Patent,” as recited in claim 1 of the ’805 patent.
Plaintiffs’ Proposed
Construction

Claim Term
“Treating a Human Patent”

“intending to cause a
therapeutic improvement in a
human patient”

Defendants’ Proposed
Construction
The preamble is not limiting
and does not require
construction.
To the extent the preamble is
determined to require
construction, it should be
given its plain and ordinary
meaning, “a method of
treating a human patient
comprising the steps of…”

Claim 1 of the ’805 patent recites,
1. A method of treating a human patient comprising the steps of:
(a) diagnosing the patient as having otitis media and an open tympanic membrane
and/or having acute otitis externa in at least one ear; and
(b) topically applying into the ear canal of the patients ear an aqueous suspension
composition containing a combination of ciprofloxacin and dexamethasone,
wherein the composition comprises a) 0.01-0.5% (wt.) dexamethasone; b) 0.1-0.4%
(wt.) ciprofloxacin; c) 0.1-0.9% (wt.) tonicity agent; d) 0.01-0.2% (wt.) of a
nonionic surfactant; and e) a buffer; wherein three or four drops of the aqueous
suspension composition are administered to the patients ear twice a day, and
wherein each drop is 30-35 μL.
Defendant DRL asserts that “treating a human patient,” as recited in claim 1 of the ’805
patent, should not be construed for reasons similar to the ones discussed above under the first claim
term. (See Def.’s Opening Br. at 20-23; D.I. 87) In support, Defendant DRL cites to Sanofi-Aventis
U.S. LLC v. Fresenius Kabi USA, LLC, 2016 WL 5898627, *5 (D.N.J. Oct. 7, 2016), where this
Court found that the preamble phrases “a method for treating” and a “method of increasing the

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survival of” merely stated the purpose of the claimed invention,” and thus were not limiting. (See
Def.’s Opening Br. at 23; D.I. 87).
The Court does not find Defendant DRL’s arguments persuasive, and determines that
“treating a human patient,” as recited in claim 1 of the ’805 patent, carries patentable weight, and
is not merely an introductory statement of purpose and intended result. Unlike, the preamble
construed by the Court in Sanofi-Aventis, the preamble term “treating a human patient” in the
instant case is recited in the body of the claim. This was not the case in the preamble construed in
Sanofi-Aventis. See Sanofi-Aventis, 2016 WL at *4-5. Claim 1 of the ’805 patent recites “the
patient” three (3) times in the body of the claim. Again, because the word “the” precedes the word
“patient,” it is apparent that it is referring to “a human patient” recited in the preamble of claim 1
to ensure proper antecedent basis; and not introducing a new or second patient. Moreover, “the
patient” is further recited in claims 16 and 22; indicating a reliance on both the preamble and the
claim body to define the claim scope. Catalina, 289 F.3d at 808.
Similarly, the word “treating” is also recited in dependent claims 19, 20 and 21. In these
dependent claims, the method of treating is further limited. That is, under claim 1 the method of
treating included two steps—(i) diagnosing the patient, and (ii) topically applying. Thereafter,
under the aforementioned dependent claims, additional steps to the method have been included.
That is, in addition to the diagnosing and topically applying, the treating also includes the steps of
treating otorrhea, treating acute otitis externa, and treating granulation tissue, respectively.
As such, the Court finds that preamble of claim 1 of the ’805 patent is ‘necessary to give
life, meaning, and vitality’ to the aforementioned claims, and thereby carry patentable weight that
are to be construed as claim limitations.

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Next, the Court considers the proposed construction of the aforementioned claim term.
Generally, claim terms are “given their ordinary and customary meaning,” which 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.” Phillips, 415 F.3d at 1303. In reading the aforementioned disputed claim term, the
Court finds that one skilled in the art would understand the meaning of the term at the time of the
invention.
The Court has reviewed Alcon’s proposed construction of “intending to cause a therapeutic
improvement in a human patient” in construing the preamble of claim 1 of the ’805 patent. Alcon
relies on extrinsic evidence, and dependent claims 19-21, to advance the position that claim 1
requires ‘intent’ to cause a therapeutic improvement. (See Pl.’s Opening Br. at 11; D.I. 88) The
Court does not find Alcon’s proposed construction persuasive because it appears to unnecessarily
complicate the meaning of a term that has a well understood ordinary and customary meaning.
In Novartis Pharms. Corp. v. Actavis, Inc., Novartis alleged that Actavis was infringing on
its patented method for “treating iron overload” in patients with excess metal present in their
bodies. 2013 U.S. Dist. LEXIS 165317 (D. Del. 2013). The court in Novartis was persuaded that
the term “treating” should be afforded its plain and ordinary meaning in its construction; and
therefore adopted “attempting to cause a therapeutic improvement in” as the proper construction
for the term “treating.” Id. at 33-34 and 41.
The Court determines that the ordinary meaning of the claim term, “treating a human
patient,” as understood by a person of ordinary skill in the art, is readily apparent to the Court, and
claim construction “involves little more than the application of the widely accepted meaning of
commonly understood words.” Phillips, 415 F.3d at 1314.

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Accordingly, the Court determines that the term, “treating a human patient,” as recited in
the preamble of claim 1 of the ’805 patent is to be given its plain, ordinary and customary meaning,
which is—“attempting to cause a therapeutic improvement in a human patient.”
ORDER
IT IS on this 27th day of June, 2017,
ORDERED that “topically administrable suspension composition intended for application
to the eye, ear or nose,” as recited in the preamble of claim 1 of the 6,284,804 patent is to be given
its plain, ordinary and customary meaning, which is—“topically administering a combination of
two or more substances in which solid particles are dispersed, but undissolved, which is intended
for application to the eye, ear or nose”; it is further
ORDERED that “topically administrable aqueous suspension composition intended for
application to the eye, ear or nose,” as recited in the preamble of claims 1, 2 and 3 of the 6,359,016
patent is to be given its plain, ordinary and customary meaning, which is—“topically administering
a combination of two or more substances in which solid particles are dispersed, but undissolved,
which is intended for application to the eye, ear or nose”; and it is further
ORDERED that “treating a human patient,” as recited in the preamble of claim 1 of the
9,402,805 patent is to be given its plain, ordinary and customary meaning, which is—“attempting
to cause a therapeutic improvement in a human patient”.

s/Peter G. Sheridan
PETER G. SHERIDAN, U.S.D.J.

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