Alcon Research, Ltd. v. Watson Laboratories, Inc. et al

Filing 177

MEMORANDUM ORDER re 152 Objections filed by Alcon Research, Ltd. are SUSTAINED. The constructions set forth in 150 REPORT AND RECOMMENDATION are NOT adopted. Signed by Judge Leonard P. Stark on 4/17/18. (ntl)

IN THE UNITED ST ATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
ALCON RESEARCH, LTD.,
Plaintiff,
C.A. No. 16-129-LPS-SRF

V.

WATSON LABORA TORIES, INC.,
Defendant.
MEMORANDUM ORDER
WHEREAS, Magistrate Judge Fallon issued a Report and Recommendation (D.1. 150) on
November 30, 2017, recommending that the Court adopt certain claim constructions for disputed
terms in U.S. Patent No. 9,662,398 ("'398 patent");
WHEREAS, on December 14, 2017, Alcon Research, Ltd. ("Alcon") objected to the
Report (D.I. 152), specifically objecting to the recommended constructions of "native guar,"
"nepafenac," and "a galactomannan at a concentration of 0.1 to 0.4 w/v %, said galactomannan
selected from the group consisting of guar, native guar, and hydroxypropyl guar;"
WHEREAS , on December 28, 2017, Watson Laboratories, Inc. ("Watson") responded to
Alcon' s objections (D.I. 155);
WHEREAS, on February 12, 2018, Alcon filed a reply to Watson' s response (D.I. 162);
WHEREAS, on February 19, 2018, Watson filed a surreply to Alcon' s reply (D.1. 163);
WHEREAS, on February 26, 2018, the Court heard oral argument on the objections
(see D.I. 168) ("Tr.");

WHEREAS , the Court has considered the parties' claim construction disputes addressed

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in the Report de novo, see St. Clair Intellectual Prop. Consultants, Inc. v. Matsushita Elec.

Indus. Co. , Ltd., 691 F. Supp. 2d 538, 541-42 (D. Del. 2010); 28 U.S.C. § 636(b)(l); Fed. R. Civ.
P. 72(b)(3);
NOW THEREFORE, IT IS HEREBY ORDERED that:
1.

Alcon' s objections (D.I. 152) to the Report' s construction of the aforementioned

terms are SUSTAINED. The constructions set forth in the Report (D.I. 150) are NOT adopted.
The Court construes the disputed terms as follows:
A.

"Native guar," as used in claims 1, 13, 14, 21 , and 32, is construed to

mean "naturally occurring guar, including such guar which has been processed to make it suitable
for ophthalmic pharmaceutical use, so long as such guar also lacks the kind of chemical
substitutions of the galactose and mannose groups of its galacatomannan polysaccharides
discussed in the ' 398 patent at col. 4 11. 1-7 ."
B.

"Nepafenac," as used in claims 1, 13-15, and 32, is construed to mean ''a

known compound having the formula C 15H 14N 20 2 and having the following structure:

"

C.

"A galactomannan at a concentration of 0.1 to 0.4 w/v %, said

galactomannan selected from the group consisting of guar, native guar, and hydroxypropyl guar,"
as used in claim 1, is construed to mean "guar, native guar, or hydroxypropyl guar at
concentration of 0.1 to 0.4 w/v %. "

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Native guar
2.

The Report recommended that the term "native guar" be found indefinite because

it does not have a plain and ordinary meaning and the intrinsic record fails to provide sufficient
clarity about its scope, in particular its structural and functional features . (See D.I. 150 at 7-9)
Alcon contends that the meaning of the term is evident from considering the plain and ordinary
meanings of its constituent words: "native" and "guar." (See D.I. 152 at 7; D.I. 162 at 6) Citing
extrinsic evidence, Alcon argues that the commonly-understood meaning of a "native" substance
in the context of pharmaceutical products is that the substance is naturally-occurring. (See D.I.
152 at 7) Thus, in Alcon' s view, a person of ordinary skill in the art ("POSA") would have
understood native guar to mean naturally-occurring guar that lacks chemical substitutions found
in "synthetic guar." (Id.) The Court agrees.
As the Report correctly found, the patent does not explicitly define "native guar," nor
does the patent define a "synthetic guar." (D.I. 150 at 7) But, in the Court' s view, Watson has
nonetheless failed to prove, by clear and convincing evidence, that a POSA would have lacked
reasonable certainty as to how the patentee was using the term "native guar" in the claims of the
' 398 patent. See Nautilus Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120, 2124 (2014). Instead,
the Court is persuaded that a POSA would have understood "native guar" to mean guar obtained
from guar gum that has not been "chemically modified;" that is, the guar retains the natural
composition of its polysaccharide groups without any chemical substitutions, such as those
described in the ' 398 patent at col. 411. 1-7.
The specification states that the patent "relates to compositions for ophthalmic drug
delivery, and more specifically to nanoparticle suspensions comprising a carboxyvinyl polymer, a

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galactomannan, and borate." ' 398 patent, col.I 11. 18-21 ( emphasis added). Claim 1 recites a
"topically administrable ophthalmic suspension composition comprising .. . galactomannan
selected from the group consisting of guar, native guar, and hydroxypropyl guar." Id. col. 8 11.
59-67 (emphasis added) . The specification explains that the galactomannans used in the claimed
compositions could be derived from natural gums, such as guar gum, or synthetic gums, adding:
The types of galactomannans that may be used in the present
invention are typically derived from guar gum, locust bean gum
and tara gum. As used herein, the term "galactomannan" refers to
polysaccharides derived from the above natural gums or similar
natural or synthetic gums containing mannose or galactose
moieties, or both groups, as the main structural components.
Preferred galactomannans of the present invention are made up of
linear chains of (1-4)-B-D-mannopyranosyl units with
a-D-galactopyranosyl units attached by (1-6) linkages.
Id. col. 3 11. 55-64 (emphasis added). Thus, according to the patent, galactomannans are
"polysaccharides ... containing mannose or galactose moieties, or both groups, as the main
structural components," irrespective -0f whether they are derived from natural or synthetic gums.
(Id.) Expressly included in this definition are "chemically modified variations of the
polysaccaharides .. . [f]or example, hydroxyethyl, hydroxypropyl and
carboxymethylhydroxypropyl substitutions," and other "non-ionic" and "anionic" substitutions.
(See id.) The Court agrees with Alcon (as supported by its expert) that a POSA would
understand these substitutions are man-made chemical modifications and are not present in
galactomannans selected from native guar. (See D.I. 128 Ex. B ,r 52)
A POSA would understand that native guar would have to undergo some form of
processing in order to be suitable for use in the claimed pharmaceutical compositions. (See, e.g.
D.I. 128 Ex. B ,r,r 54-57) (Alcon's expert explaining that ingredients derived from natural sources

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must undergo purification and sterilization, for example, to be made suitable) The Court is
persuaded that a POSA would understand there to be a meaningful - and reasonably
ascertainable - distinction between this sort of necessary process and processes which would
result in chemical substitutions. (See id. , 53) (explaining that prior art extensively used "native
guar" term to denote guar with no chemical substitutions)
The specification refers to a preferred form of native guar commercially available in
powder form and to a preferred process for obtaining native guar using a certain purification
method:
Native guar is particularly preferred, for example, USP or general
grade native guar powder obtained from TIC Gums, Inc. A
process for producing a particularly preferred native guar is
disclosed in co-pending U.S. patent application Ser. No.
12/701 ,339, [("the ' 339 application")] entitled "Process for
Purifying Guar" filed Feb. 5, 2010.
'398 patent, col. 411. 24-30 (emphasis added). Thus, the patent refers to a commercial source TIC Gums, Inc. 1 - for obtaining "native guar powder," and to a patent application - the '339
application2 - for a process to produce native guar. This is further support for the Court' s finding

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Watson' s principal position is that the term is indefinite. In the alternative, Watson's
proposed construction of "native guar" is: "A galactomannan that is not guar or hydoxypropyl
guar, that is exemplified by USP or general grade native guar powder sold by TIC Gums, Inc. in
December 2009."
2

The ' 339 application "relates to processes for purifying guar comprising combining
borate and guar in an aqueous solution and treating the aqueous solution with an organic solvent
to induce precipitation of purified guar." ' 339 application, Abstract. While the ' 339 application
does not use the term native guar, it refers to the same "native guar powder" commercial product
identified in the '398 patent in multiple ways, as, for example, "guar powder," "unprocessed
guar," or "raw guar powder." See ' 339 application, [0021] ("A preferred guar gum powder is
USP or general gradeguar powder obtained from TIC Gum.") (emphasis added); id. [0039] ("A
preferred process of the present invention utilizes USP grade guar powder obtained from TIC
Gum, Inc. The raw guar powder is used to form a 0.8% aqueous guar solution.") (emphasis
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that a POSA would be reasonably certain as to the meaning the patentee ascribed to "native
guar."3
The Court has modified Alcon's proposed construction to eliminate any risk of confusion
by the factfinder that "native guar" cannot include chemical subsitutions of its galactomannan
molecules, including where such substitutions are accomplished as discussed in col 4. 11. 1-7 of
the ' 398 patent. 4

added); id. [0042] ("TABLES 1 and 2 below show the result of an experiment comparing
unprocessed guar (USP Grade; TIC Gum, Inc.) in aqueous solution compared to" guar purified
using different methods.") (emphasis added) The '339 application further refers to the guar
purified using the corresponding claimed invention as simply "purified guar." ' 339 application,
[0043] ("As shown in TABLE 1, guar produced according to a process of the present invention
("Purified Guar") demonstrates better hydration characteristics compared to unpurified guar
powder in aqueous solution ("Raw Guar") and guar purified using ethanol/acetone precipitation
without the addition of borate.") (emphasis added). It further distinguishes guar having chemical
substitutions (which it refers to as "guar derivatives") from guar without any chemical
substitutions. Compare ' 339 application [0012] ("Embodiments of the present invention are
directed to processes for manufacturing pharmaceutical grade guar compositions which
comprise combining borate and guar in aqueous solution and precipitating guar by adding an
organic solvent to the aqueous solution.") (emphasis added) with [0013] ("The present invention
is further directed to processes for producing guar derivatives (e.g., hydroxyethyl guar and
carboxymethylhydroxypropyl guar) that are particularly suitable for use in ophthalmic
pharmaceutical compositions that are formulated for local administration.") and [0002] ("The
present invention relates to guar and guar derivatives, and more particularly to processes for
producingpurified guar and guar derivatives.") (emphasis added). In the Court' s view, the ' 339
application, therefore, supports Alcon' s position as to what a POSA would understand from the
'398 patent's use of the term "native guar."
3

The Court does not agree with the Report that borate condensation would be understood
by a POSA as a chemical modification. (Compare D.I. 150 at 8-9 with D.I. 128 Ex. B ,r 57)
4

Given the Court' s finding that the term "native guar" has not been proven to be
indefinite, the Court does not reach Alcon's additional objection to that recommendation based
on Amgen Inc. v. F. Hoffman-La Roche Ltd, 580 F.3d 1340, 1372-73 (Fed. Cir. 2009). (See, e.g.,
D.I. 150 at 9)
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Nepafenac

3.

Claim 1 recites "a sparingly soluble particulate compound ... wherein said

sparingly soluble particulate compound is nepafenac." The Report construed "nepafenac" to
mean "3-benzoylphenylacetic acid and certain of its derivatives known to possess antiinflammatory activity, including amfenac (2-amino-3-benzoylphenylacetic acid) and nepafenac
(2-amino-3-benzoylbenzeneacetamide)." (D.I. 150 at 14) (emphasis added) Alcon objects
because this construction deviates from nepafenac's commonly-understood meaning. (See D.I.
152 at 1-5) In particular, the Report includes within the construction of "nepafenac" a compound
better known as "amfenac." The Court agrees with Alcon that a POSA reading the ' 398 patent
and the entirety of the intrinsic evidence would understand "nepafenac" not to include amfenac.
The specification states:
Nepafenac is a known nonsteroidal anti-inflammatory compound,
and can be made by known methods. See, for example, U.S. Pat.
Nos. 5,475,034 and 4,313 ,949, the entire contents of which are
incorporated by reference. Nepafenac is also known as
2-amino-3-benzoylphenylacetic acid. The topical use of
nepafenac and other amide and ester derivatives of
3-benzoylphenylacetic acid to treat ophthalmic inflammation and
pain is disclosed in U.S. Pat. No. 5,475,034.
' 398 patent col. 411. 49-57 (emphasis added). The "also known as" portion of this statement
describes amfenac, that is, 2-amino-3-benzoylphenylacetic acid. While the patent expressly
states that "nepanfenac is also known as" amfenac, the Court agrees with Alcon that a POSA
would recognize this to be a misstatement, and would instead understand that nepafenac (as used
in the ' 398 patent) does not include amfenac.
The plain and ordinary meaning of "nepafenac" does not include "amfenac." Instead, to a

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POSA, the plain and ordinary meaning of nepafenac is 2-amino-3-benzoylphenylacetamide, an
amide derivative. (See D.I. 128 Ex. B ,r 32) By comparison, amfenac is known to a POSA as
2-amino-3-benzoylphenylacetic acid, a corresponding organic acid. (Id.

,r,r 31-32)

"Absent lexicography or disavowal," the Court should "not depart from the plain meaning
of the claims." Luminara Worldwide, LLC v. Liown Elecs. Co. , 814 F.3d 1343, 1353 (Fed. Cir.
2016) (citing Thorner v. Sony Computer Entm 't Am. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012)).
Here, the patentee was not its own lexicographer; that is, the patentee did not redefine nepafenac
to include amfenac. See Luminara, 814 F.3d at 1353 ("[The] standards for finding lexicography .
. . are exacting.") (internal quotation marks omitted). The "also known as" passage (on which
Watson bases its proposed construction) does not, with "reasonable clarity, deliberateness, and
precision," redefine "nepafenac." Typhoon Touch Techs., Inc. v. Dell, Inc., 659 F.3d 1376, 1383
(Fed. Cir. 2011) (internal citation omitted); see also GE Lighting Sols., 750 F.3d at 1309 ("To act
as its own lexicographer, a patentee must clearly set forth a definition of the disputed claim term,
and clearly express an intent to define the term.") (internal quotation marks omitted). For the
same reasons (as further explained below), neither the patent nor the prosecution history contains
a clear and unmistakable disavowal of claim scope.
To the contrary, in the Court' s view, a POSA would recognize the "also known as"
portion of the specification to be an error. (See D.I. 152 at 3) The specification, taken in context,
does not clearly, deliberately, and precisely indicate that the inventors redefined nepafenac to
deviate from its plain and ordinary meaning.

In the sentence just before the "also known as" error, the specification refers to nepafenac
as a "known nonsteroidal anti-inflammatory compound." ' 398 patent, col. 411. 49-51 (emphasis

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added). Nepafenac is "known" customarily as 2-amino-3-benzoylphenylacetamide, not
2-amino-3-benzoylphenylacetic acid. (See D.I. 128 Ex. B ,r 32) Numerous publications
submitted to the examiner during the prosecution of the ' 398 patent identified nepafenac using its
known chemical name: 2-amino-3-benzoylphenylacetamide. (See id.

,r 28)

Similarly, that same sentence immediately preceding the erroneous "also known as"
sentence refers to "known methods" of making nepafenac, citing to two patents, which are fully
incorporated by reference. '398 patent, col. 4 11. 49-52 (emphasis added). Both of those patents
expressly disclose methods of making 2-amino-3-benzoylphenylacetamide, i.e., nepafenac. (See
D.I. 128 Ex. B ,r,r 36-39)
Elsewhere in the specification, the ' 398 patent describes nepafenac and amfenac as
distinct from one another. See ' 398 patent Fig. 3 (showing concentration of nepafenac and
amfenac separately); see also D.I. 128 Ex. B ,r 34. The patent also refers to amfenac as a
metabolite of nepafenac. See ' 398 patent, col. 7 11. 37-38 ("amfenac (a nepafenac metabolite))";
id. col. 7 1. 52 ("distribution of nepafenac and its metabolite, amfenac"). These references are

consistent with the plain and ordinary meaning of nepafenac, and further indicate that the
differences between amfenac and nepafenac include their chemical structures as well as their
functions. Additionally, the ' 398 patent refers to NEVANAC®, Alcon' s commercial nepafenac
product, as "a commercial 0.1 w/v % suspension of nepafenac." Id. col. 711. 40-41. This, again,
is consistent with how a POSA would have understood the term to be used in the patent' s claims.
(See D.I. 128 Ex. B ,r,r 25-27)

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A galactomannan at a concentration of 0.1 to 0.4 w/v %, said galactomannan selected
from the group consisting ofguar, native guar, and hydroxypropyl guar
4.

With respect to the final dispute, the parties agree that this term includes a

Mark:ush group. (See D.I. 150 at 10) The Report construed the term as referring to "only one,
single galactomannan that is guar or native guar or hydroxypropyl guar, and not mixtures or
combinations thereof, at a concentration of 0.1 to 0.4 w/v %." Alcon contends that this
construction is incorrect because native guar and hydroxypropyl guar are both types of guar.
(D.I. 152 at 10) Again, the Court agrees with Alcon.
The intrinsic evidence shows that the types of guar described in the claims' Markush
group are open, not closed, to combinations of the selected guar types. The patent explains that
the galactomannans of this type are obtained from the guar gum plant. See ' 398 patent col. 3 11.
55-57. It is clear, then, that "guar" in this context encompasses both "native guar" and
"hydroxypropyl guar," as anything that is native guar or hydroxypropyl guar is also "guar." As
Alcon's expert explains, native guar and hydroxypropyl guar are types of guar. (D.I. 128 Ex. B
, 47) He points to the patent' s examples 1 and 4, which use the terms "native guar" and "guar,"
respectively, to refer to the same substance. (See id. , 59) Thus, the second and third substances
listed in the Markush group - native guar and hydroxypropyl guar - come within the meaning of
the first substance, guar, and do not constitute three different types of guar.
The prosecution history provides additional support for this conclusion. In response to an
office action rejecting an earlier version of the claims, the patentees amended some claims
reciting "guar" to recite "native guar." (See D.I. 137-1 pp. 38-41 of 45) They explained that the
purpose of their amendment was to "more specifically recite components," not a new component.

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(See id. at page 42 of 45) Nothing in the prosecution history indicates that combinations are

excluded.
The Court has considered Watson's other arguments against Alcon' s proposed
construction, including the doctrine of claim differention, and concludes that they do not lead to a
different result. Claim 21 recites the "composition according to claim 1 wherein said
galactomannan is guar or native guar." '398 patent col. 10 11. 11-12. As the Report correctly
concludes, if native guar and hydroxypropyl guar are simply sub-types of guar, then claim 1 and
claim 21 have identical scope. (See D.I. 150 at 12) But "claims that are written in different
words may ultimately cover substantially the same subject matter." Multiform Desiccants, Inc. v.
Medzam, Ltd., 133 F.3d 1473, 1480 (Fed. Cir. 1998) (internal citation omitted); see also
Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261 , 1269 (Fed. Cir. 1986) (affirming district

court's construction of claim although it rendered dependent claim redundant). On occasion, as
here, the same substance may be represented by more than one member of a Markush group,
notwithstanding presumptions. See Multilayer Stretch Cling Film Holdings, Inc. v. Berry
Plastics Corp., 831 F.3d 1350, 1363 (Fed. Cir. 2016) ("Court decisions construe Markush

clauses as meaning 'closed' unless other language or evidence alters that meaning.") (internal
quotation marks and emphasis omitted). Redundancy, while not a preferred outcome, does not
necessarily establish that a proposed construction is incorrect. See generally Eli Lilly & Co. v.
Teva Parenteral Medicines, Inc. , 845 F.3d 1357, 1372 (Fed. Cir. 2017) ("[F]aced with an

interpretation that would read redundancy into claim 1 and another that would violate the
doctrine of claim differentiation, we hold that the claims here support the former result over the
latter."). Because the intrinsic and extrinsic evidence, considered in totality, supports reading the
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Markush group as open to combinations of the three listed types of guar, the Court adopts
Alcon' s construction.

H
J;!:::l ~

April 17, 2018
Wilmington, Delaware

UNITED STATES DISTRICT JUDGE

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