Salix Pharmaceuticals, Inc et al v. Mylan Pharmaceuticals, Inc. et al
Filing
117
MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS. Signed by District Judge Irene M. Keeley on 4/12/16. (jss)
IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
SALIX PHARMACEUTICALS, INC. and
DR. FALK PHARMA GmbH,
Plaintiffs/Counter-Defendants,
v.
CIVIL ACTION NO. 1:15CV109
(Judge Keeley)
MYLAN PHARMACEUTICALS, INC. and
MYLAN, INC.,
Defendants/Counter-Claimants.
MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS
This patent infringement case involves four United States
patents issued to the plaintiff, Dr. Falk Pharma GmbH, and licensed
by
the
plaintiff,
“Salix”).
These
Salix
Pharmaceuticals,
include:
Patent
No.
Inc.
(collectively,
6,551,620
(“the
‘620
Patent”); Patent No. 8,337,886 (“the ‘886 Patent”); Patent No.
8,496,965 (“the ‘965 Patent”); and 8,865,688 (“the ‘688 Patent”).
The ‘620, ‘886, and ‘965 Patents, collectively referred to as the
Otterbeck patents,1 contain two disputed claim terms, while the
parties dispute one claim term in the ‘688 Patent.
The
Otterbeck
formulation
patents
containing
cover
mesalamine
a
controlled
for
the
release
treatment
pellet
of
the
intestinal tract, and associated method of treatment claims.
The
‘688 Patent covers methods of maintaining remission of ulcerative
1
The Otterbeck patents, which claim priority to a German
patent application, share a common specification.
SALIX ET AL. V. MYLAN ET AL.
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colitis for at least six months with certain dosing and target
limitations.
Salix uses the formulations and methods described in
these patents in a commercial product known as Apriso®.
I.
In
a
letter
dated
BACKGROUND
May
14,
2015,
the
defendants,
Mylan
Pharmaceuticals, Inc. and Mylan, Inc. (collectively, “Mylan”),
notified
Salix
Application
that
they
(“ANDA”)
had
seeking
filed
United
an
Abbreviated
States
Food
New
and
Drug
Drug
Administration (“FDA”) approval to market a 375 mg mesalamine oral
extended release capsule (“generic capsule”).
Mylan also filed a
certification with the FDA alleging that certain claims of the
patents-in-suit are invalid, unenforceable, and not infringed by
Mylan’s
manufacture
or
sale
of
its
generic
capsule.
Salix
responded to Mylan’s ANDA by filing this patent infringement action
pursuant to the Drug Price Competition and Patent Term Restoration
Act (the “Hatch-Waxman Act”).
See 21 U.S.C. §§ 355, 360cc; 35
U.S.C. §§ 156, 271.
In its complaint, Salix contends that the generic capsule
described in Mylan’s ANDA infringes claims in the patents-in-suit.
The parties have identified three terms from those patents in need
of construction for which they have proposed competing claim
constructions.
They
also
have
2
submitted
12
agreed
claim
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MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS
constructions.
Following a claim construction hearing and full
briefing of the issues, for the reasons that follow, the Court
adopts the following constructions.
II.
LEGAL STANDARDS
The construction of patent claims presents a matter of law
governed by federal statutes and the decisions of the Supreme Court
of the United States and the United States Court of Appeals for the
Federal Circuit.
See Markman v. Westview Instruments, Inc., 52
F.3d 967, 979 (Fed. Cir. 1995).
When interpreting the meaning of
a claim, a court may consider the claims, the specifications, and
the prosecution histories as intrinsic evidence.
Id. (quoting
Unique Concepts, Inc. v. Brown, 939 F.2d 1558, 1561 (Fed. Cir.
1991)).
According
to
a
fundamental
principle
of
claim
construction, the invention itself, and the scope of a patentee’s
right of exclusion, will be defined by the patent’s claims.
See
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)); see also
Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed.
Cir. 1996) (“[W]e look to the words of the claims themselves . . .
to define the scope of the patented invention.”).
The description
of an invention in the claims, therefore, limits the scope of the
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invention.
Id.
Claim terms should be construed according to 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.”
Claim construction therefore requires a
court to determine how a person of ordinary skill in the art would
have understood the disputed term or phrase.
“Importantly, the
person of ordinary skill in the art is deemed to read the claim
term not only in the context of the particular claim in which the
disputed term appears, but in the context of the entire patent,
including the specification.”
Id.
When construing patent claims, then, a court must consider the
context
of
the
unasserted claims.
entire
patent,
Id. at 1314.
including
both
asserted
and
Because a patent will ordinarily
use patent terms consistently, “the usage of a term in one claim
can often illuminate the meaning of the same term in other claims.”
Id. at 1314. Accordingly, “[d]ifferences among claims” can provide
insight into “understanding the meaning of particular claim terms,”
and “the presence of a dependent claim that adds a particular
limitation gives rise to a presumption that the limitation in
question is not present in the independent claim.”
Id. at 1314-15
(citing Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 910
4
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(Fed. Cir. 2004)).
Aside from the claims themselves, the specification in the
patent
often
provides
technical term.’”
the
“‘best
source
for
understanding
a
Id. at 1315 (quoting Multiform Desiccants,Inc.
v. Medzam, Ltd., 133 F.3d 1473, 1478 (Fed. Cir. 1998)).
Pursuant
to 35 U.S.C. § 112, ¶ 1, an inventor must use the specification to
describe his claimed invention in “full, clear, concise, and exact
terms.”
Accordingly, “[t]he claims of a patent are always to be
read or interpreted in the light of its specifications.” SchriberSchroth Co. v. Cleveland Trust Co., 311 U.S. 211, 217 (1940).
An inventor may alter the “ordinary and customary” meaning of
a term, however, by acting as his own lexicographer.
This occurs,
for example, when the patent specification defines a term in a
manner
different
from
its
Phillips, 415 F.3d at 1316.
ordinary
and
customary
meaning.
Thus, it is “entirely appropriate for
a court, when conducting claim construction, to rely heavily on the
written description for guidance as to the meaning of the claims.”
Id. at 1317.
Nevertheless, a court may not import a limitation into the
claims from the specification. Id. at 1323. Moreover, the Federal
Circuit has “repeatedly warned” against limiting the claims to the
embodiments specifically described in the specification.
5
Id.
In
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other words, a court should not construe the patent claims as being
limited to a single embodiment simply because the patent describes
only one embodiment.
Id. (citing Gemstar-TV Guide Int’l Inc. v.
Int’l Trade Comm’n, 383 F.3d 1352, 1366 (Fed. Cir. 2004)).
The prosecution history of a patent may also provide insight
into the meaning of a term or phrase. “Like the specification, the
prosecution history provides evidence of how the PTO and the
inventor understood the patent.”
Id. at 1317.
The inventor’s
limitation of the invention during the patent’s prosecution may
suggest that a claim has a narrower scope than it otherwise might
have.
Id.
Finally, when determining the ordinary and customary meaning
of a term, a court must be cautious when considering extrinsic
evidence, such as expert testimony, dictionaries, and learned
treatises.
Id.
Nevertheless, such sources may be reliable if
they were publicly available and establish “‘what a person of skill
in the art would have understood disputed claim language to mean.’”
Id. at 1314 (quoting Innova, 381 F.3d at 1116).
It is with these legal principles in mind that the Court turns
to the construction of the disputed terms in the patents-in-suit.
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III.
A.
ANALYSIS
“Core”
The term “core” appears in Claim 1 of the ‘620 and ‘886
Patents, and Claims 12 and 24 of the ‘965 Patent.
Salix argues
that “core” needs no construction because a person of ordinary
skill in the art would readily understand its meaning (Dkt. Nos.
75, 99).
Mylan contends that “core” should be defined as “a
composition
which
achieves
controlled
release
of
the
active
compound in the intestinal tract without the aid of a coating.”
(Dkt. Nos. 74, 101).
1.
The Claims
The parties agree that the plain language of the claim
includes both a core and a coating.
They disagree, however, as to
whether the coating contributes to the product’s controlled release
profile.
Claim 12 of the ‘965 Patent2 reads as follows:
12. A controlled release pellet formulation comprising:
1) 5-aminosalicylic acid in a core comprising a
polymer matrix, wherein the polymer matrix is
essentially insoluble in the intestinal tract
and permeable to intestinal fluid, and wherein
the polymer matrix comprises at least 1% by
weight of the total weight of the core; and
an enteric coating;
2
Claim 12 is representative of the claims in the Otterbeck
patents involving the term “core.”
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wherein about 10-30% of the 5-aminosalicylic acid
is released from the formulation in about 30
minutes at 37" C. in artificial intestinal
juice at a pH of about 6.8.
‘965 Patent, col. 10:19-28 (emphasis added). The plain language of
the claim states that the controlled release profile consists of
both the core and the coating.
See Genentech, Inc. v. Chiron
Corp., 112 F.3d 495, 501 (Fed. Cir. 1997) (citing In re Baxter, 656
F.2d 679, 686 (C.C.P.A. 1981)) (explaining that “comprising” is a
term of art meaning that the named elements are essential, but that
other elements may be added and still form a construct).
Mylan’s
proposed
coating
definition,
which
attempts
to
read
entirely, conflicts with the claim language.
out
the
See Phillips, 415
F.3d at 1312 (“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.” (internal quotation marks and
citations omitted)).
Rather than focus on the language of the claim, Mylan argues
that the Court should utilize the construction of “core” adopted by
the Honorable Gregory M. Sleet, United States District Judge in the
District of Delaware, in Salix Pharms. Inc. v. Novel Labs., Inc.,
No. 1:14CV213, 2015 WL 4240967, at *2 (D. Del. July 10, 2015) (“the
Novel case”). There, Judge Sleet construed the term “core” to mean
“a composition which achieves controlled release of the active
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MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS
compound in the intestinal tract without the aid of a coating,” the
same construction urged by Mylan (Dkt. No. 74-6 at 2).
This Court has held that another judge’s claim construction
ruling is not a final order having preclusive effect. Dey, L.P. v.
Teva Parenteral Med., Inc., 958 F. Supp. 2d 654, 672 (N.D.W. Va.
July 17, 2013).
This is particularly the case with Novel, which
has yet to be litigated to a final judgment.
Kollmorgen Corp. v.
Yaskawa Elec. Corp., 147 F. Supp. 464, 467 (W.D. Va. 2001).
For
reasons the Court will later discuss, it declines to adopt Judge
Sleet’s construction of “core,” which is based solely on the
prosecution history.
2.
The Specification
The
specification
in
the
Otterbeck
patents
mirrors
the
language from the claim, supporting Salix’s position that both a
“core” and a “coating” contribute to the controlled release profile
of Apriso®.
The specification in the Otterbeck patents reads, in
part, as follows:
The present invention thus relates to an orally
administrable pharmaceutical pellet formulation having a
controlled release profile for the treatment of the
intestinal tract, which comprises a core and an enteric
coating . . . .
‘620 Patent, col. 3:1-4 (emphasis added).
The active compound is preferably homogeneously dispersed
in the matrix described above and is released with a
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delay after dissolving the enteric coating.
‘620 Patent, col. 4:10-12 (emphasis added).
The
specification
also
provides
examples
of
four
pellet
coatings and two pellet cores, noting that “[t]he different cores
can be combined in any desired manner with the different coatings
. . . .”
‘620 Patent, col. 5:35-38.
After a careful review of the specification, it is clear that
the controlled release profile of Apriso® consists of two parts:
a core and an enteric coating.
coatings
are
listed
in
the
The fact that four different
examples
is
unavailing;
although
different coatings can be combined with different cores, some
coating is always used in conjunction with a core.
3.
The Prosecution History
Mylan’s strongest argument relies on the prosecution history
of the patents-in-suit.
In the Novel case, Judge Sleet found that
the patentee had disclaimed cores that worked in conjunction with
coatings to achieve controlled release (Dkt. No. 74-6 at 2).
He
clarified that the claims include an enteric coating, but that the
coating
does
not
play
a
role
in
mesalamine in the intestinal tract.3
3
the
controlled
Id. at 3, n. 1.
release
of
He stated
Even if the enteric coating dissolves in a patient’s
stomach, as opposed to the intestinal tract, the Court finds
Mylan’s argument unavailing. The plain language of the claim does
not restrict “the controlled release profile” to only the component
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that his “construction is intended to hold the patentee to its
prosecution history.”
Id.
Judge Sleet focused on the September 6, 2006, Amendment and
Response to Office Action regarding the Otterbeck patents, in which
the patentee distinguished the following prior art: (1) a soluble,
degrading matrix; (2) an insoluble polymer coating, as opposed to
an insoluble polymer core; and (3) an enzymatically degraded matrix
core (Dkt. No. 74-8 at 6-7).
As to the second piece of prior art,
the patentee explained that the prior art had disclosed a core
containing the active pharmaceutical ingredient (“API”) with a
coating around the core.
Because the coating was insoluble,
osmotic pressure drove the API through the exterior coating.
In contrast, the Otterbeck patents describe an insoluble
polymer matrix core containing the API.
dissolves,
intestinal
fluids
reach
After the enteric coating
the
API;
it
is
therefore
unnecessary to osmotically drive the API through an insoluble
coating.
With that background, the patentee stated that “in the
present application the release control is achieved by an insoluble
core and not by a coating, and the core is not dissolved or
destroyed during the release of the active ingredient but remains
of the product that dissolves in the intestinal tract.
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intact.”
Id. at 8 (emphasis added).
The
consistent
patentee’s
with
specifications.
statement,
the
clear
when
language
viewed
of
the
in
context,
claim
terms
is
and
See Phillips, 415 F.3d at 1317 (“Yet because the
prosecution history represents an ongoing negotiation between the
PTO and the applicant, rather than the final product of that
negotiation, it often lacks the clarity of the specification and
thus is less useful for claim construction purposes.”).
The
patentee clearly was distinguishing the prior art, which revealed
an insoluble polymer coating used to control release of the API,
rather than disavowing any coating that works in conjunction with
the core.
This isolated statement relied on by Mylan falls short
of the “clear and unmistakable disavowal” needed to overcome “the
heavy presumption that claim terms carry their full ordinary and
customary meaning.”
Biogen Idec, Inc. v. GlaxoSmithKline LLC, 713
F.3d 1090, 1095 (Fed. Cir. 2013) (internal citations and quotation
marks omitted).
The Court therefore ADOPTS Salix’s proposed
construction and CONSTRUES the term “core” consistent with its
plain and ordinary meaning.
B.
“Non gel-forming polymer matrix”
The term “non gel-forming polymer matrix” appears in Claim 1
of the ‘620 Patent and Claim 19 of the ‘886 Patent.
12
Salix urges
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the Court to construe the term as “a polymer material that does not
form a surface gel barrier when in contact with fluid, and can be
used for incorporation of, and controlled release of, an active
agent.” (Dkt. No. 75 at 17) (emphasis added).
Mylan argues that
the Court should construe the term as “a polymeric material that
does not become a gel when in contact with fluid, and can be used
for incorporation of, and controlled release of, an active agent.”
(Dkt. No. 74 at 21) (emphasis added).
1.
The Claim
Salix and Mylan dispute whether a polymer material does not
“form a surface gel barrier” or does not “become a gel” when in
contact with fluid.4
Claim 1 states as follows:
1. An orally administrable pharmaceutical pellet
formulation having a controlled release profile for the
treatment of the intestinal tract, which comprises a core
and an enteric coating and optionally pharmaceutically
tolerable
additives,
the
core
including,
as
a
pharmaceutical active compound, aminosalicylic acid or a
pharmaceutically acceptable salt, wherein the active
compound is present in the core in a non gel-forming
polymer matrix which is essentially insoluble in the
intestinal tract . . . .
‘620 Patent, col. 9:30-33 (emphasis added).
According to Mylan, Salix’s proposed construction deviates
from the plain language of the claim, and is inconsistent with the
4
Mylan does not dispute Salix’s use of the word “polymer”
rather than “polymeric.”
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intrinsic evidence. Salix contends that its proposed construction,
which is more precise than Mylan’s, stems from the prior art
distinguished in the patent specification.
2.
The Specification
Salix urges the Court to look at the content of the prior art,
French patent FR-A2 692 484, to construe the claim.
It is well-
settled, however, that it is “unnecessary, and indeed improper” for
the Court to consider prior art “when the disputed terms can be
understood
from
a
careful
Vitronics, 90 F.3d at 1584.
reading
of
the
public
record.”
The prior art may not “be used to vary
claim terms from how they are defined, even implicitly, in the
specification or file history.” Id. at 1584-85. Because the claim
and
the
specification
clearly
support
Mylan’s
proposed
construction, the Court will not consider the prior art aside from
the quotations contained in the specification.
In the specification, the patentee distinguished the invention
from the prior art French patent:
[The prior art] discloses a tablet for the controlled
release of 4-ASA in a hydrophilic matrix which consists
of swellable polymers forming a gel barrier, and having
an enteric coating. After dissolution of the coating,
the matrix swells and forms a gel barrier through which
the active compound diffuses out.
‘620 Patent, col. 1:52-54 (emphasis added).
In the same specification, however, the patentee describes the
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prior art in a manner that supports Mylan’s proposed construction:
The use of a swellable, gel-forming matrix such as
described in [the prior art] is not suitable for pellets
having a diameter of [#]3 mm, since on account of the
small diameter the polymer is very rapidly penetrated by
the water, eroded as a result, and the active compound
would thus be released virtually immediately (about 30
min).
‘620 Patent, col. 2:52-57 (emphasis added).
Importantly, the specification refers to the instant invention as
a “non gel-forming polymer matrix,” which also supports Mylan’s
proposed construction:
In the context of the present invention, however, it has
surprisingly been found that, if the active compound is
present in the pellet core in a non gel-forming polymer
matrix which is essentially insoluble and permeable to
intestinal fluids and the active compound, a markedly
reduced release of the active compound into the blood,
with simultaneously increased local concentration of the
active compound at the site of the disorder in the
intestine,
is
guaranteed
in
comparison
with
aminosalicylic acid formulations already known in the
prior art.
‘620 Patent, col. 2:58-67 (emphasis added).
In short, Salix is unable to point to any intrinsic evidence
supporting its construction save one reference to a “gel barrier”
distinguishing the prior art.5
Although the patent uses the terms
5
Judge Sleet’s construction of this claim term in Salix
Pharms. Inc. v. Lupin Ltd., Case No. 1:12CV1104, is identical to
Mylan’s proposal. Although Judge Sleet thoroughly analyzed the
claim term before adopting the same construction urged by Mylan
here, he did not deal with the issue currently before the Court.
He also stated that a polymer matrix claimed in the invention
“either forms a surface gel barrier . . . or it does not.” (Dkt.
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“gel barrier” and “gel-forming matrix” to describe the prior art,
it never qualifies the gel barrier as a “surface gel barrier,” as
urged by Salix.
Salix’s proposed construction would seemingly
narrow the claim; it has yet to offer a satisfactory explanation
for
why
the
patent
should
exclude
a
polymeric
“surface
gel
barrier,” but not any polymeric material that “becomes” a gel.
Mylan’s construction, on the other hand, tracks the language of
both the claim and the specification.
The Court therefore ADOPTS Mylan’s proposed construction and
CONSTRUES the term “non gel-forming polymer matrix” to mean “a
polymeric material that does not become a gel when in contact with
fluid, and can be used for incorporation of, and controlled release
of, an active agent.”
C.
“Remission is defined as a DAI score of 0 or 1"
The term “remission is defined as a DAI score of 0 or 1"
appears in Claims 1 and 16 of the ‘688 Patent. Generally speaking,
the term “DAI” in the context of ulcerative colitis (“UC”) refers
to the Sutherland Disease Activity Index (“SDAI” or “DAI”), an
assessment used to quantify the clinical symptoms of UC (Dkt. No 74
at 27; Dkt. No 75 at 23).
Some large clinical studies utilize the
No. 74-4 at 11). This statement seems to be a source of Salix’s
proposed construction, which it claims merely clarifies the
construction adopted in the Delaware litigation.
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DAI, which is comprised of four variables: stool frequency; rectal
bleeding; mucosal appearance; and physician’s rating of disease
activity.
Id.
Salix construes “remission is defined as a DAI score of 0 or
1" to mean “remission is defined as a rectal bleeding subscore of
0 and a mucosal appearance subscore of less than 2” (Dkt. Nos. 75,
99) (emphasis added).
Salix argues that its proposed construction
is consistent with the specification and prosecution history of the
‘688 Patent.
Id.
Mylan construes the same claim term to mean
“remission is defined as a DAI score of 0 or 1 as calculated by the
four
subscores
appearance
on
based
on
endoscopy,
stool
and
frequency,
physician’s
bleeding,
rating
activity” (Dkt. Nos. 74, 101) (emphasis added).
of
mucosal
disease
Mylan contends
that the claims, specification, and prosecution history of the ‘688
Patent support its proposed construction.
1.
Id.
The Claims
The plain language of Claims 1 and 16 explicitly states that
“remission is defined as a DAI score of 0 or 1.”
‘688 Patent, col.
34:11-18; col. 35:4-13 (emphasis added). The claims thus expressly
define the word “remission” (as “a DAI score of 0 or 1").
The
claims do not, however, define the phrase “DAI score of 0 or 1";
nor do they explain how to calculate that score using the index.
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Accordingly, the nuanced issue on which the parties disagree is how
the language “DAI score of 0 or 1" should be construed.
In other
words, the parties specifically dispute the meaning of “DAI score”
and how DAI score is calculated in the context of “remission.”
In
relevant part, Claims 1 and 16 of the ‘688 Patent provide:
1. A method of maintaining the remission of
ulcerative colitis in a subject comprising
administering to the subject a granulated
mesalamine formulation . . . wherein: said
method maintains remission of ulcerative
colitis in a subject for a period of at least
6 months of treatment; remission is defined as
a DAI score of 0 or 1 . . . .
16. A method of maintaining the remission of
ulcerative colitis in a subject comprising
advising the subject . . . wherein: said
method maintains remission of ulcerative
colitis in a subject for a period of at least
6 months of treatment; remission is defined as
a DAI score of 0 or 1 . . . .
‘688 Patent, col. 34:11-18; col. 35:4-13 (emphasis added).
Rather than focus on the language of the claims, Salix argues
that the specification and prosecution history support its position
that “DAI score of 0 or 1” as claimed refers to the sum of only two
subscores
of
the
index
(i.e.,
appearance) (Dkt. 75 at 21).
rectal
bleeding
and
mucosal
Specifically, it argues that the
patentee acted as his own lexicographer in defining “remission” as
“a rectal bleeding subscore of 0 and a mucosal appearance subscore
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of less than 2” throughout the specification.
Id.
Mylan, however, argues that the claim language, “a DAI score
of 0 or 1,” refers to a subject’s total DAI score (i.e., the sum of
all four subscores) (Dkt. No 74 at 26-27). According to Mylan, the
plain language of the claim reveals that the patentee acted as his
own lexicographer by explicitly defining “remission” in the claim:
“remission is defined as a DAI Score of 0 or 1.”
added).
Mylan
thus
controls.
Id. at 27.
argues
that
this
Id. (emphasis
“explicit
definition”
The Court disagrees.
Because the ‘688 Patent lacks any definition or explanation of
“DAI score” or “DAI score of 0 or 1" in the claim language, the
entirety of the term “remission is defined as a DAI score of 0 to
1" is not “explicitly” defined in the claims.
Additionally,
counsel for Salix explained during oral argument that multiple
“disease activity indices” are used to assess UC (Dkt. No. 114 at
23).
She further indicated that there is “confusion in the field”
regarding which index is to be used and what is specifically meant
by the term “DAI.” Id.
Undoubtedly, the words of a claim “are generally given their
ordinary and customary meaning.”
Phillips, 415 F.3d at 1312.
The
Federal Circuit has made clear that the ordinary and customary
meaning of a claim term is “the meaning that the term would have to
19
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a person of ordinary skill in the art in question at the time of
the invention.”
Id. at 1313.
Importantly, the person of ordinary
skill in the art (or “POSA”) is deemed to read the claim term “not
only in the context of the particular claim in which the disputed
term appears, but in the context of the entire patent, including
the specification.”
Id.
The court must therefore “review[] the
same resources as would that person, viz., the patent specification
and the prosecution history.”
133 F.3d at 1477).
Id. (citing Multiform Desiccants,
See also Kinik Co. v. Int'l Trade Comm'n, 362
F.3d 1359, 1365 (Fed. Cir. 2004) (“The words of patent claims have
the meaning and scope with which they are used in the specification
and prosecution history.”).
Moreover, although words in a claim are generally given their
ordinary and customary meaning, a patentee may choose to be his own
lexicographer and “use terms in a manner other than their ordinary
meaning, as long as the special definition of the term is clearly
stated in the patent specification or file history.” Vitronics, 90
F.3d at 1582. See also Hormone Research Found., Inc. v. Genentech,
Inc.,
904
F.2d
1558,
1563
(Fed.
Cir.
1990)
(“It
is
a
well-established axiom in patent law that a patentee is free to be
his or her own lexicographer and thus may use terms in a manner
contrary to or inconsistent with one or more of their ordinary
20
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meanings.”) (citations omitted)).
In such a case, the definition
selected by the patent applicant controls. Renishaw PLC v. Marposs
Societa' per Azioni, 158 F.3d 1243, 1249 (Fed. Cir. 1998).
It is
thus “always necessary to review the specification to determine
whether the inventor has used any terms in a manner inconsistent
with their ordinary meaning.”
Vitronics, 90 F.3d at 1582.
The
specification “acts as a dictionary” when it expressly defines
terms used in the claims or when it defines terms by implication.
Id. (citing Markman, 52 F.3d at 979).
Finally, although it is a “bedrock principle” of patent law
that “the claims of a patent define the invention to which the
patentee is entitled to exclude” (Phillips, 415 F.3d at 1312), the
claims “do not stand alone.”
Id. at 1315.
Rather, they are “part
of a fully integrated instrument,” consisting primarily of a
specification that concludes with the claims. Id. (citing Markman,
52 F.3d at 978).
Accordingly, claims “must be read in view of the
specification, of which they are a part.” Id.
See also Metabolite
Labs., Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1360
(Fed. Cir. 2004) (“In most cases, the best source for discerning
the proper context of claim terms is the patent specification”);
Standard Oil Co. v. Am. Cyanamid Co., 774 F.2d 448, 452 (Fed. Cir.
1985)
(“The
descriptive
part
of
21
the
specification
aids
in
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MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS
ascertaining the scope and meaning of the claims inasmuch as the
words of the claims must be based on the description.”).
Both Salix and Mylan ultimately contend that the patentee
elected to be his own lexicographer by providing an explicit
definition in the specification for the claim term (Dkt. No. 75 at
21; Dkt. No. 74 at 26-27).
If the patentee provided such a clear
definition, reference to the specification is required “because
only there is the claim term defined as used by the patentee[].”
Renishaw,
158
F.3d
at
1249.
Because
the
disputed
claims
“explicitly recite[] a term in need of definition” (i.e., the term
“a
DAI
score
of
0
or
1"),
the
claims
are
“susceptible
to
clarification by the written description,” and a definition “may
enter the claim[s] from” that description.
Id. at 1248.
For these reasons, the Court must consider Claims 1 and 16
together with the rest of the specification to determine what
“remission is defined as a DAI score of 0 to 1" means.
2.
The Specification
Salix points to repeated references to “remission” in the ‘688
patent’s specification to establish that the patentee intended to
define “remission” to mean “a rectal bleeding subscore of 0 and a
mucosal appearance subscore of less than 2.”
Meanwhile, Mylan
relies upon a single reference to the DAI in the larger context of
22
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“ulcerative colitis disease activity” to argue that the ‘688
specification supports its proposed construction.
Salix
patentee
contends
that,
explicitly
and
throughout
the
repeatedly
specification,
defined
the
“remission.”
Specifically, it argues that “remission” is consistently defined as
a “rectal bleeding score of 0 and a mucosal score of less than 2"
(Dkt. No. 75 at 2).
The specification in the ‘688 Patent reads, in
part, as follows:
“Patients with documented UC remission (revised
Sutherland Disease Activity Index [DAI] subscores:
rectal bleeding 0; mucosal appearance <2) were
randomized 2:1 to receive 1.5 g granulated mesalamine .
. . .”
‘688 Patent, col. 6:53-58 (emphasis added).
“Pooled patients . . . with documented UC remission
(revised Sutherland Disease Activity Index [DAI]
subscores: rectal bleeding 0; mucosal appearance <2) .
. . .”
Id. at col. 25:32-35; 26:21-24 (emphasis added).
“Patients . . . in remission with ulcerative colitis
(revised Sutherland Disease [SDAI] subscores: rectal
bleeding 0; mucosal appearance <2) . . . .”
Id. at col. 26:51-53(emphasis added).
“Remission was defined as both a screening rectal
bleeding score of 0 (no bleeding) and a screening
sigmoidoscopy score for mucosal appearance of 0 . . .
or 1 . . . .”
Id. at Example 10, col. 28:3-5(emphasis added).
Salix
contends
that
each
instance
where
“remission”
is
discussed in the specification reveals that the patentee “expressly
23
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MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS
limited [his] definition to mean rectal bleeding with a subscore of
zero and a mucosal appearance score of less than 2.” (Dkt No. 75 at
17).
It argues that because the patentee acted as his own
lexicographer, his explicit definition controls. Id. Accordingly,
Salix contends that Mylan’s proposed construction, which would
define remission using the sum of all four subscores, improperly
deviates from the patentee’s express definition of “remission.”
Id. at 23.
Salix also notes that “relapse” (the opposite of “remission”)
is consistently and repeatedly defined in the specification as “a
rectal bleeding subscore of one or more and a mucosal subscore of
2 or more.” Id. at 17 (emphasis added).
See, e.g., ‘688 Patent,
col. 6:53-57, col. 25: 32-35; col. 28: 3-8.
Because “relapse” is
the opposite of “remission,” Salix argues that these instances
support its contention that “remission” has the inverse definition
of “relapse” (i.e., “remission” as rectal bleeding with a subscore
of zero and a mucosal appearance score of less than 2).
Id.
In
other words, the same two subscores (rectal bleeding and mucosal
appearance) are used consistently throughout the ‘688 Patent to
describe “relapse” and “remission” as inverse terms.
Mylan nevertheless argues that the ‘688 specification supports
its proposed construction. It relies heavily on a single paragraph
24
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in one example that reads as follows:
Ulcerative colitis disease activity was assessed using
a modified Sutherland Disease Activity Index1 (DAI),
which is a sum of four subscores based on stool
frequency, rectal bleeding, mucosal appearance on
endoscopy, and physician’s rating of disease activity.
Each subscore can range from 0 to 3, for a total
possible DAI score of 12.
‘688
Patent,
Example
5,
col.
17:2-11
(hereinafter
“Example
5")(emphasis added).
According
to
Mylan,
Example
5
provides
an
“explicit
definition” for the meaning and calculation of “DAI score” as used
in the claims (Dkt. No. 74 at 27).
Specifically, it argues that
Example 5 demonstrates that the language “DAI score of 0 or 1" as
claimed refers to a total DAI score of 0 or 1, as calculated by
summing the four subscores.6
Id.
Mylan also notes that when the
patentee added the language “remission is defined as a DAI score
of 0 or 1" to the claims, he cited to Example 5, stating that
“support can be found in Example 5, entitled ‘Studies on Remission
from Ulcerative Colitis.’”
Id.
Mylan’s proposed construction, however, is grounded solely in
6
Mylan also points out that Example 10 provides a similar
definition for the SDAI: “[The index] evaluates stool frequency,
rectal bleeding, mucosal appearance, and physician’s rating of
disease severity on scales of 0 to 3, with a maximum total score of
12"(Dkt. No. 74 at 27).
25
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MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS
the
general
description
of
the
DAI—an
index
used
to
assess
“ulcerative colitis disease activity”—as outlined in the first
paragraph of Example 5.
Notably, this paragraph does not define
(nor even refer to) “remission”; nor does it explain DAI score (or
subscores) in the context of remission.
Moreover, Mylan fails to
acknowledge that Example 5, upon which its specification argument
is almost entirely based, additionally states, “[r]elapse, as used
herein, included, for example, a rectal bleeding subscore of 1 or
more and a mucosal appearance subscale score of 2 or more using
the DAI.”
‘688 Patent, Example 5, col. 17:15-18 (emphasis added).
This portion of Example 5 lends credence to Salix’s arguments that
(1)
the
terms
“relapse”
and
“remission”
are
expressly
and
consistently defined throughout the specification in terms of two
subscores (rectal bleeding and mucosal appearance), and (2) the
description of the DAI in the first paragraph of Example 5 refers
only to a generalized description of means used to assess various
aspects of UC disease activity.
Mylan’s
proposed
Id.
construction
ultimately
contradicts
the
explicit, repeated definition of “remission” used by the patentee.
Throughout
consistently
subscores.
the
specification,
defined
“remission”
the
in
patentee
terms
of
expressly
and
specific
DAI
In particular, the patentee defined “remission” as a
26
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MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS
rectal bleeding score of 0 and a mucosal appearance subscore of
less than 2.
By clearly stating the special definition of the
term in the patent specification, the patentee chose to act as his
own
lexicographer,
and
this
definition
is
thus
controlling.
Phillips, 415 F.3d at 1316.
Mylan’s additional argument for its proposed construction of
the claim term relies on the litigation history of the ‘688
Patent.
In Novel, the court construed the term “remission is
defined as a DAI score of 0 or 1" to mean the language proposed
here by Mylan.
Judge Sleet noted:
This claim term is, itself, an express definition. It
tells the court exactly how to construe “remission.” In
relevant part, Claim 1 claims: “A method of maintaining
the remission of ulcerative colitis in a subject . . .
wherein: . . . remission is defined as a DAI score of 0
or 1."
Novel, 2015 WL 4240967, at *2, n.3.
As previously discussed,
however, a prior construction of the term in the Novel litigation
does not have a preclusive effect in this case.
2d at 672.
Dey, 958 F. Supp.
Because Judge Sleet’s construction contradicts the
specification (and, as discussed in subsection 3, the prosecution
history) of the ‘688 Patent, the Court declines to adopt it.
Although Judge Sleet found that the claim term itself “tells
the court exactly how to construe ‘remission,’” he also stated in
the
same
footnote
that
“the
court
27
need
only
reference
the
SALIX ET AL. V. MYLAN ET AL.
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MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS
specification [at Example 5] to determine how a DAI score is
calculated.”
Novel, 2015 WL 4240967, at *2, n.3.
In that sense,
Judge Sleet’s observations are consistent with Salix’s position
that, although the plain language of the claims explicitly defines
“remission,” it does not explicitly define or explain “DAI score of
0 or 1” or how DAI score is calculated.
Accordingly, the Court
declines to find that the claim term in its entirety constitutes an
express definition.
Moreover, this Court declines to rest its entire analysis of
the ‘688 specification solely on the first paragraph of Example 5,
which
ultimately
refers
to
a
generalized
description
of
the
assessment means (i.e., the modified Sutherland DAI), rather than
the
specific
“remission.”
DAI
parameters
used
by
the
patentee
to
define
Rather, an examination of the entirety of the ‘688
Patent leads to the conclusion that the patentee expressly and
repeatedly defined “remission” to mean “a rectal bleeding score of
0 and a mucosal appearance subscore of less than 2" throughout the
specification.
In sum, “remission” was consistently defined throughout the
specification to mean the subscores of rectal bleeding and mucosal
appearance (and not the sum of all DAI subscores).
Accordingly,
when taken together, the claims and specification support Salix’s
28
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MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS
proposed construction.
Merck & Co. v. Teva Pharms. USA, Inc., 347
F.3d 1367, 1371 (Fed. Cir. 2003) (“[T]erms in a patent document are
construed with the meaning with which they are presented in the
patent
document.
Thus
claims
must
be
construed
so
as
to
be
consistent with the specification, of which they are a part”);
Renishaw, 158 F.3d at 1249 (“The construction that stays true to
the claim language and most naturally aligns with the patent’s
description . . . will be, in the end, the correct construction.”).
3.
The Prosecution History
Salix’s proposed construction is further supported by the
prosecution history of the ‘688 Patent.
Office
(“PTO”)
determines
the
scope
The Patent and Trademark
of
claims
in
patent
applications “not solely on the basis of the claim language,” but
also “in light of the specification as it would be interpreted by
one of ordinary skill in the art.”
Phillips, 415 F.3d at 1316
(citing In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364
(Fed. Cir. 2004)).
Based on the record, the patent examiner and
patentee understood that a “DAI score of 0 or 1" meant a “rectal
bleeding subscore of 0 and a mucosal appearance subscore of less
than 2" on the DAI.
In a summary report of a 2012 applicant-initiated interview
regarding the rejection of pending claims, the patent examiner
29
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MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS
noted that the patentee would “consider amending claims . . . to
further define the subject population in having a Sutherland Score
of 0 or 1” (Dkt. No. 75 at 21-22).
The report goes on to state
that “[r]emission was defined as both a screening rectal bleeding
score of 0 (no bleeding) and a screening sigmoidoscopy score for
mucosal appearance of 0 . . . or 1 . . . on the revised Sutherland
Disease Index (SDAI).”
Id. at 22 (emphasis added).
The patentee
then amended the claims to add “remission is defined as a DAI score
of 0 or 1" (the language in Claims 1 and 16), noting that “support
can be found in the examples and throughout the specification.”
Id.
(emphasis
specification,
added).
These
demonstrate
statements,
that
both
the
together
patent
with
the
examiner
and
patentee understood “DAI score of 0 or 1" to mean a “rectal
bleeding subscore of 0 and a mucosal appearance subscore of less
than 2."
For the reasons discussed, the Court ADOPTS Salix’s proposed
construction and CONSTRUES “remission is defined as a DAI score of
0 or 1” to mean “remission is defined as a rectal bleeding subscore
of 0 and a mucosal subscore of less than 2.”
30
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IV.
CONCLUSION
The Court CONSTRUES the contested claim terms as follows:
1.
“Core” is to be given its plain and ordinary meaning;
2.
“Non gel-forming polymer matrix” means “a polymeric
material that does not become a gel when in contact with
fluid,
and
can
be
used
for
incorporation
of,
and
controlled release of, an active agent”; and
3.
“Remission is defined as a DAI score of 0 or 1" means
“remission is defined as a rectal bleeding subscore of 0
and a mucosal subscore of less than 2.”
Further,
the
Court
adopts
the
parties’
agreed
claim
constructions and CONSTRUES the following terms and phrases as
follows:
1.
“Matrix-forming polymer” means “polymers, except pHsensitive enteric polymers, that are used to form the non
gel-forming polymer matrix”;
2.
“Essentially insoluble” is to be given its plain and
ordinary meaning;
3.
“Pharmaceutically tolerable additive(s)” is to be given
its plain and ordinary meaning;
4.
“About,” as in about # hours, is to be given its plain
and ordinary meaning;
31
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5.
“About, as in about # mm, is to be given its plain and
ordinary meaning;
6.
“About five hours” is to be given its plain and ordinary
meaning;
7.
“Mean
maximal
plasma
concentration
of
the
5-
aminosalicylic acid is reached” is to be given its plain
and ordinary meaning;
8.
“Homogeneously dispersed” is to be given its plain and
ordinary meaning;
9.
“Without food” is to be given its plain and ordinary
meaning;
10.
“Wherein: said method maintains remission of ulcerative
colitis in a subject for period of at least 6 months of
treatment” is to be given its plain and ordinary meaning;
11.
“Pellet(s)”
is
to
be
given
its
plain
and
ordinary
meaning; and
12.
“Wherein 85 to 90% of the mesalamine reaches the terminal
ileum or colon” is to be given its plain and ordinary
meaning.
It is so ORDERED.
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The Court DIRECTS the Clerk to transmit copies of this Order
to counsel of record.
DATED:
April 12, 2016.
/s/ Irene M. Keeley
IRENE M. KEELEY
UNITED STATES DISTRICT JUDGE
33
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