throbber
Case 1:15-cv-00109-IMK Document 117 Filed 04/12/16 Page 1 of 33 PageID #: 1484
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`
`SALIX PHARMACEUTICALS, INC. and
`DR. FALK PHARMA GmbH,
`Plaintiffs/Counter-Defendants,
`CIVIL ACTION NO. 1:15CV109
`(Judge Keeley)
`
`v.
`
`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 Pharmaceuticals, Inc. (collectively,
`“Salix”). These include: Patent No. 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 patents cover a controlled release pellet
`formulation containing mesalamine for the treatment 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.
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`MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS
`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. BACKGROUND
`In a letter dated May 14, 2015, the defendants, Mylan
`Pharmaceuticals, Inc. and Mylan, Inc. (collectively, “Mylan”),
`notified Salix that they had filed an Abbreviated New Drug
`Application (“ANDA”) seeking United States Food and 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 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 entire patent, including both asserted and
`unasserted claims. Id. at 1314. 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
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`(Fed. Cir. 2004)).
`Aside from the claims themselves, the specification in the
`patent often provides the “‘best source for understanding a
`technical term.’” 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.” Schriber-
`Schroth 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 ordinary and customary meaning.
`Phillips, 415 F.3d at 1316. 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. 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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`MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS
`III. ANALYSIS
`
`A.
`
`“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 definition, which attempts to read out the coating
`entirely, conflicts with the claim language. 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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`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. The fact that four different
`coatings are listed in the 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 the controlled release of
`mesalamine in the intestinal tract.3 Id. at 3, n. 1. He stated
`
`3 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. After the enteric coating
`dissolves, intestinal fluids reach 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 patentee’s statement, when viewed in context, is
`consistent with the clear language of the claim terms and
`specifications. 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. 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 reading of the public record.”
`Vitronics, 90 F.3d at 1584. 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.
`16
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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 based on stool frequency, bleeding, mucosal
`appearance on endoscopy, and physician’s rating of disease
`activity” (Dkt. Nos. 74, 101) (emphasis added). Mylan contends
`that the claims, specification, and prosecution history of the ‘688
`Patent support its proposed construction. Id.
`1.
`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.
`
`17
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`Case 1:15-cv-00109-IMK Document 117 Filed 04/12/16 Page 18 of 33 PageID #: 1501
`
`1:15CV109
`
`SALIX ET AL. V. MYLAN ET AL.
`MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS
`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., rectal bleeding and mucosal
`appearance) (Dkt. 75 at 21). 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
`
`18
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`Case 1:15-cv-00109-IMK Document 117 Filed 04/12/16 Page 19 of 33 PageID #: 1502
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`1:15CV109
`
`SALIX ET AL. V. MYLAN ET AL.
`MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS
`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.” Id. (emphasis
`added). Mylan thus argues that this “explicit definition”
`controls. Id. at 27. 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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`

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`Case 1:15-cv-00109-IMK Document 117 Filed 04/12/16 Page 20 of 33 PageID #: 1503
`
`1:15CV109
`
`SALIX ET AL. V. MYLAN ET AL.
`MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS
`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.” Id. (citing Multiform Desiccants,
`133 F.3d at 1477). 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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`Case 1:15-cv-00109-IMK Document 117 Filed 04/12/16 Page 21 of 33 PageID #: 1504
`
`1:15CV109
`
`SALIX ET AL. V. MYLAN ET AL.
`MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS
`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,

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