IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`FOREST LABORATORIES, LLC, FOREST
`LABORATORIES HOLDINGS, LTD., MERCK
`KGaA and MERCK PATENT GESELLSCHAFT
`MIT BESCHRANKTER HAFTUNG,
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`· Plaintiffs,
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`v.
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`ACCORD HEALTHCARE INC., et al.,
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`Defendants.
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`Civil Action No. 15-272-GMS
`CONSOLIDATED
`
`ORDER CONSTRUING THE TERMS OF
`U.S. PATENT NOS. 7,834,020, 8,193,195, 8,236,804, AND 8,673,921
`
`After having considered the submissions of the parties, and hearing oral argument on the
`
`matter, IT IS HEREBY ORDERED, ADJUDGED, and DECREED that, as used in the asserted
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`claims of U.S. Patent Nos. 7,834,020 ("the '020 patent"), 8,193,195 ("the '195 patent"),
`
`8,236,804 ("the '804 patent"), and 8,673,921 ("the '921 patent"):
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`1. The terms "administer," "administered," and "administering" are construed to mean
`"deliver[ ed/ing] into the body."1
`
`2. The term "corresponding to" is construed to mean "matching the values recited in the
`claims, including error ranges stated therein. "2
`
`1 Prior to the Markman hearing, the parties agreed on this construction. The parties submitted a
`stipulation to that effect on October 19, 2016.
`2 Prior to the Markman hearing, the parties agreed on this construction. The parties submitted a
`stipulation to that effect on October 19, 2016.
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`3. The term "exhibits the following XRD data" is construed to mean "show all the following
`peaks and intensities, including an error range of+/- O. le for the two-theta values."3
`
`4. The entire preamble "[a] method of treating a patient suffering from a depressive disorder, an
`anxiety disorder, a bipolar disorder, mania, dementia, a substance-related disorder, a sexual
`dysfunction, an eating disorder, obesity,Jibromyalgia, a sleeping disorder, a psychiatric
`disorder, cerebral infarct, tension, side-effects in the treatment of hypertension, a cerebral
`disorder, chronic pain, acromegaly, hypogonadism, secondary amenorrhea, premenstrual
`syndrome, undesired puerperal lactation, or combinations thereof ... " is construed as
`limiting.4
`
`5. The term "effective amount" is construed as "an amount sufficient to promote a therapeutic
`effect."5
`
`3 Prior to the Markman hearing, the parties agreed on this construction. The parties submitted a
`stipulation to that effect on October 19, 2016.
`4 Prior to the Markman hearing, the parties agreed on this construction. The parties submitted a
`stipulation to that effect on October 19, 2016.
`5 Defendants' proposed construction for "effective amount'' was "[a]n amount of the specified
`crystalline modification of vilazodone HCL sufficient to produce the desired effect." (D.I. 86 at 4).
`Plaintiffs requested that the court construe "effective amount" as an "amount sufficient to promote a
`therapeutic effect." Id. The court adopts Plaintiffs' proposed construction. We do, however, wish to
`emphasize that there must be an effective amount of whatever compound follows the term "effective
`amount" in the claims. The court notes that there does not seem to be a genuine dispute between the
`parties over this issue. Plaintiffs state that "the phrase 'the specified crystalline modification of
`vilazodone HCL' in [D]efendants' proposed construction of 'effective amount' should be rejected
`because it is redundant: each of the claims at issue identifies what substance must be present in an
`'effective amount.'" (D.I. 96 at 15). The court agrees with Plaintiffs' characterization of Defendants'
`construction as redundant. We will not say that a specific crystalline form of 1-[ 4-( 5-cyanoindol-3-
`yl)butyl]-4-(2-carbamoyl-benzofuran-5-yl)-piperazine hydrochloride must be present in an amount that is
`effective because that would lead to either a nonsensical or redundant reading of the claims.
`Claim 1 of the '195 patent discloses "an effective amount of a compound which is a crystalline
`hydrochloride salt of 1-[ 4-(5-cyanoindol-3-yl)butyl]-4-(2-carbamoyl-benzofuran-5-yl)-piperazine." '195
`patent, col. 26 II. 61--64. Claim 1 does not recite an effective amount of a specified crystalline
`modification. Therefore, it would be nonsensical to construe "effective amount'' to demand that an
`effective amount of a specific crystalline modification be present in the final compound.
`Claim 1 of the '804 patent states that there must be "an effective amount of a compound which
`is 1-[ 4-( 5-cyanoindol-3-yl)butyl]-4-(2-carbamoyl-benzofuran-5-yl)-piperazine hydrochloride anhydrate in
`crystalline modification IV (Form IV)." '804 patent, col. 27 ll.17-col. 28 ll.1. In this case, to construe
`"effective amount" to mean an amount of the specified crystalline modification ofvilazodone HCL would
`be redundant because the claim term plainly tells us that there must be an effective amount ofvilazodone
`HCL anhydrate Form IV. Therefore, the court does not find it necessary to construe "effective amount"
`to mean an amount of the specific crystalline form ofvilazodone disclosed in some of the claims.
`The parties also dispute whether an "effective amount" must "produce" ·or "promote" a desired or
`therapeutic effect. Plaintiffs contend that an "effective amount'' is one "sufficient to promote a
`therapeutic effect," whereas Defendants declare that it must be an amount "sufficient to produce the
`desired effect." (D.I. 87 at 15). First, the court notes that the parties do not dispute the meaning of
`"desired effect" versus "therapeutic effect." When Defendants were asked during the Markman hearing if
`they believed there was a difference between therapeutic and desired effect, they responded that "the
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`6. The term "crystalline modification" is construed to mean "crystalline form" and the term
`"crystalline" is construed in accordance with its plain and ordinary meaning. 6
`
`therapeutic effect here would be the desired effect." Markman Hr'g, 76:4-5. Second, the court will adopt
`Plaintiffs' proposed construction of "promoting a therapeutic effect" because the parties entered into a
`stipulation that supports such a construction.
`The parties stipulated that the term "treating" should be construed to mean "attempting to cause a
`therapeutic effect on," and the phrase "is treated in the patient" should be construed to mean "an attempt
`is made to cause a therapeutic effect in the patient." (D.I. 101 at 2). The preamble to claim 1 of the '804
`patent discloses "[a] method of treating a major depressive disorder." '804 patent, col. 271. 15. The end
`of that same claim states ''wherein the major depressive disorder is treated in the patient." Id. col. 28 I. 7.
`The plain language of the claim is clear that the effective amount is an amount sufficient to treat a patient
`with a major depressive disorder. When the court substitutes the parties' stipulation for the term "treat"
`and the phrase "is treated in the patient," it is left with an understanding that the effective amount must be
`one that is sufficient to attempt to cause a therapeutic effect on. Had the stipulation for the term
`"treating" been "to cause a therapeutic effect on," it is possible that the court would have come out the
`other way. Because the word "attempt" is inserted into the stipulated construction, however, the word
`"promote" in Plaintiffs' proposed construction is more appropriate than "produce."
`Defendants state that a clinician would consider an "effective amount" to be an amount
`necessary to "cause the desired effect." (D.I. 93 at 5). While that may be true, the parties explicitly
`stipulated that "treating" meant "attempting to cause." (D.I. 101 at 2). If the comi does not adopt
`Plaintiffs' proposed construction it is left with a nonsensical claim that effectively requires "a method of
`[attempting to cause a therapeutic effect on] a major depressive disorder ... [by] administering ... a
`pharmaceutical composition comprising an [amount ofvilazodone sufficient to produce the therapeutic
`effect]." '804 patent, col. 2711. 15-18. The court does not see how you can attempt to have a therapeutic
`effect on a patient when administering an amount of a drug sufficient to produce the therapeutic effect. It
`makes more sense, given the structure of the claim and the stipulation, to say that a physician would
`attempt to cause a therapeutic effect on a patient by giving him an amount sufficient to promote that
`effect. Therefore, the comi adopts Plaintiffs' proposed construction.
`6 Defendants request that both "crystalline" and "crystalline modification" be construed to mean
`"entirely in crystalline form comprising only Form I to XVI, and combinations thereof (as appropriate)."
`(D.I. 86 at 6). Plaintiffs contend that the term "crystalline" does not need construction and should be
`construed in accordance with its plain and ordinary meaning. (D.I. 87 at 4). It seems that both
`Defendants' and Plaintiffs' experts agree on the plain and ordinary meaning of "crystalline" to a person
`having ordinary skill in the art-a solid morphological form where "atoms or molecules are arranged with
`a three-dimensional long-range order." (D.I. 88 iii! 19, 35); see (D.I. 94 iJ 23) (Defendants' expert
`agreeing with Plaintiffs' expert that "crystalline" means "the arrangement of atoms or molecules with a
`3D long-range order"). Though the court does find some of Defendants' argument persuasive, they are
`not convincing enough to warrant a depaiiure from the plain and ordinary meaning of "crystalline" when
`the claim language, specification, and prosecution history are analyzed as a coherent whole. See Vitronics
`Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996) (there is a presumption that words of a
`claim will generally be given their "ordinary and customary meaning" absent clear intention from the
`patentees to act as their own lexicographers); see also See Markman v. Westview Instruments, Inc., 517
`U.S. 3 70, 3 89 (1996) ("a term can be defined only in a way that comports with the instrument as a
`whole.").
`Defendants state that because claim 1 of U.S. Patent No. 7,834,020, claim 1 of U.S. Patent No.
`8,236,804, and claims 5, 11, and 13 of U.S. Patent No. 8,673,921 all use "crystalline modification"
`followed by "IV" or "(V)" or a parenthetical further stating "(Form IV)," "crystalline modification" and
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`"crystalline" must refer to only forms of crystalline vilazodone disclosed in the patent. '020 patent, col.
`27 ll.42-43; '804 patent, col. 28, 1. 1; '921 patent, col. 2711. 15-26, col. 2811. 8, 33. It is not clear why
`referring specifically to certain forms of vilazodone in certain claims would mean that the terms
`"crystalline" and "crystalline modification" could only refer to the specific polymorphs identified as
`Forms I-XVI. Plaintiffs never try to argue that "crystalline" vilazodone or a "crystalline modification" of
`vilazodone refers to a form of vilazodone that is not crystalline. See Markman Hr'g 37:8 ("crystalline
`vilazodone is crystalline). Instead, Plaintiffs contend that there is no support in the specification or the
`claims for limiting "crystalline" or "crystalline modification" to only Forms I through XVI. The court
`agrees.
`
`The language in claim 1 of the '921 patent supports Plaintiffs' argument. Claim 1 discloses "a
`compound which is 1-[ 4-( 5-cyanoindol-3-yl)butyl]-4-(2-carbamoyl-benzofuran-5-yl)-piperazine
`hydrochloride in its crystalline modification." '921 patent col. 2711.13-15. Dependent claims 2, 3, and 4
`then claim the compound of claim 1 in a specific crystalline modification. Id. at col. 2711. 17-22. If the
`court adopted Defendants' proposed construction, it would be redundant to have independent claim 1 and
`then dependent claims 2 through 4-there would be no need to further disclose specific modifications in
`the dependent claims if they were already encompassed by claim 1. Additionally, construing claim 1 as
`directed to only crystalline modifications I-XVI would violate the well-known doctrine of claim
`differentiation. See Curtiss-Wright Flow Control C01p. v. Velan, Inc., 438 F.3d 1374, 1380 (Fed. Cir.
`2006) (referring "to the presumption that an independent claim should not be construed as requiring a
`limitation added by a dependent claim").
`The language in claim 1 of the '195 patent is similar to the language in claim 1 of the '921 patent
`in that it does not specify a form, I through XVI, that 1-[ 4-( 5-cyanoindol-3-yl)butyl]-4-(2-carbamoyl(cid:173)
`benzofuran-5-yl)-piperazine must take. '195 patent, col. 26 11. 60-65. Instead, claim 1 discloses "a
`compound which is a crystalline hydrochloride salt of 1-[ 4-(5-cyanoindol-3-yl)butyl]-4-(2-carbamoyl(cid:173)
`benzofuran-5-yl)-piperazine." Id. col. 26 11. 62-64. Claims 3, 4, 5, and 6 then disclose a compound that
`is a hydrate, monohydrate, and hemihydrate, respectively, of the compound in claim 1. Id. col. 2711. 4, 7,
`9-12. Claims 7-15 then go on to disclose the compound of claim 1 in the different crystalline forms,
`specifically forms III, IV, V, and VIII. Id. col. 2711. 13-24, col.11. 281-21. Under Defendants' proposed
`construction, claims 7-15 of the '195 patent would be redundant because claims 1-6 would cover all of
`the specific crystalline forms. Again, such redundancy would violate the doctrine of claim differentiation
`and fail to comport with the structure and plain meaning of the claims
`One of Defendants' most persuasive arguments for why "crystalline" should not have its plain
`and ordinary meaning is that Forms I-XVI are characterized as "products of the invention" in the
`specification shared by all the patents in suit. '195 patent, col. 14, 11. 47-48. Defendants contend that the
`use of "crystalline" and "crystalline modification" in the specification is analogous to the use of
`"injectable, aqueous pharmaceutical composition" in the specification of the patent at issue in Baxter
`Healthcare Corp. V. Mylan Laboratories, Ltd., because in both cases the specification clearly limited the
`term in ways not inherently obvious from the claim language. Nos. 14-cv-7094, 2016 WL 1337279, at
`*14-15 (D.N.J. Apr. 5, 2016). In Baxter, the court explains that in rare situations when the specification
`contains clear and unambiguous limiting statements, such as "the present invention includes" or "all
`embodiments of the present invention are," the court will limit the claims to what the invention includes
`or the preferred embodiments. Id. at *14 (quoting Pacing Techs., LLC v. Garmin Int'!, Inc., 778 F.3d
`1021, 1024 (Fed. Cir. 2015)).
`The Baxter court found that the terms "stable" and "ready to use" should be included in the claim
`phrase "injectable, aqueous pharmaceutical composition" because the specification stated that the prior art
`left open a need for a ready-to-use, stable form of the claimed compound. Id. Additionally, the Summary
`of the Invention stated that the invention related to a ready-to-use, injectable form of the composition. Id.
`Here, the specifications for the patents at issue state that the prior art was directed to mixtures of
`amorphous, crystalline and free-base forms of vilazodone, creating a need in the art for pure crystal or
`crystalline forms of the compound. '202 patent, col. 111. 60-67, col. 211. 1-6. The first sentence of the
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`Summary of the Invention makes clear that the invention is "[m]ethods for preparing pure crystals of l(cid:173)
`[4-(5-cyanoindol-3-yl)butyl]-4-(2-carbamoyl-benzofuran-5-yl)-piperazine hydrochloride." '020 patent,
`col. 211. 20-22. The Summary of the Invention section then goes on to state that "[fjurthermore,
`surprisingly" new forms of 1-[ 4-( 5-cyanoindol-3-yl)butyl]-4-(2-carbamoyl-benzofuran-5-yl)-piperazine
`were found, along with processes for their preparation. As Plaintiffs point out, this implies that the patent
`is directed generally to methods for preparing pure crystals of 1-[ 4-( 5-cyanoindol-3-yl)butyl]-4-(2-
`carbamoyl-benzofuran-5-yl)-piperazine hydrochloride. Markman Hr'g, 27:3-7. Then, in addition to that
`general method, the patent also discloses new crystalline forms that fall into four general classes:
`hydrochloride hydrates, hydrochloride anhydrates, solvates, and pure amorphous. '020 patent, col. 2 11.
`29-67, col. 3 11. 1-20. Thus, the patent is directed to a method for preparing pure crystals of 1-[ 4-( 5-
`cyanoindol-3-yl)butyl]-4-(2-carbamoyl-benzofuran-5-yl)-piperazine hydrochloride, a method for
`preparing the specific polymorphs of that general compound, and the polymorphs themselves. The
`specification here, unlike in Baxter, does not clearly limit the scope of "crystalline" or "crystalline
`modification."
`The specification routinely describes crystalline forms of 1-[ 4-( 5-cyanoindol-3-yl)butyl]-4-(2-
`carbamoyl-benzofuran-5-yl)-piperazine generally, and when the patentees wanted to refer to specific
`"preferred forms" within a broader class of a crystalline modification, they did so explicitly. In the
`section of the specification that describes solvates of l-[4-(5-cyanoindol-3-yl)butyl]-4-(2-carbamoyl(cid:173)
`benzofuran-5-yl)-piperazine hydrochloride, a number of different solvents and the molar ratios of those
`solvents and the main compound are disclosed. '020, col. 4 11. 9--40. Only after that introductory
`paragraph does the specification explain the specific "preferred forms of solvates." Id. 11. 41--43. These
`preferred forms are forms I, II, XV, X, XI, and XN. Id. 11. 44-64. Each "preferred form[]" has a specific
`molar ratio of solvent to the main compound, a "characteristic IR absorption spectra," and a
`"characteristic X-ray diffraction pattern." Id. col. 51. 21-col. 91. 12. Despite the fact that the
`specification shared by all the patents in suit refers to Forms I-XVI as the "products of the invention," the
`specification as a whole makes clear that Forms I-XVI are preferred embodiments, not the entirety of the
`invention. '020 patent, col. 4 11. 47--49. Therefore, limitations from the specification will not be read into
`the claim terms. See Williamson v. Citrix Online, LLC, 770 F.3d 1371, 1377 (Fed. Cir. 2014) (explaining
`the court's presumption against limiting the claims to specific examples or embodiments in the
`specification), vacated, 603 F. App'x 1010 (Fed. Cir. 2015).
`.
`Additionally, the prosecution histories of the patents in suit do not contain a clear disavowal of
`the argument that "crystalline" is broader than just forms I through XVI. In the '020 patent prosecution
`history, applicants amended claim 1 to include "l-[4-(5-cyanoindol-3-yl)butyl]-4-(2-carbamoyl(cid:173)
`benzofuran-5-yl)-piperazine hydrochloride anhydrate in crystalline modification N." (D.I. 97, Ex. 10 at
`2). Defendants argue that, because this amendment was in response to a rejection of that claim under 35
`U.S.C § 102(b), in light of the '241 patent, Plaintiffs are estopped from asserting that "crystalline" is
`broader than the specific forms identified in the specification and some of the claims. (D.I. 86 at 9). The
`rejection by the Examiner, however, states that "the '241 patent discloses amorphous 1-[ 4-( 5-cyanoindol-
`3-yl)butyl]-4-(2-carbamoyl-benzofuran-5-yl)-piperazine hydrochloride." (D.I. 97, Ex. 11 at 5). Prior to
`amendment by the applicants, claim 1 of the '020 patent disclosed the amorphous form of l-[4-(5-
`cyanoindol-3-yl)butyl]-4-(2-carbamoyl-benzofuran-5-yl)-piperazine hydrochloride. (D.I. 97, Ex. 12 at 2).
`Therefore, it is not clear why applicants amended claim 1 to delete a number of forms originally disclosed
`in the patent application along with the amorphous form, only leaving Form N of the compound. Omega
`Eng'g, Inc, v. Raytek Corp., 334 F.3d 1314, 1324 (Fed. Cir. 2003) (holding that the doctrine of
`prosecution disclaimer will not apply to situations where the supposed disavowal of claim scope is
`ambiguous).
`The prosecution histories of the' 195 and '921 patents only lend further support to Plaintiffs'
`proposed construction. In a non-final rejection of claims in the '195 patent, the Examiner noted that the
`closest prior art was the '241 patent, and that patent failed "to teach or suggest a crystalline form of 1-[ 4-
`( 5-cyanoindol-3-yl)butyl]-4-(2-carbamoyl-benzofuran-5-yl)-piperazine hydrochloride. (D.I 97, Ex. 13 at
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`13-14 ). Therefore, the '241 patent "fail[ ed] to anticipate or render obvious claims reciting specific
`crystalline forms of 1-[ 4-( 5-cyanoindol-3-yl)butyl]-4-(2-carbamoyl-benzofuran-5-yl)-piperazine
`hydrochloride." (D.I. 97, Ex. 13 at 13-14). The Notice of Allowability for the '921 makes a very similar
`finding with regard to the '241 patent, stating that it "does not teach the claimed crystalline forms." (D.I.
`97, Ex. 19 at 2). It is worth noting that claim 1 of the '921 is a claim broadly directed to "1-[4-(5-
`cyanoindol-3-yl)butyl]-4-(2-carbamoyl-benzofuran-5-yl)-piperazine hydrochloride in its crystalline
`- modification." '921 patent, col. 2711. 13-15. This broad claim was allowed over the compound
`disclosed in the '241 patent, further demonstrating that naming a specific crystalline form was not
`necessary to overcome the prior art.
`Oddly, during prosecution of the '804 patent the Examiner rejected claim 1 of the patent
`application as being anticipated by the '241 patent. (D.I. 97, Ex. 18 at 6). The examiner stated that the
`'241 patent did teach a method of using 1-[ 4-(5-cyanoindol-3-yl)butyl]-4-(2-carbamoyl-benzofuran-5-yl)(cid:173)
`piperazine in its crystalline hydrochloride salt form. Id. In the applicants' response, they specifically
`state that they are not acquiescing to the characterization of the claims, but they amended claim 1 to recite
`polymorphic form IV. (D.I. 97, Ex. 17 at 4). Additionally, during prosecution of the '921, the '195, and
`the '020 patents the Examiner said that the '241 patent did not disclose crystalline forms of l-[4-(5-
`cyanoindol-3-yl)butyl]-4-(2-carbamoyl-benzofuran-5-yl)-piperazine hydrochloride. For those two
`reasons, the court does not find that the amendment to the '804 patent demonstrates a clear disavowal of
`the argument that "crystalline" is broader than just Forms I-XVI.
`Defendants also ask the court to construe the term "crystalline modification" to mean "entirely in
`crystalline form comprising only Form I to XVI, and combinations thereof (as appropriate)." (D.I. 86 at
`6). This is the same construction they requested for "crystalline." Id. The court declines to adopt
`Defendants' proposed construction because the patentees have defined what they mean by "crystalline
`modification" in the specification shared by all the patents in suit. The '020 patent specification states
`"[t]hroughout the specification, the term 'Form' is generally used as a synonym for the term
`"modification" or "crystalline modification." '020 patent, col. 211. 26-29. The specification then states
`that the "present invention furthermore provides l-[4-(5-cyanoindol-3-yl)butyl]-4-(2-carbamoyl(cid:173)
`benzofuran-5-yl)-piperazine hydrochloride hydrates in crystalline modifications." Id. 11. 41--43.
`Analyzed as a whole, the specification indicates that "ciystalline modification" means a crystalline
`morphological form that 1-[ 4-( 5-cyanoindol-3-yl)butyl]:-4-(2-carbamoyl-benzofuran-5-yl)-piperazine
`hydrochloride is capable of taking.
`Claim 1 of the '921 patent is further evidence of the patentees intention to use "crystalline
`modification" to broadly define the relevant crystalline forms-crystalline anhydrates, crystalline
`hydrates, crystalline solvates, and crystalline dihydrichlorides. See '921 patent, col. 2711. 13-16 ("[a]
`compound which is 1-[ 4-(5-cyanoindol-3-yl)butyl]-4-(2-carbamoyl-benzofuran-5-yl)-piperazine
`hydrochloride in its crystalline modification, wherein the compound is an anhydrate, hydrate, solvate, or
`dihydrochloride). Therefore, the court agrees with Plaintiffs' proposed construction. "Crystalline
`modification" will be construed as crystalline form, referring broadly to the categories of crystalline
`forms that 1-[ 4-(5-cyanoindol-3-yl)butyl]-4-(2-carbamoyl-benzofuran-5-yl)-piperazine hydrochloride can
`take.
`
`The court does not believe that there is support in the claim language, specification or prosecution
`histories for Defendants' proposition that "crystalline" and "crystalline modification" must be interpreted
`to mean that the resulting compound is "entirely crystalline." (D.I. 86 at 6). When a patent recites a
`compound comprising a specific polymorphic form, that does not foreclose the possibility that other
`active ingredients are also present. See In re Armodafinil Patent Litig. Inc., 939 F. Supp. 2d 456, 474 (D.
`Del. 2013) (explaining that the claim term "comprising" allows for other forms of armodafinil to be
`present in the recited composition). Additionally, the prosecution history does not present a reason why
`crystalline must be interpreted to mean entirely crystalline. As previously noted, the prosecution history
`repeatedly characterized the '241 patent as disclosing an amorphous form of 1-[4-(5-cyanoindol-3-
`yl)butyl]-4-(2-carbamoyl-benzofuran-5-yl)-piperazine hydrochloride. (D.I. 97, Ex. 11 at 5); (D.I. 97, Ex.
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`7. The term "characteristic peak" is construed to mean "peak representative of a crystalline
`form's X-ray diffraction pattern."7
`
`Dated: November __l_l_, 2016
`
`13 at 12-13). There is no clear reason why a prior art patent disclosing an amorphous form of vilazodone
`hydrochloride would necessitate that the terms at issue be construed to mean "entirely crystalline."
`Defendants' arguments that the terms at issue, if not entirely crystalline, are anticipated or rendered
`obvious by the '241 prior art patent are invalidity arguments, not appropriate at this stage of litigation.
`Therefore, the comt will not limit the construction of "crystalline" or "crystalline modification" to
`"entirely crystalline" when nothing in the claim language, specification or prosecution history warrant
`such a limitation.
`7 Defendants maintain that "characteristic peak" should be construed as "a powder XRD peak
`having intensity 2: 3 *noise, which serves to identify the crystalline modification." (D.I. 86 at 17).
`Defendants explain that "Table III of the '804 patent lists data for powder X-ray diffraction patterns for
`sixteen polymorphic forms." Id. Defendants then point out that Form XN shows data for only seven
`characteristic peaks, whereas all the other polymorphic forms have data for ten characteristic peaks. Id. at
`17-18; see '804 patent, col. 26 11. 4 7--49. Defendants declare that, because the specification says
`"[f]urther peaks exhibit intensities <3* noise," '804 patent, col. 271. 11, the patentees do not consider a
`peak less than three times the noise level a "characteristic peak." (D.I. 86 at 17-18). The claim language,
`specification, and prosecution history, however, do not support Defendants' construction. See Markman
`v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed. Cir. 1995), affd, 517 U.S. 370 (1996) (explaining
`that to asce1tain the meaning of the claims, the comt looks to the claims, the specification, and the
`prosecution history).
`Table III is titled "[d]ata ofpowder-XRD-pattem of polymorphic Forms. (10 characteristic peaks
`of each polymorph have been taken for evaluation. The XRD instrument is controlled for 2Theta +/-0.1)."
`'804 patent, col. 24 11. 30-35. The titles indicates that "10 characteristic peaks of each polymorph have
`been taken for evaluation," which implies that there could be other characteristic peaks for each
`polymorph-the peaks shown in Table III were just those taken for evaluation. See id.
`While Form XN has an asterisk for peaks 8, 9, and 10, stating that "further peaks exhibit
`intensities <3*noise,'' that does not appear to contradict or undermine the title of Table III. See '804
`patent, col. 26 11. 47-29. Table III explicitly states the peaks it includes are "characteristic peaks." '804
`patent, col. 24 I. 32. Though applicants may have decided not to include the peaks exhibiting intensities
`<3 *noise in Table III, the plain language does nothing to suggest that those peaks do not qualify as
`characteristic peaks. If anything, the fact that the statement next to the asterisk says "further peaks"
`implies that there are possibly many more peaks that the applicants chose not to include in Table III. See
`'804 patent, col. 2 7 I. 11. The patent does not explicitly say that characteristic peaks are only those that
`exhibit intensities <3 *noise. The co mt declines to read that limitation into the term.
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