Forest Laboratories LLC et al v. Accord Healthcare Inc. et al

Filing 105

ORDER CONSTRUING THE TERMS of U.S. Patent Nos. 7,834,020, 8,193,195, 8,236,804, and 8,673,921. Signed by Judge Gregory M. Sleet on 11/21/2016. (mdb) (Main Document 105 replaced on 11/21/2016) (mdb).

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,

· Plaintiffs,
v.
ACCORD HEALTHCARE INC., et al.,
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
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"):
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.

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-3yl)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

2

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. 370, 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-carbamoylbenzofuran-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-carbamoylbenzofuran-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[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-(2carbamoyl-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-(5cyanoindol-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-(2carbamoyl-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-carbamoylbenzofuran-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-carbamoylbenzofuran-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-cyanoindol3-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-(5cyanoindol-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-(5cyanoindol-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)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-(5cyanoindol-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-carbamoylbenzofuran-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-3yl)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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