Case 1:20-cv-00968-MSG Document 114 Filed 04/08/22 Page 1 of 21 PageID #: 5328
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`
`
`
`
`
`
`
`
`
`C.A. No. 20-968 (MSG)
`(Consolidated)
`
`
`
`
`
`C.A. No. 20-1009 (MSG)
`
`
`
`v.
`
`ABBVIE INC., et al.,
`
`
`Plaintiffs,
`
`
`DR. REDDY’S LABORATORIES, LTD., et
`al.,
`
`
`Defendants.
`
`ABBVIE INC., et al.,
`
` Plaintiffs,
`
` v.
`
`ALEMBIC PHARMACEUTICALS LTD.,
`ALEMBIC PHARMACEUTICALS, INC.,
`and ALEMBIC GLOBAL HOLDING SA,
`
` Defendants.
`
`
`
`PLAINTIFFS’ OPENING CLAIM CONSTRUCTION BRIEF
`
`

`

`Case 1:20-cv-00968-MSG Document 114 Filed 04/08/22 Page 2 of 21 PageID #: 5329
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`TABLE OF CONTENTS
`
`
`Page
`
`
`I.
`INTRODUCTION ................................................................................................................... 1
`II. BACKGROUND ..................................................................................................................... 2
`III. THE LEGAL STANDARDS FOR CLAIM CONSTRUCTION ............................................ 6
`IV. THE DISPUTED CLAIM TERMS ......................................................................................... 7
`A. “a powder X-ray diffraction pattern having five or more peaks selected from those at
`6.3, 7.1, 9.0, 9.5, 12.5, 14.5, 14.7, 15.9, 16.9, and 18.9 degrees 2θ (pattern A)” ............. 7
`1. No Construction Is Necessary ................................................................................... 7
`2.
`If a Construction Is Necessary, Plaintiffs’ Construction Is Consistent with the
`Claim Language and Intrinsic Record ....................................................................... 8
`3. The Specification Supports Plaintiffs’ Construction ................................................. 9
`4. The Prosecution History Further Supports Plaintiffs’ Construction ....................... 10
`5. Defendants’ Construction Is Contrary to the Intrinsic Record and Should Be
`Rejected ................................................................................................................... 12
`B. Claim 1 of the ’649 Patent and Claim 1 of the ’873 Patent ............................................. 16
`C. Claims 4 and 7 of the ’873 Patent ................................................................................... 17
`V. CONCLUSION ..................................................................................................................... 18
`
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`Case 1:20-cv-00968-MSG Document 114 Filed 04/08/22 Page 3 of 21 PageID #: 5330
`
`Cases
`
`TABLE OF AUTHORITIES
`
`Bicon, Inc. v. Straumann Co.,
`441 F.3d 945 (Fed. Cir. 2006)................................................................................................. 15
`
`Discovery Patent Holdings, LLC v. Amazon.com, Inc.,
`769 F.Supp.2d 662 (D. Del. 2011) ............................................................................................ 8
`
`E-Pass Techs., Inc. v. 3Com Corp.,
`473 F.3d 1213 (Fed. Cir. 2007)................................................................................................. 6
`
`Forest Laboratories, LLC v. Accord Healthcare Inc.,
`No. 15-272-GMS, 2016 WL 6892094 (D. Del. Nov. 21, 2016) ............................................. 14
`
`Hill-Rom Servs. v. Stryker Corp.,
`755 F.3d 1367 (Fed. Cir. 2014)......................................................................................... 13, 17
`
`Int’l Bus. Machs. Corp. v. Priceline Grp. Inc.,
`No. 15-137-LPS, 2016 WL 6405824 (D. Del. Oct. 28, 2016) .................................................. 8
`
`Kyocera Wireless Corp. v. Int’l Trade Comm’n,
`545 F.3d 1340 (Fed. Cir. 2008)................................................................................................. 6
`
`Linear Tech. Corp. v. Int’l Trade Comm’n,
`566 F.3d 1049 (Fed. Cir. 2009)................................................................................................. 7
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005)......................................................................................... 6, 7, 9
`
`Rosco, Inc. v. Velvac, Inc.,
`No. 11-117-LPS, 2012 WL 6028239 (D. Del. Dec. 4, 2012) ................................................. 15
`
`ScriptPro LLC v. Innovation Associates, Inc.,
`833 F.3d 1336 (Fed. Cir. 2016)............................................................................................... 10
`
`Silicon Graphics, Inc. v. ATI Techs., Inc.,
`607 F.3d 784 (Fed. Cir. 2010)................................................................................................... 6
`
`Williamson v. Citrix Online, LLC,
`792 F.3d 1339 (Fed. Cir. 2015)......................................................................................... 13, 17
`
`Statutes
`
`Hatch-Waxman Act .........................................................................................................................1
`
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`Case 1:20-cv-00968-MSG Document 114 Filed 04/08/22 Page 4 of 21 PageID #: 5331
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`I.
`
`INTRODUCTION
`
`AbbVie and Genentech (“Plaintiffs”) invented and market Venclexta®, a groundbreaking
`
`“orphan drug”1 for treatment of chronic lymphocytic leukemia (“CLL”), small lymphocytic
`
`lymphoma (“SLL”), and acute myeloid leukemia (“AML”). See, e.g., Ex. 1 at 1; Ex. 2 at 1-6.2
`
`CLL and SLL are blood cancers that progress until “morbidity is considerable, both from the
`
`disease and from complications of therapy.” See, e.g., Ex. 3 at 1, 4-5. AML is “one of the most
`
`aggressive blood cancers, with a very low survival rate,” attacking with such speed that it affords
`
`few options for some patients to receive treatment before the introduction of Venclexta. See,
`
`e.g., Ex. 4 at 1.
`
`Plaintiffs filed these patent infringement cases under the Hatch-Waxman Act in response
`
`to Defendants’ Abbreviated New Drug Applications, which seek approval to market generic
`
`versions of Venclexta®. The lawsuits involve three patent families: (1) a family covering the
`
`active ingredient in Venclexta® (a compound known as “venetoclax”) and methods of use
`
`thereof; (2) a family covering certain crystalline forms, or “polymorphs,” of venetoclax; and (3)
`
`a family covering dosing/administration of venetoclax. This claim construction proceeding
`
`includes terms only from the three related patents within the second “polymorphs” family.
`
`Defendants have collectively identified five terms for construction, which implicate
`
`similar claim construction issues. These terms concern venetoclax crystalline forms with powder
`
`X-ray diffraction (“PXRD”) patterns having a recited number of peaks. PXRD, as described
`
`
`1 An orphan drug is “used to treat, prevent, or diagnose an orphan disease. An orphan disease is
`a rare disease or condition that affects fewer than 200,000 people in the United States. Orphan
`diseases are often serious or life threatening.” See Definition of Orphan Drug, NCI Dictionary of
`Cancer Terms, https://www.cancer.gov/publications/dictionaries/cancer-terms/def/orphan-drug
`(last visited Apr. 7, 2022).
`2 “Ex. _” refers to exhibits submitted with Plaintiffs’ Opening Claim Construction Brief.
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`Case 1:20-cv-00968-MSG Document 114 Filed 04/08/22 Page 5 of 21 PageID #: 5332
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`more fully below, is an analytical technique used, inter alia, to determine the crystal structure of
`
`materials of interest.
`
`The claims at issue require the presence of a certain number of recited peaks and are clear
`
`on their face. Defendants’ proposed constructions add an additional test requiring the PXRD
`
`patterns to “correspond[] to” certain exemplary patterns from the patent specification.
`
`Defendants’ additional test violates well-established claim construction principles against
`
`importing limitations into the claims and is inconsistent with the express language of the claims.
`
`Moreover, Defendants’ new test introduces ambiguity and conflict to the claims, as it is unclear
`
`how to determine whether one pattern “corresponds to” another. For example, must the patterns
`
`have all of the same peaks, half of them, or satisfy some other metric to “correspond to” each
`
`other?
`
`The claims themselves inform a person of ordinary skill in the art of exactly what is
`
`required without introducing Defendants’ new test into the analysis. As such, Plaintiffs submit
`
`that there is no need to construe these readily understood claim terms. In light of Defendants’
`
`term identifications and proposed constructions, however, Plaintiffs offer alternative
`
`constructions reflecting the plain and ordinary meaning of these terms.
`
`II.
`
`BACKGROUND
`
`Venclexta® is protected by several patents, including the three patents at issue in claim
`
`construction: U.S. Patent Nos. 8,722,657 (“the ’657 patent”), 9,238,649 (“the ’649 patent”), and
`
`10,730,873 (“the ’873 patent”) (“the asserted polymorph patents”). Claim 1 of the ’657 patent,
`
`claim 1 of the ’649 patent, and claim 4 of the ’873 patent are representative of the claim
`
`language at issue here and are copied below with the disputed claim terms emphasized.
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`Case 1:20-cv-00968-MSG Document 114 Filed 04/08/22 Page 6 of 21 PageID #: 5333
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`Independent claim 1 of the ’657 patent:
`
`1. A compound 4-(4-{[2-(4-chlorophenyl)-4,4-dimethyl-cyclohex-1-en-1-
`yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-
`ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-
`yloxy)benzamide (Compound 1) in a crystalline form wherein the
`crystalline form is Compound 1 free base anhydrate, characterized by a
`powder X-ray diffraction pattern having five or more peaks selected
`from those at 6.3, 7.1, 9.0, 9.5, 12.5, 14.5, 14.7, 15.9, 16.9, and 18.9
`degrees 2θ (pattern A), each peak being ±0.2 degrees 2θ, when measured
`at about 25° C. with Cu Kα radiation at 1.54178 Å.
`
`Independent claim 1 of the ’649 patent:
`
`1. A compound 4-(4-{[2-(4-chlorophenyl)-4,4-dimethyl-cyclohex-1-en-1-
`yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-
`ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-
`yloxy)benzamide (Compound 1) in a crystalline form, wherein the
`crystalline form is Compound 1 free base anhydrate, characterized by a
`powder X-ray diffraction pattern having five or more peaks selected
`from those at 5.8, 7.7, 8.3, 9.9, 13.0, 13.3, 14.2, 15.3, 16.6, 17.9, 18.3,
`19.8, 20.7, 21.2, 21.9, 22.5, 23.6, and 24.1 degrees 2θ (pattern B), each
`peak being ±0.2 degrees 2θ, when measured at about 25° C. with Cu Kα
`radiation at 1.54178 Å.
`
`Independent claim 4 of the ’873 patent:
`
`4. A compound 4-(4-{[2-(4-chlorophenyl)-4,4-dimethyl-cyclohex-1-en-1-
`yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-
`ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-
`yloxy)benzamide (Compound 1) in a crystalline form, characterized by a
`powder X-ray diffraction pattern having peaks at 7.1, 14.4, and 19.0
`degrees 2θ, each peak being ±0.2 degrees 2θ, when measured at about 25°
`C. with Cu Kαradiation at 1.54178 Å.
`
`These representative claims each require a compound, referred to as “Compound 1,” in “a
`
`crystalline form.” See ’657 patent3 at 3:64-4:22. Compound 1 is the chemical formula for
`
`venetoclax. See, e.g., id.; Ex. 1 at 30.
`
`
`3 The ’657, ’649, and ’873 patents share a common specification. For convenience, citation has
`been made to the ’657 patent specification throughout this brief.
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`Case 1:20-cv-00968-MSG Document 114 Filed 04/08/22 Page 7 of 21 PageID #: 5334
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`Different crystalline forms of venetoclax are described as useful for pharmaceutical
`
`compositions, as they “can provide different properties with respect to stability, solubility,
`
`dissolution rate, hardness, compressibility and melting point, among other physical and
`
`mechanical properties.” See ’657 patent at 3:51-54. For example, the “ease of manufacture,
`
`formulation, storage and transport of [venetoclax] is dependent on at least some of these
`
`properties.” See id. at 3:55-57; see also id. at 4:31-48; 20:35-49.
`
`The representative claims also specify that the crystalline forms of venetoclax are
`
`“characterized by a powder X-ray diffraction [PXRD] pattern.” PXRD uses an X-ray source and
`
`a diffractometer to detect the intensity of the diffracted X-rays at various angles of the incident
`
`X-rays in order to determine crystal structures. See, e.g., Ex. 5 at 59-60; ’657 patent at 19:55-
`
`20:4 (describing G3000 diffractometer for obtaining PXRD data). This information can be used
`
`to identify different crystalline forms within a drug product. A representative image of PXRD
`
`using a diffractometer is shown below:
`
`
`Ex. 5 at 59.
`
`
`
`
`PXRD data is often reported in terms of “two-theta” (also referred to as “2θ”) values of
`
`angles. This is reflected in each of the representative claims, which recite a crystalline form
`
`characterized by a PXRD pattern “having peaks at . . . [specific] degrees 2θ.” The detected
`
`PXRD pattern having peaks at certain degrees 2θ acts as a “fingerprint” for a given crystalline
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`Case 1:20-cv-00968-MSG Document 114 Filed 04/08/22 Page 8 of 21 PageID #: 5335
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`form of venetoclax and can be used to identify venetoclax and its various crystalline forms. See,
`
`e.g., ’657 patent at 7:16-19.
`
`Different polymorphs of venetoclax will have different PXRD patterns, which allow the
`
`polymorphs to be distinguished from one another. As described in the specification and in
`
`further detail in Section IV.A below, various inventive crystalline forms of venetoclax are
`
`identified by a recited number of peaks from a particular PXRD scan, as opposed to requiring
`
`each and every peak in that scan. See, e.g., ’657 patent at 7:22-28 (“[I]n various embodiments, a
`
`salt or crystalline form is characterized by a match of two or more peaks, a match of 3 or more
`
`peaks, 4 or more peaks, or 5 or more peaks, and so on, from the respective PXRD patterns”).
`
`This is reflected in the representative asserted claims, which recite crystalline forms of
`
`venetoclax characterized by a certain subset of peaks (e.g., “three peaks” or “at least five peaks”)
`
`selected from a larger list of peaks taken from a PXRD pattern.4
`
`The specification provides exemplary peak listings taken from PXRD patterns A-N. See
`
`’657 patent at Tables 1-14. From these peak listings, different embodiments of inventive
`
`crystalline forms of venetoclax may be characterized using a subset of the listed peaks. See, e.g.,
`
`’657 patent at 7:16-28; id. at claim 1. Some representative claims (claim 1 of the ’657 patent and
`
`claim 1 of the ’649 patent) further recite a parenthetical that identifies the source of the recited
`
`peaks in the PXRD pattern characterizing the crystalline form (e.g., “(pattern A)”).
`
`Representative claim 4 of the ’873 patent, on the other hand, recites three specific peaks in the
`
`
`4 Each representative claim also recites “each peak being ±0.2 degrees 2θ.” As recognized in
`the ’657 patent, “PXRD peak position measurements are typically ±0.2 degrees two-theta (2θ).”
`’657 patent at 20:2-4. A POSA would have understood that embodiments of the inventive
`crystalline forms of venetoclax could be determined if a certain number of the identifying peaks
`in degrees 2θ were within this accepted margin of error.
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`Case 1:20-cv-00968-MSG Document 114 Filed 04/08/22 Page 9 of 21 PageID #: 5336
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`PXRD pattern that characterize the recited crystalline form, but does not further specify the
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`source of the recited peaks by way of a parenthetical.
`
`III. THE LEGAL STANDARDS FOR CLAIM CONSTRUCTION
`
` “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.” Phillips v. AWH Corp., 415 F.3d 1303, 1312
`
`(Fed. Cir. 2005) (en banc).5 Courts “look to the words of the claims themselves to define the
`
`scope of the patented invention.” E-Pass Techs., Inc. v. 3Com Corp., 473 F.3d 1213, 1220 (Fed.
`
`Cir. 2007). The words of a claim “are generally given their ordinary and customary meaning.”
`
`Phillips, 415 F.3d at 1312-13.
`
`When construing terms, the claim language must be considered in context. See, e.g.,
`
`Kyocera Wireless Corp. v. Int’l Trade Comm’n, 545 F.3d 1340, 1347 (Fed. Cir. 2008) (“[T]his
`
`court does not interpret claim terms in a vacuum, devoid of the context of the claim as a
`
`whole.”); Phillips, 415 F.3d at 1314 (“[T]he context in which a term is used in the asserted claim
`
`can be highly instructive.”). Additionally, “the specification is always highly relevant to the
`
`claim construction analysis. Usually, it is dispositive . . . .” Phillips, 415 F.3d at 1315.
`
`“A construing court’s reliance on the specification must not go so far as to import
`
`limitations into claims from examples or embodiments appearing only in a patent’s written
`
`description unless the specification makes clear that the patentee intends for the claims and the
`
`embodiments in the specification to be strictly coextensive.” Silicon Graphics, Inc. v. ATI
`
`Techs., Inc., 607 F.3d 784, 792 (Fed. Cir. 2010). Indeed, the Federal Circuit has “repeatedly held
`
`that . . . the claims generally should not be narrowed to cover only the disclosed embodiments or
`
`
`5 Unless otherwise indicated, all emphasis has been added, and all internal citations and
`quotations have been omitted.
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`Case 1:20-cv-00968-MSG Document 114 Filed 04/08/22 Page 10 of 21 PageID #: 5337
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`examples in the specification.” See Linear Tech. Corp. v. Int’l Trade Comm’n, 566 F.3d 1049,
`
`1058 (Fed. Cir. 2009).
`
`The prosecution history may also be considered as part of claim construction because it
`
`can show “how the PTO and the inventor understood the patent.” Phillips, 415 F.3d at 1317.
`
`But “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.” Id.
`
`IV.
`
`THE DISPUTED CLAIM TERMS
`A.
`
`“a powder X-ray diffraction pattern having five
`or more peaks selected from those at 6.3, 7.1, 9.0, 9.5,
`12.5, 14.5, 14.7, 15.9, 16.9, and 18.9 degrees 2θ (pattern A)”
`(’657 patent, claim 1)
`
`
`
`Plaintiffs’ Construction
`Plain and ordinary meaning, no construction
`necessary.
`
`If a construction is necessary:
`
`“A powder X-ray diffraction pattern having
`five or more of the following peaks (found in
`pattern A) selected from those at 6.3, 7.1,
`9.0, 9.5, 12.5, 14.5, 14.7, 15.9, 16.9, and 18.9
`degrees 2θ”
`
`Defendants’ Construction
`“a powder X-ray diffraction pattern
`corresponding to pattern A having five or
`more peaks selected from those at 6.3, 7.1,
`9.0, 9.5, 12.5, 14.5, 14.7, 15.9, 16.9, and 18.9
`degrees 2θ”
`
`
`
`1.
`
`No Construction Is Necessary
`
`Claim construction begins with the language of the claims. Phillips, 415 F.3d at 1312-14.
`
`Here, claim 1 of the ’657 patent requires venetoclax characterized by a PXRD pattern having
`
`five out of 10 listed peaks:
`
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`Case 1:20-cv-00968-MSG Document 114 Filed 04/08/22 Page 11 of 21 PageID #: 5338
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`1. A compound 4-(4-{[2-(4-chlorophenyl)-4,4-dimethyl-cyclohex-1-en-1-
`yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-
`ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-
`yloxy)benzamide (Compound 1) in a crystalline form wherein the
`crystalline form is Compound 1 free base anhydrate, characterized by a
`powder X-ray diffraction pattern having five or more peaks selected
`from those at 6.3, 7.1, 9.0, 9.5, 12.5, 14.5, 14.7, 15.9, 16.9, and 18.9
`degrees 2θ (pattern A), each peak being ±0.2 degrees 2θ, when measured
`at about 25° C. with Cu Kα radiation at 1.54178 Å.
`
`The full context of the claim language makes it abundantly clear that the test is whether
`
`or not five of the peaks “from those at 6.3, 7.1, 9.0, 9.5, 12.5, 14.5, 14.7, 15.9, 16.9, and 18.9
`
`degrees 2θ (pattern A)” are present. Given the clarity of the express words of the claim, no
`
`construction is necessary. See, e.g., Discovery Patent Holdings, LLC v. Amazon.com, Inc., 769
`
`F.Supp.2d 662, 676 (D. Del. 2011) (declining to construe term where “the plain language is
`
`clear” and proposed construction “would lead to redundant language”); Int’l Bus. Machs. Corp.
`
`v. Priceline Grp. Inc., No. 15-137-LPS, 2016 WL 6405824, at *10 (D. Del. Oct. 28, 2016)
`
`(finding no construction necessary for a term where “its plain and ordinary meaning is readily
`
`ascertainable by simply reading the claim language”).
`
`2.
`
`If a Construction Is Necessary, Plaintiffs’ Construction Is
`Consistent with the Claim Language and Intrinsic Record
`
`To the extent any construction is determined to be necessary, Plaintiffs’ alternative
`
`proposed construction tracks the substance of the claim language and clarifies that the
`
`parenthetical at the end of the disputed claim term, “(pattern A),” merely indicates that the 10
`
`peaks recited in the claim are found in pattern A. In other words, Plaintiffs merely describe the
`
`plain and ordinary meaning of this claim language to a POSA, namely that the recited peaks
`
`originate from the peak listing in Table 1 of the specification for pattern A, see ’657 patent at
`
`10:57-11:8, which is recreated below for convenience:
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`Case 1:20-cv-00968-MSG Document 114 Filed 04/08/22 Page 12 of 21 PageID #: 5339
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`
`The Specification Supports Plaintiffs’ Construction
`
`3.
`
`
`
`This interpretation is further supported by the specification, which is “the single best
`
`
`
`guide” for interpreting claim language. See Phillips, 415 F.3d at 1315. The specification
`
`describes how a peak list such as that contained in Table 1 above is utilized to characterize a
`
`particular crystalline form. In particular, the specification explains that the
`
`[i]dentity of the respective crystalline forms is established by overlap or match
`of an experimentally determined PXRD pattern with the PXRD pattern of the
`crystalline forms reported herein. In various embodiments, the salts and
`crystalline forms are characterized by exhibiting at least one of the PXRD
`peaks reported here. Thus, in various embodiments, a salt or crystalline form
`is characterized by a match of two or more peaks, a match of 3 or more peaks,
`4 or more peaks, or 5 or more peaks, and so on, from the respective PXRD
`patterns.
`
`’657 patent at 7:16-28. Thus, the specification makes clear that a certain minimum number of
`
`peaks from a PXRD pattern (e.g., the peak listing for “(pattern A)”) are sufficient to characterize
`
`a crystalline form depending on the embodiment, and no further peaks beyond those expressly
`
`required in the embodiment are necessary.
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`Case 1:20-cv-00968-MSG Document 114 Filed 04/08/22 Page 13 of 21 PageID #: 5340
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`These various embodiments can be contrasted with other specification embodiments that
`
`actually require the full PXRD pattern. See, e.g., ’657 patent at 4:49-51 (“In some embodiments,
`
`the salt or crystalline form of Compound 1 includes those of Compound 1 free base anhydrate
`
`having PXRD pattern A . . .”); id. at 4:49-67 (describing “some embodiments” of salts or
`
`crystalline forms of the invention having PXRD patterns A-N). Further, the peak listings at
`
`Tables 1-14, and the subset of peaks that characterize crystalline forms of venetoclax, can be
`
`contrasted with Figures 1-14, which are precise “PXRD scan[s]” or “calculated PXRD
`
`pattern[s]” of certain crystalline forms of venetoclax. ’657 patent at 6:1-29. Figures 1-14
`
`incorporate additional information, including absolute and relative peak intensities. See, e.g., id.
`
`at 6:64-7:15; 7:16-28. The recited claims do not include this additional information, and require
`
`only that a subset of peaks found in a particular PXRD pattern are present.
`
`4.
`
`The Prosecution History Further Supports Plaintiffs’
`Construction
`
`
`The history of the claims at issue reinforces Plaintiffs’ construction.6 For instance,
`
`original claims 2-6, 8-10, 12-14, and 16-18 are drawn to certain crystalline forms “characterized
`
`by a [PXRD] pattern having at least one peak selected from” the peak lists found in PXRD
`
`Patterns A-N, respectively. See D.I. 103-8, Ex. H at 56-58. Original Claim 2 is shown below for
`
`convenience:
`
`
`6 Original claims are part of the patent specification. See, e.g., ScriptPro LLC v. Innovation
`Associates, Inc., 833 F.3d 1336, 1341 (Fed. Cir. 2016) (“As we have explained, original claims
`are part of the specification”).
`
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`Case 1:20-cv-00968-MSG Document 114 Filed 04/08/22 Page 14 of 21 PageID #: 5341
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`D.I. 103-6, Ex. F at 10. This claim characterizes the recited crystalline form by an overlap of at
`
`least one peak with a previously measured PXRD pattern. This characterization—the presence
`
`of an expressly claimed peak—tracks the specification’s discussion of crystalline forms
`
`“characterized by exhibiting at least one” peak and Plaintiffs’ proposed construction. See supra
`
`Section IV.A.3.
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`Exchanges between the applicant and the examiner during prosecution further confirm
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`this understanding. For example, in the first Non-Final Office Action issued during prosecution
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`of the application that led to the ’657 patent, the examiner rejected the then-pending claims as
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`anticipated by U.S. App. Pub. No. 2012/0108590 (“Birtalan”), alleging that Birtalan taught a
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`solid dispersion comprising venetoclax is an “essentially non-crystalline” form. See D.I. 103-6,
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`Ex. F at 5-6. In response to this Non-Final Office Action, the applicant added new dependent
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`claim 107, which, like its parent claim (original claim 2), was directed to a crystalline form of
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`Compound 1 (venetoclax) characterized by a PXRD pattern having a set number of peaks from a
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`listing of peaks found in pattern A. D.I. 103-6, Ex. F at 10, 25. This claim is incorporated below
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`for convenience:
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`Id.
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`
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`Notably, the applicant stated that “[s]upport for new claim 107 may be found inter alia
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`on page 9, paragraph [0052] of the specification.” See D.I. 103-6, Ex. F at 26. Paragraph [0052]
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`of the original application corresponds to the same paragraph discussed above from the ’657
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`patent. See D.I. 103-8, Ex. H at 9-10, [0052]; ’657 patent, at 7:16-28. Again, this paragraph
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`Case 1:20-cv-00968-MSG Document 114 Filed 04/08/22 Page 15 of 21 PageID #: 5342
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`from the specification—endorsed here by the applicant as providing the basis for new claim
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`1077—describes how various embodiments of crystalline forms can be characterized by an
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`“overlap” of certain peak values taken from an Example PXRD pattern—e.g., “5 or more peaks.”
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`See supra Section IV.A.3. The applicant thus confirmed its understanding that the recited
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`crystalline form is characterized by a PXRD pattern having five or more peaks that are found in
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`pattern A, consistent with Plaintiffs’ construction.8 And nothing in the examiner’s statements or
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`the applicants’ responsive remarks suggested that the crystalline forms of the pending claims
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`were limited to those having all peaks of PXRD pattern A. Rather, this exchange is consistent
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`with the recited PXRD pattern having five or more peaks found in pattern A, consistent with the
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`plain language of the claims and Plaintiffs’ construction.
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`5.
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`Defendants’ Construction Is Contrary
`to the Intrinsic Record and Should Be Rejected
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`While Plaintiffs’ construction is consistent with all of the disclosed embodiments and
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`clear language of the claims, Defendants’ construction seeks to import a “corresponding to
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`pattern A” requirement into the claim. Defendants’ construction modifies the meaning of the
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`claim’s parenthetical reference to “(pattern A)” such that it references the PXRD pattern, instead
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`of the peak list. In doing so, Defendants have now created a two-part test which unduly limits
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`the scope of embodiments covered by the claim: “a powder X-ray diffraction pattern [part 1]
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`corresponding to pattern A [and] [part 2] having five or more peaks selected from those at 6.3,
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`7.1, 9.0, 9.5, 12.5, 14.5, 14.7, 15.9, 16.9, and 18.9.”9 Under Defendants’ construction, a POSA
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`7 The subject matter of new claim 107 issued as claim 1 of the ’657 patent after being placed
`into independent form in a later claim amendment. See D.I. 103-6, Ex. F at 43, 46-47.
`8 The applicant also argued in its response that Birtalan did not inherently anticipate the pending
`claims. See D.I. 103-6, Ex. F at 26-28.
`9 Plaintiffs have inserted brackets into Defendants’ construction to illustrate the two-part test.
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`Case 1:20-cv-00968-MSG Document 114 Filed 04/08/22 Page 16 of 21 PageID #: 5343
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`would need to determine whether the accused product contained crystalline venetoclax with a
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`PXRD pattern “corresponding to pattern A” in addition to “having five or more peaks selected
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`from those at 6.3, 7.1, 9.0, 9.5, 12.5, 14.5, 14.7, 15.9, 16.9, and 18.9.”
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`Aside from being an added limitation, “corresponding to pattern A” is ambiguous and
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`conflicts with the express requirement of the claims. Does it require a comparison of two
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`complete PXRD patterns, the presence of all 10 recited peaks, or something else? The claim is
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`clear about what is needed—“five or more peaks.” Defendants’ test potentially raises this
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`minimum requirement to six, seven, eight, nine, or 10 peaks (to demonstrate “corresponding to”)
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`or creates other instances where the five peak requirement is met, but “corresponding to pattern
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`A” is somehow not met. These ambiguities and conflicts introduce unnecessary confusion into
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`the claim.
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`Various embodiments of crystalline forms are characterized by a PXRD pattern having
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`less than the full set of peaks shown by the particular PXRD scan in the patent Figures. See
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`supra Section IV.A.3. By requiring “a powder X-ray diffraction pattern corresponding to pattern
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`A,” Defendants’ construction improperly restricts the scope of the invention beyond what is
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`required by the claims themselves and reads in limitations from other embodiments. See Hill-
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`Rom Servs. v. Stryker Corp., 755 F.3d 1367, 1371 (Fed. Cir. 2014) (“While we read claims in
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`view of the specification, of which they are a part, we do not read limitations from the
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`embodiments in the specification into the claims.”). For at least these reasons, Defendants’
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`construction should be rejected.
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`a.
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`Defendants’ Construction
`Impermissibly Imports a Limitation into the Claims
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`Defendants’ construction seeks to impermissibly add a limitation that is absent from the
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`claims themselves. See, e.g., Williamson v. Citrix Online, LLC, 792 F.3d 1339, 1346 (Fed. Cir.
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`Case 1:20-cv-00968-MSG Document 114 Filed 04/08/22 Page 17 of 21 PageID #: 5344
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`2015) (“It is the claims . . . which define the scope of the patent right . . . . A court may not
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`import limitations from the written description into the claims.”) (emphasis in original). Here,
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`the patentee claimed the presence of five or more peaks and did not add further limitations with
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`respect to those peaks.
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`This District has rejected similar attempts to import limitations into PXRD claims. For
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`example, Forest Laboratories, LLC v. Accord Healthcare Inc. concerned polymorph claims which
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`recited a compound which is “crystalline” or in a “crystalline modification.” No. 15-272-GMS,
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`2016 WL 6892094, at *1, *1 n.6 (D. Del. Nov. 21, 2016). The Forest defendants contended that
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`these two terms should be further construed to mean “entirely in crystalline form comprising only
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`Form I to XVI, and combinations thereof (as appropriate)” because, inter alia, the specification
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`allegedly described only particular crystalline form embodiments. Id. In rejecting defendants’
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`attempt to import a limitation with respect to these terms, this District relied upon the express
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`language of the claims, as supported by the intrinsic record, including a specification that did “not
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`clearly limit the scope of ‘crystalline’ or ‘crystalline modification’” and prosecution history
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`wherein allowance of a broad claim “further demonstrat[