IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`ACERTA PHARMA B.V. et al.,
`
`Plaintiffs,
`
`v.
`
`ALEMBIC PHARMACEUTICALS
`LIMITED, et al.,
`
`Defendants.
`
`C.A. No. 22-154-GBW-SRF
`(Consolidated)
`CONFIDENTIAL
`
`PLAINTIFFS’ INITIAL INFRINGEMENT CONTENTIONS
`TO DEFENDANT SANDOZ INC.
`
`Pursuant to Paragraph 4 of the Court’s Scheduling Order (D.I. 30) Plaintiffs Acerta Pharma
`
`B.V., AstraZeneca UK Limited, AstraZeneca Pharmaceuticals LP, AstraZeneca AB
`
`(“AstraZeneca”), and Merck Sharp & Dohme B.V. (“Merck”) (collectively “Plaintiffs”) disclose
`
`the following initial infringement contentions regarding U.S. Patent No. 9,290,504 (“the ’504
`
`patent”); U.S. Patent No. 9,758,524 (“the ’524 patent”); U.S. Patent No. 10,239,883 (“the ’883
`
`patent”); U.S. Patent No. 9,796,721 (“the ’721 patent”); U.S. Patent No. 10,167,291 (“the ’291
`
`patent”); and U.S. Patent No. 10,272,083 (“the ’083 patent”) to Defendant Sandoz Inc. (“Sandoz”).
`
`Plaintiffs’ initial infringement contentions are based on the information currently available
`
`to, and known by, Plaintiffs. These initial infringement contentions are necessarily preliminary,
`
`as discovery is only just beginning. Plaintiffs have only received a limited set of documents from
`
`Sandoz, and have not obtained other discovery, such as other documents concerning Sandoz’s
`
`ANDA Product and the active ingredient contained therein, samples of Sandoz’s ANDA
`
`Product and the active ingredient contained therein, responses to written discovery, or
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`1
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`SANDOZ INC.
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`IPR2023-00478
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`Ex. 1001, p. 1 of 5
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`

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`deposition testimony. Furthermore, the Court has not yet construed any of the asserted claims of
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`the asserted patents. As a result, Plaintiffs reserve the right to modify, amend, or otherwise
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`supplement these initial infringement contentions (including to add additional claims) as the pre-
`
`trial phase of the litigation proceeds and as additional information comes to light, and as provided
`
`in the Case Scheduling Order, the Federal Rules of Civil Procedure, and the Local Rules of the
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`United States District Court for the District of Delaware.
`
`These initial claim charts are provided without prejudice to Plaintiffs’ right to introduce
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`expert opinions and demonstratives as expert discovery progresses, and to produce and introduce
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`at trial all evidence, whenever discovered, relating to the proof of currently known and
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`subsequently discovered facts. In addition, the division of each claim into individual limitations
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`is for convenience only and is without prejudice to Plaintiffs’ right to argue for a different division
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`at a later date.
`
`Dated: September 26, 2022
`
`OF COUNSEL:
`
`David I. Berl
`Stanley E. Fisher
`Alexander S. Zolan
`Kevin Hoagland-Hanson
`Sarahi Uribe
`Jihad Komis
`Min Kyung Jeon
`WILLIAMS & CONNOLLY LLP
`680 Maine Avenue, S.W.
`Washington, DC 20024
`T: (202) 434-5083
`F: (202) 434-5029
`dberl@wc.com
`sfisher@wc.com
`azolan@wc.com
`khoagland-hanson@wc.com
`suribe@wc.com
`jkomis@wc.com
`
`
`
`
`
`
`MCCARTER & ENGLISH, LLP
`
`/s/ Daniel M. Silver
`Daniel M. Silver (#4758)
`Alexandra M. Joyce (#6423)
`Renaissance Centre
`405 N. King Street, 8th Floor
`Wilmington, DE 19801
`T: (302) 984-6300
`dsilver@mccarter.com
`ajoyce@mccarter.com
`
`Attorneys for Plaintiffs Acerta Pharma B.V.,
`AstraZeneca UK Limited, AstraZeneca
`Pharmaceuticals LP, AstraZeneca AB, and
`Merck Sharp & Dohme B.V.
`
`
`
`
`2
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`SANDOZ INC.
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`IPR2023-00478
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`Ex. 1001, p. 2 of 5
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`

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`9. The method of claim 8, wherein the BTK inhibitor
`is a compound of Formula (II):
`
`Sandoz’s ANDA Product meets the limitations of
`claim 8 as set forth above. Plaintiffs incorporate by
`reference their contentions with respect to claim 8.
`
`Sandoz’s ANDA Product contains a pharmaceutical
`composition comprising the compound of Formula
`(II), specifically acalabrutinib, having the structure:
`
`or a pharmaceutically acceptable salt thereof.
`
`SDZACAL-00000650 at *754, *799; SDZACAL-
`00001232 at *233–234.
`
`In addition, Sandoz in its December 28, 2021 Notice
`Letter does not substantively contest that its proposed
`labeling provides for a method of treating MCL that
`meets the limitations of claim 9, despite that Sandoz
`was required in its Notice Letter to state its bases for
`any contention that its ANDA Product would not
`infringe the ’083 patent.
`
`To the extent the use of Sandoz’s ANDA Product in
`accordance with its proposed label does not literally
`infringe this claim, any differences are insubstantial.
`For each claim limitation, there is a corresponding
`aspect of the use of Sandoz’s ANDA Product in
`accordance with its proposed labeling that performs
`substantially the same function in substantially the
`same way to achieve substantially the same result.
`Therefore Sandoz’s ANDA Product infringes under
`the doctrine of equivalents, even assuming it does not
`infringe literally.
`
`Sandoz’s ANDA Product meets the limitations of
`claim 9 as set forth above. Plaintiffs incorporate by
`reference their contentions with respect to claim 9.
`
`The proposed labeling for Sandoz’s ANDA Product
`directs, encourages, recommends, and promotes a
`
`10. The method of claim 9, wherein the Mantle Cell
`Lymphoma (MCL) increases monocytes and NK cells
`in peripheral blood after treatment with Formula (II)
`for a period selected from the group consisting of
`about 14 days, about 28 days, and about 56 days.
`
`
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`SANDOZ INC.
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`IPR2023-00478
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`Ex. 1001, p. 3 of 5
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`

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`method of treating MCL wherein the MCL increases
`monocytes and NK cells in peripheral blood after
`treatment with the compound of Formula (II) for a
`period selected from the group consisting of about 14
`days, about 28 days, and about 56 days. One known
`salutary effect of the treatment of MCL with the
`compound of Formula (II) is to increase the levels of
`monocytes and natural killer cells in peripheral
`blood. ’083 patent, col. 4, ll. 34–52; col. 67, l. 64–
`col. 68, l. 41. Moreover, the proposed labeling for
`Sandoz’s ANDA Product directs, encourages,
`recommends, and promotes a method of treating MCL
`wherein the BTK inhibitor compound of Formula (II)
`is administered to the human subject for a period
`selected from the group consisting of about 14 days,
`about 28 days, and about 56 days. See SDZACAL-
`00004047 at *051 (describing clinical trials where
`MCL patients received acalabrutinib for a period
`ranging from “0.1 to 26.6[] months”).
`
`In addition, Sandoz in its December 28, 2021 Notice
`Letter does not substantively contest that its proposed
`labeling provides for a method of treating MCL that
`meets the limitations of claim 10, despite that Sandoz
`was required in its Notice Letter to state its bases for
`any contention that its ANDA Product would not
`infringe the ’083 patent.
`
`To the extent the use of Sandoz’s ANDA Product in
`accordance with its proposed label does not literally
`infringe this claim, any differences are insubstantial.
`For each claim limitation, there is a corresponding
`aspect of the use of Sandoz’s ANDA Product in
`accordance with its proposed labeling that performs
`substantially the same function in substantially the
`same way to achieve substantially the same result.
`Therefore Sandoz’s ANDA Product infringes under
`the doctrine of equivalents, even assuming it does not
`infringe literally.
`
`Sandoz’s ANDA Product meets the limitations of
`claim 9 as set forth above. Plaintiffs incorporate by
`reference their contentions with respect to claim 9.
`
`The proposed labeling for Sandoz’s ANDA Product
`directs, encourages, recommends, and promotes a
`
`11. The method of claim 9, wherein the MCL is
`selected from the group consisting of mantle zone
`MCL, nodular MCL, diffuse MCL, and blastoid
`MCL.
`
`
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`IPR2023-00478
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`Ex. 1001, p. 4 of 5
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`

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`method of treating MCL wherein the MCL is selected
`from the group consisting of mantle zone MCL,
`nodular MCL, diffuse MCL, and blastoid MCL. The
`subtypes of MCL commonly treated with
`acalabrutinib include mantle zone MCL, nodular
`MCL, diffuse MCL, and blastoid MCL.
`
`In addition, Sandoz in its December 28, 2021 Notice
`Letter does not substantively contest that its proposed
`labeling provides for a method of treating MCL that
`meets the limitations of claim 11, despite that Sandoz
`was required in its Notice Letter to state its bases for
`any contention that its ANDA Product would not
`infringe the ’083 patent.
`
`To the extent the use of Sandoz’s ANDA Product in
`accordance with its proposed label does not literally
`infringe this claim, any differences are insubstantial.
`For each claim limitation, there is a corresponding
`aspect of the use of Sandoz’s ANDA Product in
`accordance with its proposed labeling that performs
`substantially the same function in substantially the
`same way to achieve substantially the same result.
`Therefore Sandoz’s ANDA Product infringes under
`the doctrine of equivalents, even assuming it does not
`infringe literally.
`
`15. The method of claim 2, the method comprising
`treating chronic lymphocytic leukemia (CLL) in a
`human subject suffering from CLL.
`
`Sandoz’s ANDA Product meets the limitations of
`claim 2 as set forth above. Plaintiffs incorporate by
`reference their contentions with respect to claim 2.
`
`The proposed labeling for Sandoz’s ANDA Product
`directs, encourages, recommends, and promotes a
`method of treating chronic lymphocytic leukemia
`(CLL) and/or small lymphocytic leukemia (SLL) in a
`human subject suffering therefrom for the reasons
`detailed in Plaintiffs’ contentions with respect to
`claim 1. Plaintiffs incorporate by reference their
`contentions with respect to claim 1.
`
`To the extent the use of Sandoz’s ANDA Product in
`accordance with its proposed label does not literally
`infringe this claim, any differences are insubstantial.
`For each claim limitation, there is a corresponding
`aspect of the use of Sandoz’s ANDA Product in
`accordance with its proposed labeling that performs
`
`52
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`SANDOZ INC.
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`IPR2023-00478
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`Ex. 1001, p. 5 of 5
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`