UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`MERCK SHARP & DOHME CORP.,
`Patent Owner.
`__________________
`
`Case IPR2020-00040
`U.S. Patent 7,326,708
`__________________
`
`JOINT NOTICE REGARDING DISTRICT COURT
`CLAIM CONSTRUCTION PROCEEDINGS
`
`
`
`
`
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`MERCK SHARP & DOHME CORP.,
`Patent Owner.
`__________________
`
`Case IPR2020-00040
`U.S. Patent 7,326,708
`__________________
`
`JOINT NOTICE REGARDING DISTRICT COURT
`CLAIM CONSTRUCTION PROCEEDINGS
`
`
`
`
`
`
`Case IPR2020-00040 | U.S. Patent 7,326,708
`
`
`
`Pursuant to the Board’s instructions during the conference call conducted on
`
`March 4, 2020, see EX1017 at 23:14–24:15, Petitioner Mylan Pharmaceuticals Inc.
`
`and Patent Owner Merck Sharp & Dohme Corp. submit as attached Appendix A
`
`the Proposed Constructions for Disputed Terms in U.S. Patent No. 7,326,708
`
`(Chart 1) filed in In re Sitagliptin Phosphate (’708 & ’921) Patent Litigation, No.
`
`1:19-cv-02902-RGA (D. Del. Feb. 14, 2020), ECF No. 58. Pursuant to the
`
`scheduling order in the MDL, EX2006 at 7–9, claim construction briefing is
`
`ongoing and a hearing on claim construction is scheduled for August 18, 2020.
`
`
`Date: April 6, 2020
`
`/Jitendra Malik/
`
`
`Jitendra Malik, Ph.D. (Reg. No. 55,823)
`Alissa M. Pacchioli (Reg. No. 74,252)
`Christopher D. West, Ph.D.
`(Reg. No. 74,724)
`Heike S. Radeke, Ph.D.
`(Reg. No. 75,394)
`KATTEN MUCHIN ROSENMAN
`550 S. Tryon Street, Suite 2900
`Charlotte, NC 28202-4213
`jitty.malik@katten.com
`alissa.pacchioli@katten.com
`christopher.west@katten.com
`heike.radeke@katten.com
`
`Counsel for Petitioner
`Mylan Pharmaceuticals Inc.
`
`
`
`
` Respectfully submitted,
`
`/Stanley E. Fisher/
`Stanley E. Fisher (Reg. No. 55,820)
`Bruce R. Genderson (Pro Hac Vice)
`Jessamyn S. Berniker (Reg. No. 72,328)
`Shaun P. Mahaffy (Reg. No. 75,534)
`Anthony H. Sheh (Reg. No. 70,576)
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`sfisher@wc.com
`bgenderson@wc.com
`jberniker@wc.com
`smahaffy@wc.com
`asheh@wc.com
`
`Counsel for Patent Owner
`Merck Sharp & Dohme Corp.
`
`1
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`Case IPR2020-00040 | U.S. Patent 7,326,708
`Case IPR2020-00040 | US. Patent 7,326,708
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`APPENDIX A
`APPENDIX A
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`
`
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`2
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`
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`Case 1:19-md-02902-RGA Document 58 Filed 02/14/20 Page 1 of 13 PageID #: 472
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`
`IN RE: SITAGLIPTIN PHOSPHATE (’708
`& ’921) PATENT LITIGATION
`
`
`
`MDL No. 19-2902-RGA
`
`C.A. Nos. 19-310-RGA,
`
`19-311-RGA,
`
`19-312-RGA,
`
`19-313-RGA,
`
`19-314-RGA,
`
`19-316-RGA,
`
`19-317-RGA,
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`19-318-RGA,
`
`19-319-RGA,
`
`19-320-RGA,
`
`19-321-RGA,
`
`19-347-RGA,
`
`19-872-RGA,
`
`19-1489-RGA,
`
`19-2192-RGA
`
`
`
`
`JOINT CLAIM CONSTRUCTION CHART
`
`Pursuant to Paragraph 7 of the Court’s July 1, 2019 Scheduling Order and Paragraph 7 of
`
`the Court’s August 23, 2019 Scheduling Order, Plaintiff Merck Sharp & Dohme Corp.
`
`(“Merck”), and Defendants Alvogen Pine Brook LLC f/k/a, Alvogen Pine Brook, Inc. and
`
`Alvogen Malta Operations Ltd. (collectively, “Alvogen”), Anchen Pharmaceuticals, Inc. and Par
`
`Pharmaceutical, Inc. (collectively, “Anchen”), Sandoz, Inc. (“Sandoz”), Apotex Inc. and Apotex
`
`Corp. (collectively, “Apotex”), Zydus Pharmaceuticals (USA) Inc. and Cadila Healthcare Ltd.
`
`(collectively “Zydus”), Macleods Pharmaceuticals Limited and Macleods Pharma USA, Inc.
`
`(collectively, “Macleods”), Teva Pharmaceuticals USA, Inc. (“Teva”), Watson Laboratories, Inc.
`
`and Teva Pharmaceuticals USA, Inc. (collectively, “Watson”), Sun Pharmaceutical Industries
`
`Ltd. (“Sun”), Torrent Pharmaceuticals Limited and Torrent Pharma Inc. (collectively, “Torrent”),
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`ME1 32658815v.1
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`1
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`Case 1:19-md-02902-RGA Document 58 Filed 02/14/20 Page 2 of 13 PageID #: 473
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`
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`Wockhardt Bio AG and Wockhardt USA LLC (collectively, “Wockhardt”), Lupin Limited and
`
`Lupin Pharmaceuticals, Inc. (collectively, “Lupin”), Mylan Pharmaceuticals Inc. (“Mylan”),1
`
` and Accord Healthcare, Inc. (“Accord”) (all collectively, “Defendants”) respectfully file
`
`this Joint Claim Construction Chart identifying the parties’ proposed claim construction
`
`positions with respect to certain terms in the asserted claims of U.S. Patent No. 7,326,708 (“the
`
`’708 patent”) (Chart 1), and the parties’ proposed claim construction positions with respect to
`
`certain terms in the asserted claims of U.S. Patent No. 8,414,921 (“the ’921 patent”) (Chart 2).2
`
`
`
`Exhibit No.
`A
`B
`C
`D
`E
`F
`G
`H
`I
`J
`
`
`
`EXHIBITS
`
`Document Description
`International Patent Publication No. WO 2005/003135
`U.S. Patent No. 7,326,708
`U.S. Patent No. 8,414,921
`U.S. Application No. 12/085,722, 4/6/12 Response
`U.S. Application No. 12/085,722, 9/7/11 Response
`U.S. Application No. 12/085,722, 6/7/12 Final Rejection
`U.S. Application No. 12/085,722, 8/6/12 Response
`U.S. Application No. 12/085,722, 8/9/12 Notice of Allowance
`U.S. Application No. 10/874,992, 6/11/2007 Non-Final Rejection
`U.S. Application No. 10/874,992, 8/6/2007 Response
`
`
`
`1 Defendant Mylan does not join any of the proposed constructions herein.
`2 Each Defendant only joins to the extent the claims are asserted against them respectively at this
`time, unless otherwise stated. Defendants reserve their rights to modify, amend, or otherwise
`supplement these Charts with respect to any additional claims Plaintiff may seek to assert later.
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`ME1 32658815v.1
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`2
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`Case 1:19-md-02902-RGA Document 58 Filed 02/14/20 Page 3 of 13 PageID #: 474
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`
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`
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`Proposed Constructions for Disputed Terms in U.S. Patent No. 7,326,708 (Exhibit A):
`
`CHART 1
`
`Claim Term/Phrase
`
`Claims 2, 3, and 21
`
`“the salt of claim 1[or 2] . . .”3
`
`Plaintiff Proposed Construction and
`Supporting Intrinsic Evidence
`Does not exclude hydrates.
`
`See e.g., ’708 Patent at: Claims 1-4, 17-20; 1:13-
`28; 1:66-2:19; 2:44-65; 3:7-56; 4:33-53; 5:59-67;
`7:46-52. (Ex. A)
`
`
`Claims 4 and 24
`
`“crystalline monohydrate [of
`the dihydrogen phosphate salt
`of sitagliptin”
`
`Plain and ordinary meaning.
`
`To the extent the Court deems a construction to
`be necessary, then:
`
`“a repeating unit cell incorporating a 1:1 ratio of
`water to a dihydrogenphosphate salt of
`sitagliptin”
`
`See e.g., ’708 Patent at: 1:58-62; 2:23-39; 3:47-
`52; 6:29-55; 13:22-14:47; Figures 1-5. (Ex. B)
`
`
`Defendants’ Proposed Construction and
`Supporting Intrinsic Evidence
`Excludes hydrates of the claimed salt.
`
`See, e.g., Ex. B (’708 patent) at claims 1, 2, 3,
`and 19
`
`See, e.g., Ex. I (’992 app. 6/11/2007 non-final
`rejection) at passim
`
`See, e.g., Ex. J (’992 app. 8/6/2007 response) at
`passim
`“a repeating unit cell incorporating a fixed 1:1
`ratio of water hydrogen-bound to a
`dihydrogenphosphate salt of sitagliptin”
`
`See, e.g., Ex. B (’708 patent) at 1:53-57; 2:23-
`39; 3:53-56; 6:52-7:42; 13:22-14:47; Figures 1-
`5.
`
`
`3 Defendant Zydus does not join Defendants’ proposed construction for “the salt of claim 1” and “the salt of claim 2” for claims 2, 3,
`and 21 of the ’708 patent.
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`ME1 32658815v.1
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`Case 1:19-md-02902-RGA Document 58 Filed 02/14/20 Page 4 of 13 PageID #: 475
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`
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`Claim Term/Phrase
`
`Claims 5-7
`
`“characteristic absorption
`bands obtained from the X-
`ray powder diffraction pattern
`at spectral d-spacings of”
`Claim 24
`
`“crystallizing the
`dihydrogenphosphate salt of
`[sitagliptin] at 25° C”
`
`Plaintiff Proposed Construction and
`Supporting Intrinsic Evidence
`Not indefinite: “characteristic diffraction peaks
`corresponding to d-spacings of”
`
`See e.g., ’708 Patent at: 13:22-36; Figure 1. (Ex.
`B)
`
`“performing the crystallization of the
`dihydrogenphosphate salt of sitagliptin wherein
`some or all of the crystallization occurs at 25° C”
`
`See e.g., ’708 Patent at: 6:56-13:21. (Ex. B)
`
`Defendants’ Proposed Construction and
`Supporting Intrinsic Evidence
`Indefinite.
`
`
`
`“performing the crystallization of the
`monohydrate of sitagliptin
`dihydrogenphosphate wherein the formation of
`crystalline solids begins at 25° C”
`
`See, e.g., Ex. B (’708 patent), including the
`specification at 6:52-7:42; 12:61-13:21; and the
`claims at 17:37-18:5.
`
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`ME1 32658815v.1
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`2
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`Case IPR2020-00040 | U.S. Patent 7,326,708
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`CERTIFICATION UNDER 37 C.F.R. § 42.24(d)
`
`Pursuant to 37 C.F.R. 42.6(e), the undersigned hereby certifies that a true
`
`and correct copy of the foregoing was served on April 6, 2020, by delivering a
`
`copy via electronic mail on the following attorneys of record:
`
`Jitendra Malik
`Alissa M. Pacchioli
`Christopher W. West
`Heike S. Radeke
`KATTEN MUCHIN ROSEMAN LLP
`550 South Tryon, Street Suite 2900
`Charlotte, NC 28202-4213
`(704) 444-2000
`jitty.malik@kattenlaw.com
`alissa.pacchioli@kattenlaw.com
`christopher.west@katten.com
`heike.radeke@katten.com
`
`/Stanley E. Fisher/
`Stanley E. Fisher
`Reg. No. 55,820
`
`
`
`
`
`
`
`
`3
`
`
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