Case 1:22-md-03038-CFC Document 119 Filed 05/01/23 Page 1 of 129 PageID #: 2253
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`MDL NO. 22-MD-3038 (CFC)
`ANDA CASE
`
`C.A. No. 22-294 (CFC)
`CONSOLIDATED
`ANDA CASE
`
`C.A. No. 22-1040 (CFC)
`ANDA CASE
`
`)))))
`
`)))))))))))
`
`))))))))))
`
`IN RE: OZEMPIC (SEMAGLUTIDE)
`PATENT LITIGATION
`
`NOVO NORDISK INC. and
`NOVO NORDISK A/S,
`
`Plaintiffs,
`
`v.
`
`RIO BIOPHARMACEUTICALS INC.,
`et al.,
`
`Defendants.
`NOVO NORDISK INC. and
`NOVO NORDISK A/S,
`
`Plaintiffs,
`
`v.
`
`MYLAN PHARMACEUTICALS INC.
`
`Defendant.
`
`JOINT CLAIM CONSTRUCTION BRIEF
`
`MPI EXHIBIT 1090 PAGE 1
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1090, p. 1 of 129
`
`

`

`Case 1:22-md-03038-CFC Document 119 Filed 05/01/23 Page 2 of 129 PageID #: 2254
`
`TABLE OF CONTENTS
`
`Page
`
`I.
`
`INTRODUCTION ............................................................................................. 1
`
`A. NOVO NORDISK’S OPENING POSITION ............................................................ 1
`
`B. NOVO NORDISK’S REPLY POSITION ................................................................ 2
`
`II. AGREED UPON CONSTRUCTIONS ............................................................. 4
`III. DISPUTED CONSTRUCTIONS ...................................................................... 7
`
`A. THE ’462 PATENT ........................................................................................ 7
`
`1. Novo Nordisk’s Opening Position on the Preamble .................................. 7
`
`a.
`
`b.
`
`Introduction to the Patent ....................................................................... 7
`
`“A Method for Treating Type 2 Diabetes” ............................................ 8
`
`(1) The Preamble Gives “Life, Meaning, and Vitality” to the Claim
`and Therefore Is a Limitation ................................................................ 9
`
`(2) The Preamble Provides Antecedent Basis for “A Subject in Need
`Thereof” and Therefore Is a Limitation ...............................................10
`
`(3) The Specification Supports Construing the Preamble As Limiting
` ……………………………………………………………...12
`
`(4) The Preamble Should Be Construed According to the Definition
`Provided in the Specification ...............................................................13
`
`2. Defendants’ Answering Position on the Preamble ..................................15
`
`a.
`
`’462 Patent: “A Method for Treating Type 2 Diabetes” .....................15
`
`(1) The preamble is a statement of intended result ...........................15
`
`i
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`MPI EXHIBIT 1090 PAGE 2
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1090, p. 2 of 129
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`

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`(2) Plaintiffs’ “antecedent basis” and specification arguments also
`fail ………………………………………………………………….18
`
`(a) The claim body provides all the context needed .....................18
`
`(b) Any need for antecedent basis does not convert the full
`preamble into a claim limitation nor impart efficacy ......................19
`
`(c) Plaintiffs’ specification argument fails ....................................20
`
`(3) If the entire preamble is a limitation, Defendants’ definition is
`correct based on the specification ........................................................21
`
`3. Novo Nordisk’s Reply Position on the Preamble ....................................23
`
`a.
`
`“A Method for Treating Type 2 Diabetes” ..........................................23
`
`(1) Contrary to Defendants’ Argument, the Preamble Is Far More
`Than a Statement of Intended Result ...................................................23
`
`(2) The Body of Claim 1 Lacks the Necessary Antecedent Basis for
`“A Subject in Need Thereof” ...............................................................27
`
`(3) The Focus of the Specification Supports Construing the Preamble
`as a Limitation ......................................................................................28
`
`(4) Defendants Cannot Refute that “As Used Herein” Signifies a
`Definition, But Nonetheless Persist with Their Arbitrary Construction .
`………………………………………………………………….29
`
`4. Defendants’ Sur-Reply Position on the Preamble ...................................32
`
`a. The Preamble is Not a Limitation ........................................................32
`
`b. The Preamble Imparts No Efficacy Requirement ................................33
`
`c. Plaintiffs’ “Antecedent Basis” and Specification Argument Also Fail
`……………………………………………………………………….34
`
`ii
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`MPI EXHIBIT 1090 PAGE 3
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1090, p. 3 of 129
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`

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`B. THE ’383 AND ’953 PATENTS ..................................................................34
`
`1.
`
`Introduction to the Patents .......................................................................34
`
`a. Novo Nordisk’s Opening Position .......................................................34
`
`b. Defendants’ Answering Position .........................................................37
`
`2.
`
`“Limiter” and “Driver” ............................................................................38
`
`a. Novo Nordisk’s Opening Position .......................................................38
`
`(1) “Limiter” Should Be Given Its Plain and Ordinary Meaning .....38
`
`(2) “Driver” Should Be Given Its Plain and Ordinary Meaning .......39
`
`(3) “Limiter” and “Driver” Are Not Means-Plus-Function
`Limitations ...........................................................................................41
`
`b. Defendants’ Answering Position .........................................................44
`
`(1) “Limiter” ......................................................................................44
`
`(a) “Limiter” is a means-plus-function limitation. ........................44
`
`(b) If not a means-plus-function limitation, “limiter” should be
`construed commensurate with the specification. .............................46
`
`(2) “Driver” ........................................................................................49
`
`(a) “Driver” is a means-plus-function limitation. .........................49
`
`(b) If not a means-plus-function term, “driver” should be
`construed commensurate with the specification. .............................50
`
`c. Novo Nordisk’s Reply Position ...........................................................53
`
`(1) “Limiter” Should Be Given Its Plain and Ordinary Meaning .....53
`
`iii
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
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`(2) “Driver” Should Be Given Its Plain and Ordinary Meaning .......56
`
`(3) Defendants Fail To Show Why “Limiter” and “Driver” Should
`Be Treated as Means-Plus-Function Limitations ................................58
`
`d. Defendants’ Sur-Reply Position ..........................................................60
`
`(1) “Limiter” ......................................................................................60
`
`(a) “Limiter” Has No Plain Meaning ............................................60
`
`(b) Plaintiffs’ Construction Underscores the Need to Construe
`“Limiter” as a Means-Plus-Function Limitation .............................61
`
`(2) “Driver” ........................................................................................63
`
`3.
`
`“Defining a Passage” ...............................................................................65
`
`a. Novo Nordisk’s Opening Position .......................................................65
`
`b. Defendants’ Answering Position .........................................................66
`
`c. Novo Nordisk’s Reply Position ...........................................................70
`
`d. Defendants’ Sur-Reply Position ..........................................................70
`
`4.
`
`“Housing”.................................................................................................71
`
`a. Novo Nordisk’s Opening Position .......................................................71
`
`b. Defendants’ Answering Position .........................................................72
`
`c. Novo Nordisk’s Reply Position ...........................................................75
`
`d. Defendants’ Sur-Reply Position ..........................................................77
`
`5.
`
`“Coupled”.................................................................................................79
`
`iv
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`MPI EXHIBIT 1090 PAGE 5
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1090, p. 5 of 129
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`a. Novo Nordisk’s Opening Position .......................................................79
`
`b. Defendants’ Answering Position .........................................................81
`
`c. Novo Nordisk’s Reply Position ...........................................................85
`
`d. Defendants’ Sur-Reply Position ..........................................................87
`
`6.
`
`“Piston Rod” and “The Piston Rod Rotates and Translates Axially
`
`Forward” ..........................................................................................................89
`
`a. Novo Nordisk’s Opening Position .......................................................89
`
`b. Defendants’ Answering Position .........................................................92
`
`(1) “Piston Rod” ................................................................................92
`
`(a) “a shaft…within the syringe barrel…to directly drive the
`plunger…and thus expel medicament from the device” .................93
`
`(b) The piston rod “rotates and translates axially … in the distal
`direction” ..........................................................................................96
`
`(2) “The Piston Rod Rotates and Translates Axially Forward” ........97
`
`(a) “Rotates” means “rotates relative to a housing of the injection
`device.” ............................................................................................98
`
`(b) “Translates axially forward” means “translates toward a distal
`end of the injection device through which the dose is administered
`during dose administration.” ..........................................................100
`
`c. Novo Nordisk’s Reply Position .........................................................103
`
`(1) “Piston Rod” ..............................................................................103
`
`(2) “The Piston Rod Rotates and Translates Axially Forward” ......106
`
`v
`
`MPI EXHIBIT 1090 PAGE 6
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1090, p. 6 of 129
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`d. Defendants’ Sur-Reply Position ........................................................107
`
`(1) “Piston Rod” ..............................................................................107
`
`(2) “The Piston Rod Rotates and Translates Axially Forward” ......109
`
`vi
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`MPI EXHIBIT 1090 PAGE 7
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1090, p. 7 of 129
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`Case 1:22-md-03038-CFC Document 119 Filed 05/01/23 Page 8 of 129 PageID #: 2260
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Cases
`Abbott Labs. v. Andrx Pharms., Inc.,
`473 F.3d 1196 (Fed. Cir. 2007) .......................................................................... 13
`Al-Site Corp. v. VSI Int’l, Inc.,
`174 F.3d 1308 (Fed. Cir. 1999) .................................................................... 45, 50
`Alloc, Inc. v. ITC,
`342 F.3d 1361 (Fed. Cir. 2003) ...................................................................passim
`Apex Inc. v. Raritan Comput., Inc.
`325 F.3d 1364 (Fed. Cir. 2003) .................................................................... 45, 50
`Apple, Inc., v. Ameranth, Inc.,
`842 F.3d at 1238 ................................................................................................. 92
`Applied Materials, Inc. v. Advanced Semiconductor Materials Am.,
`Inc.,
`98 F.3d 1563 (Fed. Cir. 1996) ............................................................................ 12
`Barry v. Stryker Corp.,
`No. 20-1787-RGA, 2023 WL 1765651 (D. Del. Feb. 3, 2023).......................... 62
`Bicon, Inc. v. Straumann Co.,
`441 F.3d 945 (Fed. Cir. 2006) .............................................................. 93, 95, 101
`Bioverativ Inc. v. CSL Behring LLC,
`C.A. No. 1:17-cv-00914-RGA, 2019 WL 1276030 (D. Del. Mar.
`20, 2019) ....................................................................................................... 14, 15
`Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp.,
`320 F.3d 1339 (Fed. Cir. 2003) ...................................................................passim
`Bristol-Myers Squibb Co. v. Ben Venue Lab’ys, Inc.,
`246 F.3d 1368 (Fed. Cir. 2001) ...................................................................passim
`Bristol-Myers Squibb Co. v. Merck & Co., Inc.,
`2016 WL 11711498 (D. Del. June 6, 2016) ................................................. 20, 21
`
`vii
`
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
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`
`Brookhill-Wilk 1, LLC v. Intuitive Surgical, Inc.,
`334 F.3d 1294 (Fed. Cir. 2003) ........................................................................ 107
`Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc.,
`289 F.3d 801 (Fed. Cir. 2002) .................................................................. 9, 15, 21
`Chaffin v. Braden,
`696 F. App’x 1001 (Fed. Cir. 2017) ................................................................... 91
`Choon’s Design, LLC v. IdeaVillage Prods. Corp.,
`776 F. App’x 691 (Fed. Cir. 2019) ..................................................................... 48
`Civix-DDI, LLC v. Cellco P’ship,
`387 F.Supp.2d 869 (N.D. Ill. 2005) .................................................................... 32
`Cordis Corp. v. Boston Sci. Corp.,
`658 F.3d 1347 (Fed. Cir. 2011) ........................................................................ 110
`Depomed, Inc. v. Sun Pharma Global FZE,
`2012 WL 3201962 (D.N.J. Aug. 3, 2012) .......................................................... 53
`Diebold Nixdorf, Inc. v. ITC,
`899 F.3d 1291 (Fed. Cir. 2018) .......................................................................... 60
`Dyfan LLC v. Target Corp.,
`28 F.4th 1360 (Fed. Cir. 2022) ........................................................................... 41
`Eaton Corp. v. Rockwell Int’l Corp.,
`323 F.3d 1332 (Fed. Cir. 2003) .................................................................... 11, 19
`Egenera, Inc. vs. Cisco Sys., Inc., 972 F.3d 1367 (Fed. Cir. 2020) ......................... 63
`Eli Lilly & Co. v. Teva Pharms. Int’l GmbH,
`8 F.4th 1331 (Fed. Cir. 2021) ......................................................................passim
`EPOS Techs. Ltd. v. Pegasus Techs. Ltd.,
`766 F.3d 1338 (Fed. Cir. 2014) .................................................................... 56, 58
`Forest Lab’ys., LLC v. Apotex Corp.,
`2016 WL 6645784 (D. Del. Nov. 8, 2016) ......................................................... 26
`G.I. Sportz, Inc. v. Walken, Inc.,
`2019 WL 2724081 (D.N.J. June 30, 2019) ......................................................... 84
`
`viii
`
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
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`
`Galderma Labs., L.P. v. Sun Pharm. Indus. Ltd.,
`411 F. Supp. 3d 271 (D. Del. 2019).................................................................... 91
`GE Lighting Sols., LLC v. AgiLight, Inc.,
`750 F.3d 1304 (Fed. Cir. 2014) .......................................................................... 56
`Greenberg v. Ethicon Endo Surgery, Inc.,
`91 F.3d 1580 (Fed. Cir. 1996) ............................................................................ 59
`Howmedica Osteonics Corp. v. Zimmer, Inc.,
`822 F.3d 1312 (Fed. Cir. 2016) ...................................................................passim
`Huawei Techs. Co. Ltd. v. T-Mobile US, Inc.,
`2017 WL 2691227 (E.D. Tex. June 22, 2017) ................................................... 84
`Intercept Pharms., Inc. v. Apotex Inc.,
`C.A. No. 20-1105, 2022 WL 856859 (D. Del. Mar. 23, 2022) .......................... 13
`Inventio AG v. ThyssenKrupp Elevator Ams. Corp.,
`649 F.3d 1350 (Fed. Cir. 2011) .......................................................................... 59
`Jansen v. Rexall Sundown, Inc.,
`342 F.3d 1329 (Fed. Cir. 2003) ...................................................................passim
`In re Katz Interactive Call Processing Pat. Litig.,
`639 F.3d 1303 (Fed. Cir. 2011) .................................................................... 14, 31
`Kyocera Senco Indus. Tools Inc. v. ITC,
`22 F.4th 1369 (Fed. Cir. 2022) ............................................................... 45, 50, 62
`Liebel-Flarsheim Co. v. Medrad, Inc.,
`358 F.3d 898 (Fed. Cir. 2004) .................................................................... 58, 106
`Liquid Dynamics Corp. v. Vaughan Co.,
`355 F.3d 1361 (Fed. Cir. 2004) .......................................................................... 57
`Magnolia Med. Tech., Inc. v. Kurin, Inc.,
`No. 19-97-CFC-CJB, 2020 WL 2559795 (D. Del. May 20, 2020) .................... 63
`Meds. Co. v. Mylan, Inc.,
`853 F.3d 1296 (Fed. Cir. 2017) .................................................................... 47, 79
`
`ix
`
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
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`
`Merck & Co. v. Teva Pharms. USA, Inc.,
`347 F.3d 1367 (Fed. Cir. 2003) .......................................................................... 94
`MTD Prods. Inc. v. Iancu,
`933 F.3d 1336 (Fed. Cir. 2019) .............................................................. 46, 61, 62
`Mylan Pharms. Inc. v. Novo Nordisk A/S,
`Case No. IPR2023-00724, Paper 1, 14-15 (PTAB March 16, 2023) ................. 30
`Netword, LLC v. Centraal Corp.,
`242 F.3d 1347 (Fed. Cir. 2001) .......................................................................... 48
`Nobel Biocare Servs. AG v. Instradent USA, Inc.,
`903 F.3d 1365 (Fed. Cir. 2018) .......................................................................... 39
`Novartis Pharms. Corp. v. Accord Healthcare Inc., 387 F. Supp. 3d
`429 (D. Del. 2019) ............................................................................ 10, 18, 20, 25
`Novartis Pharms. Corp. v. Actavis, Inc.,
`2013 WL 6142747 (D. Del. Nov. 21, 2013) ................................................passim
`Novo Nordisk Inc. et al. v. Orbicular Pharm. Techs. Pvt. Ltd.,
`C.A. No. 22-856-CFC, D.I. 69 (D. Del. Mar. 24, 2023) .................................... 60
`Par Pharm., Inc. v. Hospira, Inc.,
`Civ. Action No. 17-944-JFB-SRF, 2019 WL 2004756 (D. Del.
`Apr. 30, 2019) ..................................................................................................... 61
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) ...................................................................passim
`Rapoport v. Dement,
`254 F.3d 1053 (Fed Cir. 2001) ....................................................................passim
`RF Delaware, Inc. v. Pac. Keystone Techs., Inc.,
`326 F.3d 1255 (Fed. Cir. 2003) ........................................................................ 103
`Sanofi Mature IP v. Mylan Lab'ys Ltd.,
`757 F. App’x 988 (Fed. Cir. 2019) ..............................................................passim
`Sanofi-Aventis U.S., LLC v. Merck Sharp & Dohme Corp.,
`2018 WL 389183 (D. Del. Jan. 12, 2018) .............................................. 47, 48, 61
`
`x
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`DR. REDDY’S LABORATORIES, INC.
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`
`TDM Am., LLC v. U.S.,
`85 Fed. Cl. 774 (2009) ........................................................................................ 48
`TEK Global S.R.L. v. Sealant Sys. Int’l, Inc.,
`920 F.3d 777 (Fed. Cir. 2019) ................................................................ 41, 43, 58
`Teleflex, Inc. v. Ficosa N. Am. Corp.,
`299 F.3d 1313 (Fed. Cir. 2002) .......................................................................... 97
`Trustees of Columbia Univ. in City of New York v. Symantec Corp.,
`811 F.3d 1359 (Fed. Cir. 2016) .......................................................................... 92
`Tyco Healthcare Grp. LP v. Mut. Pharm. Co.,
`No. 07-1299, 2009 WL 44745 (D.N.J. Jan. 5, 2009) ............................. 22, 31, 32
`Unitherm Food Sys. v. Swift-Eckrich, Inc.,
`375 F.3d 1341 (Fed. Cir. 2004) .......................................................................... 75
`Wasica Fin. GmbH v. Cont’l Auto. Sys., Inc.,
`853 F.3d 1272 (Fed. Cir. 2017) ............................................................ 93, 95, 101
`WesternGeco LLC v. ION Geophysical Corp.,
`889 F.3d 1308 (Fed. Cir. 2018) .......................................................................... 54
`Williamson v. Citrix Online, LLC,
`792 F.3d 1339 (Fed. Cir. 2015) .............................................................. 44, 45, 50
`Zelinski v. Brunswick Corp.,
`185 F.3d 1311 (Fed. Cir. 1999) .......................................................................... 81
`Statutes
`35 U.S.C. § 112, ¶ 6 ..........................................................................................passim
`
`xi
`
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`TABLE OF EXHIBITS AND ABBREVIATIONS
`
`Abbreviation
`Opening
`Answering
`Reply
`’462 Patent
`’383 patent
`’953 Patent
`
`’003 Patent
`Cameron
`Decl.
`
`Exhibit
`
`A
`B
`C
`D
`E
`
`F
`G
`
`H
`I
`
`J
`K
`L
`
`1
`
`2
`3
`4
`5
`6
`
`7
`
`8
`
`9
`
`Description
`Novo Nordisk’s Opening Claim Construction Position
`Defendants’ Answering Claim Construction Position
`Novo Nordisk’s Reply Claim Construction Position
`U.S. Patent No. 10,335,462
`U.S. Patent No. 8,920,383
`U.S. Patent No. 9,775,953
`Definition of “Limiter,” Collins English Dictionary
`Definition of “Driver,” Merriam-Webster Collegiate
`Dictionary
`U.S. Patent No. 9,764,003
`Declaration of Kimberly K. Cameron, Ph.D., P.E.
`(Apr. 6, 2023)
`PCT Pub. No. WO2002/092153A2
`Definition of “Housing,” Merriam-Webster Collegiate
`Dictionary
`Definition of “Coupled,” Oxford English Dictionary
`U.S. Patent No. 6,235,004
`U.S. Patent No. 8,920,383 prosecution history excerpt:
`Jan. 2010 Response to Office Action
`Excerpt of Novo’s Resp. to Defs. Initial Invalidity
`Contentions
`Excerpt of Novo’s Initial Infringement Contentions
`Generic Drugs-Specific Labeling Resources
`US9,968,659 (SEMAJDG_0003107-32)
`US11,278,596 (SEMAJDG_0003085-3106)
`Meriam, J. L., and L. G. Kraige. Engineering
`Mechanics. Statics. 7th ed., J. Wiley, 2012
`(SEMA(JDG)_0002989-3081)
`Academic Press Mechanical Engineers Handbook
`2001 (SEMA(JDG)_0002936-964)
`Khurmi, R S. Textbook of Engineering Mechanics. S
`Chand & Co Ltd, 2010 (SEMA(JDG)_0002966-985)
`Luebkeman, Chris, and Peting, Donald. "What Are
`Couples?" Architectonics The Science of
`Architecture, 1995,
`
`xii
`
`MPI EXHIBIT 1090 PAGE 13
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1090, p. 13 of 129
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`Case 1:22-md-03038-CFC Document 119 Filed 05/01/23 Page 14 of 129 PageID #: 2266
`
`Exhibit
`
`10
`
`11
`
`12
`13
`
`14
`
`Description
`web.mit.edu/4.441/1_lectures/1_lecture12
`/1_lecture12.html. Accessed 20 Jan. 2023
`(SEMA(JDG)_0002986-2988)
`The American Heritage Dictionary – New College
`Edition – ISBN: 0-395-20360-0
`(SEMA(JDG)_0002965)
`Friction-Induced Vibration in Lead Screw Drives, Ch.
`2, Lead Screws (Springer 2011)
`Declaration of Karl R. Leinsing, MSME, PE
`The Oxford American Dictionary and Thesaurus with
`Language Guide (2003)
`U.S. Patent No. 8,920,383 prosecution history excerpt:
`Amendment (July 1, 2010)
`
`Abbreviation
`
`Leinsing Decl.
`
`xiii
`
`MPI EXHIBIT 1090 PAGE 14
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
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`Case 1:22-md-03038-CFC Document 119 Filed 05/01/23 Page 15 of 129 PageID #: 2267
`
`I.
`
`INTRODUCTION
`
`A.
`
`Novo Nordisk’s Opening Position
`
`This case concerns Plaintiffs Novo Nordisk Inc. and Novo Nordisk A/S’s
`
`(collectively, “Novo Nordisk”) blockbuster diabetes medicine Ozempic®. The
`
`parties dispute claim construction of nine terms, one of which appears in Novo
`
`Nordisk’s U.S. Patent No. 10,335,462 (the “’462 patent”), which claims methods of
`
`treating diabetes. The remaining claim terms are found in U.S. Patent Nos.
`
`8,920,383 (the “’383 patent) and 9,775,953 (the “’953 patent,” and together with the
`
`’383 patent, the “end-of-content patents”), and concern aspects of the pen injector
`
`device that patients use to self-administer Ozempic® via subcutaneous injection.
`
`The ’462 patent claims novel methods of treating type 2 diabetes with
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`semaglutide, Ozempic®’s active ingredient. The patent’s inventor discovered that
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`administering 1.0 mg of semaglutide once weekly provided dramatic and unexpected
`
`improvements in controlling blood sugar.
`
`Defendants dispute that the preamble of the ’462 patent’s claims—“[a]
`
`method for treating type 2 diabetes”—is a limitation. Binding Federal Circuit
`
`precedent, however, dictates that preambles like this one, which identify the disorder
`
`to be treated by the claimed method, are limiting. Moreover, the preamble provides
`
`necessary antecedent basis for the later claim term “a subject in need thereof.”
`
`1
`
`MPI EXHIBIT 1090 PAGE 15
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1090, p. 15 of 129
`
`

`

`Case 1:22-md-03038-CFC Document 119 Filed 05/01/23 Page 16 of 129 PageID #: 2268
`
`The parties also dispute how to construe the preamble of the ’462 patent’s
`
`claims. Novo Nordisk’s construction matches the phrase’s plain meaning and tracks
`
`the specification’s definition of “treating,” which should control the preamble’s
`
`construction. Defendants’ construction builds in limitations redundant of other
`
`claim terms and improperly limits “treating” to certain treatment outcomes, contrary
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`to the patent’s definition and the plain and ordinary meaning of the word.
`
`The end-of-content patents are in the same family and use similar (often
`
`identical) terms to claim novel mechanisms that prevent patients from injecting
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`themselves with incorrect doses of the medication, thus providing an important
`
`safety benefit. Defendants urge the Court to construe seven terms from the end-of-
`
`content patents, proposing constructions that are redundant of other claim terms and
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`would improperly limit the scope to embodiments from the specification. By
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`contrast, Novo Nordisk’s constructions are consistent with the intrinsic evidence and
`
`the terms’ plain and ordinary meanings. For these reasons and those given below,
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`Novo Nordisk respectfully requests that the Court enter its proposed constructions
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`of the disputed claim terms.
`
`B.
`
`Novo Nordisk’s Reply Position
`
`Defendants fail to overcome the numerous reasons for construing the
`
`preamble of the claims in the ’462 patent as limiting. They do not distinguish
`
`binding Federal Circuit precedent for construing a method of treatment preamble,
`
`2
`
`MPI EXHIBIT 1090 PAGE 16
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1090, p. 16 of 129
`
`

`

`Case 1:22-md-03038-CFC Document 119 Filed 05/01/23 Page 17 of 129 PageID #: 2269
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`like the one in the ’462 patent, as a limitation. Defendants also concede that the
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`phrase “a subject in need thereof,” which is recited in the body of claim 1 of the ’462
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`patent, requires an antecedent basis. They assert instead that the antecedent basis is
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`found not in the preamble, but elsewhere in the claim. Defendants’ arguments fail
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`in light of the claim language as a whole and contrary case law.
`
`Regarding the preamble’s construction, Defendants do not dispute that in a
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`patent specification the phrase, “as used herein,” generally signals a term’s
`
`definition. They instead pursue a construction that limits “treating” to certain
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`outcomes listed in the specification, without explaining the inclusion of some and
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`omission of others. The Court should adopt Novo Nordisk’s straightforward
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`construction of the preamble, which is based on the ’462 patent’s definition of
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`“treating.”
`
`Defendants seek to construe the end-of-content patent terms by adding
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`extraneous requirements to straightforward device elements. Not only are
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`Defendants’ constructions excessively complicated, but they import limitations from
`
`select embodiments and read out others entirely. Novo Nordisk’s constructions, by
`
`contrast, draw on the intrinsic evidence in plainly understood language. The Court
`
`should adopt Novo Nordisk’s proposed constructions.
`
`3
`
`MPI EXHIBIT 1090 PAGE 17
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1090, p. 17 of 129
`
`

`

`Case 1:22-md-03038-CFC Document 119 Filed 05/01/23 Page 18 of 129 PageID #: 2270
`
`II.
`
`AGREED UPON CONSTRUCTIONS
`
`CLAIM TERMS AGREED UPON IN THE ’833 PATENT
`Term or Phrase for
`Claim(s)
`Agreed Upon Construction
`Construction
`“about”
`
`1, 7, 16,
`and 22
`
`When used in connection with pH,
`“[plus] or [minus] 0.1 pH units from
`[the stated number]”
`
`“A method for reducing
`deposits on production
`equipment during production
`of a GLP-1 agonist
`formulation”
`“A method for reducing
`deposits in the final product
`during production of a GLP-
`1 agonist formulation”
`“A method for reducing the
`clogging of injection devices
`by a GLP-1 agonist
`formulation”
`
`23
`
`26
`
`29
`
`“replacing the isotonicity
`agent previously utilized in
`said formulation with
`propylene glycol”
`
`23, 26, and
`29
`
`“the isotonicity agent to be
`replaced by propylene
`glycol”
`
`25, 28, and
`31
`
`4
`
`The phrase is an express limitation
`of claim 23 and it carries its plain
`and ordinary meaning.
`
`The phrase is an express limitation
`of claim 26 and it carries its plain
`and ordinary meaning.
`
`The phrase is an express limitation
`of claim 29 and it carries its plain
`and ordinary meaning.
`
`“Having a first formulation that
`utilized an isotonicity agent other
`than propylene glycol and having a
`second formulation wherein the
`isotonicity agent used in the first
`formulation is substituted or
`replaced with propylene glycol”
`
`“Having a first formulation that
`utilized an isotonicity agent other
`than propylene glycol and having a
`second formulation wherein the
`isotonicity agent used in the first
`
`MPI EXHIBIT 1090 PAGE 18
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1090, p. 18 of 129
`
`

`

`Case 1:22-md-03038-CFC Document 119 Filed 05/01/23 Page 19 of 129 PageID #: 2271
`
`formulation is substituted or
`replaced with propylene glycol”
`
`CLAIM TERMS AGREED UPON IN THE ’383 PATENT
`Term or Phrase for
`Claim(s)
`Agreed Upon Construction
`Construction
`“dose setting member”
`
`1
`
`Plain and ordinary meaning, which
`is “the member used to set the dose”
`Plain and ordinary meaning, which
`is “medication”
`Plain and ordinary meaning, which
`is “a component that contains the
`medication, which component is
`included only once in the injection
`device”
`Plain and ordinary meaning, which
`is “a mechanism for locking the
`piston rod against rotation in at least
`one direction”
`5, 8, and 9 Plain and ordinary meaning, which
`is “a surface adapted to engage a
`corresponding surface”
`Plain and ordinary meaning, which
`is “a mechanism that allows linear
`or rotary motion in only one
`direction while preventing motion
`in the opposite direction”
`
`“medicament”
`
`“reservoir”
`
`“locking means”
`
`“engaging surface”
`
`“ratchet mechanism”
`
`1
`
`1
`
`3
`
`10
`
`CLAIM TERMS AGREED UPON IN THE ’953 PATENT
`Term or Phrase for
`Claim(s)
`Agreed Upon Construction
`Construction
`“longitudinal direction”
`
`1
`
`Plain and ordinary meaning, which
`is “running lengthwise”
`
`5
`
`MPI EXHIBIT 1090 PAGE 19
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1090, p. 19 of 129
`
`

`

`Case 1:22-md-03038-CFC Document 119 Filed 05/01/23 Page 20 of 129 PageID #: 2272
`
`“dose setting member”
`
`“medicament”
`
`“reservoir”
`
`1
`
`1
`
`1
`
`“causes the pist