Filed: March 16, 2023
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MYLAN PHARMACEUTICALS INC.,
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`Petitioner,
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`v.
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`NOVO NORDISK A/S,
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`Patent Owner.
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`Case No. IPR2023-00722
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`Patent No. 8,536,122
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`PETITION FOR INTER PARTES REVIEW OF
`U.S. PATENT NO. 8,536,122
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`TABLE OF CONTENTS
`
`
`Introduction ..................................................................................................... 1
`I.
`II. Mandatory Notices.......................................................................................... 2
`A.
`Real Parties-In-Interest ......................................................................... 2
`B.
`Related Matters ..................................................................................... 2
`C.
`Identification of Counsel (37 C.F.R. § 42.8(b)(3)) .............................. 4
`D.
`Service Information (37 C.F.R. § 42.8(b)(4)) ...................................... 4
`III. Requirements for Inter Partes Review ........................................................... 5
`A. Grounds for Standing ........................................................................... 5
`B.
`Identification of Challenge and Statement of Precise Relief
`Requested ............................................................................................. 5
`IV. Threshold Requirement for Inter Partes Review ........................................... 6
`V.
`Statement of Reasons for the Relief Requested ............................................. 6
`A.
`Summary of the Argument ................................................................... 6
`B.
`Level of Ordinary Skill in the Art ........................................................ 7
`C.
`The ’122 Patent .................................................................................... 9
`1.
`Disclosure ................................................................................... 9
`2.
`Priority Date ............................................................................. 10
`3.
`Claims ...................................................................................... 10
`4.
`Prosecution History .................................................................. 15
`Claim Construction (37 C.F.R. §§ 42.100(b), 42.104(b)(3)) ............. 16
`Scientific Background ........................................................................ 16
`1.
`Diabetes .................................................................................... 16
`2.
`GLP-1 ....................................................................................... 17
`3.
`Peptide Synthesis and Structure Screening .............................. 18
`Scope and Content of the Prior Art .................................................... 19
`1.
`Knudsen 2004 (Ex. 1010) ........................................................ 20
`2.
`The Knudsen Patent (Ex. 1012) ............................................... 21
`3.
`Dong (Ex. 1013) ....................................................................... 23
`
`D.
`E.
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`F.
`
`i
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`

`

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`
`I.
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`J.
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`Bridon (Ex. 1014) .................................................................... 24
`4.
`Knudsen 2001 (Ex. 1011) ........................................................ 25
`5.
`Legal Standard .................................................................................... 27
`G.
`H. Ground 1: Knudsen 2004 in view of the Knudsen Patent, Dong,
`and Bridon (lead-compound framework) ........................................... 28
`1.
`Claim 1 ..................................................................................... 29
`2.
`Claims 2 and 4-11 .................................................................... 46
`3.
`Claim 13 ................................................................................... 48
`4.
`Claim 15 ................................................................................... 49
`Ground 2: Knudsen 2001 in view of the Knudsen Patent, Dong,
`and Bridon (Lead-Compound Framework) ........................................ 50
`1.
`Claim 1 ..................................................................................... 50
`2.
`Claims 2 and 4-11 .................................................................... 55
`3.
`Claim 13 ................................................................................... 56
`4.
`Claim 15 ................................................................................... 56
`Ground 3: Obviousness over the prior art and common drug
`development principles (under KSR) ................................................. 56
`1.
`If applied as a rigid subject-matter-specific obviousness
`analysis, the lead-compound doctrine is inconsistent with
`KSR ........................................................................................... 57
`Under Graham and KSR, semaglutide would have been
`obvious because the differences between it and the
`closest prior art, liraglutide, involve predictable elements
`and tweaking result-effective variables ................................... 62
`K. Any Secondary Considerations Fail to Overcome Prima Facie
`Obviousness ........................................................................................ 65
`1.
`There were no unexpected or surprising results ...................... 66
`2.
`The prior art did not teach away from semaglutide ................. 66
`3.
`There was no long-felt but unmet need ................................... 66
`4.
`Commercial sales do not save the ’122 patent ......................... 67
`5.
`There was no industry skepticism ............................................ 68
`6.
`Copying by generic drug makers is irrelevant ......................... 68
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`2.
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`ii
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`VI. This Petition Should Not Be Denied Institution Under 35 U.S.C.
`§ 325(d) ......................................................................................................... 68
`A.
`This Petition Presents Different Art and Arguments than Were
`Before the Examiner ........................................................................... 69
`The Examiner Materially Erred .......................................................... 72
`B.
`VII. This Petition Should Not Be Denied Institution Under 35 U.S.C. § 314 ..... 72
`VIII. Conclusion .................................................................................................... 73
`
`
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`iii
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`
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`CASES
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`TABLE OF AUTHORITIES
`
`
`Advanced Bionics, LLC, v MED-EL Elektromedizinische Geräte GmbH,
`IPR2019-01469, Paper 6 (PTAB Feb. 13, 2020) (precedential) ........................ 69
`
`Altana Pharma AG v. Teva Pharms. USA, Inc.,
`566 F.3d 999 (Fed. Cir. 2009) ............................................................................ 56
`
`Apple Inc. v. Fintiv, Inc.,
`IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) (precedential) ...................... 72
`
`Aventis Pharma Deutschland GmbH v. Lupin, Ltd.,
`499 F.3d 1293 (Fed. Cir. 2007) .......................................................................... 29
`
`Bayer Healthcare Pharms., Inc. v. Watson Pharms., Inc.,
`713 F.3d 1369 (Fed. Cir. 2013) .......................................................................... 68
`
`Becton, Dickinson & Co. v. B. Braun Melsungen AG,
`IPR2017-01586, Paper 8 (PTAB Dec. 15, 2017) (precedential) ........................ 69
`
`Collective Minds Gaming Co. v. Ironburg Inventions Ltd.,
`IPR2018-00356, Paper 11 (PTAB June 7, 2018) ............................................... 70
`
`Daiichi Sankyo Co. v. Matrix Labs., Ltd.,
`619 F.3d 1346 (Fed. Cir. 2010) .................................................................... 27, 57
`
`Donner Tech., LLC v. Pro Stage Gear, LLC,
`979 F.3d 1353 (Fed. Cir. 2020) .................................................................... 59, 60
`
`E.I. DuPont de Nemours & Co. v. Synvina C.V.,
`904 F.3d 996 (Fed. Cir. 2018) ............................................................................ 28
`
`Eisai Co. v. Dr. Reddy's Labs., Ltd.,
`533 F.3d 1353, 1357 (Fed. Cir. 2008) ................................................................ 28
`
`Galderma Labs., L.P. v. Tolmar, Inc.,
`737 F.3d 731 (Fed. Cir. 2013) ............................................................................ 66
`
`GMG Prods. LLC v. Traeger Pellet Grills LLC,
`PGR2019-00024, Paper 17 (PTAB July 17, 2019) ...................................... 71, 72
`
`iv
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`Graham v. John Deere Co.,
`383 U.S. 1 (1966) .............................................................................. 34, 58, 62, 65
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`Henny Penny Corp. v. Frymaster LLC,
`938 F.3d 1324 (Fed. Cir. 2019) .......................................................................... 65
`
`In re Applied Materials, Inc.,
`692 F.3d 1289 (Fed. Cir. 2012) ........................................................ 28, 45, 55, 61
`
`In re Boesch,
`617 F.2d 272 (CCPA 1980) .............................................................. 28, 61, 63, 64
`
`In re Dillon,
`919 F.2d 688 (Fed. Cir. 1990) (en banc) ............................................................ 57
`
`In re Kao,
`639 F.3d 1057 (Fed. Cir. 2011) .......................................................................... 65
`
`Intel Corp. v. PACT XPP Schweiz AG,
`No. 2022-1037, slip op. (Fed. Cir. Mar. 13, 2023) ....................................... 59, 62
`
`J.T. Eaton & Co. v. Atl. Paste & Glue Co.,
`106 F.3d 1563 (Fed. Cir. 1997) .......................................................................... 67
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) .....................................................................................passim
`
`McNeil-PPC, Inc. v. L. Perrigo Co.,
`337 F.3d 1362 (Fed. Cir. 2003) .......................................................................... 68
`
`Mylan Pharms. Inc. v. Bausch Health Ir. Ltd.,
`No. IPR2022-00722, Paper 16 (PTAB Sept. 14, 2022) ...................................... 27
`
`Netflix, Inc. v. DivX, LLC,
`IPR2020-00558, Paper 10 (PTAB Aug. 26, 2020) ............................................. 70
`
`NOF Corp. v. Nektar Therapeutics,
`IPR2019-01394, Paper 68 (PTAB July 30, 2021) .............................................. 56
`
`Otsuka Pharm. Co. v. Sandoz, Inc.,
`678 F.3d 1280 (Fed. Cir. 2012) ...................................................................passim
`
`
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`v
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`

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`Pentec, Inc. v. Graphic Controls Corp.,
`776 F.2d 309 (Fed. Cir. 1985) ............................................................................ 68
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`Pfizer, Inc. v. Apotex, Inc.,
`480 F.3d 1348 (Fed. Cir. 2007) .......................................................................... 65
`
`Sand Revolution II, LLC v. Cont’l Intermodal Grp.,
`IPR2019-01393, Paper 24 (PTAB June 16, 2020) (informative) ....................... 73
`
`Standard Oil Co. v. Am. Cyanamid Co.,
`774 F.2d 448 (Fed. Cir. 1985) ............................................................................ 58
`
`Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd.,
`492 F.3d 1350 (Fed. Cir. 2007) .................................................................... 58, 60
`
`Therasense, Inc. v. Becton, Dickinson & Co.,
`593 F.3d 1289 (Fed. Cir. 2010),
`reinstated in relevant part,
`649 F.3d 1276 (Fed. Cir. 2011) (en banc) .......................................................... 67
`
`UCB, Inc. v. Accord Healthcare, Inc.,
`890 F.3d 1313, 1329 (Fed. Cir. 2018) ................................................................ 58
`
`Unified Patents Inc. v. Pen-One Acquisition Grp., LLC,
`IPR2017-02167, Paper 12 (PTAB Apr. 4, 2018) ............................................... 70
`
`Yamanouchi Pharm. Co. v. Danbury Pharmacal, Inc.,
`231 F.3d 1339 (Fed. Cir. 2000) .......................................................................... 57
`
`ZUP, LLC v. Nash Mfg., Inc.,
`896 F.3d 1365 (Fed. Cir. 2018) .......................................................................... 65
`
`STATUTES
`
`35 U.S.C. § 102 ............................................................................................ 57, 59, 60
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`35 U.S.C. § 102(a) ................................................................................................... 21
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`35 U.S.C. § 102(b) ................................................................................. 10, 23, 24, 26
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`35 U.S.C. § 112 ........................................................................................................ 16
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`35 U.S.C. §§ 311-319................................................................................................. 1
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`
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`vi
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`35 U.S.C. § 314 ........................................................................................................ 72
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`35 U.S.C. § 314(a) ............................................................................................... 6, 72
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`35 U.S.C. § 325(d) ....................................................................................... 68, 69, 72
`
`OTHER AUTHORITIES
`
`37 C.F.R. § 42 ............................................................................................................ 1
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`37 C.F.R. § 42.8(b)(1) ................................................................................................ 2
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`37 C.F.R. § 42.8(b)(2) ................................................................................................ 2
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`37 C.F.R. § 42.8(b)(3) ................................................................................................ 4
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`37 C.F.R. § 42.8(b)(4) ................................................................................................ 4
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`37 C.F.R. § 42.22(a) ................................................................................................... 5
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`37 C.F.R. § 42.100(b) .............................................................................................. 16
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`37 C.F.R. § 42.103 ..................................................................................................... 2
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`37 C.F.R. § 42.104(a) ................................................................................................. 5
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`37 C.F.R. § 42.104(b) ................................................................................................ 5
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`37 C.F.R. § 42.104(b)(3) .......................................................................................... 16
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`37 C.F.R. § 42.106(a) ................................................................................................. 2
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`
`
`vii
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`TABLE OF EXHIBITS
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`DESCRIPTION
`
`U.S. Patent No. 8,536,122
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`U.S. Patent No. 8,129,343
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`Prosecution history excerpts for U.S. Patent No. 8,536,122
`
`
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`EXHIBIT
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`1001
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`1002
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`1003
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`1004
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`Prosecution history excerpts for U.S. Patent No. 8,129,343
`
`1005
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`1006
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`1007
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`1008
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`1009
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`1010
`
`1011
`
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`269(9) J. BIO. CHEM. 6275 (1994)
`
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`55(2) BIOPOLYMERS 123 (2000)
`
`Baggio, A Recombinant Human Glucagon-Like Peptide (GLP)-1–
`Albumin Protein (Albugon) Mimics Peptidergic Activation of GLP-
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`Gastrointestinal Motility, and Glucose Homeostasis, 53(9)
`DIABETES 2492 (2004) (“Baggio 2004a”)
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`(“Cistola II”)
`
`Knudsen, Glucagon-Like Peptide-1: The Basis of a New Class of
`Treatment for Type 2 Diabetes, 47(17) J MED CHEM. 4128 (2004)
`
`Knudsen, GLP-1 Derivatives as Novel Compounds for the
`Treatment of Type 2 Diabetes: Selection of NN2211 for Clinical
`Development, 26(7) DRUGS OF THE FUTURE (2001)
`
`1012
`
`U.S. Patent No. 6,268,343 (“Knudsen Patent”)
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`viii
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`EXHIBIT
`
`DESCRIPTION
`
`1013
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`Improved in vivo Activity, in PEPTIDES: THE WAVE OF THE FUTURE
`(Michal Lebl et al. eds., 2001)
`
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`U.S. Patent No. 6,514,500 (“Bridon”)
`
`1015
`
`1016
`
`1017
`
`Clodfelter, Effects of Non-Covalent Self-Association on the
`Subcutaneous Absorption of a Therapeutic Peptide, 15(2) PHARM.
`RSCH. 254 (1998)
`
`Nulf, DNA Assembly using Bis-Peptide Nucleic Acids (bisPNAs),
`30(13) NUCLEIC ACIDS RES.2782 (2002)
`
`Drucker, Development of Glucagon-Like Peptide-1-Based
`Pharmaceuticals as Therapeutic Agents for the Treatment of
`Diabetes, 7 CURRENT PHARM. DESIGN 1399 (2001)
`
`1018
`
`Drucker, Discovery, Characterization, and Clinical Development of
`the Glucagon-Like Peptides, 127(12) J. CLIN. INVEST. 4217 (2017)
`
`1019
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`U.S. Patent No. 5,359,030
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`1020
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`1021
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`CV of Peter Flatt, Ph.D.
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`1022
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`Declaration of Christopher Soares, Ph.D.
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`1023
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`CV of Christopher Soares, Ph.D.
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`1024
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`Declaration of Paul Dalby, Ph.D.
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`1025
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`1026
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`1027
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`CV of Paul Dalby, Ph.D.
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`Declaration of John Bantle, M.D.
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`CV of John Bantle, M.D.
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`1028
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`U.S. Patent No. 7,576,050
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`ix
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`EXHIBIT
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`DESCRIPTION
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`
`Holst, The Incretin Approach for Diabetes Treatment Modulation
`of Islet Hormone Release by GLP-1 Agonism, 53 (suppl. 3)
`DIABETES S197 (2004)
`
`Holz, Glucagon-Like Peptide-1 Synthetic Analogs: New
`Therapeutic Agents for Use in Treatment of Diabetes Mellitus, 10
`CURRENT MED. CHEM. 2471 (2003)
`
`Kenyon, 13C NMR Studies of the Binding of Medium-Chain Fatty
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`
`Kim, Development and Characterization of a Glucagon-Like
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`Glucagon-Like Peptide 1 Receptor In Vivo, 52(3) DIABETES 751
`(2003)
`
`Knudsen, Potent Derivatives of Glucagon-Like Peptide-1 with
`Pharmacokinetic Properties Suitable for Once Daily
`Administration, 43(9) J MED CHEM. 1664 (2000)
`
`Kurtzhals, Albumin Binding of Insulins Acylated with Fatty Acids:
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`
`Luu, Automated Multiple Peptide Synthesis: Improvements in
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`
`Markussen, Soluble, Fatty Acid Acylated Insulins Bind to Albumin
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`
`
`
`x
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`

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`
`DESCRIPTION
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`
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`WO 91/11457 (“Buckley”)
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`
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`

`
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`EXHIBIT
`
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`
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`
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`
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`
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`
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`xii
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`

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`EXHIBIT
`
`DESCRIPTION
`
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`
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`
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`
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`
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`
`
`
`xiii
`
`

`

`
`
`EXHIBIT
`
`DESCRIPTION
`
`1078
`
`1079
`
`1080
`
`1081
`
`Bayliss, The Mechanism of Pancreatic Secretion, 28(5) J.
`PHYSIOLOGY 325 (1902)
`
`Buse, Effects of Exenatide (Exendin-4) on Glycemic Control Over
`30 Weeks in Sulfonylurea-Treated Patients with Type 2 Diabetes,
`27 DIABETES CARE 2628 (2004)
`
`Chang, The GLP-1 Derivative NN2211 Restores β-Cell Sensitivity
`to Glucose in Type 2 Diabetic Patients After a Single Dose, 52
`DIABETES 1786 (2003)
`
`Degn, One Week’s Treatment with the Long-Acting Glucagon-Like
`Peptide 1 Derivative Liraglutide (NN2211) Markedly Improves 24-
`h Glycemia and α- and β-Cell Function and Reduces Endogenous
`Glucose Release in Patients with Type 2 Diabetes, 53 DIABETES
`1187 (2004)
`
`1082
`
`Edwards, GLP-1: Target for a New Class of Antidiabetic Agents?,
`97 J. R. SOC. MED. 270 (2004)
`
`1083
`
`1084
`
`1085
`
`1086
`
`Elbrond, Pharmacokinetics, Pharmacodynamics, Safety, and
`Tolerability of a Single-Dose of NN2211, a Long-Acting Glucagon-
`Like Peptide 1 Derivative, in Healthy Male Subjects, 25 DIABETES
`CARE 1398 (2002)
`
`Gault, Glucose-Dependent Insulinotropic Polypeptide Analogues
`and Their Therapeutic Potential for the Treatment of Obesity-
`Diabetes, 308 BIOCHEM. & BIOPHYSICAL RSCH. COMMC’NS 207
`(2003)
`
`Harder, The Effect of Liraglutide, a Long-Acting Glucagon-Like
`Peptide 1 Derivative, on Glycemic Control, Body Composition, and
`24-h Energy Expenditure in Patients with Type 2 Diabetes, 27
`DIABETES CARE 1915 (2004)
`
`Larsen, Systemic Administration of the Long-Acting GLP-1
`Derivative NN2211 Induces Lasting and Reversible Weight Loss in
`Both Normal and Obese Rats, 50 DIABETES 2530 (2001)
`
`
`
`xiv
`
`

`

`
`
`EXHIBIT
`
`DESCRIPTION
`
`1087
`
`1088
`
`1089
`
`1090
`
`1091
`
`1092
`
`1093
`
`1094
`
`1095
`
`Ribel, NN2211: A Long-Acting Glucagon-Like Peptide-1
`Derivative with Anti-Diabetic Effects in Glucose-Intolerant Pigs,
`451 EUR. J. PHARMACOLOGY 217 (2002)
`
`REMINGTON: THE SCIENCE AND PRACTICE OF PHARMACY (Alfonso
`R. Gennaro ed., 20th ed. 2000)
`
` Boylan, Parenteral Products, in MODERN PHARMACEUTICS
`(Gilbert S. Banker et al. eds., 3d ed. 1996)
`
`MacDonald, The Multiple Actions of GLP-1 on the Process of
`Glucose-Stimulated Insulin Secretion, 51 (suppl. 3) DIABETES S434
`(2002)
`
`U.S. Patent No. 7,022,674
`
`WO 00/37098
`
`WO 03/002136
`
`Accardo, Physicochemical Properties of Mixed Micellar
`Aggregates Containing CCK Peptides and Gd Complexes Designed
`as Tumor Specific Contrast Agents in MRI, 126 J. AM. CHEM. SOC.
`3097 (2004)
`
`Autio, Mini-PEG Spacering of VAP-1-Targeting 68Ga-DOTAVAP-
`P1 Peptide Improves PET Imaging of Inflammation, 1 EJNMMI
`RSCH. 1 (2011)
`
`1096
`
`U.S. Patent No. 7,615,532
`
`1097
`
`1098
`
`Göke, Glycosylation of the GLP-1 Receptor is a Prerequisite for
`Regular Receptor Function, 15(4) PEPTIDES 675 (1994)
`
`Nicholson, The Role of Albumin in Critical Illness, 85(4) BR. J.
`ANAESTHESIA 599 (2000)
`
`1099
`
`PDR MEDICAL DICTIONARY 472-73 (1st ed. 1995)
`
`
`
`xv
`
`

`

`
`
`EXHIBIT
`
`1100
`
`DESCRIPTION
`
`Holst, Implementation of GLP-1 Based Therapy of Type 2 Diabetes
`Mellitus Using DPP-IV Inhibitors, in DIPEPTIDYL
`AMINOPEPTIDASES IN HEALTH AND DISEASE (Martin Hildebrandt et
`al. eds., 2003)
`
`1101
`
`https://www.caranddriver.com/ford/f-150
`
`1102
`
`https://modernairliners.com/boeing-737/boeing-737-specifications/
`
`1103
`
`https://pubchem.ncbi.nlm.nih.gov/compound/Glucagon-like-
`peptide-1-_1-37
`
`1104
`
`https://pubchem.ncbi.nlm.nih.gov/compound/16133830
`
`1105
`
`1106
`
`Scheduling Order, Novo Nordisk Inc. v. Rio Biopharmaceuticals
`Inc., No. 22-294 (CFC) (D. Del. June 30, 2022), ECF No. 22
`
`Transfer Order, In re: Ozempic (Semaglutide) Patent Litigation,
`No. 3038 (MDL Aug. 5, 2022)
`
`1107
`
`Victoza prescribing information (June 2022)
`
`1108
`
`1109
`
`1110
`
`1111
`
`1112
`
`Holst, Glucagon-Like Peptide 1 and Inhibitors of Dipeptidyl
`Peptidase IV in the Treatment of Type 2 Diabetes Mellitus, 4
`CURRENT OP. IN PHARM. 589 (2004) (“Holst 2004b”)
`
`HARRISON’S PRINCIPLES OF INTERNAL MEDICINE Ch. 333 (Eugene
`Braunwald et al. eds., 15th ed. 2001)
`
`Giannoukakis, CJC-1131 ConjuChem, 4(10) CURRENT OP. IN
`INVESTIGATIONAL DRUGS 1245 (2003)
`
`Polonsky, What’s so Tough About Taking Insulin? Addressing the
`Problem of Psychological Insulin Resistance in Type 2 Diabetes,
`22(3) CLINICAL DIABETES 147 (2004)
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`ACS Publications, https://pubs.acs.org/toc/jmcmar/47/17;
`https://pubs.acs.org/doi/10.1021/jm030630m
`
`
`
`
`
`xvi
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`

`

`
`
`I.
`
`INTRODUCTION
`
`Mylan Pharmaceuticals Inc. (“Petitioner”) petitions for inter partes review of
`
`claims 1-2, 4-11, 13, and 15 (“the challenged claims”) of U.S. Patent No. 8,536,122
`
`(“the ’122 patent”) (Ex. 1001), which is assigned to Novo Nordisk A/S (“Patent
`
`Owner”) under 35 U.S.C. §§ 311-319 and 37 C.F.R. § 42. Petitioner seeks a
`
`determination that those claims be canceled as unpatentable.
`
`The ’122 patent claims glucagon-like peptide 1 (“GLP-1”) analogue
`
`compounds that may be useful in treating type-2 diabetes, among other conditions.
`
`GLP-1 is a peptide hormone produced in the human body that promotes insulin
`
`secretion. Because native GLP-1 breaks down within minutes, researchers have long
`
`investigated chemically modified GLP-1 peptides (i.e., analogues) with extended
`
`durations of action (e.g., longer half-lives) to make a suitable drug product. Through
`
`these studies, scientists have discerned which parts of GLP-1 are important to its
`
`activity and which are amenable to changes, and what sort of changes should be
`
`made to extend the compound’s half-life. Patent Owner itself has produced prior art
`
`GLP-1 analogues, some with good pharmacological activity. The prior art was
`
`therefore replete with information concerning GLP-1 and its analogues, serving as a
`
`catalog of known variables and solutions from which scientists could choose to make
`
`new analogues.
`
`
`
`1
`
`

`

`
`
`Patent Owner made and characterized its first-generation GLP-1 analogue,
`
`called liraglutide, well before the priority date of the ’122 patent. Using the catalog
`
`of well-known variables and solutions, Patent Owner made a few trivial changes to
`
`liraglutide to make its second-generation compound—semaglutide—which is
`
`encompassed by the challenged claims. But these trivial changes do not warrant
`
`patent protection; they fall squarely in the realm of obviousness. The Board should
`
`cancel these claims.
`
`II. MANDATORY NOTICES
`
`This Petition is filed in accordance with 37 C.F.R. § 42.106(a). Filed herewith
`
`is a power of attorney and exhibit list per § 42.10(b) and § 42.63(e). Under 37 C.F.R.
`
`§ 42.103, the fee set forth in § 42.15(e) accompanies this Petition.
`
`A. Real Parties-In-Interest
`
`In accordance with 37 C.F.R. § 42.8(b)(1), the real parties-in-interest for
`
`Petitioner are Mylan Pharmaceuticals Inc., Mylan Inc., and Viatris Inc.
`
`B. Related Matters
`
`In accordance with 37 C.F.R. § 42.8(b)(2), Petitioner is not aware of any
`
`reexamination certificates or pending prosecution concerning the ’122 patent.
`
`Petitioner is a defendant in the following litigation involving the ’122 patent:
`
` Novo Nordisk Inc. v. Mylan Pharmaceuticals Inc.,
`No. 22-cv-01040-CFC (D. Del.);
`
`2
`
`

`

`
`
` Novo Nordisk Inc. v. Viatris Inc.,
`No. 1:23-cv-00013-TSK (N.D. W. Va.);
` Novo Nordisk Inc. v. Viatris Inc.,
`No. 1:23-cv-00101-CFC (D. Del);
` In re: Ozempic (Semaglutide) Patent Litig.,
`No. 22-md-3038-CFC (D. Del.).
`
`In addition, the following litigations also involve the ’122 patent:
`
` Novo Nordisk Inc. v. Aurobindo Pharma USA, Inc.,
`No. 1:22-cv-00295 (D. Del.) (dismissed on March 28, 2022).
` Novo Nordisk Inc. v. Rio Biopharmaceuticals, Inc.,
`No. 1:22-cv-00294 (D. Del.)
` Novo Nordisk A/S v. Sun Pharm. Indus. Ltd.,
`No. 1:22-cv-00296 (D. Del.)
` Novo Nordisk Inc. v. Zydus Worldwide DMCC,
`No. 1:22-cv-00297 (D. Del.)
` Novo Nordisk Inc. v. Dr. Reddy’s Labs. Ltd.,
`No. 1:22-cv-00298 (D. Del.)
` Novo Nordisk Inc. v. Alvogen, Inc.,
`
`No. 1:22-cv-00299 (D. Del.)
`
`Petitioner is concurrently filing a petition for one other patent in the same
`
`family as the ’122 patent: U.S. Patent No. 8,129,343.
`
`Petitioner is not aware of any other pending litigation, or any pending
`
`proceedings before the Patent Trial and Appeal Board.
`
`
`
`3
`
`

`

`
`
`C.
`
`Identification of Counsel (37 C.F.R. § 42.8(b)(3))
`
`Lead Counsel
`Brandon M. White
`Reg No. 52,354
`Perkins Coie LLP
`700 13th Street NW, Ste 800
`Washington, DC 20005
`Phone: (202) 654-6200
`Back-Up Counsel
`Courtney Prochnow, Ph.D.
`Reg. No. 67,639
`Perkins Coie LLP
`633 W. 5th St., Ste 5850
`Los Angeles, CA 90071
`Phone: (310) 788-9900
`Back-Up Counsel
`Jonathan I. Tietz, Ph.D.
`Reg No. 76,753
`Perkins Coie LLP
`700 13th Street NW, Ste 800
`Washington, DC 20005
`Phone: (202) 654-6200
`
`Back-Up Counsel
`Emily J. Greb
`Reg No. 68,244
`Perkins Coie LLP
`33 East Main Street, Ste 1
`Madison, WI 53703
`Phone: (608) 663-7460
`Back-Up Counsel
`Christopher D. Jones
`Reg No. 76,472
`Perkins Coie LLP
`700 13th Street, NW, Ste 800
`Washington, DC 20005
`Phone: (202) 654-6200
`Back-Up Counsel
`Matthew A. Lembo
`Reg No. 75,633
`Perkins Coie LLP
`1155 Avenue of the Americas, Floor 22
`New York, NY 10036
`Phone: (212) 262-6900
`
`D.
`
`Service Information (37 C.F.R. § 42.8(b)(4))
`
`Petitioner respe