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`
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`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`
`PFIZER INC.,
`Petitioner
`
`v.
`
`NOVO NORDISK A/S,
`Patent Owner.
`_______________
`
`Case No.: IPR2020-01252
`United States Patent No. 8,114,833 B2
`Issued: February 14, 2012
`Filed: May 17, 2006
`
`Title: Propylene Glycol-Containing Peptide Formulations Which Are Optimal for
`Productions and for Use in Injection devices
`________________
`
`PETITION FOR INTER PARTES REVIEW
`
`
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`Submitted Electronically via the Patent Review Processing System
`
`

`

`IPR2020-01252 Patent No. 8,114,833
`
`TABLE OF CONTENTS
`
`Page
`
`a.
`
`b.
`c.
`
`i
`
`
`INTRODUCTION ........................................................................................... 1
`I.
`II. MANDATORY NOTICES ............................................................................. 1
`A.
`Real Parties-In-Interest .......................................................................... 1
`B.
`Related Matters ...................................................................................... 1
`C.
`Identification of Counsel (37 C.F.R. § 42.8(b)(3)) ............................... 2
`D.
`Service Information ............................................................................... 3
`III. GROUNDS FOR STANDING ........................................................................ 3
`IV.
`IDENTIFICATION OF CHALLENGES AND STATEMENT OF PRECISE
`RELIEF REQUESTED ................................................................................... 3
`THRESHOLD REQUIREMENTS FOR INTER PARTES REVIEW ............. 4
`V.
`VI. STATEMENT OF REASONS FOR THE RELIEF REQUESTED ............... 4
`A.
`Summary of the Argument .................................................................... 4
`B.
`Level of Ordinary Skill in the Art ......................................................... 5
`C.
`The ’833 Patent and Its Prosecution ...................................................... 5
`The ʼ833 Patent Disclosures ............................................................ 5
`The ʼ833 Patent Priority Date .......................................................... 7
`The ʼ833 Patent Claims .................................................................... 8
`Prosecution History of the ʼ833 Patent ............................................ 9
`Claim Construction (37 C.F.R. §§ 42.100(b), 42.104(b)(3)) ..............11
`The POSA’s Knowledge of GLP-1 Agonists and Drug Formulation.12
`GLP-1 Agonists Were Well Known in the Art ..............................13
`The POSA’s Knowledge of Parenteral Dosage Forms ..................14
`Parenteral dosage forms are preferred for peptide-based drugs
` ...................................................................................................14
`Stability of peptide formulations ..............................................15
`Formulation design for peptide-containing parenteral
`formulations ..............................................................................16
`i. pH and Buffering Capacity .......................................................17
`
`1.
`2.
`3.
`4.
`
`1.
`2.
`
`D.
`E.
`
`

`

`IPR2020-01252 Patent No. 8,114,833
`
`d.
`
`F.
`
`1.
`
`ii.
`iii.
`iv.
`v.
`
`Vehicles and Diluents ..........................................................17
`Tonicity and Osmolarity ......................................................18
`Particulates ...........................................................................19
`Excipient Selection ..............................................................19
`Propylene glycol offers several advantages in a peptide
`formulation ................................................................................20
`i. Propylene glycol is a multi-functional excipient ......................20
`ii.
`Propylene glycol is safe .......................................................21
`iii.
`Propylene glycol’s advantages over other isotonic agents ..21
`Scope and Content of the Prior Art Relied Upon in Grounds 1-3 ......24
`International Publication No. WO003/002136 (“Flink”) (Ex. 1004)
` ........................................................................................................24
`International Publication No. WO04/004781 (“Betz”) (Ex. 1005)27
`2.
`G. Ground 1: Flink Anticipated Claims 1-15 ...........................................28
`1.
`Claim 1 ...........................................................................................28
`2.
`Claims 2-4 ......................................................................................35
`3.
`Claims 5-7 ......................................................................................36
`4.
`Claims 8-9 ......................................................................................37
`5.
`Claim 10 .........................................................................................37
`6.
`Claim 11 .........................................................................................37
`7.
`Claim 12 .........................................................................................38
`8.
`Claim 13 .........................................................................................39
`9.
`Claim 14 .........................................................................................39
`10. Claim 15 .........................................................................................40
`H. Ground 2: Claims 1-15 Would Have Been Obvious Over Flink ........40
`1.
`Claim 1 ...........................................................................................41
`Differences between the claimed invention and the prior art ...41
`i. Flink taught a POSA to use disodium phosphate dihydrate
`buffer ....................................................................................42
`Flink taught a POSA to use propylene glycol as an isotonic
`agent .....................................................................................43
`
`a.
`
`ii.
`
`ii
`
`

`

`ii.
`
`a.
`
`b.
`
`a.
`
`b.
`
`2.
`3.
`4.
`5.
`
`iii. Determining concentrations of isotonicity agents is routine
` ..............................................................................................45
`Claims 2-15 ....................................................................................48
`Ground 3: Claims 1-31 Would Have Been Obvious Over Flink In
`View of Betz ........................................................................................48
`Claim 1 ...........................................................................................49
`The combination of Flink and Betz disclosed each element of
`claim 1 .......................................................................................49
`A POSA would have been motivated to modify Flink in view of
`Betz ...........................................................................................51
`i. Flink taught away from using mannitol in formulations having a
`pH of 7.4 ..............................................................................51
`Betz and Flink both address the problem of peptide stability
`in formulation ......................................................................52
`Claims 2-15 ....................................................................................53
`Claim 16 .........................................................................................54
`Claims 17-22 ..................................................................................55
`Independent Claims 23, 26, and 29 ................................................55
`The effects recited in the preambles of claims 23, 26, and 29 are
`inherent to the claimed formulation ..........................................55
`Betz motivated the POSA to use propylene glycol in place of
`mannitol ....................................................................................58
`Claims 24, 27, and 30 .....................................................................58
`Claims 25, 28, and 31 .....................................................................60
`No Secondary Considerations Overcome Prima Facie Obviousness.61
`The Methods Recited in the ʼ833 Patent Produce No Unexpected
`Results ............................................................................................61
`Long-Felt But Unmet Need ............................................................62
`2.
`There Was No Commercial Success ..............................................62
`3.
`There Was No Industry Skepticism ...............................................62
`4.
`Copying by Generic Drug Makers Is Irrelevant ............................63
`5.
`VII. THIS PETITION SHOULD NOT BE DENIED INSTITUION UNDER 35
`U.S.C. § 325(D) .............................................................................................63
`
`I.
`
`2.
`
`1.
`
`6.
`7.
`
`1.
`
`J.
`
`IPR2020-01252 Patent No. 8,114,833
`
`iii
`
`

`

`IPR2020-01252 Patent No. 8,114,833
`
`A.
`
`B.
`
`C.
`
`D.
`
`Factor 1: Similarities and Material Differences Between the Asserted
`Art and the Prior Art Involved During Examination ..........................63
`Factor 2: Cumulative Nature of the Asserted Art to the Prior Art
`Evaluated During Examination ...........................................................64
`Factor 3: Extent to Which the Asserted Art Was Evaluated During
`Examination, Including Whether the Prior Art Was the Basis for
`Rejection ..............................................................................................65
`Factor 4: Extent of the Overlap Between the Arguments Made During
`Examination and the Manner in Which Petitioner Relies on the Prior
`Art or Patent Owner Distinguishes the Prior Art ................................65
`Factor 5: Whether Petitioner Pointed Out Sufficiently How the
`Examiner Erred in Its Evaluation of the Asserted Prior Art ...............65
`Factor 6: Extent to Which Additional Evidence and Facts Presented in
`the Petition Warrant Reconsideration of the Prior Art or Arguments 66
`VIII. CONCLUSION ..............................................................................................66
`
`
`E.
`
`F.
`
`
`
`
`
`iv
`
`

`

`IPR2020-01252 Patent No. 8,114,833
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Cases
`Ex parte A,
`1990 WL 354589 (BPAI June 5, 1990) .............................................................. 33
`Acorda Therapeutics, Inc. v. Roxane Labs., Inc.,
`903 F.3d 1310 (Fed. Cir. 2018), cert. denied, 140 S. Ct. 111 (2019) ................. 62
`Bayer Healthcare Pharm., Inc. v. Watson Pharm., Inc.,
`713 F.3d 1369, 1377 (Fed. Cir. 2013) ................................................................ 63
`Becton, Dickinson & Co. v. B. Braun Melsungen AG,
`IPR2017-01586, Paper 8 (PTAB Dec. 15, 2017) ............................................... 63
`Braintree Labs., Inc. v. Novel Labs., Inc.,
`749 F.3d 1349 (Fed. Cir. 2014) .......................................................................... 12
`Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc.,
`289 F.3d 801 (Fed. Cir. 2002) ............................................................................ 12
`ClearValue, Inc. v. Pearl River Polymers, Inc.,
`668 F.3d 1340 (Fed. Cir. 2012) .................................................................... 35, 36
`Collective Minds Gaming Co. v. Ironburg Inventions Ltd.,
`IPR2018-00356, Paper 11 (PTAB June 7, 2018) ............................................... 65
`In re: Copaxone Consol. Cases,
`906 F.3d 1013 (Fed. Cir. 2018) .......................................................................... 12
`Famy Care Ltd. v. Allergan, Inc.,
`2017 WL 2983375 (P.T.A.B. July 10, 2017) ..................................................... 35
`In re Fout,
`675 F.2d 297 (CCPA 1982) ................................................................................ 53
`Galderma Laboratories, L.P. v. Tolmar, Inc.,
`737 F.3d 731 (Fed. Cir. 2013) ............................................................................ 62
`In re Huai-Hung Kao,
`639 F.3d 1057 (Fed. Cir. 2011) .......................................................................... 56
`
`v
`
`

`

`IPR2020-01252 Patent No. 8,114,833
`
`Illumina, Inc. v. Trustees of Columbia University,
`IPR2013-00011, Paper 130 (PTAB Mar. 6, 2014) ............................................. 33
`In re Katz,
`687 F.2d 450 (CCPA 1982) .................................................................................. 8
`Kennametal, Inc. v. Ingersoll Cutting Tool Co.,
`780 F.3d 1376 (Fed. Cir. 2015) .............................................................. 32, 34, 35
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ............................................................................................ 41
`Merck & Co. v. Biocraft Labs., Inc.,
`874 F.2d 804 (Fed. Cir. 1989) ............................................................................ 42
`Merck & Co. v. Teva Pharmaceuticals USA, Inc.,
`395 F.3d 1364 (Fed. Cir. 2005) .......................................................................... 62
`Perricone v. Medicis Pharm. Corp.,
`432 F.3d 1368 (Fed. Cir. 2005) .......................................................................... 33
`Pfizer, Inc. v. Apotex, Inc.,
`480 F.3d 1348 (Fed. Cir. 2007) .................................................................... 44, 61
`Pharms., Inc. v. Eon Labs, Inc.,
`616 F.3d 1267 (Fed. Cir. 2010) .......................................................................... 57
`Purdue Pharma Prod. L.P. v. Par Pharm., Inc.,
`377 F. App’x 978 (Fed. Cir. 2010) ..................................................................... 42
`Sanofi-Aventis Deutschland GMBH v. Mylan Pharm. Inc.,
`2019 WL 6130471 (Fed. Cir. Nov. 19, 2019) .................................................... 52
`In re Sivaramakrishnan,
`673 F.2d 1383 (CCPA 1982) .............................................................................. 33
`Unified Patents Inc. v. Pen-One Acquisition Grp., LLC,
`IPR2017-02167, Paper 12, at 27 (PTAB Apr. 4, 2018) ..................................... 65
`Wm. Wrigley Jr. Co. v. Cadbury Adams USA, LLC,
`683 F.3d 1356 (Fed. Cir. 2012) .................................................................... 32, 52
`
`vi
`
`

`

`IPR2020-01252 Patent No. 8,114,833
`
`Statutes
`35 U.S.C. § 102(b) ............................................................................................... 7, 28
`35 U.S.C. § 102(e) ............................................................................................ 10, 28
`35 U.S.C. § 103(a) ................................................................................................... 41
`35 U.S.C. § 103(c) ............................................................................................. 11, 64
`35 U.S.C. § 119(a) ..................................................................................................... 7
`35 U.S.C. § 282(b) ................................................................................................... 11
`35 U.S.C. § 311-319................................................................................................... 1
`35 U.S.C. § 314(a) ..................................................................................................... 4
`35 U.S.C. § 325(d) ................................................................................................... 63
`Other Authorities
`37 C.F.R. § 42 ............................................................................................................ 1
`37 C.F.R. § 42.8(b)(1) ................................................................................................ 1
`37 C.F.R. § 42.8(b)(2) ................................................................................................ 1
`37 C.F.R. § 42.8(b)(3) ................................................................................................ 2
`37 C.F.R. § 42.8(b)(5) ................................................................................................ 3
`37 C.F.R. § 42.22(a) ................................................................................................... 3
`37 C.F.R. § 42.100(b) .............................................................................................. 11
`37 C.F.R. § 42.103 ..................................................................................................... 1
`37 C.F.R. § 42.104(a) ................................................................................................. 3
`37 C.F.R. § 42.104(b) ................................................................................................ 3
`37 C.F.R. § 42.106(a) ................................................................................................. 1
`C.F.R. § 42.10(b) ....................................................................................................... 1
`
`vii
`
`

`

`IPR2020-01252 Patent No. 8,114,833
`
`C.F.R. § 42.15(e) ........................................................................................................ 1
`C.F.R. § 42.63(e) ........................................................................................................ 1
`MPEP 706.02 ............................................................................................................. 7
`MPEP 2123(II) ........................................................................................................... 8
`MPEP 2143(I)(B) ..................................................................................................... 51
`
`
`
`
`
`viii
`
`

`

`Exhibit
`No.
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`IPR2020-01252 Patent No. 8,114,833
`
`LIST OF EXHIBITS
`
`Description
`
`U.S. Patent No. 8,114,833, Propylene Glycol-Containing Peptide
`Formulations which are Optimal for production and for Use in
`Injection Devices (issued Feb. 14, 2012)
`
`Declaration of Laird Forrest, Ph.D. in Support of Petition for Inter-
`Partes Review
`
`Prosecution history excerpts for U.S. Patent No. 8,114,833
`
`International Publication NO. WO 03/002136, Stable Formulation
`of Modified GLP-1 (published Jan. 9, 2003) (“Flink”)
`
`International Publication No. WO 2004/004781, Liquid
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`Hormone (hgh) Comprising 1,2-Propylene Glycol (published Jan.
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`
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`
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`
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`
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`
`ix
`
`

`

`IPR2020-01252 Patent No. 8,114,833
`
`Description
`
`MODERN PHARMACEUTICS (Gilbert S. Banker et al. eds., 3d ed.
`1996)
`
`Exhibit
`No.
`
`1012
`
`1013
`
`REMINGTON’S PHARMACEUTICAL SCIENCES (18th ed. 1990)
`
`1014
`
`1015
`
`1016
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`1017
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`1018
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`1021
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`1022
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`1023
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`1025
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`International Publication No. WO 03/072195, Method for
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`
`INTENTIONALLY LEFT BLANK
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`INTENTIONALLY LEFT BLANK
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`
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`
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`Formulations of CNTF (published Aug. 24, 1995)
`
`U.S. Patent No. 6,458,924, Derivatives of GLP-1 Analogs (filed
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`
`International Publication No. WO 00/37098 A1, Shelf-Stable
`Formulation of Glucagon-Like Peptide-1 (published June 29, 2000)
`
`Handbook of Pharmaceutical Excipients (3d ed. 2000)
`
`Handbook of Pharmaceutical Excipients (4th ed. 2003)
`
`Akers, Formulation Development of Protein Dosage Forms in
`DEVELOPMENT AND MANUFACTURE OF PROTEIN PHARMACEUTICALS
`(2002)
`
`International Patent Publication No. WO 1999/040788, Inotropic
`and Diuretic Effects of Exendin and GLP-1 (published August 19,
`1999)
`
`x
`
`

`

`IPR2020-01252 Patent No. 8,114,833
`
`Description
`
`DEVELOPMENT OF BIOPHARMACEUTICAL PARENTERAL DOSAGE
`FORMS (John A. Bontempo ed., 1997)
`
`Gaitlin, Formulation and Administration Techniques to Minimize
`Injection Pain and Tissue Damage Associated with Parenteral
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`
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`No.
`
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`
`1029
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`
`xi
`
`

`

`IPR2020-01252 Patent No. 8,114,833
`
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`No.
`
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`xii
`
`

`

`Exhibit
`No.
`
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`IPR2020-01252 Patent No. 8,114,833
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`xiii
`
`

`

`IPR2020-01252 Patent No. 8,114,833
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`J. Bothe et al., Peptide Oligomerization Memory Effects and Their
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`MOL. PHARMACEUTICS 2153 (2019)
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`M.J. Akers, Excipient-Drug Interactions in Parenteral
`Formulations, J PHARM SCI 91(11) (2002)
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`1068
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`U.S. PHARMACOPEIA XXII, NATIONAL FORMULARY XVII (1990)
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`1069
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`1070
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`R. Noel, Statistical Quality Control in the Manufacture of
`Pharmaceuticals, 4(4) QUALITY ENGINEERING 649 (1992)
`
`NOTE FOR GUIDANCE SPECIFICATIONS: TEST PROCEDURES AND
`ACCEPTANCE CRITERIA FOR NEW DRUG SUBSTANCES AND NEW
`
`xiv
`
`

`

`IPR2020-01252 Patent No. 8,114,833
`
`Description
`
`DRUG PRODUCTS: CHEMICAL SUBSTANCES (CPMP/ICH/367/96)
`(2000)
`
`M. Gnanalingham et al., Accuracy and Reproducibility of Low
`Dose Insulin Administration Using Pen-Injectors and Syringes, 79
`ARCH. DIS. CHILD 59 (1998)
`
`C. Burke et al., The Adsorption of Proteins to Pharmaceutical
`Container Surfaces, 86 INT’L J. OF PHARMACEUTICS 89 (1992)
`
`T. Asakura et al., Occurrence of Coring in Insulin Vials and
`Possibility of Rubber Piece Contamination by Self-Injection, 121(6)
`YAKUGAKU ZASSHI 459 (2001)
`
`M. Roe et al., Dose Accuracy Testing of the Humalog® Humulin®
`Insulin Pen Device, 3(4) DIABETES TECH. & THERAPEUTICS 623
`(2001)
`
`Exhibit
`No.
`
`1071
`
`1072
`
`1073
`
`1074
`
`1075
`
`Parenteral Drug Association, Points to Consider for Cleaning
`Validation. Technical Report No. 29, 52(6 suppl) PDA J PHARM SCI
`TECHNOL. 1 (1998)
`1076 WIPO Patentscope PCT Bibliography Data for
`PCT/DK2004/000792
`
`xv
`
`

`

`IPR2020-01252 Patent No. 8,114,833
`
`I.
`
`INTRODUCTION
`Petitioner Pfizer Inc. (“Petitioner”) petitions for Inter Partes Review of claims
`
`1-31 of U.S. Patent No. 8,114,833 (“the ’833 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 and seeks a determination that all claims (1-31) of the ’833 patent be canceled
`
`as unpatentable.
`
`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). Pursuant to 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 are
`
`Pfizer Inc. and Hospira, 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 ʼ833 patent.
`
`The Board has instituted review of claims 1-31 of the ’833 patent in Mylan
`
`Institutional LLC. v. Novo Nordisk A/S, No. IPR2020-00324, and Petitioner has
`
`moved to join this Petition with that proceeding.
`
`The ’833 patent has been asserted in: Novo Nordisk Inc. et al. v. Teva
`
`Pharmaceuticals USA, Inc., No. 1:17-cv-00227 (D. Del.); Novo Nordisk Inc. et al.
`
`1
`
`

`

`IPR2020-01252 Patent No. 8,114,833
`
`v. Mylan Institutional LLC, No. 1:19-cv-01551 (D. Del.); Novo Nordisk Inc. et al. v.
`
`Mylan Institutional LLC, No. 1:19-cv-00164 (N.D. W.Va); Novo Nordisk Inc. et al.
`
`v. Sandoz, Inc., No. 1:20-cv-00747 (D. Del.); and Novo Nordisk Inc. et al. v. Sandoz,
`
`Inc., No. 1:20-cv-06842 (D.N.J.). The real parties-in-interest listed above are not
`
`parties to these litigations.
`
`Petitioner is not aware of any other pending litigation, or any other pending
`
`proceedings in front of the Patent Trial and Appeal Board.
`
`A patent application in the same patent family as the ʼ833 patent is pending as U.S.
`
`Patent Application No. 16/260,204, filed January 29, 2019.
`
`C.
`
`Identification of Counsel (37 C.F.R. § 42.8(b)(3))
`Lead Counsel
`Back-Up Counsel
`
`
`Jovial Wong (Reg. No. 60,115)
`Charles B. Klein*
`WINSTON & STRAWN LLP
`WINSTON & STRAWN LLP
`1901 K Street, NW
`1901 K Street, NW
`Washington, DC 20036
`Washington, DC 20036
`Telephone No.: (202) 282-5867
`Telephone No.: (202) 282-5977
`Facsimile No.: (202) 628-5116
`Facsimile No.: (202) 628-5116
`jwong@winston.com
`cklein@winston.com
`
`
`
`Sharon Lin*
`
`WINSTON & STRAWN LLP
`1901 K Street, NW
`Washington, DC 20036
`Telephone No.: (202) 282-5756
`Facsimile No.: (202) 628-5116
`slin@winston.com
`
`
` Back-up counsel to seek pro hac vice admission.
`
`2
`
` *
`
`

`

`IPR2020-01252 Patent No. 8,114,833
`
`
`
`Service Information
`D.
`Pursuant to 37 C.F.R. § 42.8(b)(5), Petitioner respectfully requests that all
`
`correspondence be directed to lead counsel and back-up counsel at the contact
`
`information provided below. Petitioner consents to electronic service by e-mail at
`
`the below listed email address:
`
` Email address:
`
`PfizerIPRs@winston.com
`
` Mailing address: WINSTON & STRAWN LLP
`
`1901 K Street, NW
`
`Washington, DC 20036
`
` Telephone number:
`
`(202) 282-5000
`
` Fax number:
`
`
`
`(202) 282-5100
`
`III. GROUNDS FOR STANDING
`Pursuant to 37 C.F.R. § 42.104(a), Petitioner certifies that the ’833 patent is
`
`available for inter partes review and Petitioner is not barred or estopped from
`
`requesting inter partes review on the grounds identified herein.
`
`IV.
`
`IDENTIFICATION OF CHALLENGES AND STATEMENT OF
`PRECISE RELIEF REQUESTED
`Pursuant to 37 C.F.R. § 42.22(a) and 37 C.F.R. § 42.104(b), Petitioner
`
`requests inter partes review and cancellation of claims 1-31 on the following
`
`grounds:
`
`3
`
`

`

`
`
`Ground 1: Claims 1-15 of the ʼ833 patent were anticipated by Flink (Ex.
`
`IPR2020-01252 Patent No. 8,114,833
`
`1004).
`
`
`
`Ground 2: Claims 1-15 of the ʼ833 patent would have been obvious over Flink
`
`(Ex. 1004).
`
`
`
`Ground 3: Claims 1-31 of the ʼ833 patent would have been obvious over Flink
`
`(Ex. 1004) in view of Betz (Ex. 1005).
`
`Petitioner’s statement of the reasons for the relief is set forth below. In support
`
`of these grounds for unpatentability, Petitioner submits the declaration of Laird
`
`Forrest, Ph.D., and relies on the Exhibits identified in the concurrently-filed Listing
`
`of Exhibits.
`
`V. THRESHOLD REQUIREMENTS FOR INTER PARTES REVIEW
`A petition for inter partes review must demonstrate “a reasonable likelihood
`
`that the petitioner would prevail with respect to at least 1 of the claims challenged
`
`in the petition.” 35 U.S.C. § 314(a). This Petition clears that threshold. There is a
`
`reasonable likelihood that Petitioner will prevail with respect to at least one of the
`
`challenged claims.
`
`VI. STATEMENT OF REASONS FOR THE RELIEF REQUESTED
`Summary of the Argument
`A.
`The challenged clai