IPR2020-01060
`U.S. Patent No. 7,326,708
`Petition for Inter Partes Review
`Attorney Docket No. REDDY 7.1R-024
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`DR. REDDY’S LABORATORIES, INC.
`AND DR. REDDY’S LABORATORIES, LTD.
`Petitioner,
`v.
`
`MERCK SHARP & DOHME CORP.
`Patent Owner.
`U.S. Patent No. 7,326,708 to Cypes et al.
`Issue Date: February 5, 2008
`Title: Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor
`
`Inter Partes Review No. IPR2020-01060
`
`
`PETITION FOR INTER PARTES REVIEW
`OF U.S. PATENT NO. 7,326,708 UNDER
`35 U.S.C. §§ 311-319 AND 37 C.F.R. §§ 42.1-.80, 42.100-.123
`
`
`
`
`
`
`
`
`
`
`
`
`

`

`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Petition for Inter Partes Review
` 
`
`
`C. 
`
`TABLE OF CONTENTS
`TABLE OF AUTHORITIES .................................................................................... v 
`PETITIONER’S EXHIBIT LIST .......................................................................... xii 
`I. 
`INTRODUCTION .......................................................................................... 1 
`II. 
`OVERVIEW ................................................................................................... 1 
`III. 
`STANDING (37 C.F.R. § 42.104(a));
`PROCEDURAL STATEMENTS .................................................................. 5 
`IV.  MANDATORY NOTICES (37 C.F.R. § 42.8(a)(1)) ..................................... 6 
`A. 
`Each Real Party In Interest (37 C.F.R. § 42.8(b)(1)) ............................. 6 
`B. 
`Notice Of Related Matters (37 C.F.R. § 42.8(b)(2)) ............................. 6 
`1. 
`Judicial Matters Involving The ’708 Patent ................................ 6 
`2. 
`Administrative Matters ................................................................ 7 
`Designation Of Lead And Backup Counsel
`And Service (37 C.F.R. §§ 42.8(b)(3), 42.8(b)(4)) .............................. 7 
`STATEMENT OF THE PRECISE RELIEF REQUESTED AND THE
`REASONS THEREFOR (37 C.F.R. § 42.22(a)) ............................................ 8 
`VI.  THE ’708 PATENT ........................................................................................ 8 
`VII.  CLAIM CONSTRUCTION ......................................................................... 10 
`VIII.  PERSON OF ORDINARY SKILL IN THE ART (“POSA”) ...................... 11 
`IX. 
`IDENTIFICATION OF CHALLENGE (37 C.F.R. § 42.104(b)) ................ 12 
`X. 
`INVALIDITY ANALYSIS .......................................................................... 13 
`A.  Ground 1: Claims 1-3, 17, 19, And 21-23 Are
`Anticipated by WO ’498 ..................................................................... 13 
`1. 
`Disclosure Of WO ’498 ............................................................ 14 
`
`V. 
`
`

`

`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Petition for Inter Partes Review
` 
`
`2. 
`3. 
`4. 
`5. 
`
`Claim 1 ..................................................................................... 17 
`Claim 2 ..................................................................................... 25 
`Claim 3 ..................................................................................... 25 
`Claim 17 ................................................................................... 26 
`a. 
`A pharmaceutical composition comprising .................... 26 
`b. a therapeutically effective
`amount of the salt according to claim 2 .......................... 26 
`in association with one or more pharmaceutically
`acceptable carriers. ......................................................... 27 
`Claim 19 ................................................................................... 27 
`a. 
`A method for the treatment
`of type 2 diabetes comprising ...................................... 27 
`administering to a patient in need of such
`treatment a therapeutically effective amount
`of the salt according to claim 2 or a hydrate
`thereof. ............................................................................ 27 
`Claims 21-22 ............................................................................ 28 
`7. 
`Claim 23 ................................................................................... 30 
`8. 
`Ground 2: Claims 1-3, 17, 19 And 21-23
`Are Anticipated By The ’871 Patent ................................................ 31 
`1. 
`Claims 1 And 2 .......................................................................... 32 
`2. 
`Claim 3 ...................................................................................... 33 
`3. 
`Claims 17 And 19 ...................................................................... 34 
`4. 
`Claims 21-23 ............................................................................. 36 
`Ground 3: Claims 3, 17, 19, And 21-23 Would Have Been Obvious
`In View Of WO ’498 ........................................................................... 38 
`1. 
`The Level Of Ordinary Skill In The Pertinent Art .................. 39 
`ii
`
`c. 
`
`b. 
`
`6. 
`
`B. 
`
`C. 
`
` 
`
`

`

`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Petition for Inter Partes Review
` 
`
`2. 
`
`The Scope And Content Of The Prior Art .................................. 39 
`a.  WO ’498 (EX1004) ........................................................ 39 
`b. 
`Claim 3 ............................................................................ 39 
`c.
`Claim 17 .......................................................................... 41
`i.  A pharmaceutical composition comprising ............. 41 
`ii. a therapeutically effective amount of the
`salt according to claim 2 ........................................ 42 
`iii.In association with one or more
`pharmaceutically acceptable carriers ..................... 42 
`Claim 19 .......................................................................... 42
`i.  A method for the treatment of type 2
`diabetes comprising ............................................... 42 
`ii. administering to a patient in need of such
`treatment a therapeutically effective
`amount of the salt according to claim 2 or a
`hydrate thereof ....................................................... 43 
`Claims 21-23 ................................................................... 43 
`e. 
`D.  Ground 4: Claims 1-3, 17, 19, And 21-23 Would Have Been Obvious
`In View Of WO ’498 And Bastin ........................................................ 46 
`1.
`The Level of Ordinary Skill In The Pertinent Art .................... 46
`a.
`The Scope And Content Of The Prior Art ...................... 46
`i.  WO ’498 (EX1004) ................................................. 46 
`
`d.
`
`2.
`
`ii. Bastin (EX1006) ...................................................... 46 
`The Differences Between The Claims And Prior Art ............... 47
`a.
`Claim 1 ............................................................................ 47
`i. There Is No Requirement to Select a Lead
`Compound in Salt Selection Cases ......................... 47
`iii
`
` 
`
`

`

`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Petition for Inter Partes Review
` 
`
`E. 
`
`F. 
`
`b.  WO ’498 And Bastin Would Have Rendered The
`Phosphoric Acid Salt Obvious ........................................ 50 
`Claims 2 And 3 ............................................................... 56 
`c. 
`Claims 17 And 19 ........................................................... 56 
`d. 
`Claims 21-23 ................................................................... 57 
`e. 
`Ground 5: Claim 4 Would Have Been Obvious in View Of WO ’498,
`Bastin And Brittain .............................................................................. 59 
`1. 
`The Level Of Ordinary Skill In The Pertinent Art ................... 59 
`2. 
`The Scope And Content Of The Prior Art ................................ 59 
`a.  WO ’498 (EX1004) and Bastin (EX1006) ..................... 59 
`b. 
`Brittain (EX1005) ........................................................... 59 
`The Differences Between The Claim And Prior Art ................. 60 
`3. 
`Ground 6: Claim 4 Would Have Been
`Obvious In View Of WO ’498 And Brittain ........................................ 62 
`1. 
`The Level of Ordinary Skill in the Pertinent Art ..................... 62 
`2. 
`The Scope And Content Of The Prior Art ............................... 62 
`a.  WO ’498 (EX1004) And Brittain (EX1005) .................. 62 
`The Differences Between The Claim And Prior Art ............... 62 
`3. 
`Secondary Considerations Of Nonobviousness ................................... 63 
`G. 
`XI.  THE BOARD SHOULD INSTITUTE TRIAL BASED
`ON DRL’S PETITION (35 U.S.C. § 325(d) OR § 314(a)) ........................ 66 
`XII.  CONCLUSION ............................................................................................ 69 
`
`
`
`
`
` 
`
`iv
`
`

`

`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Petition for Inter Partes Review
` 
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Cases
`Acorda Therapeutics Inc. v. Roxane Labs., Inc.,
`903 F.3d 1310 (Fed. Cir. 2018) .......................................................................... 66
`Amgen Inc. v. Alexion Pharms. Inc.,
`IPR2019-00740, Paper 15 (P.T.A.B. Aug. 20, 2019)...................................67, 69
`Amgen Inc. v. F. Hoffmann-La Roche Ltd.,
`580 F.3d 1340 (Fed. Cir. 2009) ......................................................................... 30
`Amneal Pharm. LLC v. Purdue Pharma L.P.,
`IPR2016-01412, Paper 9 (P.T.A.B. Feb. 14, 2017) ........................................... 48
`Amneal Pharms., LLC v. Supernus Pharms., Inc.,
`IPR2013-00368, Paper 8 (P.T.A.B. Dec. 2013) ................................................ 64
`Amneal Pharms. LLC v. Hospira, Inc.,
`IPR2016-01577, Paper 11 (P.T.A.B. at Feb. 9, 2017) ....................................... 65
`Apotex Inc. v. UCB Biopharma SPRL,
`IPR2019-00400, Paper 17 (P.T.A.B. July 15, 2019) ......................................... 68
`Associated British Foods, PLC v. Cornell Research Found. Inc.,
`IPR2019-00578, Paper 25 (P.T.A.B July 25, 2019) .................................... 31, 32
`Bayer Pharma AG v. Watson Labs., Inc.,
`874 F.3d 1316 (Fed. Cir. 2017) .......................................................................... 48
`Bayer Schering Pharma AG v. Barr Labs.,
`575 F.3d 1341 (Fed. Cir. 2008) .......................................................................... 55
`
`Becton, Dickinson & Co. v. B. Braun Melsungen AG,
`IPR2017-01586, slip op. (P.T.A.B. Dec. 15, 2017) ........................................... 66
`Boston Sci. Scimed, Inc. v. Cordis Corp.,
`554 F.3d 982 (Fed. Cir. 2009) ............................................................................ 41
`
` 
`
`v
`
`

`

`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Petition for Inter Partes Review
` 
`
`Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc.,
`246 F.3d 368 (Fed. Cir. 2001) ......................................................................13, 14
`Celanese Int’l Corp. v. Daicel Corp.,
`IPR2017-00163, Paper 46 (P.T.A.B. May 3, 2018) ........................................... 48
`Cohesive Techs., Inc. v. Waters Corp.,
`543 F.3d 1351,1364 (Fed. Cir. 2008) ................................................................. 63
`Constant v. Advanced Micro-Devices, Inc.,
`848 F.2d 1560 (Fed. Cir. 1988) ......................................................................3, 50
`Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc.,
`807 F.2d 955 (Fed. Cir. 1986) ............................................................................ 11
`Dr. Falk Pharma GmbH v. GeneriCo, LLC,
`No. 2017-2312, 2019 WL 2452362 (Fed. Cir. June 12, 2019) .......................... 65
`Eli Lilly & Co. v. Zenith Goldline Pharm., Inc.,
`471 F.3d 1369 (Fed. Cir. 2006) .......................................................................... 21
`Glaxo Group Ltd. v. Apotex, Inc.,
`376 F.3d 1339 (Fed. Cir. 2004) ......................................................................... 19
`Gnosis SPA v. S. Alabama Med. Sci. Found.,
`IPR2013-00116, Paper 68 (P.T.A.B. June 20, 2014) ......................................... 48
`Google Inc. v. Jongerius Panoramic Techs, LLC,
`IPR2013-00191, Paper 70 (P.T.A.B. Aug. 12, 2014)..................................passim
`Graham v. John Deere Co. of Kansas City,
`383 U.S. 1 (1966) ............................................................................................... 38
`Greenliant Sys., Inc. v. Xicor LLC,
`692 F.3d 1261 (Fed. Cir. 2012) ....................................................................30, 38
`Grunenthal GMBH v. Alkem Labs. Ltd.,
`919 F.3d 1333 (Fed. Cir. 2019) ....................................................................54, 55
`Hologic Inc. v. Becton, Dickinson & Co.,
`IPR2016-00820, Paper 52 (P.T.A.B. Sept. 28, 2017) ........................................ 40
`
` 
`
`vi
`
`

`

`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Petition for Inter Partes Review
` 
`
`In re Aller,
`220 F.2d 454 (C.C.P.A. 1955)......................................................................44, 55
`In re Cyclobenzaprine Hydrochloride,
`676 F.3d 1063 (Fed. Cir. 2012) .......................................................................... 55
`In re Fong,
`378 F.2d 977 (CCPA 1967) ................................................................................ 31
`In re Fout,
`675 F.2d 297 (C.C.P.A. 1982)......................................................................50, 54
`In re Gleave,
`560 F.3d 1331 (Fed. Cir. 2009) .......................................................................... 24
`In re Graves,
`69 F.3d 1147 (Fed. Cir. 1995) ............................................................................ 13
`In re Harris,
`409 F.3d 1339 (Fed. Cir. 2005) .......................................................................... 65
`In re Nomiya,
`509 F.2d (C.C.P.A. 1975) ................................................................................... 50
`
`In re O’Farrell,
`853 F.2d 894 (Fed. Cir. 1988) ............................................................................ 39
`In re Petering,
`301 F.2d 676 (C.C.P.A. 1962) ....................................................... 23, 24, 26, 34
`In re Peterson,
`315 F.3d 1325 (Fed. Cir. 2003) .......................................................................... 45
`In re Preda,
`401 F.2d 825 (C.C.P.A. 1968) ........................................................................... 14
`In re Sitagliptin Phosphate (’708 & ’921) Patent Litig.,
`C.A. No. 19-md-2902-RGA (D. Del.) ................................................................. 7
`In re Thorpe,
`777 F.2d 695 (Fed. Cir. 1985) ......................................................................30, 38
`
` 
`
`vii
`
`

`

`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Petition for Inter Partes Review
` 
`
`In re Wesslau,
`353 F.2d 238 (C.C.P.A. 1965) ........................................................................... 39
`In re Williams,
`36 F.2d 436 (C.C.P.A. 1929) ............................................................................. 65
`Iron Grip Barbell Co., Inc. v. USA Sports, Inc.,
`392 F.3d 1317 (Fed. Cir. 2004) .......................................................................... 65
`Kao Corp. v. Unilever U.S., Inc.,
`441 F.3d 963 (Fed. Cir. 2006) ............................................................................ 65
`Kois Pharms. LLC v. medac Gesellschaft
`für klinische Spezialpräparate mbH,
`IPR2016-01370, Paper 13 (P.T.A.B. Feb. 8, 2017) ........................................... 64
`Kashiv Biosciences, LLC v. Amgen Inc.,
`IPR2019-00791, Paper 15 (P.T.A.B. Sept. 11, 2019) ........................................ 68
`Kennametal, Inc. v. Ingersoll Cutting Tool Co.,
`780 F.3d 1376 (Fed. Cir. 2015) ..................................................................................... 13, 22
`KSR Int’l Co. v. Teleflex, Inc.,
`550 U.S. 398 (2007) ........................................................................................... 11
`
`Merck Sharp & Dohme Corp. v. Alvogen Pine
`Brook f/k/a Alvogen Pine Brook, Inc.,
`1:19-cv-00310 (D. Del.) ....................................................................................... 6
`Merck Sharp & Dohme Corp. v. Anchen Pharms., Inc.,
`1:19-cv-00311 (D. Del.) ....................................................................................... 6
`Merck Sharp & Dohme Corp. v. Apotex Inc..,
`1:19-cv-00313 (D. Del.) ....................................................................................... 6
`Merck Sharp & Dohme Corp. v. Lupin Ltd.,
`1:19-cv-00347 (D. Del.) ....................................................................................... 7
`
`Merck Sharp & Dohme Corp. v. Macleods Pharms., Ltd.,
`1:19-cv-00316 (D. Del.) ....................................................................................... 6
`Merck Sharp & Dohme Corp. v. Mylan Pharms. Inc.,
`1:19-cv-00101 (N.D. W. Va.) .............................................................................. 6
`viii
`
` 
`
`

`

`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Petition for Inter Partes Review
` 
`
`Merck Sharp & Dohme Corp. v. Mylan Pharms. Inc.,
`1:19-cv-01489 (D. Del.) ....................................................................................... 6
`
`Merck Sharp & Dohme Corp. v. Sandoz, Inc.,
`1:19-cv-00312 (D. Del.) .................................................................................... 6
`Merck Sharp & Dohme Corp. v. Sun Pharma Global FZE,
`1:19-cv-00319 (D. Del.) ..................................................................................... 6
`Merck Sharp & Dohme Corp. v. Teva Pharms. USA, Inc.,
`1:19-cv-00318 (D. Del.) ..................................................................................... 6
`Merck Sharp & Dohme Corp. v. Torrent Pharms. Ltd.,
`1:19-cv-00320 (D. Del.) ..................................................................................... 6
`Merck Sharp & Dohme Corp. v. Torrent Pharms. Ltd.,
`1:19-cv-00872 (D. Del.) ..................................................................................... 7
`Merck Sharp & Dohme Corp. v. Watson Pharms., Inc.,
`1:19-cv-00317 (D. Del.) ..................................................................................... 6
`Merck Sharp & Dohme Corp. v. Wockhardt Bio AG,
`1:19-cv-00321 (D. Del.) ..................................................................................... 7
`Merck Sharp & Dohme Corp. v. Zydus Pharms. (USA) Inc.,
`1:19-cv-00314 (D. Del.) ..................................................................................... 6
`Modernatx Inc. v. Curevac AG,
`IPR2017-02194, Paper 45 (P.T.A.B. Apr. 16, 2019) .................................. 65, 66
`Mylan Pharms. Inc. v. UCB Pharma GMBH,
`IPR2016-00510, Paper No. 45 (P.T.A.B. July 19, 2017).......................49, 54, 55
`Mylan Pharms. Inc. v. Cosmo Techs. Ltd.,
`IPR2017-01035, Paper 17 (P.T.A.B. Sept. 21, 2017) ........................................ 14
`
`Mylan Pharms. Inc. v. Sanofi-Aventis Deutschland GMBH,
`IPR2018-01680, Paper 22 (P.T.A.B. Apr. 3, 2019) .....................................67, 68
`Newell Cos., Inc. v. Kenney Mfg. Co.,
`864 F.2d 757 (Fed. Cir. 1988) ............................................................................ 63
`
` 
`
`ix
`
`

`

`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Petition for Inter Partes Review
` 
`
`NHK Spring Co. v. Intri-Plex Techs., Inc.,
`Case IPR2018-00752, Paper 8 (P.T.A.B. Sept. 12, 2018) ....................... 67, 68, 69
`One World Techns. Inc. v. Chamberlain Group Inc.,
`IPR2017-00126, Paper 67 (P.T.A.B. Apr. 4, 2019) ....................................passim
`Otsuka Pharm. Co. v. Sandoz, Inc.,
`678 F.3d 1280 (Fed. Cir. 2012) .......................................................................... 48
`Perricone v. Medicis Pharms. Corp.,
`432 F.3d 1368 (Fed. Cir. 2005) .......................................................................... 18
`Pfizer, Inc. v. Apotex, Inc.,
`480 F.3d 1348 (Fed. Cir. 2007) ...................................................................passim
`PharmaStem Therapeutics, Inc. v. ViaCell, Inc.,
`491 F.3d 1342 (Fed. Cir. 2007) .......................................................................... 3
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc) ......................................................... 10
`Provepharm Inc. v. Wista Labs. Ltd.,
`IPR2018-00182, Paper 16 (P.T.A.B. July 5, 2018) ........................................... 15
`Purdue Pharma Prods. L.P. v. Par Pharm., Inc.,
`377 F. App’x 978 (Fed. Cir. 2010) ..................................................................... 64
`Quanergy Sys., Inc. v. Velodyne Lidar, Inc.,
`IPR2018-00256, Paper 14 (P.T.A.B. May 25, 2018) ......................................... 64
`Rasmusson v. SmithKline Beecham Corp.,
`413 F.3d 1318 (Fed. Cir. 2005) .......................................................................... 14
`Realtime Data, LLC v. Iancu,
`912 F.3d 1368 (Fed. Cir. 2019) .......................................................................... 38
`Sandoz Inc. v. Pharmacylics LLC,
`IPR2019-00865, Paper 8 (P.T.A.B. Sept. 26, 2019) .......................................... 69
`Sinclair & Carroll Co. v. Interchemical Corp.,
`325 U.S. 327 (1945) ........................................................................................... 24
`
` 
`
`x
`
`

`

`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Petition for Inter Partes Review
` 
`
`Sjolund v. Musland,
`847 F.2d 1573 (Fed. Cir. 1988) ............................................................................ 3
`Syntex (U.S.A.) LLC v. Apotex Inc.,
`407 F.3d 1371 (Fed. Cir. 2005) .......................................................................... 18
`Titanium Metals Corp. of Am. v. Banner,
`778 F.2d 775 (Fed. Cir. 1985) ............................................................................ 45
`Valve Corp. v. Elec. Scripting Prods., Inc.,
`IPR2019-00062, -00063, -00084 ........................................................................ 67
`Warner Chilcott Co. v. Teva Pharms. USA,
`89 F. Supp. 3d 641 (D.N.J. 2015) ...................................................................... 22
`Watson Labs., Inc. v. United Therapeutics Corp.,
`IPR2017-01621, Paper 10 (P.T.A.B. Jan. 11, 2018) .......................................... 31
`Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC,
`683 F.3d 1356 (Fed. Cir. 2012) ....................................................................21, 22
`
` 
`STATUTES, RULES & OTHER AUTHORITIES
`35 U.S.C. § 102 ......................................................................................................... 10
`35 U.S.C. § 102(a) ...............................................................................................2, 14
`
`35 U.S.C. § 102(b) .............................................................................................46, 59
`35 U.S.C. § 102(e)(2).........................................................................................31, 32
`35 U.S.C. § 325(d). .............................................................................................66, 69
`37 C.F.R. § 42.6(d) .................................................................................................... 12
`37 C.F.R. § 42.100(b) .............................................................................................10,11
`37 C.F.R. § 42.106(a) .................................................................................................. 6
`
` 
`
`xi
`
`

`

`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Petition for Inter Partes Review
` 
`
`PETITIONER’S EXHIBIT LIST
`
`
`
` 
`
`Pet’r Ex.#
`1001
`1002
`1003
`1004
`1005
`1006
`
`1007
`1008
`1009
`1010
`
`1011
`1012
`1013
`1014
`1015
`
`1016
`
`1017
`1018
`
`Description
`U.S. Patent No. 7,326,708
`Declaration of Dr. Mukund Chorghade
`CV of Dr. Mukund Chorghade
`WO 03/004498 to Edmonson
`Brittain, Polymorphism in Pharmaceutical Solids
`Bastin et al., Salt Selection and Optimisation [sic] Procedures
`for Pharmaceutical New Chemical Entities
`U.S. Patent No 6,699,871
`Orange Book Entry for Janumet®
`Orange Book Entry for Januvia®
`Complete copy of the prosecution history of the ’708 Patent
`as available for download from the USPTO website
`U.S. Patent No. 4,572,909
`U.S. Provisional Application No. 60/303,474, filed July 6, 2001
`Prescribing Information for Janumet®
`Prescribing Information for Januvia®
`Merck Sharpe & Dohme’s Responses and Objections to
`Defendants’ First Set of Joint Interrogatories (1-10)
`Brown et al., Chemistry: The Central Science (8th rev. ed
`615-618 (2002)
`Declaration of Joseph M. Fortunak, Ph.D.
`CV of Joseph M. Fortunak, Ph.D.
`
`xii
`
`

`

`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Petition for Inter Partes Review
` 
`
`I.
`
`INTRODUCTION
`Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. (“DRL”
`
`or “Petitioner”) petition for Inter Partes Review (“IPR”) seeking cancellation of
`
`claims 1-4, 17, 19, and 21-23 (“challenged claims”) of U.S. Patent No. 7,326,708
`
`(“the ’708 Patent”) (EX1001), which is assigned to Merck, Sharpe & Dohme
`
`Corp. (“Merck” or “Patent Owner”).
`
`A Motion for Joinder
`
`is filed herewith requesting
`
`joinder with
`
`IPR2020-00040. IPR2020-00040 was filed by Mylan Pharmaceuticals Inc. on
`
`October 30, 2019, and inter partes review of claims 1-4, 17, 19, and 21-23 was
`
`instituted May 12, 2020. (See IPR2020-00040, Paper 21.) The instant Petition is
`
`substantially identical to the petition filed by Mylan, challenging the same claims
`
`of the ’708 Patent on the same grounds and relying on substantially identical
`
`expert testimony.
`
`II. OVERVIEW
`The ’708 Patent claims a compound commonly known as sitagliptin
`
`phosphate (depicted below), or a hydrate thereof. (EX1001 cl. 1, 16:1-14.)1
` 
`
`1 Sitagliptin
`
`is
`
`also
`
`known
`
`as
`
`4-oxo-4-[3-(trifluoromethyl)-5,6-dihydro
`
`[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-1-(2,4,5-trifluorophenyl)butan-2-amine or 7-
`
`[(3R)-3-Amino-4-(2,4,5-trifluorophenyl)butanoyl]-3-(trifluoromethyl)-5,6,7,8-
`
`tetrahydro-l,2,4-triazolo[4,3-a]pyrazine.
`
`(EX1004,
`
`15:64-66,
`
`Example 7;
`
`

`

`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Petition for Inter Partes Review
` 
`
`
`Dependent claims 2-3, 17, 19, and 21-23 recite the phosphate salt of sitagliptin
`
`while claims 4-16, 18, 20, and 24 recite the monohydrate thereof or various
`
`monohydrate forms thereof. (EX1001, 15:63-18:36.) The ’708 Patent, however, is
`
`not the first disclosure of sitagliptin phosphate. WO 03/004498 (“WO ’498”)
`
`(EX1004), prior art to the ’708 Patent under 35 U.S.C. § 102(a), discloses sitagliptin
`
`and its “pharmaceutically acceptable salts.” Patent Owner can hardly dispute
`
`otherwise since the ’708 Patent plainly admits these facts in the “Background of the
`
`Invention”:
`
`WO 03/004498 (published 16 Jan. 2003), assigned to Merck & Co.,
`describes a class of beta-amino tetrahydrotriazolo [4,3-a]pyrazines, which are
`potent inhibitors of DP IV and therefore useful for the treatment of Type 2
`4-oxo-4-[3-
`diabetes. Specifically disclosed
`in WO 03/004498
`is
`(trifluoromethyl)-5,6-dihydro
`[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-1-
`(2,4,5-trifluorophenyl)butan-2-amine. Pharmaceutically acceptable salts
`
`EXS1002/1017 ¶ 65.)
`
`
`
`2
`
` 
`
`

`

`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Petition for Inter Partes Review
` 
`
`of this compound are generically encompassed within the scope of
`WO 03/004498.
`(EX1001, 1:49-57 (emphasis added).) “Admissions in the specification regarding the
`
`prior art are binding on the patentee.” PharmaStem Therapeutics, Inc. v. ViaCell,
`
`Inc., 491 F.3d 1342, 1362 (Fed. Cir. 2007); Constant v. Advanced Micro-Devices,
`
`Inc., 848 F.2d 1560, 1570 (Fed. Cir. 1988) (“A statement in the patent that
`
`something is in the prior art is binding on the applicant and patentee for
`
`determinations of anticipation and obviousness.”); Sjolund v . Musland, 847 F.2d
`
`1573, 1577-79 (Fed. Cir. 1988) (patent specification admitted that certain matter was
`
`prior art, and thus “the jury was not free to disregard [that matter]” and “must have
`
`accepted [it] as prior art, as a matter of law”); One World Techs. Inc. v.
`
`Chamberlain Grp. Inc., IPR2017-00126, Paper 67, at 14-15 (P.T.A.B. Apr. 4,
`
`2019) (“[T]he Court of Customs and Patent Appeals [has] long held that admissions
`
`in a patent may be considered prior art for any purpose.”).2
`
`As to “pharmaceutically acceptable salts,” WO ’498 teaches the term can refer
`
`to salts generated from either bases or acids. (EX1004, 9:27-30.) As to the acid salts,
`
`“[p]articularly preferred” are “citric, hydrobromic, hydrochloric, maleic,
` 
`2 The fact that the patentee’s admissions about WO ’498 were made in the
`
`“Background of the Invention” of the ’708 Patent gives further weight to this prior
`
`art admission. One World, IPR2017-00126, Paper 67, at 15.
`
`
`
`3
`
`

`

`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Petition for Inter Partes Review
` 
`phosphoric, sulfuric, fumaric, and tartaric acids.” (Id. 10:14-15 (emphasis added).)
`
`And much like the ’708 Patent, the compounds of WO ’498 are dipeptidyl peptidase-
`
`IV enzyme inhibitors that are useful for the treatment or prevention of diseases such
`
`as diabetes and particularly type 2 diabetes. (EX1004 Abstract.)
`
`
`
`As to salts of sitagliptin specifically, WO ’498 exemplifies one of the
`
`“[p]articularly preferred” salts (i.e., the hydrochloride salt) of sitagliptin as
`
`Example 7:
`
`
`(Id. 46:1-4.) There is no dispute about this fact either; the ’708 Patent admits it.
`
`(EX1001, 4:19-22.) Further, WO ’498 claims sitagliptin and its “pharmaceutically
`
`acceptable salts.” (EX1004 cl. 15 (7th structure), 55 (bottom structure); id. 60:5
`
`(“pharmaceutically acceptable salts thereof”).)
`
`In reference to WO ’498, the ’708 Patent inventors may state: “there is no
`
`specific disclosure in the above reference of the newly discovered monobasic
`
`dihydrogen
`
`phosphate
`
`salt
`
`of
`
`4-oxo-4-[3-(trifluoromethyl)-5,6-dihydro
`
`[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-1-(2,4,5-trifluorophenyl)butan-2-amine.”
`
`
`
`4
`
`

`

`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Petition for Inter Partes Review
` 
`(EX1001, 1:58-62.) However, WO ’498 teaches and claims sitagliptin and its
`
`“pharmaceutically acceptable salts” and then identifies the phosphoric acid salt as a
`
`“[p]articularly preferred” salt. (Id. 10:14-15.) Under applicable legal precedents,
`
`sitagliptin phosphate was disclosed. For that matter, any attempt by Patent Owner to
`
`devalue the disclosure of WO ’498 and assert that it does not teach sitagliptin
`
`phosphate is belied by the fact that U.S. 6,699,871 (EX1007), which is related to
`
`WO ’498, is listed in the FDA Orange Book along with the ’708 Patent for Janumet®
`
`and Januvia®. (EX1008, EX1009.)3
`
`III. STANDING (37 C.F.R. § 42.104(a)); PROCEDURAL STATEMENTS
`Petitioner certifies that: (1) the ’708 Patent is available for IPR; and
`
`(2) Petitioner is not barred or estopped from requesting IPR of any claim of the
`
`’708 Patent on the grounds identified herein. This Petition is filed in accordance
`
` 
`3 WO ’498 (EX1004) and U.S. 6,699,871 (EX1007) both claim priority to U.S.
`
`Provisional Application No. 60/303,474 and share the same specification in all
`
`relevant material respects. (Compare EX1004, 9:27-10:15 (“pharmaceutically
`
`acceptable salts”), 46:1-5 (Example 7, sitagliptin hydrochloride) with EX1007,
`
`6:38-7:4 (“pharmaceutically acceptable salts”), 32:1-16 (Example 7, sitagliptin
`
`hydrochloride).) WO ’498 was not used by the Examiner during prosecution of the
`
`’708 Patent to formulate any prior art rejection.
`
`
`
`5
`
`

`

`IPR2020-01060 (U.S. Patent No. 7,326,708)
`Petition for Inter Partes Review
` 
`with 37 C.F.R. § 42.106(a). Filed herewith are a Power of Attorney and an Exhibit
`
`List pursuant to Section 42.10(b) and Section 42.63(e), respectively. The required
`
`fee is paid when filing the Petition and the Office is authorized to charge any fee
`
`deficiencies and credit overpayments to Deposit Acct. No. 12-1095 (Customer ID
`
`No. 00530).
`
`IV. MANDATORY NOTICES (37 C.F.R. § 42.8(a)(1))
`A.
`Each Real Party In Interest (37 C.F.R. § 42.8(b)(1))
`The
`following
`real parties
`in
`interest are
`identified: Dr. Reddy’s
`
`Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd.
`
`B. Notice Of Related Matters (37 C.F.R. § 42.8(b)(2))
`1.
`Judicial Matters Involving The ’708 Patent
`The ’708 Patent is currently the subject of the following litigations: Merck
`
`Sharp & Dohme Corp. v. Mylan Pharmaceuticals Inc. et al., 1:19-cv-00101 (N.D.
`
`W. Va.); Merck Sharp & Dohme Corp. v. Mylan Pharmaceuticals Inc. et al.,
`
`1:19-cv-01489 (D. Del.); Merck Sharp & Dohme Corp. v. Alvogen Pine Brook f/k/a
`
`Alvogen Pine Brook, Inc. et al., 1:19-cv-00310 (D. Del.);