`
`Case IPR2015-
`Patent No. 8,603,506
`Petition for Inter Partes Review
`Attorney Docket No. REDDYPP 7.1R-015
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________________
`
`DR. REDDY’S LABORATORIES, LTD. and
`DR. REDDY’S LABORATORIES, INC.
`
`Requestors
`
`v.
`
`GALDERMA LABORATORIES, INC.
`Patent Owner
`
`
`Patent No. 8,603,506
`Issue Date: December 10, 2013
`Title: METHOD OF TREATING ACNE
`____________________________
`
`Inter Partes Review No. Unassigned
`
`__________________________________________________________________
`
`PETITION FOR INTER PARTES REVIEW OF
`CLAIMS 1, 7, 8, 14, 15, AND 20 OF U.S. PATENT
`NO. 8,603,506 AND MANDATORY NOTICES UNDER 37 C.F.R. § 42.8
`
`
`
`

`

`Case IPR2015-
`Petition for Inter Partes Review
`Attorney Docket No. REDDYPP 7.1R-015
`TABLE OF CONTENTS
`
`Page
`
`TABLE OF AUTHORITIES ................................................................................... iii
`
`EXHIBIT LIST ......................................................................................................... v
`
`STATEMENT OF REASONS FOR RELIEF REQUESTED .................................. 6
`
`I.
`
`II.
`
`INTRODUCTION AND SUMMARY OF ARGUMENT .............................. 6
`
`THE CLAIMS UNDER CONSIDERATION ................................................. 9
`
`III. THE SPECIFICATION AND
`PROSECUTION HISTORY OF THE ‘506 PATENT ..................................11
`
`A. The Specification Of The ‘506 Patent ....................................................11
`
`B. The Prosecution History Of The ‘506 Patent .........................................14
`
`IV. THE EFFECTIVE FILING DATE OF THE
`CHALLENGED CLAIMS IS OCTOBER 20, 2011 .....................................19
`
`A. No Teaching Of Treating Papules And Pustules Of Rosacea ................22
`
`B. No Teaching Of Using Doxycycline To
`Treat Papules And Pustules Of Rosacea .................................................24
`
`C. No Teaching Of The Claimed Doses Of
`Doxycycline To Treat Papules And Pustules Of Rosacea ......................25
`
`D. No Teaching Of Administering Doxycycline Without A
`Bisphosphonate To Treat The Papules And Pustules Of Rosacea .........29
`
`E. Other Pending Petitions ..........................................................................30
`
`V.
`
`CLAIM CONSTRUCTION ..........................................................................30
`
`A. Rosacea ...................................................................................................30
`
`B. Papules And Pustules ..............................................................................31
`
`
`
`i
`
`

`

`Case IPR2015-
`Petition for Inter Partes Review
`Attorney Docket No. REDDYPP 7.1R-015
`VI. ANALYSIS ....................................................................................................32
`
`A. Ground 1 ____ Claims 1, 7, 8, 14, 15, And 20 Are
`Anticipated By Ashley, U.S. Patent No. 7,232,572................................32
`B. Ground 2 ____ Claims 1, 7, 8, 14, 15, And 20 Are
`Obvious Over Ashley, U.S. Patent No. 7,252,572 .................................34
`
`1. The Level Of Ordinary Skill In The Art ..........................................35
`
`2. Scope And Content Of The Prior Art ..............................................37
`C. Ground 3 ____ Claims 1, 7, 8, 14, 15, And 20 Are
`Obvious Over Ashley, U.S. Patent No. 7,211,267 .................................41
`
`1. The Level Of Ordinary Skill In The Art ..........................................41
`
`2. The Scope And Content Of The Prior Art .......................................42
`
`D. Ground 4 ____ Claims 1, 7, 8, 14, 15, And 20 Are Anticipated
`By The ORACEA Prescribing Information (Exh.1043) ........................46
`
`VII. CONCLUSION ..............................................................................................51
`
`CERTIFICATE OF COMPLIANCE ...................................................................... 51
`
`
`
`
`
`ii
`
`

`

`Case IPR2015-
`Petition for Inter Partes Review
`Attorney Docket No. REDDYPP 7.1R-015
`TABLE OF AUTHORITIES
`
`Page(s)
`
`
`CASES
`Alcon Research, Ltd. v. Apotex Inc.,
`687 F.3d 1362 (Fed. Cir. 2012),
`cert denied, 133 S. Ct. 1736 (2013) .................................................................... 35
`Asyst Techs., Inc. v. Emtrak, Inc.,
`544 F.3d 1310 (Fed. Cir. 2008) .......................................................................... 17
`Brown v. 3M, 265 F.3d 1349,
`60 U.S.P.Q.2d 1375, 1376 (Fed. Cir. 2001) ....................................................... 32
`Cable Elec. Prods., Inc. v. Genmark, Inc.,
`770 F.2d 1015 (Fed. Cir. 1985), overruled on other grounds ............................ 17
`In re Cuozzo Speed Techs., LLC,
`778 F.3d 1271 (Fed. Cir. 2015), rh’g en banc denied. ....................................... 30
`Graham v. John Deere Co.,
`383 U.S. 1 (1966) ................................................................................................ 34
`J.T. Eaton & Co. v. Atl. Paste & Glue Co.,
`106 F.3d 1563 (Fed. Cir. 1997) .......................................................................... 17
`KSR Int'l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ...................................................................................... 34, 35
`Lockwood v. Am. Airlines, Inc.,
`107 F.3d 1565 (Fed. Cir. 1997) .............................................................. 21, 27, 42
`Martin v. Mayer,
`823 F.2d 500 (Fed. Cir. 1987) ............................................................................ 27
`Mintz v. Dietz & Watson, Inc.,
`679 F.3d 1372 (Fed. Cir. 2012) .......................................................................... 35
`In re NTP, Inc.,
`654 F.3d 1268 (Fed. Cir. 2011) .......................................................................... 21
`
`
`
`iii
`
`

`

`Case IPR2015-
`Petition for Inter Partes Review
`Attorney Docket No. REDDYPP 7.1R-015
`Novozymes A/S v. Dupont Nutrition Biosciences APS,
`723 F.3d 1336 (Fed. Cir. 2013), cert. denied, 134 S. Ct. 1501 (2014) .............. 26
`Par Pharm. Inc. v. TWI Pharms., Inc.,
`773 F.3d 1186, No. 2014-1391, 2014 U.S. App.
`LEXIS 22737 (Fed. Cir. Dec. 3, 2014) ............................................................... 35
`In re Ruschig,
`379 F.2d 990 (C.C.P.A. 1967) ............................................................................ 27
`Santarus, Inc. v. Par Pharm., Inc.,
`694 F.3d 1344 (Fed. Cir. 2012) .................................................................... 29, 30
`In re Seversky,
`474 F.2d 671, 177 U.S.P.Q. 144 (C.C.P.A. 1973) .............................................. 21
`Titanium Metals Corp. v. Banner,
`778 F.2d 775227 U.S.P.Q. 773 (Fed. Cir. 1985) ................................................ 47
`Verdegaal Bros. v. Union Oil Co. of Cal.,
`814 F.2d 628 2 U.S.P.Q.2d 1051 (Fed. Cir. 1987). ........................................... 32
`STATUTES, RULES & OTHER AUTHORITIES
`35 U.S.C. § 102 .......................................................................................................... 4
`35 U.S.C. § 103 .................................................................................................... 6, 34
`35 U.S.C. § 112 .................................................................................................... 7, 42
`35 U.S.C. § 119(e) ................................................................................................... 20
`35 U.S.C. § 120 .................................................................................................passim
`35 U.S.C. § 132 ...................................................................................................... 7, 8
`35 U.S.C. § 314(a) ..................................................................................................... 6
`35 U.S.C. § 315(b) ..................................................................................................... 3
`37 C.F.R. § 42.100(b) .............................................................................................. 30
`M.P.E.P. § 716.03(b)................................................................................................ 17
`M.P.E.P. § 2143.01 IV ............................................................................................. 18
`
`
`
`iv
`
`

`

`Case IPR2015-
`Petition for Inter Partes Review
`Attorney Docket No. REDDYPP 7.1R-015
`EXHIBIT LIST
`
`
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`Exhibit # Reference
`U.S. Patent No. 8,603,506
`1001
`1002
`Specification of Application No. 60/281,916 filed Apr. 5, 2001
`1003
`Specification of Application No. 60/325,489 filed Sept. 26, 2001
`1004
`Declaration of Michael Payette, M.D.
`1005
`C.V. of Michael Payette, M.D.
`I. B. Sneddon, A CLINICAL TRIAL OF TETRACYCLINE IN
`1006
`ROSACEA, 78 British J. Dermatology 649-52 (Jan.-Dec. 1966)
`R. Marks & J. Ellis, COMPARATIVE EFFECTIVENESS OF
`TETRACYCLINE AND AMPICILLIN IN ROSACEA A Controlled
`Trial, II(7733) Lancet 1049-52 (Nov. 13, 1971)
`E.M. Saihan and J.L. Burton, A double-blind trial of metronidazole
`versus oxytetracycline therapy for rosacea, 102 British J.
`Dermatology 443-45 (1980)
`P.G. Nielsen, A double-blind study of I% metronidazole cream versus
`systemic oxytetracycline therapy for rosacea, 109(1) British J.
`Dermatology 63-65 (1983)
`Claudio Torresani et al., Clarithromycin versus doxycycline in the
`treatment of rosacea, 36(12) International J. Dermatology 942-46
`(Dec. 1997)
`Joseph B. Bikowski, Treatment of Rosacea With Doxycycline
`Monohydrate, 66(2) Cutis 149-52 (Aug. 2000)
`U.S. Serial No. 13/277,789 Notice of Allowance, Oct. 9, 2013
`1012
`1013 WO 2000/018230 (Ramamurthy et al.)
`E-mail from PDR Customer Service Department to Lerner, David,
`1014
`Littenberg, Krumholz & Mentlik Library (May 14, 2015, 13:04 EST)
`(on file with recipient)
`Beth A. Kapes, Doxycycline hyclate reduces comedones by 50
`percent, Dermatology Times, 2001 Suppl. 22 (November (11)):S19
`U.S. Patent No. 7,211,267
`R. Russel Martin et al., Effects of Tetracycline on Leukotaxis, 129(2)
`J. Infectious Disease 110-16 (Feb. 1974)
`Gerd Plewig, M.D. & Erwin Schöpf, M.D., ANTI-INFLAMMATORY
`EFFECTS OF ANTIMICROBIAL AGENTS: AN IN VIVO STUDY,
`65(6) J. Investigative Dermatology 532-36 (Dec. 1975)
`
`1015
`
`1016
`1017
`
`1018
`
`
`
`v
`
`

`

`1020
`1021
`
`1022
`
`Case IPR2015-
`Petition for Inter Partes Review
`Attorney Docket No. REDDYPP 7.1R-015
`Exhibit # Reference
`Nancy B. Esterly et al., THE EFFECT OF ANTIMICROBIAL
`1019
`AGENTS ON LEUKOCYTE CHEMOTAXIS, 70(1) J. Investigative
`Dermatology 51-55 (1978)
`U.S. Patent No. 7,232,572
`L.M. Golub et al., Minocycline reduces gingival collagenolytic
`activity during diabetes Preliminary observations and a proposed
`new mechanism of action, 18(5) J. Periodontal Research 516-26
`(1983)
`L.M. Golub et al., A Non-antibacterial Chemically-modified
`Tetracycline Inhibits Mammalian Collagenase Activity, 66(8) J.
`Dental Research 1310-14 (Aug. 1987)
`1023 Waldemar Pruzanski et al., INHIBITION OF ENZYMATIC
`ACTIVITY OF PHOSPHOLIPASES A2 BY MINOCYCLINE AND
`DOXYCYCLINE, 44(6) Biochemical Pharmacol. 1165-70 (1992)
`Ashok R. Amin et al., A novel mechanism of action of tetracyclines:
`Effects on nitric oxide synthases, 93(24) Proc. Nat’l Acad. Sci. USA.
`14014-019 (Nov. 1996)
`Ashok R. Amin et al., Post-transcriptional regulation of inducible
`nitric oxide synthase mRNA in murine macrophages by doxycycline
`and chemically modified tetracyclines, 410(2-3) FEBS Letters
`259-64 (June 1997)
`U.S. Patent No. 7,014,858
`L.M. Golub et al., TETRACYCLINES INHIBIT CONNECTIVE TISSUE
`BREAKDOWN BY MULTIPLE NON-ANTIMICROBIAL MECHANISMS, 12(2)
`Advances in Dental Research 12-26 (Nov. 1998)
`Kari K. Eklund & Timo Sorsa, Tetracycline Derivative CMT-3
`Inhibits Cytokine Production, Degranulation, and Proliferation in
`Cultured Mouse and Human Mast Cells, 878 Annals N.Y. Academy
`Sciences 689-91 (1999)
`Keith L. Kirkwood et al., Non-antimicrobial and Antimicrobial
`Tetracyclines Inhibit IL-6 Expression in Murine Osteoblasts, 878
`Annals N.Y. Academy Sciences 667-70 (1999)
`Y.H. Thong & A. Ferrante, Inhibition of mitogen-induced human
`lymphocyte proliferative responses by tetracycline analogues, 35(3)
`Clin. exp. Immunol. 443-46 (1979)
`
`1024
`
`1025
`
`1026
`1027
`
`1028
`
`1029
`
`1030
`
`
`
`vi
`
`

`

`1032
`
`1033
`
`1034
`
`1035
`
`1036
`1037
`
`Case IPR2015-
`Petition for Inter Partes Review
`Attorney Docket No. REDDYPP 7.1R-015
`Exhibit # Reference
`A. Naess et al., In vivo and in vitro effects of doxycycline on
`1031
`leucocyte membrane receptors, 62(2) Clin. exp. Immunol. 310-14
`(1985)
`Hirohko Akamatsu et al., Effect of Doxycycline on the Generation of
`Reactive Oxygen Species: A Possible Mechanism of Action of Acne
`Therapy with Doxycycline, 72(3) Acta Dermo-Venereologica 178-79
`(1992)
`Y. Ueyama et al., Effects of antibiotics on human polymorphonuclear
`leukocyte chemotaxis in vitro, 32(2) British J. Oral Maxillofacial
`Surgery 96-99 (1994)
`Thomas Jansen MD & Gerd Plewig MD, Rosacea: classification and
`treatment, 90(3) J. Royal Society Med. 144-50 (Mar. 1997)
`R. Marks, Histogenesis of the Inflammatory Component of Rosacea,
`66(8) Proc. roy. Soc. Med. 742-45 (Aug. 1973)
`U.S. Patent No. 8,052,983
`R.K. Curley & J.L. Verbov, Stevens-Johnson syndrome due to
`tetracyclines ____ a case report (doxycycline) and review of the
`literature. 12(2) Clinical and Experimental Dermatology 124-25
`(Mar. 1987)
`R.M. Truëb & G. Burg, Acute Generalized Exanthematous Pustulosis
`due to Doxycycline, 186(1) Dermatology 75-78 (1993)
`Lori E. Shapiro et al., Comparative Safety of Tetracycline,
`Minocycline, and Doxycycline, 133(10) Archives of Dermatology
`1224-30 (Oct. 1997)
`Application Serial No. 11/876,478 Specification, filed Oct. 22, 2007
`Jerry D. Smilack M.D., The Tetracyclines, 74(7) Mayo Clinic Proc.
`727-29 (July 1999)
`PERIOSTAT. (2000). In Physicians’ Desk Reference 944-46 (54th
`ed. 2000) Montvale, NJ: PDR Network
`ORACEA™ (2007). In Physicians’ Desk Reference 1000-100 (61st
`ed 2007), Retrieved from http://www.pdr.net
`A.K. Gupta & M.M Chaudhry, Rosacea and its management: an
`overview, 19(3) J. European Academy of Dermatology and
`Venereology 273-85 (2005)
`
`1038
`
`1039
`
`1040
`1041
`
`1042
`
`1043
`
`1044
`
`
`
`vii
`
`

`

`1047
`
`1048
`
`1049
`
`Case IPR2015-
`Petition for Inter Partes Review
`Attorney Docket No. REDDYPP 7.1R-015
`Exhibit # Reference
`Complaint of Galderma Laboratories, Inc. in Civil Action No. 00670,
`1045
`filed on July 31, 2015, in the United States District Court for the
`District of Delaware
`1046 Webster’s Ninth New Collegiate Dictionary 852, 958 (1983),
`“papules” and “pustules,” respectively
`Stedman’s Medical Dictionary 1023, 1175 (24th ed 1982), “papules”
`and “pustules,” respectively
`L.M. Golub et al., Low-dose doxycycline therapy:Effect on gingival
`and eravicular fluid collagenase activity in humans, 25 J. Periodontal
`Research 321-30 (1990)
`Clay Walker et al., Long-Term Treatment With Subantimicrobial
`Dose Doxycycline Exerts No Antibacterial Effects on the Subgingival
`Microflora Associated With Adult Periodontitis, 71(9) J. of
`Periodontology 1465-71 (Sept. 2000)
`U.S. Patent No. 4,666,897 (Golub et. al.)
`Vibramycin®.(1974). In Physicians’ Desk Reference 942-43 (28th
`ed. 1974). Oradell, N.J.: PDR Network.
`Vital Therapies Incorporated.(2015). Management, Robert A. Ashely,
`M.A., Chief Technical Officer, Executive Vice President. Retrieved
`from http://vitaltherapies.com/corporate/management/
`Center for Drug Evaluation and Research, Fed. Food and Drug
`Admin., Approval Package for Application Number: NDA 50-744,
`Trade Name: PERIOSTAT CAPSULES, 20MG (Sept. 30, 1998),
`www.accessdata.fda.gov/drugsatfda_docs/nda/98/50744_
`appltr.pdf
`1054 Mark L. Nelson & Stuart B. Levy, The history of the tetracyclines,
`1241 Annals N.Y. Academy Sciences 17-32 (2011)
`Alicia Mack, Examination of the Evidence for Off-Label Use of
`Gabapentin, 9(6) J. Managed Care Pharmacy 559-68 (Nov./Dec.
`2003)
`Thomas B. Fitzpatrick et al., Dermatology in General Medicine (3rd
`ed. 1987)
`John Berth-Jones MRCP et al., The successful use of minocycline in
`pyoderma gangrenosum—a report of seven cases and review of the
`literature, 1(1) J. Dermatological Treatment 23–25 (June 1989)
`
`1050
`1051
`
`1052
`
`1053
`
`1055
`
`1056
`
`1057
`
`
`
`viii
`
`

`

`1059
`
`1061
`
`1062
`
`1063
`
`1064
`
`Case IPR2015-
`Petition for Inter Partes Review
`Attorney Docket No. REDDYPP 7.1R-015
`Exhibit # Reference
`R.K. Joshi et al. Successful treatment of Sweet’s syndrome with
`1058
`doxycycline, 128 British J. Dermatology 584-86 (1993)
`P. Senet et al., Minocycline for the treatment of cutaneous silicone
`granulomas, 140 British J. Dermatology 985-87 (1999)
`1060 Mark Allen Berk & Allan L. Lorincz, The Treatment of Bullous
`Pemphigoid With Tetracycline and Niacinamide. A preliminary
`report. 122(6) Archives Dermatology 670-74 (June 1986)
`Carl R. Thornfeldt & Andrew W. Menkes, Bullous pemphigoid
`controlled by tetracycline, 16(2)(1) J. American Academy
`Dermatology 305-10 (Feb. 1987)
`Isabelle Thomas et al., Treatment of generalized bullous pemphigoid
`with oral tetracycline, 28(1) J. American Academy Dermatology
`74-77 (January 1993)
`David P. Fivenson et al., Nicotinamide and Tetracycline Therapy of
`Bullous Pemphigoid, 130 Arch. Dermatol. 753-58 (June 1994
`Ronald M. Reisner, MD, Systemic Agents in the Management of
`Acne, California Medicine 28-34 (Jan. 1967)
`1065 Marsha L. Chaffins et al., Treatment of pemphigus and linear IgA
`dermatosis with nicotinamide and tetracycline: a review of 13 cases,
`28(6) J. Am. Acad. Dermatol. 998-1000 (June 1998)
`L. Reiche L et al., Combination therapy with nicotinamide and
`tetracyclines for cicatricial pemphigoid: further support for its
`efficacy, 23(6) Clin. and Experimental Dermatol. 254-57 (Nov. 1998)
`Howard Maibach, MD, Second-Generation Tetracyclines, A
`Dermatologic Overview: Clinical Uses and Pharmacology, 48(5)
`cutis 411-17 (Nov. 1991)
`U.S. Serial No. 13/277,789 Fifth Preliminary Amendment, Apr. 30,
`2012
`U.S. Serial No. 13/277,789 Official Action, May 14, 2012
`U.S. Serial No. 13/277,789 Resp. to May 14, 2012 Office Action,
`Sept. 19, 2012
`U.S. Serial No. 13/277,789 Resp. to November 19, 2012 Final Office
`Action and Substance of February 7, 2013 Interview in Reply to
`February 19, 2013 Interview Summary, Feb. 22, 2013
`U.S. Serial No. 13/277,789 Declaration under 37 C.F.R. § 1.132 [of
`Vasant Manna], Feb. 22, 2013
`
`1066
`
`1067
`
`1068
`
`1069
`1070
`
`1071
`
`1072
`
`
`
`ix
`
`

`

`Case IPR2015-
`Petition for Inter Partes Review
`Attorney Docket No. REDDYPP 7.1R-015
`Exhibit # Reference
`1073 MONODOX®, VIBRAMYCIN®. (2000). In Physician’s Desk
`Reference 2082-2083, 2384-2386 (54th ed. 2000) Montvale, NJ:
`PDR Network
`
`
`
`
`x
`
`

`

`Case IPR2015-
`Petition for Inter Partes Review
`Attorney Docket No. REDDYPP 7.1R-015
`Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. (“DRL,”
`
`“Requestor,” or “Petitioner”) requests inter partes review of claims 1, 7, 8, 14, 15,
`
`and 20 of U.S. Patent No. 8,603,506 (“the ‘506 Patent”) (Exh.1001).
`
`NOTICE OF LEAD AND BACKUP COUNSEL
`
`Lead Counsel:
`William L. Mentlik
`(Reg. No. 27,108)
`WMentlik.ipr@ldlkm.com
`Postal and Hand-Delivery Address
`600 South Avenue West
`Westfield, NJ 07090
`Telephone: 908.518.6305
`Fax: 908.654.7866
`
`
`
`Backup Counsel:
`Michael H. Teschner
`(Reg. No. 32,862)
`MTeschner.ipr@ldlkm.com
`Postal and Hand-Delivery Address
`600 South Avenue West
`Westfield, NJ 07090
`Telephone: 908.518.6313
`Fax: 908.654.7866
`
`Brian R. Tomkins
`(Reg. No. 58,550)
`BTomkins.ipr@ldlkm.com
`Postal and Hand-Delivery Address
`600 South Avenue West
`Westfield, NJ 07090
`Telephone: 908.518.6380
`Fax: 908.654.7866
`
`Maegan A. Fuller
`(Reg. No. 71,596)
`MFuller.ipr@ldlkm.com
`Postal and Hand-Delivery Address
`600 South Avenue West
`Westfield, NJ 07090
`Telephone: 908.518.6324
`Fax: 908.654.7866
`
`
`
`
`

`

`Case IPR2015-
`Petition for Inter Partes Review
`Attorney Docket No. REDDYPP 7.1R-015
`
`NOTICE OF EACH REAL-PARTY-IN-INTEREST
`The Real-Parties-In-Interest for this Petition are Requestor, Dr. Reddy’s
`
`Laboratories, Ltd. (“DRL LTD”) an Indian company, and Dr. Reddy’s
`
`Laboratories, Inc. (“DRL Inc.”) a U.S. company, and wholly owned subsidiary of
`
`DRL LTD. (collectively referred
`
`to herein as “DRL,” “Requestor,” or
`
`“Petitioner”).
`
`NOTICE OF RELATED MATTERS
`Patent Owner1 has asserted the ‘506 Patent as well as U.S. Patent
`
`Nos. 7,211,267 and 7,232,572 in a civil action filed in the United States District
`
`Court for the District of Delaware (Civil Action No. 15-670), on July 31, 2015
`
`(“the Litigation”). (Exh.1045.) Requestor has also filed concurrent inter partes
`
`review (also referred to herein as “IPR”) petitions against the same claims of the
`
`
`1 Galderma is listed as the patent owner in the caption of this Petition, and as of
`
`August 19, 2015, is the recorded assignee of the ‘506 Patent in the USPTO
`
`Assignment Database. However, in the Litigation (defined herein), the Complaint
`
`states that Nestle Skin Health S.A. (“Nestlé”) is now the owner of the ‘506 Patent.
`
`While the purported assignment to Nestlé is not yet recorded, Petitioner is serving
`
`both Galderma and Nestlé with this Petition, and as used herein, “Patent Owner”
`
`refers to both Galderma and Nestlé.
`
`2
`
`

`

`Case IPR2015-
`Petition for Inter Partes Review
`Attorney Docket No. REDDYPP 7.1R-015
`‘506 Patent
`under
`different
`theories
`
`bearing
`
`attorney
`
`docket
`
`nos. REDDYPP 7.1R-009 and REDDYPP 7.1R-017.
`
`NOTICE OF SERVICE INFORMATION
`Please address all correspondence to the lead and backup counsel
`
`at
`
`the address
`
`shown above. Requestor also consents
`
`to electronic
`
`service by e-mail at: WMentlik.ipr@ldlkm.com, MTeschner.ipr@ldlkm.com,
`
`BTomkins.ipr@ldlkm.com, and MFuller.ipr@ldlkm.com.
`
`GROUNDS FOR STANDING
`Requestor certifies that the patent for which review is sought is available for
`
`inter partes review, and that Requestor is not barred or estopped from requesting
`
`an inter partes review on the grounds identified in the Petition. The Petition is filed
`
`within one year of the filing of the Complaint in the Litigation. (Exh.1045.) The
`
`Petition is thus timely under 35 U.S.C. § 315(b). The fee for this Petition has been
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`paid. However, the U.S. Patent and Trademark Office is hereby authorized to
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`charge Deposit Account No. 12-1095 for any fees that may be due and owing in
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`connection with this Petition.
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`STATEMENT OF PRECISE RELIEF REQUESTED
`Requestor requests that claims 1, 7, 8, 14, 15, and 20 of the ‘506 Patent be
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`held unpatentable based on the following grounds:
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`3
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`

`

`Case IPR2015-
`Petition for Inter Partes Review
`Attorney Docket No. REDDYPP 7.1R-015
`Ground 1. Claims 1, 7, 8, 14, 15, and 20 are anticipated by Ashley, U.S.
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`Patent No. 7,232,572. (Exh.1020.)2
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`Ground 2. Claims 1, 7, 8, 14, 15, and 20 are obvious over Ashley, U.S.
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`Patent No. 7,232,572. (Exh.1020.)
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`Ground 3. Claims 1, 7, 8, 14, 15, and 20 are obvious over Ashley, U.S.
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`Patent No. 7,211,267. (Exh.1016.)
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`Ground 4. Claims 1, 7, 8, 14, 15, and 20 are anticipated by the ORACEA
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`prescribing information in its FDA approved label. (Exh.1043.)
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`Although Petitioner provides multiple grounds of unpatentability, they are
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`meaningfully distinct from each other and from those found in the co-pending IPR
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`Petitions having attorney docket nos. REDDYPP 7.1R-009 and REDDYPP
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`7.1R-017. Unlike the other grounds offered in the co-pending Petitions, each of
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`these grounds depends upon a determination of the earliest effective date to be
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`accorded to the various challenged claims. Specifically none of the claims of the
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`‘506 Patent is entitled to a date earlier than the actual filing date of October 20,
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`2011. Thus, the ‘506 Patent is unable to validly claim priority under 35 U.S.C.
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`2 The pre-AIA version of 35 U.S.C. §§ 102 and 103 applies to each ground in this
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`proceeding, because the ‘506 Patent has an effective filing date before March 16,
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`2013.
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`4
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`

`

`Case IPR2015-
`Petition for Inter Partes Review
`Attorney Docket No. REDDYPP 7.1R-015
`§ 120, as explained below. If Petitioner is correct that the ‘506 Patent is not entitled
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`to any date earlier than October 20, 2011, the challenged claims are either
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`anticipated or rendered obvious by the claims of a cousin, U.S. Patent
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`No. 7,232,572 (Exh.1020) (Grounds 1 and 2, respectively), which issued in 2007
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`and claims the use of 40mg/day of doxycycline to treat the papules and pustules of
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`rosacea without a bisphosphonate and without reducing skin microflora. Ground 3
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`is predicated on obviousness based on the ‘506 Patent’s direct linear ancestor, U.S.
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`Patent No. 7,211,267 (Exh.1016), which published on May 1, 2007. These are not
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`redundant grounds. While the ‘572 Patent claims to be based on a series of
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`continuations of the ‘267 Patent, surprisingly their disclosures are not identical.
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`The added subject matter in the ‘572 Patent, including late filed claims, anticipates
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`or renders obvious the challenged claims of the ‘506 Patent. However, even the
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`common subject matter in the ‘572 Patent (and ‘267 Patent), without the added
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`claim language, renders the claims of the ‘506 Patent obvious. Under Ground 4,
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`the challenged claims of the ‘506 Patent are anticipated by the prescribing
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`information for ORACEA (Exh.1043), a 40mg/day doxycycline product given to
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`treat the papules and pustules of rosacea, which was commercially available, and
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`whose prescribing information was a printed publication, at least as early as 2007.
`
`5
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`

`

`Case IPR2015-
`Petition for Inter Partes Review
`Attorney Docket No. REDDYPP 7.1R-015
`Petitioner submits that these theories are sufficiently different from one
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`another to each merit independent consideration and grant by the Board. However,
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`if Petitioner had to prioritize these grounds, Petitioner would suggest Ground 4,
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`followed by Ground 1, followed by Grounds 2 and 3, respectively.
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`THRESHOLD REQUIREMENT FOR INTER PARTES REVIEW
`A petition for inter partes review must demonstrate “a reasonable likelihood
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`that the petitioner would prevail with respect to at least one of the claims
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`challenged in the petition.” 35 U.S.C. § 314(a). This Petition meets that threshold.
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`All of the elements of claims 1, 7, 8, 14, 15, and 20 of the ‘506 Patent are taught,
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`either expressly or inherently, in the prior art, or are obvious in view of the prior
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`art, as explained below in the grounds of unpatentability. The reasons to combine
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`the cited references, where applicable, are established under 35 U.S.C. § 103(a).
`
`I.
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`STATEMENT OF REASONS FOR RELIEF REQUESTED
`INTRODUCTION AND SUMMARY OF ARGUMENT
`If one reads the challenged claims of the ‘506 Patent, it is quite clear that
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`they are directed to treating the papules and pustules of rosacea by administering
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`some fraction of a 50mg dose of doxycycline once a day, without
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`co-administration of a bisphosphonate and without causing a reduction in the
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`skin’s microflora after six months of treatment. If one reads the specification of the
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`‘506 Patent, and importantly in this context, its immediate parent, Serial
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`6
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`

`

`Case IPR2015-
`Petition for Inter Partes Review
`Attorney Docket No. REDDYPP 7.1R-015
`No. 11/876,478 filed on October 22, 2007 (Exh.1040), now U.S. Patent
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`No. 8,052,983 (Exh.1036), that is about the last conclusion one would come to.
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`The challenged claims of the ‘506 Patent find no written description support in the
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`specification of the ‘506 Patent, or any earlier direct predecessor. (Exhs.1016,
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`1036, 1040.)
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`Petitioner is not arguing that the claims are invalid because they constitute
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`new matter and/or violate 35 U.S.C. §§ 112 and 132, per se. However, because the
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`claims introduced in the ‘506 Patent do not find written description support in the
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`‘983 Patent, and more particularly, in the specification of that application as filed,
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`the ‘506 Patent is not entitled to claim the benefit of the ‘983 Patent’s filing date
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`pursuant to 35 U.S.C. § 120.
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`Specifically, nothing in the specification of the ‘506 Patent, or its immediate
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`parent, points to the treatment of rosacea, let alone to the treatment of papules and
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`pustules of rosacea with doxycycline.3 In both the ‘506 Patent and ‘478
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`3 The earliest disclosure of any method of treating the papules and pustules of
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`rosacea appears during the prosecution of the ‘983 Patent in claim amendments
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`made on August 10, 2009, which are not found in the ‘983 Patent as they were
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`canceled prior to its issuance. The introduction of these claims during prosecution,
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`which were not present in the application at the time of filing of the application
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`7
`
`

`

`Case IPR2015-
`Petition for Inter Partes Review
`Attorney Docket No. REDDYPP 7.1R-015
`Application (which issued as the ‘983 Patent) specifications, rosacea is merely one
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`of 30 conditions generically described, and it is discussed in only one line of the
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`patent. (Exhs.1001 col.4 ll.31-41; 1040, p.7 l.34 to p.8 l.3.4) Similarly, papules and
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`pustules are but some of many symptoms allegedly, but erroneously, shared by
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`those 30 species. (Exhs.1001 col.4 ll.24-30; 1040, p.7 ll.28-32.) Neither treating
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`rosacea nor treating papules and pustules of rosacea are exemplified or even
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`specifically referenced. The specifications also identify hundreds, if not more,
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`tetracycline compounds and derivatives, some of which are antibiotic and some of
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`which are not. (Exhs.1001 col.4 l.58 to col.5 l.28, col.7 l.37 to col.8 l.13, Exs.1-36,
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`col.20 l.45 to col.31 l.58; 1040 p.8 l.20 to p.9 l.22, p.14 ll.4-33, Exs.1-36, p.37 l.1
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`to p.53 l.14.) However, the specifications identify none of these for use in
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`treatment of rosacea and/or its papules and pustules. Indeed, doxycycline, the
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`single compound claimed in the ‘506 Patent, is touted throughout the specification
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`for its ability to address comedones. (See Exhs.1001 col.5 ll.54-58, col.5 l.64 to
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`col.6 l.4, col.7 ll.1-16, Ex.38; 1040 p.10 ll.17-20, p.10 l.27 to p.11 l.2, p.13 ll.1-7,
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`
`(see Exh.1040), cannot add to the disclosure of the application as filed, and cannot
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`establish an effective filing date. 35 U.S.C. § 132(a).
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`4 Page numbers are based on exhibit page numbers, not specification page
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`numbers.
`
`8
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`

`

`Case IPR2015-
`Petition for Inter Partes Review
`Attorney Docket No. REDDYPP 7.1R-015
`Ex.38.) Comedones are one of the many symptoms mentioned in the specification,
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`and are best known as a feature of acne vulgaris or common acne. But they are not
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`a feature of rosacea. (Exh.1004 ¶ 13.) Thus, there is nothing in the specification to
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`specifically point to the use of doxycycline to treat rosacea.
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`The specifications of the ‘506 Patent and ‘478 Application are similarly
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`deficient on issues such as dose, not using a bisphosphonate when treating rosacea,
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`and that the resulting selection of drug and dose would not cause a reduction in
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`skin microflora after six months of treatment. To make matters worse, the
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`specification contains irreconcilable differences as to which doses constitute
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`antibacterial amounts and which doses do not. In short, there is no direction given
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`to select from the thousands, or potentially tens of thousands of permutations
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`embodied within the specification, those elements necessary to arrive at the
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`claimed invention. Because the ‘506 Patent is not entitled to § 120 benefit, the
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`challenged claims are entitled to no filing date earlier than its own filing date of
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`October 20, 2011. Therefore, the challenged claims are anticipated or rendered
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`obvious by some of its predecessors and cousins and by the prescribing
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`information of a drug commercially sold and falling within the scope of its claims.
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`II. THE CLAIMS UNDER CONSIDERATION
`1.
`A method for treating papules and pustules of rosacea in a human
`in need thereof, the method comprising administering orally to said human
`
`9
`
`

`

`Case IPR2015-
`Petition for Inter Partes Review
`Attorney Docket No. REDDYPP 7.1R-015
`doxycycline, or a pharmaceutically acceptable salt thereof,