Post Grant Review No. PGR2016-00007
`Patent No. 9,173,942
`Petition for Post Grant Review
`Attorney Docket No. REDDY 7.2R-021
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________________
`
`DR. REDDY’S LABORATORIES, LTD. and
`DR. REDDY’S LABORATORIES, INC.
`Petitioners
`
`v.
`
`HELSINN HEALTHCARE S.A. and ROCHE PALO ALTO LLC
`Patent Owners
`
`
`U.S. Patent No. 9,173,942 to Giorgio Calderari et al.
`Issue Date: November 3, 2015
`Title: LIQUID PHARMACEUTICAL FORMULATIONS OF PALONOSETRON
`____________________________
`
`Post Grant Review No. PGR2016-00007
`__________________________________________________________________
`
`PETITION FOR POST GRANT REVIEW OF
`CLAIMS 1-6, 10, AND 11 OF U.S. PATENT NO. 9,173,942
`UNDER 35 U.S.C. §§ 321-329 AND 37 C.F.R. § 42.200 ET SEQ.
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`4354014_1.docx
`
`

`

`Post Grant Review No. PGR2016-00007
`Patent No. 9,173,942
`Petition for Post Grant Review
`Attorney Docket No. REDDY 7.2R-021
`
`
`TABLE OF CONTENTS
`
`Page
`TABLE OF AUTHORITIES ................................................................................... iv
`
`EXHIBIT LIST ......................................................................................................... v
`
`NOTICE OF LEAD AND BACKUP COUNSEL PURSUANT TO 37 C.F.R.
`§ 42.8(b)(3) ................................................................................................................ 1
`
`NOTICE OF EACH REAL PARTY IN INTEREST PURSUANT TO 37 C.F.R.
`§ 42.8(b)(1) ................................................................................................................ 1
`
`NOTICE OF RELATED MATTERS PURSUANT TO 37 C.F.R. § 42.8(b)(2) ..... 2
`
`NOTICE OF SERVICE INFORMATION PURSUANT TO 37 C.F.R.
`§ 42.8(b)(4) ................................................................................................................ 3
`
`GROUNDS FOR STANDING UNDER 37 C.F.R. §42.204 .................................... 4
`
`IDENTIFICATION OF CHALLENGE STATEMENT OF PRECISE RELIEF
`REQUESTED PURSUANT TO 37 C.F.R. §§ 42.22(a)(1) AND 42.204(b) ........... 6
`
`SUPPORTING EVIDENCE UNDER 37 C.F.R. § 42.204(b)(5) .............................. 7
`
`STATEMENT OF REASONS FOR RELIEF REQUESTED PURSUANT TO 37
`C.F.R. § 42.22(a)(2) ................................................................................................... 7
`
`I.
`
`II.
`
`INTRODUCTION AND SUMMARY OF ARGUMENT .............................. 7
`
`THE CLAIMS UNDER CONSIDERATION ...............................................10
`
`III. THE SPECIFICATION AND PROSECUTION HISTORY OF THE
`‘942 PATENT ................................................................................................10
`
`A. The Specification Of The ‘942 Patent ....................................................10
`
`B. The Prosecution History Of The ‘942 Patent And Its Ancestors ..........12
`
`IV. CLAIM CONSTRUCTION PURSUANT TO 37 C.F.R. § 42.204(B)(3) ....18
`
`i
`
`

`

`Post Grant Review No. PGR2016-00007
`Patent No. 9,173,942
`Petition for Post Grant Review
`Attorney Docket No. REDDY 7.2R-021
`
`V. ANALYSIS ....................................................................................................23
`
`A. Ground 1. Claims 1-6, 10, And 11 Are Invalid As Obvious Over Berger
`In View Of Eglen, Gibson, And PDR 2001 ...........................................23
`
`1. The Level Of Ordinary Skill In The Art ..........................................26
`
`2. The Scope And Content Of The Prior Art .......................................28
`
`3. The Difference Between The Claimed Invention And The Prior Art
` ..........................................................................................................38
`
`a.
`
`b.
`
`Concentration .........................................................................38
`
`pH ...........................................................................................40
`
`c. Mannitol .................................................................................41
`
`d.
`
`e.
`
`Citrate And Chelating Agent .................................................42
`
`Amount Of 0.25mg ................................................................44
`
`4. The Claims Are Obvious .................................................................44
`
`B. Ground 2. Claims 1-6, 10 And 11 Are Invalid As Obvious Over Tang
`In View Of Gibson And PDR 2001 ........................................................51
`
`1. The Scope And Content Of The Prior Art .......................................51
`
`2. The Difference Between The Claimed Invention And The Prior Art
` ..........................................................................................................54
`
`3. Tang Is Not A Teaching Away ........................................................59
`
`C. Ground 3. Claims 1-6, 10 And 11 Are Invalid As Obvious Over Tang
`In View Of Berger, Gibson, And PDR 2001 ..........................................64
`
`D. The Scope And Content Of The Prior Art ..............................................64
`
`E. The Difference Between The Claimed Invention And The Prior Art ...68
`
`ii
`
`

`

`Post Grant Review No. PGR2016-00007
`Patent No. 9,173,942
`Petition for Post Grant Review
`Attorney Docket No. REDDY 7.2R-021
`
`VI. SECONDARY CONSIDERATIONS ...........................................................76
`
`VII. CONCLUSION ..............................................................................................78
`
`iii
`
`

`

`Post Grant Review No. PGR2016-00007
`Patent No. 9,173,942
`Petition for Post Grant Review
`Attorney Docket No. REDDY 7.2R-021
`
`
`TABLE OF AUTHORITIES
`
`
`CASES
`3M v. Chemque, Inc.,
`303 F.3d 1294 (Fed. Cir. 2002) .......................................................................... 25
`
`Page(s)
`
`Asyst Techs., Inc. v. Emtrak, Inc.,
`544 F.3d 1310 (Fed. Cir. 2008) .................................................................... 78, 79
`
`In re Baxter Travenol Labs.,
`952 F.2d 388 (Fed. Cir. 1991) ............................................................................ 25
`
`Bayer Healthcare Pharms., Inc. v. Watson Pharms., Inc.,
`713 F.3d 1369 (Fed. Cir. 2013) .......................................................................... 24
`
`In re Cuozzo Speed Techs., LLC,
`793 F.3d 1268 (Fed. Cir. 2015), cert. granted, 2016 U.S. LEXIS 632
`(Jan. 15, 2016)..................................................................................................... 18
`
`In re DBC,
`545 F.3d 1373 (Fed. Cir. 2008) .......................................................................... 78
`
`In re Fout,
`675 F.2d 297 (C.C.P.A. 1982) ................................................................ 43, 56, 70
`
`Galderma Labs., L.P. v. Tolmar, Inc.,
`737 F.3d 731 (Fed. Cir. 2013), cert. denied, 134 S. Ct. 2740 (2014) .........passim
`
`In re Geisler,
`116 F.3d 1465 (Fed. Cir. 1997) ...................................................................passim
`
`Haynes Int'l Inc. v. Jessop Steel Co.,
`8 F.3d 1573 (Fed. Cir 1993) ........................................................................passim
`
`Ineos USA LLC v. Berry Plastics Corp.,
`783 F.3d 865 (Fed. Cir. 2015) ............................................................................ 26
`
`iv
`
`

`

`Post Grant Review No. PGR2016-00007
`Patent No. 9,173,942
`Petition for Post Grant Review
`Attorney Docket No. REDDY 7.2R-021
`
`J.T. Eaton & Co. v. Atl. Paste & Glue Co.,
`106 F.3d 1563 (Fed. Cir. 1997) .......................................................................... 78
`
`Kara Tech. Inc. v. Stamps.com Inc.,
`582 F.3d 1341 (Fed. Cir. 2009) .......................................................................... 47
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) .......................................................................... 24, 55, 59, 70
`
`Merck & Co. v. Biocraft Labs., Inc.,
`874 F.2d 804 (Fed. Cir. 1989) ............................................................................ 26
`
`Millennium Pharms. Inc. v. Sandoz,
`No. 12-1011, 2015 U.S. Dist. LEXIS 110099 (D. Del. Aug. 20, 2015) ............ 37
`
`Mintz v. Dietz & Watson, Inc.,
`679 F.3d 1373 (Fed. Cir. 2012) .......................................................................... 27
`
`Par Pharm. Inc. v. TWi Pharms., Inc.,
`773 F.3d 1186 (Fed. Cir. 2014) .................................................................... 24, 26
`
`Rowe v. Dror,
`112 F.3d 473 (Fed. Cir. 1997) ...................................................................... 48, 49
`
`Warner Chilcott Co. v. Lupin Ltd,
`Civ. Action Nos. 11-5048, 12-2928, 2014 U.S. Dist. LEXIS 6228
`(D.N.J. Jan. 17, 2014) ......................................................................................... 27
`
`In re Woodruff,
`919 F.2d 1575 (Fed. Cir. 1990) ...................................................................passim
`
`STATUTES, RULES & OTHER AUTHORITIES
`
`35 U.S.C. § 102(a)(1) ................................................................................... 34, 36, 52
`
`35 U.S.C. § 103 .......................................................................................................... 7
`
`35 U.S.C. § 103(a) ............................................................................................. 13, 24
`
`35 U.S.C. § 112 ........................................................................................................ 19
`
`v
`
`

`

`Post Grant Review No. PGR2016-00007
`Patent No. 9,173,942
`Petition for Post Grant Review
`Attorney Docket No. REDDY 7.2R-021
`
`35 U.S.C. § 324(a) ..................................................................................................... 4
`
`37 C.F.R. 42.24(a) .................................................................................................... 81
`
`37 C.F.R. 42.24(d) ................................................................................................... 81
`
`37 C.F.R. § 1.78(d)(3) and ......................................................................................... 5
`
`37 C.F.R. § 42.15(b)(1) and (2) ................................................................................. 6
`
`37 C.F.R. §§ 42.22(a)(1) ............................................................................................ 6
`
`37 C.F.R. § 42.22(a)(2) .............................................................................................. 8
`
`37 C.F.R. § 42.100(b) .............................................................................................. 18
`
`37 C.F.R. § 42.204 ..................................................................................................... 4
`
`37 C.F.R. § 42.204(b)(3) .......................................................................................... 18
`
`37 C.F.R. § 42.204(b)(5) ............................................................................................ 7
`
`American Heritage Dictionary of English Language (4th ed. 2000) ...................... 21
`
`vi
`
`

`

`Post Grant Review No. PGR2016-00007
`Patent No. 9,173,942
`Petition for Post Grant Review
`Attorney Docket No. REDDY 7.2R-021
`
`
`EXHIBIT LIST
`
`Exhibit #
`1001
`1002
`1003
`
`1004
`
`1005
`
`1006
`1007
`
`1008
`
`Reference
` U.S. Patent No. 9,173,942
` Prosecution history of Serial No. 13/901,830
` Complaint, Helsinn Healthcare S.A. and Roche Palo Alto LLC v.
`Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc.,
`Civil Action No. 15-8662 (DNJ), filed 12/15/2015
` Complaint for Patent Infringement, Helsinn Healthcare S.A. and
`Roche Palo Alto LLC v. Dr. Reddy’s Laboratories, Ltd. and
`Dr. Reddy’s Laboratories, Inc., Civil Action No. 14-4274 (DNJ)
`filed 7/7/2014 and amended on 9/2/2015
` Complaints for Patent Infringement, Helsinn Healthcare S.A. and
`Roche Palo Alto LLC v. Dr. Reddy’s Laboratories, Ltd. and
`Dr. Reddy’s Laboratories, Inc. et al. U.S.D.C.N.J. Civil Action
`No. 3:11-cv-03962-MLC-TJB filed 7/8/2011; Helsinn Healthcare
`S.A. and Roche Palo Alto LLC v. Dr. Reddy’s Laboratories, Ltd.,
`Dr. Reddy’s Laboratories, Inc. et al., U.S.D.C.N.J. Civil Action
`Nos. 3:11-cv-05579-MLC-DEA filed 9/23/2011; Helsinn
`Healthcare S.A. and Roche Palo Alto LLC v. Dr. Reddy’s
`Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc.,
`U.S.D.C.N.J. Civil Action No. 3:12-cv-02867-MLC-DEA filed
`5/11/2012; and Helsinn Healthcare S.A. and Roche Palo Alto
`LLC v. Dr. Reddy’s Laboratories, Ltd., Dr. Reddy’s Laboratories,
`Inc. et al., 3:13-cv-05815-MLC-DEA filed 9/30/2013 and amended
`on 12/27/2013
` U.S. Patent No. 5,202,333 (“Berger”)
` Mark Gibson (ed.), Pharmaceutical Preformulation and
`Formulation, A Practical Guide from Candidate Drug Selection to
`Commercial Dosage Form (Ch.3 p.34; Ch.6 pp.175, 196-210; Ch.8
`pp.309-11, 318; Ch.9 pp.332-36, 341-42) (2001)
` Tang et al., The Efficacy of RS-25259, a Long-Acting Selective
`5-HT3 Receptor Antagonist, for Preventing Postoperative Nausea
`and Vomiting After Hysterectomy Procedures, 87 Anesth. Analg.,
`462-7 (1998) (“Tang”)
`
`vii
`
`

`

`Post Grant Review No. PGR2016-00007
`Patent No. 9,173,942
`Petition for Post Grant Review
`Attorney Docket No. REDDY 7.2R-021
`
`Exhibit #
`1009
`
`1010
`
`1011
`
`1012
`1013
`1014
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`Reference
` ZOFRAN (2001). In Physician’s Desk Reference 1503-07 (55th
`ed.) Montvale, NJ: PDR Network
` KYTRIL (2001). In Physician’s Desk Reference 3104-06 (55th ed.)
`Montvale, NJ: PDR Network
` ANZEMET (2001). In Physician’s Desk Reference 680-83 (55th
`ed.) Montvale, NJ: PDR Network
` Declaration of Dr. Joanne Broadhead
` Curriculum Vitae of Dr. Joanne Broadhead
` U.S. Patent No. 8,598,219
` Application Data Sheet of Continuation-in-Part Serial
`No. 13/901,437 (8,598,219)
` Letter entitled “Identification of Continuation-in-Part Claim
`Support Required Under 37 C.F.R. § 1.78(d)(3) and Choice of
`Law” filed May 23, 2013, in Serial No. 13/901,437 (8,598,219)
` Office Communication dated July 12, 2013, in Serial
`No. 13/901,437 (8,598,219)
` Examiner Initiated Interview Summary dated July 16, 2013, in
`Serial No. 13/901,437 (8,598,219)
` Application Data Sheet filed May 24, 2013, in Serial
`No. 13/901,830
` Preliminary Amendment filed May 24, 2013, in Serial
`No. 13/901,830
` Office Communication dated September 16, 2013, in Serial
`No. 13/901,830
` Trial Tr. of Dr. Amidon direct 156:15-165:9, June 15, 2015
`(K.I.S.S. 5ml, Golden Rule, Ex.13 commercially viable)
` Avis et al. (eds.), 1 (Chs.2,4, 5) Pharmaceutical Dosage
`Forms:Parenteral Medications 115-16, 140-43, 146-48, 193-95
`(2nd ed. rev. expanded Marcel Dekker, Inc. 1992)
` R.E. Leak and J.D. Woodford, Pharmaceutical Development of
`Ondansetron Injection, 25 (Suppl. 1) Eur. J. Cancer Clin.
`Oncol. 567-69 (1989)
` Eglen et al., Pharmacological characterization of RS 25259-197, a
`novel and selective 5-HT3 receptor antagonist, in vivo, 114 British
`J. Pharmacol. 860-66 (1995) (“Eglen”)
`
`viii
`
`

`

`Post Grant Review No. PGR2016-00007
`Patent No. 9,173,942
`Petition for Post Grant Review
`Attorney Docket No. REDDY 7.2R-021
`
`Exhibit #
`1026
`1027
`1028
`
`Reference
` Declaration of Dr. Christopher A. Fausel
` Curriculum Vitae of Dr. Christopher A. Fausel
` Trial Tr. Candiotti (direct) 18:19-20:7, Helsinn v. Dr. Reddy’s,
`Civil Action No. 11-3962, June 10, 2015 (“POSA”)
` Definition of “formula” (formulation),” The American Heritage
`Dictionary of English Language 691 (4th ed. 2000)
` Definition of “pharmaceutical,” The American Heritage Dictionary
`of the English Language 1316 (4th ed. 2000)
` Notice of Allowance mailed October 11, 2013, in Serial
`No. 13/901,437
` Leon Lachman, Ph.D. et al., The Theory and Practice of Industrial
`Pharmacy 642-784 (3rd ed. Lea & Febiger 1986)
` James Swarbrick & James C. Boylan (editors), Excipients: Their
`Role in Parenteral Dosage Forms 137-72, 19 (Supp.2)
`Encyclopedia of Pharmaceutical Technology (2000)
`(“Swarbrick”)
` James I. Wells, PHARMACEUTICAL PREFORMULATION:The
`Physicochemical Properties of Drug Substances 152-91 (1988)
` Robert R. Strickley, Parenteral Formulations of Small Molecule
`Therapeutics Marketed in the United States (1999) ____ Parts I, II,
`III, 53(6) PDA J. of Pharmaceutical Science & Technology
`(Nov./Dec. 1999).)
` Arthur H. Kibbe (ed.), Citric Acid Monohydrate , Handbook of
`Pharmaceutical Excipients 140-42 (3d ed. 2000)
` Trial Tr. Amidon (cross-examination) 106:2-107:18, Helsinn v.
`Dr. Reddy’s, Civil Action No. 11-3962, June 16, 2015 (EDTA &
`citric acid)
` U.S. Food and Drug Administration, Guidance for Industry and
`Reviewers Estimating the safe starting dose in clinical trials for
`therapeutics in adult healthy volunteers (Draft Guidance document)
`Center for Drug Evaluation and Research and Center for Biologics
`Evaluation and Research (Dec. 2002)
` Chong Min Won et al., Photolytic and oxidative degradation of an
`antiemetic agent, RG 12915, 121 Int’l J. Pharmaceutics 95-105
`(July 6, 1995)
`
`1029
`
`1030
`
`1031
`
`1032
`
`1033
`
`1034
`
`1035
`
`1036
`
`1037
`
`1038
`
`1039
`
`ix
`
`

`

`Post Grant Review No. PGR2016-00007
`Patent No. 9,173,942
`Petition for Post Grant Review
`Attorney Docket No. REDDY 7.2R-021
`
`Exhibit #
`1040
`
`1041
`
`1042
`
`1043
`
`1044
`
`1045
`
`1046
`
`1047
`
`1048
`
`1049
`
`1050
`1051
`1052
`1053
`
`Reference
` Non-Final Office Action dated November 22, 2013, in Serial
`No. 13/901,830
` Applicants’ Response dated February 21, 2014, in Serial
`No. 13/901,830
` Supplemental Response dated March 3, 2015 in Serial
`No. 13/901,830
` Notice of Allowance dated August 25, 2015, in Serial
`No. 13/901,830)
` Trial Tr. Candiotti, direct 108:4-109:23, Helsinn v. Dr. Reddy’s,
`Civil Action No. 11-3962, June 10, 2015 (“5ml”)
` Stipulation and Order, Helsinn Healthcare S.A. et al. v. Dr. Reddy’s
`Laboratories, Ltd. et al., Civ. Action No. 11-3962 (D.N.J.), June 1,
`2015, Mary L. Cooper, U.S.D.J. (“18-24 month stability (“18-24
`month stability”)
` Gaia Piraccini et al., Clinical Care-Transplantation Regimen
`Toxicities and Engraftment, 98(11) Part 2, J. Am. Society of
`Hematology, Abstract #5169 (43rd Annual meeting program and
`abstracts (Dec. 7-11, 2001))
` G. Piraccini et al., Pharmacokinetic Features of a Novel
`5-HT3 -Receptor-Antagonist: Palonosetron (RS-25259-197),
`Symptom Management 400, Am. Society of Clinical Oncology
`(ASCO) (May 12-15, 2001 San Francisco-USA)
` Order, Helsinn Healthcare S.A. et al. v. Dr. Reddy’s Laboratories,
`Ltd. et al., Civil Action No. 12-2867 (Dkt.91), Feb. 19, 2015,
`Mary L. Cooper, U.S.D.J. (505(b)(2) Litigation ____ chelating agent)
` Trial Tr. Kirsch (direct) 19:12-20:7, Helsinn v. Dr. Reddy’s, Civil
`Action No. 11-3962, June 5, 2015 (DRL “POSA”)
` ‘437 Application claims as originally filed
` U.S. Patent No. 8,729,094
` U.S. Patent No. 9,066,980
` Paul F. White, Ph.D., M.D. & Phillip Scuderi, M.D., Prevention of
`Postoperative Nausea and Vomiting (PONV): A Dose-Ranging
`Study Involving Palonosetron, a Potent 5-HT3 Receptor
`Antagonist, Anestheslogy 2005; 103:A703
`
`x
`
`

`

`Post Grant Review No. PGR2016-00007
`Patent No. 9,173,942
`Petition for Post Grant Review
`Attorney Docket No. REDDY 7.2R-021
`
`Exhibit #
`1054
`
`1055
`
`1056
`
`1057
`
`1058
`
`1059
`1060
`
`1061
`
`Reference
` Statutory Declaration of Daniele Bonadeo, M. Chem. Pharm. 37
`C.F.R. §§ 131 and 132, filed Mar. 2, 2007
` The American Heritage Dictionary of English Language 61 (4th
`ed. 2000) (definition of “amount”)
` The American Heritage Dictionary of English Language 537 (4th
`ed. 2000) (definition of “dose”)
` Order Construing the Terms of U.S. Patent Nos. 7,947,724;
`7,947,725; 7,960,424; 8,598,219 & 8,729,094, Helsinn Healthcare
`S.A. et al. v. CIPLA Ltd. et al. (D. Del. 13-688), filed Mar. 9, 2015
` Markman Order, Helsinn Healthcare S.A. et al. v. Dr. Reddy’s
`Laboratories, Ltd. et al., Civil Action No. 11-3962, filed Apr. 22,
`2015, Mary L. Cooper, U.S.D.J. (originally under seal, currently
`published) (ANDA Litigation ____ CINV)
` reserved
` Final Judgment, Helsinn Healthcare S.A. et al. v. Dr. Reddy’s
`Laboratories, Ltd. et al., Civ. Action No. 11-3962 (consolidated)
`D.N.J., Nov. 16, 2015, Mary L. Cooper, U.S.D.J. (ANDA
`Litigation)
` Memorandum Opinion, Helsinn Healthcare S.A. et al. v.
`Dr. Reddy’s Laboratories, Ltd. et al., Civ. Action No. 11-3962
`(D.N.J.), Nov. 13, 2015, Mary L. Cooper, U.S.D.J. (originally
`under seal, currently published) (Partial Op. ANDA Litigation)
`
`xi
`
`

`

`
`
`
`
`Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. requests
`
`post grant review (“PGR”) of claims 1-6, 10, and 11 of U.S. Patent No. 9,173,942
`
`(“the ‘942 Patent”) (Exh.1001).
`
`NOTICE OF LEAD AND BACKUP
`COUNSEL PURSUANT TO 37 C.F.R. § 42.8(b)(3)
`
`
`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
`
`Nichole M. Valeyko
`(Reg. No. 55,832)
`nvaleyko@lernerdavid.com
`Postal and Hand-Delivery Address
`600 South Avenue West
`Westfield, NJ 07090
`Telephone: 908.518.6313
`Fax: 908.654.7866
`
`
`
`
`
`NOTICE OF EACH REAL PARTY IN
`INTEREST PURSUANT TO 37 C.F.R. § 42.8(b)(1)
`The Real-Parties-In-Interest for this Petition are Requestor, Dr. Reddy’s
`
`Laboratories, Ltd. (“DRL LTD”) an Indian company, and Dr. Reddy’s
`
`
`
`
`
`

`

`Post Grant Review No. PGR2016-00007
`Patent No. 9,173,942
`Petition for Post Grant Review
`Attorney Docket No. REDDY 7.2R-021
`
`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
`PURSUANT TO 37 C.F.R. § 42.8(b)(2)
`Patent Owner most recently has asserted the ‘942 Patent in a civil action
`
`filed in the United States District Court for the District of New Jersey (Civil Action
`
`No. 15-8662), filed on December 15, 2015. (Exh.1003.) Patent Owner previously
`
`asserted U.S. Patent No. 8,729,094 (“the ‘094 Patent) in a civil action filed in the
`
`United States District Court for the District of New Jersey (Civ. Action
`
`No. 14-4274), on July 7, 2014 (“the 505(b)(2) Litigation”). It amended that
`
`complaint to add U.S. Patent No. 9,066,980 to that civil action (collectively
`
`presented in Exhibit 1004). Patent Owner also asserted U.S. Patent No. 7,947,724
`
`in the 505(b)(2) Litigation. Patent Owner has also filed Civ. Action No. 11-3962,
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`on July 8, 2011, alleging infringement of U.S. Patent Nos. 7,947,724 and
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`7,947,725; Civ. Action No. 11-5579, filed September 23, 2011, alleging
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`infringement of U.S. Patent No. 7,960,424; Civ. Action No. 13-5815, filed
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`September 30, 2013, and amended December 27, 2013 (alleging infringement of
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`U.S. Patent Nos. 8,518,981; 8,598,218; and 8,598,219); and Civ. Action
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`2
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`

`

`Post Grant Review No. PGR2016-00007
`Patent No. 9,173,942
`Petition for Post Grant Review
`Attorney Docket No. REDDY 7.2R-021
`
`No. 12-2867
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`filed May 11, 2012, alleging
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`infringement of U.S. Patent
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`No. 7,947,724 (these complaints collectively presented in Exh.1005). All of these
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`patents are members of the same family and all of these cases are before The
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`Honorable Judge Cooper in the U.S. District Court for the District of New Jersey.
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`A trial was held before Judge Cooper regarding U.S. Patent Nos. 7,947,724;
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`7,947,725; 7,960,424; and 8,598,219 in June 2015 (“the ANDA Litigation”).
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`Petitioner was a party to the trial. However, Petitioner and Patent Owner reached a
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`settlement between the hearing and a decision. A Final Judgment Order finding
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`that these four patents were valid and infringed against the remaining defendant
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`was issued on November 16, 2015. (Exh.1060.) In addition to the Final Judgment
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`Order, the court provided a partial opinion that was filed under seal. That partial
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`opinion is now publicly available. (Exh.1061.) Also filed concurrently herein is a
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`second Petition for PGR filed seeking a final written opinion of invalidity as to all
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`claims (1-19) of the ‘942 Patent bearing Attorney Docket No. REDDY 7.2R-022.
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`NOTICE OF SERVICE INFORMATION
`PURSUANT TO 37 C.F.R. § 42.8(b)(4)
`Please address all correspondence to the lead and backup counsel
`
`at
`
`the address
`
`shown above. Requestor also consents
`
`to electronic
`
`3
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`

`

`Post Grant Review No. PGR2016-00007
`Patent No. 9,173,942
`Petition for Post Grant Review
`Attorney Docket No. REDDY 7.2R-021
`
`service by e-mail at: WMentlik.ipr@ldlkm.com, MTeschner.ipr@ldlkm.com,
`
`nvaleyko@lernerdavid.com.
`
`GROUNDS FOR STANDING UNDER 37 C.F.R. §42.204
`Petitioner certifies that the patent for which review is sought is available for
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`post grant review, and that the Petitioner is not barred or estopped from requesting
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`post grant review on the grounds identified in this petition. This Petition is filed
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`within nine months of the November 3, 2015 issue date of the ‘942 Patent.
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`Petitioner has not filed a civil action challenging the validity of a claim of the
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`‘942 Patent. This Petition demonstrates that it is more likely than not that at least
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`one of the claims challenged in the Petition is unpatentable. 35 U.S.C. § 324(a).
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`The ‘942 Patent is an AIA first-to-file patent. The ‘942 Patent claims priority
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`to
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`continuation-in-part
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`application
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`serial
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`number 13/901,437
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`(“the
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`‘437 Application), which issued as U.S. Patent No. 8,598,219. (Exh.1014.) The
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`‘437 Application was filed on May 23, 2013, the day before the ‘942 Patent was
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`filed. The ‘437 Application was filed with an Application Data Sheet (“ADS”)
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`identifying it as an AIA application. (Exh.1015, at 4.)
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`As of February 4, 2016, the PAIR listing for US 8,598,219 Patent, the direct
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`parent of the ‘942 Patent, indicates “yes” in the section of the PAIR entry
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`identifying AIA status. However, its immediate child, the ‘942 Patent, is still listed
`
`4
`
`

`

`Post Grant Review No. PGR2016-00007
`Patent No. 9,173,942
`Petition for Post Grant Review
`Attorney Docket No. REDDY 7.2R-021
`
`as “No” in the section of the PAIR entry identifying AIA status. The PAIR entry
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`for the ‘942 Patent is in error.
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`In the ‘437 Application a letter was filed entitled “Identification of
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`Continuation-In-Part Claim Support Required Under 37 C.F.R. § 1.78(d)(3) and
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`Choice of Law” in which Applicants asserted that the ‘437 Application is subject
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`to AIA. (Exh.1016, at 2-3.) The letter stated that claim 9 had support only in newly
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`added Example 8 of the Continuation-in-Part application. Notwithstanding that
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`letter, the USPTO sent a communication to the Applicants stating that the
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`application was a continuation of its predecessor and thus pre-AIA law applied.
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`(Exh.1017.) Subsequently, Applicants held an interview with the Examiner and, as
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`reflected by the Interview Summary (Exh.1018) and on the USPTO PAIR system,
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`the Examiner indicated that the Applicants successfully argued that the application
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`is an AIA application. It was acknowledged that the application was a CIP and that
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`the ADS as filed indicated both that the application was a CIP and designated the
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`application as an AIA application. (Id.)
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`The ‘942 Patent is a continuation of the ‘437 Application as was indicated
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`on its ADS and in a Preliminary Amendment. (Exhs.1019, at 13; 1020, at 2.)
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`Despite this, on September 16, 2013, the USPTO sent a communication to the
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`5
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`

`

`Post Grant Review No. PGR2016-00007
`Patent No. 9,173,942
`Petition for Post Grant Review
`Attorney Docket No. REDDY 7.2R-021
`
`Applicants stating that the ‘942 Patent was a continuation of an application filed
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`before March 16, 2013, and thus would be examined under pre-AIA law.
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`(Exh.1021.) Each of Applicants’ subsequent responses to office actions, however,
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`included a discussion of AIA status noting that it should be treated as an AIA
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`application. (See, for example, Exhs.1041, at 14-16; 1042, at 5 fn.1.) As a
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`continuation of the ‘437 Application, which was acknowledged as an AIA
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`application by the Examiner (Exh. 1018), the ‘942 Patent must be an AIA patent
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`and should be available for PGR.
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`The fees pursuant to 37 C.F.R. § 42.15(b)(1) and (2) for this Petition
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`($12,000.00 and $18,000.00, respectively) have been paid. However, the U.S.
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`Patent and Trademark Office is hereby authorized to charge Deposit Account
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`No. 12-1095 for any fees that may be due and owing in connection with this
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`Petition.
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`IDENTIFICATION OF CHALLENGE
`STATEMENT OF PRECISE RELIEF REQUESTED
`PURSUANT TO 37 C.F.R. §§ 42.22(a)(1) AND 42.204(b)
`Petitioner requests that claims 1-6, 10, and 11 of the ‘942 Patent be
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`canceled, as they are unpatentable based on the following grounds:
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`6
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`

`

`Post Grant Review No. PGR2016-00007
`Patent No. 9,173,942
`Petition for Post Grant Review
`Attorney Docket No. REDDY 7.2R-021
`
`
`Ground 1. Claims 1-6, 10, and 11 are invalid as obvious pursuant to 35
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`U.S.C. § 103 over Berger (Exh.1006) in view of Eglen, Gibson, and the PDR 2001
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`(Exhs.1025, 1007, 1009-1011, respectively).
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`Ground 2. Claims 1-6, 10, and 11 are invalid as obvious pursuant to 35
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`U.S.C. § 103 over Tang (Exh.1008) in view of Gibson (Exh.1007) and PDR 2001
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`(Exhs.1009-1011).
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`Ground 3. Claims 1-6, 10, and 11 are invalid as obvious pursuant to 35
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`U.S.C. § 103 over Tang (Exh.1008) in view of Berger, Gibson, and PDR 2001
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`(Exhs.1006, 1007, 1009-1011, respectively).
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`SUPPORTING EVIDENCE UNDER 37 C.F.R. § 42.204(b)(5)
`A list of supporting evidence pursuant to 37 C.F.R. § 42.204(b)(5) is
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`provided in the exhibit list beginning on page vii. A copy of each exhibit is
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`submitted herewith. This petition is additionally supported by the testimony set
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`forth in the expert declarations of Dr. Christopher Fausel (Pharm.D) (Exh.1026)
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`and Dr. Joanne Broadhead (Parenteral Drug Formulator) (Exh.1012).
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`STATEMENT OF REASONS FOR RELIEF
`REQUESTED PURSUANT TO 37 C.F.R. § 42.22(a)(2)
`INTRODUCTION AND SUMMARY OF ARGUMENT
`One would think in this day and age, or even as of January 2003, when the
`
`I.
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`provisional application leading to the ‘942 Patent was filed, that it would not be
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`7
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`

`

`Post Grant Review No. PGR2016-00007
`Patent No. 9,173,942
`Petition for Post Grant Review
`Attorney Docket No. REDDY 7.2R-021
`
`possible to patent a formulation containing nothing more than a known drug in a
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`solution of sugar water. And one might be downright shocked to find a recent
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`patent issuing with such a claim when the prior art taught a formulation of the
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`same drug in an isotonic sugar water solution in a patent that published about 20
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`years earlier. But that is exactly what the ‘942 Patent claims.
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`Not content with a bevy of prior patents directed specifically to particular
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`methods of medical treatment and allegedly stabilized formulations capable of
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`obtaining specified storage stability (e.g., U.S. Patent Nos. 9,066,094; 7,947,724;
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`7,947,725; 7,960,424; 9,066,980; 8,598,219), the Patent Owner went back to the
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`Patent Office “well” and obtained claims to formulations of undue scope. Unlike
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`many of their predecessors, these claimed formulations are not limited to storage
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`stable formulations or formulations for a particular use. They do not recite a dose.
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`They do not recite a volume. These claimed formulations require only three
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`ingredients: palonosetron, sugar (mannitol), and water.
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`Formulations comprising this exact drug, water, and a sugar (dextrose), or
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`another well-known tonicity agent (sodium chloride-salt), were well known long
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`before the earliest effective filing date of the ‘942 Patent. The differences between
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`this prior art and the claimed invention all fall within the purview of substituting
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`8
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`

`

`Post Grant Review No. PGR2016-00007
`Patent No. 9,173,942
`Petition for Post Grant Review
`Attorney Docket No. REDDY 7.2R-021
`
`one known tonicity agent for another or selecting a value in a known or obvious
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`prior art range.
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`Moreover, the art utilized preclinical and early clinical formulations. A
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`person of ordinary skill in the art would have ample reason to further develop those
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`formulations by adjusting the very variables and making the types of substitutions
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`claimed.
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`Finally, the preformulation and formulation processes for injectable drugs
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`are very well established ____ so much so that before the earliest effective filing
`
`d