`
`
`
`
`
`Michael H. Teschner
`908.518.6313
`mteschner@lernerdavid.com
`
`
`
`
`February 5, 2016
`
`
`(Electronically Filed)
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P O Box 1450
`Alexandria, VA 22313-1450
`
`Post Grant Review of U.S. Patent No. 9,173,942
`Exhibit Cover Letter Per 37 C.F.R. § 42.6(e)(4)(ii)
`
`
`Dear Patent Trial and Appeal Board:
`
`
`This transmittal letter identifies Exhibits 1001-1061, being filed concurrently with the
`present Post Grant Review. Pursuant to 37 C.F.R. § 42.6(e)(4)(ii), the Certificate of Service
`attached to the end of the Petition for Post Grant Review filed herewith, incorporates
`Exhibits 1001-1061, as listed below:
`
`Exhibit #
`1001
`1002
`1003
`
`1004
`
`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
`
`4395050_1.docx
`
`

`

`
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`February 5, 2016
`Page 2
`
`
`Exhibit #
`1005
`
`Reference
` 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”)
` 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
`
`1006
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`1013
`1014
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`1020
`1021
`4395050_1.docx
`
`

`

`
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`February 5, 2016
`Page 3
`
`
`Exhibit #
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`1027
`1028
`
`1029
`
`1030
`
`1031
`1032
`
`1033
`
`1034
`
`1035
`
`1036
`
`1037
`
`1038
`
`1039
`
`1040
`1041
`4395050_1.docx
`
`Reference
` 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”)
` 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)
` 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
`
`

`

`
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`February 5, 2016
`Page 4
`
`
`Exhibit #
`1042
`1043
`1044
`
`Reference
` 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
` 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
`
`1045
`
`1046
`
`1047
`
`1048
`
`1049
`
`1050
`1051
`1052
`1053
`
`1054
`
`1055
`
`1056
`
`1057
`
`1058
`
`1059
`
`4395050_1.docx
`
`

`

`Reference
` 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)
`
`Respectfully submitted,
`LERNER, DAVID, LITTENBERG,
` KRUMHOLZ & MENTLIK, LLP
`
`MICHAEL H. TESCHNER
`Registration No. 32,862
`Counsel for Petitioner
`
`
`
`
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`February 5, 2016
`Page 5
`
`
`Exhibit #
`1060
`
`1061
`
`/dmf
`
`
`4395050_1.docx
`
`