July 3, 2015
`
`
`
`
`Michael H. Teschner
`908.518.6313
`MTeschner@ldlkm.com
`
`
`
`(Electronically Filed)
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P O Box 1450
`Alexandria, VA 22313-1450
`Inter Partes Review of U.S. Patent No. 8,729,094
`Exhibit Cover Letter Per 37 C.F.R. § 42.6(e)(4)(ii)
`
`Dear Patent Trial and Appeal Board:
`This transmittal letter identifies Exhibits 1001-1055, being filed concurrently with the
`present Petition for Inter Partes Review. Pursuant to 37 C.F.R. § 42.6(e)(4)(ii), the Certificate of
`Service attached to the end of the Petition for Inter Partes Review filed herewith, incorporates
`Exhibits 1001-1055, as listed below:
`
`Exhibit #
`1001
`1002
`1003
`1004
`1005
`1006
`
`Reference
` U.S. Patent No. 8,729,094
` U.S. Patent No. 7,947,724
` U.S. Patent No. 7,947,725
` U.S. Patent No. 7,960,424
` U.S. Patent No. 8,598,219
` 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., U.S.D.C.N.J. Civil Action No. 3:14-cv-04274-MLC-DEA
`
`4124732_1.docx
`
`

`
`
`
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`July 3, 2015
`Page 2
`
`
`
`
`Exhibit #
`1007
`
`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., Dr. Reddy’s
`Laboratories, Inc., et al., 3:13-cv-05815-MLC-DEA filed 12/27/2013; and
`Helsinn Healthcare S.A. and Roche Palo Alto LLC v. Dr. Reddy’s
`Laboratories, Ltd. & Dr. Reddy’s Laboratories, Inc., U.S.D.C.N.J. Civil
`Action No. 3:12-cv-02867-MLC-DEA filed 5/12/2012
` Serial No. 13/902,132 Final Rejection, Dec. 6, 2013
` Serial No. 13/902,132, Amendment After Final, Feb. 21, 2014
` U.S. Patent No. 5,202,333 (“Berger”)
` 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
`(1985) (“Eglen”)
` Chelly et al., Oral RS-25259 Prevents Postoperative Nausea and Vomiting
`Following Laparoscopic Surgery, Abstracts of Scientific Papers 1996 Annual
`Meeting, 85 Anesthesiology, No. 34, A21 (Sept. 1996) (“Chelly”)
` Gralla et al., Recommendations for the Use of Antiemetics: Evidence-Based,
`Clinical Practice Guidelines, 17 J. Clin. Oncology, No. 9, 2971-94 (Sept.
`1999)
` Gibson, Parenteral Dosage Forms, Pharmaceutical Preformulation and
`Formulation, A Practical Guide from Candidate Drug Selection to Commercial
`Dosage Form 175-237, 295-354 (2001)
` 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
` Gaia Piraccini et al., An Interesting 5-HT3 Receptor Antagonist Antiemetic for
`Patients Undergoing Chemotherapy-Based Conditioning Regimens,
`Abstract 5169, 98(11) J. of the American Society of Hematology 350b
`(Nov. 16, 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”)
`
`1008
`1009
`1010
`1011
`
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`4124732_1.docx
`
`

`
`
`
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`July 3, 2015
`Page 3
`
`
`
`
`Exhibit #
`1020
`
`Reference
` Lauri P. Cohen, Many Medicines Are Potent Years Past Expiration Dates,
`Wall St. J., March 28, 2000.
` Declaration of William McGuire, M.D.
` William McGuire, M.D. curriculum vitae
` Declaration of David G. Frame, Pharm.D.
` David G. Frame, Pharm.D. curriculum vitae
` Tr. transcript Dr. Kirsch 19:12-20:23, June 5, 2015 (what is a POSA)
` Tr. transcript Dr. Candiotti 18:19-20:4, June 10, 2015 (what is a POSA)
` Gandara et al., Consensus Proposal for 5-HT3 Antagonists in the Prevention of
`Acute Emesis Related to Highly Emetogenic Chemotherapy, Support Care
`Cancer (1998) 6:237-243 (“Gandara”)
` Tr. transcript Dr. Frame direct 109:2-110:15, 121:18-123:3, 124:20-128:4,
`June 8, 2015 (PONV to CINV)
` Tr. transcript Dr. Candiotti direct 82:12-83:15, June 10, 2015 (PONV to
`CINV)
` Tr. Transcript Dr. Frame direct 107:14-108:25, June 8, 2015 (oral to IV)
` U.S. Food and Drug Administration. 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)
` Tr. transcript Dr. Candiotti direct 108:21-109:20, June 10, 2015 (5 ml volume)
` January 16, 2002 Helsinn Press Release
` October 3, 2001 Helsinn Press Release
` April 10, 2001 Helsinn Press Release
` Kibbe, Handbook of Pharmaceutical Excipients, Citric Acid 191-94 (3rd ed.
`2000)
` U.S. Patent No. 9,066,980
` Serial No. 13/902,132 Official Action, Aug. 8, 2013
` Serial No. 13/902,182 Applicants’ Amendment and Response to Office
`Action, Oct. 9, 2013
` Declaration of Dr. Patrick P. DeLuca
` Dr. Patrick P. DeLuca curriculum vitae
` Patrick P. DeLuca and James C. Boylan, 5 Formulation of Small Volume
`Parenterals, 1 Pharmaceutical Dosage Forms:Parenteral Medications, 173(2nd
`ed. rev. expanded Marcel Dekker, Inc. 1992)
` Tr. transcript Dr. Amidon direct156:15-165:9, June 15, 2015 (K.I.S.S. 5ml,
`Golden Rule, Ex.13 commercially viable)
`
`1021
`1022
`1023
`1024
`1025
`1026
`1027
`
`1028
`
`1029
`
`1030
`1031
`
`1032
`1033
`1034
`1035
`1036
`
`1037
`1038
`1039
`
`1040
`1041
`1042
`
`1043
`
`4124732_1.docx
`
`

`
`
`
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`July 3, 2015
`Page 4
`
`
`
`
`Exhibit #
`1044
`
`Reference
` Brown et al., The Effectiveness of a Single Intravenous Dose of Ondansetron,
`Oncology 1992;49:273-278
` Helsinn Healthcare S.A. et al. v. Dr. Reddy’s Laboratories, Ltd. et al., Civil
`Action No. 12-2867-MLC (D.N.J. Feb. 19, 2015) Markman Order (Dkt.91),
`Feb. 19, 2015
` Tr. transcript Dr. Amidon direct 106:2-107:18, June 16, 2015 (EDTA citric
`acid)
` Tr. transcript Dr. Candiotti cross-examination 141:15-143:25, June 10, 2015
`(human dose based on animals)
` Prosecution History of U.S. Patent No. 7,947,724 (U.S. Ser. No. 11/186311),
`Amend. Resp., Apr. 6, 2009
` Mikawa et al., Optimal Dose of Granisetron for Prophylaxis Against
`Postoperative Emesis After Gynecological Surgery, 85 Anesth. Analg., 652-6
`(1997)
` Avis et al., 2 Parental Drug Administration: Routes, Precautions, Problems,
`Complications, and Drug Delivery Systems, 1 Pharmaceutical Dosage
`Forms:Parenteral Medications 173(2nd ed. rev. expanded Marcel Dekker, Inc.
`1992)
` Reproduction of Figure 5 of Eglen Exh.1011, at 863
` Reproduction of Figure 6a of Eglen Exh.1011, at 863
` Dose response curves for Chelly (Exh.1012) and Tang (Exh.1019)
` Approved KYTRIL Label, Aug. 16, 2002
` R.E. Leak and J.D. Woodford, Pharmaceutical Development of Ondansetron
`Injection, 25 (Suppl. 1) Eur. J. Cancer Clin. Oncol. 567-69 (1989)
`
`Respectfully submitted,
`LERNER, DAVID, LITTENBERG,
` KRUMHOLZ & MENTLIK, LLP
`
`
`MICHAEL H. TESCHNER
`Registration No. 32,862
`Counsel for Petitioner
`
`
`
`1045
`
`1046
`
`1047
`
`1048
`
`1049
`
`1050
`
`1051
`1052
`1053
`1054
`1055
`
`
`
`MHT/la
`
`4124732_1.docx