Helsinn Healthcare Exhibit 2070
`Dr. Reddy's Laboratories, Ltd., et al. v. Helsinn Healthcare S.A.
`Trial PGR2016-00007
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`Page 1 of 2
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`Dr. Reddy's Laboratories, Ltd., et al. v. Helsinn Healthcare S.A.
`Trial PGR2016-00007
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`Page 1 of 2
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`Receipt date: 07/28/2015
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`33901830 ~ GAE}: 1628
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`IN FORMATION DISC LOSU RE
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`(Use as many sheets as necessary)
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`Application Number
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`I’:”’”9ND5"edl
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`Irs
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`Art Unit
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`Attorney Docket Number
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`Complete if Known
`13/901,830
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`2'33’ 24vC2°|:j3
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`I0rgI0
`3 erarl
`1628
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`Shir|ey V_ GEMBEH
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`244168-000007US9
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`NONPATENT LITERATURE DOCUMENTS
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`Dr. Reddy's Laboratories, Ltd. and Dr. Reddy's Laboratories, Inc. Petition for Inter Partes Review of U.S.
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`Patent No. 8,729,094 dated July 3, 2015 (|PR2015-01554).
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`Exhibit 1021 to Dr. Reddy's Laboratories, Ltd. and Dr. Reddy's Laboratories, Inc. Petitions for Inter Partes
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`Review of U.S. Patent No. 8,729,094, Declaration of William P. McGuire, Ph.D., dated July 2, 2015
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`(IPR2015-01550, -01151, -01553, -01554).
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`Exhibit 1023 to Dr. Reddy's Laboratories, Ltd. and Dr. Reddy's Laboratories, Inc. Petitions for Inter Partes
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`Review of U.S. Patent No. 8,729,094, Declaration of David G. Frame, Pharm.D., dated July 1, 2015
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`(IPR2015-01550, -01151, -01553, -01554).
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`Exhibit 1040 to Dr. Reddy's Laboratories, Ltd. and Dr. Reddy's Laboratories, Inc. Petitions for Inter Partes
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`Review of U.S. Patent No. 8,729,094, Declaration of Dr. Patrick P. DeLuca dated July 1, 2015 (|PR2015-
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`01550, -01151, -01553, -01554).
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`R. J. Gralla, et al., “Recommendations for the Use of Antiemetics: Evidence-Based, Clinical Practice
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`Guidelines,” J. Clin. Oncol. 17(9):2971-94 (1999) (Exhibit 1013 of IPR2015-01550, -01151, -01553, -01554).
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`L. P. Cohen, “Many Medicines Prove Potent for Years Past Their Expiration Dates,” Wall St. J., March 28,
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`2000 (Exhibit 1020 of IPR2015-01550, -01151, -01553, -01554).
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`D. R. Gandara, et al., “Consensus Proposal for 5HT3 Antagonists in the Prevention of Acute Emesis
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`Related to Highly Emetogenic Chemotherapy: Dose, Schedule, and Route of Administration,” Support Care
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`Cancer 6:237-243 (1998) (Exhibit 1027 of IPR2015-01550, -01151, -01553, -01554).
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`U.S. Food and Drug Administration, Center for Drug Evaluation and Research and Center for Biologics
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`Evaluation and Research, “Estimating the Safe Starting Dose in Clinical Trials for Therapeutics in Adult
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`Healthy Volunteers,” Draft Guidance, December 2002 (Exhibit 1031 of IPR2015-01550, -01151, -01553,
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`-01554).
`“Helsinn & MGI Pharma Announce Completion of Pivotal Phase 3 Trials of Pa|onosetron,” 2002 (Exhibit
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`1033 of IPR2015-01550, -01151, -01553, -01554).
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`“Helsinn Healthcare Announce the Completion of Patient Enrollment for First Palonosetron Phase 3 Pivotal
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`Trial,” 2001 (Exhibit 1034 of IPR2015-01550, -01151, -01553, -01554).
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`“MGI Pharma Sign Exclusive License Agreement with Helsinn Healthcare SA, for Palonosetron, a Phase 3
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`Anti-emetic,” 2001 (Exhibit 1035 of IPR2015-01550, -01151, -01553, -01554).
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`G. W. Brown, et al., “The Effectiveness of a Single Intravenous Dose of Ondansetron,” Oncology 49:273-
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`278 (1992) (Exhibit 1044 of IPR2015-01550, -01151, -01553, -01554).
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`Helsinn Healthcare S.A. v. Dr. Reddy's Laboratories, Ltd., Claim Construction Order, dated February 19,
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`2015 (D.N.J. 12-2867) (Exhibit 1045 of IPR2015-01550, -01151, -01553, -01554).
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`K. Mikawa, et al., “Optimal Dose of Granisetron for Prophylaxis Against Postoperative Emesis after
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`Gynecological Surgery,” Anesth Analg 852652-6 (1997) (Exhibit 1049 of IPR2015-01550, -01151, -01553,
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`-01554).
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`Pharmaceutical Dosage Forms: Parenteral Medications, Vol. 1, pp. 17-25, 115-6, 140-43, 150-51, 173-5,
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`190-203, 207-12 (Avis, Lieberman, Lachman eds., Marcel Dekker Inc. 2d ed. 1992) (Exhibit 1050 of
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`IPR2015-01550, -01151, -01553, -01554).
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`Exhibit 1053 to Dr. Reddy's Laboratories, Ltd. and Dr. Reddy's Laboratories, Inc. Petitions for Inter Partes
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`Review of U.S. Patent No. 8,729,094, Dose response curves for Chelly 1996 Exh. 1012 and Tang 1998 Exh.
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`1019.
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`Kytril amended label, August 16, 2002 (Exhibit 1054 of IPR2015-01550, -01151, -01553, -01554).
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`©(73 \I
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`EXAMINER:
`Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through
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`citation if not in conformance and not considered.
`Include copy of this form with next communication to applicant.
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`ALL REFERENCES CQNSEEBERED EXCEPT WHERE LENED THROUGH.
`Page 2 of 2
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`/S.G./
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`Page 2 of 2
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