UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_____________________
`
`DR. REDDY’S LABORATORIES, LTD. and
`DR. REDDY’S LABORATORIES, INC.,
`Petitioner
`
`v.
`
`HELSINN HEALTHCARE S.A.,
`Patent Owner
`
`______________________
`
`Case PGR2016-00008
`Patent 9,173,942
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`______________________
`
`Patent Owner’s List of Exhibits
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`Case PGR2016-00008
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`Exhibit
`2001
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`2002
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`2003
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`2004
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`2007
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`2008
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`2009
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`2010
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`2011
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`2012
`
`Description
`Excerpts from Trial Tr. (Calderari), Helsinn Healthcare, S.A. v. Dr.
`Reddy’s Labs., Ltd., No. 11-3962 (D.N.J. June 2, 2015).
`Excerpts from Trial Tr. (Calderari), Helsinn Healthcare, S.A. v. Dr.
`Reddy’s Labs., Ltd., No. 11-3962 (D.N.J. June 3, 2015).
`Excerpts from Trial Tr. (Fruehauf), Helsinn Healthcare, S.A. v. Dr.
`Reddy’s Labs., Ltd., No. 12-2867 (D.N.J. June 4, 2015)
`Excerpts from Trial Tr. (Kirsch), Helsinn Healthcare, S.A. v. Dr.
`Reddy’s Labs., Ltd., No. 11-3962 (D.N.J. June 5, 2015)
`2005 RESERVED
`Excerpts from Trial Tr. (Marriott), Helsinn Healthcare, S.A. v. Dr.
`2006
`Reddy’s Labs., Ltd., No. 11-3962 (D.N.J. June 9, 2015).
`Excerpts from Trial Tr. (Benhamza), Helsinn Healthcare, S.A. v. Dr.
`Reddy’s Labs., Ltd., No. 11-3962 (D.N.J. June 9, 2015).
`Excerpts from Trial Tr. (Candiotti), Helsinn Healthcare, S.A. v. Dr.
`Reddy’s Labs., Ltd., No. 11-3962 (D.N.J. June 10, 2015).
`Excerpts from Trial Tr. (Peck), Helsinn Healthcare, S.A. v. Dr. Reddy’s
`Labs., Ltd., No. 11-3962 (D.N.J. June 11, 2015).
`Excerpts from Trial Tr. (Saab), Helsinn Healthcare, S.A. v. Dr. Reddy’s
`Labs., Ltd., No. 11-3962 (D.N.J. June 12, 2015).
`Excerpts from Trial Tr. (Markman), Helsinn Healthcare, S.A. v. Dr.
`Reddy’s Labs., Ltd., No. 11-3962 (D.N.J. June 15, 2015).
`Excerpts from Trial Tr. (Amidon), Helsinn Healthcare, S.A. v. Dr.
`Reddy’s Labs., Ltd., No. 11-3962 (D.N.J. June 15, 2015)
`2013 RESERVED
`2014 RESERVED
`2015
`Excerpts of Defendants’ Contested Facts, from Final Pretrial Order,
`Helsinn Healthcare, S.A. v. Dr. Reddy’s Labs., No. 11-3962 (D.N.J.
`Apr. 17, 2015).
`2016 RESERVED
`Excerpts from Christopher Fausel Deposition Tr., Helsinn Healthcare,
`2017
`S.A. v. Dr. Reddy’s Labs., Ltd., No. 12-2867 (D.N.J. Apr. 15, 2016).
`Excerpts from Joanne Broadhead Deposition Tr., Helsinn Healthcare,
`S.A. v. Dr. Reddy’s Labs., Ltd., No. 12-2867 (D.N.J. Apr. 29, 2016).
`Excerpts from Bertram Spilker Deposition Tr., Helsinn Healthcare, S.A.
`v. Dr. Reddy’s Labs., Ltd., No. 11-3962 (D.N.J. Jan.17, 2014).
`Excerpts from Bertram Spilker Deposition Tr., Helsinn Healthcare, S.A.
`v. Dr. Reddy’s Labs., Ltd., No. 11-3962 (D.N.J. Jan.16, 2014).
`2021 RESERVED
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`2018
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`2019
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`2020
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`1
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`

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`Case PGR2016-00008
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`2022 RESERVED
`2023 RESERVED
`2024
`Excerpts from Rebuttal Expert Report of Tanios Bekaii-Saab, M.D.,
`Helsinn Healthcare, S.A. v. Dr. Reddy’s Labs., Ltd., No. 11-3962 (D.N.J.
`Oct. 25, 2013) (“Saab Initial ANDA Action Report”).
`2025 RESERVED
`2026 RESERVED
`Excerpts from Expert Report of Lee Kirsch, Ph.D., Helsinn Healthcare,
`2027
`S.A. v. Dr. Reddy’s Labs., Ltd., No. 11-3962 (D.N.J. Sept. 9, 2013)
`(“Kirsch ANDA Action Report”) (as submitted in prosecution of U.S.
`Patent Application No. 13/901,830).
`2028 RESERVED
`Excerpts from Reply Expert Report of Patrick P. DeLuca, Ph.D., Helsinn
`2029
`Healthcare, S.A. v. Dr. Reddy’s Labs., Ltd., No. 11-3962 (D.N.J. Nov.
`21, 2013) (“DeLuca Reply ANDA Action Report”) (as submitted in
`prosecution of U.S. Patent Application No. 13/901,830).
`2030 RESERVED
`2031 RESERVED
`2032 RESERVED
`2033 RESERVED
`2034 RESERVED
`2035 RESERVED
`2036 RESERVED
`2037 RESERVED
`2038 RESERVED
`2039 Kelly B. Pendergrass, Options in the Treatment of Chemotherapy-
`Induced Emesis, 6 Cancer Prac. 276 (Sept.-Oct. 1998) (“Pendergrass
`1998”).
`2040 RESERVED
`2041 RESERVED
`2042 RESERVED
`2043 RESERVED
`2044 RESERVED
`2045 RESERVED
`Joe Matal, A Guide to the Legislative History of the America Invents
`2046
`Act: Part I of II, 21 Fed. Cir. B.J. 435 (2012)
`2047 Merriam-Webster’s Collegiate Dictionary 879 (11th ed. 2005).
`2048 RESERVED
`2049 RESERVED
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`2
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`Case PGR2016-00008
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`2052
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`2050 RESERVED
`2051 A Dose-Ranging Efficacy, Safety, and Pharmacokinetic Study of Single
`Intravenous Doses of RS-25259 for Prevention of Nausea and Vomiting
`in Chemotherapy-Naive Cancer Patients Receiving Highly Emetogenic
`Chemotherapy, Study No. 25259S2330 (“Study 2330 Report”).
`PALO-99-03 Clinical Study Report, dated July 19, 2002 (“PALO-99-03
`Report”).
`2053 Helsinn’s NDA 21-372 Submission Letter dated Sept. 26, 2002.
`2054 Highlights of Prescribing Information, ALOXI® (palonosetron HCl)
`Injection for Intravenous Use, revised Feb. 2008.
`2055 Approval letter from FDA to Helsinn for New Drug Application No. 21-
`372 (ALOXI®) (July 25, 2003).
`2056 RESERVED
`2057 RESERVED
`2058 RESERVED
`2059 RESERVED
`2060 RESERVED
`2061 RESERVED
`2062 RESERVED
`2063 RESERVED
`2064 RESERVED
`2065 RESERVED
`2066 RESERVED
`2067 RESERVED
`2068 RESERVED
`2069
`Information Disclosure Sheet, filed Mar. 5, 2015, in U.S. Patent
`Application No. 13/901,830 (Signed July 27, 2015).
`2070 RESERVED
`2071 RESERVED
`2072 Declaration of Daniele Bonadeo, signed Feb. 9, 2009, in U.S. Patent
`Application No. 11/186,311 (“2/9/09 Bonadeo Decl.”).
`Summary of Interview, conducted June 13, 2013, submitted June 17,
`2013 in U.S. Patent Application No. 13/901,830.
`2074 RESERVED
`Petition, Dr. Reddy’s Labs. v. Helsinn Healthcare, S.A., PGR2016-
`2075
`00007, Paper 1 (P.T.A.B. Feb. 5, 2016) (“DRL PGR1”).
`2076 RESERVED
`2077 Declaration of Christopher Fausel, signed Feb. 5, 2016, submitted in
`DRL PGR1 as Ex 1026 (“Fausel Decl. (DRL PGR1)”).
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`2073
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`3
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`Case PGR2016-00008
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`2078 RESERVED
`2079 RESERVED
`2080 RESERVED
`2081 Helsinn Healthcare S.A., v. Dr. Reddy’s Labs., Ltd., No. 11-3962, 2016
`WL 832089 (D.N.J. Mar. 3, 2016) (the “Supplemental ANDA
`Opinion”).
`2082 Complaint, Helsinn Healthcare S.A., v. Dr. Reddy’s Labs., Ltd., No. 12-
`2867 (D.N.J. May 11, 2012).
`2083 Complaint, Helsinn Healthcare S.A., v. Dr. Reddy’s Labs., Ltd., No. 14-
`4274 (D.N.J. July 7, 2014).
`2084 Amended Complaint, Helsinn Healthcare S.A., v. Dr. Reddy’s Labs.,
`Ltd., No. 14-4274 (D.N.J. Sep. 2, 2015).
`2085 Corrected Brief for Defendants-Appellants Teva Pharmaceuticals USA,
`Inc., Teva Pharmaceutical Industries, Ltd., No. 2016-1284 (Fed. Cir.
`filed Mar. 8, 2016)
`2086 Brief for the United States as Amicus Curiae in Support of Appellees,
`Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc., No. 2016-1284
`(Fed. Cir. filed May 2, 1016) (“U.S. Helsinn Brief”).
`En Banc Brief for the United States as Amicus Curiae in Support of
`Appellant, Medicines Co. v. Hospira, Inc., Nos. 2014-1469, 2014-1504
`(Fed. Cir. filed Mar. 2, 2016) (“U.S. Medicines Brief”).
`2088 Brief of Amicus Curiae Congressman Lamar Smith in Support of
`Appellees, Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc., No.
`2016-1284 (Fed. Cir. filed Apr. 21, 2016).
`2089 Brief for Amicus Curiae Pharmaceutical Research and Manufacturers of
`America and Biotechnology Innovation Organization in Support of
`Plaintiffs-Appellees, Helsinn Healthcare S.A. v. Teva Pharms. USA,
`Inc., Nos. 2016-1284, -1797 (Fed. Cir. filed May 2, 2016).
`2090 Brief of Amicus Curiae American Intellectual Property Law Association
`in Support of Plaintiffs-Appellees, Helsinn Healthcare S.A. v. Teva
`Pharms. USA, Inc., Nos. 2016-1284, -1797 (Fed. Cir. filed May 2,
`2016).
`2091 Brief of Amicus Curiae The Naples Roundtable, Inc. in Support of
`Plaintiffs-Appellees, Helsinn Healthcare S.A. v. Teva Pharms. USA,
`Inc., No. 2016-1284 (Fed. Cir. filed Apr. 27, 2016).
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`2087
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`Dated: May 18, 2016
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`Case PGR2016-00008
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`Respectfully submitted,
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`By: /Eric W. Dittmann/
`Eric W. Dittmann
`Registration No. 51,188
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`Counsel for Patent Owner
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`Case PGR2016-00008
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`Certificate of Service
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`Pursuant to 37 C.F.R. § 42.6(e), I certify that I caused to be served on the
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`counsel for Petitioner a true and correct copy of the foregoing Patent Owner’s List
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`of Exhibits, by electronic means on May 18, 2016, at the following address of
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`record:
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`William L. Mentlik
`Michael H. Teschner
`Maegan A. Fuller
`600 South Avenue West
`Westfield, NJ 07090
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`WMentlik.ipr@ldlkm.com
`MTeschner.ipr@ldlkm.com
`MFuller.ipr@lernerdavid.com
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`Respectfully submitted,
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`
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`By: /Eric W. Dittmann/
`Eric W. Dittmann
`Reg. No. 51,188
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`Counsel for Patent Owner
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`Dated: May 18, 2016