UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________
`
`DR. REDDY’S LABORATORIES, LTD. and
`DR. REDDY’S LABORATORIES, INC.,
`Petitioner
`
`v.
`
`HELSINN HEALTHCARE S.A.,
`Patent Owner
`
`______________________
`
`Case PGR2016-00007
`Patent 9,173,942
`
`______________________
`
`Patent Owner’s List of Exhibits
`
`
`
`
`
`
`
`
`
`

`
`Case PGR2016-00007
`
`Exhibit
`2001
`
`2005
`
`2006
`
`2007
`
`2008
`
`2011
`
`2012
`
`2002
`
`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).
`2003 RESERVED
`Excerpts from Trial Tr. (Kirsch), Helsinn Healthcare, S.A. v. Dr.
`2004
`Reddy’s Labs., Ltd., No. 11-3962 (D.N.J. June 5, 2015)
`Excerpts from Trial Tr. (Frame), Helsinn Healthcare, S.A. v. Dr. Reddy’s
`Labs., Ltd., No. 11-3962 (D.N.J. June 8, 2015).
`Excerpts from Trial Tr. (Marriott), Helsinn Healthcare, S.A. v. Dr.
`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).
`2009 RESERVED
`Excerpts from Trial Tr. (Saab), Helsinn Healthcare, S.A. v. Dr. Reddy’s
`2010
`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)
`Excerpts from Trial Tr. (DeLuca), Helsinn Healthcare, S.A. v. Dr.
`Reddy’s Labs., Ltd., No. 11-3962 (D.N.J. June 16, 2015).
`Excerpts from Trial Demonstrative Ex. 12 (Kirsch) Helsinn Healthcare,
`S.A. v. Dr. Reddy’s Labs., Ltd., No. 11-3962 (D.N.J. June 5, 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).
`Excerpts from William McGuire Deposition Tr., Helsinn Healthcare,
`S.A. v. Dr. Reddy’s Labs., Ltd., No. 12-2867 (D.N.J. Apr. 16, 2016).
`Excerpts from Christopher Fausel Deposition Tr., Helsinn Healthcare,
`S.A. v. Dr. Reddy’s Labs., Ltd., No. 12-2867 (D.N.J. Apr. 15, 2016).
`2018 RESERVED
`2019 RESERVED
`2020 RESERVED
`Excerpts from Maurie Markman Deposition Tr., Helsinn Healthcare,
`2021
`S.A. v. Dr. Reddy’s Labs., Ltd., No. 11-3952 (D.N.J. Jan. 7, 2015).
`
`2013
`
`2014
`
`2015
`
`2016
`
`2017
`
`
`
`

`
`Case PGR2016-00007
`
`2022
`
`2024
`
`2025
`
`2026
`
`2027
`
`2028
`
`2023
`
`Excerpts from Markman Hearing Tr. (Schoneich) Helsinn Healthcare,
`S.A. v. Dr. Reddy’s Labs., Ltd., No. 12-2867 (D.N.J.Oct. 21, 2014).
`Excerpts from Rebuttal Expert Report of Tanios Bekaii-Saab, M.D.,
`with respect to U.S. Patent No. 8,598,219, Helsinn Healthcare, S.A. v.
`Dr. Reddy’s Labs., Ltd., No. 11-3962 (D.N.J. Sept. 15, 2014) (“Saab
`ANDA Action ’219 Report”).
`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”).
`Excerpts from Rebuttal Expert Report of Keith A. Candiotti, M.D. with
`respect to U.S. Patent Nos. 8,729,094 & 9,066,980, Helsinn Healthcare,
`S.A. v. Dr. Reddy’s Labs., Ltd., No. 112-2867 (D.N.J. Feb. 11, 2016)
`(“Candiotti 505(b)(2) Action Report”).
`Excerpts from Expert Report of David G. Frame, Helsinn Healthcare,
`S.A. v. Dr. Reddy’s Labs., Ltd., No. 11-3962 (D.N.J. Sept. 5, 2013)
`(“Frame ANDA Action Report”) (as submitted in prosecution of U.S.
`Patent Application No. 13/901,830).
`Excerpts from Expert Report of Lee Kirsch, Ph.D., Helsinn Healthcare,
`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).
`Excerpts from Expert Report of Patrick P. DeLuca, Ph.D., Helsinn
`Healthcare, S.A. v. Dr. Reddy’s Labs., Ltd., No. 11-3962 (D.N.J. Sept. 9,
`2013) (“DeLuca ANDA Action Report”) (as submitted in prosecution of
`U.S. Patent Application No. 13/901,830).
`2029 RESERVED
`Excerpts from Expert Report of Dr. Joanne Broadhead, Helsinn
`2030
`Healthcare, S.A. v. Dr. Reddy’s Labs., Ltd., No. 12-2867 (D.N.J. Jan.6,
`2016) (“Broadhead 505(b)(2) Action Report”).
`Jeremy D. Gale et al., Tachykinin NK1 receptor antagonists for the
`control of chemotherapy-induced nausea and vomiting, 11(12) Expert
`Opin. Ther. Pat. 1837-47 (2001) (“Gale 2001”).
`2032 Approval Package for Zolfran® Injection (ondansetron), approved Apr.
`11, 2000.
`2033 R.M. Eglen & D.W. Bonhaus, 5-hydroxytryptamine (5-HT)3 receptors:
`molecular biology, pharmacology and therapeutic importance, 2 Curr.
`Pharm. Des. 367 (Aug. 1996) (“Eglen 1996”).
`Jean Latreille et al., Use of dexamethasone and granisetron in the
`control of delayed emesis for patients who receive highly emetogenic
`
`2031
`
`2034
`
`
`
`

`
`Case PGR2016-00007
`
`2037
`
`chemotherapy, 16 J. Clin. Oncol. 1174 (Mar. 1998) (“Latreille 1998”).
`2035 H. Tsukada et al., Randomised comparison of ondansetron plus
`dexamethasone with dexamethasone alone for the control of delayed
`cisplatin-induced emesis, 37 Eur. J. Cancer 2398 (2001) (“Tsukada
`2001”).
`2036 Andre N. Rizk & Paul J. Hesketh, Antiemetics for Cancer
`Chemotherapy-Induced Nausea and Vomiting: A Review of Agents in
`Development, 2 Drugs R&D 229 (Oct. 1999) (“Rizk 1999”).
`Peter S. Loewen, Anti-emetics in development, 11 Expert Opin. Investig.
`Drugs 801 (2002) (“Loewen 2002”).
`2038 Henry Grabowski, The Effect of Pharmacoeconomics on Company
`Research and Development Decisions, 11 Pharmacoecon. 389 (May
`1997) (“Grabowski 1997”).
`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
`Pamela Sauer, Generic Formulators Position for Profits, 260 Chem.
`2042
`Mkt. Rep. FR12 (Aug. 13, 2001) (“Sauer 2001”).
`2043 Anita Greil, Roche, Novartis Feed on GlaxoSmithKline Castoffs, Dow
`Jones Int’l News, Aug. 31, 2000 (“Greil 2000”).
`P.J. Hesketh et al., Randomized Phase II Study of the Neurokinin 1
`Receptor Antagonist CJ-11,974 in the Control of Cisplatin-Induced
`Emesis, 17 J. Clin. Oncol. 338 (Jan. 1999) (“Hesketh 1999”).
`Fausto Roila et al., Delayed Emesis: Incidence, Pattern, Prognostic
`Factors and Optimal Treatment, 10 Support Cancer Care 88 (2002)
`(“Roila 2002”).
`2046 RESERVED
`2047 RESERVED
`2048 RESERVED
`2049 RESERVED
`2050 RESERVED
`2051 RESERVED
`2052 RESERVED
`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-
`
`2044
`
`2045
`
`
`
`

`
`Case PGR2016-00007
`
`2062
`
`2063
`
`2064
`
`2065
`
`2056
`
`372 (ALOXI®) (July 25, 2003).
`Product Monograph, ALOXI® (palonosetron hydrochloride), revised
`Mar. 12, 2012.
`5/5/99 Email from Zeneca to Helsinn.
`2057
`3/14/00 Letter from Chiron to Helsinn.
`2058
`5/31/00 Email from Ortho Biotech to Helsinn.
`2059
`3/13/2000 Letter from Amgen to Helsinn.
`2060
`2061 Collection of letters to Helsinn from Baxter, Bayer, Berlex, Bristol-
`Meyers Squibb, Cephalon, Chiron, Coulter, CTI, Eli Lilly, Forest,
`Fujisawa, Genzyme, Ilex, Ligand, Liposome, Merck, and TAP Pharma.
`Information Disclosure Sheet, filed Jan. 12, 2006, in U.S. Patent
`Application No. 11/186,311 (Signed on Aug. 7, 2006).
`Information Disclosure Sheet, filed Dec. 20, 2011, in U.S. Patent
`Application No. 13/087,012 (Signed on July 6, 2012).
`Information Disclosure Sheet, filed Dec. 20, 2012, in U.S. Patent
`Application No. 13/087,012. (Signed on Feb. 14, 2013).
`Information Disclosure Sheet, filed Oct. 2, 2013, in U.S. Patent
`Application No. 13/901,437 (Signed on Oct. 7, 2013).
`Information Disclosure Sheet, filed May 23, 2013, in U.S. Patent
`Application No. 13/901,437 (Signed on July 23, 2013).
`Information Disclosure Sheet, filed May 24, 2013, in U.S. Patent
`Application No. 13/901,830 (Signed on Nov. 7, 2013).
`Information Disclosure Sheet, filed Mar. 27, 2014, in U.S. Patent
`Application No. 13/901,830 (Signed Apr. 9, 2014).
`Information Disclosure Sheet, filed Mar. 5, 2015, in U.S. Patent
`Application No. 13/901,830 (Signed July 27, 2015).
`Information Disclosure Sheet, filed July 28, 2015, in U.S. Patent
`Application No. 13/901,830 (Signed July 29, 2015).
`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.”).
`2073 RESERVED
`Petition, Dr. Reddy’s Labs. v. Helsinn Healthcare, S.A., IPR2015-01550,
`2074
`Paper 1 (P.T.A.B. July 3, 2015) (“7/3/15 DRL IPR”).
`2075 RESERVED
`Petition, Dr. Reddy’s Labs. v. Helsinn Healthcare, S.A., PGR2016-
`2076
`00008, Paper 1 (P.T.A.B. Feb. 5, 2016) (“DRL PGR2”).
`2077 RESERVED
`2078 RESERVED
`
`2066
`
`2067
`
`2068
`
`2069
`
`2070
`
`
`
`

`
`Case PGR2016-00007
`
`2079 RESERVED
`2080
`Email from Russell W. Faegenburg, of Lerner, David, Littenberg,
`Krumholz & Mentlik, LLP, to Dana R. Weir, of Paul Hastings, LLP
`(May 10, 2016).
`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).
`
`
`
`Dated: May 18, 2016
`
`Respectfully submitted,
`
`By: /Eric W. Dittmann/
`Eric W. Dittmann
`Registration No. 51,188
`
`Counsel for Patent Owner
`
`
`
`
`
`

`
`Case PGR2016-00007
`
`Certificate of Service
`
`Pursuant to 37 C.F.R. § 42.6(e), I certify that I caused to be served on the
`
`counsel for Petitioner a true and correct copy of the foregoing Patent Owner’s List
`
`of Exhibits by electronic means on May 18, 2016, at the following address of
`
`record:
`
`
`
`
`
`
`
`
`
`
`
`William L. Mentlik
`Michael H. Teschner
`Nichole M. Valeyko
`600 South Avenue West
`Westfield, NJ 07090
`
`WMentlik.ipr@ldlkm.com
`MTeschner.ipr@ldlkm.com
`nvaleyko@lernerdavid.com
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`
`
`By: /Eric W. Dittmann/
`Eric W. Dittmann
`Reg. No. 51,188
`
`Counsel for Patent Owner
`
`
`
`
`Dated: May 18, 2016