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`Helsinn Healthcare Exhibit 2066
`Dr. Reddy's Laboratories, Ltd., et al. v. Helsinn Healthcare S.A.
`Trial PGR2016-00007
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`Rec-eit date: 05/23/2013
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`INFORMATION DISCLOSURE
`STATEMENT BY APPLTCANT
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`(Use as many sheets as necessanl)
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`1890143? ~ C}/RU: 1628
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`Complete if Known
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`F”l”9 Dale
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`Art Unit‘
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`A~omeyooc««ex~umi»er
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`zszmusis
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`NONPATENT LITERATURE DOCUMENTS
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`Palonosetron: a phase ii dose ranging study to assess over a 7 day period the single dose pharmacokinetic
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`profile of palonosetron in patients receiving highly emetogenic chemotherapy. Piraccini et al., Proc. Am.
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`Soc. Clin. Oncol 2002 21 Abs 449 (2002)
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`Formulation and administration techniques to minimize injection pain and tissue damage associated with
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`parenteral products. Larry A. Gatlin and Carol A. Brister Gatlin, from lnjectable Drug Development:
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`Techniques to Reduce Pain and Irritation (Edited by Pramod K. Gupta and Gayle A. Brazeau; published by
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`lnforma Health Care) 1999; ISBN 1574910957, 9781574910957, p. 401-421
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`Parenteral Dosage Forms. Joanne Broadhead, from Part 11—Early drug development, pharmaceutical
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`preformulation and formulation; a practice guide from candidate drug selection to commercial dosage form
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`(Edited by Mark Gibson; Published by lnterpharma Press, 2001; ISBN 1574911201, 9781574911206), p.
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`331-353
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`Opposition Brief filed by Tecnimede Sociedade Tecnico-Medicinal SA. in opposition to European Patent
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`No. 1601359 B1, July 8,2009
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`Response brieffiled by Helsinn Healthcare S.A. dated July 13, 2007, in response to the communication
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`pursuant to Art. 96(2) EPC of 3 January 2007 regarding Serial Number 04 706 6576-2123
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`European Patent Office official communication dated July 19, 2006, regarding Serial No. 04 706 657.6
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`Response of Helsinn Healthcare S.A. dated November 29, 2006, regarding EPO official communication
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`date July 19, 2006
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`Lachman et al., The Theory and Practice of Industrial Phannacy, 1986, third edition, pp. 652-784
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`Declaration of Valentino J. Stella, Ph.D. dated September 19, 2007
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`Opposition Brief filed by Martin Paul White, opposition to European Patent No. 1601359 B1, July 8, 2009
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`Wong et al. (1995), in British Journal of Pharmacology, volume 114, pages 851-859
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`Cover page and pages 642-644 and 783-784 of The Theory and Practice of Industrial Pharmacy, Third
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`Edition, Lea and Febiger (1986)
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`Cover page and pages 514-515 of Modern Pharmaceutics, Second Edition, Marcel Dekker (1990)
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`Cover page and pages 142-143 of Pharmaceutical Dosage Forms: Parenteral Medications Volume 1,
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`Second Edition, Marcel Dekker (1992)
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`Mitsuo Matsumoto et al., "Yakuzaigaku Manual", 1st edition, Nanzando Co., Ltd. (1989) 2 pages
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`Michael J. Pikal, "Freeze Drying", Encyclopedia of Pharmaceutical Technology, Third Edition, January 2007,
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`Pages 1824-1825, Volume 3, lnforma Pharmaceuticals and Healthcare
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`Daniele Bonadeo, "Supplemental Declaration of Daniele Bonadeo Under 37 C.F.R. 1.132", filed in U.S.
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`Patent Application Serial No. 11/388,270, June 8, 2009
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`Kranke et al., 2007 "Recent advances, trends, and economic considerations in..." Expert Opinion
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`Pharmacotherp, 8(18): 3217-3235
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`Morrow et al., 1995, "Progress in reducing nausea and emesis: Comparisons of ondansetron, granisetron,
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`and tropisetron." Cancer. Volume 76, No. 3 pages 343-357.
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`USPTO Notice of Allowance and Fees Due, USSN 11/388,270, Filing Date 03/24/2006, Date Mailed
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`01/26/2010
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`USPTO Office Action, USSN 11/129,839, Date Mailed 01/15/2010
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`(lsraili, Zafar H., “Clinical Pharmacology of Serotonin Receptor Type 5-HT3) Antagonists," Curr. Med.
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`Chem. Central Nervous System Agents, 2001:1, 171-199
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`Barton (Citrate Buffer Calculation) 2000, 2 pages
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`USPTO Office Action, USSN 11/201,035, Date Mailed 08/19/2009
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`Response of Helsinn Healthcare to opposition of EP Serial No. 04 706 657.6, dated February 11, 2010
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`Annex 1 (Statement of Walso Mossi, Ph.D.) to Response of Helsinn Healthcare to Opposition of EP Serial
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`No. 04 706 657.6 dated February 11, 2010
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`131
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`5579790v1
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`ALL REFERENCES CONSIDERED EXCEPT WHERE l_iE\iE{) THROUGH.
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`/'S.t'3./’
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`Page 2 of 11
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`Rec-eit date: 05/23/2013
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`1390143? ~ QAU: 128
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`Complete if Known
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`INFORMATION DISCLOSURE
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`STATEMENT BY APPLICANT
`(Use as many sheets as necessary)
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`Application Number
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`F’””9 D315‘
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`l:i'rrtsLi\]I;2med inventor
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`Examiner Name
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`Giorgio Calderari
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`23278.2.US.8
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`NON PATENT LITERATURE DOCUMENTS
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`139
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`- Annex 2 to Response of Helsinn Healthcare to Opposition of EP Serial No. 04 706 657.6 dated February 11,
`2010
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`I Annex 3 to Response of Helsinn Healthcare to Opposition of EP Serial No, 04 706 657.6 dated February 11,
`2010
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`200
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`- Summary of Product Characteristics for Aloxi 250 (2009)
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`Scientific Discussion from the European Public Assessment Report for Aloxi (Palonoseteron Hydrochloride)
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`2006
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`6th Edition, Handbook of Pharmaceutical Excipients (2009), pp. 247-250 (RPS Publishing)
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`202
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`Lewis, Gareth A (2006) ‘Optimization Methods,‘ Encyclopedia of Pharmaceutical Technology, 1:1, 2452-
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`2467
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`May 24, 2011 Para. IV notice from Teva Pharmaceuticals re "724 and '725 patents
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`May 24, 2011 Para. IV notice from Sandoz re '724 and '725 patents
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`Aug. 19, 2011 Para. lV notice from Teva Pharmaceuticals re '424 patent
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`(
`Sept. 23, 2011 Complaint for patent infringement D. N.J. case No. 11-5579
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`August 31, 2011 Answer and counterclaim of Dr. Reddy's Laboratories, Ltd. and Dr. Reddy's Laboratories,
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`Inc. (D. N.J. case No. 11-03962)
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`Sept. 13, 2011 Sandoz lnc.‘s answer to complaint for patent infringement and counterclaims (D. N.J. case
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`No. 11-03962)
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`Sept. 13, 2011 Teva Pharmaceuticals USA, inc. and Teva Pharmaceutical industries Ltd.‘s answer (D. N.J.
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`case No. 11-03962)
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`Oct. 5, 2011 Plaintiff's reply to answer and counterclaim of Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy
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`Laboratories, Inc. (0. N.J. case No. 11-03962)
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`Oct. 21, 2011 Plaintiff's reply to Sandoz lnc.‘s answer to complaint for patent infringement and
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`counterclaims (D. N.J. case No. 11-03962)
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`Oct. 24, 2011 Answer and counterclaim of Dr. Reddy's Laboratories, Ltd. and Dr. Reddy's Laboratories, Inc.
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`(D. N.J. case No. 11-5579)
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`Oct. 24, 2011 Sandoz |nc.'s answer to complaint for patent infringement and counterclaims (D. N.J. case
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`No. 11-5579)
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`Oct. 27, 2011 Order consolidating the two cases (D. N.J. case No. 11-5579)
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`Nov. 17, 2011 Plaintiffs‘ reply to answer and counterclaim of Dr. Reddy's Laboratories, Ltd. and Dr. Reddy's
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`Laboratories, inc. (D. N.J. case No. 11-03962)
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`Nov. 17, 2011 Plaintiffs’ reply to Sandoz lnc.‘s answer to complaint for patent infringement and
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`counterclaims (D. N.J. case No. 11-03962)
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`Dec. 5, 2011 Teva Pharmaceuticals USA inc. and Teva Pharmaceuticals Industries Ltd.’s answer to
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`complaint for patent infringement of the '424 patent (D. N.J. case No, 11-03962)
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`May 21, 2012 Defendants‘ opening claim construction brief (including exhibits 1-31)
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`May 21, 2012 Plaintiffs‘ opening claim construction brief (including exhibits 1-15)
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`5579790v1
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`ALL REFERENCES CONSlDERElZ‘t EXCEPT WHERE LlE\lE{) THROUGH.
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`/'S.t'3./’
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`Page 3 of 11
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`iN|=oRMAT|oN D|sc|_osuRE
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`STATEMENT BY APPLICANT
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`Application Number
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`Zirrtsi/lr\7/:med Inventor
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`/worn-yooc«er~umber
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`Complete if Known
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`Giorgio Calderari
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`2s2vs.2.us.s
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`NONPATENT LITERATURE DOCUMENTS
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`July 20, 2012 Defendants’ responsive claim construction brief (including exhibits 1-3)
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`July 20, 2012 Plaintiffs‘ responsive claim construction brief (including Exhibits A and B)
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`Sept. 7, 2012 Court transcript from September 7, 2012 Markman hearing and Plaintiffs‘ PowerPoint
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`presentation (D. N..J. case No. 11-03962)
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`Dec. 1, 2011 Sandoz lnc.'s invalidity contentions pursuant to L. Pat. R. 3.6(c) (D. N.J. case No. 11-03962)
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`Dec. 1, 2011 Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries, Ltd.'s invalidity
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`contentions, pursuant to L. Pat. R. 3.6(c)(D. N.J. case No. 11-03962)
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`Dec. 1, 2011 Dr. Reddy's Laboratories, Ltd.'s and Dr. Reddy's Laboratories, lnc.’s invalidity contentions
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`pursuant to L. Pat. R. 3.6(c) (D. N.J. case No. 11-03962)
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`Jan. 31, 2012 Plaintiff's responses to defendants’ invalidity contentions (D. N.J. case No. 11-03962)
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`Sept. 25, 2012 Sandoz lnc.'s first amended invalidity contentions pursuant to L. Pat. R. 3.6(c) (D. N.J. case
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`No. 11-03962)
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`Nov. 19, 2012 Plaintiffs’ responses to Sandoz lncfs first amended invalidity contentions (D. N.J. case No.
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`11-03962)
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`L.G. Wade Jr., Organic Chemistry, Ch. 19: Amines, pp. 867-936 (Prentice Hall 3d ed. 1995)
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`L. Lachman et al., The Theory and Practice of Industrial Pharmacy, pp. 642-644, 783-784 (Lea & Febiger 3d
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`ed. 1986)
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`P.P. DeLuca et al,, Formulation of Small Volume Parenterals in Pharmaceutical Dosage Forms: Parenteral
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`Medications, Vol. 1, Ch. 5, pp. 173-248 (Avis, Lieberman, Lachman eds, Marcel Dekker Inc. 2d ed. 1992)
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`Handbook of Pharmaceutical Excipients, 3d Ed., (Kibbe ed. Pharmaceutical Press 2000); pp. 140-143, 191-
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`23278-2~US-8
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`i Application Number
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`Filing Date
`INFORMATION DISCLOSURE
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`STATEMENT BY APPLICANT
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`G. Stacher, Palonosetron (Helsinn), Curro. Opin. lnvestig. Drugs, 3(10) 1502-7 (2002)
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`‘ June 8, 2009 Bonadeo Declaration, Exhibit 2
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`- June 8, 2009 Bonadeo Declaration, Exhibit 3
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`February 13, 2007 Statutory Declaration of Daniele Bonadeo, with Exhibit A
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`November 21, 2007 Statutory Declaration of Giorgio Calderari, Daniele Bonadeo, Roberta Cannella, Enrico
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`Braglia, and Riccardo Braglia
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`Reddy's Paragraph IV notice regarding all three patents (D. N.J. Case No. 12-2867), dated March 30, 2012
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`May 11,2012 Complaint for patent infringement filed by Helsinn and Roche (D. N.J. Case NO. 12-2867)
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`June 26, 2012 Notice Of Reddy's motion to dismiss (D. N.J. Case. NO. 12-2867)
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`June 26, 2012 Dr. Reddy's Laboratories, Ltd.'s and Dr. Reddy's Laboratories, lnc.'s memorandum of law in
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`support Of their motion to dismiss or for summary judgment of rion—infrlngement of U.S. patent NO.
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`7,947,724 (D. N.J. Case No. 12-2867) (including Exhibits 1-10)
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`Aug. 16, 2012 Notice of Plaintiffs‘ cross-motion for partial summary judgment of infringement (D. N.J. Case
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`No. 12-2867)
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`Aug. 6, 2012 Plaintiffs‘ Opposition to Defendants‘ motion to dismiss or for summary judgment of
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`noninfringement and cross—motion for partial summary judgment of infringement (D. N.J. Case No. 12-1867)
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`(including exhibits 1-4)
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`Schoneich declaration (D. N.J. Case No. 12-2867) (Including Exhibits A and 1-24), dated August 6, 2012
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`Sept. 4, 2012 Reddy's brief in opposition to Plaintiffs’ cross-motion for partial summary judgment and reply
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`memorandum of law in further support of Reddy's motion to dismiss or for summary judgment of non-
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`infringement (D. N.J. Case NO. 12-2867)(|nc|uding Exhibits 1-4)
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`DeLuca Declaration (D. N.J. Case No. 12-2867)(lncluding exhibits A-J), dated September 3, 2012
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`Sept. 10, 2012 Plaintiffs’ letter to Judge Cooper in response to Reddy's combined opposition to Plaintiffs’
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`cross-motion for partial summary judgment and reply in support of Reddy's motion to dismiss Or for
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`summary judgment of noninfringement (D. N.J. Case No. 12-2867)(inciuding exhibits A and B)
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`Sept. 14, 2012 Dr. Reddy's letter in response to Plaintiffs’ September 10, 2012 letter (D. N.J. Case No. 12-
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`2867)
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`USPTO Office Action, USSN 11/388,268, Filing Date 03/24/2006, Mail Date 03/29/2010
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`USPTO Non-Final Office Action, USSN 11/186,311, mailed August 30, 2006.
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`USPTO Non-Final Office Action, USSN 11/186,311, mailed October 5, 2007.
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`USPTO NOn—Final Office Action, USSN 11/186,311, mailed October 6, 2008.
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`USPTO Final Office Action, USSN 11/186,311, mailed May 20, 2009.
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`5579790v1
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`ALL REFERENCES CONSWEREEE EXCEPT WHERE UNED THROUGH.
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`/8.3../’
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`1390143?’ ~ CEAUS 1628
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`INFORMATION DISCLOSURE
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`STATEMENT BY APPLICANT
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`(Use as many sheets as necessary)
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`Complete if Known
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`NONPATENT LITERATURE DOCUM ENTS
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`- USPTO Advisory Action, USSN 11/186,311, mailed July 15, 2009.
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`USPTO Non—Final Office Action, USSN 11/388,268, mailed October 3, 2007.
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`USPTO Non—Final Office Action, USSN 11/388,268, mailed March 26, 2008.
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`USPTO Final Office Action, USSN 11/388,268, mailed November 12,2008
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`USPTO Non-Final Office Action, USSN 11/388,268, mailed July 15, 2009.
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`1‘USPTO Notice of Allowance and Fees Due, USSN 11/388,268, mailed December 22, 2010.
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`USPTO Non-Final Office Action, USSN 11/388,269, mailed July 19, 2006.
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`USPTO Non—Final Office Action, USSN 11/388,269, mailed November 17, 2006.
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`USPTO Non-Final Office Action, USSN 11/388,269, mailed September 20, 2007,
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`USPTO Interview Summary, USSN 11/388,269, dated April 28, 2009.
`USPTO Final Office Action, USSN 11/388,269, mailed May 20, 2009.
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`USPTO Notice of Allowance and Fees Due, USSN 11/388,270, mailed January 5, 2011.
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`USPTO Non-Final Office Action, USSN 13/087,012, mailed March 12, 2012.
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`USPTO Non-Final Office Action, USSN 13/087,012, mailed July 19, 2012.
`USPTO Interview Summary, USSN 13/087,012, dated February 15, 2013.
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`USPTO Notice of Allowance and Fees Due, USSN 13/087,012, mailed February 27, 2013.
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`USPTO Response to Amendment under Rule 312, USSN 13/087,012, mailed April 4, 2013.
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`5579790v1
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`Receit date: 05/23/2013
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`13901437 ~ CEAU: 1628
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`Complete if Known
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`—INFORMATION DISCLOSURE
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`F”’”9 Daie
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`:I:‘S:‘//I:/I:I77ed Inventor
`Giorgio Calderari
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`(Use as many sheets as necessary)
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`23278.2.US.8
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`NONPATENT LITERATURE DOCUMENTS
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`USPTO Non-Final Office Action, USSN 11/129,839. mailed June 10, 2008.
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`Eisenberg et al. 2004, “Efficacy, safety and pharmacoklnetics of palonosetron in patients receiving highly
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`emetogenic cisplatin-based chemotherapy: a dose-ranging clinical study. “Annals of Oncology. Volume 15,
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`pages 330-337.
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`Mayron et al. 1996, “Stability and compatibility of granistron hydrochloride in i.v. solutions and oral liquids
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`and during simulated Y—site injection with selected drugs." Am J Health-Sys Pharm, 53: 294-304.
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`Trissel et al. 1997, “Compatibility of granisetron hydrochloride with selected drugs during simulated Y -site
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`5579790v1
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`ALL REFERENCES COi\lStlI)EREl3 EXCEPT WHERE l_iNEi} THROUGH.
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`/8.3../’
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`Page 7 of 11
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`Rec-eit date: 05/23/2013
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`‘$390143?’ ~ GAU: 1628
`Complete if Known
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`INFORMATION DISCLOSURE
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`STATEMENT BY APPLICANT
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`ruseasmanyasnecessarw
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`Application Number
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`First Named Inventor
`Arf Unit
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`exammerwame T
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`Attorney Docket Number
`23278.2.US.8
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`Giorgio Calderan
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`NONPATENT LITERATURE DOCUMENTS
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`- Full Prescribing lnforrnation for Aloxi (palonosetron HCI) injection for intravenous Use (2008).
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