Helsinn Healthcare Exhibit 2067
`Dr. Reddy's Laboratories, Ltd., et al. v. Helsinn Healthcare S.A.
`Trial PGR2016-00007
`
`Page 1 of 12
`
`

`
`
`
`
`
`
`
`
`
`‘$901830 ~ GAL}: 1628
`
`Receit date: 05/24/2013
`
`
`
`
`Complete if Known
`
`
`
`
`
`
`INFORMATION DISCLOSURE
`
`
`
`
`
`
`G org 0 Calderar
`firrtsi/lr\7I;.vmed Inventor
`BY APPLICANT
`
`
`
`
`
`
`
`
`
`
`
`wseasm-nyasnecessaw» T
`
`
`
`
`
`
`
`
`
`Anorneyoom-Number
`2s27e.2.us.e
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`U.S. PUBLISHED PATENT APPLICATIONS
`
`
`
`
`
`
`Examiner
`Initials
`
`
`
`
`Cite
`
`No.3
`
`
`
`
`
`
`
`
`
`
`
`
`Name of Patentee or
`
`
`
`
`Applicant of Cited Document
`
`
`
`
`
`
`
`
`Issue or
`Pages, Columns, Lines, Where
`
`
`
`
`
`
`Publication Date
`Relevant Passages or Relevant
`4
`
`
`
`
`
`
`MM_DD_yyyy
`Figures Appear
`Number-Kind Code (ifknown)
`
`
`
`
`
`
`
`
`
`°"'°‘3'2°°‘—
`”S‘2°°‘°°2°°2"
`f 29
`
`
`
`
`
`
`””99e'*"' —
`°5‘22‘2°°3
`”5'2°°3°°9592“
`1 3°
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Note: Submission of copies of U.S. Patents and published U.S. Patent Applications is not required.
`
`
`
`Examiner
`
`
`
`
`Cite
`‘
`
`
`
`
`Foreign patent Document
`
`
`
`
`
`co0:Z
`
`Country Code5 Number6 Kind Code7 (if known)
`
`
`
`
`
`
`
`31 WO-2004067005
`
`
`32 wo-2003100091
`
`
`3 wo-2004703714
`WO 2004045615
`
`
`
`
`
`
`
`
`
`
`08-12-2004
`12-04-2003
`09-02-2004
`06-03-2004
`
`
`
`
`
`
`
`
`
`FOREIGN PATENT DOCUMENTS
`
`
`Publication Date
`
`
`MM-DD-YYYY
`
`
`
`Pages, Columns, Lines,
`Name of Patentee or
`
`
`
`
`
`
`
`Applicant of Cited Document Where Relevant Passages
`
`
`
`
`
`
`or Relevant Figures
`
`
`
`Appear
`
`
`Translations
`
`
`
`
`
`
`
`Helsinn Healthcare s.A. —
`
`Brockméller —
`
`
`
`Helsinn Healthcare s.A. —
`Helsinn Healthcare S.A.
`
`
`
`
`(.0
`
`5
`
`
`EP-0 512 400 A1
`
`
`
`
`
`04-29-1992
`
`
`
`Hallinan, E. Ann (G.D.
`
`
`
`Searle & Co.)
`
`
`
`
`
`
`Examiner
`
`
`
`
`'
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`NONPATENT LITERATURE DOCUMENTS
`
`
`
`Include name of the author (in CAPITAL LETTERS), title of the article (when appropriate), title of the item
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`(book, magazine, journal, serial, symposium, catalog, etc.), date, page(s), volume-issue number(s),
`
`
`
`
`
`
`
`
`
`
`
`publisher, city and/or country where published.
`
`
`
`
`
`
`R. M. Eglen et al., "Pharmacological characterization of RS 25259-197, a novel and selective 5-HT3
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`receptor antagonist, in vivo," Br. J Pharmacology 114:860-866 (1995)
`
`
`
`
`
`
`
`
`
`Chelly, Jacques et al., Oral RS-25259 Prevents Postoperative Nausea and Vomiting Following Laparoscopic
`
`
`
`
`
`
`
`
`
`
`
`
`Surgery, Anesthesiology, 1996, Vol., 85, No. 3A, p. A21
`
`
`
`
`
`
`
`
`
`Sorbe, Bengt, 5-HT-3 Receptor Antagonists as Antiemetic Agents in Cancer Chemotherapy, extracted from
`
`
`
`
`
`
`
`
`
`
`
`
`
`Expert Opinion on lnvestigational Drugs, 1996, vol. 5 no. 4, pp. 389-407
`
`
`
`
`
`
`
`
`
`
`
`
`Gaster, Laramie M. and King, Frank D., Serotonin 5-HT3 and 5-HT4 Receptor Antagonists, extracted from
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Medicinal Research Reviews, 1997 vol. 17, no. 2, pp. 163-214
`
`
`
`
`
`
`
`
`
`
`Tang, Jun et al., "Efficacy of RS-25259, a Novel 5-HT3 Antagonist, In the Prevention of Postoperative
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Nausea and Vomiting after Major Gynecologic Surgery," Anesthesiology, 1997, vol. 85, No. 3 suppl. p. A329
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Tang, Jun et al., The Etficacy of RS-25259, a Long-Acting Selective 5-HT3 Receptor Antagonist, for
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Preventing Postoperative Nausea and Vomiting After Hysterectomy Procedures, Anesthesia and Analgesia,
`
`
`
`
`
`
`
`
`
`
`1998, vol. 87, pp. 462-467
`
`
`
`
`
`Adis R&D Profile, Palonosetron R8 25259 197, Drugs in R&D, October 1999, vol. 2, no. 4, pp. 251-252
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Translations
`
`
`
`
`
`
`
`
`
`
`
`
`Piraccini Gaia et al., An Interesting 5-HT3 Receptor Antagonist Antiemetic for Patients Undergoing
`
`
`
`
`
`
`
`
`
`
`
`
`
`Chemotheraphy-based Conditioning Regimens," Blood, Nov. 16, 2001, vol. 98, no. 11, part 2, p. 350b,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`abstract no. 5169
`
`
`
`Stacher, Georg, Palonosetron Helsinn, Current Opinion in Investigational Drugs. October 2002, vol. 3, no.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`10, pp. 1502-7
`
`
`
`Navari, Rudolph M., Pathogenesis-Based Treatment of Chemotherapy-Induced Nausea and Vomiting - Two
`
`
`
`
`
`
`
`
`
`New Agents, Journal of Supportive Oncology, 2003, vol. 1(2), pp. 89-103
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Opposition Brief filed by Dr. Reddy‘s Laboratories (UK) Limited, opposition to European Patent No. 1601359
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`B1 dated July 7, 2009
`
`
`
`
`
`Photolytic and oxidative degradation of an antiemetic agent, RG 12915 (Won C. M. et al., International
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Journal of Pharmaceutics 121, 95-105 (1995)
`
`
`
`
`
`
`
`
`
`
`
`5582040v1
`
`
`
`
`
`
`
`
`
`ALL REFERENCES CONSEBEREED EXCEPT WHERE t_tNE{i) THROUGH.
`
`
`
`/SC./’
`
`
`
`Page 2 of 12
`
`Page 2 of 12
`
`

`
`
`
`
`
`
`
`
`
`
`
`33901830 ~ GAL}: 1628
`Receit date: 05/24/2013
`
`
`
`
`Complete if Known
`Apm-canon Number T
`
`
`
`
`
`
`
`
`
`
`
`INFORMATION DISCLOSURE
`
`
`
`
`
`
`
`
`STATEMENT BY A"'°”°A“T T
`
`
`
`(Use as many sheets as necessary)
`Examiner Name
`
`
`
`
`
`
`
`
`
`
`
`
`Attorney Docket Number
`
`
`
`
`
`
`
`
`
`
`23278-2-Us-9
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`NONPATENT LITERATURE DOCUMENTS
`
`
`
`Palonosetron: a phase II dose ranging study to assess over a 7 day period the single dose pharmacokinetic
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`profile of palonosetron in patients receiving highly emetogenic chemotherapy. Piraccini et al., Proc. Am.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Soc. Clin. Oncol 2002 21 Abs 449 (2002)
`
`
`
`
`
`
`
`
`Formulation and administration techniques to minimize injection pain and tissue damage associated with
`
`
`
`
`
`
`
`
`
`
`
`
`parenteral products. Larry A. Gatlin and Carol A. Brister Gatlin, from lnjectable Drug Development:
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Techniques to Reduce Pain and irritation (Edited by Pramod K. Gupta and Gayle A. Brazeau; published by
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Informa Health Care) 1999; ISBN 1574910957, 9781574910957, p. 401-421
`
`
`
`
`
`
`
`
`Parenteral Dosage Forms. Joanne Broadhead, from Part 11-Early drug development, pharmaceutical
`
`
`
`
`
`
`
`
`
`
`
`preformulation and formulation: a practice guide from candidate drug selection to commercial dosage form
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`(Edited by Mark Gibson; Published by lnterpharma Press, 2001; ISBN 1574911201, 9781574911206), p.
`
`
`
`
`
`
`
`
`
`
`
`
`
`331-353
`
`Opposition Brief filed by Tecnimede Sociedade Tecnico-Medicinal S.A. in opposition to European Patent
`
`
`
`
`
`
`
`
`
`
`
`
`No. 1601359 B1, July 8, 2009
`
`
`
`
`
`
`Response brief filed by Helsinn Healthcare S.A. dated July 13, 2007, in response to the communication
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`pursuant to Art. 96(2) EPC of 3 January 2007 regarding Serial Number 04 706 657.6-2123
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`European Patent Office official communication dated July 19, 2006, regarding Serial No. 04 706 657.6
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Response of Helsinn Healthcare S.A. dated November 29, 2006, regarding EPO official communication
`
`
`
`
`
`
`
`
`
`
`
`
`date July 19, 2006
`
`
`
`
`Lachman et al., The Theory and Practice of industrial Pharmacy, 1986, third edition, pp. 652-784
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Declaration of Valentino J. Stella, Ph.D. dated September 19, 2007
`
`
`
`
`
`
`
`
`
`
`
`Opposition Brief filed by Martin Paul White, opposition to European Patent No. 1601359 B1, July 8, 2009
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`116
`
`
`
`117
`
`118
`
`119
`
`
`
`
`
`
`
`120
`
`
`
`121
`
`
`
`122
`
`
`
`123 Wong et al. (1995), in British Journal of Pharmacology, volume 114, pages 851-859
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`124
`
`
`
`125
`
`
`
`
`
`Cover page and pages 642-644 and 783-784 of The Theory and Practice of Industrial Pharmacy, Third
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Edition, Lea and Febiger (1986)
`
`
`
`
`
`Cover page and pages 514-515 of Modern Pharmaceutics, Second Edition, Marcel Dekker (1990)
`
`
`
`
`
`
`
`
`
`
`
`
`
`Cover page and pages 142-143 of Pharmaceutical Dosage Forms: Parenteral Medications Volume 1,
`
`
`
`
`
`
`
`
`
`
`
`
`Second Edition, Marcel Dekker (1992)
`
`
`
`
`
`Mitsuo Matsumoto et al., "Yakuzaigaku Manual", 1st edition, Nanzando Co., Ltd. (1989) 2 pages
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Michael J. Pikal, "Freeze Drying", Encyclopedia of Pharmaceutical Technology. Third Edition, January 2007,
`
`
`
`
`
`
`
`
`
`
`
`
`Pages 1824-1825, Volume 3, Informa Pharmaceuticals and Healthcare
`
`
`
`
`
`
`
`
`Daniele Bonadeo, "Supplemental Declaration of Daniele Bonadeo Under 37 C.F.R. 1.132", filed in US.
`
`
`
`
`
`
`
`
`
`
`
`
`
`PatentApp|ication Serial No. 11/388,270, June 8,2009
`
`
`
`
`
`
`
`
`Kranke et al., 2007 "Recent advances, trends, and economic considerations in..." Expert Opinion
`
`
`
`
`
`
`
`
`
`
`
`
`Pharmacotherp., 8(18): 3217-3235
`
`
`
`Morrow et al., 1995, "Progress in reducing nausea and emesis: Comparisons of ondansetron, granisetron,
`
`
`
`
`
`
`
`
`
`
`
`
`
`and tropisetron." Cancer, Volume 76, N0. 3 pages 343-357.
`
`
`
`
`
`
`
`
`USPTO Notice of Allowance and Fees Due, USSN 11/388,270, Filing Date 03/24/2006, Date Mailed
`
`
`
`
`
`
`
`
`
`
`
`
`
`01/26/2010
`
`USPTO Office Action, USSN 11/129,839, Date Mailed 01/15/2010
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`12 6
`
`127
`
`128
`
`129
`
`130
`
`131
`
`
`
`132
`
`
`
`133
`
`1
`
`34
`
`
`
`
`
`135
`
`
`
`136
`
`
`
`
`
`
`
`
`
`Israili, Zafar H., "Clinical Pharmacology of Serotonin Receptor Type (5-HT3) Antagonists," Curr. Med.
`
`
`
`
`
`
`
`
`
`
`
`
`Chem. Central Nervous System Agents, 2001 :1, 171-199
`
`
`
`
`
`
`
`Barton (Citrate Buffer Calculation) 2000, 2 pages
`
`
`
`
`
`
`
`
`
`
`
`USPTO Office Action, USSN 11/201,035, Date Mailed O8/19/2009
`
`
`
`
`
`
`
`
`
`
`Response of Helsinn Healthcare to opposition of EP Serial No. 04 706 657.6, dated February 11, 2010
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Annex 1 (Statement of Walso Mossi, Ph.D.) to Response of Helsinn Healthcare to Opposition of EP Serial
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`No. 04 706 657.6 dated February 11, 2010
`
`
`
`
`
`
`
`
`
`
`
`5582040v1
`
`
`
`ALL REFERENCES CONSEBEREED EXCEPT WHERE UNEB THROUGH.
`
`
`
`
`
`
`Page 3 of 12
`
`/8.3./’
`
`
`
`
`
`Page 3 of 12
`
`

`
`
`
`
`
`
`
`Receit date: 05/24/2013
`
`
`
`Complete if Known
`
`
`
`
`
`‘$901830 ~ GAL}: 1628
`
`
`
`
`
`
`
`Application Number
`
`
`
`
`
`
`
`Fl//were
`INFORMATION DISCLOSURE
`
`
`
`
`
`
`
`
`
`
`
`
`(Use as many sheets as necessary)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Attorney Docket Number
`
`
`
`
`
`23278-2-Us-9
`
`
`
`139
`
`
`
`40
`
`
`
`In
`
`200
`
`
`
`201
`
`
`202
`
`
`2
`
`03
`
`
`
`204
`
`
`
`05
`
`2
`
`206
`
`
`
`
`
`NONPATENT LITERATURE DOCUMENTS
`
`
`
`Annex 2 to Response of Helsinn Healthcare to Opposition of EP Serial No. 04 706 657.6 dated February 11,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`2010
`
`Annex 3 to Response of Helsinn Healthcare to Opposition of EP Serial No. 04 706 657.6 dated February 11,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`2010
`
`
`
`
`
`
`Summary of Product Characteristics for Aloxi 250 (2009)
`
`
`
`
`
`
`
`
`
`
`Scientific Discussion from the European Public Assessment Report for Aloxi (Palonoseteron Hydrochloride)
`
`
`
`
`
`
`
`
`
`
`
`2006
`
`6th Edition, Handbook of Pharmaceutical Excipients (2009), pp. 247-250 (RPS Publishing)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Lewis, Gareth A (2006) ‘Optimization Methods,‘ Encyclopedia of Pharmaceutical Technology, 1:1, 2452-
`
`
`
`
`
`
`
`
`
`
`
`2467
`
`May 24, 2011 Para. IV notice from Teva Pharmaceuticals re '724 and '725 patents
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`May 24, 2011 Para. IV notice from Sandoz re '724 and '725 patents
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Sept. 22, 2011 Para. IV notice from Sandoz re '724, '725 and '424 patents
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`July 8,2011 Complaint for patent infringement (D. N.J. case No. 11-03962)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Sept. 23, 2011 Complaint for patent infringement (D. N.J. case No. 11-5579)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`August 31, 2011 Answer and counterclaim of Dr. Reddy's Laboratories, Ltd. and Dr. Reddy's Laboratories,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Inc. (D. N.J. case No. 11-03962)
`
`
`
`
`
`
`Sept. 13,2011 Sandoz |nc.'s answer to complaint for patent infringement and counterclaims (D. N.J. case
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`No. 11-03962)
`
`
`Sept. 13, 2011 Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd.'s answer (D. N.J.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`case No. 11-03962)
`
`
`
`Oct. 5, 2011 Plaintiff's reply to answer and counterclaim of Dr. Reddy's Laboratories, Ltd. and Dr. Reddy
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Laboratories, Inc. (D. N.J. case No. 11-03962)
`
`
`
`
`
`
`
`Oct. 21, 2011 Plaintiff's reply to Sandoz |nc.'s answer to complaint for patent infringement and
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`counterclaims (D. N.J. case No. 11-03962)
`
`
`
`
`
`
`Oct. 24, 2011 Answer and counterclaim of Dr. Reddy's Laboratories, Ltd. and Dr. Reddy's Laboratories, lnc.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`(D. N.J. case No. 11-5579)
`
`
`
`
`
`Oct. 24, 2011 Sandoz lnc.'s answer to complaint for patent infringement and counterclaims (D. N.J. case
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`No. 11-5579)
`
`
`Oct. 27, 2011 Order consolidating the two cases (D. N.J. case No. 11-5579)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`209
`
`210
`
`
`
`211
`
`
`212
`
`
`
`213
`
`
`214
`
`
`
`215
`
`
`
`216
`
`217
`
`
`
`
`
`218
`
`219
`
`220
`
`
`
`
`
`
`
`221
`
`
`222
`
`
`223
`
`224
`
`
`
`
`
`Nov. 17, 2011 Plaintiffs’ reply to answer and counterclaim of Dr. Reddy's Laboratories, Ltd. and Dr. Reddy's
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Laboratories, lnc. (D. N.J. case No. 11-03962)
`
`
`
`
`
`
`
`Nov. 17, 2011 Plaintiffs‘ reply to Sandoz |nc.'s answer to complaint for patent infringement and
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`counterclaims (D. N.J. case No. 11-03962)
`
`
`
`
`
`
`Dec. 5, 2011 Teva Pharmaceuticals USA Inc. and Teva Pharmaceuticals Industries Ltd.'s answer to
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`complaint for patent infringement of the '424 patent (D. N.J. case No. 11-03962)
`
`
`
`
`
`
`
`
`
`
`
`
`
`May 21, 2012 Defendants‘ opening claim construction brief (including exhibits 1-31)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`May 21, 2012 Plaintiffs‘ opening claim construction brief (including exhibits 1-15)
`
`
`
`
`
`
`
`
`
`
`
`
`
`5582040v1
`
`
`
`
`
`
`
`
`
`ALL REFERENCES CONSEBEREED EXCEPT WHERE i_tNEti) THROUGH.
`
`
`
`/SE./’
`
`
`
`Page 4 of 12
`
`Page 4 of 12
`
`

`
`
`
`
`
`
`
`Receit date: 05/24/2013
`
`
`
`
`
`
`33901830 ~ GAL}: 1628
`
`
`
`
`
`Complete if Known
`
`
`
`
`
`
`
`
`
`
`Application Number
`
`
`
`F{’’”9 De“?
`
`
`First Named Inventor
`
`
`Examiner Name
`
`
`
`
`Attorney Docket Number
`
`
`
`_
`_
`_
`
`Giorgio Calderari
`
`
`
`
`
`232782-US-9
`
`
`
`
`
`
`
`
`
`
`
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPIJCANT
`
`
`(Use as many sheets as necessary)
`
`
`
`
`
`
`
`
`
`
`
`
`NONPATENT LITERATURE DOCUMENTS
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`- July 20, 2012 Defendants‘ responsive claim construction brief (including exhibits 1-3)
`226
`July 20, 2012 Plaintiffs’ responsive claim construction brief (including Exhibits A and B)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Sept. 7, 2012 Court transcript from September 7, 2012 Markman hearing and Plaintiffs‘ PowerPoint
`
`
`
`
`
`
`
`
`
`
`
`
`
`presentation (D. N.J. case No. 11-03962)
`
`
`
`
`
`
`Dec. 1, 2011 Sandoz lnc.'s invalidity contentions pursuant to L. Pat. R. 3.6(c) (D. N.J. case No. 11-03962)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Dec. 1, 2011 Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries, Ltd.'s invalidity
`
`
`
`
`
`
`
`
`
`
`
`
`contentions, pursuant to L. Pat. R. 3.6(c)(D. N.J. case No. 11-03962)
`
`
`
`
`
`
`
`
`
`
`
`Dec. 1, 2011 Dr. Reddy's Laboratories, Ltd.’s and Dr. Reddy's Laboratories, lnc.'s invalidity contentions
`
`
`
`
`
`
`
`
`
`
`
`
`
`pursuant to L. Pat. R. 3.6(c) (D. N.J. case No. 11-03962)
`
`
`
`
`
`
`
`
`
`
`
`Jan. 31, 2012 Plaintiffs responses to defendants‘ invalidity contentions (D. N.J. case No. 11-03962)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Sept. 25, 2012 Sandoz lnc.'s first amended invalidity contentions pursuant to L. Pat. R. 3.6(c) (D. N.J. case
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`No. 11-03962)
`
`
`Nov. 19, 2012 Plaintiffs‘ responses to Sandoz lnc.'s first amended invalidity contentions (D. N.J. case No.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`11-03962)
`
`L.G. Wade Jr., Organic Chemistry, Ch. 19: Amines, pp. 867-936 (Prentice Hall 3d ed. 1995)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`27
`2
`
`228
`
`229
`
`
`
`
`
`
`
`I\)O.)O
`
`
`
`231
`
`
`232
`
`233
`
`
`
`
`
`234
`
`
`
`235
`
`
`
`
`
`
`
`
`
`236
`
`237
`
`238
`
`239
`
`
`
`
`ANZEMET®, in The Physician's Desk Reference, pp. 680-83 (5th ed. 2001)
`
`
`
`
`
`
`
`
`
`
`
`
`
`KYTRlL®, in The Physician's Desk Reference, pp. 3104-06 (5th ed. 2001)
`
`
`
`
`
`
`
`
`
`
`
`
`
`L.A. Trissel, Ondansetron HCI, in Handbook on lnjectable Drugs, pp. 683-88 (ASHP 7th ed. 1992)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`NAVOBAN® (tropisetron HCI) Malaysian Prescribing Information (Sep. 2000)
`
`
`
`
`
`
`
`
`
`
`)
`KYTR|L® (granisetron HCI South African Prescribing Information (Dec. 1993)
`
`
`
`
`
`
`
`
`
`
`
`S. Motola and S. Agharkar, Preformulation Research of Parenteral Medications, Pharmaceutical Dosage
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Forms: Parenteral Medications, Vol. 1, Ch, 4, pp. 115-72 (Avis, Lieberman, Lachman eds., Marcel Dekker
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Inc. 2d ed. 1992)
`
`
`
`
`J. Wells, Pharmaceutical Preformuatlion: The Physicochemical Properties of Drug Substances, Ch. 5: Drug
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` Stability, pp. 152-91 (Ellis Horvvod Ltd. 1988)
`
`
`
`
`
`
`
`J. Swarbrick and Boylan, Encyclopedia of Pharmaceutical Technology, Excipients Chapter: Their Role in
`
`
`
`
`
`
`
`
`
`
`
`
`
`Parenteral Dosage Forms, Vol. 19(2):137-172 (Marcel Dekker, Inc. 2000)
`
`
`
`
`
`
`
`
`
`Handbook of Pharmaceutical Excipients, 3d Ed., (Kibbe ed. Pharmaceutical Press 2000); pp. 140-143, 191-
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`194, 324-238
`
`
`
`
`
`
`
`
`
`
`
`
`5582040v1
`
`
`
`
`
`
`
`
`ALL REFERENCES CONSEBEREED EXCEPT WHERE UNEE) THROUGH.
`
`
`
`/8.3./’
`
`
`
`Page 5 of 12
`
`L. Lachman et al., The Theory and Practice of Industrial Pharmacy, pp. 642-644, 783-784 (Lea & Febiger 3d
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`ed. 1986)
`
`
`P.P. DeLuca et al., Formulation of Small Volume Parenterals in Pharmaceutical Dosage Forms: Parenteral
`
`
`
`
`
`
`
`
`
`
`
`
`
`Medications, Vol. 1, Ch. 5, pp. 173-248 (Avis, Lieberman, Lachman eds., Marcel Dekker Inc. 2d ed. 1992)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`C.M. Won et al, Photolytic and Oxidative Degradation of an Antiemetic Agent, RGl2915, |nt'l J
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Pharmaceutics 121 :95-105 (1995)
`
`
`
`R.D. Clark et al., 2-(Quinuciidin-3-yl)pyrido-[4,3-b]indol-I-ones and lsoquinoin-I-ones. Potent
`
`
`
`
`
`
`
`
`
`Conformationally Restricted 5-HT3 Receptor Antagonists, J Med. Chem. 3622645-57 (1993)
`
`
`
`
`
`
`
`
`
`
`L.A. Trissel, Drug Stability and Compatibility Issues, Handbook on lnjectable Drugs, pp. Xl-XVI (ASHP 7th
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`ed. 1992)
`
`
`J. Broadhead, Parenteral Dosage Forms, Pharmaceutical Preformulation and Formulation: A Practical
`
`
`
`
`
`
`
`
`
`
`
`Guide from Candidate Drug Selection to Commercial Dosage Form, Ch. 9, pp. 331-54 (Gibson ed., CRC
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Press 1st ed. 2001)
`
`
`
`
`K.A. Connors et al,, Chemical Stability of Pharmaceuticals: A Handbook for Pharmacists (John Wiley &
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Sons 2d ed. 1986)
`
`
`
`
`
`ZOFRAN®, in The Physician's Desk Reference, op. 1503-07 (5th ed. 2001)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`240
`
`241
`
`
`242
`
`243
`
`244
`
`245
`
`246
`
`2
`
`47
`
`248
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`249
`
`
`
`250
`
`
`
`251
`
`
`
`Page 5 of 12
`
`

`
`
`
`
`
`
`
`
`
`‘$901830 ~ GAL}: 1628
`Receit date: 05/24/2013
`
`
`
`
`
`Complete if Known
`Application Number
`
`
`Filing Date
`
`
`
`
`
`INFORMATION DISCLOSURE
`First Named Inventor
`
`
`
`
`
`
`
`STATEMENT BY APPLICANT
`Art Unit
`
`
`
`Examiner Name
`(Use as many sheets as necessary)
`
`
`
`
`
`
`
`
`
`
`
`
`Attorney Docket Number
`
`
`
`
`
`11
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Giorgio Calderari
`
`
`
`
`
`
`23278.2.US.9
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`-
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`November 21, 2007 Statutory Declaration of Giorgio Calderari, Daniele Bonadeo, Roberta Cannella, Enrico
`
`
`
`
`
`
`
`
`
`
`
`
`
` Braglia, and Riccardo Braglia
`
`
`
`
`Reddy's Paragraph lV notice regarding all three patents (D. N.J. Case No. 12-2867), dated March 30, 2012
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`May 11, 2012 Complaint for patent infringement filed by Helsinn and Roche (D. N.J. Case No. 12-2867)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`259
`
`260
`
`261
`
`
`262
`
`
`263
`
`
`
`
`
`June 26, 2012 Notice of Reddy's motion to dismiss (D. N.J. Case. No. 12-2867)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`June 26, 2012 Dr. Reddy's Laboratories, Ltd.'s and Dr. Reddy's Laboratories, lnc.'s memorandum of law in
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`support of their motion to dismiss or for summary judgment of non-infringement of U.S. patent No.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`7,947,724 (D. N.J. Case No. 12-2867) (including Exhibits 1-10)
`
`
`
`
`
`
`
`
`
`Aug. 16, 2012 Notice of Plaintiffs‘ cross—motion for partial summaryjudgment of infringement (D. N.J. Case
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`No. 12-2867)
`
`
`Aug. 6, 2012 Plaintiffs‘ opposition to Defendants‘ motion to dismiss or for summary judgment of
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`noninfringement and cross-motion for partial summary judgment of infringement (D. N.J. Case No. 12-1867)
`
`
`
`
`
`
`
`
`
`
`
`
`
`(including exhibits 1-4)
`
`
`
`Schéneich declaration (D. N.J. Case No. 12-2867) (Including Exhibits A and 1-24), dated August 6, 2012
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Sept. 4, 2012 Reddy's brief in opposition to Plaintiffs‘ cross—motion for partial summary judgment and reply
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`memorandum of law in further support of Reddy's motion to dismiss or for summary judgment of non-
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`infringement (D. N.J. Case No. 12-2867)(lncluding Exhibits 1-4)
`
`
`
`
`
`
`
`
`DeLuca Declaration (D. N.J. Case No. 12-2867)(lncluding exhibits A-J), dated September 3, 2012
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Sept. 10, 2012 Plaintiffs’ letter to Judge Cooper in response to Reddy's combined opposition to Plaintiffs’
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`cross-motion for partial summary judgment and reply in support of Reddy's motion to dismiss or for
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`summary judgment of noninfringement (D. N.J. Case No. 12-2867)(lncluding exhibits A and B)
`
`
`
`
`
`
`
`
`
`
`
`
`
`Sept. 14, 2012 Dr. Reddy's letter in response to Plaintiffs‘ September 10, 2012 letter (D. N.J. Case No. 12-
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`2867)
`
`USPTO Office Action, USSN 11/388,268, Filing Date 03/24/2006, Mail Date 03/29/2010
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`264
`
`
`
`265
`
`
`
`266
`
`
`
`267
`
`
`
`268
`
`
`
`269
`
`270
`
`
`
`
`
`271
`
`
`272
`
`
`300
`
`
`
`301
`
`
`302
`
`
`303
`
`
`
`
`
`USPTO Non—Fina| Office Action, USSN 11/186,311, mailed August 30, 2006.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`USPTO Non-Final Office Action, USSN 11/186,311, mailed October 5,2007.
`
`
`
`
`
`
`
`
`
`
`
`
`USPTO Non—Final Office Action, USSN 11/186,311, mailed October 6, 2008.
`
`
`
`
`
`
`
`
`
`
`
`
`USPTO Final Office Action, USSN 11/186,311, mailed May 20, 2009.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`5582040v1
`
`
`
`
`
`
`
`
`
`ALL REFERENCES CONSWEREED EXCEPT WHERE i_iNEii) THROUGH.
`
`
`
`/8.3./’
`
`
`
`Page 6 of 12
`
`Page 6 of 12
`
`

`
`
`
`
`
`
`
`
`
`
`23278.2.Us.9
`
`
`
`
`
`
`
`Giorgio Calderari
`
`
`
`
`
`
`
`
`
`
`
`13901830 ~ GAE}: 1628
`Receipt date: 05/24/2013
`
`
`
`
`Complete if Known
`
`
`Application Number
`
`Fmng Date
`
`
`
`
`
`First Named Inventor
`
`
`Art Unit
`
`
`Examiner Name
`
`
`
`
`Attorney Docket Number
`
`
`
`
`
`INFORMATION DISCLOSURE
`
`
`
`STATEMENT BY APPLICANT
`
`(Use as many sheets as necessan/)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`304
`
`305
`
`306
`
`307
`
`308
`
`
`
`
`
`
`
`
`
`
`
`
`
`333
`333
`
`311
`
`
`NONPATENT LITERATURE DOCUMENTS
`
`
`USPTO Advisory Action, USSN 11/186,311, mailed July 15, 2009.
`
`
`
`
`
`
`
`
`
`USPTO Notice of Allowance and Fees Due, USSN 11/186,311, mailed March 4, 2011.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`USPTO Notice of Allowability, USSN 11/186,311, dated May 24, 2011.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`USPTO Non-Final Office Action, USSN 11/388,268, mailed July 17, 2006.
`
`
`
`
`
`
`
`
`
`
`USPTO Non-Final Office Action, USSN 11/388,268, mailed November 17, 2006.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`USPTO Final Office Action, USSN 11/388,268, mailed November 12, 2008
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`333
`333
`3”
`3”‘
`
`333
`3"
`3‘3
`333
`320
`
`
`
`
`
`
`
`
`33‘
`
`333
`333
`
`333
`333
`326
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`USPTO Advisory Action, USSN 11/388,269, mailed July 15, 2009.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`USPTO lnten/iew Summary, USSN 11/388,270, dated December 14, 2007.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`USPTO Notice of Allowance and Fees Due, USSN 11/388,270, mailed January 5,2011.
`
`
`
`
`
`
`
`
`
`
`
`
`USPTO Non-Final Office Action, USSN 13/087,012, mailed March 12, 2012.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`USPTO Non-Final Office Action, USSN 13/087,012, mailed July 19, 2012.
`
`
`
`
`
`
`
`
`
`
`
`USPTO interview Summary, USSN 13/087,012, dated February 15, 2013.
`
`
`
`
`
`
`
`
`
`
`USPTO Notice of Allowance and Fees Due, USSN 13/087,012, mailed February 27, 2013.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`USPTO Response to Amendment under Rule 312, USSN 13/087,012, mailed April 4, 2013.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`337
`333
`333
`33°
`
`33‘
`
`332
`
`333
`
`334
`
`
`
`335
`
`336
`
`337
`
`
`
`
`
`
`
`5582040v1
`
`
`
`
`
`
`
`
`ALL REFERENCES CONSEBEREED EXCEPT WHERE UNEE) THROUGH.
`
`
`
`/SQ./’
`
`
`
`Page 7 of 12
`
`Page 7 of 12
`
`

`
`
`
`
`
`
`
`
`
`
`
`
`
`‘i3901830 ~ GAL}: 1628
`Receit date: 05/24/2013
`
`
`
`
`Complete if Known
`Application Number
`
`
`
`
`
`
`
`
`Ff/i~aDate
`INFORMATION DISCLOSURE
`
`
`First Named Inventor
`Giorgio Calderari
`
`
`
`
`
`
`
`
`STATEMENT BY A""”°A"'T L
`
`
`
`
`Examiner Name
`(Use as many sheets as necessary)
`
`
`
`
`
`
`
`
`
`
`
`
`
`11 Anomeyoockerwumner
`
`
`
`
`
`
`
`2a2m.us.e
`
`
`
`
`
`
`
`
`
`
`NONPATENT LITERATURE DOCUMENTS
`
`
`USPTO Non-Final Office Action, USSN 11/129,839, mailed June 10,2008.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`400
`
`
`
`401
`
`
`
`
`Eisenberg et al. 2004, “Efficacy, safety and pharmacokinetics of palonosetron in patients receiving highly
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`emetogenic cisplatin-based chemotherapy: a dose-ranging clinical study. “Annals of Oncology, Volume 15,
`
`
`
`
`
`
`
`
`
`
`
`pages 330-337.
`
`
`402 Mayron et al. 1996, “Stability and compatibility of granistron hydrochloride in i.v. solutions and oral liquids
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`and during simulated Y-site injection with selected drugs." Am J Health-Sys Pharm, 53: 294-304.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Trissel et al. 1997, “Com patibility of granisetron hydrochloride with selected drugs during simulated Y -site
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`administration.” Am J Health-Syst Pharm 54: 56-60.
`
`
`
`
`
`
`
`USPTO Final Office Action, USSN 11/129,839, mailed March 17, 2009.
`
`
`
`
`
`
`
`
`
`
`403
`
`404
`
`
`
`
`
`
`
`
`
`
`
`
`
`405
`
`406
`
`407
`
`408
`
`409
`
`410
`
`
`
`
`
`
`
`
`
`
`
`
`
`411
`
`
`412
`
`USPTO Advisory Action, USSN 11/129,839, mailed July 22, 2009.
`
`
`
`
`
`
`
`
`
`
`
`USPTO Non-Final Office Action, USSN 11/129,839, mailed January 15, 2010.
`
`
`
`
`
`
`
`
`
`
`
`
`USPTO Examiner Interview Summary, USSN 11/129,839, mailed November 9,2010.
`
`
`
`
`
`
`
`
`
`
`
`
`USPTO Notice of Allowance and Fees Due, USSN 11/129,839, mailed January 3, 2011.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`USPTO Notice of Abandonment, USSN 11/129,839, mailed April 18, 2011.
`
`
`
`
`
`
`
`
`
`
`
`
`USPTO Non-Final Office Action, USSN 13/077,374, mailed February 17, 2012.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Roila et al. 1998, “Prevention of chemotherapy- and radiotherapy-induced emesis: Results of the Perugia
`
`
`
`
`
`
`
`
`
`
`
`
`consensus conference.” Annals of Oncology, Volume 9, pages 811-819.
`
`
`
`
`
`
`
`
`
`USPTO Final Office Action, USSN 13/077,374, mailed November 23,2012.
`
`
`
`
`
`
`
`
`
`
`Piraccini, Gaia et al., American Society of Clinical Oncology May 12-15, 2001 San Francisco- USA (Vol. 20,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`part 1 of 2, 2001) (Abstract no. 1595).
`
`
`
`
`
`
`
`
`
`
`
`USPTO Non-Final Office Action, USSN 11/201,035, mailed May 16, 2008.
`
`
`
`
`
`
`
`
`
`
`
`
`USPTO Final Office Action, USSN 11/201,035, mailed February 4, 2009.
`
`
`
`
`
`
`
`
`
`
`
`
`USPTO Final Office Action, USSN 11/201,035, mailed June 8,2010.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`413
`
`450
`
`
`
`451
`
`452
`
`
`
`500
`
`
`
`FDA approval letter of Aloxi (palonosetron hydrochloride injection), dated July 25, 2003.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`501
`
`
`
`
`Grunberg SM, Hajdenberg J, Charu V, et al. Palonosetron is active in preventing acute and delayed emesis 502
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Macciocchi A, Chernoff SB, Gallagher SC. A phase II dose-ranging study to assess intravenous doses of
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`palonosetron for the prevention of highly emetogenic chemotherapy-induced nausea and vomiting. In:
`
`
`
`
`
`
`
`
`
`
`
`
`Program/Proceedings of the 38th Annual Meeting of the American Society of Clinical Oncology; May 18-21,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`2002; Orlando, Fla. Abstract 1480.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` 503
`following moderately emetogenic chemotherapy: results of a phase III trial. Support Care Cancer
`
`
`
`
`
`
`
`
`
`
`
`2002;10:Abstract F’-1 13
`
`
`
`Aapro MS, Selak E, Lichinitser M, et al. Palonosetron is more effective than ondansetron in preventing
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy:
`
`
`
`
`
`
`
`
`
`
`results of a phase III trial. In: Program/Proceedings of the 39th Annual Meeting of the American Society of
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Clinical Oncology; May 31—June 3, 2003; Chicago, Ill. Abstract 2918.
`
`
`
`
`
`
`
`
`
`
`Aapro MS, Bertoli L, Lordick F, et al. Palonosetron is effective in preventing acute and delayed
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`chemotherapy induced nausea and vomiting in patients receiving highly emetogenic chemotherapy. 15"‘
`
`
`
`
`
`
`
`
`
`
`
`
`
`MASCC International Symposium, Berlin, Germany. Support Care Cancer, Vol. 11, No. 6, June 2003, A17.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Cartmell AD, Ferguson 8, Yanaglhara R, et al. Protection against chemotherapy-induced nausea and
`
`
`
`
`
`
`
`
`
`
`
`
`
`vomiting is maintained over multiple cycles of moderately or highly emetogenic chemotherapy by
`
`
`
`
`
`
`
`
`
`
`
`
`
`palonosetron, a potent 5 HT3 receptor antagonist. In: Program/Proceedings of the 39th Annual Meeting of
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`the American Society of Clinical Oncology; May 31—June 3, 2003; Chicago, Ill. Abstract 3041.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Sabra, Choice of a 5-HT3 Receptor Antagonist for the Hospital Formulary, EHP, October 1996, vol. 2, Supp
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1, S19-S24.
`
`
`Gregory and Ettinger, 5HT3 receptor antagonists for the prevention of chemotherapy-induced nausea and
`
`
`
`
`
`
`
`
`
`
`
`
`
`vomiting. A comparison of their pharmacology and clinical efficacy. Drugs, February 1998; 55(2): 173-189.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`504
`
`505
`
`506
`
`
`
`
`
`507
`
`
`
`
`
`5582040v1
`
`
`
`
`
`
`
`
`
`ALL REFERENCES CONSEBERED EXCEPT WHERE IJNED THROUGH.
`
`
`
`/8.3./’
`
`
`
`Page 8 of 12
`
`Page 8 of 12
`
`

`
`
`
`
`
`Application Number
`
`Filing Date
`
`
`First Named Inventor
`
`
`
`
`
`
`
`Giorgio Calderari
`
`
`
`
`
`
`
`
`
`Receipt date: 05/24/2013
`‘$901830 ~ GAE}: 1628
`
`
`
`
`
`Complete if Known
`
`
`
`
`
`INFORMATION DISCLOSURE
`
`
`
`STATEMENT BY APPLICANT
`
`
`
`
`
`
`
`
`
`(use-smanyasnecessam T
`
`
`
`
`
`
`
`
`
`:1 Anorneyoocker~umber
`2s2vs.2.us.e
`
`
`
`
`
`
`
`
`
`
`
`
`
`NONPATENT LITERATURE DOCUMENTS
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`- Full Prescribing Information for Aloxi (palonosetron HCl) injection for Intravenous Use (2008). _
`509
`Drug, Dose & Schedule Recommendations for Antiemetic Regimens (American Society for Clinical
`
`
`
`
`
`
`