`
`
`
`Michael H. Teschner
`908.518.6313
`mteschner@lernerdavid.com
`
`
`
`February 5, 2016
`
`
`
`(Electronically Filed)
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P O Box 1450
`Alexandria, VA 22313-1450
`
`Post Grant Review of U.S. Patent No. 9,173,942
`Exhibit Cover Letter Per 37 C.F.R. § 42.6(e)(4)(ii)
`
`
`Dear Patent Trial and Appeal Board:
`This transmittal letter identifies Exhibits 1001-1049, being filed concurrently with the
`present Post Grant Review. Pursuant to 37 C.F.R. § 42.6(e)(4)(ii), the Certificate of Service
`attached to the end of the Petition for Post Grant Review filed herewith, incorporates
`Exhibits 1001-1049, as listed below:
`
`1001
`1002
`1003
`
`1004
`
`1005
`
` U.S. Patent No. 9,173,942
` Prosecution history of Serial No. 13/901,830
` Complaint, Helsinn Healthcare S.A. and Roche Palo Alto LLC v. Dr. Reddy’s
`Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc., Civil Action No.
`15-8662 (DNJ), filed 12/15/2015
` Complaint for Patent Infringement, Helsinn Healthcare S.A. and Roche Palo
`Alto LLC v. Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories,
`Inc., Civil Action No. 14-4274 (DNJ), filed 7/7/2014 and amended on
`9/2/2015
` Complaints for Patent Infringement, Helsinn Healthcare S.A. and Roche Palo
`Alto LLC v. Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc.
`et al., U.S.D.C.N.J. Civil Action No. 3:11-cv-03962-MLC-TJB, filed
`7/8/2011; Helsinn Healthcare S.A. and Roche Palo Alto LLC v. Dr. Reddy’s
`Laboratories, Ltd., Dr. Reddy’s Laboratories, Inc. et al., U.S.D.C.N.J. Civil
`Action Nos. 3:11-cv-05579-MLC-DEA, filed 9/23/2011; Helsinn Healthcare
`S.A. and Roche Palo Alto LLC v. Dr. Reddy’s Laboratories, Ltd. and
`Dr. Reddy’s Laboratories, Inc., U.S.D.C.N.J. Civil Action
`No. 3:12-cv-02867-MLC-DEA, filed 5/11/2012; and Helsinn Healthcare S.A.
`and Roche Palo Alto LLC v. Dr. Reddy’s Laboratories, Ltd., Dr. Reddy’s
`Laboratories, Inc. et al., 3:13-cv-05815-MLC-DEA, filed 9/30/2013 and
`amended on 12/27/2013
`
`4395089_1.docx
`
`

`

`
`
`
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`February 5, 2016
`Page 2
`
`
` U.S. Patent No. 5,202,333 (“Berger”)
` U.S. Provisional Application No. 60/444,351
` Applicant Initiated Interview Summary dated June 17, 2013, in Serial No.
`13/901,830
` PCT Application No. PCT/EP2004/000888
` U.S. Patent No.7,947,724
` U.S. Patent No. 7,947,725
` U.S. Patent No. 7,960,424
` Stipulation and Order, Helsinn Healthcare S.A. et al. v. Dr. Reddy’s
`Laboratories, Ltd. et al., Civ. Action No. 11-3962 (D.N.J.), June 1, 2015,
`Mary L. Cooper, U.S.D.J. (“18-24 month stability (“18-24 month stability”)
` U.S. Patent No. 8,598,219
` Application Data Sheet of Continuation-in-Part Serial No. 13/901,437
`(8,598,219)
` Letter entitled “Identification of Continuation-in-Part Claim Support Required
`Under 37 C.F.R. § 1.78(d)(3) and Choice of Law” filed May 23, 2013, in
`Serial No. 13/901,437 (8,598,219)
` Office Communication dated July 12, 2013, in Serial No. 13/901,437
`(8,598,219)
` Examiner Initiated Interview Summary dated July 16, 2013, in Serial
`No. 13/901,437 (8,598,219)
` Application Data Sheet filed May 24, 2013, in Serial No. 13/901,830
` Preliminary Amendment filed May 24, 2013, in Serial No. 13/901,830
` Office Communication dated September 16, 2013, in Serial No. 13/901,830
` Non-Final Office Action dated November 22, 2013, in Serial No. 13/901,830
` Applicants’ Response dated February 21, 2014, in Serial No. 13/901,830
` Supplemental Response dated March 3, 2015 in Serial No. 13/901,830
` Originally Filed Claims dated May 23, 2013, in Serial No.13/901,437
`(8,598,219)
` U.S. Patent No. 8,729,094
` U.S. Patent No. 9,066,980
` Trial Tr. Candiotti (direct) 18-20, Helsinn v. Dr. Reddy’s, Civil Action
`No. 11-3962, June 10, 2015 (“POSA”)
` Definition of “formula” (formulation),” The American Heritage Dictionary of
`English Language 691 (4th ed. 2000)
` Definition of “pharmaceutical,” The American Heritage Dictionary of the
`English Language 1316 (4th ed. 2000)
` The American Heritage Dictionary of English Language 61 (4th ed. 2000)
`(definition of “amount”)
`
`1006
`1007
`1008
`
`1009
`1010
`1011
`1012
`1013
`
`1014
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`1020
`1021
`1022
`1023
`1024
`1025
`
`1026
`1027
`1028
`
`1029
`
`1030
`
`1031
`
`4395089_1.docx
`
`

`

`
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`February 5, 2016
`Page 3
`
`
`1032
`
`1033
`1034
`
`1035
`
`1036
`
`1037
`
`1038
`1039
`1040
`
`1041
`
`1042
`
`1043
`
`1044
`
`1045
`
`1046
`
`1047
`
`1048
`
`1049
`
`
`
` Statutory Declaration of Daniele Bonadeo, M. Chem. Pharm. 37 C.F.R. §§ 131
`and 132, filed Mar. 2, 2007
` Notice of Allowance dated August 25, 2015, in Serial No. 13/901,830)
` The American Heritage Dictionary of English Language 537 (4th ed. 2000)
`(definition of “dose”)
` Order Construing the Terms of U.S. Patent Nos. 7,947,724; 7,947,725;
`7,960,424; 8,598,219 & 8,729,094, Helsinn Healthcare S.A. et al. v. CIPLA
`Ltd. et al. (D. Del. 13-688), filed Mar. 9, 2015
` Memorandum Opinion, Helsinn Healthcare S.A. et al. v. Dr. Reddy’s
`Laboratories, Ltd. et al., Civil Action No. 11-3962, filed Apr. 22, 2015,
`Mary L. Cooper, U.S.D.J. (ANDA Litigation ____ CINV)
` Order, Helsinn Healthcare S.A. et al. v. Dr. Reddy’s Laboratories, Ltd. et al.,
`Civil Action No. 12-2867 (Dkt.91), Feb. 19, 2015, Mary L. Cooper, U.S.D.J.
`(originally under seal, currently published) (505(b)(2) Litigation ____ chelating
`agent)
` Declaration of Dr. Christopher A. Fausel
` Curriculum Vitae of Dr. Christopher A. Fausel
` Final Judgment, Helsinn Healthcare S.A. et al. v. Dr. Reddy’s Laboratories,
`Ltd. et al., Civ. Action No. 11-3962 (consolidated) D.N.J., Nov. 16, 2015,
`Mary L. Cooper, U.S.D.J. (ANDA Litigation)
` Memorandum Opinion, Helsinn Healthcare S.A. et al. v. Dr. Reddy’s
`Laboratories, Ltd. et al., Civ. Action No. 11-3962 (D.N.J.), Nov. 13, 2015,
`Mary L. Cooper, U.S.D.J. (originally under seal, currently published) (Interim
`Op. ANDA Litigation)
` Supply and Purchase Agreement Between Helsinn Birex Pharmaceuticals Ltd.
`and MGI Pharma, Inc., dated April 6, 2001
` License Agreement between Helsinn Healthcare SA and MGI Pharma, Inc. for
`Palonosetron, dated April 6, 2001
` EDGAR filing documents for MGI Pharma, Inc., filed April 25, 2001, SEC
`Accession No. 0001045969-01-500128
` Trial Tr. Calderari (direct) 105-225 Helsinn v. Dr. Reddy’s, Civil Action
`No. 11-3962, June 2, 2015 (“On-sale”)
` Trial Tr. O’Malley (opening), 90, Helsinn v. Dr. Reddy’s, Civil Action
`No. 11-3962, June 2, 2015
` “MGI Pharma Signs Exclusive License Agreement with Helsinn Healthcare
`SA, For Palonosetron, a Phase 3 Anti-Emetic,” Helsinn News, April 10, 2001.
` Trial Tr. O’Malley (opening) 89:9-15, Helsinn v. Dr. Reddy’s, Civil Action
`No. 11-3962, June 2, 2015
` Mark Gibson (ed.), Pharmaceutical Preformulation and Formulation, A
`Practical Guide from Candidate Drug Selection to Commercial Dosage Form,
`p. 202 (2001)
`
`4395089_1.docx
`
`Respectfully submitted,
`
`

`

`
`
`
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`February 5, 2016
`Page 4
`
`
`/cmc
`
`
`LERNER, DAVID, LITTENBERG,
` KRUMHOLZ & MENTLIK, LLP
`
`MICHAEL H. TESCHNER
`Registration No. 32,862
`Counsel for Petitioner
`
`
`
`4395089_1.docx
`
`