Post Grant Review No.
`Patent No. 9,173,942
`Petition for Post Grant Review
`Attorney Docket No. REDDY 7.2R-022
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________________
`
`DR. REDDY’S LABORATORIES, LTD. and
`DR. REDDY’S LABORATORIES, INC.,
`Petitioners
`
`v.
`
`HELSINN HEALTHCARE S.A. and ROCHE PALO ALTO LLC,
`Patent Owners.
`
`
`U.S. Patent No. 9,173,942 to Giorgio Calderari et al.
`Issue Date: November 3, 2015
`Title: LIQUID PHARMACEUTICAL FORMULATIONS OF PALONOSETRON
`____________________________
`
`Post Grant Review No. PGR2016-00008
`__________________________________________________________________
`
`PETITION FOR POST GRANT REVIEW OF
`CLAIMS 1-19 OF U.S. PATENT NO. 9,173,942
`UNDER 35 U.S.C. §§ 321-329 AND 37 C.F.R. § 42.200 ET SEQ.
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`4387562_1.docx
`
`

`

`Post Grant Review No.
`Patent No. 9,173,942
`Petition for Post Grant Review
`Attorney Docket No. REDDY 7.2R-022
`
`
`TABLE OF CONTENTS
`
`Page
`
`TABLE OF AUTHORITIES ................................................................................... iii
`
`EXHIBIT LIST ......................................................................................................... v
`
`NOTICE OF LEAD AND BACKUP COUNSEL PURUSANT
`TO 37 C.F.R. § 42.8(b)(3) ......................................................................................... 1
`NOTICE OF EACH REAL PARTY IN INTEREST PURSUANT
`TO 37 C.F.R. § 42.8(b)(3) ......................................................................................... 1
`NOTICE OF RELATED MATTERS PURSUANT TO
`37 C.F.R. § 42.8(b)(2) ................................................................................................ 2
`NOTICE OF SERVICE INFORMATION PURSUANT TO
`37 C.F.R. § 42.8(b)(4) ................................................................................................ 3
`GROUNDS FOR STANDING UNDER 37 C.F.R. § 42.204 ................................... 4
`IDENTIFICATION OF CHALLENGE STATEMENT OF PRECISE RELIEF
`REQUESTED PURSUANT TO 37 C.F.R. §§ 42.22(a)(1) AND 42.204(b) ............ 6
`SUPPORTING EVIDENCE UNDER 37 C.F.R. § 42.204(b)(5) .............................. 7
`STATEMENT OF REASONS FOR RELIEF REQUESTED .................................. 7
`I.
`INTRODUCTION AND SUMMARY OF ARGUMENT .............................. 7
`II.
`THE CLAIMS UNDER CONSIDERATION ...............................................10
`III. THE SPECIFICATION AND PROSECUTION HISTORY OF THE
`‘942 PATENT ................................................................................................10
`A. The Specification Of The ‘942 Patent ....................................................10
`B. The Prosecution History Of The ‘942 Patent And Its Ancestors ...........14
`1. The Original Formulation Claims Of The Priority Applications
`Required A Stable Solution For Preventing Emesis ........................14
`
`i
`
`

`

`Post Grant Review No.
`Patent No. 9,173,942
`Petition for Post Grant Review
`Attorney Docket No. REDDY 7.2R-022
`
`
`2. The Patent Owners’ Earlier-Issued U.S. Patents Claimed Various
`Combinations Of Ingredients, Method Steps, And The Like, But
`Always A Stable Solution ................................................................16
`IV. CLAIM CONSTRUCTION PURSUANT TO 37 C.F.R. § 42.204(B)(3) ....20
`V. ANALYSIS ....................................................................................................24
`A. Ground 1: Claims 1-19 Are Invalid Under The Written Description
`Provision of 35 U.S.C. § 112(a) .............................................................24
`B. Ground 2: Claims 1-19 Are Invalid Under The On-Sale Bar Of
`§ 102(a)(1) ..............................................................................................30
`1. The Supply And Purchase Agreement Between Patent Owner
`and MGI ...........................................................................................30
`2. The Supply Agreement Was A Commercial Offer for Sale
`Of The Claimed Invention ...............................................................34
`3. The Invention Was Ready For Patenting Prior To The
`Critical Date .....................................................................................36
`4. The Offer For Sale Complied With Post-AIA Section 102 .............39
`a.
`The AIA Did Not Change The Law To Require That
`“On Sale” Activity Be “Public” In Order To Qualify As
`Invalidating Prior Art .............................................................39
`The Supply Agreement Was A Public Offer For Sale
`In Any Event ..........................................................................43
`5. Claims 1-19 Are Invalid Because Of The Supply Agreement ........44
`VI. CONCLUSION ..............................................................................................61
`
`
`
`b.
`
`ii
`
`

`

`Post Grant Review No.
`Patent No. 9,173,942
`Petition for Post Grant Review
`Attorney Docket No. REDDY 7.2R-022
`
`
`TABLE OF AUTHORITIES
`
`
`CASES
`A-Transp. Nw. Co. v. United States,
`36 F.3d 1576 (Fed. Cir. 1994) ............................................................................ 35
`
`Page(s)
`
`Air Wis. Airlines Corp. v. Hoeper,
`134 S. Ct. 852 (2014) .......................................................................................... 42
`
`Anascape, Ltd. v. Nintendo of Am., Inc.,
`601 F.3d 1333 (Fed. Cir. 2010) .................................................................... 30, 31
`
`Buildex, Inc. v. Kason Indus., Inc.,
`849 F.2d 1461 (Fed. Cir. 1988) .................................................................... 36, 44
`
`Cooper Cameron Corp. v. Kvaerner Oilfield Prods., Inc.,
`291 F.3d 1317 (Fed. Cir. 2002) .................................................................... 25, 27
`
`Enzo Biochem, Inc. v. Gen-Probe Inc.,
`424 F.3d 1276 (Fed. Cir. 2005) ...................................................................... 9, 35
`
`FAA v. Cooper,
`132 S. Ct. 1441, 1449 (2012) .............................................................................. 43
`
`F.C.C. v. Fox Television Stations, Inc.,
`556 U.S. 502 (2009) ............................................................................................ 43
`
`Gentry Gallery, Inc. v. Berkline Corp.,
`134 F.3d 1473 (Fed. Cir. 1988) .......................................................................... 27
`
`Group One, Ltd. v. Hallmark Cards, Inc.,
`254 F.3d 1041 (Fed. Cir. 2001) .......................................................................... 35
`
`ICU Med., Inc. v. Alaris Med. Sys., Inc.,
`558 F.3d 1368 (Fed. Cir. 2009) .................................................................... 29, 30
`
`In re Caveny,
`761 F.2d 671 (Fed. Cir. 1985) ............................................................................ 44
`
`iii
`
`

`

`Post Grant Review No.
`Patent No. 9,173,942
`Petition for Post Grant Review
`Attorney Docket No. REDDY 7.2R-022
`
`In re Cuozzo Speed Techs., LLC,
`793 F.3d 1268 (Fed. Cir. 2015), cert. granted, 2016 U.S. LEXIS 632
`(Jan. 15, 2016)..................................................................................................... 21
`
`In re Nuijten,
`500 F.3d 1346 (Fed. Cir. 2007) .......................................................................... 42
`
`J.A. LaPorte, Inc. v. Norfolk Dredging Co.,
`787 F.2d 1577 (Fed. Cir. 1986) .......................................................................... 44
`
`Neder v. United States,
`527 U.S. 1 (1999) ................................................................................................ 42
`
`Netscape Commc’n Corp. v. Konrad,
`295 F.3d 1315 (Fed. Cir. 2002) .......................................................................... 33
`
`Pfaff v. Wells Elec., Inc.,
`525 U.S. 55 (1998) ........................................................................................ 33, 37
`
`PIN-NIP, Inc. v. Platte Chem. Co.,
`304 F.3d 1235 (Fed. Cir. 2002) .................................................................... 28, 29
`
`Reiffin v. Microsoft Corp.,
`214 F.3d 1342, 1345 (Fed. Cir. 2000) ................................................................ 28
`
`Special Devices, Inc. v. OEA, Inc.,
`270 F.3d 1353 (Fed. Cir. 2002) .......................................................................... 40
`
`Univ. of Rochester v. G.D. Searle & Co.,
`358 F.3d 916 (Fed. Cir. 2004) ...................................................................... 27, 28
`
`Woodland Trust v. Flowertree Nursery, Inc.,
`148 F.3d 1368 (Fed. Cir. 1998) .................................................................... 40, 41
`
`Zacharin v. United States,
`213 F.3d 1366 (Fed. Cir. 2000) .......................................................................... 35
`
`STATUTES, RULES & OTHER AUTHORITIES
`
`35 U.S.C. § 101 ........................................................................................................ 42
`
`iv
`
`

`

`Post Grant Review No.
`Patent No. 9,173,942
`Petition for Post Grant Review
`Attorney Docket No. REDDY 7.2R-022
`
`35 U.S.C. § 102 .................................................................................................passim
`
`35 U.S.C. § 103(a) ................................................................................................... 20
`
`35 U.S.C. § 112 .................................................................................................passim
`
`35 U.S.C. § 324(a) ..................................................................................................... 4
`
`37 C.F.R. § 1.78(d)(3) ................................................................................................ 5
`
`37 C.F.R. § 42.8(b)(2), (3), (4) .......................................................................... 1, 2, 3
`
`37 C.F.R. §§ 42.15(b)(1) and (2) ............................................................................... 6
`
`37 C.F.R. §§ 42.22(a)(1) ............................................................................................ 6
`
`37 C.F.R. § 42.100(b) .............................................................................................. 21
`
`37 C.F.r. § 42.204 ............................................................................................ 4, 7, 21
`
`American Heritage Dictionary of English Language (4th ed. 2000) ...................... 24
`
`v
`
`

`

`Post Grant Review No.
`Patent No. 9,173,942
`Petition for Post Grant Review
`Attorney Docket No. REDDY 7.2R-022
`
`
`EXHIBIT LIST
`
`Reference
` 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
` 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
`
`Exhibit #
`1001
`1002
`1003
`
`1004
`
`1005
`
`1006
`1007
`1008
`
`1009
`1010
`1011
`1012
`
`vi
`
`

`

`Post Grant Review No.
`Patent No. 9,173,942
`Petition for Post Grant Review
`Attorney Docket No. REDDY 7.2R-022
`
`Exhibit #
`1013
`
`Reference
` 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)
`
`1014
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`1027
`1028
`
`1029
`
`vii
`
`

`

`Post Grant Review No.
`Patent No. 9,173,942
`Petition for Post Grant Review
`Attorney Docket No. REDDY 7.2R-022
`
`Exhibit #
`1030
`
`Reference
` 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”)
` 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
`
`1031
`
`1032
`
`1033
`
`1034
`
`1035
`
`1036
`
`1037
`
`1038
`1039
`1040
`
`1041
`
`1042
`
`1043
`
`viii
`
`

`

`Post Grant Review No.
`Patent No. 9,173,942
`Petition for Post Grant Review
`Attorney Docket No. REDDY 7.2R-022
`
`Exhibit #
`1044
`
`Reference
` 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)
`
`
`1045
`
`1046
`
`1047
`
`1048
`
`1049
`
`
`
`ix
`
`

`

`Case IPR2015-
`Petition for Inter Partes Review
`Attorney Docket No. REDDYPP 7.1R-015
`
`
`Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories,
`
`Inc.
`
`(collectively “DRL,” “Requestor,” or “Petitioner”) requests post grant review of
`
`claims 1-19 of U.S. Patent No. 9,173,942 (“the ‘942 Patent”) (Exh.1001).
`
`NOTICE OF LEAD AND BACKUP
`COUNSEL PURUSANT TO 37 C.F.R. § 42.8(b)(3)
`
`
`Lead Counsel:
`William L. Mentlik
`(Reg. No. 27,108)
`WMentlik.ipr@ldlkm.com
`Postal and Hand-Delivery Address
`600 South Avenue West
`Westfield, NJ 07090
`Telephone: 908.518.6305
`Fax: 908.654.7866
`
`Backup Counsel:
`Michael H. Teschner
`(Reg. No. 32,862)
`MTeschner.ipr@ldlkm.com
`Postal and Hand-Delivery Address
`600 South Avenue West
`Westfield, NJ 07090
`Telephone: 908.518.6313
`Fax: 908.654.7866
`
`Maegan A. Fuller
`(Reg. No. 71,596)
`MFuller.ipr@ldlkm.com
`Postal and Hand-Delivery Address
`600 South Avenue West
`Westfield, NJ 07090
`Telephone: 908.518.6313
`Fax: 908.654.7866
`
`
`
`NOTICE OF EACH REAL PARTY IN
`INTEREST PURSUANT TO 37 C.F.R. § 42.8(b)(3)
`The Real-Parties-In-Interest for this Petition are Requestor, Dr. Reddy’s
`
`Laboratories, Ltd. (“DRL LTD”), an Indian company, and Dr. Reddy’s
`
`
`
`
`
`

`

`Post Grant Review No.
`Patent No. 9,173,942
`Petition for Post Grant Review
`Attorney Docket No. REDDY 7.2R-022
`
`Laboratories, Inc. (“DRL Inc.”), a U.S. company, and wholly owned subsidiary of
`
`DRL LTD (collectively referred to herein as “DRL,” “Requestor,” or “Petitioner”).
`
`NOTICE OF RELATED MATTERS
`PURSUANT TO 37 C.F.R. § 42.8(b)(2)
`Patent Owner most recently has asserted the ‘942 Patent in a civil action
`
`filed in the United States District Court for the District of New Jersey (Civil Action
`
`No. 15-8662), filed on December 15, 2015. (Exh.1003.) Patent Owner previously
`
`asserted U.S. Patent No. 8,729,094 (“the ‘094 Patent”) in a civil action filed in the
`
`United States District Court for the District of New Jersey (Civ. Action
`
`No. 14-4274), on July 7, 2014 (“the 505(b)(2) Litigation”). It amended that
`
`complaint to add U.S. Patent No. 9,066,980 (“the ‘980 Patent”) to that civil action.
`
`(These complaints are collectively presented in Exh.1004.) Patent Owner also
`
`asserted U.S. Patent No. 7,947,724 in the 505(b)(2) Litigation. Civ. Action
`
`No. 12-2867, filed May 11, 2012. Patent Owner has also filed Civ. Action
`
`No. 11-3962,
`
`filed July 8, 2011, alleging
`
`infringement of U.S. Patent
`
`Nos. 7,947,724 and 7,947,725; Civ. Action No. 11-5579, filed September 23, 2011,
`
`alleging infringement of U.S. Patent No. 7,960,424; and Civ. Action No. 13-5815,
`
`filed September 30, 2013, and amended December 27, 2013 (alleging infringement
`
`of U.S. Patent Nos. 8,518,981; 8,598,218; and 8,598,219) (these complaints are
`
`2
`
`

`

`Post Grant Review No.
`Patent No. 9,173,942
`Petition for Post Grant Review
`Attorney Docket No. REDDY 7.2R-022
`
`collectively presented in Exh.1005). All of these cases are before The Honorable
`
`Judge Cooper in the U.S. District Court for the District of New Jersey.
`
`A trial was held before Judge Cooper regarding U.S. Patent Nos. 7,947,724;
`
`7,947,825; 7,960,424; and 8,598,219 in June of 2015 (“the ANDA Litigation”).
`
`Petitioner was a party to the trial. However, Petitioner and Patent Owner reached a
`
`settlement between the hearing and a decision. A Final Judgment Order finding
`
`that these four patents were valid and infringed against the remaining defendant
`
`was issued on November 16, 2015. (Exh.1040.) In addition to the Final Judgement
`
`Order, the court provided an initial opinion that was first filed under seal. That
`
`opinion is now publicly available. (Exh.1049.)
`
`Also filed concurrently herewith is a Petition for PGR seeking a final written
`
`opinion of invalidity as to claims 1-6, 10 and 11 of the ‘942 Patent bearing
`
`Attorney Docket No. REDDY 7.2R-021.
`
`NOTICE OF SERVICE INFORMATION
`PURSUANT TO 37 C.F.R. § 42.8(b)(4)
`Please address all correspondence to the lead and backup counsel
`
`at
`
`the address
`
`shown above. Requestor also consents
`
`to electronic
`
`service by e-mail at: WMentlik.ipr@ldlkm.com, MTeschner.ipr@ldlkm.com,
`
`MFuller.ipr@ldlkm.com.
`
`3
`
`

`

`Post Grant Review No.
`Patent No. 9,173,942
`Petition for Post Grant Review
`Attorney Docket No. REDDY 7.2R-022
`
`
`GROUNDS FOR STANDING UNDER 37 C.F.R. § 42.204
`Petitioner certifies that the patent for which review is sought is available for
`
`post grant review, and that the Petitioner is not barred or estopped from requesting
`
`post grant review on the grounds identified in this petition. This Petition is filed
`
`within nine months of the November 3, 2015 issue date of the ‘942 Patent.
`
`Petitioner has not filed a civil action challenging the validity of a claim of the
`
`‘942 Patent. This Petition demonstrates that it is more likely than not that at least
`
`one of the claims challenged in the Petition is unpatentable. 35 U.S.C. § 324(a).
`
`The ‘942 Patent is an AIA first-to-file patent. The ‘942 Patent claims priority
`
`to continuation-in-part application number 13/901,437 (“the ‘437 Application),
`
`which issued as U.S. Patent No. 8,598,219. (Exh.1014.) The ‘437 Application was
`
`filed on May 23, 2013, the day before the ‘942 Patent was filed. The
`
`‘437 Application was filed with an Application Data Sheet (“ADS”) identifying it
`
`as an AIA application. (Exh.1015, at 4.)
`
`As of February 4, 2016, the PAIR listing for US 8,598,219 Patent, the direct
`
`parent of the ‘942 Patent, indicates “yes” in the section of the PAIR entry
`
`identifying AIA status. However, its immediate child, the ‘942 Patent, is still listed
`
`as “No” in the section of the PAIR entry identifying AIA status. The PAIR entry
`
`for the ‘942 Patent is in error.
`
`4
`
`

`

`Post Grant Review No.
`Patent No. 9,173,942
`Petition for Post Grant Review
`Attorney Docket No. REDDY 7.2R-022
`
`
`In the ‘437 Application a letter was filed entitled “Identification of
`
`Continuation-In-Part Claim Support Required Under 37 C.F.R. § 1.78(d)(3) and
`
`Choice of Law” in which Applicants asserted that the ‘437 Application is subject
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`to AIA. (Exh.1016, at 2-3.) The letter stated that claim 9 had support only in newly
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`added Example 8 of the Continuation-in-Part application. Notwithstanding that
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`letter, the USPTO sent a communication to the Applicants stating that the
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`application was a continuation of its predecessor and thus pre-AIA law applied.
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`(Exh.1017.) Subsequently, Applicants held an interview with the Examiner and, as
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`reflected by the Interview Summary (Exh.1018) and on the USPTO PAIR system,
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`the Examiner indicated that the Applicants successfully argued that the application
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`is an AIA application. It was acknowledged that the application was a CIP and that
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`the ADS as filed indicated both that the application was a CIP and designated the
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`application as an AIA application. (Id.)
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`The ‘942 Patent is a continuation of the ‘437 Application as was indicated
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`on its ADS and in a Preliminary Amendment. (Exhs.1019, at 13; 1020, at 2.)
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`Despite this, on September 16, 2013, the USPTO sent a communication to the
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`Applicants stating that the ‘942 Patent was a continuation of an application filed
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`before March 16, 2013, and thus would be examined under pre-AIA law.
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`5
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`

`

`Post Grant Review No.
`Patent No. 9,173,942
`Petition for Post Grant Review
`Attorney Docket No. REDDY 7.2R-022
`
`(Exh.1021.) Each of Applicants’ subsequent responses to office actions, however,
`
`included a discussion of AIA status noting that it should be treated as an AIA
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`application. (See, for example, Exhs.1023, at 14-16; 1024, at 5 fn.1.) As a
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`continuation of the ‘437 Application, which was acknowledged as an AIA
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`application by the Examiner (Exh.1018), the ‘942 Patent must be an AIA patent
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`and should be available for PGR.
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`The fees pursuant to 37 C.F.R. §§ 42.15(b)(1) and (2) for this Petition
`
`($12,000.00 and $18,000.00, respectively) have been paid. However, the U.S.
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`Patent and Trademark Office is hereby authorized to charge Deposit Account
`
`No. 12-1095 for any fees that may be due and owing in connection with this
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`Petition.
`
`IDENTIFICATION OF CHALLENGE
`STATEMENT OF PRECISE RELIEF REQUESTED
`PURSUANT TO 37 C.F.R. §§ 42.22(a)(1) AND 42.204(b)
`Petitioner requests that claims 1-19 of the ‘942 Patent be canceled because
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`they are unpatentable based on the following grounds:
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`Ground 1. Claims 1-19 are invalid for failing to satisfy the written
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`description provision of 35 U.S.C. § 112(a).
`
`Ground 2. Claims 1-19 are invalid for violating the on-sale bar provision
`
`of 35 U.S.C. § 102.
`
`6
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`

`

`Post Grant Review No.
`Patent No. 9,173,942
`Petition for Post Grant Review
`Attorney Docket No. REDDY 7.2R-022
`
`
`SUPPORTING EVIDENCE UNDER 37 C.F.R. § 42.204(b)(5)
`A list of supporting evidence pursuant to 37 C.F.R. § 42.204(b)(5) is
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`provided in the exhibit list appearing above. A copy of each exhibit is submitted
`
`herewith. This petition is additionally supported by the testimony set forth in the
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`expert declaration of Dr. Christopher Fausel (Exh.1038).
`
`I.
`
`STATEMENT OF REASONS FOR RELIEF REQUESTED
`INTRODUCTION AND SUMMARY OF ARGUMENT
`One would think in this day and age, or even as of January 2003, when the
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`provisional application leading to the ‘942 Patent was filed, that it would not be
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`possible to patent a formulation containing nothing more than a known drug (see
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`Exh.1006, disclosing palonosetron) in a solution of sugar water. But that is what
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`the ‘942 Patent claims.
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`Not content with a bevy of prior patents in the same family directed to
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`allegedly stabilized formulations of palonosetron capable of obtaining specified
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`storage stability and the use of such formulations (e.g., U.S. Patent Nos. 9,066,094;
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`7,947,724; 7,947,725; 7,960,424; 9,066,980; 8,598,219), the Patent Owner went
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`back to the Patent Office with its application for the ‘942 Patent and obtained
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`claims to formulations of surprising simplicity and scope. Unlike many of their
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`predecessors, these claimed formulations do not have to be stable. The claimed
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`7
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`

`

`Post Grant Review No.
`Patent No. 9,173,942
`Petition for Post Grant Review
`Attorney Docket No. REDDY 7.2R-022
`
`formulations are also not limited by a particular use. They do not recite a dose.
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`They do not recite a volume, let alone an amount to be administered. And, these
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`claimed
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`formulations
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`require only
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`three
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`ingredients: palonosetron, sugar
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`(mannitol), and water.
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`A review of the specification makes clear that the claimed invention, broadly
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`claimed as it is, is not supported by the specification. As discussed in detail below,
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`the entirety of the invention described in the specification and, up until now,
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`claimed in numerous related patents, is directed to the production and uses of
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`“stable” palonosetron formulations; indeed, not merely stable, but capable of
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`obtaining particular levels of storage stability. And yet, claims 1-19 ____ none of
`
`which are original ____ are all broad enough to encompass stable and unstable
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`formulations. Therefore, claims 1-19 violate the written description requirement of
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`35 U.S.C. § 112(a).
`
`Claims 1-19 are also invalid by virtue of an on-sale bar. On April 6, 2001,
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`some 21 months before the earliest effective filing date, the Patent Owner placed
`
`the claimed invention on sale to MGI Pharma, Inc. (“MGI”) in a Supply and
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`Purchase Agreement (“Supply Agreement”) that was publicly disclosed in MGI’s
`
`Form 8-K filing with Securities and Exchange Commission, thus violating the
`
`8
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`

`

`Post Grant Review No.
`Patent No. 9,173,942
`Petition for Post Grant Review
`Attorney Docket No. REDDY 7.2R-022
`
`on-sale bar under 35 U.S.C. § 102(a)(1). (See Exhs.1042, 1044.) To bar
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`patentability under the on-sale provision of § 102(a)(1), the claimed invention must
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`be sold or be the subject of a commercial offer for sale, and be ready for patenting,
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`more than one year prior to the earliest effective filing date, which in this case, is
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`January 30, 2003. All of those conditions are satisfied here.
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`Under the Supply Agreement, MGI agreed to purchase exclusively from
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`Helsinn’s subsidiary all of its requirements for a palonosetron formulation falling
`
`within the scope of the claims of the ‘942 Patent. Such a requirements contract has
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`been recognized by the Federal Circuit to be a binding agreement that constitutes a
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`commercial offer for sale ____ a commercial offer that has been accepted. See e.g.,
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`Enzo Biochem, Inc. v. Gen-Probe Inc., 424 F.3d 1276, 1281-82 (Fed. Cir. 2005).
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`On the same day and in addition to the Supply Agreement, Patent Owner signed a
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`corresponding License and Distribution Agreement with similar contract terms as
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`the Supply Agreement. (Exh.1043.) The consideration to Patent Owner for signing
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`these agreements and a previous letter of intent was payment in excess of
`
`$11 million. (Id.at 15.)
`
`The claimed invention of the ‘942 Patent was also ready for patenting well
`
`before January 30, 2002. The claims of the ‘942 Patent are directed to a simple
`
`9
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`

`

`Post Grant Review No.
`Patent No. 9,173,942
`Petition for Post Grant Review
`Attorney Docket No. REDDY 7.2R-022
`
`sugar water solution without any requirements for storage stability or efficacy for
`
`treatment of CINV or any other ailment for that matter. Formulations practicing
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`these claims, and contracted for in the Supply Agreement, had been reduced to
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`practice prior to January 30, 2002. Specifically, formulations practicing Example 4
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`of the ‘942 Patent, and having 0.25 mg of palonosetron hydrochloride, had been
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`prepared for use in Phase III clinical trials at the time the MGI contract was signed.
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`(Exh.1045, at 112:13-113:25, 206:22-209:2, 214:23-218:4) Those formulations
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`included every limitation of the claims of the ‘942 Patent. Therefore, claims 1-19
`
`of the ‘942 Patent are invalid for violating the on-sale bar under § 102(a)(1).
`
`II. THE CLAIMS UNDER CONSIDERATION
`The claims being challenged hereby are claims 1-19. The text of those
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`claims is found in the Claims Charts and in Exhibit 1001, column 7, line 57 to
`
`column 8 line 63.
`
`III. THE SPECIFICATION AND
`PROSECUTION HISTORY OF THE ‘942 Patent
`A. The Specification Of The ‘942 Patent
`From the very outset, the Abstract of the ‘942 Patent makes clear that the
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`patent is directed to “shelf-stable” formulations of palonosetron: “The present
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`invention relates to shelf-stable liquid formulations of palonosetron for reducing
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`chemotherapy and
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`radiotherapy
`
`induced emesis with palonosetron. The
`
`10
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`

`

`Post Grant Review No.
`Patent No. 9,173,942
`Petition for Post Grant Review
`Attorney Docket No. REDDY 7.2R-022
`
`formulations are particularly useful in the preparation of intravenous and oral
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`liquid medicaments.” (Exh.1001 Abstract.)
`
`The ‘942 Patent acknowledges
`
`in
`
`the “BACKGROUND OF THE
`
`INVENTION” that the known structure of palonosetron, and its salt form of
`
`palonosetron hydrochloride had been reported in a 1993 patent (Exh.1006) as
`
`having high potency and effectiveness in reducing delayed-onset nausea induced
`
`by chemotherapeutic agents. (Exh.1001, at 1:56-62.) It then notes that formulating
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`palonosetron in liquid formulations has not proven to be easy, typically due to
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`“shelf-stability issues.” (Exh.1001, at 1:62-64.)
`
`In turning to the needs and concerns that prompted the alleged invention, the
`
`inventors again make c