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`Paper No. ___
`July 8, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`WOCKHARDT BIO AG
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`PETITIONER
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`V.
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`ELI LILLY & COMPANY
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`PATENT OWNER
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`CASE NO.: UNASSIGNED
`PATENT NO. 7,772,209
`
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`
`PETITION FOR INTER PARTES REVIEW OF
`U.S. PATENT NO. 7,772,209 PURSUANT TO
`35 U.S.C. §§ 311-319 AND 37 C.F.R. § 42
`
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`
`
`TABLE OF CONTENTS
`
`
`I.
`
`II.
`
`INTRODUCTION ........................................................................................... 1
`
`OVERVIEW .................................................................................................... 2
`
`III. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8(a)(1) .......................... 4
`
`A.
`
`B.
`
`Real Party-In-Interest ............................................................................ 4
`
`Related Matters ...................................................................................... 4
`
`1.
`
`2.
`
`Related Litigations ...................................................................... 4
`
`Related Proceedings Before the Board ....................................... 6
`
`C.
`
`Lead and Back-Up Counsel ................................................................... 7
`
`IV. PAYMENT OF FEES (37 C.F.R. § 42.15(a) and § 42.103) ........................... 8
`
`V. GROUNDS FOR STANDING ........................................................................ 8
`
`VI.
`
`IDENTIFICATION OF CHALLENGE AND
`STATEMENT OF THE PRECISE RELIEF REQUESTED .......................... 8
`
`VII. THRESHOLD REQUIREMENT FOR INTER PARTES REVIEW ............... 9
`
`VIII. STATEMENT OF REASONS FOR THE RELIEF REQUESTED ............. 10
`
`A.
`
`B.
`
`Summary of the Argument .................................................................. 10
`
`Background of the ’209 Patent ............................................................ 13
`
`1.
`
`2.
`
`3.
`
`Prior Art Administration of Pemetrexed
`Resulted in Toxicity Caused by Elevated
`Homocysteine Levels ................................................................ 13
`
`It Was Well-Known that Elevated Baseline
`Homocysteine Levels Are Most Effectively
`Treated by Administering Both Folic Acid
`and Vitamin B12 ......................................................................... 15
`The ’209 Patent ......................................................................... 17
`
`i
`
`
`
`
`
`C.
`
`D.
`
`4.
`
`The Prosecution of the ’209 Patent ........................................... 17
`
`Person of Ordinary Skill in the Art ..................................................... 19
`
`Claim Construction ............................................................................. 20
`
`1.
`
`2.
`
`3.
`
`“Patient” .................................................................................... 20
`
`The “Effective Amount” Limitations ....................................... 23
`
`“Methylmalonic Acid Lowering Agent” .................................. 24
`
`E.
`
`Patents and Printed Publications Relied on in this Petition ................ 25
`
`1.
`
`2.
`
`Calvert (Ex. 1007) Teaches that Elevated
`Baseline Homocysteine Levels Associated
`with Pemetrexed Toxicity Are Caused by
`Either Folic Acid or Vitamin B12 Deficiencies ......................... 25
`Niyikiza I (Ex. 1006) Teaches a Strong
`Correlation between Baseline Homocysteine
`Levels and Pemetrexed Toxicity ............................................... 26
`
`3. Worzalla (Ex. 1013) Teaches Pretreating
`Animal Patients with Folic Acid before
`Pemetrexed Therapy ................................................................. 27
`
`4.
`
`Hammond I (Ex. 1015) Teaches Pretreating
`Human Patients with Folic Acid before
`Starting Pemetrexed Therapy .................................................... 28
`
`F.
`
`The Challenged Claims Are Unpatentable as
`Obvious over the Prior Art .................................................................. 29
`
`1.
`
`Calvert and Niyikiza I Would Have Motivated
`a POSA to Add Vitamin B12 to the Folic
`Acid Pretreatment Regimen of Worzalla
`or Hammond I ........................................................................... 29
`
`a.
`
`A POSA Would Know to Pretreat patients
`with Vitamin B12 to Reduce High
`Homocysteine Levels Linked to
`Pemetrexed Toxicity ....................................................... 29
`
`ii
`
`
`
`
`
`2.
`
`3.
`
`4.
`
`5.
`
`b.
`
`The Prior Art Taught Combining Antifolates
`with Vitamin B12 and Folic Acid .................................... 34
`Claims 1 and 2 Are Obvious Over Calvert
`and Niyikiza I in View of Worzalla or Hammond I,
`and a POSA’s Knowledge of the Relationship
`between Homocysteine, Folic Acid and Vitamin B12 ............... 36
`a.
`The POSA Would Have Had a
`Reasonable Expectation of Success ................................ 42
`
`b.
`
`c.
`
`No Secondary Considerations Support
`Non-Obviousness ............................................................ 47
`
`The Patent Owner’s “Teaching Away”
`Arguments Lack Merit .................................................... 51
`
`Claims 3-10, 12, and 14-21 Are Obvious in
`Further View of the Known Dosages and
`Schedules for Administering Folic Acid
`and Vitamin B12 ......................................................................... 54
`Claim 11 Is Obvious in Further View of
`the POSA’s Knowledge of the Benefit of
`Combining Cisplatin with Pemetrexed ..................................... 60
`
`Claims 13 and 22 Are Obvious over Worzalla
`or Hammond I in View of Niyikiza I, Calvert in
`Further View of the POSA’s Knowledge of the
`Claimed Dosages, Schedules and Combination
`with Cisplatin ............................................................................ 62
`
`IX. CONCLUSION .............................................................................................. 62
`
`
`
`
`iii
`
`
`
`
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`TABLE OF AUTHORITIES
`
` Pages
`
`Cases
`Aventis Pharma Deutschland GmbH v. Lupin, Ltd.,
`499 F.3d 1293 (Fed. Cir. 2007) .......................................................................... 34
`
`Bayer Healthcare Pharm., Inc. v. Watson Pharm. Inc.,
`713 F.3d 1369 (Fed. Cir. 2013) .......................................................................... 48
`
`Bell Commc’ns Research, Inc. v. Vitalink Commc’ns Corp.,
`55 F.3d 615 (Fed. Cir. 1995) ............................................................................. 34
`
`Bristol-Myers Squibb Co. v. Teva Pharm. USA, Inc.,
`923 F. Supp. 2d 602 (D. Del. 2013) .................................................................. 49
`
`Dow Jones & Co., Inc. v. Ablaise Ltd.,
`606 F.3d 1338 (Fed. Cir. 2010) .......................................................................... 49
`
`In re Am. Acad. of Sci. Tech Ctr.,
`367 F.3d 1359 (Fed. Cir. 2004) .......................................................................... 23
`
`In re Cuozzo Speed Techs., LLC,
`793 F.3d 1268 (Fed. Cir. 2015) .......................................................................... 20
`
`In re Droge,
`695 F.3d 1334 (Fed. Cir. 2012) .......................................................................... 42
`
`In re Fulton,
`391 F.3d 1195 (Fed. Cir. 2004) .......................................................................... 51
`
`In re Trans Texas Holdings Corp.,
`498 F.3d 1290 (Fed. Cir. 2007) ............................................................................ 6
`
`In re Young,
`927 F.2d 588 (Fed. Cir. 1991) ............................................................................ 53
`
`Key Pharm. Inc. v. Hercon Labs. Corp.,
`161 F.3d 709 (Fed. Cir. 1998) ...................................................................... 23, 24
`
`Medichem, S.A. v. Rolabo S.L.,
`437 F.3d 1157 (Fed. Cir. 2006) .................................................................... 46, 53
`
`iv
`
`
`
`
`
`Merck & Co. v. Teva Pharm. USA, Inc.,
`395 F.3d 1364 (Fed. Cir. 2005) .......................................................................... 50
`
`Noven Pharm, Inc. v. Novartis AG,
`No. IPR2014-549, 2015 WL 5782080 (PTAB Sept. 28, 2015) ........................... 6
`
`Novo Nordisk A/S v. Eli Lilly & Co.,
`No. 98-643, 1999 WL 1094213 .......................................................................... 22
`
`Pfizer, Inc. v. Apotex, Inc.,
`480 F.3d 1348 (Fed. Cir. 2007) .......................................................................... 47
`
` Santarus, Inc. v. Par Pharm., Inc.,
`720 F. Supp.2d 427 (D. Del. 2010) ..................................................................... 49
`
`Santarus, Inc. v. Par Pharm., Inc.,
`694. F.3d 1344 (Fed. Cir. 2012) ......................................................................... 49
`
`Syntex (U.S.A.) LLC v. Apotex, Inc., 407 F.3d 1371, 1380 (Fed. Cir.
`2005) ............................................................................................................. 51, 53
`
`Tyco Healthcare Grp. LP v. Mut. Pharm. Co. Inc.,
`642 F.3d 1370 (Fed. Cir. 2011) .......................................................................... 48
`
`Statutes and Codes
`
`United States Code
`35 §102(a) ........................................................................................................... 60
`35 §102(b) ....................................................................................................passim
`35 §103 .............................................................................................................. 3, 5
`35 pre-AIA § 103 .................................................................................................. 8
`35 § 103(a) ............................................................................................................ 8
`35 § 314(a) ............................................................................................................ 9
`
`
`
`v
`
`
`
`
`
`Rules and Regulations
`
`Code of Federal Regulations
`21 § 312.30(b) ..................................................................................................... 49
`37 C.F.R. §42.24(a) ............................................................................................ 63
`37 C.F.R. § 42.24(d) ........................................................................................... 63
`37 § 42.6(c) ........................................................................................................... 8
`37 § 42.8(a)(1) ...................................................................................................... 4
`37 § 42.8(b)(1) ...................................................................................................... 4
`37 § 42.8(b)(2) ...................................................................................................... 4
`37 § 42.8(b)(3) ...................................................................................................... 7
`37 § 42.8(b)(4) ...................................................................................................... 7
`37 § 42.10(b) ......................................................................................................... 7
`37 § 42.15(a) ......................................................................................................... 8
`37 § 42.103 ............................................................................................................ 8
`37 § 42.100(b) ..................................................................................................... 20
`37 § 42.103(a) ....................................................................................................... 8
`37 § 42.104(a) ....................................................................................................... 8
`
`
`
`
`
`
`vi
`
`
`
`
`
`Exhibit
`No.
`
`Exhibit
`1001
`
`Exhibit
`1002
`
`Exhibit
`1003
`
`Exhibit
`1004
`
`Exhibit
`1005
`
`Exhibit
`1006
`
`Exhibit
`1007
`
`Exhibit
`1008
`
`Exhibit
`1009
`
`EXHIBIT LIST
`
`Description
`
`U.S. Patent No. 7,772,209
`
`Referred To In
`The Petition As
`
`“’209 patent”
`
`File History of U.S. Patent Application No.
`11/776,329, which issued as U.S. Patent No.
`7,772,209 on August 10, 2010
`
`“’209 file
`history”
`
`Findings Of Fact And Conclusions Of Law
`Following Bench Trial August 19, 2013, in Eli
`Lilly & Co. v. Teva Parenteral Medicines, Inc.,
`Case No. 1:10-cv-1376, Dkt. 336 (S.D. Ind.
`March 31, 2014)
`
`“Teva Decision”
`
`Declaration of Ron D. Schiff, M.D., Ph.D.
`
`“Schiff Decl.”
`
`U.S. Patent No. 5,217,974
`
`C. Niyikiza, et al., MTA (LY231514):
`Relationship of vitamin metabolite profile, drug
`exposure, and other patient characteristics to
`toxicity, Annals Oncology 9 (Suppl. 4): 125-140,
`Abstract 609P, (1998)
`
`Hilary Calvert, An Overview of Folate
`Metabolism: Features Relevant to the Action and
`Toxicities of Antifolate Anticancer Agents,
`Seminars Oncology, 26: 3-10 (1999)
`
`Textbook of Small Animal Medicine (John K.
`Dunn ed. 1999)
`
`Sidney Farber, et al., Temporary Remissions in
`acute leukemia in children produced by folic acid
`antagonist, 4-aminopteroylglutamic acid
`(aminopterin), New Eng. J. Med., 238(23): 787-
`
`“’974 patent”
`
`“Niyikiza I”
`
`“Calvert”
`
`“Animal
`Medicine”
`
`“Farber”
`
`vii
`
`
`
`
`
`Exhibit
`No.
`
`Exhibit
`1010
`
`Exhibit
`1011
`
`Exhibit
`1012
`
`Exhibit
`1013
`
`Exhibit
`1014
`
`Description
`
`Referred To In
`The Petition As
`
`793
`
`Sarah L. Morgan, et al., Supplementation with
`Folic Acid during Methotrexate Therapy for
`Rheumatoid Arthritis, Annals Internal Med., 121:
`833-841 (1994)
`
`G.B. Grindey, et al., Reversal of the toxicity but
`not the antitumor activity of Lometrexol by folic
`acid, Am. Ass’n Cancer Res., 32: 324, Abstract
`1921 (1991)
`
`Laurane G. Mendelsohn, et al., Preclinical and
`Clinical Evaluation of the Glycinamide
`Ribonucleotide Formyltransferase Inhibitors
`Lometrexol and LY309887, in Anticancer Drug
`Dev. Guide: Antifolate Drugs Cancer Therapy,
`(Ann L. Jackman, ed.) Ch. 12: 261-80 (1999)
`
` John F. Worzalla, et al., Role of Folic Acid in
`Modulating the Toxicity and Efficacy of the
`Multitargeted Antifolate, LY231514, Anticancer
`Res., 18: 3235-3240 (1998)
`
`L. Hammond, et al., A Phase I and
`Pharmacokinetic (PK) Study of the Multitargeted
`Antifol (MTA) LY231514 with Folic Acid, Proc.
`Am. Soc’y Clinical Oncology, 17: Abstract 866
`(1998)
`
`“Morgan”
`
`“Grindey”
`
`“Mendelsohn”
`
`“Worzalla”
`
`“Hammond II”
`
`Exhibit
`1015
`
`L. Hammond, et al., A phase I and
`pharmacokinetic (PK) study of the multitargeted
`antifolate (MTA, LY231514) with folic acid (FA),
`Annals Oncology, 9: 129, Abstract 620P (1998)
`
`“Hammond I”
`
`Exhibit
`1016
`
`C. Niyikiza, et al., LY231514 (MTA):
`Relationship of vitamin metabolite profile to
`toxicity, Proc. Am. Ass’n Cancer Res., 17: 558a,
`
`“Niyikiza II”
`
`viii
`
`
`
`
`
`Exhibit
`No.
`
`Exhibit
`1017
`
`Exhibit
`1018
`
`Exhibit
`1019
`
`Exhibit
`1020
`
`Exhibit
`1021
`
`Exhibit
`1022
`
`Description
`
`Abstract 2139 (1998)
`
`R. Thödtmann, et al., Preliminary Results of a
`Phase I Study with MTA (LY231415) in
`Combination with Cisplatin in Patients with Solid
`Tumors, Seminars Oncology, 26 (2, Suppl. 6): 89-
`93 (1999)
`
`Referred To In
`The Petition As
`
`“Thödtmann I”
`
`U.S. Patent No. 5,563,126
`
`“’126 patent”
`
`Ernest Beutler & James K. Weick, Blood and
`Neoplastic Disorders, in Current Clinical Practice
`(Messerli, ed., 1987), Ch. 1: 291-302
`
`“Beutler”
`
`Lars Brattström, Vitamins as Homocysteine-
`Lowering Agents, J. Nutrition, 126: 1276S-1280S
`(1996)
`
`“Brattström”
`
`Chuan Shih, et al., LY231514, a Pyrrolo[2,3-
`d]pyrimidine-based Antifolate That Inhibits
`Multiple Folate-requiring Enzymes, Cancer Res.,
`57, 1116- 1123 (1997)
`
`“Shih”
`
`G. Robbin Westerhof, et al., Carrier- and
`Receptor-Mediated Transport of Folate
`Antagonists Targeting Folate-Dependent
`Enzymes: Correlates of Molecular-Structure and
`Biological Activity, Am. Soc’y Pharmacology
`Experimental Therapeutics, 48: 459-471 (1995)
`
`“Westerhof”
`
`Exhibit
`1023
`
`F. G. Arsenyan, et al., Influence of
`Methylcobalamin on the Antineoplastic Activity of
`Methotrexate, Pharmaceutical Chemistry J.,
`12(10): 1299-1303 (1978)
`
`“Arsenyan”
`
`Exhibit
`1024
`
`File History of U.S. Patent Application No.
`11/288,807, Abandoned
`
`“’807 File
`History”
`
`ix
`
`
`
`
`
`Exhibit
`No.
`
`Exhibit
`1025
`
`Exhibit
`1026
`
`Exhibit
`1027
`
`Exhibit
`1028
`
`Exhibit
`1029
`
`Exhibit
`1030
`
`Exhibit
`1031
`
`Description
`
`U.S. Food & Drug Administration, Approved
`Drug Products with Therapeutic Equivalents
`Evaluations (30th ed. 2010)
`
`Z.P. Sofyina, et al., Possibility to Increase the
`Antitumor Effect of Folic Acid Antagonist with
`the Help of Methylcobalamine Analogs, Sci.
`Center Oncology 1:72-78 (1979)
`
`Referred To In
`The Petition As
`
`“Orange Book
`Listing for
`Alimta®”
`
`“Sofyina”
`
`Victor Herbert, The Role of Vitamin B12 and
`Folate in Carcinogenesis, Advances
`Experimental Med. Biology, 206: 293-311 (1986)
`
`“Herbert”
`
`Glenn Tisman, et al., Overcoming Colon Cancer
`Resistance to Hepatic Artery Infusional 5FUdR
`Chemotherapy with Folinic Acid, Clinical Res.,
`33(2): 459A (1985)
`
`J.D. Kinloch, Maintenance Treatment of
`Pernicious Anaemia by Massive Parenteral
`Doses of Vitamin B12 at Intervals of Twelve
`Weeks, Brit. Med. J., 1:99-100 (1960)
`
`“Tisman”
`
`“Kinloch”
`
`D. Wray, et al., Recurrent Aphthae: Treatment
`with Vitamin B12, Folic Acid, and Iron, Brit. Med.
`J., 2:490-93 (1975)
`
`“Wray”
`
`J. Tamura, et al., Immunomodulation by Vitamin
`B12: Augmentation of CD8+ T Lymphocytes and
`Natural Killer (NK) Cell Activity in Vitamin B12-
`Deficient Patients by Methyl-B12 Treatment, Clin.
`Experimental Immunology, 116:28-32 (1999)
`
`“Tamura”
`
`Exhibit
`1032
`
`Carrasco et al., Acute Megaloblastic Anemia:
`Homocysteine Levels Are Useful for Diagnosis
`and Follow-Up, Haematologica, 84: 767- 768
`(1999)
`
`“Carrasco”
`
`x
`
`
`
`
`
`Exhibit
`No.
`
`Exhibit
`1033
`
`Exhibit
`1034
`
`Exhibit
`1035
`
`Exhibit
`1036
`
`Exhibit
`1037
`
`Exhibit
`1038
`
`Exhibit
`1039
`
`Exhibit
`1040
`
`Description
`
`Referred To In
`The Petition As
`
`European Patent Application No. 0 595 005
`
`“EP005”
`
`U.S. Patent No. 5,344,932
`
`“’932 patent”
`
`Amended Joint Claim Construction Statement in
`Eli Lilly & Co. v. Teva Parenteral Medicines, Inc.
`et al., No. 1:10-cv-1376 (S.D. Ind.), filed April
`19, 2012 (Dkt. 110)
`
`“Joint Claim
`Construction
`Statement”
`
`Excerpts from transcript of the trial on invalidity
`held between August 19 and August 29, 2013 in
`Eli Lilly & Co. v. Teva Parenteral Medicines,
`Inc., Case No. 1:10-cv-1376 (S.D. Ind.)
`
`E. Bajetta et al., Phase II study of pemetrexed
`disodium (Alimta®) administered with oral folic
`acid in patients with advanced gastric cancer,
`Annals of Oncology, 14:1543-48 (2003).
`
`“Teva Litigation
`Trial Tr.”
`
`“Bajetta”
`
`Letter dated February 4, 2004 from Robert
`Temple to John Worzalla concerning NDA 21-
`462
`
`“Alimta®
`Approval Letter”
`
`Johan B. Ubbink et al., Vitamin Requirements for
`the Treatment of Hyperhomocysteinemia in
`Humans, J. Nutrition, 124:1927-1933 (1994)
`
`“Ubbink I”
`
`Anja Brönstrup et al., Effects of folic acid and
`combinations of folic acid on plasma
`homocysteine concentrations in healthy, young
`women, Am. J. Clin. Nutr., 1998:68:1104-10
`(1998)
`
`“Brönstrup”
`
`Exhibit
`1041
`
`J. B. Ubbink, The role of vitamins in the
`pathogenesis and treatment of
`hyperhomocyst(e)inaemia, J. Inherited Metabolic
`
`“Ubbink II”
`
`xi
`
`
`
`
`
`Exhibit
`No.
`
`Exhibit
`1042
`
`Exhibit
`1043
`
`Exhibit
`1044
`
`Exhibit
`1045
`
`Exhibit
`1046
`
`Exhibit
`1047
`
`Exhibit
`1048
`
`Exhibit
`1049
`
`Exhibit
`1050
`
`Description
`
`Referred To In
`The Petition As
`
`Disease, 20:316-25 (1997)
`
`S. Sörenson et al., A systematic overview of
`chemotherapy effects in non-small cell lung
`cancer, Acta Oncologica, 40(2-3):327-29 (2001)
`
`“Sörenson”
`
`R. Thödtmann et al., Phase I study of different
`sequences of MTA (LY231514) in combination
`with cisplatin in patients with solid tumours,
`Annals Oncology, 9: 129, 618P (Abstract) (1998)
`
`“Thödtmann II”
`
`Complaint filed in Eli Lilly & Co. v. Teva
`Parenteral Medicines, Inc., No. 1:08-cv-335 (D.
`Del.) on June 5, 2008
`
`“Delaware Teva
`Litigation
`Complaint”
`
`Calvert, MTA: Summary and Conclusions,
`Seminars in Oncology, 26 (2, Suppl. 6): 105-08
`(1999)
`
`“MTA: Summary
`& Conclusions”
`
`Center for Drug Evaluation and Research,
`Product Development under the Animal Rule:
`Guidance for the Industry (October 2015)
`
`“FDA Animal
`Rule Guidance”
`
`A.H. Calvert & J.M. Walling, Clinical Studies
`with MTA, British J. Cancer (1998) 78 (Suppl. 3):
`35-40
`
`“Calvert &
`Walling”
`
`Center for Drug Evaluation and Research,
`Guidance for Industry: Single Dose Acute
`Toxicity Testing for Pharmaceuticals (August
`1996)
`
`“FDA Single
`Dose Guidance”
`
`Center for Drug Evaluation and Research, E6
`Good Clinical Practice: Consolidated Guidance
`(April 1996)
`
`“FDA E6
`Guidance”
`
`Robert H. Allen et al., Diagnosis of Cobalamin
`Deficiency I: Usefulness of Serum Methylmalonic
`Acid and Total Homocysteine Concentrations,
`
`Allen
`
`xii
`
`
`
`
`
`Description
`
`Am. J. Hematology 34:90-98 (1990)
`
`Eli Lilly & Company, Alimta® Labeling
`(Revised Sept. 2013)
`
`Rusthoven et al., Multitargeted Antifolate
`LY231514 as First-Line Chemotherapy for
`Patients with Advanced Non-Small-Cell Lung
`Cancer: A Phase II Study, J. Clin. Oncology, 17
`(4) 1194-99 (April 1999)
`
`FDA, Electronic Orange Book: Approved Drug
`Products and Therapeutic Equivalence
`Evaluations Entry for Alimta®, available at
`http://www.accessdata.fda.gov/scripts/cder/ob/d
`ocs/patexclnew.cfm?Appl_No=021462&Produc
`t_No=001&table1=OB_Rx (last accessed Dec.
`14, 2015)
`
`Exhibit
`No.
`
`Exhibit
`1051
`
`Exhibit
`1052
`
`Exhibit
`1053
`
`
`
`Referred To In
`The Petition As
`
`“Alimta
`Labeling”
`
`“Rusthoven”
`
`“2015 Alimta®
`Orange Book
`Listing”
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`xiii
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`I.
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`INTRODUCTION
`On June 16, 2016, the Board instituted Inter Partes Review (“IPR”) of
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`claims 1-22 of U.S. Patent No. 7,772,209 (“the ’209 Patent”) (Ex. 1001) in
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`IPR2016-00318. In its decision of institution, the Board determined that it is
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`reasonably likely that claims 1-22 of the ’209 Patent would have been obvious in
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`view of the following:1
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`Sandoz, Inc. v. Eli Lilly & Company, No. IPR2016-00318, Paper 14 at 21 (PTAB
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`June 16, 2016).
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`Wockhardt Bio AG (“Wockhardt”) submits this Petition for IPR (“Petition”)
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`also seeking cancellation of claims 1-22 of the ’209 Patent as unpatentable under
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`35 U.S.C. §103(a) over (1) Calvert in view of Niyikiza I, Worzalla, and the
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`1 The Board slightly modified the Grounds of unpatentability set forth in the
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`Sandoz IPR by substituting EP ‘005 and the ‘974 Patent for the knowledge of a
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`person of ordinary skill.
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`1
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`knowledge of a person of ordinary skill; and (2) Calvert in view of Niyikiza I,
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`Hammond I and the knowledge of a person of ordinary skill. This petition presents
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`the same arguments, based on the same prior art presented in the IPR2016-00318
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`Petition (IPR2016-00318, Paper 1), and on which the Board instituted IPR in
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`IPR2016-00318, along with a Motion for Joinder to join this Petition with the
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`IPR2016-00318 proceedings. Indeed, this petition is an almost verbatim copy of
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`the petition in IPR2016-00318.2
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`For the reasons explained below, and for the reasons the Board instituted
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`IPR in IPR2016-00318, Wockhardt is reasonably likely to prevail on Grounds 1
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`and 2 with respect to the challenged claims. Wockhardt requests that this Board
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`institute this IPR and cancel each of claims 1-22 of the ’209 Patent.
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`II. OVERVIEW
`The Board has already issued its Decision Instituting Inter Partes Review
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`(“Decision”) on all challenged claims of the ’209 Patent on the same grounds
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`raised herein. Sandoz Inc. v. Eli Lilly and Company, Case IPR2016-00318 (the
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`“Sandoz IPR” or “IPR 318”) (Paper 14). In its Decision, the Board found that
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`2 Wockhardt’s intention is to copy the relevant portions of IPR2016-00318
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`verbatim. To the extent discrepancies exist between the respective petitions,
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`those differences are due to solely to transcription errors.
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`2
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`Petitioner Sandoz Inc. (“Sandoz”) had demonstrated a reasonable likelihood that
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`claims 1-22 of the ’209 Patent are unpatentable for failing to satisfy the
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`nonobviousness requirement of 35 U.S.C. § 103. Id. The Board instituted IPR of
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`the challenged claims on the following grounds:
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`Ground 1: Claims 1-22 are obvious over Calvert in view of Niyikiza I,
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`Worzalla, and the knowledge of a person of ordinary skill.
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`Ground 2: Claims 1-22 are obvious over Calvert in view of Niyikiza I,
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`Hammond I, and the knowledge of a person of ordinary skill.
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`IPR2016-00318 (Paper 14). Petitioner Wockhardt hereby files its own petition on
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`the same ground and concurrently seeks joinder of this IPR to the instituted IPR
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`proceedings on these challenged claims.
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`For the sake of completeness and efficiency, the present Petition is a
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`practical copy of the petition in the Sandoz IPR. Specifically, the present Petition
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`is narrowly-tailored to the same claims, prior art, and grounds of unpatentability
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`that are the subject of the Sandoz IPR, and, in addition, relies on the same expert as
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`the Sandoz IPR. A motion for Joinder with the Sandoz IPR is being filed
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`concurrently with this Petition.
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`3
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`III. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8(a)(1)
`A. Real Party-In-Interest
`In accordance with 37 C.F.R. § 42.8(b)(1), Petitioner identifies the real
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`party-in-interest as Wockhardt Bio AG, Wockhardt Limited, Wockhardt USA
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`LLC, and Morton Grove Pharmaceuticals, Inc. (collectively “Wockhardt”).
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`B. Related Matters
`1.
`Related Litigations
`Petitioner is not aware of any reexamination certificates or pending
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`prosecution concerning the ’209 Patent. The Patent Owner has asserted the ’209
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`Patent in the following litigations: Pursuant to 37 C.F.R. § 42.8(b)(2), Wockhardt
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`states that the ’209 Patent has been the subject of the following lawsuits: Eli Lilly
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`and Company v. Biocon Limited, INSD-1:16-cv-00469 (filed Feb 26, 2016); Eli
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`Lilly and Company v. Dr. Reddy's Laboratories, Ltd. et al., INSD-1:16-cv-00308
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`(filed Feb. 5, 2016); Petition for Inter Partes Review by Sandoz Inc., PTAB-
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`IPR2016-00318 (filed Dec. 14, 2015); Petition for Inter Partes Review by Neptune
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`Generics, LLC, PTAB- IPR2016-00237 (filed Nov. 24, 2015); Petition for Inter
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`Partes Review by Neptune Generics, LLC, PTAB-IPR2016-00240 (filed Nov. 24,
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`2015); Eli Lilly and Company v. Fresenius Kabi USA, LLC, INSD-1:15-cv-00096
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`(filed Jan. 23, 2015); Eli Lilly and Company v. Sandoz Inc., INSD-1:14-cv-02008
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`(filed Dec. 5, 2014); Eli Lilly and Company et al. v. Nang Kuang Pharm. Co., Ltd.
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`4
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`et al., INSD-1:14-cv-01647 (filed Oct. 8, 2014); Eli Lilly and Company v.
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`Glenmark Pharm. Ltd. et al., INSD-1:14-cv-00104 (filed Jan. 23, 2014); Eli Lilly
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`and Company v. Sun Pharm. Global FZE et al., INSD-1:13-cv-01469 (filed Sept.
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`13, 2013); Petition for Inter Partes Review by Accord Healthcare, Inc., PTAB-
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`IPR2013-00356 (filed June 14, 2013); Eli Lilly and Company v. Accord
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`Healthcare, Inc., USA, INSD-1:13-cv-00335 (filed Feb. 28, 2013); Eli Lilly and
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`Company v. Apotex, Inc. et al., INSD-1:12-cv-00499 (filed Apr. 17, 2012); Eli
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`Lilly and Company v. Accord Healthcare, Inc., USA, INSD-1:12-cv-00086 (filed
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`Jan. 20, 2012); Eli Lilly and Company v. App Pharm., LLC, INSD-1:11-cv-00942
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`(filed Jul. 15, 2011); and Eli Lilly and Company v. Teva Parental Medicines, Inc.,
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`et al., INSD-1:10-cv-01376 (filed Oct. 29, 2010).
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`On March 31, 2014, the U.S. District Court for the Southern District of
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`Indiana ruled in the Teva Litigation that Teva failed to establish by clear and
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`convincing evidence that claims 9, 10, 12, 14, 15, 18, 19, and 21 of the ’209 patent
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`are invalid as obvious under 35 U.S.C. § 103. Ex. 1003, Teva Decision at 9-27. An
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`appeal of the Teva Decision is currently pending in the Federal Circuit. Eli Lilly &
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`Co. v. Teva Parenteral Meds., No. 1:10-cv-1376, 2015 U.S. Dist. LEXIS 112221
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`(S.D. Ind. Aug. 25, 2015), appeal docketed, No. 15-2067 (Fed. Cir. Sept. 25,
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`2015).
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`5
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`The Teva Decision is not binding in this proceeding. See Noven Pharm., Inc.
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`v. Novartis AG, No. IPR2014-549, 2015 WL 5782080, at *2 (PTAB Sept. 28,
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`2015) (“[W]hile we have considered the Federal Circuit’s decision, we have
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`independently analyzed patentability of the challenged claims based on the
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`evidence and standards that are applicable to this proceeding.”); In re Trans Texas
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`Holdings Corp., 498 F.3d 1290, 1297 (Fed. Cir. 2007) (finding the PTO, in a
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`reexamination procedure, was not bound by prior district court litigation to which
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`it was not a party). Moreover, the district court made erroneous factual and legal
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`findings that if corrected would likely have led to a different outcome under the
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`standards applicable in that proceeding.
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`Related Proceedings Before the Board
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`2.
`The ’209 Patent has also been challenged before the Board in the following
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`proceedings in which Petitioner was not and is not a party: Accord Healthcare,
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`Inc., USA v. Eli Lilly & Co., IPR2013-356 (PTAB, filed June 14, 2013); Neptune
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`Generics, LLC v. Eli Lilly & Co., IPR2016-237 (PTAB, filed November 24, 2015)
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`(“Neptune IPR 1”); Neptune Generics, LLC v. Eli Lilly & Co., IPR2016-240
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`(PTAB, filed November 24, 2015) (“Neptune IPR 2”); Sandoz Inc. v. Eli Lilly &
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`Co., IPR2016-318 (PTAB, filed December 14, 2015); Apotex Inc. & Apotex Corp.
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`v. Eli Lilly & Company, IPR2016-01190 (PTAB, filed July 1, 2016); Apotex Inc.
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`and Apotex Corp. v. Eli Lilly & Company, IPR2016-01191 (PTAB, filed July 1,
`6
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`2016); Teva Pharmaceuticals USA, Inc. and Fresenius Kabi USA, LLC v. Eli Lilly
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`& Company, IPR2016-01340 (PTAB, filed July 1, 2016); Teva Pharmaceuticals
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`USA, Inc. and Fresenius Kabi USA, LLC v. Eli Lilly & Company, IPR2016-01341
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`(PTAB, filed July 1, 2016); Teva Pharmaceuticals USA, Inc. and Fresenius Kabi
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`USA, LLC v. Eli Lilly & Company, IPR2016-01343 (PTAB, filed July 1, 2016);
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`Wockhardt Bio AG v. Eli Lilly & Company, IPR2016-01335 (PTAB, filed July 1,
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`2016) and Wockhardt Bio AG v. Eli Lilly & Company, IPR2016-01337 (PTAB,
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`filed July 1, 2016).
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`C. Lead and Back-Up Counsel
`In accordance with 37 C.F.R. § 42.8(b)(3), Petitioner identifies Patrick A.
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`Doody as lead counsel and Bryan P. Collins as back-up counsel. Concurrently
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`filed is a Power of Attorney pursuant to 37 C.F.R. § 42.10(b).
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`In accordance with 37 C.F.R. § 42.8(b)(4), Petitioner identifies the following
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`service information:
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`Back-up Counsel
`Lead Counsel
`Bryan P. Collins, Reg. No. 43,560
`Patrick A. Doody, Reg. No. 35,022
`Pillsbury Winthrop Shaw Pittman LLP Pillsbury Winthrop Shaw Pittman LLP
`1650 Tysons Boulevard
`1650 Tysons Boulevard
`McLean, VA 22102
`McLean, VA 22102
`Direct Line: (703) 770-7755
`Direct Line: (703) 770-7538
`Fax: (703) 770-7901
`Fax: (703) 770-7901
`email:
`email:
`patrick.doody@pillsburylaw.com
`bryan.collins@pillsburylaw.com
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`7
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`Wockhardt consents to electronic service.
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`IV. PAYMENT OF FEES (37 C.F.R. § 42.15(a) and § 42.103)
`The required fees are submitted herewith in accordance with 37 C.F.R. §
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`42.103(a) and 42.15(a). If any additional fees are due during this proceeding, the
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`Office is authorized to charge such fees to Deposit Account No. 033975. Any
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`overpayment or refund of fees may also be deposited in this Deposit Account.
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`V. GROUNDS FOR STANDING
`As required by 37 C.F.R. § 42.104(a), Petitioner certifies that the ’209 Patent
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`is available for IPR and that Petitioner is not barred or estopped from requesting
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`IPR on the grounds identified herein.
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`VI.
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`IDENTIFICATION OF CHALLENGE AND STATEMENT OF THE
`PRECISE RELIEF REQUESTED
`Petitioner requests inter partes review and cancellation of claims 1-22 of the
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`’209 Patent on one or more of grounds pursuant to 35 U.S.C. § 103 as set forth
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`herein. The ’209 Patent is to be reviewed under pre-AIA § 103. Petitioner’s
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`detailed statement of the reasons for the relief requested is set forth below in the
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`section titled “Statement of Reasons for the Relief Requested.” In accordance with
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`37 C.F.R. § 42.6(c), copies of the exhibits are filed herewith. In addition, the
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`Petition is accompanied by the declaration of Dr. Ron D. Schiff, Ex. 1004.
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`8
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`Claims 1-22 of the ’209 Patent are unpatentable based upon the following
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`grounds:
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`Ground 1: Claims 1-22 are obvious over
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