throbber
UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`ARGENTUM PHARMACEUTICALS LLC
`Petitioner
`
`v.
`
`CIPLA LTD.
`Patent Owner
`
`Patent No. 8,168,620
`Issue Date: May 1, 2012
`Title: COMBINATION OF AZELASTINE AND STEROIDS
`_______________
`
`Inter Partes Review No. IPR2017-00807
`
`PETITION FOR INTER PARTES REVIEW
`UNDER 35 U.S.C. §§ 311-319 AND 37 C.F.R. § 42.100 ET SEQ.
`
`

`

`Patent No. 8,168,620
`
`Petition For Inter Partes Review
`
`TABLE OF CONTENTS
`
`I.
`
`II.
`
`MANDATORY NOTICES UNDER 37 C.F.R. § 42.8 ................................... 1
`Real Parties-In-Interest under 37 C.F.R. § 42.8(b)(1) .......................... 1
`Related Matters under 37 C.F.R. § 42.8(b)(2) ...................................... 1
`Lead and Backup Counsel under 37 C.F.R. § 42.8(b)(3) ...................... 1
`Service Information under 37 C.F.R. § 42.8(b)(4) ................................ 2
`REQUIREMENTS FOR IPR UNDER 37 C.F.R. § 42.104 ............................ 2
`
`Identification of Challenge under 37 C.F.R. § 42.104(b) ..................... 2
`SUMMARY OF ARGUMENT ....................................................................... 2
`THE ’620 PATENT ......................................................................................... 4
`
`III.
`IV.
`
`V.
`
`A.
`B.
`C.
`D.
`A. Grounds For Standing under 37 C.F.R. § 42.104(a) ............................. 2
`B.
`A. Overview ............................................................................................... 4
`B.
`A. Hettche (Ex. 1007) .............................................................................. 12
`B.
`C.
`D.
`E.
`F.
`A. Ground 1: Claims 1 and 25 are anticipated by Segal ......................... 16
`B.
`
`Prosecution History ............................................................................... 6
`CLAIM CONSTRUCTION ............................................................................ 6
`LACK OF ENTITLEMENT TO FOREIGN PRIORITY DATE ................... 8
`VI.
`VII. LEVEL OF SKILL AND KNOWLEDGE IN THE ART ............................. 10
`
`Astelin® Label (Ex. 1008) .................................................................. 12
`Phillipps (Ex. 1009) ............................................................................. 13
`Flonase® Label (Ex. 1010) ................................................................. 13
`Cramer (Ex. 1011) ............................................................................... 14
`Segal (Ex. 1012) .................................................................................. 15
`VIII. CLAIM-BY-CLAIM EXPLANATION OF GROUNDS FOR
`UNPATENTABILITY .................................................................................. 16
`
`Ground 2: Claims 1, 4-6, 24-26, 29 are obvious over Hettche,
`Phillipps, and Segal ............................................................................. 21
`1.
`All claim elements were known ................................................ 22
`a.
`Claims 1 and 4 ........................................................................... 22
`b.
`Claims 5-6, 26, and 29 .............................................................. 23
`c.
`Claims 24 and 25....................................................................... 25
`Reasons to select and to combine azelastine and fluticasone ... 33
`2.
`a.
`Selection .................................................................................... 33
`b.
`Motivation to combine .............................................................. 33
`Known techniques to make the co-formulation ........................ 35
`3.
`4.
`Combination yields predictable results ..................................... 41
`Ground 3: Claims 42-44 are obvious over Hettche, Phillipps, Segal,
`and Flonase® Label ............................................................................. 43
`
`C.
`
`i
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`

`

`Patent No. 8,168,620
`
`
`
`Petition For Inter Partes Review
`
`IX. NO SECONDARY CONSIDERATIONS OF NONOBVIOUSNESS ......... 52
`A. No Teaching Away .............................................................................. 53
`B.
`No unexpected results compared to closest prior art .......................... 54
`C.
`No long-felt unmet need in the art ...................................................... 55
`D.
`Blocking patents negate secondary considerations ............................. 56
`E.
`Commercial success evidence is weak and lacks nexus ..................... 58
`X. NO BASIS TO DENY THE PETITION UNDER 35 U.S.C. § 325(D) ....... 59
`CONCLUSION ........................................................................................................ 61
`CERTIFICATE OF COMPLIANCE ....................................................................... 62
`CERTIFICATE OF SERVICE ................................................................................ 63
`
`
`
`
`
`
`
`
`
`
`
`ii
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`

`

`Patent No. 8,168,620
`
`
`
`Petition For Inter Partes Review
`
`TABLE OF AUTHORITIES
`
`
`
`Page(s)
`
`Cases
`
`Amgen Inc. v. Hoechst Marion Roussel,
`314 F.3d 1313 (Fed. Cir. 2003)................................................................................................40
`
`Ariad Pharms., Inc. v. Eli Lilly & Co.,
`598 F.3d 1336 (Fed. Cir. 2010) (en banc) ........................................................................8, 9, 10
`
`Constant v. Advanced Micro-Devices Inc.,
`848 F.2d 1560 (Fed. Cir. 1988)................................................................................................17
`
`Custom Accessories, Inc. v. Jeffrey-Allan Indus.,
`807 F.2d 955 (Fed. Cir. 1986)..................................................................................................10
`
`DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc.,
`567 F.3d 1314 (Fed. Cir. 2009)................................................................................................53
`
`Ecolochem Inc. v. S.Cal. Edison Co.,
`227 F.3d 1361 (Fed. Cir. 2000)................................................................................................58
`
`Elan Pharms., Inc. v. Mayo Found. for Med. Educ. & Research,
`346 F.3d 1051 (Fed. Cir. 2003)................................................................................................16
`
`In re Epstein,
`32 F.3d 1559 (Fed. Cir. 1994)..................................................................................................39
`
`Galderma Labs., L.P. v. Tolmar, Inc.,
`737 F.3d 731 (Fed. Cir. 2013)..................................................................................................57
`
`In re GPAC Inc.,
`57 F.3d 1573 (Fed. Cir. 1995)..................................................................................................11
`
`Great Atl. & Pac. Tea Co. v. Supermarket Equip. Corp.,
`340 U.S. 147 (1950) .................................................................................................................49
`
`Ex parte Jellá,
`90 USPQ2d 1009 (BPAI 2008)................................................................................................58
`
`King Pharms., Inc. v. Eon Labs, Inc.,
`616 F.3d 1267,1281 (Fed. Cir. 2010).......................................................................................58
`
`KSR Int'l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) .....................................................................................................21, 22, 49
`
`
`
`
`
`iii
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`

`

`Patent No. 8,168,620
`
`
`
`Petition For Inter Partes Review
`
`Mars Inc. v. H.J. Heinz Co.,
`377 F.3d 1369, 71 USPQ2d 1837 (Fed. Cir. 2004) .................................................................57
`
`Meda Pharms. Inc. v. Apotex Inc.,
`14-cv-01453 (D. Del.) ............................................................................................................1, 7
`
`Meda Pharms. Inc. v. Perrigo UK Finco Ltd.,
`16-cv-00794 (D. Del.) ................................................................................................................1
`
`Meda Pharms. Inc. v. Teva Pharms.,
`15-cv-00785 (D. Del.) ................................................................................................................1
`
`Media Techs. Licensing, LLC v. Upper Deck Co.,
`596 F.3d 1334 (Fed. Cir. 2010)................................................................................................59
`
`Merck v. Biocraft,
`874 F.2d 804 (Fed. Cir. 1989)..................................................................................................16
`
`Merck v. Gnosis,
`808 F.3d 829 (Fed. Cir. 2015)..................................................................................................53
`
`Net MoneyIN, Inc. v. VeriSign, Inc.,
`545 F.3d 1359 (Fed. Cir. 2008)................................................................................................16
`
`Perricone v. Medicis Pharm. Corp.,
`432 F.3d 1368 (Fed.Cir.2005)..................................................................................................19
`
`In re Petering,
`301 F.2d 676 (CCPA 1962) ...............................................................................................16, 19
`
`In re Peterson,
`315 F.3d 1325 (Fed. Cir. 2003)................................................................................................24
`
`Pharmastem Therapeutics, Inc. v. Viacell, Inc.,
`491 F.3d 1342 (Fed. Cir. 2007)..........................................................................................41, 48
`
`PowerOasis, Inc. v. T-Mobile USA,
`522 F.3d 1299 (Fed. Cir. 2008)..................................................................................................8
`
`In re Schaumann,
`572 F.2d 312 (CCPA 1978) .....................................................................................................16
`
`Senju Pharm. Co. v. Apotex, Inc.,
`717 F. Supp. 2d 404 (D. Del. 2010) .........................................................................................48
`
`Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC,
`683 F.3d 1356 (Fed. Cir. 2012)..........................................................................................19, 58
`
`
`
`
`
`iv
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`Patent No. 8,168,620
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`
`
`Petition For Inter Partes Review
`
`Statutes
`
`35 U.S.C. §102(b) ............................................................................................................2, 8, 16, 44
`
`35 U.S.C. §103(a) ..........................................................................................................................43
`
`35 U.S.C. § 325(d) .........................................................................................................................59
`
`35 U.S.C. § 371 ................................................................................................................................5
`
`35 USC 102 ..............................................................................................................................16, 17
`
`Other Authorities
`
`37 C.F.R. § 42.8 ...............................................................................................................................1
`
`37 C.F.R. § 42.8(b)(1) ......................................................................................................................1
`
`37 C.F.R. § 42.8(b)(2) ......................................................................................................................1
`
`37 C.F.R. § 42.8(b)(3) ......................................................................................................................1
`
`37 C.F.R. § 42.8(b)(4) ......................................................................................................................2
`
`37 C.F.R. § 42.104 ...........................................................................................................................2
`
`37 C.F.R. § 42.104(a).......................................................................................................................2
`
`37 C.F.R. § 42.104(b) ......................................................................................................................2
`
`37 CFR § 42.6(a)(2)(ii) ..................................................................................................................61
`
`37 CFR § 42.6(a)(2)(iii) .................................................................................................................61
`
`37 CFR § 42.24(a)(1)(i) .................................................................................................................61
`
`
`
`v
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`

`

`Patent No. 8,168,620
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`
`
`Petition For Inter Partes Review
`
`TABLE OF EXHIBITS
`
`Ex #
`
`Exhibit
`
`1001 U.S. Patent No. 8,168,620 (“’620 patent”)
`1002
`Prosecution History of U.S. Patent No. 8,168,620
`1003 Declaration of Dr. Robert Schleimer
`1004 Declaration of Dr. Maureen Donovan
`1005 Meda Pharms. Inc. v. Apotex Inc., 14-cv-1453 (D. Del. May 12, 2016)
`(Claim Construction Memorandum and Order)
`1006 UK Patent Application GB 0213739.6
`1007 U.S. Patent No. 5,164,194 (“Hettche”)
`1008
`Physician’s Desk Reference, Astelin® Label, rev.1/99, pp.3147-3148
`(54th ed. 2000) (“Astelin® Label”)
`1009 U.S. Patent No. 4,335,121 (“Phillipps”)
`1010
`Flonase® Label (1998)
`1011
`European Patent Application No. 0780127 (“Cramer”)
`1012
`PCT Publication No. WO 98/48839 to Segal (“Segal”)
`1013 British Pharmaceutical Codex (1973)
`1014 U.S. Patent Publication No. 20040136918 (“Garrett”)
`Falser, N., et al., “Comparative efficacy and safety of azelastine and
`1015
`levocabastine nasal sprays in patients with seasonal allergic rhinitis.”
`ARZNEIMITTELFORSCHUNG, 51(5):387-93 (2001)
`1016 Kusters, S., et al., “Effects of Antihistamines on Leukotriene and
`Cytokine Release from Dispersed Nasal Polyp Cells.” ARZNEIM-
`FORSCH/DRUG RES., 52(2): 97-102 (Feb. 2002)
`Stellato, C., et al., An in vitro Comparison of Commonly Used Topical
`Glucocorticoid Preparations, J. ALLERGY CLIN. IMMUNOL., Vol. 104, No.
`3, Part 1,623-629 (Sept. 1999)
`Johnson, M., Development of fluticasone propionate and comparison
`with other inhaled corticosteroids, J. Allergy Clin. Immunol., Vol. 101,
`vi
`
`1018
`
`1017
`
`
`
`
`
`

`

`Patent No. 8,168,620
`
`
`
`Petition For Inter Partes Review
`
`1023
`
`1020
`
`No. 4, Part 2, S434-S439 (1998)
`1019 Dykewicz, Mark S., et al., “Diagnosis and management of rhinitis:
`complete guidelines of the joint task force on practice parameters in
`allergy, asthma and immunology,” ANNALS OF ALLERGY, ASTHMA &
`IMMUNOLOGY, Vol. 81, 478-518 (1998)
`Stoloff, R., et al., “Combination Therapy with Inhaled Long-Acting ß2-
`Agonists and Inhaled Corticosteroids: A Paradigm Shift in Asthma
`Management,” PHARMACOTHERAPY, Vol. 22, No. 2, 212-226 (Feb.
`2002)
`1021 Berger, W. E. et al., “Double-blind trials of azelastine nasal spray
`monotherapy versus combination therapy with loratadine tablets and
`beclomethasone nasal spray in patients with seasonal allergic rhinitis,”
`ANNALS OF ALLERGY, ASTHMA & IMMUNOLOGY, Vol. 82, 535-541
`(1999)
`1022 Cauwenberge, P. et al., “Consensus statement on the treatment of
`allergic rhinitis,” ALLERGY, Vol. 55: 116-134 (2000)
`Spector, S., “Ideal Pharmacology for Allergic Rhinitis,” J. ALLERGY
`CLIN. IMMUNOL., Vol. 103, No. 3, Part 2, S386-87 (1999)
`1024 Bousquet et al., Management of Allergic Rhinitis and Its Impact on
`Asthma, JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY, Vol. 108,
`No. 5 (2001)
`1025 Markham, A., et al., “Inhaled Salmeterol-Fluticasone Propionate
`Combination, A Review of its Use in Persistent Asthma,” DRUGS 60(5)
`1207-1233 (Nov. 2000)
`
`1026
`1027 Ansel, et al., Pharmaceutical Dosage Forms and Drug Delivery Systems,
`ch. 7 (6th ed. 1995)
`
`1028
`
`1029
`1030 Advair Diskus Prescribing Information (2000)
`1031
`Juniper, E., "First-line Treatment of Seasonal (Ragweed)
`Rhinoconjunctivitis)," Canadian Medical Association Journal, Vol. 156,
`No. 8, April 1997, 1123-31.
`
`
`
`
`
`vii
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`Patent No. 8,168,620
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`Petition For Inter Partes Review
`
`1036
`
`1039
`
`
`1032
`1033 Wade & Weller, HANDBOOK OF PHARMACEUTICAL EXCIPIENTS (1994)
`1034 Ratner, P., et al., “A Comparison of the Efficacy of Fluticasone
`Propionate Aqueous Nasal Spray and Loratadine, Alone and in
`Combination, for the Treatment of Seasonal Allergic Rhinitis,” JOURNAL
`OF FAMILY PRACTICE, Vol. 47, No. 2, 118-125 (Aug. 1998)
`1035 Drouin, M., et al. “Adding Loratadine to Topical Nasal Steroid Therapy
`Improves Moderately Severe Seasonal Allergic Rhinoconjunctivitis.”
`ADVANCES IN THERAPY, 12(6): 340-349; 1995.
`Simpson, R., Budesonide and terfenadine, separately and in
`combination, in the treatment of hay fever, ANNALS OF ALLERGY, Vol.
`73 497-502 (Dec. 1994)
`
`1037
`1038 Brooks, C. et al. “Spectrum of Seasonal Allergic Rhinitis Symptom
`Relief with Topical Corticoid and Oral Antihistamine Given Singly or in
`Combination.” AM. J. RHINOL., Vol. 10, 193-196 (1996)
`Juniper, E F., et al., “Comparison of beclomethasone dipropionate
`aqueous nasal spray, astemizone, and the combination in the
`prophylactic treatment of ragweed pollen-induced rhinoconjunctivitis,”
`JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY, Vol. 83, No. 3,
`Cover page, Publications page, 627-633 (Mar. 1989)
`1040 Benincasa, C. & Lloyd, R.S., “Evaluation of Fluticasone Propionate
`Aqueous Nasal Spray Taken Alone and in Combination with Cetirizine
`in the Prophylactic Treatment of Seasonal Allergic Rhinitis,” DRUG
`INVEST., Vol. 8, Issue 4, 225-233 (1994)
`1041 Galant, S. and Wilkinson, R., “Clinical Prescribing of Allergic Rhinitis
`Medication in the Preschool and Young School-Age Child.” BIODRUGS,
`15(7): 453-463; 2001
`Schleimer, R., “Glucocorticosteroids: Their Mechanisms of Action and
`Use in Allergic Diseases,” ALLERGY PRINCIPLES & PRACTICE, pp.638-
`660 (1998)
`
`
`
`1042
`
`1043
`1044
`
`
`
`
`
`viii
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`Petition For Inter Partes Review
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`1045 Ratner, Paul H., et al., “Combination therapy with azelastine
`hydrochloride nasal spray and fluticasone propionate nasal spray in the
`treatment of patients with seasonal allergic rhinitis,” ANNALS OF
`ALLERGY, ASTHMA & IMMUNOLOGY, VOL. 100, 74-81 (2008)
`IMITREX Prescribing Information (2013)
`1046
`1047 NASACORT AQ Prescribing Information (2013)
`1048 Rabago, David, et al., “Efficacy of daily hypertonic saline nasal
`irrigation among patients with sinusitis: A randomized controlled trial,”
`The Journal of Family Practice, Vol. 51, No. 12, 1049-1055 (2002)
`1049 Budavari, S., et al. (Ed), “Edetate Disodium,” The Merck Index,
`Eleventh Edition, 550 (1989)
`1050 Ratner, Paul H., et al., “A double-blind, controlled trial to assess the
`safety and efficacy of azelastine nasal spray in seasonal allergic
`rhinitis,” Journal of Allergy and Clinical Immunology, Vol. 94, No. 5,
`818-825 (1994)
`1051 Curriculum Vitae of Dr. Robert Schleimer
`1052 Curriculum Vitae of Dr. Maureen Donovan
`1053
`Patent Certification for U.S. Patent No. 5,164,194 - Astelin® Nasal
`Spray (2000)
`“Avicel® RC-591 Microcrystalline Cellulose and
`Carboxymethylcellulose Sodium, NF, BP,” FMC Corporation (1994)
`
`1054
`
`
`
`
`
`
`
`ix
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`

`Patent No. 8,168,620
`
`
`
`Petition For Inter Partes Review
`
`Petitioner Argentum Pharmaceuticals LLC (“Petitioner”) petitions for inter
`
`partes review (“IPR”) of U.S. Patent No. 8,168,620 (“’620 patent) (Ex.1001),
`
`purportedly owned by CIPLA Ltd. (“Patent Owner”).
`
`I. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8
`
`A. Real Parties-In-Interest under 37 C.F.R. § 42.8(b)(1)
`
`Argentum Pharmaceuticals LLC; Intelligent Pharma Research LLC; APS
`
`GP LLC; APS GP Investors LLC; and KVK-TECH, Inc.
`
`B. Related Matters under 37 C.F.R. § 42.8(b)(2)
`
` (1) Meda Pharms. Inc. v. Apotex Inc., 14-cv-01453 (D. Del.); (2) Meda
`
`Pharms. Inc. v. Teva Pharms., 15-cv-00785 (D. Del.); (3) Meda Pharms. Inc. v.
`
`Perrigo UK Finco Ltd., 16-cv-00794 (D. Del.). Petitioner is not a party to any of
`
`those cases.
`
`C. Lead and Backup Counsel under 37 C.F.R. § 42.8(b)(3)
`
`Lead Counsel
`Michael R. Houston, Ph.D.
`Reg. No. 58,486
`Foley & Lardner LLP
`
`
`
`Backup Counsel
`Joseph P. Meara, Ph.D.
`Reg. No. 44,932
`James P. McParland, Ph.D.
`Reg. No. 69,440
`Foley & Lardner LLP
`
`Backup Counsel
`Tyler C. Liu
`Reg. No. 72,126
`Argentum
`Pharmaceuticals LLC
`
`
`
`
`
`1
`
`

`

`Patent No. 8,168,620
`
`
`
`Petition For Inter Partes Review
`
`D.
`
`Service Information under 37 C.F.R. § 42.8(b)(4)
`
`Foley & Lardner LLP, 3000 K St. NW, Suite 600, Washington, DC. 20008.
`
`Petitioner consents to service by email at: ARG-dymista@foley.com.
`
`II. REQUIREMENTS FOR IPR UNDER 37 C.F.R. § 42.104
`
`A. Grounds For Standing under 37 C.F.R. § 42.104(a)
`
`Petitioner certifies that the ’620 patent is available for IPR and that
`
`Petitioner is not barred or estopped from requesting an IPR challenging the claims
`
`on the grounds identified in this petition.
`
`B.
`
`Identification of Challenge under 37 C.F.R. § 42.104(b)
`
`Petitioner requests cancellation of claims 1, 4-6, 24-26, 29, 42-44 of the ’620
`
`patent on the following grounds (pre-AIA):
`
`Ground Claims
`
`Basis
`
`Reference(s)
`
`1, 25
`
`§ 102(b) Segal
`
`1, 4-6, 24-26, 29 § 103
`
`Hettche, Phillipps, and Segal
`
`42-44
`
`§ 103
`
`Hettche, Phillipps, Segal, Flonase® Label
`
`1
`
`2
`
`3
`
`
`III. SUMMARY OF ARGUMENT
`
`The claims of the ’620 patent are invalid for anticipation as well as
`
`obviousness over numerous prior art references in the field. The ‘620 patent
`
`
`
`
`
`2
`
`

`

`Patent No. 8,168,620
`
`
`
`Petition For Inter Partes Review
`
`merely claims the co-formulation of two FDA-approved drugs, fluticasone and
`
`azelastine, for their known use and with known excipients. Well before the
`
`priority date of the ’620 patent, both drugs had been marketed individually as
`
`Astelin (azelastine hydrochloride) and Flonase (fluticasone propionate) nasal
`
`sprays for treating allergic rhinitis. Even the patentee admits that these drugs were
`
`well-known for this use, that the excipients were known, and that techniques for
`
`preparing the formulations were well-known. See Ex. 1001, 1:20-29, 8:1-2. Not
`
`only are these admissions from the ‘620 patent binding on Patent Owner as a
`
`matter of law, they are further confirmed by the overwhelming prior art evidence
`
`detailed in the instant petition, along with clear motivations to combine and a
`
`reasonable expectation of success.
`
`The scientific literature had already acknowledged the complementary
`
`mechanisms of action of these two classes of drugs in achieving a superior level of
`
`asthma control and increasing quality of life, including a public statement from the
`
`European Academy of Allergology and Immunology in 2000 recommending a
`
`combination of nasal steroids and antihistamines for treating allergic rhinitis. The
`
`beneficial effect from the combined drugs was hardly surprising given that a
`
`similar complementary effect had already been observed when fluticasone was
`
`combined with other inhalable asthma medications.
`
`
`
`
`
`3
`
`

`

`Patent No. 8,168,620
`
`Petition For Inter Partes Review
`
`While Patent Owner ultimately obtained allowance of the ’620 patent claims
`
`based on declarations attesting to unexpected results, commercial success and
`
`long-felt but unmet need, closer inspection shows these arguments to be
`
`flawed. Patent Owner’s own evidence reveals that the combined drug formulation
`
`actually performed no better than concurrent monotherapies of fluticasone and
`
`azelastine, highlighting that the main shortcoming of the monotherapy approach
`
`was nothing more than achieving patient compliance—hardly a surprising
`
`discovery. Patent Owner’s evidence also failed to establish a nexus between the
`
`claimed invention and the alleged success and unmet need.
`
`In any event, such arguments are moot in view of the anticipation of the
`
`claims by the Segal reference. The instant petition also establishes an
`
`insurmountable prima facie case of obviousness based on the well-known drugs,
`
`and the well-known uses, formulations, and techniques for making their
`
`combination.
`
`IV. THE ’620 PATENT
`
`A. Overview
`
`The ’620 patent is listed in the FDA’s Orange Book as covering
`
`DYMISTA®, a nasal spray incorporating fluticasone propionate (a corticosteroid),
`
`and azelastine (an antihistamine). The Orange Book states that the ’620 patent will
`
`4
`
`

`

`Patent No. 8,168,620
`
`Petition For Inter Partes Review
`
`expire on February 24, 2026. The ’620 patent issued from U.S. Patent Application
`
`No. 10/518,016, which purports to be the 35 U.S.C. § 371 national stage
`
`application of International Application No. PCT/GB03/02557
`
`(“PCT/GB03/02557”) filed on June 13, 2003. PCT/GB03/02557 purports on its
`
`face to claim priority to UK Patent Application No. 0213739.6 (“GB 0213739.6”),
`
`filed on June 14, 2002 (the earliest possible effective date).
`
`Claim 1 of the ’620 patent recites a two-component pharmaceutical
`
`formation suitable for nasal administration:
`
`1. A pharmaceutical formulation comprising:
`azelastine, or a pharmaceutically acceptable salt thereof, and
`a pharmaceutically acceptable ester of fluticasone,
`wherein said pharmaceutical formulation is in a dosage form suitable for
`nasal administration.
`
`According to the specification of the ’620 patent, each of the two claimed
`
`components (azelastine and fluticasone) were “known” to be used as a “nasal spray”
`
`in the treatment of “allergy-related conditions,” including “allergic rhinitis”:
`
`It is known to use antihistamines in nasal sprays and eye drops
`to treat allergy-related conditions. Thus, for example, it is known to
`use the antihistamine azelastine (usually as the hydrochloride salt) as a
`nasal spray against seasonal or perennial allergic rhinitis, or as eye
`drops against seasonal and perennial allergic conjunctivitis.
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`It is also known to treat these conditions using a corticosteroid,
`which will suppress nasal and ocular inflammatory conditions.
`Among the corticosteroids known for nasal use are, for example,
`beclomethasone, mometasone, fluticasone, budesonide and
`cyclosenide.
`Ex. 1001, 1:20-30 (emphasis added).
`
`To combine these two ingredients, the ’620 patent admits: “where only the
`
`ingredients of formulations according to the present invention are listed, these
`
`formulations are prepared by techniques well known in the art.” Id. at 7:67-8:2
`
`(emphasis added).
`
`B.
`
`Prosecution History
`
`The ’620 patent issued after numerous rounds of rejection-and-response
`
`before two different examiners. Ultimately, the second examiner allowed the
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`claims based entirely on three declarations submitted by the applicant: the Chopra
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`Declaration (commercial success), Rajan Declaration (long unmet need), and Maus
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`Declaration (unexpected results). See Ex. 1002, 143-146 (Reasons of
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`Allowability). Applicant submitted these three declarations solely “[a]s evidence
`
`of … secondary considerations” of nonobviousness. Id., 226. However, nowhere
`
`in the “Reasons for Allowability” (id., 143-145) did the examiner identify any
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`claim element that was missing in the Cramer reference (EP 0780127), despite
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`having found Cramer to anticipate most of the claims in the last-issued Office
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`Action (id., 510-512).
`
`V. CLAIM CONSTRUCTION
`
`Claim 24 contains the term “conditions.” The term appears within the
`
`phrase “treatment of conditions for which administration of one or more anti-
`
`histamine and/or one or more steroid is indicated.” Ex. 1001, cl.24. For purposes
`
`of this IPR, and consistent with the court’s order in Meda Pharms. Inc. v. Inc. (Ex.
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`1005, 5), Petitioner proposes that the broadest reasonable construction of the term
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`“conditions” is “disease(s) or illness(es).” Ex. 1003, ¶18.
`
`The specification of the ’620 patent expressly refers to “conditions” when
`
`discussing the well-known prior art nasal spray treatments of “allergy-related
`
`conditions” using antihistamines (including azelastine hydrochloride) and
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`corticosteroids (including fluticasone). Ex. 1001, 1:20-33. It mentions allergic
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`conditions such as “seasonal or perennial allergic rhinitis,” “seasonal and perennial
`
`allergic conjunctivitis” and “nasal and ocular inflammatory conditions.” Id. While
`
`“conditions” must be broad enough to encompass the foregoing specific diseases or
`
`illnesses mentioned, nothing in the specification or prosecution history limits
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`“conditions” to only those specific diseases or illnesses themselves. Ex. 1003, ¶19.
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`The Board may take judicial notice of the fact that the District Court has
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`construed “conditions,” consistent with the foregoing, to mean “disease(s) or
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`illness(es),” while rejecting a narrower construction proffered by Patent Owner that
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`would have limited it to “allergic reactions.” Ex. 1005, 5. The broadest reasonable
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`interpretation of “conditions” should be at least as broad as the District Court’s,
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`which applies the narrower Phillips standard. Ex. 1003, ¶20.
`
`VI. LACK OF ENTITLEMENT TO FOREIGN PRIORITY DATE
`
`The prior art cited in the Grounds below all constitute § 102(b) pre-AIA
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`prior art, even if all claims of the ’620 patent were entitled to the effective filing
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`date of the earliest priority application, GB 0213739.6 (filed June 14, 2002).
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`Nevertheless, to preserve the issue for trial, Petitioner hereby disputes the
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`entitlement of claims 1, 4-6, 25, 42, and 44 to any effective date earlier than June
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`13, 2003.
`
`Raising priority issues in an IPR involves “identifying, specifically, the
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`features, claims, and ancestral applications allegedly lacking § 112, first paragraph,
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`written description and enabling disclosure support for the claims based on the
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`identified features.” Polaris Wireless, Inc. v. TruePosition, Inc., IPR2013-00323,
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`Paper 9 at 29; see also SAP America, Inc. v. Pi-Net Int’l, Inc., IPR2014-00414,
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`Paper 11 at 13-14. The test for sufficiency under the written description
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`requirement is whether the application disclosure relied on reasonably conveys to a
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`POSA that the inventors had possession of the claimed subject matter. Ariad
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`Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc).
`
`The USPTO never considered priority during prosecution of the ’620 patent, and
`
`therefore no presumption of priority applies. PowerOasis, Inc. v. T-Mobile USA,
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`522 F.3d 1299, 1305 (Fed. Cir. 2008) (explaining that when neither the Office nor
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`the Board has considered priority, there is no presumption that patent claims are
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`entitled to the effective filing date of an earlier-filed application).
`
`Here, the genus term “pharmaceutically acceptable ester of fluticasone”
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`lacks written description support in the GB 0213739.6 application. GB 0213739.6
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`does not demonstrate possession of the genus “pharmaceutically acceptable ester
`
`of fluticasone.” In fact, GB 0213739.6 only discloses, generally, “an ester” of
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`fluticasone in claim 5, and provides only one specific example—“fluticasone
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`propionate”—in claim 6. Ex. 1006, cls. 5-6. Moreover, GB 0213739.6 provides
`
`no additional examples, no qualitative guidance, no definition, no test, and no
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`structure-function relationship for what it considered “pharmaceutically
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`acceptable” esters of fluticasone. Ex. 1003, ¶¶22-23.
`
`Under Ariad, “an adequate written description of a claimed genus requires
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`more than a generic statement of an invention’s boundaries.” 598 F.3d at 1350.
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`“[A] sufficient description of a genus instead requires the disclosure of either a
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`representative number of species falling within the scope of the genus or structural
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`features common to the members of the genus so that one of skill in the art can
`
`‘visualize or recognize’ the members of the genus.” Id. at 1351. “[A]n adequate
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`written description requires a precise definition, such as by structure, formula,
`
`chemical name, physical properties, or other properties, of species falling within
`
`the genus sufficient to distinguish the genus from other materials.” Id.
`
`“[F]unctional claim language can meet the written description requirement when
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`the art has established a correlation between structure and function.” Id.
`
`The broad genus of “an ester” of fluticasone in claim 5 of GB 0213739.6,
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`and one specific example of “fluticasone propionate” in claim 6 of GB 0213739.6,
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`are insufficient under Ariad to convey possession of the functional genus
`
`“pharmaceutically acceptable ester of fluticasone” in the ’620 patent. Therefore,
`
`all cla

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