`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v .
`
`COSMO TECHNOLOGIES LIMITED,
`Patent Owner.
`
`U.S. Patent No. 8,784,888 to Villa et al.
`Issue Date: June 22, 2014
`Title: Controlled Release and Taste Masking Oral Pharmaceutical Compositions
`
`
`
`Inter Partes Review No.: IPR2017-01034
`
`
`
`
`
`
`Petition for Inter Partes Review of U.S. Patent No. 8,784,888 Under
`35 U.S.C. §§ 311-319 and 37 C.F.R. §§ 42.1-.80, 42.100-.123
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`

`

`
`
`TABLE OF CONTENTS
`
`
`
`Page
`
`I.
`
`INTRODUCTION ........................................................................................... 1
`
`II.
`
`OVERVIEW .................................................................................................... 1
`
`III.
`
`PROCEDURAL
`42.104(a);
`§
`(37 C.F.R.
`STANDING
`STATEMENTS) .............................................................................................. 1
`
`IV. MANDATORY NOTICES (37 C.F.R. § 42.8(a)(1)) ...................................... 2
`
`A.
`
`Each Real Party-In-Interest (37 C.F.R. § 42.8(b)(1)) ........................... 2
`
`B.
`
`Notice of Related Matters (37 C.F.R. § 42.8(b)(2)) .............................. 2
`
`1.
`
`2.
`
`Judicial Matters ........................................................................... 2
`
`Administrative Matters ............................................................... 2
`
`C.
`
`Designation of Lead and Back-Up Counsel and Service (37
`C.F.R. §§ 42.8(b)(3), 42.8(b)(4), 42.10(a), and 42.10(b)): ................... 3
`
`V.
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED AND THE
`REASONS THEREFORE (37 C.F.R. § 42.22(a)) .......................................... 4
`
`VI. THE ’888 PATENT ......................................................................................... 4
`
`A.
`
`Claim Construction................................................................................ 5
`
`VII. A PERSON OF ORDINARY SKILL IN THE ART ...................................... 7
`
`VIII. IDENTIFICATION OF CHALLENGE (37 C.F.R. § 42.104(b)) ................... 8
`
`IX.
`
`INVALIDITY ANALYSIS ............................................................................. 9
`
`A. Ground 1: Claims 1-9 of the ’888 Patent Would Have Been
`Obvious over U.S. Patent No. 6,239,120 in view of U.S. Patent
`No. 5,681,584 ........................................................................................ 9
`
`1.
`
`The Level of Ordinary Skill in the Pertinent Art and the
`Scope and Content of the Prior Art ...........................................10
`
`a.
`
`The ’120 Patent ...............................................................11
`
`i
`
`

`

`
`
`b.
`
`The ’584 Patent ...............................................................12
`
`2.
`
`Differences Between the Prior Art and the Claims at Issue
` ...................................................................................................14
`
`a.
`b.
`
`c.
`
`d.
`
`e.
`
`Claim 1 ............................................................................14
`Claims 2, 4, 6, 8: “at least one hydrogel-forming
`hydrophilic excipient comprises at
`least one
`hydroxyalkyl cellulose” ..................................................27
`Claim 3: “said gastro-resistant film consists
`essentially of at least one methacrylic acid polymer”
` ........................................................................................28
`Claims 5 and 9: “at least one lipophilic excipient
`comprises stearic acid or magnesium stearate” ..............30
`Claim 7: “at least one amphiphilic excipient
`comprises lecithin” .........................................................31
`
`B.
`
`Ground 2: Claims 1-9 of the ’888 Patent Would Have Been
`Obvious over U.S. Patent No. 5,681,584 ............................................32
`
`1.
`
`The Level of Ordinary Skill in the Pertinent Art and the
`Scope and Content of the Prior Art ...........................................32
`
`2.
`
`Differences Between the Claims and the Prior Art ..................32
`
`a.
`a.
`
`b.
`
`c.
`
`d.
`
`e.
`
`Claim 1 ............................................................................32
`Claims 2, 4, 6, 8: “at least one hydrogel-forming
`hydrophilic excipient comprises at
`least one
`hydroxyalkyl cellulose” ..................................................45
`Claim 3: “said gastro-resistant film consists
`essentially of at least one methacrylic acid polymer”
` ........................................................................................46
`Claims 5 and 9: “at least one lipophilic excipient
`comprises stearic acid or magnesium stearate” ..............47
`Claim 7: “at least one amphiphilic excipient
`comprises lecithin” .........................................................47
`Reasonable Expectation of Success ................................48
`
`C.
`
`Ground 3: Claims 1-9 are Anticipated by U.S. Patent App. Pub.
`No. 2006/0134208 ...............................................................................49
`
`1.
`
`Effective Filing Date of the ’888 Patent ...................................49
`
`ii
`
`

`

`
`
`a.
`b.
`c.
`
`Legal Standard for Priority Dates ...................................49
`“Other Than Gum” Limitation .......................................51
`The ’888 Patent Cannot Have a Priority Date Earlier
`Than September 14, 2012 ...............................................51
`
`2.
`
`3.
`
`The ’208 Publication is Prior Art ..............................................57
`
`Disclosure of the ’208 Publication ............................................58
`
`D. Objective Indicia of Non-Obviousness ...............................................64
`
`1.
`
`2.
`
`3.
`
`4.
`
`No Long-Felt Unmet Need .......................................................65
`
`No Failure of Others .................................................................65
`
`No Unexpected Results Over the Closest Prior Art ..................66
`
`No Commercial Success ...........................................................67
`
`X.
`
`CONCLUSION ..............................................................................................68
`
`
`
`
`
`iii
`
`

`

`
`
`
`
`CASES
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Amneal Pharmaceuticals. LLC v. Hospira, Inc.,
`IPR2016-01577, Paper 11 (P.T.A.B. Feb. 9, 2017) ............................................ 66
`
`Amneal Pharmaceuticals, LLC v. Supernus Pharmaceuticals, Inc.,
`IPR2013-00368, Paper 8 (P.T.A.B. Dec. 17, 2013) ........................................... 64
`
`Amneal Pharms, LLC v. Purdue Pharma L.P.,
`IPR2016-01412, Paper 9 (P.T.A.B. Feb. 14, 2017) ............................................ 12
`
`Amneal Pharms, LLC v. Purdue Pharma L.P.,
`IPR2016-01413, Paper 9 (P.T.A.B. Jan. 18, 2017) ............................................ 12
`
`Ariad Pharm., Inc. v. Eli Lilly & Co.,
`598 F.3d 1336 (Fed. Cir. 2010) (en banc) .......................................................... 49
`
`Automotive Data Solutions, Inc. v. AAMP of Florida, Inc.,
`IPR2016-00061, Paper 23 (P.T.A.B. May 13, 2016) ......................................... 49
`
`Bristol-Myers Squibb Co. v. Ben Venue Labs.,
`246 F.3d 1368 (Fed. Cir. 2001) .......................................................................... 64
`
`Centocor Ortho Biotech, Inc. v. Abbott Labs.,
`636 F.3d 1341 (Fed. Cir. 2011) .......................................................................... 50
`
`Chi Mei Innolux Corp. v. Semiconductor Energy Lab. Co., Ltd.,
`IPR2013-00028, Paper 14 (P.T.A.B. Mar. 21, 2014) ........................................... 9
`
`Coalition For Affordable Drugs II, LLC v. Cosmo Technologies, Ltd.,
`IPR2015-00988, Paper 8 (P.T.A.B. Oct. 7, 2015) ........................................ 19, 34
`
`Cuozzo Speed Techs., LLC v. Lee,
`136 S. Ct. 2131 (2016) .......................................................................................... 7
`
`Dow Jones & Co. v. Ablaise Ltd.,
`606 F.3d 1338 (Fed. Cir. 2010) .......................................................................... 10
`
`iv
`
`

`

`
`
`Ex parte Grasselli,
`231 U.S.P.Q. 393 (B.P.A.I. 1983), aff’d mem., 738 F.2d 453 (Fed
`Cir. 1984) ............................................................................................................ 53
`
`Ex Parte Ziegler,
`APPEAL 2012-001248, 2013 WL 3873064 (P.T.A.B. July 23,
`2013) ................................................................................................................... 53
`
`Friskit, Inc. v. Real Networks, Inc.,
`306 F. App’x 610 (Fed. Cir. 2009) ..................................................................... 65
`
`Graham v. John Deere Co. of Kansas City,
`383 U.S. 1 (1966) .................................................................................................. 9
`
`Illumina, Inc. v. Scripps Research Institute,
`IPR2016-01619, Paper 15 6 (P.T.A.B. Feb. 13, 2017) ....................................... 49
`
`In Re Bigio,
`381 F.3d 1320 (Fed. Cir. 2004) .......................................................................... 14
`
`In re Bimeda Research & Dev. Ltd.,
`724 F.3d 1320 (Fed. Cir. 2013) .................................................................... 50, 52
`
`In Re Chu,
`66 F.3d 292 (Fed. Cir. 1995) .............................................................................. 57
`
`In re De Blauwe,
`736 F.2d 699 (Fed. Cir. 1984) ............................................................................ 66
`
`In re Depomed,
`Case No. 2016-1378, Slip Op. (Fed. Cir. Feb. 21, 2017) ................................... 26
`
`In re Herz,
`537 F.2d 549 (C.C.P.A. 1976) ...................................................................... 41, 44
`
`In re Johnson,
`558 F.2d 1008 (C.C.P.A. 1977) .......................................................................... 54
`
`In re Merchant,
`575 F.2d 865 (C.C.P.A. 1978) ............................................................................ 66
`
`v
`
`

`

`
`
`In re Paulson,
`30 F.3d 1475 (Fed. Cir. 1994) ............................................................................ 64
`
`In re Peterson,
`315 F.3d 1325 (Fed. Cir. 2003) .......................................................................... 66
`
`In re Spada,
`911 F.2d 705 (Fed. Cir. 1990) ............................................................................ 40
`
`In re Translogic Tech., Inc.,
`504 F.3d 1249 (Fed. Cir. 2007) ............................................................................ 7
`
`In re Van Langenhoven,
`458 F.2d 132 (C.C.P.A. 1972) ............................................................................ 58
`
`Inphi Corp. v. Netlist, Inc.,
`805 F.3d 1350 (Fed. Cir. 2015) .......................................................................... 53
`
`Iron Grip Barbell Co. v. USA Sports, Inc.,
`392 F.3d 1317 (Fed. Cir. 2004) .......................................................................... 65
`
`Koios Pharm LLC v. Medac Gesellschaft Fur Klinische
`Spezialpraparate,
`IPR2016-01370, Paper 13 (P.T.A.B. Feb. 8, 2017) ............................................ 65
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) .......................................................................... 23, 32, 38, 48
`
`Lockwood v. Am. Airlines, Inc.,
`107 F.3d 1565 (Fed. Cir. 1997) .......................................................................... 50
`
`Newell Cos., Inc. v. Kenney Mfg. Co.,
`864 F.2d 757 (Fed. Cir. 1988) ............................................................................ 64
`
`Ormco Corp. v. Align Tech., Inc.,
`463 F.3d 1299 (Fed. Cir. 2006) .......................................................................... 65
`
`Owens Corning v. Fast Felt Corp.,
`IPR2015-00650, Paper 9 (P.T.A.B. Aug. 13, 2015) ............................................. 9
`
`vi
`
`

`

`
`
`PPG Industries v. Guardian Industries,
`156 F.3d 1351 (Fed. Cir. 1998) .......................................................................... 41
`
`Paperless Accounting v. Bay Area Rapid Transit System,
`804 F.2d 659 (Fed. Cir. 1986) ............................................................................ 57
`
`Par Pharm. Inc. v. Novartis AG,
`IPR2016-01479, Paper 8 (P.T.A.B. Feb. 15, 2017) ............................................ 27
`
`Pfizer, Inc. v. Apotex, Inc.,
`480 F.3d 1348, 1372 (Fed. Cir. 2008) .......................................................... 30, 64
`
`Pharmacosmos A/S v. Luitpold Pharms., Inc.
`IPR2015-01490 Paper 54 (P.T.A.B. Jan. 4, 2017) ................................. 22, 27, 29
`
`PowerOasis, Inc. v. T-Mobile USA, Inc.,
`522 F.3d 1299 (Fed. Cir. 2008) .......................................................................... 49
`
`Praxair Distrib., Inc. v. Ino Therapeutics, LLC,
`IPR2015-00893, Paper 14 (P.T.A.B. Sept. 22, 2015)........................................... 9
`
`Santarus, Inc. v. Par Pharm., Inc.,
`694 F.3d 1344 (Fed. Cir. 2012) .................................................................... 50, 52
`
`Sharp Corp. v. Surpass Tech Innovation LLC,
`IPR2015-00021, Paper 10 (P.T.A.B. Mar. 18, 2015) ........................................... 8
`
`Stratoflex, Inc. v. Aeroquip Corp.,
`713 F.2d 1530 (Fed. Cir. 1983) .......................................................................... 66
`
`Upsher-Smith Labs., Inc. v. Pamlab, LLC,
`412 F. 3d 1319 (Fed. Cir. 2005) ......................................................................... 61
`
`Vandenberg v. Dairy Equip. Co.,
`740 F.2d 1560 (Fed. Cir. 1984) .......................................................................... 67
`
`STATUTES
`
`35 U.S.C. 102(b) ...................................................................................................... 57
`
`35 U.S.C. 325(d) ...................................................................................................... 12
`
`vii
`
`

`

`
`
`35 U.S.C. § 102 .......................................................................................................... 8
`35 U.S.C. § 102 ........................................................................................................ ..8
`
`35 U.S.C. § 102(b) ............................................................................................. 13, 58
`35 U.S.C. § 102(b) ........................................................................................... ..13, 58
`
`35 U.S.C. § 103 .......................................................................................................... 8
`35 U.S.C. § 103 ........................................................................................................ ..8
`
`35 U.S.C. § 112 ........................................................................................................ 51
`35 U.S.C. § 112 ...................................................................................................... ..51
`
`35 U.S.C. § 325(d) ................................................................................................... 13
`35 U.S.C. § 325(d) ................................................................................................. ..13
`
`35 U.S.C. §371 ..................................................................................................... 7, 55
`35 U.S.C. §371 ................................................................................................... ..7, 55
`
`REGULATIONS
`REGULATIONS
`
`37 C.F.R. § 42.6(d) .................................................................................................... 8
`37 CPR. § 42.6(d) .................................................................................................. ..8
`
`37 C.F.R. § 42.8(a)(1) ................................................................................................ 2
`37 CPR. § 42.8(a)(1) .............................................................................................. ..2
`
`37 C.F.R. § 42.8(b)(1) ................................................................................................ 2
`37 CPR. § 42.8(b)(1) .............................................................................................. ..2
`
`37 C.F.R. § 42.8(b)(2) ................................................................................................ 2
`37 CPR. § 42.8(b)(2) .............................................................................................. ..2
`
`37 C.F.R. § 42.8(b)(3) ................................................................................................ 3
`37 CPR. § 42.8(b)(3) .............................................................................................. ..3
`
`37 C.F.R. § 42.8(b)(4) ................................................................................................ 3
`37 C.F.R. § 42.8(b)(4) .............................................................................................. ..3
`
`37 C.F.R. § 42.10(a) ................................................................................................... 3
`37 C.F.R. § 42.10(a) ................................................................................................. ..3
`
`37 C.F.R. § 42.10(b) .................................................................................................. 3
`37 C.F.R. § 42.10(b) ................................................................................................ ..3
`
`37 C.F.R. § 42.22(a) ................................................................................................... 4
`37 C.F.R. § 42.22(a) ................................................................................................. ..4
`
`37 C.F.R. § 42.63(e) ................................................................................................... 1
`37 CPR. § 42.63(e) ................................................................................................. ..1
`
`37 C.F.R. § 42.100(b) ................................................................................................ 6
`37 C.F.R. § 42.100(b) .............................................................................................. ..6
`
`37 C.F.R. § 42.104(a) ................................................................................................. 1
`37 CPR. § 42.104(a) ............................................................................................... ..1
`
`37 C.F.R. § 42.104(b) ................................................................................................ 8
`37 C.F.R. § 42.104(b) .............................................................................................. ..8
`
`37 C.F.R. § 42.106(a) ................................................................................................. 1
`37 CPR. § 42.106(a) ............................................................................................... ..1
`
`viii
`Viii
`
`

`

`
`
`OTHER AUTHORITIES
`OTHER AUTHORITIES
`
`M.P.E.P. § 2111.03 .................................................................................................. 45
`M.P.E.P. § 2111.03 ................................................................................................ ..45
`
`
`
`ix
`ix
`
`

`

`
`
`I.
`
`INTRODUCTION
`
`Mylan Pharmaceuticals Inc. (“Petitioner”) petitions for Inter Partes Review
`
`(“IPR”), and seeks cancellation of Claims 1–9 (“challenged claims”) of U.S. Patent
`
`No. 8,784,888 (“the ’888 patent”) (EX1002), which is assigned to Cosmo
`
`Technologies Limited (“Patent Owner”).
`
`II. OVERVIEW
`
`The ’888 patent generally claims a composition of a well-known drug—
`
`budesonide—for the treatment of inflammatory bowel disease, a disease that
`
`budesonide was known to treat. The other limitations of the claims provide only
`
`common classes of excipients used in formulations containing budesonide. Nothing
`
`new is claimed.
`
`III. STANDING (37 C.F.R. § 42.104(a); PROCEDURAL STATEMENTS)
`
`Petitioner certifies that: (1) the ’888 patent is available for IPR; and (2)
`
`Petitioner is not barred or estopped from requesting IPR of any claim of the ’888
`
`patent on the grounds identified herein. This Petition is filed in accordance with 37
`
`C.F.R. § 42.106(a). Filed herewith are a Power of Attorney and an Exhibit List
`
`pursuant to § 42.10(b) and § 42.63(e). The required fee is paid through an online
`
`credit card, and the Office is authorized to charge any fee deficiencies and credit
`
`overpayments to Deposit Acct. No. 160605 (Customer ID No. 00826).
`
`
`
`

`

`Petition for Inter Partes Review
` of U.S. Patent No. 8,784,888
`
`
`IV. MANDATORY NOTICES (37 C.F.R. § 42.8(a)(1))
`
`A. Each Real Party-In-Interest (37 C.F.R. § 42.8(b)(1))
`
`Mylan Pharmaceuticals Inc., Mylan Inc., and Mylan N.V.
`
`B. Notice of Related Matters (37 C.F.R. § 42.8(b)(2))
`
`1.
`
`Judicial Matters
`
`The ’888 patent is currently the subject of the following litigations: Cosmo
`
`Technologies Limited et al. v. Mylan Pharmaceuticals Inc., 16-cv-00152 (D. Del.);
`
`Cosmo Technologies Limited et al. v. Mylan Pharmaceuticals Inc., 16-cv-00040
`
`(N.D.W.Va.); Cosmo Technologies Ltd. et al. v. Lupin Ltd. et al, 15-cv-00669 (D.
`
`Del.); Cosmo Technologies Limited et al. v. Alvogen Pine Brook, Inc., 15-cv-00193
`
`(D. Del.); Cosmo Technologies Ltd et al. v Actavis Laboratories FL, Inc., 15-cv-
`
`01312 (D.N.J.); Cosmo Technologies Ltd et al. v Actavis Laboratories FL, Inc., 15-
`
`cv-00164 (D. Del.); Cosmo Technologies Limited et al. v. Par Pharmaceutical, Inc.,
`
`15-cv-00116 (D. Del.).
`
`2.
`
`Administrative Matters
`
`At least the following related ’888 patent family members exist: U.S. Patent
`
`No. 7,410,651 (“the ’651 patent”) (EX1004); U.S. Patent No. 9,320,716 (“the ’716
`
`patent”) (EX1001); U.S. Patent No. RE 43,799 (“the ’799 patent”) (EX1003),
`
`formally U.S. Patent No. 8,029,823 (“the ’823 patent”); U.S. Patent No. 8,293,273
`
`(“the ’273 patent”); U.S. Patent No. 7,431,943 (“the ’943 patent”); U.S. Patent No.
`
`2
`
`

`

`
`9,532,954 (“the ’954 patent”); U.S. Patent No. 7,410,652 (“the ’652 patent”); U.S.
`
`Petition for Inter Partes Review
` of U.S. Patent No. 8,784,888
`
`App. No. 14/514,967; and U.S. App. No. 15/369,296.
`
`Concurrently filed herewith is a petition for inter partes review of the
`
`following patent: ’716 patent (IPR2017-01035).
`
`C. Designation of Lead and Back-Up Counsel and Service (37 C.F.R.
`§§ 42.8(b)(3), 42.8(b)(4), 42.10(a), and 42.10(b)):
`
`Lead Counsel
`Jitendra Malik, Ph.D.
`Reg. No. 55,823
`ALSTON & BIRD LLP
`4721 Emperor Boulevard, Suite 400
`Durham, North Carolina 27703-8580
`919.862.2200
`jitty.malik@alston.com
`
`Back-Up Counsel
`H. James Abe
`Reg. No. 61,182
`ALSTON & BIRD LLP
`333 South Hope Street, 16th Floor
`Los Angeles, CA 90071
`213.576.1000
`james.abe@alston.com
`
`Lance Soderstrom
`Reg. No. 65,405
`ALSTON & BIRD LLP
`90 Park Avenue, 15th Floor
`New York, New York 10016-1387
`212.210.9400
`lance.soderstrom@alston.com
`
`Joseph M. Janusz
`Reg. No. 70,396
`ALSTON & BIRD LLP
`101 S. Tryon Street, Suite 4000
`Charlotte, NC 28280
`704-444-1000
`joe.janusz@alston.com
`
`Petitioner consents to email service.
`
`3
`
`

`

`Petition for Inter Partes Review
` of U.S. Patent No. 8,784,888
`
`
`V.
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED AND THE
`REASONS THEREFORE (37 C.F.R. § 42.22(a))
`
`Petitioner requests IPR and cancellation of Claims 1–9 of the ’888 patent.
`
`Petitioner’s full statement of the reasons for the relief requested is set forth in detail
`
`below.
`
`VI. THE ’888 PATENT
`
`The ’888 patent has one independent claim. Independent Claim 1 is
`
`reproduced below:
`
`1. A controlled release oral pharmaceutical composition
`
`consisting essentially of:
`
`(1) a tablet core consisting essentially of:
`
`a) budesonide in an amount effective to treat intestinal
`
`inflammatory disease; and
`
`b) a macroscopically homogeneous composition
`
`comprising at least one lipophilic excipient, at least one
`
`amphiphilic excipient, and at least one hydrogel-
`
`forming hydrophilic excipient other than a gum,
`
`wherein said budesonide
`
`is dispersed
`
`in said
`
`macroscopically homogeneous composition; and
`
`(2) a coating on said tablet core, said coating consisting
`
`essentially of a gastro-resistant film.
`
`
`
`
`
`EX1002, 10:20–32.
`
`Generally, the claims of the ’888 patent recite classes of excipients based on
`
`4
`
`

`

`Petition for Inter Partes Review
` of U.S. Patent No. 8,784,888
`
`
`a recited property (e.g., “lipophilic excipient,” “hydrophilic excipient” or
`
`“amphiphilic excipient”) rather than specific excipients. EX1006, ¶41. The
`
`dependent claims may alternatively recite a narrowed class of compounds (e.g.,
`
`“methacrylic acid polymers,” “cellulose derivatives,” “hydroxyalkyl cellulose” or
`
`Markush groups of compounds). Id. Only in some instances do the claims recite a
`
`specific compound (e.g., dependent Claim 7 reciting lecithin) but even here, the
`
`claim could be coupled with any “hydrophilic excipient” or “lipophilic excipient.”
`
`Id. Petitioner offers these observations to show the broad scope of the claims.
`
`A complete analysis of the claims, as well as application of the relevant prior
`
`art, is presented below.
`
`A. Claim Construction
`
`The District of Delaware provided the following constructions with respect to
`
`the ’888 patent and its related patents:
`
`Construction
`A homogeneous structure in all its volume
`A composition of uniform structure throughout, as
`observed by the naked eye
`
`or
`
`Term
`“matrix”
`“macroscopically
`homogeneous
`composition”
`“macroscopically
`homogeneous
`structure”
`“outer
`matrix”
`
`hydrophilic
`
`A matrix with an affinity for water within which other
`matrices are incorporated
`
`5
`
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`Petition for Inter Partes Review
` of U.S. Patent No. 8,784,888
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`“lipophilic matrix”
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`A matrix having an affinity for lipids and a poor affinity
`towards aqueous fluids
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`“amphiphilic matrix” A matrix containing amphiphilic substances, and as a
`result having both an affinity for lipids and an affinity for
`water
`The temperature at which solid and liquid phases of a
`compound are at equilibrium
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`“melting point”
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`“lipophilic/amphiphilic
`matrix”
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`Lipophilic and amphiphilic matrices
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`
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`EX1012 (Order), 2. Petitioner notes some of the claims of the ’888 patent may not
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`recite these exact terms. That said, the Markman Opinion provides meaning to terms
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`such as “hydrophilic,” “lipophilic,” and “amphiphilic”—terms which do appear in
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`the claims of the ’888 patent. Petitioner also asserts that the Markman Opinion’s
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`definitions of terms such as “hydrophilic,” “lipophilic,” and “amphiphilic” are
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`consistent with their broadest reasonable interpretation (“BRI”). 37 C.F.R. §
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`42.100(b); EX1006, ¶¶ 45-46. To the extent the claim terms are contained in the
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`’888 patent (e.g., “macroscopically homogeneous composition”), Petitioner asserts
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`that at the very least, the BRI should encompass the district court’s constructions.
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`37 C.F.R. § 42.100(b); EX1006, ¶46.
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`All remaining claim terms should be given their BRI, i.e., their ordinary and
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`customary meaning as would have been understood by a POSA at the time, in the
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`context of the entire patent disclosure. Id.; 37 C.F.R. § 42.100(b); Cuozzo Speed
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`Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016); In re Translogic Tech., Inc.,
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`Petition for Inter Partes Review
` of U.S. Patent No. 8,784,888
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`504 F.3d 1249, 1257 (Fed. Cir. 2007).
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`VII. A PERSON OF ORDINARY SKILL IN THE ART
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`The earliest alleged priority date of the ’888 patent is June 9, 2000.1 As
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`explained below, Petitioner disputes that the ’888 patent is entitled to the benefit of
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`the June 9, 2000 filing date. For purposes of discussing the skill level of a POSA,
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`Petitioner will apply—without waiving its argument regarding the lack of priority—
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`the date of June 9, 2000.2
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`As of June 9, 2000, a POSA in the relevant field would have had education or
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`experience in the field of drug delivery systems, including controlled release
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`compositions. Id. at ¶34. The education and experience levels may vary between
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`POSAs, with some having a bachelor’s degree in the chemical or pharmaceutical
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`1 During prosecution of the ’888 patent, Applicant asserted that “the claims as
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`amended are entitled to an effective filing date of at least June 9, 2000, which is the
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`filing date of the PCT application of which application Serial No. 10/009,532, which
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`matured into U.S. Patent No. 7,431,943, was the national stage entry under 35 U.S.C.
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`§371.” EX1015, 37.
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`2 See also EX1006, ¶48 (Dr. Palmieri stating that his opinions would not change
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`even if the priority date were June 14, 1999).
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`Petition for Inter Partes Review
` of U.S. Patent No. 8,784,888
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`arts (e.g., pharmacy or pharmaceutics) plus five years of relevant work experience,
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`or with others holding more advanced degrees—e.g., Ph.D. or Pharm.D.—while
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`having fewer years of experience. Id. at ¶35.
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`VIII. IDENTIFICATION OF CHALLENGE (37 C.F.R. § 42.104(b))
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`Petitioner respectfully requests IPR of Claims 1-9 of the ’888 patent on each
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`specific ground of unpatentability outlined below. Per 37 C.F.R. § 42.6(d), copies
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`of the references are filed herewith. In support of the proposed grounds, this Petition
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`includes the declaration of a technical expert, Anthony Palmieri III, Ph.D., R.Ph.
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`(EX1006), explaining what the art would have conveyed to a POSA as of the priority
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`date of the ’888 patent.
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`Ground
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`References
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`Basis
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`Claims
`Challenged
`1-9
`1-9
`1-9
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`’120 patent and ’584 patent
`’584 patent
`’208 publication
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`35 U.S.C. § 103
`35 U.S.C. § 103
`35 U.S.C. § 102
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`1
`2
`3
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`Prior art references, in addition to the primary references listed above, provide
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`further background in the art, motivation to combine the teachings of these
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`references, and/or support for why a POSA would have had a reasonable expectation
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`of success to arrive at the purported invention recited in the challenged claims.
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`Moreover, the fact that a reference was disclosed to the Examiner is not a bar
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`to institution of an IPR. For example, the Board instituted IPR in Sharp Corp. v.
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`Surpass Tech Innovation LLC, IPR2015-00021, Paper 10 (P.T.A.B. Mar. 18, 2015)
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`Petition for Inter Partes Review
` of U.S. Patent No. 8,784,888
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`even though the petitioner relied on previous considered references, because the
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`petitioner presented different arguments that “shed[] a different light on the
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`[repeated] reference.” Id. at 14; Chi Mei Innolux Corp. v. Semiconductor Energy
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`Lab. Co., Ltd., IPR2013-00028, Paper 14 at 10 (P.T.A.B. Mar. 21, 2014) (instituting
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`IPR where the petitioner submitted an expert declaration even though the same
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`arguments and prior art were allegedly considered). The Board also instituted IPR
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`in Owens Corning v. Fast Felt Corp., IPR2015-00650, Paper 9 (P.T.A.B. Aug. 13,
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`2015) even though the Examiner considered Petitioner’s primary reference, because
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`secondary references were added by the Petitioner. Id. at 25–26; Praxair Distrib.,
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`Inc. v. Ino Therapeutics, LLC, IPR2015-00893, Paper 14 at 7–9 (P.T.A.B. Sept. 22,
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`2015) (instituting IPR even though the two main references were considered,
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`because the same combination of references was not before the examiner, including
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`the declaration of petitioner’s expert).
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`IX.
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`INVALIDITY ANALYSIS
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`A. Ground 1: Claims 1-9 of the ’888 Patent Would Have Been
`Obvious over U.S. Patent No. 6,239,120 in view of U.S. Patent No.
`5,681,584
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`The inquiry for obviousness was established by the Supreme Court in Graham
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`v. John Deere Co. of Kansas City, 383 U.S. 1, 17 (1966). The Graham factors
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`require an examination of: (1) the scope and content of the prior art; (2) differences
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`between the prior art and the claims at issue; (3) the level of ordinary skill in the
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`Petition for Inter Partes Review
` of U.S. Patent No. 8,784,888
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`pertinent art; and (4) secondary considerations of non-obviousness. Id.
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`1.
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`The Level of Ordinary Skill in the Pertinent Art and the
`Scope and Content of the Prior Art
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`A POSA is defined above. Supra Section VII. Graham’s “scope and content
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`of the prior art” requirement not only focuses on the disclosure of the prior art, but
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`also serves to provide an understanding of the state of the art as of the priority date.
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`See Dow Jones & Co. v. Ablaise Ltd., 606 F.3d 1338, 1340 (Fed. Cir. 2010).
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`Controlled release oral pharmaceutical compositions containing budesonide
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`for treatment of intestinal inflammatory diseases were well known in the art.
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`EX1017, 1:10-13, 2:66-3:6; 3:13-19; EX1018, 209; EX1008, 1:10-13, 6:60-65;
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`EX1040, 1: