`
`
`
`
`
`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. 9,320,716 to Villa et al.
`Issue Date: April 26, 2016
`Title: Controlled Release and Taste Masking Oral Pharmaceutical Compositions
`
`
`
`Inter Partes Review No.: IPR2017-01035
`
`
`
`
`
`
`Petition for Inter Partes Review of U.S. Patent No. 9,320,716 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)) .......................................... 3
`
`VI. THE ’716 PATENT ......................................................................................... 4
`
`A.
`
`Claim Construction................................................................................ 5
`
`VII. A PERSON OF ORDINARY SKILL IN THE ART ...................................... 6
`
`VIII. IDENTIFICATION OF CHALLENGE (37 C.F.R. § 42.104(b)) ................... 7
`
`IX.
`
`INVALIDITY ANALYSIS ............................................................................. 9
`
`A. Ground 1: U.S. Patent No. 5,681,584 Anticipates Claims 1-29 .......... 9
`
`1.
`
`2.
`
`3.
`
`Disclosure of the ’584 Patent ....................................................10
`
`Analysis of Independent Claims 1, 12 and 22 ..........................10
`
`Analysis of Dependent Claims .................................................19
`
`i
`
`

`

`
`
`B.
`
`Ground 2: Claims 1-29 are Rendered Obvious by U.S. Patent
`No. 5,681,584 ......................................................................................23
`
`1.
`
`The Level of Ordinary Skill in the Pertinent Art and the
`Scope and Content of the Prior Art ...........................................23
`
`2.
`
`Differences Between the Claims and the Prior Art ..................24
`
`a.
`b.
`
`c.
`
`d.
`
`e.
`
`a.
`
`b.
`
`c.
`
`d.
`
`e.
`
`Claim 1 ............................................................................24
`Claims 6, 12, and 22: “at least one amphiphilic
`compound” ......................................................................30
`Claims 2 and 13: “wherein the gastro-resistant
`coating is . . . methacrylic acid polymers and
`cellulose derivatives” ......................................................31
`Claims 3-5 and 14-16: “wherein the at least one
`hydrophilic compound is . . . a hydroxyalkyl
`cellulose” ........................................................................32
`Claims 7, 8, 17 and 18: “wherein the at least one
`amphiphilic compound . . . lecithin” ..............................32
`Claims 9, 10, 19 and 20: “wherein the at least one
`lipophilic compound is . . . an unsaturated or
`hydrogenated alcohol or fatty acid, salt, ester, or
`amide thereof . . .”/“lipophilic compound is stearic
`acid” ................................................................................33
`Claims 11, 21 and 23: “The controlled release oral
`pharmaceutical composition . . . further comprising
`. . . an acrylic acid polymer” ...........................................34
`Claims 24, 25 and 26: “wherein the macroscopically
`homogenous structure comprises microcrystalline
`cellulose” ........................................................................35
`Claims 27, 28 and 29: “A method for treating
`intestinal
`inflammatory
`disease
`comprising
`administering to a patient the controlled release oral
`pharmaceutical composition according to claim
`[1/12/22]” ........................................................................36
`Reasonable Expectation of Success ................................37
`
`C.
`
`Ground 3: U.S. Patent No. 5,811,388 Anticipates Claims 1-7, 9,
`11-17, 19 and 21-29.............................................................................38
`
`1.
`
`Disclosure of the ’388 Patent ....................................................39
`
`ii
`
`

`

`
`
`2.
`
`3.
`
`Analysis of Independent Claims 1, 12 and 22 ..........................39
`
`Analysis of Dependent Claims 2-7, 9, 11, 13-17, 19, 21,
`and 23-29 ...................................................................................47
`
`D. Ground 4: U.S. Patent No. 5,811,388 Renders Obvious Claims
`1-29 ......................................................................................................50
`
`1.
`
`Differences Between the Claims and the Prior Art ..................51
`
`a.
`b.
`
`c.
`
`d.
`
`e.
`
`f.
`
`g.
`
`h.
`
`i.
`
`a.
`
`Claim 1 ............................................................................51
`Claims 6, 12, and 22: “at least one amphiphilic
`compound” ......................................................................53
`Claims 2 and 13: “wherein the gastro-resistant
`coating is . . . methacrylic acid polymers and
`cellulose derivatives” ......................................................54
`Claims 3-5 and 14-16: “wherein the at least one
`hydrophilic compound is . . . a hydroxyalkyl
`cellulose” ........................................................................55
`Claims 7, 8, 17 and 18: “wherein the at least one
`amphiphilic
`compound
`is.
`.
`.[phosphatidylcholines/lecithin]” ....................................55
`Claims 9, 10, 19 and 20: “wherein the at least one
`lipophilic compound is . . . an unsaturated or
`hydrogenated alcohol or fatty acid, salt, ester, or
`amide thereof”/“lipophilic compound is stearic
`acid” ................................................................................57
`Claims 11, 21 and 23: “The controlled release oral
`pharmaceutical composition . . . further comprising
`. . . . an acrylic acid polymer” .........................................57
`Claims 24, 25 and 26: “wherein the macroscopically
`homogenous structure comprises microcrystalline
`cellulose” ........................................................................58
`Claims 27, 28 and 29: “A method for treating
`intestinal
`inflammatory
`disease
`comprising
`administering to a patient the controlled release oral
`pharmaceutical composition according to claim
`[1/12/22]” ........................................................................59
`Reasonable Expectation of Success ................................60
`
`iii
`
`

`

`
`
`X.
`
`
`
`E.
`
`Ground 5: U.S. Patent No. 5,811,388 in View of U.S. Patent No.
`5,681,584 Renders Obvious Claims 8, 10, 18, and 20 ........................60
`
`1.
`
`Differences Between the Claims and the Prior Art ..................61
`
`a.
`
`b.
`
`Claims 8 and 18: “wherein the at least one
`amphiphilic compound is. . . .lecithin.” ..........................61
`Claims 10 and 20: “wherein the at least one
`lipophilic compound is stearic acid” ..............................62
`
`F.
`
`Objective Indicia of Non-Obviousness ...............................................63
`
`1.
`
`2.
`
`3.
`
`4.
`
`No Long-Felt Unmet Need .......................................................64
`
`No Failure of Others .................................................................64
`
`No Unexpected Results Over the Closest Prior Art ..................65
`
`No Commercial Success ...........................................................66
`
`CONCLUSION ..............................................................................................66
`
`
`
`iv
`
`

`

`
`
`
`
`CASES
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Amneal Pharmaceuticals. LLC v. Hospira, Inc.,
`IPR2016-01577, Paper 11 (P.T.A.B. Feb. 9, 2017) ............................................ 65
`
`Amneal Pharmaceuticals LLC v. Purdue Pharma L.P.,
`IPR2016-01412, Paper 9 (P.T.A.B. Feb. 14, 2017) .............................................. 9
`
`Amneal Pharmaceuticals LLC v. Purdue Pharma L.P.,
`IPR2016-01413, Paper 9 (P.T.A.B. Jan. 18, 2017) ............................................ 10
`
`Amneal Pharmaceuticals LLC v. Supernus Pharmaceuticals, Inc.,
`IPR2013-00368, Paper 8 (P.T.A.B. Dec. 17, 2013) ............................................. 4
`
`Biomarin Pharmaceutical Inc. v. Genzyme Therapeutic Products Ltd.
`Partnership,
`IPR2013-00534, Paper 81 (P.T.A.B. Feb. 23, 2015) ............................................ 3
`
`Boston Sci. Scimed, Inc. v. Cordis Corp.,
`554 F.3d 982 (Fed. Cir. 2009) ............................................................................ 23
`
`Bristol-Myers Squibb Co. v. Ben Venue Labs.,
`246 F.3d 1368 (Fed. Cir. 2001) ............................................................................ 3
`
`Chi Mei Innolux Corp. v. Semiconductor Energy Lab. Co., Ltd.,
`IPR2013-00028, Paper 14 (P.T.A.B. Mar. 21, 2014) ........................................... 8
`
`Coalition For Affordable Drugs II, LLC v. Cosmo Technologies, Ltd.,
`IPR2015-00988, Paper 8 (P.T.A.B. Oct. 7, 2015) .............................................. 25
`
`Cosmo Technologies Limited et al. v. Alvogen Pine Brook, Inc.,
`15-cv-00193 (D. Del.) ........................................................................................... 2
`
`Cosmo Technologies Limited et al. v. Mylan Pharmaceuticals Inc.,
`16-cv-00152 (D. Del.) ........................................................................................... 2
`
`Cosmo Technologies Limited et al. v. Par Pharmaceutical, Inc.,
`15-cv-00116 (D. Del.) ........................................................................................... 2
`
`v
`
`

`

`
`
`Cosmo Technologies Limited v. Alvogen Pine Brook,
`LLC., C.A. No. 15-193-LPS (D. Del. Sept. 7, 2016) ........................................... 2
`
`Cosmo Technologies Ltd et al. v Actavis Laboratories FL, Inc.,
`15-cv-00164 (D. Del.) ........................................................................................... 2
`
`Cosmo Technologies Ltd. et al. v. Lupin Ltd. et al,
`15-cv-00669 (D. Del.) ........................................................................................... 2
`
`Cuozzo Speed Techs., LLC v. Lee,
`136 S. Ct. 2131 (2016) .......................................................................................... 6
`
`Friskit, Inc. v. Real Networks, Inc.,
`306 F. App’x 610 (Fed. Cir. 2009) ....................................................................... 4
`
`Graham v. John Deere Co. of Kansas City,
`383 U.S. 1 (1966) ................................................................................................ 23
`
`In re Aller,
`220 F.2d 454 (C.C.P.A. 1955) .............................................................................. 3
`
`In Re Baxter Travenol Labs.,
`952 F.2d 388 (Fed. Cir. 1991) ........................................................................ 29, 3
`
`In re De Blauwe,
`736 F.2d 699 (Fed. Cir. 1984) .............................................................................. 5
`
`In re Depomed,
`Case No. 2016-1378, Slip Op. (Fed. Cir. Feb. 21, 2017) ................................. 7, 0
`
`In re Fout,
`675 F.2d 297 (C.C.P.A. 1982) ............................................................................ 57
`
`In re Fulton,
`391 F.3d 1195 (Fed. Cir. 2004) ...................................................................... 6, 59
`
`In re Mayne,
`104 F.3d 1339 (Fed. Cir. 1997) ........................................................................ 657
`
`In re Merchant,
`575 F.2d 865 (C.C.P.A. 1978) .............................................................................. 5
`
`vi
`
`

`

`
`
`In re Mouttet,
`686 F.3d 1322 (Fed. Cir. 2012) .................................................................... 37, 63
`
`In re Paulson,
`30 F.3d 1475 (Fed. Cir. 1994) .............................................................................. 9
`
`In re Peterson,
`315 F.3d 1325 (Fed. Cir. 2003) .......................................................................... 65
`
`In re Siebentritt,
`372 F.2d 566 (C.C.P.A. 1967) ............................................................................ 57
`
`In re Spada,
`911 F.2d 705, 15 USPQ2d 1655 (Fed. Cir. 1990) ..................................... 17, 7,58
`
`In re Translogic Tech., Inc.,
`504 F.3d 1249 (Fed. Cir. 2007) ............................................................................ 6
`
`Iron Grip Barbell Co. v. USA Sports, Inc.,
`392 F.3d 1317 (Fed. Cir. 2004) ............................................................................ 4
`
`Kennametal Inc. v. Ingersoll Cutting Tool Co.,
`780 F.3d 1376 (Fed. Cir. 2015) .......................................................................... 18
`
`Koios Pharm LLC v. Medac Gesellschaft Fur Klinische
`Spezialpraparate,
`IPR2016-01370, Paper 13 (P.T.A.B. Feb. 8, 2017) .................................... 6, 59, 4
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) .............................................................................................. 6
`
`Lupin Ltd. et al. v. Senju Pharmaceutical Co., Ltd.,
`IPR2015-01099, Paper 69 (P.T.A.B. Sep. 12, 2016) .................................... 57, 63
`
`Newell Cos., Inc. v. Kenney Mfg. Co.,
`864 F.2d 757 (Fed. Cir. 1988) .............................................................................. 3
`
`Ormco Corp. v. Align Tech., Inc.,
`463 F.3d 1299 (Fed. Cir. 2006) ............................................................................ 4
`
`vii
`
`

`

`
`
`Par Pharm. Inc. v. Novartis AG,
`IPR2016-01479, Paper 8 (P.T.A.B. Feb. 15, 2017) .............................................. 8
`
`Pfizer, Inc. v. Apotex, Inc.,
`480 F.3d 1348 (Fed. Cir. 2008) ............................................................................ 3
`
`Purdue Pharma L.P. v. Epic Pharma, LLC,
`811 F.3d 1345 (Fed. Cir. 2016) .......................................................................... 18
`
`Santarus, Inc. v. Par Pharm., Inc.,
`694 F.3d 1344 (Fed. Cir. 2012) ...................................................................... 29, 3
`
`Sharp Corp. v. Surpass Tech Innovation LLC,
`IPR2015-00021, Paper 10 (P.T.A.B. Mar. 18, 2015) ........................................... 8
`
`Syntex (U.S.A.) LLC v. Apotex Inc.,
`407 F.3d 1371 (Fed. Cir. 2005) ............................................................................ 6
`
`Vandenberg v. Dairy Equip. Co.,
`740 F.2d 1560 (Fed. Cir. 1984) ............................................................................ 6
`
`Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC
`683 F. 3d 1356 (Fed. Cir. 2012) ................................................................... 18, 47
`
`STATUTES
`
`35 U.S.C. § 325(d) ............................................................................................... 9, 38
`
`35 U.S.C. § 102 ...................................................................................................... 8, 9
`
`35 U.S.C. § 102(b) ................................................................................................. 9, 8
`
`35 U.S.C. § 103 .......................................................................................................... 8
`
`REGULATIONS
`
`37 C.F.R. § 42.6(d) .................................................................................................... 7
`
`37 C.F.R. § 42.8(a)(1) ................................................................................................ 2
`
`37 C.F.R. § 42.8(b)(1) ................................................................................................ 2
`
`viii
`
`

`

`
`
`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 CPR. § 42.8(b)(4) .............................................................................................. ..3
`
`37 C.F.R. § 42.10(a) ................................................................................................... 3
`37 CPR. § 42.10(a) ................................................................................................. ..3
`
`37 C.F.R. § 42.10(b) .............................................................................................. 1, 3
`37 CPR. § 42.10(b) ............................................................................................ ..1, 3
`
`37 C.F.R. § 42.22(a) ................................................................................................... 3
`37 CPR. § 42.22(a) ................................................................................................. ..3
`
`37 C.F.R. § 42.63(e) ................................................................................................... 1
`37 CPR. § 42.63(e) ................................................................................................. ..1
`
`37 C.F.R. § 42.100(b) ................................................................................................ 6
`37 CPR. § 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) ................................................................................................ 7
`37 CPR. § 42.104(b) .............................................................................................. ..7
`
`37 C.F.R. § 42.106(a) ................................................................................................. 1
`37 CPR. § 42.106(a) ............................................................................................... ..1
`
`
`
`
`
`ix
`ix
`
`

`

`
`
`I.
`
`INTRODUCTION
`
`Mylan Pharmaceuticals Inc. (“Petitioner”) petitions for Inter Partes Review
`
`(“IPR”), and seeks cancellation of Claims 1–29 (“challenged claims”) of U.S. Patent
`
`No. 9,320,716 (“the ’716 patent”) (EX1001), which is assigned to Cosmo
`
`Technologies Limited (“Patent Owner”).
`
`II. OVERVIEW
`
`The ’716 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 claim limitations 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 ’716 patent is available for IPR; and (2)
`
`Petitioner is not barred or estopped from requesting IPR of any claim of the ’716
`
`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. 9,320,716
`
`
`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 ’716 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 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-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 ’716 patent family members exist: U.S. Patent
`
`No. 7,410,651 (“the ’651 patent”); U.S. Patent No. 8,784,888 (“the ’888 patent”);
`
`U.S. Patent No. RE 43,799 (“the ’799 patent”) 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. 9,532,954 (“the ’954 patent”); U.S.
`
`Patent No. 7,410,652 (“the ’652 patent”); U.S. App. No. 14/514,967; and U.S. App.
`
`No. 15/369,296.
`
`2
`
`

`

`
`
`Concurrently filed herewith is a petition for inter partes review of the ’888
`
`Petition for Inter Partes Review
` of U.S. Patent No. 9,320,716
`
`patent (IPR2017-01034).
`
`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.
`
`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 1–29 of the ’716 patent.
`
`3
`
`

`

`
`Petitioner’s full statement of the reasons for the relief requested is set forth in detail
`
`Petition for Inter Partes Review
` of U.S. Patent No. 9,320,716
`
`below.
`
`VI. THE ’716 PATENT
`
`The ’716 patent has three independent claims (Claims 1, 12 and 22). Claim 1
`
`recites a controlled release oral pharmaceutical composition comprising: (i)
`
`budesonide in an amount effective to treat intestinal inflammatory disease; (ii) a
`
`macroscopically homogenous structure comprising: (a) at least one lipophilic
`
`compound and (b) at least one hydrophilic compound, wherein the macroscopically
`
`homogenous structure controls the release of the budesonide; and (iii) a gastro-
`
`resistant coating on the macroscopically homogenous structure that prevents release
`
`of budesonide in the stomach, wherein the macroscopically homogenous structure is
`
`a tablet. EX1001, 10:12–26; EX1006, ¶39. Claims 12 and 22 are similar to Claim
`
`1 except that Claim 12 requires “at least one amphiphilic compound” rather than the
`
`“at least one lipophilic compound” of Claim 1, whereas Claim 21 requires “at least
`
`one amphiphilic compound” and “at least one lipophilic compound.” EX1001, 11:4-
`
`15; 12:9-25; EX1006, ¶39.
`
`Generally, the claims are directed to compositions with compounds having a
`
`recited property (e.g., “lipophilic compounds,” “hydrophilic compounds” or
`
`“amphiphilic compounds”) rather than specific compounds. Id. at ¶41. The claims
`
`may alternatively recite a class of compounds (e.g., “methacrylic acid polymers,”
`
`4
`
`

`

`Petition for Inter Partes Review
` of U.S. Patent No. 9,320,716
`
`
`“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 10 reciting stearic acid) but even then, the specific compound
`
`is coupled with any “hydrophilic compound” or anything that may function as a
`
`“gastro-resistant coating.” Id. Petitioner offers these observations to show the broad
`
`scope of the claims.
`
`A. Claim Construction
`
`The District of Delaware provided the following constructions with respect to
`
`the ’716 patent and other 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
`
`“lipophilic matrix”
`
`A matrix having an affinity for lipids and a poor affinity
`towards aqueous fluids
`
`“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
`
`“melting point”
`
`5
`
`

`

`Petition for Inter Partes Review
` of U.S. Patent No. 9,320,716
`
`Lipophilic and amphiphilic matrices
`
`
`
`“lipophilic/amphiphilic
`matrix”
`
`
`
`EX1012 (Order), 2. Petitioner notes that some of the claims of the ’716 patent may
`
`not recite these same terms. Nevertheless, the Markman Opinion provides meaning
`
`to terms such as “hydrophilic,” “lipophilic,” and “amphiphilic”—terms which
`
`appear in the claims of the ’716 patent, and which Petitioner asserts are consistent
`
`with their broadest reasonable interpretation (“BRI”). 37 C.F.R. § 42.100(b);
`
`EX1006, ¶¶45-46. To the extent the same terms are contained in the ’716 patent
`
`(e.g., “macroscopically homogeneous structure”), Petitioner asserts that, at the very
`
`least, the BRI should encompass the district court’s constructions. 37 C.F.R. §
`
`42.100(b); EX1006, ¶46.
`
`
`
`All remaining claim terms should be given their BRI, i.e., their ordinary and
`
`customary meaning as would have been understood by a POSA at the time, in the
`
`context of the entire patent disclosure. Id.; 37 C.F.R. § 42.100(b); Cuozzo Speed
`
`Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016); In re Translogic Tech., Inc.,
`
`504 F.3d 1249, 1257 (Fed. Cir. 2007).
`
`VII. A PERSON OF ORDINARY SKILL IN THE ART
`
`The ’716 patent claims priority under 35 U.S.C. § 119 to two Italian patent
`
`applications, MI2000A000422 and MI99A001317, filed March 3, 2000 and June 14,
`
`6
`
`

`

`Petition for Inter Partes Review
` of U.S. Patent No. 9,320,716
`
`
`1999, respectively. The ’716 patent claims priority under 35 U.S.C. § 120 to U.S.
`
`Application No. 10/009,532 filed as International Application No. PCT/EP00/05356
`
`on June 9, 2000. The relevant potential priority date of the ’716 patent is June 9,
`
`2000.1 Even under the June 14, 1999 date, the claims of the ’716 patent are invalid
`
`based on the cited prior art. EX1006, ¶48.
`
`As of June 9, 2000, a POSA in the relevant field would have had education or
`
`experience in the field of drug delivery systems, including controlled release
`
`compositions. Id. at ¶34. The education and experience levels may vary between
`
`POSAs, with some having a bachelor’s degree in the chemical or pharmaceutical
`
`arts (e.g., pharmacy or pharmaceutics) plus five years of relevant work experience,
`
`and others holding more advanced degrees—e.g., Ph.D. or Pharm.D.—while having
`
`fewer years of experience. Id. at ¶35.
`
`VIII. IDENTIFICATION OF CHALLENGE (37 C.F.R. § 42.104(b))
`
`Petitioner respectfully requests IPR of Claims 1-29 of the ’716 patent on each
`
`specific ground of unpatentability outlined below. Per 37 C.F.R. § 42.6(d), copies
`
`of the references are filed herewith. In support of the proposed grounds, this Petition
`
`
`1 See M.P.E.P. § 2133 (“The 1-year time bar is measured from the U.S. filing date.
`
`. . . A rejection under pre-AIA 35 U.S.C. 102(b) cannot be overcome by . . .
`
`foreign priority dates . . . .”); see also 35 U.S.C. § 119(a).
`
`7
`
`

`

`Petition for Inter Partes Review
` of U.S. Patent No. 9,320,716
`
`
`includes the declaration of Anthony Palmieri III, Ph.D., R.Ph. (EX1006) explaining
`
`what the art would have conveyed to a POSA as of the priority date of the ’716
`
`patent.
`
`Ground
`
`References
`
`Basis
`
`1
`2
`3
`
`’584 patent
`’584 patent
`’388 patent
`
`35 U.S.C. § 102
`35 U.S.C. § 103
`
`35 U.S.C. § 102
`
`Claims
`Challenged
`1-29
`1-29
`1-7, 9, 11-17, 19,
`and 21-29
`1-29
`8, 10, 18 and 20
`
`’388 patent
`’388 patent and ’584 patent
`
`35 U.S.C. § 103
`35 U.S.C. § 103
`
`4
`5
`
`Prior art references in addition to the primary references listed above provide
`
`further background in the art, motivation to combine the teachings of these
`
`references, and/or support for why a POSA would have had a reasonable expectation
`
`of success to arrive at the purported invention recited in the challenged claims.
`
`Moreover, the fact that a reference was disclosed to the Examiner is not a bar
`
`to institution of an IPR. For example, the Board instituted IPR in Sharp Corp. v.
`
`Surpass Tech Innovation LLC, IPR2015-00021, Paper 10 (P.T.A.B. Mar. 18, 2015)
`
`even though the petitioner relied on previously considered references, because the
`
`petitioner presented different arguments that “shed[] a different light on the
`
`[repeated] reference.” Id. at 14; Chi Mei Innolux Corp. v. Semiconductor Energy
`
`Lab. Co., Ltd., IPR2013-00028, Paper 14 at 10 (P.T.A.B. Mar. 21, 2014) (instituting
`
`8
`
`

`

`
`IPR where the petitioner submitted an expert declaration even though the same
`
`Petition for Inter Partes Review
` of U.S. Patent No. 9,320,716
`
`arguments and prior art were allegedly considered).
`
`IX.
`
`INVALIDITY ANALYSIS
`
`A. Ground 1: U.S. Patent No. 5,681,584 Anticipates Claims 1-29
`
`Anticipation under 35 U.S.C. § 102 requires that each and every element of
`
`the claimed invention be disclosed expressly or inherently in a single prior art
`
`reference. In re Paulson, 30 F.3d 1475, 1478-79 (Fed. Cir. 1994). “[A] reference
`
`can anticipate a claim even if it ‘[d]oes not expressly spell out’ all the limitations
`
`arranged or combined as in the claim.” Kennametal Inc. v. Ingersoll Cutting Tool
`
`Co., 780 F.3d 1376, 1381 (Fed. Cir. 2015).
`
`U.S. Patent No. 5,681,584 (“the ’584 patent”) (EX1008) anticipates Claims 1-
`
`29 of the ’716 patent. The ’584 patent, entitled “Controlled Release Drug Delivery
`
`Device,” issued on October 28, 1997. Accordingly, the ’584 patent is prior art under
`
`35 U.S.C. § 102(b). Although the ’584 patent was disclosed to the PTO (with 112
`
`other references) during prosecution of the application that led to the ’716 patent, it
`
`was not addressed during its prosecution. While the ’584 patent was cited by the
`
`Examiner during prosecution of a (prior) related family member (i.e., the ’888
`
`patent), this does not bar institution of this IPR under 35 U.S.C. § 325(d). Amneal
`
`Pharms. LLC v. Purdue Pharma L.P., IPR2016-01412, Paper 9 at 19 (P.T.A.B. Feb.
`
`9
`
`

`

`
`14, 2017); Amneal Pharms. LLC v. Purdue Pharma L.P., IPR2016-01413, Paper 9
`
`Petition for Inter Partes Review
` of U.S. Patent No. 9,320,716
`
`at 23 (P.T.A.B. Jan. 18, 2017).
`
`1.
`
`Disclosure of the ’584 Patent
`
`The ’584 patent discloses coated time-controlled tablets that release an active
`
`agent intermittently or at a pre-selected region of the gastro-intestinal tract. EX1008,
`
`1:10-13; Id. at Title; EX1006, ¶57. The ’584 patent teaches a solid core within the
`
`tablet that comprises the active agent—for example, budesonide. EX1008, 6:48;
`
`EX1006, ¶57. The ’584 patent explains that “[s]uch treatment would be beneficial for
`
`a variety of colonic diseases including inflammatory bowel disease, colitis ulcerosa,
`
`enteritis, regionalis Crohn, chronic nonspecific colitis