Paper 1
`Date: August 12, 2015
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`COALITION FOR AFFORDABLE DRUGS VII LLC,
`Petitioner,
`
`v.
`
`HORIZON PHARMA USA, INC.,
`Patent Owner.
`
`
`
`
`
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`
`
`IPR2015-01718
`Patent 8,945,621
`
`
`
`
`
`
`
`
`PETITION FOR INTER PARTES REVIEW
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`

`

`IPR2015-01718
`Patent 8,945,621
`
`
`TABLE OF CONTENTS
`
`I. 
`
`Introduction .................................................................................................... 1 
`
`II.  Mandatory Notices Per 37 C.F.R. § 42.8 ..................................................... 1 
`
`A. 
`
`B. 
`
`C. 
`
`Real Party-In-Interest ............................................................................ 1 
`
`Notice of Related Matters ..................................................................... 2 
`
`Lead and Back-Up Counsel and Service Information .......................... 3 
`
`III.  Payment of Fees ............................................................................................. 4 
`
`IV.  Requirements Per 37 C.F.R. § 42.104 .......................................................... 4 
`
`A.  Grounds for Standing ............................................................................ 4 
`
`B. 
`
`C. 
`
`D. 
`
`Identification of Challenge and Precise Relief Requested .................... 4 
`
`Evidence Relied Upon to Support the Challenge .................................. 5 
`
`The Grounds Are Not Redundant or Duplicative ................................. 5 
`
`V. 
`
`Background .................................................................................................... 6 
`
`A. 
`
`B. 
`
`C. 
`
`State of the Art ...................................................................................... 6 
`
`Overview of the ’621 Patent .................................................................. 7 
`
`Person of Ordinary Skill in the Art (POSA) ......................................... 8 
`
`VI.  Claim Construction ....................................................................................... 9 
`
`A. 
`
`B. 
`
`C. 
`
`“Low Dose Aspirin” and “LDA” .......................................................... 9 
`
`“Unit Dose Form” and “Unit Dosage Form” ........................................ 9 
`
`All Remaining Terms .......................................................................... 10 
`
`i
`
`

`

`IPR2015-01718
`Patent 8,945,621
`
`
`VII.  Ground 1: Plachetka in view of Graham and Goldstein Renders
`Obvious Claims 1-16 .................................................................................... 10 
`
`A.  A POSA Would Have Combined Plachetka, Graham, and
`Goldstein ............................................................................................. 10 
`
`B. 
`
`Claim 1: ............................................................................................... 13 
`
`1. 
`
`2. 
`
`3. 
`
`4. 
`
`5. 
`
`6. 
`
`7. 
`
`8. 
`
`A method of reducing the incidence of NSAID-
`associated gastric ulcers in patients taking low dose
`aspirin who are at risk of developing such ulcers, .................... 13 
`
`wherein the method comprises administering to said
`patient in need thereof a pharmaceutical composition in
`unit dose form comprising: ....................................................... 14 
`
`(a) 20 mg of esomeprazole, or pharmaceutically
`acceptable salt thereof, .............................................................. 14 
`
`in a form and route sufficient to raise the gastric pH of
`said patient to at least 3.5 upon administration of one or
`more of said unit dose forms and .............................................. 14 
`
`(b) 500 mg of naproxen, or pharmaceutically acceptable
`salt thereof; ................................................................................ 15 
`
`wherein said unit dose form provides for coordinated
`release of the esomeprazole and the naproxen, ......................... 15 
`
`wherein at least a portion of said esomeprazole, or
`pharmaceutically acceptable salt thereof, is released
`independent of the pH of the surrounding medium, ................. 15 
`
`wherein the unit dosage form releases less than 10% of
`the naproxen or a pharmaceutically acceptable salt
`thereof after 2 hours when tested using the USP Paddle
`Method in 1000 ml of 0.1N HCl at 75 rpm at 37º C. +/-
`0.5º C., ....................................................................................... 16 
`
`ii
`
`

`

`IPR2015-01718
`Patent 8,945,621
`
`
`9. 
`
`wherein said pharmaceutical composition in unit dose
`form reduces the incidence of NSAID-associated ulcers
`in said patient and ..................................................................... 17 
`
`10.  wherein administration of the unit dose form is more
`effective at reducing the incidence of the NSAID-
`associated ulcers in patients taking LDA than in patients
`not taking LDA who are administered the unit dose form. ...... 17 
`
`Claim 2: The method according to claim 1, wherein the risk is
`associated with chronic NSAID treatment. ......................................... 20 
`
`Claim 3: The method according to claim 1, wherein said patient
`is treated for a disease or disorder selected from pain and
`inflammation. ...................................................................................... 20 
`
`Claim 4: The method according to claim 1, wherein said patient
`is treated for a disease or disorder selected from osteoarthritis,
`rheumatoid arthritis, ankylosing spondylitis, and a combination
`thereof. ................................................................................................. 20 
`
`Claim 5: The method according to claim 1, wherein said unit
`dose form is at least about 95% free of sodium bicarbonate. ............. 21 
`
`Claim 6: The method according to claim 1, wherein said unit
`dose form begins to release said naproxen, or a
`pharmaceutically acceptable salt thereof, when the pH of the
`surrounding medium is at about 4.0 or greater. .................................. 21 
`
`Claim 7: The method according to claim 1, wherein said unit
`dose form begins to release said naproxen, or a
`pharmaceutically acceptable salt thereof, when the pH of the
`surrounding medium is at about 4.5 or greater. .................................. 22 
`
`C. 
`
`D. 
`
`E. 
`
`F. 
`
`G. 
`
`H. 
`
`I. 
`
`Claim 8: ............................................................................................... 22 
`
`1. 
`
`A method of reducing the incidence of NSAID-
`associated gastric ulcers in patients taking low dose
`aspirin who are at risk of developing such ulcers, .................... 22 
`
`iii
`
`

`

`IPR2015-01718
`Patent 8,945,621
`
`
`2. 
`
`3. 
`
`4. 
`
`5. 
`
`6. 
`
`7. 
`
`8. 
`
`9. 
`
`wherein the method comprises administering to the
`patient a pharmaceutical composition in unit dosage form
`suitable for oral administration comprising: ............................. 23 
`
`(a) 20 mg of esomeprazole or a pharmaceutically
`acceptable salt thereof, .............................................................. 23 
`
`that is immediately soluble when the dosage form is
`placed in an aqueous medium, independent of pH, .................. 23 
`
`in an amount effective to raise the gastric pH of the
`patient to at least 3.5 upon administration of one or more
`of the unit dosage forms, and .................................................... 24 
`
`(b) 500 mg of naproxen or pharmaceutically acceptable
`salt thereof, ................................................................................ 24 
`
`wherein the unit dosage form releases less than 10% of
`the naproxen or a pharmaceutically acceptable salt
`thereof after 2 hours when tested using the USP Paddle
`Method in 1000ml of 0.1N HCl at 75 rpm at 37º C. +/-
`0.5º C.; ....................................................................................... 24 
`
`wherein said pharmaceutical composition in unit dose
`form reduces the incidence of NSAID-related ulcers in
`said patient and .......................................................................... 24 
`
`wherein administration of the unit dose form is more
`effective at reducing the incidence of the NSAID-
`associated ulcers in patients taking LDA than in patients
`not taking LDA who are administered the unit dose form. ...... 25 
`
`J. 
`
`K. 
`
`Claim 9: The method of claim 8, wherein the risk is associated
`with chronic NSAID treatment. .......................................................... 25 
`
`Claim 10: The method of claim 8, wherein the patient is treated
`for a disease or disorder selected from pain, inflammation,
`osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and
`combinations thereof. .......................................................................... 25 
`
`iv
`
`

`

`IPR2015-01718
`Patent 8,945,621
`
`
`L. 
`
`Claim 11: The method of claim 8, wherein the pharmaceutical
`composition is formulated to be administered to a patient twice
`daily. .................................................................................................... 25 
`
`M.  Claim 12: The method according to claim 8, wherein the unit
`dosage form further comprises a pharmacologically inert water
`soluble coating or film. ........................................................................ 26 
`
`N. 
`
`O. 
`
`Claim 13: The method of claim 12, wherein the inert coating or
`film comprises a water soluble sugar. ................................................. 27 
`
`Claim 14: The method of claim 8, wherein administration of the
`unit dosage form is more effective at reducing the risk of ulcer
`than treatment with enteric coated naproxen or a
`pharmaceutically acceptable salt thereof. ........................................... 27 
`
`P. 
`
`Claim 15: ............................................................................................. 28 
`
`1. 
`
`2. 
`
`3. 
`
`4. 
`
`5. 
`
`6. 
`
`A method of reducing the incidence of NSAID-
`associated gastric ulcers in patients taking low dose
`aspirin (LDA) who are at risk of developing such ulcers, ........ 28 
`
`wherein the method comprises administering to said
`patient in need thereof twice a day for 1 month a
`pharmaceutical composition in unit dose form
`comprising: ................................................................................ 29 
`
`(a) 20 mg of esomeprazole, or pharmaceutically
`acceptable salt thereof, .............................................................. 29 
`
`in a form and route sufficient to raise the gastric pH of
`said patient to at least 3.5 upon administration of one or
`more of said unit dose forms, and ............................................. 30 
`
`(b) 500 mg of naproxen, or pharmaceutically acceptable
`salt thereof; ................................................................................ 30 
`
`wherein said unit dose form provides for coordinated
`release of the esomeprazole and the naproxen, ......................... 30 
`
`v
`
`

`

`IPR2015-01718
`Patent 8,945,621
`
`
`7. 
`
`8. 
`
`9. 
`
`wherein at least a portion of said esomeprazole, or
`pharmaceutically acceptable salt thereof, is released
`independent of the pH of the surrounding medium, ................. 30 
`
`wherein the unit dosage form releases less than 10% of
`the naproxen or a pharmaceutically acceptable salt
`thereof after 2 hours when tested using the USP Paddle
`Method in 1000 ml of 0.1N HCl at 75 rpm at 37º C. +/-
`0.5º C., ....................................................................................... 30 
`
`wherein administration of the unit dose form is more
`effective at reducing the incidence of the NSAID-
`associated gastric ulcers in patients taking LDA than in
`patients not taking LDA who are administered the unit
`dose form. .................................................................................. 31 
`
`Q. 
`
`Claim 16: ............................................................................................. 31 
`
`1. 
`
`2. 
`
`3. 
`
`4. 
`
`5. 
`
`6. 
`
`A method of reducing the incidence of NSAID-
`associated gastric ulcers in patients taking low dose
`aspirin (LDA) who are at risk of developing such ulcers, ........ 31 
`
`wherein the method comprises administering to said
`patient in need thereof twice a day for 3 months a
`pharmaceutical composition in unit dose form
`comprising: ................................................................................ 31 
`
`(a) 20 mg of esomeprazole, or pharmaceutically
`acceptable salt thereof, .............................................................. 32 
`
`in a form and route sufficient to raise the gastric pH of
`said patient to at least 3.5 upon administration of one or
`more of said unit dose forms, and ............................................. 32 
`
`(b) 500 mg of naproxen, or pharmaceutically acceptable
`salt thereof; ................................................................................ 32 
`
`wherein said unit dose form provides for coordinated
`release of the esomeprazole and the naproxen such that: ......... 32 
`
`vi
`
`

`

`IPR2015-01718
`Patent 8,945,621
`
`
`7. 
`
`8. 
`
`9. 
`
`wherein at least a portion of said esomeprazole, or
`pharmaceutically acceptable salt thereof, is released
`independent of the pH of the surrounding medium, ................. 33 
`
`wherein the unit dosage form releases less than 10% of
`the naproxen or a pharmaceutically acceptable salt
`thereof after 2 hours when tested using the USP Paddle
`Method in 1000 ml of 0.1N HCl at 75 rpm at 37º C. +/-
`0.5º C., ....................................................................................... 33 
`
`wherein administration of the unit dose form is more
`effective at reducing the incidence of said ulcers in
`patients taking LDA than in patients not taking LDA who
`are administered the unit dose form. ......................................... 33 
`
`VIII.  Ground 2: Plachetka Renders Obvious Claims 1-16 ............................... 33 
`
`A. 
`
`Claim 1: ............................................................................................... 33 
`
`1. 
`
`2. 
`
`3. 
`
`4. 
`
`5. 
`
`6. 
`
`A method of reducing the incidence of NSAID-
`associated gastric ulcers in patients taking low dose
`aspirin who are at risk of developing such ulcers, .................... 33 
`
`wherein the method comprises administering to said
`patient in need thereof a pharmaceutical composition in
`unit dose form comprising: ....................................................... 35 
`
`(a) 20 mg of esomeprazole, or pharmaceutically
`acceptable salt thereof, .............................................................. 35 
`
`in a form and route sufficient to raise the gastric pH of
`said patient to at least 3.5 upon administration of one or
`more of said unit dose forms and .............................................. 35 
`
`(b) 500 mg of naproxen, or pharmaceutically acceptable
`salt thereof; ................................................................................ 35 
`
`wherein said unit dose form provides for coordinated
`release of the esomeprazole and the naproxen, ......................... 36 
`
`vii
`
`

`

`IPR2015-01718
`Patent 8,945,621
`
`
`7. 
`
`8. 
`
`9. 
`
`wherein at least a portion of said esomeprazole, or
`pharmaceutically acceptable salt thereof, is released
`independent of the pH of the surrounding medium, ................. 36 
`
`wherein the unit dosage form releases less than 10% of
`the naproxen or a pharmaceutically acceptable salt
`thereof after 2 hours when tested using the USP Paddle
`Method in 1000 ml of 0.1N HCl at 75 rpm at 37º C. +/-
`0.5º C., ....................................................................................... 37 
`
`wherein said pharmaceutical composition in unit dose
`form reduces the incidence of NSAID-associated ulcers
`in said patient and ..................................................................... 37 
`
`10.  wherein administration of the unit dose form is more
`effective at reducing the incidence of the NSAID-
`associated ulcers in patients taking LDA than in patients
`not taking LDA who are administered the unit dose form. ...... 38 
`
`Claim 2: The method according to claim 1, wherein the risk is
`associated with chronic NSAID treatment. ......................................... 40 
`
`Claim 3: The method according to claim 1, wherein said patient
`is treated for a disease or disorder selected from pain and
`inflammation. ...................................................................................... 41 
`
`Claim 4: The method according to claim 1, wherein said patient
`is treated for a disease or disorder selected from osteoarthritis,
`rheumatoid arthritis, ankylosing spondylitis, and a combination
`thereof. ................................................................................................. 41 
`
`Claim 5: The method according to claim 1, wherein said unit
`dose form is at least about 95% free of sodium bicarbonate. ............. 41 
`
`Claim 6: The method according to claim 1, wherein said unit
`dose form begins to release said naproxen, or a
`pharmaceutically acceptable salt thereof, when the pH of the
`surrounding medium is at about 4.0 or greater. .................................. 42 
`
`B. 
`
`C. 
`
`D. 
`
`E. 
`
`F. 
`
`G. 
`
`Claim 7: The method according to claim 1, wherein said unit
`
`viii
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`

`

`IPR2015-01718
`Patent 8,945,621
`
`
`dose form begins to release said naproxen, or a
`pharmaceutically acceptable salt thereof, when the pH of the
`surrounding medium is at about 4.5 or greater. .................................. 42 
`
`H. 
`
`Claim 8: ............................................................................................... 43 
`
`1. 
`
`2. 
`
`3. 
`
`4. 
`
`5. 
`
`6. 
`
`7. 
`
`8. 
`
`A method of reducing the incidence of NSAID-
`associated gastric ulcers in patients taking low dose
`aspirin who are at risk of developing such ulcers, .................... 43 
`
`wherein the method comprises administering to the
`patient a pharmaceutical composition in unit dosage form
`suitable for oral administration comprising: ............................. 43 
`
`(a) 20 mg of esomeprazole or a pharmaceutically
`acceptable salt thereof, .............................................................. 43 
`
`that is immediately soluble when the dosage form is
`placed in an aqueous medium, independent of pH, .................. 44 
`
`in an amount effective to raise the gastric pH of the
`patient to at least 3.5 upon administration of one or more
`of the unit dosage forms, and .................................................... 44 
`
`(b) 500 mg of naproxen or pharmaceutically acceptable
`salt thereof, ................................................................................ 44 
`
`wherein the unit dosage form releases less than 10% of
`the naproxen or a pharmaceutically acceptable salt
`thereof after 2 hours when tested using the USP Paddle
`Method in 1000ml of 0.1N HCl at 75 rpm at 37º C. +/-
`0.5º C.; ....................................................................................... 45 
`
`wherein said pharmaceutical composition in unit dose
`form reduces the incidence of NSAID-related ulcers in
`said patient and .......................................................................... 45 
`
`ix
`
`

`

`IPR2015-01718
`Patent 8,945,621
`
`
`9. 
`
`wherein administration of the unit dose form is more
`effective at reducing the incidence of the NSAID-
`associated ulcers in patients taking LDA than in patients
`not taking LDA who are administered the unit dose form. ...... 45 
`
`Claim 9: The method of claim 8, wherein the risk is associated
`with chronic NSAID treatment. .......................................................... 45 
`
`Claim 10: The method of claim 8, wherein the patient is treated
`for a disease or disorder selected from pain, inflammation,
`osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and
`combinations thereof. .......................................................................... 46 
`
`Claim 11: The method of claim 8, wherein the pharmaceutical
`composition is formulated to be administered to a patient twice
`daily. .................................................................................................... 46 
`
`Claim 12: The method according to claim 8, wherein the unit
`dosage form further comprises a pharmacologically inert water
`soluble coating or film. ........................................................................ 46 
`
`I. 
`
`J. 
`
`K. 
`
`L. 
`
`M.  Claim 13: The method of claim 12, wherein the inert coating or
`film comprises a water soluble sugar. ................................................. 46 
`
`N. 
`
`Claim 14: The method of claim 8, wherein administration of the
`unit dosage form is more effective at reducing the risk of ulcer
`than treatment with enteric coated naproxen or a
`pharmaceutically acceptable salt thereof. ........................................... 47 
`
`O. 
`
`Claim 15: ............................................................................................. 48 
`
`1. 
`
`2. 
`
`A method of reducing the incidence of NSAID-
`associated gastric ulcers in patients taking low dose
`aspirin (LDA) who are at risk of developing such ulcers, ........ 48 
`
`wherein the method comprises administering to said
`patient in need thereof twice a day for one month a
`pharmaceutical composition in unit dose form
`comprising: ................................................................................ 48 
`
`x
`
`

`

`IPR2015-01718
`Patent 8,945,621
`
`
`3. 
`
`4. 
`
`5. 
`
`6. 
`
`7. 
`
`8. 
`
`9. 
`
`(a) 20 mg of esomeprazole, or pharmaceutically
`acceptable salt thereof, .............................................................. 49 
`
`in a form and route sufficient to raise the gastric pH of
`said patient to at least 3.5 upon administration of one or
`more of said unit dose forms, and ............................................. 49 
`
`(b) 500 mg of naproxen, or pharmaceutically acceptable
`salt thereof; ................................................................................ 49 
`
`wherein said unit dose form provides for coordinated
`release of the esomeprazole and the naproxen, ......................... 49 
`
`wherein at least a portion of said esomeprazole, or
`pharmaceutically acceptable salt thereof, is released
`independent of the pH of the surrounding medium, ................. 49 
`
`wherein the unit dosage form releases less than 10% of
`the naproxen or a pharmaceutically acceptable salt
`thereof after 2 hours when tested using the USP Paddle
`Method in 1000 ml of 0.1N HCl at 75 rpm at 37º C. +/-
`0.5º C., ....................................................................................... 50 
`
`wherein administration of the unit dose form is more
`effective at reducing the incidence of the NSAID-
`associated gastric ulcers in patients taking LDA than in
`patients not taking LDA who are administered the unit
`dose form. .................................................................................. 50 
`
`P. 
`
`Claim 16: ............................................................................................. 50 
`
`1. 
`
`2. 
`
`A method of reducing the incidence of NSAID-
`associated gastric ulcers in patients taking low dose
`aspirin (LDA) who are at risk of developing such ulcers, ........ 50 
`
`wherein the method comprises administering to said
`patient in need thereof twice a day for three months a
`pharmaceutical composition in unit dose form
`comprising: ................................................................................ 50 
`
`xi
`
`

`

`IPR2015-01718
`Patent 8,945,621
`
`
`3. 
`
`4. 
`
`5. 
`
`6. 
`
`7. 
`
`8. 
`
`9. 
`
`(a) 20 mg of esomeprazole, or pharmaceutically
`acceptable salt thereof, .............................................................. 51 
`
`in a form and route sufficient to raise the gastric pH of
`said patient to at least 3.5 upon administration of one or
`more of said unit dose forms, and ............................................. 51 
`
`(b) 500 mg of naproxen, or pharmaceutically acceptable
`salt thereof; ................................................................................ 51 
`
`wherein said unit dose form provides for coordinated
`release of the esomeprazole and the naproxen such that: ......... 52 
`
`wherein at least a portion of said esomeprazole, or
`pharmaceutically acceptable salt thereof, is released
`independent of the pH of the surrounding medium, ................. 52 
`
`wherein the unit dosage form releases less than 10% of
`the naproxen or a pharmaceutically acceptable salt
`thereof after 2 hours when tested using the USP Paddle
`Method in 1000 ml of 0.1N HCl at 75 rpm at 37º C. +/-
`0.5º C., ....................................................................................... 52 
`
`wherein administration of the unit dose form is more
`effective at reducing the incidence of said ulcers in
`patients taking LDA than in patients not taking LDA who
`are administered the unit dose form. ......................................... 52 
`
`IX.  Any Secondary Considerations of Nonobviousness Would Fail ............. 52 
`
`X.  Conclusion .................................................................................................... 60 
`
`
`
`
`
`xii
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`

`

`IPR2015-01718
`Patent 8,945,621
`
`
`TABLE OF AUTHORITIES
`
`Cases 
`
`Alcon Research, Ltd. v. Apotex, Inc.,
`687 F.3d 1362 (Fed. Cir. 2012)............................................................................ 40
`
`In re Kao,
`639 F.3d 1057 (Fed. Cir. 2011)............................................................................ 39
`
`In re Kubin,
`561 F.3d 1351 (Fed. Cir. 2009)............................................................................ 39
`
`In re Merck & Co., Inc.,
`800 F.2d 1091 (Fed. Cir. 1986)............................................................................ 18
`
`In re Swinehart,
`439 F.2d 210 (C.C.P.A. 1971) ..................................................................... passim
`
`Iron Dome LLC v. Chinook Licensing DE LLC,
`IPR2014-00674, Paper 9 (P.T.A.B. Sept. 10, 2014) .............................................. 4
`
`Leapfrog Enters. Inc. v. Fisher-Price Inc.,
`485 F.3d 1157 (Fed. Cir. 2007)............................................................................ 53
`
`Novo Nordisk A/S v. Caraco Pharmaceutical Labs., Ltd.,
`719 F.3d 1346 (Fed. Cir. 2013)............................................................................ 19
`
`Par Pharm., Inc. v. TWI Pharm., Inc.,
`773 F.3d 1186 (Fed. Cir. 2014)..................................................................... 39, 40
`
`Pfizer, Inc. v. Apotex, Inc.,
`480 F.3d 1348 (Fed. Cir. 2008)..................................................................... 53, 60
`
`Richardson-Vicks Inc. v. Upjohn Co.,
`122 F.3d 1476 (Fed. Cir. 1997)............................................................................ 53
`
`xiii
`
`

`

`IPR2015-01718
`Patent 8,945,621
`
`
`Statutes 
`
`35 U.S.C. § 102(b) .................................................................................................5, 8
`
`35 U.S.C. § 103(a) .................................................................................................4, 5
`
`35 U.S.C. § 311(a) ..................................................................................................... 4
`
`35 U.S.C. §§ 311-319 ................................................................................................ 1
`
`Other Authorities 
`
`MPEP § 2143(I) ....................................................................................................... 13
`
`Regulations 
`
`37 C.F.R. § 42.10(b) .................................................................................................. 3
`
`37 C.F.R. § 42.100 et seq. .......................................................................................... 1
`
`37 C.F.R. § 42.100(b) .............................................................................................. 10
`
`37 C.F.R. § 42.104 ..................................................................................................... 4
`
`37 C.F.R. § 42.15(a) ................................................................................................... 4
`
`37 C.F.R. § 42.6(c) ..................................................................................................... 5
`
`37 C.F.R. § 42.63(e) ................................................................................................... 5
`
`37 C.F.R. § 42.8 ......................................................................................................... 1
`
`37 C.F.R. § 42.8(b)(1) ................................................................................................ 1
`
`37 C.F.R. § 42.8(b)(2) ................................................................................................ 2
`
`37 C.F.R. § 42.8(b)(3) ................................................................................................ 3
`
`xiv
`
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`37 C.F.R. § 42.8(b)(4) ................................................................................................ 3
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`37 C.F.R. § 42.8(b)(4) .............................................................................................. ..337 C.F.R. § 42.8(b)(4) ................................................................................................ 3
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`IPR2015-01718
`IPR2015-01718
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`IPR2015-01718
`Patent 8,945,621
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`Patent 8,945,621Patent 8,945,621
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`IPR2015-01718
`Patent 8,945,621
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`EXHIBIT LIST
`
`Exhibit No. Description
`
`1001
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`1002
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`1003
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`1004
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`1005
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`1006
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`1007
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`1008
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`1009
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`1010
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`1011
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`1012
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`1013
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`xvi
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`IPR2015-01718
`Patent 8,945,621
`
`
`Exhibit No. Description
`Malta College of Pharmacy Practice, Issue 10 (2005)
`
`1014
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`1015
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`1016
`
`1017
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`1018
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`1019
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`xvii
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`IPR2015-01718
`Patent 8,945,621
`
`
`Exhibit No. Description
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`VI