Paper 1
`Date: May 21, 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.
`
`POZEN INC.,
`Patent Owner.
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`IPR2015-01241
`Patent 6,926,907
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`PETITION FOR INTER PARTES REVIEW
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`IPR2015-01241
`Patent 6,926,907
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`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 ............................................................................................. 3 
`
`IV.  Requirements Per 37 C.F.R. § 42.104 .......................................................... 4 
`
`A.  Grounds for Standing ............................................................................ 4 
`
`B. 
`
`C. 
`
`Identification of Challenge and Precise Relief Requested .................... 4 
`
`Evidence Relied Upon to Support the Challenge .................................. 5 
`
`V. 
`
`Background .................................................................................................... 5 
`
`A. 
`
`B. 
`
`State of the Art ...................................................................................... 5 
`
`Person of Ordinary Skill in the Art (POSA) ......................................... 9 
`
`VI.  Claim Construction ..................................................................................... 10 
`
`A. 
`
`B. 
`
`C. 
`
`“Unit Dosage Form” ............................................................................ 10 
`
`“Acid Inhibitor” ................................................................................... 10 
`
`“Coordinated Release” ........................................................................ 11 
`
`D.  All Remaining Terms .......................................................................... 11 
`
`VII.  Ground 1: Gimet in View of Chiverton Renders Obvious Claims
`1, 7, 8, 12, 13, 22, and 23 .............................................................................. 12 
`
`A.  A POSA Would Have Combined Chiverton with Gimet ................... 12 
`
`i
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`IPR2015-01241
`Patent 6,926,907
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`B. 
`
`Claim 1: ............................................................................................... 12 
`
`1. 
`
`2. 
`
`3. 
`
`4. 
`
`5. 
`
`A pharmaceutical composition in unit dosage form
`suitable for oral administration to a patient, comprising: ......... 12 
`
`(a) an acid inhibitor present in an amount effective to
`raise the gastric pH of said patient to at least 3.5 upon the
`administration of one or more of said unit dosage forms; ........ 13 
`
`(b) a non-steroidal anti-inflammatory drug (NSAID) in
`an amount effective to reduce or eliminate pain or
`inflammation in said patient upon administration of one
`or more of said unit dosage forms; ........................................... 14 
`
`and wherein said unit dosage form provides for
`coordinated release such that: i) said NSAID is
`surrounded by a coating that, upon ingestion of said unit
`dosage form by said patient, prevents the release of
`essentially any NSAID from said dosage form unless the
`pH of the surrounding medium is 3.5 or higher; ...................... 14 
`
`ii) at least a portion of said acid inhibitor is not
`surrounded by an enteric coating and, upon ingestion of
`said unit dosage form by said patient, is released
`regardless of whether the pH of the surrounding medium
`is below 3.5 or above 3.5. ......................................................... 15 
`
`C. 
`
`D. 
`
`Claim 7: The pharmaceutical composition of claim 1, wherein
`said NSAID is a cyclooxygenese-2 (COX-2) inhibitor. ..................... 17 
`
`Claim 8: The pharmaceutical composition of claim 7, wherein
`said COX-2 inhibitor is selected from the group consisting of
`celecoxib; rofecoxib; meloxicam; piroxicam; valdecoxib,
`parecoxib, etoricoxib, CS-502, JTE-522; L-745,337; and
`NS398. ................................................................................................. 17 
`
`E. 
`
`Claim 12: ............................................................................................. 17 
`
`1. 
`
`The pharmaceutical composition of claim 1 wherein said
`unit dosage form is a multilayer tablet comprising .................. 17 
`
`ii
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`IPR2015-01241
`Patent 6,926,907
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`2. 
`
`3. 
`
`4. 
`
`5. 
`
`a single core and one or more layers outside of said
`single core, wherein: ................................................................. 18 
`
`i) said NSAID is present in said core; ....................................... 18 
`
`ii) said coating that does not release said NSAID unless
`the pH of the surrounding medium is 3.5 or higher
`surrounds said core; and ............................................................ 18 
`
`iii) said acid inhibitor is in said one more layers outside
`said core. ................................................................................... 19 
`
`F. 
`
`Claim 13: The pharmaceutical composition of claim 12,
`wherein said one or more layers outside of said core do not
`contain NSAID and are not surrounded by an enteric coating. .......... 19 
`
`G. 
`
`Claim 22: ............................................................................................. 19 
`
`1. 
`
`2. 
`
`A method of treating a patient for pain or inflammation,
`comprising ................................................................................. 20 
`
`administering to said patient the pharmaceutical
`composition of any one of claims 1-14. .................................... 20 
`
`H. 
`
`Claim 23: The method of claim 22, wherein said pain or
`inflammation is due to either osteoarthritis or rheumatoid
`arthritis. ................................................................................................ 20 
`
`VIII.  Ground 2: Gimet in View of Goldman in Further View of
`Remington Renders Obvious Claims 1-5 and 7-23................................... 21 
`
`A.  A POSA Would Have Combined Goldman, Remington and
`Gimet ................................................................................................... 21 
`
`B. 
`
`Claim 1: ............................................................................................... 22 
`
`1. 
`
`2. 
`
`A pharmaceutical composition in unit dosage form
`suitable for oral administration to a patient, comprising: ......... 22 
`
`(a) an acid inhibitor present in an amount effective to
`raise the gastric pH of said patient to at least 3.5 upon the
`
`iii
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`IPR2015-01241
`Patent 6,926,907
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`3. 
`
`4. 
`
`5. 
`
`administration of one or more of said unit dosage forms; ........ 22 
`
`(b) a non-steroidal anti-inflammatory drug (NSAID) in
`an amount effective to reduce or eliminate pain or
`inflammation in said patient upon administration of one
`or more of said unit dosage forms; ........................................... 23 
`
`and wherein said unit dosage form provides for
`coordinated release such that: i) said NSAID is
`surrounded by a coating that, upon ingestion of said unit
`dosage form by said patient, prevents the release of
`essentially any NSAID from said dosage form unless the
`pH of the surrounding medium is 3.5 or higher; ...................... 23 
`
`ii) at least a portion of said acid inhibitor is not
`surrounded by an enteric coating and, upon ingestion of
`said unit dosage form by said patient, is released
`regardless of whether the pH of the surrounding medium
`is below 3.5 or above 3.5. ......................................................... 24 
`
`C. 
`
`D. 
`
`E. 
`
`F. 
`
`Claim 2: The pharmaceutical composition of claim 1, wherein
`said acid inhibitor is an H2 blocker. .................................................... 24 
`
`Claim 3: The pharmaceutical composition of claim 2, wherein
`said H2 blocker is selected from the group consisting of:
`cimetidine; ranitidine; ebrotidine; pabutidine; lafutidine;
`loxtidine and famotidine. ..................................................................... 24 
`
`Claim 4: The pharmaceutical composition of claim 3, wherein
`said H2 blocker is famotidine, present in said unit dosage form
`in an amount of between 5 mg and 100 mg. ....................................... 25 
`
`Claim 5: The pharmaceutical composition of claim 1, wherein
`said acid inhibitor is a proton pump inhibitor selected from the
`group consisting of: omeprazole, esomeprazole, lansoprazole,
`pantoprazole and rabeprazole. ............................................................. 26 
`
`G. 
`
`Claim 7: The pharmaceutical composition of claim 1, wherein
`said NSAID is a cyclooxygenese-2 (COX-2) inhibitor. ..................... 26 
`
`iv
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`IPR2015-01241
`Patent 6,926,907
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`H. 
`
`I. 
`
`J. 
`
`K. 
`
`Claim 8: The pharmaceutical composition of claim 7, wherein
`said COX-2 inhibitor is selected from the group consisting of
`celecoxib; rofecoxib; meloxicam; piroxicam; valdecoxib,
`parecoxib, etoricoxib, CS-502, JTE-522; L-745,337; and
`NS398. ................................................................................................. 26 
`
`Claim 9: The pharmaceutical composition of claim 1, wherein
`said NSAID is selected from the group consisting of: aspirin;
`acetaminophen; ibuprofen; flurbiprofen; ketoprofen;
`lornoxicam; naproxen; oxaprozin; etodolac; indomethacin;
`ketorolac; and nabumetone. ................................................................. 27 
`
`Claim 10: The pharmaceutical composition of claim 9, wherein
`said NSAID is naproxen present in an amount of between 50
`mg and 1500 mg. ................................................................................. 27 
`
`Claim 11: The pharmaceutical composition of claim 10,
`wherein said naproxen is present in an amount of between 200
`mg and 600 mg. ................................................................................... 28 
`
`L. 
`
`Claim 12: ............................................................................................. 29 
`
`1. 
`
`2. 
`
`3. 
`
`4. 
`
`5. 
`
`The pharmaceutical composition of claim 1 wherein said
`unit dosage form is a multilayer tablet comprising .................. 29 
`
`a single core and one or more layers outside of said
`single core, wherein: ................................................................. 29 
`
`i) said NSAID is present in said core; ....................................... 29 
`
`ii) said coating that does not release said NSAID unless
`the pH of the surrounding medium is 3.5 or higher
`surrounds said core; and ............................................................ 29 
`
`iii) said acid inhibitor is in said one more layers outside
`said core. ................................................................................... 29 
`
`M.  Claim 13: The pharmaceutical composition of claim 12,
`wherein said one or more layers outside of said core do not
`contain NSAID and are not surrounded by an enteric coating. .......... 29 
`
`v
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`IPR2015-01241
`Patent 6,926,907
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`N. 
`
`Claim 14: ............................................................................................. 30 
`
`1. 
`
`2. 
`
`The pharmaceutical composition of claim 13, wherein
`said unit dosage form is a bilayer tablet having an outer
`layer of said acid inhibitor and an inner core of said
`NSAID and ................................................................................ 30 
`
`wherein said outer layer of said tablet is surrounded by a
`non-enteric film coating that releases said acid inhibitor
`upon ingestion by patient. ......................................................... 31 
`
`O. 
`
`Claim 15: The pharmaceutical composition of any one of
`claims 1 or 7-14, wherein said acid inhibitor is a proton pump
`inhibitor. .............................................................................................. 31 
`
`P. 
`
`Claim 16: ............................................................................................. 32 
`
`1. 
`
`2. 
`
`The pharmaceutical composition of any one of claims 12-
`14, wherein said acid inhibitor is a proton pump inhibitor
`and ............................................................................................. 32 
`
`wherein said coating surrounding said core does not
`dissolve unless the pH of the surrounding medium is 4 or
`greater. ....................................................................................... 33 
`
`Q. 
`
`Claim 17: ............................................................................................. 33 
`
`1. 
`
`2. 
`
`The pharmaceutical composition of any one of claims 12-
`14, wherein said acid inhibitor is a proton pump inhibitor
`and ............................................................................................. 33 
`
`wherein said coating surrounding said core does not
`dissolve unless the pH of the surrounding medium is 5 or
`greater. ....................................................................................... 34 
`
`R. 
`
`Claim 18: The pharmaceutical composition of any one of
`claims 7-14, wherein said acid inhibitor is an H2 blocker. ................. 35 
`
`S. 
`
`Claim 19: ............................................................................................. 35 
`
`1. 
`
`The pharmaceutical composition of any one of claims 12-
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`IPR2015-01241
`Patent 6,926,907
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`14, wherein said acid inhibitor is an H2 blocker and ............... 35 
`
`2. 
`
`wherein said tablet has an inner core of said NSAID
`surrounded by a barrier coating that dissolves at a rate
`such that said NSAID is not released until the pH of the
`surrounding medium is 4 or greater. ......................................... 36 
`
`T. 
`
`Claim 20: ............................................................................................. 36 
`
`1. 
`
`2. 
`
`The pharmaceutical composition of any one of claims 12-
`14, wherein said acid inhibitor is an H2 blocker and ............... 37 
`
`wherein said tablet has an inner core of said NSAID
`surrounded by a barrier coating that dissolves at a rate
`such that said NSAID is not released until the pH of the
`surrounding medium is 5 or greater. ......................................... 37 
`
`U. 
`
`Claim 21: The pharmaceutical composition of claim 1, wherein
`said unit dosage form is a capsule. ...................................................... 38 
`
`V. 
`
`Claim 22: ............................................................................................. 38 
`
`1. 
`
`2. 
`
`A method of treating a patient for pain or inflammation,
`comprising ................................................................................. 38 
`
`administering to said patient the pharmaceutical
`composition of any one of claims 1-14. .................................... 39 
`
`W.  Claim 23: The method of claim 22, wherein said pain or
`inflammation is due to either osteoarthritis or rheumatoid
`arthritis. ................................................................................................ 39 
`
`IX.  Ground 3: Goldman in View of Remington in Further View of
`Abe Renders Obvious Claims 1-5, 7-18, 21, and 22.................................. 39 
`
`A.  A POSA Would Have Combined Remington, Abe, and
`Goldman .............................................................................................. 39 
`
`B. 
`
`Claim 1: ............................................................................................... 40 
`
`1. 
`
`A pharmaceutical composition in unit dosage form
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`vii
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`IPR2015-01241
`Patent 6,926,907
`
`
`2. 
`
`3. 
`
`4. 
`
`5. 
`
`suitable for oral administration to a patient, comprising: ......... 40 
`
`(a) an acid inhibitor present in an amount effective to
`raise the gastric pH of said patient to at least 3.5 upon the
`administration of one or more of said unit dosage forms; ........ 40 
`
`(b) a non-steroidal anti-inflammatory drug (NSAID) in
`an amount effective to reduce or eliminate pain or
`inflammation in said patient upon administration of one
`or more of said unit dosage forms; ........................................... 41 
`
`and wherein said unit dosage form provides for
`coordinated release such that: i) said NSAID is
`surrounded by a coating that, upon ingestion of said unit
`dosage form by said patient, prevents the release of
`essentially any NSAID from said dosage form unless the
`pH of the surrounding medium is 3.5 or higher; ...................... 42 
`
`ii) at least a portion of said acid inhibitor is not
`surrounded by an enteric coating and, upon ingestion of
`said unit dosage form by said patient, is released
`regardless of whether the pH of the surrounding medium
`is below 3.5 or above 3.5. ......................................................... 43 
`
`C. 
`
`D. 
`
`E. 
`
`F. 
`
`Claim 2: The pharmaceutical composition of claim 1, wherein
`said acid inhibitor is an H2 blocker. .................................................... 44 
`
`Claim 3: The pharmaceutical composition of claim 2, wherein
`said H2 blocker is selected from the group consisting of:
`cimetidine; ranitidine; ebrotidine; pabutidine; lafutidine;
`loxtidine and famotidine. ..................................................................... 44 
`
`Claim 4: The pharmaceutical composition of claim 3, wherein
`said H2 blocker is famotidine, present in said unit dosage form
`in an amount of between 5 mg and 100 mg. ....................................... 45 
`
`Claim 5: The pharmaceutical composition of claim 1, wherein
`said acid inhibitor is a proton pump inhibitor selected from the
`group consisting of: omeprazole, esomeprazole, lansoprazole,
`pantoprazole and rabeprazole. ............................................................. 45 
`
`viii
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`IPR2015-01241
`Patent 6,926,907
`
`
`G. 
`
`H. 
`
`I. 
`
`J. 
`
`K. 
`
`Claim 7: The pharmaceutical composition of claim 1, wherein
`said NSAID is a cyclooxygenese-2 (COX-2) inhibitor. ..................... 45 
`
`Claim 8: The pharmaceutical composition of claim 7, wherein
`said COX-2 inhibitor is selected from the group consisting of
`celecoxib; rofecoxib; meloxicam; piroxicam; valdecoxib,
`parecoxib, etoricoxib, CS-502, JTE-522; L-745,337; and
`NS398. ................................................................................................. 46 
`
`Claim 9: The pharmaceutical composition of claim 1, wherein
`said NSAID is selected from the group consisting of: aspirin;
`acetaminophen; ibuprofen; flurbiprofen; ketoprofen;
`lornoxicam; naproxen; oxaprozin; etodolac; indomethacin;
`ketorolac; and nabumetone. ................................................................. 46 
`
`Claim 10: The pharmaceutical composition of claim 9, wherein
`said NSAID is naproxen present in an amount of between 50
`mg and 1500 mg. ................................................................................. 46 
`
`Claim 11: The pharmaceutical composition of claim 10,
`wherein said naproxen is present in an amount of between 200
`mg and 600 mg. ................................................................................... 47 
`
`L. 
`
`Claim 12: ............................................................................................. 47 
`
`1. 
`
`2. 
`
`3. 
`
`4. 
`
`5. 
`
`The pharmaceutical composition of claim 1 wherein said
`unit dosage form is a multilayer tablet comprising .................. 47 
`
`a single core and one or more layers outside of said
`single core, wherein: ................................................................. 48 
`
`i) said NSAID is present in said core; ....................................... 48 
`
`ii) said coating that does not release said NSAID unless
`the pH of the surrounding medium is 3.5 or higher
`surrounds said core; and ............................................................ 49 
`
`iii) said acid inhibitor is in said one more layers outside
`said core. ................................................................................... 49 
`
`M.  Claim 13: The pharmaceutical composition of claim 12,
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`IPR2015-01241
`Patent 6,926,907
`
`
`wherein said one or more layers outside of said core do not
`contain NSAID and are not surrounded by an enteric coating. .......... 50 
`
`N. 
`
`Claim 14: ............................................................................................. 51 
`
`1. 
`
`2. 
`
`The pharmaceutical composition of claim 13, wherein
`said unit dosage form is a bilayer tablet having an outer
`layer of said acid inhibitor and an inner core of said
`NSAID and ................................................................................ 51 
`
`wherein said outer layer of said tablet is surrounded by a
`non-enteric film coating that releases said acid inhibitor
`upon ingestion by patient. ......................................................... 51 
`
`O. 
`
`Claim 15: The pharmaceutical composition of any one of
`claims 1 or 7-14, wherein said acid inhibitor is a proton pump
`inhibitor. .............................................................................................. 52 
`
`P. 
`
`Claim 16: ............................................................................................. 52 
`
`1. 
`
`2. 
`
`The pharmaceutical composition of any one of claims 12-
`14, wherein said acid inhibitor is a proton pump inhibitor
`and ............................................................................................. 52 
`
`wherein said coating surrounding said core does not
`dissolve unless the pH of the surrounding medium is 4 or
`greater. ....................................................................................... 53 
`
`Q. 
`
`Claim 17: ............................................................................................. 53 
`
`1. 
`
`2. 
`
`The pharmaceutical composition of any one of claims 12-
`14, wherein said acid inhibitor is a proton pump inhibitor
`and ............................................................................................. 54 
`
`wherein said coating surrounding said core does not
`dissolve unless the pH of the surrounding medium is 5 or
`greater. ....................................................................................... 54 
`
`R. 
`
`Claim 18: The pharmaceutical composition of any one of
`claims 7-14, wherein said acid inhibitor is an H2 blocker. ................. 54 
`
`x
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`IPR2015-01241
`Patent 6,926,907
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`S. 
`
`T. 
`
`Claim 21: The pharmaceutical composition of claim 1, wherein
`said unit dosage form is a capsule. ...................................................... 55 
`
`Claim 22: ............................................................................................. 55 
`
`1. 
`
`2. 
`
`A method of treating a patient for pain or inflammation,
`comprising ................................................................................. 55 
`
`administering to said patient the pharmaceutical
`composition of any one of claims 1-14. .................................... 55 
`
`X.  Ground 4: Goldman in View of Remington in Further View of
`Fitton Renders Obvious Claims 1, 5, and 6 ............................................... 56 
`
`A.  A POSA Would Have Combined Remington, Fitton, and
`Goldman .............................................................................................. 56 
`
`B. 
`
`Claim 1: ............................................................................................... 57 
`
`1. 
`
`2. 
`
`3. 
`
`4. 
`
`5. 
`
`A pharmaceutical composition in unit dosage form
`suitable for oral administration to a patient, comprising: ......... 57 
`
`(a) an acid inhibitor present in an amount effective to
`raise the gastric pH of said patient to at least 3.5 upon the
`administration of one or more of said unit dosage forms; ........ 57 
`
`(b) a non-steroidal anti-inflammatory drug (NSAID) in
`an amount effective to reduce or eliminate pain or
`inflammation in said patient upon administration of one
`or more of said unit dosage forms; ........................................... 58 
`
`and wherein said unit dosage form provides for
`coordinated release such that: i) said NSAID is
`surrounded by a coating that, upon ingestion of said unit
`dosage form by said patient, prevents the release of
`essentially any NSAID from said dosage form unless the
`pH of the surrounding medium is 3.5 or higher; ...................... 58 
`
`ii) at least a portion of said acid inhibitor is not
`surrounded by an enteric coating and, upon ingestion of
`said unit dosage form by said patient, is released
`
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`IPR2015-01241
`Patent 6,926,907
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`regardless of whether the pH of the surrounding medium
`is below 3.5 or above 3.5. ......................................................... 59 
`
`C. 
`
`D. 
`
`Claim 5: The pharmaceutical composition of claim 1, wherein
`said acid inhibitor is a proton pump inhibitor selected from the
`group consisting of: omeprazole, esomeprazole, lansoprazole,
`pantoprazole and rabeprazole. ............................................................. 59 
`
`Claim 6: The pharmaceutical composition of claim 5, wherein
`said proton pump inhibitor is pantoprazole, present in said unit
`dosage form in an amount of between 10 mg and 200 mg. ................ 60 
`
`XI.  Any Secondary Considerations of Nonobviousness Would Fail ............. 60 
`
`XII.  Conclusion .................................................................................................... 60 
`
`
`
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`IPR2015-01241
`Patent 6,926,907
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`TABLE OF AUTHORITIES
`
`Statutes
`
`35 U.S.C. § 102(b) .................................................................................................4, 5
`
`35 U.S.C. § 103(a) .................................................................................................4, 5
`
`35 U.S.C. §§ 311-319 ................................................................................................ 1
`
`Regulations
`
`37 C.F.R. 42.8(b)(3) ................................................................................................... 3
`
`37 C.F.R. § 42.10(b) .................................................................................................. 3
`
`37 C.F.R. § 42.100 et seq. .......................................................................................... 1
`
`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)(4) ................................................................................................ 3
`
`
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`IPR2015-01241
`Patent 6,926,907
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`EXHIBIT LIST
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`
`
`Exhibit No. Description
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`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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`1014
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`U.S. Patent No. 6,926,907 (“the ’907 Patent”)
`
`File History of the ’907 Patent
`
`Declaration of Leon Shargel, Ph.D., R.Ph.
`
`U.S. Patent No. 5,698,225 (“Gimet”)
`
`U.S. Patent No. 5,204,118 (“Goldman”)
`
`“Remington’s Pharmaceutical Sciences,” Alfonso R. Gennaro, et
`al., Mack Publ’g Co., Seventeenth Edition, 1985 (“Remington”)
`
`“Does Misoprostol Given as a Single Large Dose Improve its
`Antisecretory Effect?” S.G. Chiverton, et al., Aliment. Pharmacol.
`Therap., Vol. 3 (1989) (“Chiverton”)
`
`U.S. Patent No. 4,757,060 (“Lukacsko”)
`
`“The Mechanism of Action of Aspirin,” J.R. Vane, et al., Pergamon
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