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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,
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`v.
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`POZEN INC.,
`Patent Owner.
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`IPR2015-01241
`Patent 6,926,907
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`DECLARATION OF LEON SHARGEL, PH.D., R.PH.
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`CFAD EXHIBIT 1003
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`

`

`IPR2015-01241
`Patent 6,926,907
`
`
`TABLE OF CONTENTS
`
`I. 
`
`Introduction and Bases for Opinions ........................................................... 1 
`
`A.  Qualifications ........................................................................................ 2 
`
`B.  Materials Reviewed ............................................................................... 4 
`
`C. 
`
`Legal Principles Used In Analysis ...................................................... 10 
`
`II. 
`
`Background .................................................................................................. 16 
`
`A. 
`
`B. 
`
`State of the Art .................................................................................... 16 
`
`Overview of the ’907 Patent ................................................................ 28 
`
`A.  Applicant’s Admitted Prior Art ........................................................... 31 
`
`B. 
`
`Person of Ordinary Skill in the Art (POSA) ....................................... 33 
`
`III.  Claim Construction ..................................................................................... 33 
`
`A. 
`
`B. 
`
`C. 
`
`“Unit Dosage Form” ............................................................................ 34 
`
`“Acid Inhibitor” ................................................................................... 34 
`
`“Coordinated Release” ........................................................................ 35 
`
`D.  All Remaining Terms .......................................................................... 35 
`
`E. 
`
`The Invalidity Grounds ....................................................................... 36 
`
`1. 
`
`2. 
`
`3. 
`
`4. 
`
`Ground 1: Claims 1, 7, 8, 12, 13, 22, and 23 Are Obvious
`Under 35 U.S.C. § 103(a) ......................................................... 36 
`
`Ground 2: Claims 1-5 and 7-22 Are Obvious Under 35
`U.S.C. § 103(a) ......................................................................... 36 
`
`Ground 3: Claims 1-5, 7-18, 21, and 22 Are Obvious
`Under 35 U.S.C. § 103(a) ......................................................... 37 
`
`Ground 4: Claims 1, 5, and 6 Are Obvious Under 35
`U.S.C. § 103(a) ......................................................................... 37 
`
`i
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`

`

`IPR2015-01241
`Patent 6,926,907
`
`
`IV.  Ground 1: Gimet in View of Chiverton Renders Claims 1, 7, 8, 12,
`13, 22, and 23 Obvious Under U.S.C. § 103(a) .......................................... 38 
`
`A.  A POSA Would Have been Motivated to Combine Chiverton
`with Gimet ........................................................................................... 38 
`
`B. 
`
`Claim 1: ............................................................................................... 39 
`
`1. 
`
`2. 
`
`3. 
`
`4. 
`
`5. 
`
`A pharmaceutical composition in unit dosage form
`suitable for oral administration to a patient, comprising: ......... 39 
`
`(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; ........................................... 42 
`
`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. ......................................................... 44 
`
`C. 
`
`D. 
`
`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
`
`ii
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`

`

`IPR2015-01241
`Patent 6,926,907
`
`
`NS398. ................................................................................................. 46 
`
`E. 
`
`Claim 12: ............................................................................................. 46 
`
`1. 
`
`2. 
`
`3. 
`
`4. 
`
`5. 
`
`The pharmaceutical composition of claim 1 wherein said
`unit dosage form is a multilayer tablet comprising .................. 46 
`
`a single core and one or more layers outside of said
`single core, wherein: ................................................................. 47 
`
`i) said NSAID is present in said core; ....................................... 47 
`
`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 ............................................................ 47 
`
`iii) said acid inhibitor is in said one more layers outside
`said core. ................................................................................... 48 
`
`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. .......... 49 
`
`G. 
`
`Claim 22: ............................................................................................. 50 
`
`1. 
`
`2. 
`
`A method of treating a patient for pain or inflammation,
`comprising ................................................................................. 50 
`
`administering to said patient the pharmaceutical
`composition of any one of claims 1-14. .................................... 50 
`
`H. 
`
`Claim 23: The method of claim 22, wherein said pain or
`inflammation is due to either osteoarthritis or rheumatoid
`arthritis. ................................................................................................ 50 
`
`I. 
`
`Conclusion ........................................................................................... 51 
`
`iii
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`

`IPR2015-01241
`Patent 6,926,907
`
`
`V.  Ground 2: Gimet in View of Goldman in Further View of
`Remington Renders Claims 1-5 and 7-23 Obvious Under 35
`U.S.C. § 103(a) .............................................................................................. 51 
`
`A.  A POSA Would Have Been Motivated to Combine Goldman
`and Remington with Gimet ................................................................. 51 
`
`B. 
`
`Claim 1: ............................................................................................... 53 
`
`1. 
`
`2. 
`
`3. 
`
`4. 
`
`5. 
`
`A pharmaceutical composition in unit dosage form
`suitable for oral administration to a patient, comprising: ......... 53 
`
`(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; ........ 54 
`
`(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; ........................................... 55 
`
`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; ...................... 56 
`
`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. ......................................................... 57 
`
`C. 
`
`D. 
`
`Claim 2: The pharmaceutical composition of claim 1, wherein
`said acid inhibitor is an H2 blocker. .................................................... 59 
`
`Claim 3: The pharmaceutical composition of claim 2, wherein
`said H2 blocker is selected from the group consisting of:
`cimetidine; ranitidine; ebrotidine; pabutidine; lafutidine;
`
`iv
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`

`

`IPR2015-01241
`Patent 6,926,907
`
`
`E. 
`
`F. 
`
`G. 
`
`H. 
`
`I. 
`
`J. 
`
`K. 
`
`loxtidine and famotidine. ..................................................................... 60 
`
`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. ....................................... 61 
`
`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. ............................................................. 61 
`
`Claim 7: The pharmaceutical composition of claim 1, wherein
`said NSAID is a cyclooxygenese-2 (COX-2) inhibitor. ..................... 62 
`
`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. ................................................................................................. 62 
`
`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. ................................................................. 63 
`
`Claim 10: The pharmaceutical composition of claim 9, wherein
`said NSAID is naproxen present in an amount of between 50
`mg and 1500 mg. ................................................................................. 64 
`
`Claim 11: The pharmaceutical composition of claim 10,
`wherein said naproxen is present in an amount of between 200
`mg and 600 mg. ................................................................................... 65 
`
`L. 
`
`Claim 12: ............................................................................................. 65 
`
`1. 
`
`2. 
`
`The pharmaceutical composition of claim 1 wherein said
`unit dosage form is a multilayer tablet comprising .................. 65 
`
`a single core and one or more layers outside of said
`
`v
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`

`

`IPR2015-01241
`Patent 6,926,907
`
`
`single core, wherein: ................................................................. 66 
`
`3. 
`
`4. 
`
`5. 
`
`i) said NSAID is present in said core; ....................................... 66 
`
`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 ............................................................ 66 
`
`iii) said acid inhibitor is in said one more layers outside
`said core. ................................................................................... 68 
`
`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. .......... 68 
`
`N. 
`
`Claim 14: ............................................................................................. 69 
`
`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 ................................................................................ 69 
`
`wherein said outer layer of said tablet is surrounded by a
`non-enteric film coating that releases said acid inhibitor
`upon ingestion by patient. ......................................................... 70 
`
`O. 
`
`Claim 15: The pharmaceutical composition of any one of
`claims 1 or 7-14, wherein said acid inhibitor is a proton pump
`inhibitor. .............................................................................................. 71 
`
`P. 
`
`Claim 16: ............................................................................................. 72 
`
`1. 
`
`2. 
`
`The pharmaceutical composition of any one of claims 12-
`14, wherein said acid inhibitor is a proton pump inhibitor
`and ............................................................................................. 72 
`
`wherein said coating surrounding said core does not
`dissolve unless the pH of the surrounding medium is 4 or
`greater. ....................................................................................... 72 
`
`Q. 
`
`Claim 17: ............................................................................................. 73 
`
`vi
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`

`

`IPR2015-01241
`Patent 6,926,907
`
`
`1. 
`
`2. 
`
`The pharmaceutical composition of any one of claims 12-
`14, wherein said acid inhibitor is a proton pump inhibitor
`and ............................................................................................. 74 
`
`wherein said coating surrounding said core does not
`dissolve unless the pH of the surrounding medium is 5 or
`greater. ....................................................................................... 74 
`
`R. 
`
`Claim 18: The pharmaceutical composition of any one of
`claims 7-14, wherein said acid inhibitor is an H2 blocker. ................. 75 
`
`S. 
`
`Claim 19: ............................................................................................. 76 
`
`1. 
`
`2. 
`
`The pharmaceutical composition of any one of claims 12-
`14, wherein said acid inhibitor is an H2 blocker and ............... 76 
`
`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. ......................................... 76 
`
`T. 
`
`Claim 20: ............................................................................................. 78 
`
`1. 
`
`2. 
`
`The pharmaceutical composition of any one of claims 12-
`14, wherein said acid inhibitor is an H2 blocker and ............... 78 
`
`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. ......................................... 78 
`
`U. 
`
`Claim 21: The pharmaceutical composition of claim 1, wherein
`said unit dosage form is a capsule. ...................................................... 80 
`
`V. 
`
`Claim 22: ............................................................................................. 80 
`
`1. 
`
`2. 
`
`A method of treating a patient for pain or inflammation,
`comprising ................................................................................. 80 
`
`administering to said patient the pharmaceutical
`composition of any one of claims 1-14. .................................... 81 
`
`vii
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`

`

`IPR2015-01241
`Patent 6,926,907
`
`
`W.  Claim 23: The method of claim 22, wherein said pain or
`inflammation is due to either osteoarthritis or rheumatoid
`arthritis. ................................................................................................ 81 
`
`X. 
`
`Conclusion ........................................................................................... 82 
`
`VI.  Ground 3: Goldman in View of Remington in Further View of
`Abe Renders Claims 1-5, 7-18, 21, and 22 Obvious Under U.S.C. §
`103(a) ............................................................................................................. 82 
`
`A.  A POSA Would Have been Motivated to Combine Remington
`and Abe with Goldman ....................................................................... 82 
`
`B. 
`
`Claim 1: ............................................................................................... 83 
`
`1. 
`
`2. 
`
`3. 
`
`4. 
`
`5. 
`
`A pharmaceutical composition in unit dosage form
`suitable for oral administration to a patient, comprising: ......... 83 
`
`(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; ........ 84 
`
`(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; ........................................... 85 
`
`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; ...................... 85 
`
`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. ......................................................... 87 
`
`viii
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`

`

`IPR2015-01241
`Patent 6,926,907
`
`
`C. 
`
`D. 
`
`E. 
`
`F. 
`
`G. 
`
`H. 
`
`I. 
`
`J. 
`
`K. 
`
`Claim 2: The pharmaceutical composition of claim 1, wherein
`said acid inhibitor is an H2 blocker. .................................................... 89 
`
`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. ..................................................................... 89 
`
`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. ....................................... 90 
`
`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. ............................................................. 90 
`
`Claim 7: The pharmaceutical composition of claim 1, wherein
`said NSAID is a cyclooxygenese-2 (COX-2) inhibitor. ..................... 91 
`
`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. ................................................................................................. 91 
`
`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. ................................................................. 92 
`
`Claim 10: The pharmaceutical composition of claim 9, wherein
`said NSAID is naproxen present in an amount of between 50
`mg and 1500 mg. ................................................................................. 92 
`
`Claim 11: The pharmaceutical composition of claim 10,
`wherein said naproxen is present in an amount of between 200
`mg and 600 mg. ................................................................................... 93 
`
`ix
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`

`

`IPR2015-01241
`Patent 6,926,907
`
`
`L. 
`
`Claim 12: ............................................................................................. 93 
`
`1. 
`
`2. 
`
`3. 
`
`4. 
`
`5. 
`
`The pharmaceutical composition of claim 1 wherein said
`unit dosage form is a multilayer tablet comprising .................. 93 
`
`a single core and one or more layers outside of said
`single core, wherein: ................................................................. 94 
`
`i) said NSAID is present in said core; ....................................... 94 
`
`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 ............................................................ 95 
`
`iii) said acid inhibitor is in said one more layers outside
`said core. ................................................................................... 96 
`
`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. .......... 97 
`
`N. 
`
`Claim 14: ............................................................................................. 98 
`
`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 ................................................................................ 98 
`
`wherein said outer layer of said tablet is surrounded by a
`non-enteric film coating that releases said acid inhibitor
`upon ingestion by patient. ......................................................... 99 
`
`O. 
`
`Claim 15: The pharmaceutical composition of any one of
`claims 1 or 7-14, wherein said acid inhibitor is a proton pump
`inhibitor. ............................................................................................100 
`
`P. 
`
`Claim 16: ...........................................................................................101 
`
`1. 
`
`The pharmaceutical composition of any one of claims 12-
`14, wherein said acid inhibitor is a proton pump inhibitor
`and ...........................................................................................101 
`
`x
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`

`

`IPR2015-01241
`Patent 6,926,907
`
`
`2. 
`
`wherein said coating surrounding said core does not
`dissolve unless the pH of the surrounding medium is 4 or
`greater. .....................................................................................101 
`
`Q. 
`
`Claim 17: ...........................................................................................102 
`
`1. 
`
`2. 
`
`The pharmaceutical composition of any one of claims 12-
`14, wherein said acid inhibitor is a proton pump inhibitor
`and ...........................................................................................102 
`
`wherein said coating surrounding said core does not
`dissolve unless the pH of the surrounding medium is 5 or
`greater. .....................................................................................103 
`
`Claim 18: The pharmaceutical composition of any one of
`claims 7-14, wherein said acid inhibitor is an H2 blocker. ...............104 
`
`Claim 21: The pharmaceutical composition of claim 1, wherein
`said unit dosage form is a capsule. ....................................................104 
`
`Claim 22: ...........................................................................................104 
`
`1. 
`
`2. 
`
`A method of treating a patient for pain or inflammation,
`comprising ...............................................................................105 
`
`administering to said patient the pharmaceutical
`composition of any one of claims 1-14. ..................................105 
`
`R. 
`
`S. 
`
`T. 
`
`U. 
`
`Conclusion .........................................................................................105 
`
`VII.  Ground 4: Goldman in View of Remington in Further View of
`Fitton Renders Claims 1, 5, and 6 Obvious Under U.S.C. § 103(a) ......106 
`
`A.  A POSA Would Have Been Motivated to Combine Remington
`and Fitton with Goldman ...................................................................106 
`
`B. 
`
`Claim 1: .............................................................................................107 
`
`1. 
`
`A pharmaceutical composition in unit dosage form
`suitable for oral administration to a patient, comprising: .......107 
`
`xi
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`

`

`IPR2015-01241
`Patent 6,926,907
`
`
`2. 
`
`3. 
`
`4. 
`
`5. 
`
`(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; ......107 
`
`(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; .........................................109 
`
`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; ....................109 
`
`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. .......................................................111 
`
`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. ...........................................................112 
`
`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. ..............114 
`
`E. 
`
`Conclusion .........................................................................................115 
`
`Additional Considerations Support a Finding of
`V I I I .  
`Obviousness ................................................................................................116 
`
`A. 
`
`The Prior Art Does Not Teach Away from the Use of Non-
`Enterically Coated PPIs .....................................................................116 
`
`B. 
`
`There is Nothing Surprising and Unexpected Achieved by the
`
`xii
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`

`

`IPR2015-01241
`Patent 6,926,907
`
`
`Claimed Acid Inhibitor/NSAID Combination ..................................121 
`
`C. 
`
`No Skepticism in the Art ...................................................................123 
`
`IX.  Conclusion ..................................................................................................125 
`
`
`
`
`
`xiii
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`

`

`IPR2015-01241
`Patent 6,926,907
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`
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`
`
`TABLE OF APPENDICES
`
`Appendix A:
`
`Curriculum Vitae of Leon Shargel, Ph.D., R.Ph.
`
`Appendix B:
`
`Appendix C:
`
`Appendix D:
`
`Appendix E:
`
`Claim Chart for Ground 1: Gimet in View of Chiverton
`Renders Claims 1, 7, 8, 12, 13, 22, and 23 Obvious Under
`U.S.C. § 103(a)
`
`Claim Chart for Ground 2: Gimet in View of Goldman in
`Further View of Remington Renders Claims 1-5 and 7-23
`Obvious Under 35 U.S.C. § 103(a)
`
`Claim Chart for Ground 3: Goldman in View of Remington in
`Further View of Abe Renders Claims 1-5, 7-18, 21, and 22
`Obvious Under U.S.C. § 103(a)
`
`Claim Chart for Ground 4: Goldman in View of Remington in
`Further View of Fitton Renders Claims 1, 5, and 6 Obvious
`Under U.S.C. § 103(a)
`
`xiv
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`

`

`IPR2015-01241
`Patent 6,926,907
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`I, Leon Shargel, Ph.D., R.Ph., declare and state as follows:
`I.
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`Introduction and Bases for Opinions
`1. My name is Leon Shargel, and I reside in Raleigh, North Carolina. I
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`have been retained by Conley Rose, P.C. on behalf of the Coalition for Affordable
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`Drugs VII LLC (“CFAD or Petitioner”) and understand that I am submitting this
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`Declaration in connection with the above-referenced inter partes review (IPR)
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`proceeding.
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`2.
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`Specifically, I have been requested to evaluate claims 1-23 of U.S.
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`Patent No. 6,926,907 (“the ’907 Patent”) (Ex. 1001). As detailed in this
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`Declaration, it is my opinion that claims 1-23 are anticipated or rendered obvious
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`by prior art references that predate the ’907 Patent. If requested by the parties to
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`this proceeding or the Patent Trial and Appeal Board (“Board”), I will testify about
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`my opinions expressed herein.
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`3.
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`I reserve the right to modify or supplement my opinions, as well as the
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`basis for my opinions, based on the nature and content of the documentation, data,
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`proof, and other evidence or testimony that other experts may present or based on
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`any additional discovery or other information provided to me or found by me in
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`this matter.
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`IPR2015-01241
`Patent 6,926,907
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`A. Qualifications
`4.
`I have over 45 years of educational and work experience in the fields
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`of pharmaceutics, pharmacology, and pharmacokinetics. Along with the
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`experience listed in my curriculum vitae (CV), attached hereto as Appendix A, I
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`note the following experience that is uniquely relevant to the subject matter at issue
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`in this proceeding.
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`5.
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`I currently am the manager and founder of Applied Biopharmaceutics,
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`LLC. I founded Applied Biopharmaceutics in 2007. Applied Biopharmaceutics
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`provides scientific and technical consulting services for the pharmaceutical
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`industry. For instance, Applied Biopharmaceutics assists clients in developing
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`new dosage forms for Abbreviated New Drug Application (ANDA) and New Drug
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`Application (NDA) submissions with the Food and Drug Administration (FDA).
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`6.
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`I have been an affiliate professor at the Virginia Commonwealth
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`University School of Pharmacy in Richmond, Virginia since 2006. I have been an
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`adjunct associate professor at the University of Maryland School of Pharmacy in
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`Baltimore, Maryland since 1995.
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`7.
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`From 2001-2006, I was the Vice President, Biopharmaceutics, at
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`Sandoz, Inc. (formerly Eon Labs) in Wilson, North Carolina. From 1997-2001, I
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`was the Vice President and Technical Director at the National Association of
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`2
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`IPR2015-01241
`Patent 6,926,907
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`Pharmaceutical Manufacturers in Ronkonkoma, New York. From 1996-1997, I
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`was a Senior Research Pharmacist at Johns Hopkins Bayview Medical Center in
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`Baltimore, Maryland.
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`8.
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`From 1995-1996, I was an Adjunct Visiting Associate Professor of
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`Pharmacy at Howard University School of Pharmacy and Pharmacal Sciences in
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`Washington, DC. In 1995, I served as the Vice President, Scientific Affairs, at
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`Pharmakinetics Laboratories, Inc. in Baltimore, Maryland. From 1993-1994, I was
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`the Director of Biochemistry and Pharmacokinetics at Forest Laboratories, Inc. in
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`New York, New York. From 1991-1993, I was the Director of Pharmacokinetics
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`at Chelsea Laboratories, Inc. in West Hempstead, New York.
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`9.
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`From 1982-1991, I was an Associate Professor of Pharmacy and
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`Pharmacology and the Director of Pfeiffer Pharmaceutical Sciences Laboratory,
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`Inc. at Massachusetts College of Pharmacy and Allied Health Sciences in Boston,
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`Massachusetts. From 1975-1982, I was the Section Leader, Pharmaceutics, and an
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`Associate Professor of Pharmacy and Pharmacology at Northeastern University
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`College of Pharmacy and Allied Health Professions in Boston, Massachusetts.
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`From 1969-1975, I was an Associate Research Biologist and Group Leader of
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`Drug Metabolism and Disposition at Sterling-Winthrop Research Institute in
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`Rensselaer, New York.
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`10.
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`I hold a Bachelor of Science in Pharmacy from the University of
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`Maryland and a Doctor of Philosophy (Ph.D.) in Pharmacology (with minors in
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`Physiology, Biochemistry, and Drug Metabolism) from the George Washington
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`University Medical Center in Washington, D.C. I am a Registered Pharmacist in
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`the state of Maryland, the state of Massachusetts, and in the District of Columbia.
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`11.
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`I am an active member of several professional societies and have
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`served on various national and international committees. I have organized and
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`participated in many workshops and symposia, and have lectured widely on
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`biopharmaceutics, generic drug development, bioequivalence and
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`pharmacokinetics.
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`12.
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`I have authored over 150 publications and several leading textbooks in
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`pharmacy and the pharmaceutical industry, including Applied Biopharmaceutics
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`and Pharmacokinetics, which will be publi