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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`IPR2015-01680
`Patent 8,852,636
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`DECLARATION OF LEON SHARGEL, PH.D., R.PH.
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`CFAD EXHIBIT 1003
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`

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`IPR2015-01680
`Patent 8,852,636
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`
`TABLE OF CONTENTS
`
`I. 
`
`Introduction and Bases for Opinions ........................................................... 1 
`
`A.  Qualifications ........................................................................................ 1 
`
`B.  Materials Reviewed ............................................................................... 4 
`
`C. 
`
`Legal Principles Used In Analysis ........................................................ 8 
`
`II. 
`
`Background .................................................................................................. 15 
`
`A. 
`
`B. 
`
`C. 
`
`D. 
`
`State of the Art .................................................................................... 15 
`
`Overview of the ’636 Patent ................................................................ 27 
`
`Applicant’s Admitted Prior Art ........................................................... 28 
`
`Person of Ordinary Skill in the Art (POSA) ....................................... 30 
`
`III.  Claim Construction ..................................................................................... 31 
`
`A. 
`
`B. 
`
`C. 
`
`“Unit Dose Form” and “Unit Dosage Form” ...................................... 31 
`
`All Remaining Terms .......................................................................... 32 
`
`The Invalidity Grounds ....................................................................... 33 
`
`1. 
`
`2. 
`
`3. 
`
`Ground 1: Claims 1-18 Are Obvious Under 35 U.S.C. §
`103(a) ........................................................................................ 33 
`
`Ground 2: Claims 1-6 and 13-15 Are Obvious Under 35
`U.S.C. § 103(a) ......................................................................... 33 
`
`Ground 3: Claims 7-12 and 16-18 Are Obvious Under 35
`U.S.C. § 103(a) ......................................................................... 34 
`
`IV.  Ground 1: Goldman in View of Remington in Further View of
`Lindberg Renders Claims 1-19 Obvious Under U.S.C. § 103(a) ............. 34 
`
`A.  A POSA Would Have Combined Goldman, Remington, and
`Lindberg .............................................................................................. 35 
`
`i
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`IPR2015-01680
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`B. 
`
`Claim 1: ............................................................................................... 37 
`
`1. 
`
`2. 
`
`3. 
`
`4. 
`
`5. 
`
`6. 
`
`7. 
`
`8. 
`
`9. 
`
`A pharmaceutical composition in unit dose form suitable
`for oral administration to a patient, comprising: ...................... 37 
`
`(a) esomeprazole 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; ........ 37 
`
`(b) naproxen present 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;
`and wherein: .............................................................................. 40 
`
`i) said unit dosage form is a tablet in which said naproxen
`is present in a core;.................................................................... 41 
`
`ii) said tablet comprises a coating, wherein said coating
`surrounds said core and does not release said naproxen
`until the pH of the surrounding medium is 3.5 or higher;
`and ............................................................................................. 41 
`
`iii) said esomeprazole is in one or more layers outside
`said core, wherein said one or more layers: .............................. 42 
`
`A) do not include an naproxen; ................................................. 43 
`
`B) are not surrounded by an enteric coating; and ..................... 44 
`
`C) upon ingestion of said tablet by a patient, release said
`esomeprazole into said patient’s stomach. ................................ 44 
`
`C. 
`
`D. 
`
`E. 
`
`Claim 2: The pharmaceutical composition of claim 1, wherein
`there is a single core comprising said naproxen. ................................ 45 
`
`Claim 3: The pharmaceutical composition of claim 2, wherein
`said esomeprazole is present in said unit dosage form in an
`amount of between 5 mg and 100 mg. ................................................ 46 
`
`Claim 4: The pharmaceutical composition of claim 2, wherein
`naproxen is present in said unit dosage form in an amount of
`
`ii
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`IPR2015-01680
`Patent 8,852,636
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`200-600 mg. ......................................................................................... 47 
`
`F. 
`
`G. 
`
`Claim 5: A method of treating a patient for pain or
`inflammation, comprising administering to said patient a
`therapeutically effective amount of the pharmaceutical
`composition of claim 1. ....................................................................... 47 
`
`Claim 6: The method of claim 5, wherein said pain or
`inflammation is due to either osteoarthritis or rheumatoid
`arthritis. ................................................................................................ 48 
`
`H. 
`
`Claim 7: ............................................................................................... 48 
`
`1. 
`
`2. 
`
`3. 
`
`4. 
`
`5. 
`
`6. 
`
`7. 
`
`8. 
`
`9. 
`
`A pharmaceutical composition in unit dose form suitable
`for oral administration to a patient, comprising: ...................... 48 
`
`(a) esomeprazole 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; ........ 49 
`
`(b) naproxen present 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;
`and wherein: .............................................................................. 52 
`
`i) said unit dosage form is a capsule in which said
`naproxen is present in a core; .................................................... 52 
`
`ii) said capsule comprises a coating, wherein said coating
`surrounds said core containing said naproxen and does
`not release said naproxen until the pH of the surrounding
`medium is 3.5 or higher; and .................................................... 53 
`
`iii) said esomeprazole is in one or more layers outside
`said core, wherein said one or more layers: .............................. 54 
`
`A) do not include an naproxen; ................................................. 55 
`
`B) are not surrounded by an enteric coating; and ..................... 56 
`
`C) upon ingestion of said capsule by a patient, release
`
`iii
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`IPR2015-01680
`Patent 8,852,636
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`I. 
`
`J. 
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`K. 
`
`L. 
`
`said esomeprazole into said patient’s stomach. ........................ 56 
`
`Claim 8: The pharmaceutical composition of claim 7, wherein
`there are multiple particles of said naproxen each constituting a
`core surrounded by said coating that does not release said
`naproxen until the pH of the surrounding medium is 3.5 or
`higher. .................................................................................................. 57 
`
`Claim 9: The pharmaceutical composition of claim 8, wherein
`said esomeprazole is present in said unit dosage form in an
`amount of between 5 mg and 100 mg. ................................................ 59 
`
`Claim 10: The pharmaceutical composition of claim 8, wherein
`naproxen is present in said unit dosage form in an amount of
`200-600 mg. ......................................................................................... 60 
`
`Claim 11: A method of treating a patient for pain or
`inflammation, comprising administering to said patient a
`therapeutically effective amount of the pharmaceutical
`composition of claim 7. ....................................................................... 60 
`
`M.  Claim 12: The method of claim 11, wherein said pain or
`inflammation is due to either osteoarthritis or rheumatoid
`arthritis. ................................................................................................ 61 
`
`N. 
`
`O. 
`
`P. 
`
`Q. 
`
`Claim 13: The pharmaceutical composition of claim 1, further
`comprising at least one carrier. ........................................................... 61 
`
`Claim 14: The pharmaceutical composition of claim 1, further
`comprising at least one auxiliary agent chosen from the group
`consisting of lubricants, preservatives, disintegrants, stabilizers,
`wetting agents, emulsifiers, salts, buffers, coloring agents,
`flavoring agents, and aromatic substances. ......................................... 62 
`
`Claim 15: The pharmaceutical composition of claim 1, further
`comprising at least one ingredient to adjust pH. ................................. 62 
`
`Claim 16: The pharmaceutical composition of claim 7, further
`comprising at least one carrier. ........................................................... 63 
`
`iv
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`IPR2015-01680
`Patent 8,852,636
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`R. 
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`S. 
`
`T. 
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`Claim 17: The pharmaceutical composition of claim 7, further
`comprising at least one auxiliary agent chosen from the group
`consisting of lubricants, preservatives, disintegrants, stabilizers,
`wetting agents, emulsifiers, salts, buffers, coloring agents,
`flavoring agents, and aromatic substances. ......................................... 64 
`
`Claim 18: The pharmaceutical composition of claim 7, further
`comprising at least one ingredient to adjust pH. ................................. 64 
`
`Conclusion ........................................................................................... 65 
`
`V.  Ground 2: Gimet in View of Goldman and Lindberg Renders
`Claims 1-6 and 13-15 Obvious Under 35 U.S.C. § 103(a) ........................ 65 
`
`A.  A POSA Would Have Combined Gimet, Goldman, and
`Lindberg .............................................................................................. 66 
`
`B. 
`
`Claim 1: ............................................................................................... 69 
`
`1. 
`
`2. 
`
`3. 
`
`4. 
`
`5. 
`
`6. 
`
`A pharmaceutical composition in unit dose form suitable
`for oral administration to a patient, comprising: ...................... 69 
`
`(a) esomeprazole 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; ........ 69 
`
`(b) naproxen present 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;
`and wherein: .............................................................................. 72 
`
`i) said unit dosage form is a tablet in which said naproxen
`is present in a core;.................................................................... 73 
`
`ii) said tablet comprises a coating, wherein said coating
`surrounds said core and does not release said naproxen
`until the pH of the surrounding medium is 3.5 or higher;
`and ............................................................................................. 73 
`
`iii) said esomeprazole is in one or more layers outside
`said core, wherein said one or more layers: .............................. 75 
`
`v
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`IPR2015-01680
`Patent 8,852,636
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`7. 
`
`8. 
`
`9. 
`
`A) do not include an naproxen; ................................................. 75 
`
`B) are not surrounded by an enteric coating; and ..................... 76 
`
`C) upon ingestion of said tablet by a patient, release said
`esomeprazole into said patient’s stomach. ................................ 76 
`
`Claim 2: The pharmaceutical composition of claim 1, wherein
`there is a single core comprising said naproxen. ................................ 77 
`
`Claim 3: The pharmaceutical composition of claim 2, wherein
`said esomeprazole is present in said unit dosage form in an
`amount of between 5 mg and 100 mg. ................................................ 77 
`
`Claim 4: The pharmaceutical composition of claim 2, wherein
`naproxen is present in said unit dosage form in an amount of
`200-600 mg. ......................................................................................... 78 
`
`Claim 5: A method of treating a patient for pain or
`inflammation, comprising administering to said patient a
`therapeutically effective amount of the pharmaceutical
`composition of claim 1. ....................................................................... 79 
`
`Claim 6: The method of claim 5, wherein said pain or
`inflammation is due to either osteoarthritis or rheumatoid
`arthritis. ................................................................................................ 80 
`
`Claim 13: The pharmaceutical composition of claim 1, further
`comprising at least one carrier. ........................................................... 80 
`
`Claim 14: The pharmaceutical composition of claim 1, further
`comprising at least one auxiliary agent chosen from the group
`consisting of lubricants, preservatives, disintegrants, stabilizers,
`wetting agents, emulsifiers, salts, buffers, coloring agents,
`flavoring agents, and aromatic substances. ......................................... 81 
`
`C. 
`
`D. 
`
`E. 
`
`F. 
`
`G. 
`
`H. 
`
`I. 
`
`J. 
`
`Claim 15: The pharmaceutical composition of claim 1, further
`comprising at least one ingredient to adjust pH. ................................. 81 
`
`vi
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`IPR2015-01680
`Patent 8,852,636
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`VI.  Ground 3: Ouali in View Of Lindberg Renders Claims 7-12 and
`16-18 Obvious Under 35 U.S.C. § 103(a) ................................................... 82 
`
`A.  A POSA Would Have Combined Ouali and Lindberg ....................... 82 
`
`B. 
`
`Claim 7: ............................................................................................... 85 
`
`1. 
`
`2. 
`
`3. 
`
`4. 
`
`5. 
`
`6. 
`
`7. 
`
`8. 
`
`9. 
`
`A pharmaceutical composition in unit dose form suitable
`for oral administration to a patient, comprising: ...................... 85 
`
`(a) esomeprazole 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; ........ 85 
`
`(b) naproxen present 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;
`and wherein: .............................................................................. 88 
`
`i) said unit dosage form is a capsule in which said
`naproxen is present in a core; .................................................... 88 
`
`ii) said capsule comprises a coating, wherein said coating
`surrounds said core containing said naproxen and does
`not release said naproxen until the pH of the surrounding
`medium is 3.5 or higher; and .................................................... 89 
`
`iii) said esomeprazole is in one or more layers outside
`said core, wherein said one or more layers: .............................. 90 
`
`A) do not include an naproxen; ................................................. 91 
`
`B) are not surrounded by an enteric coating; and ..................... 92 
`
`C) upon ingestion of said capsule by a patient, release
`said esomeprazole into said patient’s stomach. ........................ 92 
`
`C. 
`
`Claim 8: The pharmaceutical composition of claim 7, wherein
`there are multiple particles of said naproxen each constituting a
`core surrounded by said coating that does not release said
`naproxen until the pH of the surrounding medium is 3.5 or
`
`vii
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`

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`IPR2015-01680
`Patent 8,852,636
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`D. 
`
`E. 
`
`F. 
`
`G. 
`
`H. 
`
`I. 
`
`higher. .................................................................................................. 93 
`
`Claim 9: The pharmaceutical composition of claim 8, wherein
`said esomeprazole is present in said unit dosage form in an
`amount of between 5 mg and 100 mg. ................................................ 94 
`
`Claim 10: The pharmaceutical composition of claim 8, wherein
`naproxen is present in said unit dosage form in an amount of
`200-600 mg. ......................................................................................... 96 
`
`Claim 11: A method of treating a patient for pain or
`inflammation, comprising administering to said patient a
`therapeutically effective amount of the pharmaceutical
`composition of claim 7. ....................................................................... 96 
`
`Claim 12: The method of claim 11, wherein said pain or
`inflammation is due to either osteoarthritis or rheumatoid
`arthritis. ................................................................................................ 97 
`
`Claim 16: The pharmaceutical composition of claim 7, further
`comprising at least one carrier. ........................................................... 97 
`
`Claim 17: The pharmaceutical composition of claim 7, further
`comprising at least one auxiliary agent chosen from the group
`consisting of lubricants, preservatives, disintegrants, stabilizers,
`wetting agents, emulsifiers, salts, buffers, coloring agents,
`flavoring agents, and aromatic substances. ......................................... 98 
`
`J. 
`
`Claim 18: The pharmaceutical composition of claim 7, further
`comprising at least one ingredient to adjust pH. ................................. 98 
`
`V I I .  Additional Considerations Support a Finding of Obviousness ............... 99 
`
`A. 
`
`B. 
`
`The Prior Art Does Not Teach Away from the Use of Non-
`Enterically Coated PPIs ....................................................................... 99 
`
`There is Nothing Surprising and Unexpected Achieved by the
`Claimed Acid Inhibitor/NSAID Combination ..................................104 
`
`C. 
`
`No Skepticism in the Art ...................................................................106 
`
`viii
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`VIII.  Conclusion ..................................................................................................108 
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`IPR2015-01680
`Patent 8,852,636
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`ix
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`IPR2015-01680
`Patent 8,852,636
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`TABLE OF APPENDICES
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`Appendix A:
`
`Curriculum Vitae of Leon Shargel, Ph.D., R.Ph.
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`Appendix B:
`
`Appendix C:
`
`Claim Chart for Ground 1: Goldman in View of Remington in
`Further View of Lindberg Renders Claims 1-18 Obvious Under
`35 U.S.C. § 103(a)
`
`Claim Chart for Ground 2: Gimet in View of Goldman and
`Lindberg Renders Claims 1-6 and 13-15 Obvious Under 35
`U.S.C. § 103(a)
`
`Appendix D:
`
`Claim Chart for Ground 3: Ouali in View of Lindberg Renders
`Claims 7-12 and 16-18 Obvious Under 35 U.S.C. § 103(a)
`
`
`
`x
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`

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`IPR2015-01680
`Patent 8,852,636
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`I, Leon Shargel, Ph.D., R.Ph., declare and state as follows:
`I.
`
`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.
`
`2.
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`Specifically, I have been requested to evaluate claims 1-18 of U.S.
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`Patent No. 8,852,636 (“the ’636 Patent”) (Ex. 1001). As detailed in this
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`declaration, it is my opinion that claims 1-18 are anticipated or rendered obvious
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`by prior art references that predate the ’636 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.
`
`3.
`
`I reserve the right to modify or supplement my opinions, as well as the
`
`bases for my opinions, based on the nature and content of the documentation, data,
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`proof, and other evidence that other experts may present or based on any additional
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`discovery or other information provided to me or found by me in this matter.
`
`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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`1
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`

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`IPR2015-01680
`Patent 8,852,636
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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.
`
`5.
`
`I currently am the manager and founder of Applied Biopharmaceutics,
`
`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
`
`Application (NDA) submissions with the Food and Drug Administration (FDA).
`
`6.
`
`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.
`
`7.
`
`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
`
`Pharmaceutical Manufacturers in Ronkonkoma, New York. From 1996-1997, I
`
`was a Senior Research Pharmacist at Johns Hopkins Bayview Medical Center in
`
`Baltimore, Maryland.
`
`2
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`

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`IPR2015-01680
`Patent 8,852,636
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`8.
`
`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
`
`Pharmakinetics Laboratories, Inc. in Baltimore, Maryland. From 1993-1994, I was
`
`the Director of Biochemistry and Pharmacokinetics at Forest Laboratories, Inc. in
`
`New York, New York. From 1991-1993, I was the Director of Pharmacokinetics
`
`at Chelsea Laboratories, Inc. in West Hempstead, New York.
`
`9.
`
`From 1982-1991, I was an Associate Professor of Pharmacy and
`
`Pharmacology and the Director of Pfeiffer Pharmaceutical Sciences Laboratory,
`
`Inc. at Massachusetts College of Pharmacy and Allied Health Sciences in Boston,
`
`Massachusetts. From 1975-1982, I was the Section Leader, Pharmaceutics, and an
`
`Associate Professor of Pharmacy and Pharmacology at Northeastern University
`
`College of Pharmacy and Allied Health Professions in Boston, Massachusetts.
`
`From 1969-1975, I was an Associate Research Biologist and Group Leader of
`
`Drug Metabolism and Disposition at Sterling-Winthrop Research Institute in
`
`Rensselaer, New York.
`
`10.
`
`I hold a Bachelor of Science in Pharmacy from the University of
`
`Maryland and a Doctor of Philosophy (Ph.D.) in Pharmacology (with minors in
`
`Physiology, Biochemistry, and Drug Metabolism) from the George Washington
`
`3
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`

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`IPR2015-01680
`Patent 8,852,636
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`University Medical Center in Washington, D.C. I am a Registered Pharmacist in
`
`the state of Maryland, the state of Massachusetts, and the District of Columbia.
`
`11.
`
`I am an active member of several professional societies and have
`
`served on various national and international committees. I have organized and
`
`participated in many workshops and symposia, and have lectured widely on
`
`biopharmaceutics, generic drug development, bioequivalence, and
`
`pharmacokinetics.
`
`12.
`
`I have authored over 150 publications and several leading textbooks in
`
`pharmacy and the pharmaceutical industry, including Applied Biopharmaceutics
`
`and Pharmacokinetics, which will be published in its 7th edition by McGraw-Hill
`
`later this year.
`
`13.
`
`I am being compensated at a rate of $425 per hour for my non-
`
`testifying work and $500 per hour for my testifying work in this matter. My
`
`compensation is not conditioned on the outcome of this matter.
`
`B. Materials Reviewed
`14.
`In preparing this declaration, I reviewed the following materials:
`
`Exhibit No. Description
`
`1001
`
`1002
`
`U.S. Patent No. 8,852,636 (“the ’636 Patent”)
`
`File History of the ’636 Patent, U.S. Patent App. No. 14/045,156
`(“the ’156 Application”)
`
`4
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`

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`IPR2015-01680
`Patent 8,852,636
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`Exhibit No. Description
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`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”)
`
`U.S. Patent No. 5,698,225 (“Gimet”)
`
`U.S. Patent No. 5,714,504 (“Lindberg”)
`
`U.S. Patent No. 6,183,779 (“Ouali”)
`
`U.S. Patent No. 6,926,907 (“the ’907 Patent”)
`
`Certificate of Correction for the ’907 Patent (December 25, 2007)
`
`“Esomeprazole Provides Improved Acid Control vs. Omeprazole in
`Patients with Symptoms of Gastro-Oesophageal Reflux Disease,”
`T. Lind, et al., Alimentary Pharmacology & Therapeutics, Vol. 14,
`Issue 7 (July 2000) (“Lind”)
`
`U.S. Patent No. 4,757,060
`
`“The Mechanism of Action of Aspirin,” J.R. Vane, et al., Pergamon
`(June 15, 2003)
`
`G.B. Patent No. 1211134
`
`“Drug-Induced Peptic Ulcer Disease,” Valerie Vella, Journal of the
`Malta College of Pharmacy Practice, Issue 10 (2005)
`
`“Goodman & Gilman’s The Pharmacological Basis of
`Therapeutics,” Joel G. Hardman, et al., McGraw-Hill Publ’g Co.,
`Ninth Edition (1996)
`
`“Upper Gastrointestinal (GI) pH in Young, Healthy Men and
`Women,” Jennifer B. Dressman, et al., Pharmaceutical Research,
`Vol. 7, No. 7 (July 1990)
`
`5
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`Exhibit No. Description
`
`1018
`
`1019
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`1020
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`1021
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`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`“Effect of Orally Administered Prostaglandin E2 and its 15-Methyl
`Analogues on Gastric Secretion,” S. M. M. Karim, et al., British
`Med. Journal (Jan. 20, 1973)
`
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`Vol. 21, Issue 6 (Dec. 21, 1999)
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`1029
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`U.S. Patent No. 6,319,519
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`6
`
`

`
`IPR2015-01680
`Patent 8,852,636
`
`
`Exhibit No. Description
`
`1030
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`1031
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`1032
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`1033
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`1034
`
`1035
`
`1036
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`1037
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`1038
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`1039
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`1040
`
`1041
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`1042
`
`U.S. Patent No. 6,365,184 (“Depui”)
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`7
`
`

`
`IPR2015-01680
`Patent 8,852,636
`
`
`Exhibit No. Description
`
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`1047
`
`C. Legal Principles Used In Analysis
`15.
`I have been asked to provide my opinions as to whether claims 1-18
`
`of the ’636 Patent would have been anticipated or obvious to a person of ordinary
`
`skill in the art (POSA) at the time of the invention of the ’636 Patent. I understand
`
`that a POSA is a hypothetical person who is presumed to have known the relevant
`
`art at the time of the invention. I also understand that this hypothetical person is a
`
`person of ordinary creativity, and that this person in many cases will be able to fit
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`the teachings of multiple patents together like pieces of a puzzle. I also understand
`
`that the inferences and creative steps that a POSA would employ may be
`
`considered in an obviousness analysis.
`
`16.
`
`I provide my opinions in this declaration based on the following legal
`
`principles that were provided to me by counsel for Petitioner.
`
`17.
`
`I understand that my analysis requires an understanding of the scope
`
`of claims 1-18 of the ’636 Patent. I understand that a patent claim subject to inter
`
`partes review is given the “broadest reasonable construction in light of the
`
`specification of the patent in which it appears.” 42 C.F.R. § 42.100(b).
`
`18.
`
`I understand that, pursuant to 35 U.S.C. § 311(b), a petitioner in an
`
`inter partes review may request to cancel, as unpatentable, one or more claims of a
`
`patent only on a ground that could be raised under 35 U.S.C. § 102 (anticipation)
`
`or 35 U.S.C. § 103 (obviousness), and only on the basis of prior art consisting of
`
`patents or printed publications.
`
`19.
`
`I understand that a claim is unpatentable under 35 U.S.C. § 102 if it is
`
`anticipated. I understand that the anticipation analysis involves comparing a claim
`
`to a prior art reference to determine whether each and every element of the claimed
`
`invention is disclosed in a single prior art reference, either expressly or inherently.
`
`I also understand that material not expressly recited in a single prior art document
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`may still be considered for purposes of anticipation if that material is incorporated
`
`by reference into the document. I further understand that an anticipation analysis
`
`may include one or more extra references when the extra references are cited to:
`
`(A) prove the primary reference contains an “enabled disclosure,” (B) explain the
`
`meaning of a term used in the primary reference, or (C) show that a characteristic
`
`not disclosed in the reference is inherent.
`
`20.
`
`I understand that a claim is unpatentable under 35 U.S.C. § 103 if the
`
`differences between the invention and the prior art are such that the subject matter
`
`as a whole would have been obvious to a POSA at the time the alleged invention
`
`was made. I understand that the obviousness analysis involves a consideration of
`
`the scope and content of the prior art, the level of ordinary skill in the pertinent art,
`
`and the differences between the claimed invention and the prior art. I understand
`
`that, where there is a range disclosed in the prior art and the claimed invention
`
`overlaps even slightly within the prior art’s range, there is a presumption of
`
`obviousness. I also understand that, when