UNITED STATES PATENT AND TRADEMARK OFFICE
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`________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`________________
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`AMNEAL PHARMACEUTICALS LLC, PAR PHARMACEUTICAL, INC. and
`WOCKHARDT BIO AG,
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`Petitioners,
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`v.
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`JAZZ PHARMACEUTICALS, INC.
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`Patent Owner
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`________________
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`Case IPR2015-005541
`Patent 7,668,730
`________________
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`DECLARATION OF CRAIG F. KIRKWOOD, PHARM.D.
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`1 Case IPR2015-01818 has been joined with this proceeding.
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`JAZZ EXHIBIT 2053
`Amneal Pharms. et al. (Petitioners) v. Jazz Pharms., Inc. (Patent Owner)
`Case IPR2015-00554
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`Page 1 of 7
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`I, Craig F. Kirkwood, Pharm.D., hereby declare and state as follows:
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`1.
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`I submit this declaration on behalf of Jazz Pharmaceuticals, Inc.
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`(“Jazz”), Patent Owner of U.S. Patent No. 7,668,730 (the “’730 patent”) in
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`connection with this inter partes review, Case IPR2015-00554.
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`2.
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`3.
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`I have been a registered pharmacist for 35 years.
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`I received a Bachelor of Science degree in pharmacy from the
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`University of Buffalo in 1980, and a Doctorate in Pharmacy from the University of
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`Buffalo in 1983. I completed residency training in Hospital Pharmacy at Buffalo
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`General Hospital in 1981, and in Drug Information Practice at North Carolina
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`Memorial Hospital at the University of North Carolina in 1984.
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`4.
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`I am currently an Associate Professor in the Department of
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`Pharmacotherapy and Outcomes Science at Virginia Commonwealth University
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`School of Pharmacy. As part of my teaching duties, I instruct and coordinate a
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`course entitled, “Evidence-based Pharmacy I: Introduction to Pharmacy
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`Information Skills” (the “Drug Literature Course”). This drug literature course is a
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`required course for all pharmacy students.
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`5.
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` In the drug literature course, I instruct and precept instruction on the
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`commonly-used sources of information for pharmacists to access for obtaining,
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`distributing, managing, and providing education about pharmaceuticals. These are
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`the sources that will be relevant and useful to the students’ pharmacy practice once
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`they have graduated and are practicing, registered pharmacists. I, and the
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`instructors that I precept, do not teach about the Federal Register. I do not consider
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`it one of the commonly-used sources of information.
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`Executed this 6th day of November 2015. I declare under penalty of perjury
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`that the foregoing is true and correct.
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`________________________________
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`Craig F. Kirkwood, Pharm.D
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`- 2 -
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`Page 3 of 7
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`Exhibit 1
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`Exhibit 1
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`Page 4 of 7
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`CURRICULUM VITAE
`ABBREVIATED
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`CRAIG F. KIRKWOOD
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`October 2015
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`Department of Pharmacy Services
`Virginia Commonwealth University Health System
`Box 980042, VCU Medical Center
`Richmond, VA 23298
`PHN: (804) 828-6609
`FAX: (804) 828-5589
`EML: craig.kirkwood@vcuhealth.org
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`Department of Pharmacotherapy & Outcomes Science
`School of Pharmacy
`Virginia Commonwealth University
`Box 980533, VCU Medical Center
`Richmond, VA 23298
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`7011 Old Reflection Drive
`Mechanicsville, VA 23111
`PHN: (804) 730-6314
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`Virginia (New York on-hold)
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`PERSONAL
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`Practice Address:
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`School Address:
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`Residence:
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`Current Licensure:
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`EDUCATION
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`1983
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`State University of New York
` at Buffalo
`School of Pharmacy
`Amherst, NY
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`State University of New York
` at Buffalo
`School of Pharmacy
`Amherst, NY
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`Doctor of Pharmacy
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`B.S. in Pharmacy
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`Specialty Residency in Drug Information Practice
`North Carolina Memorial Hospital
`University of North Carolina
`Chapel Hill, NC
`ASHP accredited
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`Hospital Pharmacy Residency
`The Buffalo General Hospital
`Buffalo, NY
`ASHP accredited, with Clinical Emphasis
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`1980
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`RESIDENCY EXPERIENCE
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`1983-1984
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`1980-1981
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`Craig F. Kirkwood
`Page 2.
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`PROFESSIONAL PRACTICE
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`1991 - Present
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`Manager for Pharmacotherapy Services, Department of Pharmacy Services
`VCU Health System. VCU Medical Center. Richmond, VA
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`Director, Drug Information Services, Department of Pharmacy Services, Medical College
`of Virginia Hospitals. Richmond, VA
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`Consultant, Drug Utilization Review and Formulary Management Committee
`Veterans Administration Medical Center. Richmond, VA
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`Clinical Pharmacist, Clinical Pharmacokinetics Service. Buffalo General Hospital. Buffalo,
`NY
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`Staff Pharmacist. Buffalo General Hospital. Intensive Care Unit Satellite and Antibiotic
`Reconstitution Program [Part-time]
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`Pharmacy Intern. Buffalo General Hospital. Community Mental Health Center and
`Intensive Care Unit Satellite
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`Pharmacy Intern. Rite Aid Pharmacy. Buffalo, NY
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`1984 - 1991
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`1985 (summer)
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`1982
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`1981 – 1983
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`1980 (spring)
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`1979 – 1980
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`TEACHING AND TRAINING EXPERIENCE
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`1999 – Present
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`Coordinator, Pharmacy Residency Programs, VCUHS
`Interim Program Director, Pharmacy Practice Residency Program (2005-2006)
`Interim Program Director, Pharmacy Practice Residency Program (2000-2001)
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`Associate Professor, VCU/MCV School of Pharmacy, VCU
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`Program Director, Drug Information Residency Program, VCUHS
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`Assistant Professor, VCU/MCV School of Pharmacy, VCU
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`Clinical Assistant Professor, School of Pharmacy, University of North Carolina
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`Graduate Teaching Assistant, School of Pharmacy, SUNY at Buffalo
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`Adjunct Clinical Instructor, School of Pharmacy, SUNY at Buffalo
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`1992 - Present
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`1985 – 1996
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`1984 - 1992
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`1983 - 1984
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`1981 - 1983
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`1980 - 1981
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`RESEARCH EXPERIENCE AND SERVICE
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`1982 - Present
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`More than 30 projects, primarily focused on the provision of drug information; selection of
`information resources; influencing prescribing behavior; drug use decision-making;
`adverse drug events monitoring and reporting; adverse drug events prevention;
`medication reconciliation processes; and clinical research process.
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`VCU Institutional Review Board (Member; Transition Team; Panel Vice-Chair and Chair)
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`1985 - Present
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`PUBLICATIONS AND ABSTRACTS
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`Thirty-six publications, including critical reviews, primary research reports, and letters; twenty-nine abstracts
`published from invited platform, peer-reviewed platform, or poster presentations
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`Craig F. Kirkwood
`Page 3.
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`INVITED PRESENTATIONS
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`Thirty-five platform presentations and eight poster presentations without abstracts; seven major sessions as
`invited workshop\roundtable leader. Most recent presentation posters and abstracts, and invited presentations:
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`Clinical Resource Manager / Clinical Database Project Group. CRM User Group Meeting. University Health-
`System Consortium. November 2012
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`Leadership. Panel Discussion, VCU School of Pharmacy, November 2011
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`Engaging the Part-Time Pharmacist. UHC Webinar. January 2010
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`Heparin Practices. Pharmacy Council Meeting, University Health-System Consortium. December 2008
` [A. Erickson as presenter]
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`Assessment of pharmacy residency's formal training in teaching. Poster session and abstract. ACCP meeting.
`October 22, 2008 [L. Keyser as presenter]
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`Adverse Drug Events, Patient Safety Fellowship Program, School of Allied Health, Virginia Commonwealth
`University, Richmond, VA. June 25, 2008.
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`Anticoagulation Rule to Improve Medication Safety. Virginians for Improving Patient Care. Richmond, VA. May
`2008. [A. Dow as primary author]
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`Clinical Trials. The Good, the Bad and the Ugly Series. Mini-Med School Program. School of Medicine, Virginia
`Commonwealth University. Richmond, VA. September 5, 2007.
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`SPONSORED SYMPOSIUM (CO-CHAIR)
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`Improving Pharmacotherapy through Drug Usage Evaluation, Palm Springs, December 1989:
`Platform Presentations: Interpreting Data and Results; Developing Recommendations.
`Workshops (Leader): Criteria Development; Developing Recommendations; DUE Program Development.
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`AWARDS AND HONORS
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`2013
`1990
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`1990
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`Fellowship, Manchester College, Oxford University (Fellow)
`ASHP Research and Education Foundation, Drug Information Fellowship
`1990-91 (Preceptor)
`Consultant, United States Senate, Special Committee on Aging
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`PROFESSIONAL EDITORIAL ACTIVITIES
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`Editor
`Drug Forecast column, P&T and Drug Therapy (1990 - 1993)
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`Editorial Contribution
`AHFS - Drug Information (1989); Drugdex, Assistant Editor (1987 - 1996); USP Drug Information, Review
`Committee (1986 - present); Clinical Pharmacy [Therapy Consultation] (1986 - 1992)
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`Editorial Peer Review
`P&T (1992 - 1999); American Journal of Hospital Pharmacy [including Clinical Pharmacy] (1983 - present);
`Hospital Formulary (1986); New York State Journal of Pharmacy (1983); Antimicrobial Agents and Chemotherapy
`(1982)
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`Page 7 of 7