UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`AMNEAL PHARMACEUTICALS LLC and
`PAR PHARMACEUTICAL, INC.
`Petitioners
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.
`Patent Owner
`
`_____________________
`
`CASE IPR: Unassigned
`Patent 8,731,963
`_____________________
`
`DECLARATION OF ROBERT J. VALUCK, Ph.D., R.Ph.
`
`PAR1007
`
`

`
`Inter Partes Review of USPN 8,731,963
`Declaration of Robert J. Valuck, Ph.D., R.Ph. (Exhibit 1007)
`
`TABLE OF CONTENTS
`
`I.
`
`Overview..........................................................................................................1
`
`II. My background and qualifications ..................................................................6
`
`III.
`
`IV.
`
`V.
`
`Person of ordinary skill in the art ..................................................................11
`
`State of the art................................................................................................12
`
`The ’963 patent and its claims.......................................................................16
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`F.
`
`G.
`
`Claim 1 ................................................................................................17
`
`Claims 2-22 .........................................................................................21
`
`Claim 23 ..............................................................................................26
`
`Claim 24 ..............................................................................................27
`
`Claim 25 ..............................................................................................27
`
`Claims 26-28 .......................................................................................28
`
`Orange Book listing of the ’963 patent...............................................28
`
`VI. A POSA exercising reasonable diligence would have located the
`Advisory Committee Art. ..............................................................................29
`
`VII. Basis of my analysis with respect to obviousness.........................................30
`
`A.
`
`A POSA reading the ACA would have had a reason and the
`know-how to arrive at the computer-implemented methods of
`claims 1-7 & 9-23................................................................................30
`
`1.
`
`Claim 1......................................................................................32
`
`(a)
`
`(b)
`
`(c)
`
`(d)
`
`Preamble .........................................................................32
`
`Claim 1, element 1.1.......................................................40
`
`Claim 1, elements 1.2-1.4...............................................47
`
`Claim 1, element 1.5.......................................................55
`ii
`
`

`
`Inter Partes Review of USPN 8,731,963
`Declaration of Robert J. Valuck, Ph.D., R.Ph. (Exhibit 1007)
`
`(e)
`
`(f)
`
`Claim 1, element 1.6.......................................................59
`
`Claim 1, elements 1.7-1.8...............................................61
`
`Claim 2......................................................................................67
`
`Claim 3......................................................................................68
`
`Claim 4......................................................................................69
`
`Claim 5......................................................................................70
`
`Claim 6......................................................................................70
`
`Claim 7......................................................................................71
`
`Claim 9......................................................................................71
`
`Claim 10....................................................................................73
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`8.
`
`9.
`
`10. Claim 11....................................................................................73
`
`11. Claim 12....................................................................................74
`
`12. Claim 13....................................................................................75
`
`13. Claim 14....................................................................................75
`
`14. Claim 15....................................................................................78
`
`15. Claims 16-19.............................................................................78
`
`16. Claim 20....................................................................................79
`
`17. Claims 21-22.............................................................................81
`
`18. Claim 23....................................................................................81
`
`B.
`
`Claims 8 and 24-28 would have been obvious over the ACA in
`view of Korfhage...............................................................................104
`
`1.
`
`2.
`
`Claim 8....................................................................................105
`
`Claim 24..................................................................................107
`
`iii
`
`

`
`Inter Partes Review of USPN 8,731,963
`Declaration of Robert J. Valuck, Ph.D., R.Ph. (Exhibit 1007)
`
`3.
`
`4.
`
`Claim 25..................................................................................130
`
`Claims 26-28...........................................................................131
`
`VIII. Secondary considerations of non-obviousness............................................131
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`No commercial success .....................................................................132
`
`No long-felt but unmet need or failure of others...............................133
`
`No failure of others............................................................................135
`
`Copying .............................................................................................136
`
`No unexpected superior results .........................................................136
`
`IX. Conclusion ...................................................................................................137
`
`iv
`
`

`
`Inter Partes Review of USPN 8,731,963
`Declaration of Robert J. Valuck, Ph.D., R.Ph. (Exhibit 1007)
`
`I, Robert J. Valuck, do hereby declare as follows:
`
`I.
`
`Overview
`
`1.
`
`I am over the age of 18 and otherwise competent to make this
`
`declaration. This declaration is based on my personal knowledge as an expert in
`
`the fields of drug safety, drug abuse prevention, and prescription drug distribution.
`
`I understand that this declaration is being submitted together with a petition for
`
`Inter Partes Review (“IPR”) of claims 1-28 of U.S. Patent No. 8,731,963 (“the
`
`’963 patent”) (PAR1001.)
`
`2.
`
`I have been retained as an expert witness on behalf of Par
`
`Pharmaceutical, Inc. (“Par”) for this IPR. I am being compensated for my time in
`
`connection with this declaration at my standard consulting rate. I have no personal
`
`or financial interest in the outcome of this proceeding.
`
`3.
`
`I understand that the ’963 patent issued on May 20, 2014, and
`
`resulted from U.S. Ser. No. 13/592,202, filed on August 22, 2012. I also
`
`understand that the U.S. Patent and Trademark Office (“USPTO”) records state
`
`that the ’963 patent is currently assigned to Jazz Pharmaceuticals, Inc. (“Jazz”).
`
`4.
`
`The face page of the ’963 patent lists other patent applications. I
`
`understand that the ’963 patent is related to a patent application which was filed
`
`on December 17, 2002.
`
`1
`
`

`
`Inter Partes Review of USPN 8,731,963
`Declaration of Robert J. Valuck, Ph.D., R.Ph. (Exhibit 1007)
`
`5.
`
`In preparing this declaration, I have reviewed the ’963 patent
`
`(PAR1001) and its file history (PAR1002). I have also considered each of the
`
`documents listed in the table below, in light of general knowledge in the art as of
`
`December 17, 2002.
`
`Par
`Exhibit #
`
`Description
`
`1003
`
`1004
`
`1005
`
`1006
`
`1009
`
`1011
`
`1012
`
`FDA Peripheral & Central Nervous System Drugs Advisory
`Committee, Transcript and Slides (“Advisory Committee
`Transcript and Slides”) (July 13, 2001)
`
`FDA Peripheral & Central Nervous System Drugs Advisory
`Committee, Briefing Information, Division of
`Neuropharmacological Drug Products Preliminary Clinical
`Safety Review of NDA 21-196 (“Preclinical Safety Review”)
`(July 13, 2001)
`
`FDA Peripheral & Central Nervous System Drugs Advisory
`Committee, Briefing Information, Briefing Booklet (“Briefing
`Booklet”) (July 13, 2001)
`
`FDA Peripheral & Central Nervous System Drugs Advisory
`Committee, Briefing Information, Xyrem Prescription and
`Distribution Process Video and Transcript (“Xyrem Video and
`Transcript”) (July 13, 2001)
`
`Shulman, S., “The Broader Message of Accutane,” Am. J. of
`Public Health, 79:1565-1568 (1989)
`
`Honigfeld, G., “Effects of the Clozapine National Registry
`System on Incidence of Deaths Related to Agranulocytosis,”
`Psychiatric Services, 47:52-56 (1996)
`
`Burleson, K., “Review of computer applications in institutional
`pharmacy—1975-1981,” Am. J. Hosp. Pharm., 39:53-70 (1982)
`
`2
`
`

`
`Inter Partes Review of USPN 8,731,963
`Declaration of Robert J. Valuck, Ph.D., R.Ph. (Exhibit 1007)
`
`Par
`Exhibit #
`
`Description
`
`1013
`
`1014
`
`1015
`
`1016
`
`1019
`
`1020
`
`1021
`
`1022
`
`Zeldis, J., et al., “S.T.E.P.S.™: A Comprehensive Program for
`Controlling and Monitoring Access to Thalidomide,” Clin.
`Therapeutics, 21:319-330 (1999)
`
`“Managing the Risks from Medical Product Use: Creating a
`Risk Management Framework,” Report to the FDA
`Commissioner from the Task Force on Risk Management, U.S.
`Dept. of Health and Human Services, Food and Drug
`Administration (1999)
`
`66 Fed. Reg. 24,391
`
`File History for U.S. Patent No. 7,668,730 (filed Dec. 17, 2002;
`issued Feb. 23, 2010)
`
`Internet Archive Wayback Machine, FDA Peripheral & Central
`Nervous System Drugs Advisory Committee, Briefing
`Information for Xyrem NDA 21-196, available at
`https://web.archive.org/web/20010701233052/http://www.fda.g
`ov/ohrms/dockets/ac/01/briefing/3754b1.htm (dated July 1,
`2001)
`
`Internet Archive Wayback Machine, Center for Drug Evaluation
`and Research 2001 Meeting Documents, available at
`https://web.archive.org/web/20011004081740/http://www.fda.g
`ov/ohrms/dockets/ac/cder01.htm (dated Oct. 4, 2001)
`
`Orange Book Entries for Xyrem, available at
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cf
`m?Appl_No=021196&TABLE1=OB_Rx; and
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.
`cfm?Appl_No=021196&Product_No=001&table1=OB_Rx
`
`Rome, E., “It’s a rave new world: Rave culture and illicit drug
`use in the young,” Cleveland Clinic J. of Med., 68:541-550
`(2001)
`
`3
`
`

`
`Inter Partes Review of USPN 8,731,963
`Declaration of Robert J. Valuck, Ph.D., R.Ph. (Exhibit 1007)
`
`Par
`Exhibit #
`
`1023
`
`1027
`
`Description
`
`FDA, Center for Drug Evaluation and Research, NDA 21-196,
`Approved Labeling, available at
`http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-
`196_Xyrem_prntlbl_P1.pdf
`
`FDA’s Center for Drug Evaluation and Research, Advisory
`Committees CDER 2001 Meeting Documents, available at
`http://www.fda.gov/ohrms/dockets/ac/cder01.htm#Peripheral%
`20&%20Central%20Nervous 1/
`
`1028
`
`Affidavit from the Internet Archive Wayback Machine
`
`1029
`
`1032
`
`1037
`
`1040
`
`Mitchell, A., et al., “A Pregnancy-Prevention Program in
`Women of Childbearing Age Receiving Isotretinoin,” The New
`England Journal of Medicine, 333:101-106 (1995)
`
`Scrima, L., et al., “Efficacy of Gamma-Hydroxybutyrate versus
`Placebo in Treating Narcolepsy-Cataplexy: Double-Blind
`Subjective Measures,” Biol. Psychiatry, 26:331-343 (1989)
`
`Korfhage, R.R., “Information Storage and Retrieval,” (1997)
`(“Korfhage”)
`
`Declaration of Barry Gilman (May 26, 2015)
`
`6.
`
`Generally,
`
`the ’963 patent claims are directed to a computer
`
`implemented system used to distribute a prescription drug that has a potential for
`
`misuse, abuse, or diversion, wherein the prescription drug is sold by a company
`
`that obtained approval for distribution of the prescription drug through an
`
`exclusive central pharmacy that comprises:
`
`(1) storing in the memory of a
`
`computer (or multiple computers) a single computer database that contains
`
`4
`
`

`
`Inter Partes Review of USPN 8,731,963
`Declaration of Robert J. Valuck, Ph.D., R.Ph. (Exhibit 1007)
`
`prescription fields, patient fields, and prescriber fields where data from a
`
`prescription request can be entered, stored, and analyzed; (2) querying all data
`
`related to the prescription, prescriber, and patient fields within the single computer
`
`database before a prescription request is processed by the single central pharmacy;
`
`(3) checking for current or anticipated patterns of abuse, including flagging cash-
`
`paying patients or prescribers who are related to the narcoleptic patient, through
`
`periodic reports generated by the single computer database, (4) providing the
`
`prescription drug to the patient if no abuse is found on the part of the patient or the
`
`prescriber after querying the single computer database; and (5) reconciling
`
`inventory of the prescription drug before shipments for a day or other time period
`
`are sent by querying the database. (See PAR1001, 8:39-12:36.)
`
`7.
`
`It is my opinion that a person of ordinary skill in the art (“POSA”)
`
`would have had a reason and the know-how to arrive at the subject matter recited
`
`in claims 1-7 & 9-23 of the ‘963 patent in view of the Advisory Committee Art
`
`(PAR1003-PAR1006) (“ACA”), as discussed in this declaration below, with a
`
`reasonable expectation of success.
`
`8.
`
`It is also my opinion that a POSA would have had a reason and the
`
`know-how to arrive at the subject matter recited in claims 8 & 24-28 of the ’963
`
`patent
`
`in view of the ACA (PAR1003-1006) and Korfhage (PAR1037) as
`
`discussed in this declaration below, with a reasonable expectation of success.
`
`5
`
`

`
`Inter Partes Review of USPN 8,731,963
`Declaration of Robert J. Valuck, Ph.D., R.Ph. (Exhibit 1007)
`
`9.
`
`In formulating my opinions, I have relied upon my experience in the
`
`relevant art. I have also considered the viewpoint of a POSA (i.e., a person of
`
`ordinary skill in the fields of drug safety, drug abuse prevention, and prescription
`
`drug distribution) as of December 17, 2002.
`
`II. My background and qualifications
`10. My qualifications and credentials are fully set forth in my curriculum
`
`vitae, attached as PAR1008. I am an expert in the fields of drug safety, drug abuse
`
`prevention, and prescription drug distribution. I am knowledgeable about the
`
`methods used in the fields of drug safety, drug abuse prevention, and prescription
`
`drug distribution. I also have many years of experience with computerized control
`
`of the distribution of pharmaceutical products. I have been an expert in these fields
`
`since 1994. For the past 20 years, I have accumulated significant training and
`
`experience in these and related fields.
`
`11.
`
`I received a Bachelor’s Degree in Pharmacy from the University of
`
`Colorado School of Pharmacy in Denver, Colorado in 1987. I received a Master’s
`
`Degree in 1992 and a Ph.D. in 1994 in Pharmacy Administration from the
`
`University of Illinois at Chicago in Chicago, Illinois.
`
`12.
`
`Since 1987, I have been a registered pharmacist in the state of
`
`Colorado. And, since 1989, I have been a registered pharmacist in the state of
`
`Illinois.
`
`6
`
`

`
`Inter Partes Review of USPN 8,731,963
`Declaration of Robert J. Valuck, Ph.D., R.Ph. (Exhibit 1007)
`
`13.
`
`In 1987, I was a Pharmacist at Hodel’s Drug in Denver, Colorado.
`
`From 1987 to 1988, I was a Pharmacy Manager at Watson’s Tabor Center Drug in
`
`Denver, Colorado. In these positions, I was a practicing pharmacist (and, at the
`
`latter, manager of the pharmacy component of a full service drug store), and
`
`performed all usual and customary duties, including filling prescriptions, receiving
`
`prescriptions, entering patient
`
`information into computer database systems,
`
`contacting physicians to verify prescriptions, submitting insurance claims for
`
`payment, maintaining product inventory, ordering products from wholesalers,
`
`running dispensing reports, checking for potentially hazardous
`
`situations,
`
`maintaining controlled substance inventory and records, and performing other
`
`duties as needed to operate the pharmacy.
`
`14.
`
`From 1988 to 1989, I was a Decentralized Pharmacist at University
`
`Hospital
`
`in Denver, Colorado. In this position, I performed all usual and
`
`customary duties of a hospital clinical pharmacist, including taking medication
`
`histories from patients, interacting and providing drug-related advice to physicians
`
`and nurses, filling prescriptions, entering patient
`
`information into computer
`
`database systems, running reports for specific patients and prescribers, counseling
`
`patients prior to hospital discharge, and performing other duties as needed to serve
`
`the patient population.
`
`7
`
`

`
`Inter Partes Review of USPN 8,731,963
`Declaration of Robert J. Valuck, Ph.D., R.Ph. (Exhibit 1007)
`
`15.
`
`From 1989 to 1993, I was a Registered Pharmacist at Pharmstaff, Inc.
`
`in Chicago, Illinois. In this position, I was a temporary (“relief”) pharmacist, and
`
`worked shifts at various retail and hospital pharmacies in the Chicago area,
`
`performing all usual and customary duties in these settings. This included all
`
`duties listed in items 15, 16, and 17 above—with use of a variety of computer
`
`systems (varying by location, but common in their purpose and uses).
`
`16.
`
`From 1990 to 1993, I was a Clinical Pharmacist at Critical Care
`
`America in Elk Grove, Illinois. From 1993 to 1994, I was a Clinical Pharmacist at
`
`Cardiac Alliance in Northbrook, Illinois. In this position, I performed all usual and
`
`customary duties of a home health care (a/k/a “home infusion therapy”)
`
`pharmacist
`
`serving a national market,
`
`including receiving and entering
`
`prescriptions into computer database systems, preparing custom infusion therapy
`
`products for patients, supervising secure shipping of products to patients across
`
`the United States, monitoring patients’ therapeutic progress via remote telemetry
`
`systems, communicating with physicians and nurses regarding patient status, and
`
`running patient and provider specific reports regarding drug therapy.
`
`17.
`
`From 1994 to 2001, I was an Assistant Professor in the Department of
`
`Pharmacy Practice at the University of Colorado-Denver. From 1998 to 2003, I
`
`was a Guest Lecturer for the Primary Care Residency Program at the University of
`
`8
`
`

`
`Inter Partes Review of USPN 8,731,963
`Declaration of Robert J. Valuck, Ph.D., R.Ph. (Exhibit 1007)
`
`Colorado School of Medicine. From 2001 to 2008, I was an Associate Professor in
`
`the Department of Clinical Pharmacy at the University of Colorado-Denver.
`
`18.
`
`Since 1994,
`
`I have been a Graduate Faculty Member
`
`in the
`
`Department of Pharmaceutical Sciences at the University of Colorado-Denver.
`
`Since 1996, I have been a member of the Graduate College at the University of
`
`Colorado-Denver. Since 2006, I have been a Guest Lecturer in the Department of
`
`Preventive Medicine and Biometrics at the University of Colorado School of
`
`Medicine. Since 2008, I have been a Professor in the Department of Clinical
`
`Pharmacy at the University of Colorado-Denver School of Pharmacy. Since 2009,
`
`I have been a Professor in the Department of Family Medicine at the University of
`
`Colorado-Denver School of Medicine. Since 2011, I have been a Professor in the
`
`Department of Epidemiology at the Colorado School of Public Health.
`
`19.
`
`Since 1995, I have received over 53 grants and contracts to study
`
`prescription drug safety, abuse prevention, and distribution. I have published over
`
`80 papers in peer-reviewed journals on topics including prescription drug safety,
`
`abuse prevention, and distribution. I serve as a reviewer for professional journals
`
`in my field and am a member of
`
`the Editorial Boards of Advances in
`
`Pharmacoepidemiology and Current Medical Research and Opinion. Since 2002,
`
`I have been a member of the Risk Management and Medication Compliance
`
`Special Interest Groups of the International Society for Pharmacoeconomics and
`
`9
`
`

`
`Inter Partes Review of USPN 8,731,963
`Declaration of Robert J. Valuck, Ph.D., R.Ph. (Exhibit 1007)
`
`Outcomes Research. I am a member of multiple professional societies including
`
`the Academy of Managed Care Pharmacy, the American Association of Colleges
`
`of Pharmacy,
`
`the American Pharmacists Association,
`
`the Drug Information
`
`Association, the International Society for Pharmacoeconomics and Outcomes
`
`Research, and the International Society for Pharmacoepidemiology. I have
`
`collaborated with several prominent researchers in the fields of drug safety, drug
`
`abuse prevention, and prescription drug distribution. In addition to my educational
`
`training, professional experiences, and research experiences described above, I
`
`attend conferences on drug safety, drug abuse prevention, and prescription drug
`
`distribution each year, and I have been invited to speak at such conferences.
`
`20. Accordingly, I am an expert in the fields of drug safety, drug abuse
`
`prevention, and prescription drug distribution. I also have expertise in the practice,
`
`administration, and day-to-day operations of pharmacy, including computerized
`
`control of the distribution of pharmaceutical products. Additionally, I have
`
`experience dispensing drugs subject
`
`to risk management programs, such as
`
`Accutane® and Clozaril®. Moreover, I have experience in evaluating the risks
`
`associated with prescription drug use. I am qualified to provide an opinion as to
`
`what a POSA would have understood, known, or concluded as of December of
`
`2002. Additionally, I at least meet the criteria of a POSA as outlined below.
`
`10
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`

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`Inter Partes Review of USPN 8,731,963
`Declaration of Robert J. Valuck, Ph.D., R.Ph. (Exhibit 1007)
`
`III. Person of ordinary skill in the art
`
`21.
`
`I understand that a POSA is a hypothetical person who is presumed to
`
`be aware of all pertinent art, thinks along conventional wisdom in the art, and is a
`
`person of ordinary creativity. A POSA may work as part of a multi-disciplinary
`
`team and draw upon not only his or her own skills, but also take advantage of
`
`certain specialized skills of others in the team, to solve a given problem. For
`
`example, a POSA would hold a Bachelor’s or Doctor of Pharmacy degree and a
`
`license as a registered pharmacist with 3-5 years of relevant work experience, or a
`
`computer science undergraduate degree or equivalent work experience and work
`
`experience relating to business applications, for example, including familiarity
`
`with drug distribution procedures. Alternatively, a POSA may have a blend of
`
`computer science and pharmacy drug distribution knowledge and/or experience.
`
`For example, such a POSA may have computer science education qualifications
`
`and experience relating to computerized drug distribution systems, or pharmacy
`
`education qualifications and experience relating to computerized drug distribution
`
`systems. A POSA would have had knowledge of the literature concerning
`
`pharmacy practice and prescription drug distribution, such as the prior art
`
`presented herein, that was available before the earliest effective filing date of the
`
`’963 patent,
`
`including knowledge about methods employed in the art.
`
`Accordingly, a POSA would have been well aware of techniques related to the
`
`11
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`

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`Inter Partes Review of USPN 8,731,963
`Declaration of Robert J. Valuck, Ph.D., R.Ph. (Exhibit 1007)
`
`mitigation of the risk associated with the distribution of potentially hazardous, but
`
`therapeutically beneficial prescription drugs.
`
`IV.
`
`State of the art
`
`22.
`
`The mitigation of the risks associated with the distribution of
`
`potentially hazardous prescription drugs was well-known in the art. For example,
`
`in 1982, Hoffman-La Roche (“Roche”) gained approval
`
`for Accutane®
`
`(isotretinoin). (PAR1009, 1565:2, ¶1.) However, it soon became apparent that
`
`Accutane® was a potent teratogen that was responsible for several birth defects.
`
`(Id., 1565:1, ¶¶1, 3.) To address that risk, Roche developed a Pregnancy
`
`Prevention Program Kit for distribution to physicians who prescribe Accutane®.
`
`(Id., 1567:1, ¶2.) The kit included various forms, such as an informed consent
`
`document, that the patient and doctor must fill out indicating that they understand
`
`the risks associated with using Accutane. (Id., 1567:1, ¶¶1, 2.) The Accutane®
`
`mitigation plan also included patient counseling on the teratogenic risk of
`
`Accutane, the need to avoid pregnancy, and the practicing of proper birth control
`
`methods. (Id.) Additionally, women of childbearing potential had to test serum
`
`negative for a pregnancy within two weeks prior to beginning treatment. (Id.)
`
`23.
`
`Following in the footsteps of Accutane,
`
`in 1990, Clozaril®
`
`(clozapine) entered the United States market for the treatment of treatment-
`
`resistant schizophrenia. (PAR1011, 52:1, ¶1 and 53:2, ¶1.) However, Clozaril use
`
`12
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`Inter Partes Review of USPN 8,731,963
`Declaration of Robert J. Valuck, Ph.D., R.Ph. (Exhibit 1007)
`
`was associated with agranulocytosis, a potentially fatal blood disorder resulting in
`
`white blood cell loss. (Id., Abstract, 52:1, and 53:1, ¶1.) To mitigate these risks
`
`and control the distribution of Clozaril®, the manufacturer implemented a national
`
`registry system that limited the distribution of the drug. (Id., 52:2, ¶2.) The
`
`distribution system required registration in an integrated computerized database—
`
`collecting information identifying the patient and the physician. (Id., 53:2, ¶3.)
`
`Additionally, each filling of the prescription required the physician to measure the
`
`patient’s white blood cell count—terminating treatment if the patient tests positive
`
`for agranulocytosis. (Id., 53:1, ¶¶1, 2.) If a patient or physician was non-compliant
`
`with the program, the national registry took corrective action, such as contacting
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`and re-educating the prescribing physician and/or discontinuing supplying of the
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`prescription to the patient. (Id., 53:1, ¶1 & 53:3, ¶3.) Overall, the Clozaril®
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`distribution system resulted in 97% patient/physician compliance over its first five
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`years of implementation. (Id., 53:3, ¶2.)
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`24. And while the use of a computer differentiated the Clozaril® system
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`from the Accutane® system, the use of a computer was not novel to prescription
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`drug distribution, and especially distribution of hazardous drugs, because by 1990
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`pharmacies had long been using computers when filling prescriptions. (See, e.g.,
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`PAR1012, 53:1 & 56:2, ¶1 through 61:1, ¶3.)
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`13
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`Inter Partes Review of USPN 8,731,963
`Declaration of Robert J. Valuck, Ph.D., R.Ph. (Exhibit 1007)
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`25.
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`In 1999, on the heels of Accutane® and Clozapine® restricted
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`distribution systems, the manufacturers of prescription thalidomide—a known
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`teratogen—developed a hybrid system, taking the computerized registry system of
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`Clozaril® and the pregnancy monitoring, pregnancy prevention steps, and
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`informed consent requirements of Accutane®. (PAR1013, 319:1, ¶1, 320:2, ¶1,
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`324:1, ¶2, 325 (all) and 327:2, ¶¶3, 4.) Additionally, attempts at early refills were
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`blocked. (Id.) This computerized registry system and preventative testing served to
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`monitor and control the distribution of the drug. (Id., 328:2, ¶¶1, 2 & 329:2, ¶2.)
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`26. As such, by 1999, at least three systems for the distribution of
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`effective yet hazardous prescription drugs were known in the art and implemented
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`in the industry. Realizing the necessity of developing “[a] better understanding of
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`risks and a more integrated risk management system [to] enable more effective
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`risk interventions,” the FDA convened a task force to develop a framework for
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`risk management of medical products. (PAR1014, 1:¶1, & 2:¶1.) Part of the task
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`force’s recommendation was to increase “postmarketing risk interventions for
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`products with special risks, such as restricted distribution of products or requiring
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`mandatory educational programs for healthcare professionals and patients.” (Id.,
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`15:¶3.) For example, the task force pointed to the restricted computer-based
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`distribution of thalidomide as an example of a successful risk management
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`Inter Partes Review of USPN 8,731,963
`Declaration of Robert J. Valuck, Ph.D., R.Ph. (Exhibit 1007)
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`program, and noted that restricted distribution can be favorable for certain drugs.
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`(Id., 83:¶2.)
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`27. Moreover, while risk management programs were developing during
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`the 1980s through 1990s, pharmacies were also making use of computerized
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`systems to track and control the distribution of controlled substances, i.e., drugs
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`with potential for abuse. (PAR1012, 56:2, ¶1 through 57:1, ¶1.) Because of the
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`need to reduce time commitment
`
`to dispensing,
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`improve accuracy and
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`accountability, and streamline record keeping,
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`the distribution of controlled
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`substances veered toward automation via the implementation of computerized
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`systems of distribution. (Id.) Computerized systems were helpful in accelerating
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`the process of generating reports that notified pharmacists if patients were
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`receiving excessive supplies of controlled substances.
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`(Id., 56:2, ¶¶2, 3.)
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`Distribution of controlled substances could be tied to information identifying the
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`patient, the prescribing doctor, the quantity of the drug dispensed, and hospital
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`inventory of a drug. (Id., 56:2, ¶3.) In addition, the systems could be queried to
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`provide data, such as prescriptions by doctor and patient. (Id.) Ultimately, these
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`systems allowed for detecting patterns of abuse. (Id., 56:2, ¶1 through 57:1, ¶1.)
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`28. Consequently, by December of 2002 (the earliest effective filing date
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`of the ‘963 patent), multiple sources existed in the art that would have led a POSA
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`to develop computerized and centralized distribution systems to minimize the risks
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`15
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`Inter Partes Review of USPN 8,731,963
`Declaration of Robert J. Valuck, Ph.D., R.Ph. (Exhibit 1007)
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`associated with the distribution of hazardous, but
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`therapeutically beneficial,
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`prescription drugs.
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`V.
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`The ‘963 patent and its claims
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`29.
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`I understand that this declaration is being submitted together with a
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`petition for IPR of claims 1-28 of the ’963 patent.
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`30.
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`I have considered the disclosure of the ’963 patent in light of the
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`general knowledge in the art as of the earliest possible priority date of the ’963
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`patent, which I understand to be December 17, 2002.
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`31.
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`The ’963 patent specification is generally directed towards “[a] drug
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`distribution system and method utiliz[ing] a central pharmacy and database to
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`track all prescriptions for a sensitive drug.” (PAR1001, Abstract.) According to
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`the ’963 patent specification, prescription patterns by physicians and patients are
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`monitored for abuse using an exclusive central database. (Id., 2:20-25.) Further,
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`physician eligibility to prescribe the drug is also verified using a database,
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`including determining whether any corrective or approved disciplinary actions
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`have been brought against the physician. (Id., 1:54-60.) Prior to shipment of a
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`prescription drug, the central pharmacy confirms whether the patient has been
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`educated about the prescription, and only ships the prescription drug when no
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`abuse is found related to the patient and prescribing doctor. (Id., 1:63-66 & 5:25-
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`16
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`Inter Partes Review of USPN 8,731,963
`Declaration of Robert J. Valuck, Ph.D., R.Ph. (Exhibit 1007)
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`34.) Reports are then generated to evaluate potential diversion patterns. (Id., 2:23-
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`25.) The prescription drug is then delivered to the patient. (Id., 1:59-2:1-3).
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`32.
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`I have been informed that claim terms are given their broadest
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`reasonable interpretation, as understood by a POSA, in view of their specification.
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`After reading the ’963 patent’s specification, it is my opinion that a POSA reading
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`the ’963 patent would have understood that all the terms of claims 1-28 should be
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`given their ordinary meaning except as discussed below.
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`It
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`is also my
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`understanding that a dependent claim contains all the limitations of the claim from
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`which it depends.
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`A.
`
`Claim 1
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`33. Claim 1 of the ’963 patent, from which claims 2-23 depend explicitly
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`or implicitly upon, in general claims a computer-implemented system (i.e., a
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`computerized method) for distributing a prescription drug under exclusive control
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`of an exclusive central pharmacy through the use of a single computer database.
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`(PAR1001, 8:39-9:13.)
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`34.
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`In particular, claim 1 requires using a computer that contains one or
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`more computer memories for storing a single computer database (of the company
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`that obtained approval for distribution of the prescription drug) that contains
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`separate data fields for prescription, patient, and prescriber information to be
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`entered, stored, and analyzed for potential abuse situations (claim 1, clause 1).
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`17
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`Inter Partes Review of USPN 8,731,963
`Declaration of Robert J. V