UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`ROXANE LABORATORIES, INC. and PAR PHARMACEUTICAL, INC.
`Petitioners
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.
`Patent Owner
`
`_____________________
`
`CASE CBM: Unassigned
`_____________________
`
`DECLARATION OF ROBERT J. VALUCK, Ph.D., R.Ph.
`
`ROX 1007
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`Covered Business Method Patent Review of USPN 7,765,107
`Declaration of Robert J. Valuck, Ph.D., R.Ph. (Exhibit 1007)
`
`TABLE OF CONTENTS
`
`I.
`
`Overview ......................................................................................................1
`
`II. My background and qualifications ................................................................7
`
`III.
`
`IV.
`
`V.
`
`Person of ordinary skill in the art ................................................................12
`
`State of the art.............................................................................................13
`
`The ‘107 patent and its claims.....................................................................18
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`Claim 1 .............................................................................................19
`
`Claim 4 .............................................................................................26
`
`The preamble is not a limitation........................................................26
`
`The claims of the ‘107 patent recite financially related activities ......27
`
`The recitations of a generic computer processor and a generic
`computer database in the claims of the ‘107 patent provide no
`advances over known pharmacy practices.........................................27
`
`F.
`
`Orange Book listing of the ‘107 patent .............................................30
`
`VI. A POSA exercising reasonable diligence would have located the
`Advisory Committee Art.............................................................................30
`
`VII. Basis of my analysis with respect to anticipation and obviousness..............31
`
`A.
`
`B.
`
`The Advisory Committee Art discloses a method that would meet
`all the elements of claims 1-6............................................................33
`
`A POSA reading the Advisory Committee Art would have had
`the reason and the know-how to arrive at the methods of claims
`1-6 ..................................................................................................106
`
`VIII. Secondary considerations of non-obviousness ..........................................111
`
`A.
`
`B.
`
`No commercial success...................................................................112
`
`No long-felt but unmet need or failure of others .............................113
`
`ii
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`Covered Business Method Patent Review of USPN 7,765,107
`Declaration of Robert J. Valuck, Ph.D., R.Ph. (Exhibit 1007)
`
`C.
`
`No unexpected superior results .......................................................115
`
`IX. Conclusion................................................................................................116
`
`iii
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`Covered Business Method Patent Review of USPN 7,765,107
`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 eighteen (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 a Covered Business Methods Patent Review (“CBM”) of claims 1-6 of
`
`U.S. Patent No. 7,765,107 (“the ‘107 patent,” ROX1001.)
`
`2.
`
`I have been retained as an expert witness on behalf of Roxane
`
`Laboratories, Inc. (“Roxane”) and Par Pharmaceutical, Inc. (“Par”) for this CBM.
`
`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 ‘107 patent issued on July 27, 2010, and resulted
`
`from U.S. Ser. No. 11/097,985, filed on April 1, 2005. I also understand that the
`
`U.S. Patent and Trademark Office (“USPTO”) records state that the ‘107 patent is
`
`currently assigned to Jazz Pharmaceuticals, Inc. (“Jazz”).
`
`4.
`
`The face page of the ‘107 patent lists U.S. Ser. No. 10/322,348 under
`
`“Related U.S. Application Data” which issued as U.S. Patent No. 7,668,730 (“the
`
`1
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`Covered Business Method Patent Review of USPN 7,765,107
`Declaration of Robert J. Valuck, Ph.D., R.Ph. (Exhibit 1007)
`
`’730 patent”).
`
`I understand that
`
`the ‘107 patent
`
`is related to this patent
`
`application, which was filed on December 17, 2002.
`
`5.
`
`In preparing this declaration, I have reviewed the ‘107 patent
`
`(ROX1001) and its file history (ROX1002).
`
`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.
`
`Roxane
`Exhibit #
`
`Description
`
`1003
`
`1004
`
`1005
`
`1006
`
`1009
`
`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 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)
`
`2
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`Covered Business Method Patent Review of USPN 7,765,107
`Declaration of Robert J. Valuck, Ph.D., R.Ph. (Exhibit 1007)
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`Roxane
`Exhibit #
`
`Description
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`1021
`
`1022
`
`Spurgeon D., “Advent of Mail-Order Pharmacy Causes Concern
`Among Some Pharmacists,” Can. Med. Assoc. J., 152:1485-
`1486 (1995)
`
`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)
`
`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. 24391
`
`File History for U.S. Patent No. 7,668,730 (filed Dec. 17, 2002;
`issued Feb. 23, 2010)
`
`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
`
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`Covered Business Method Patent Review of USPN 7,765,107
`Declaration of Robert J. Valuck, Ph.D., R.Ph. (Exhibit 1007)
`
`Roxane
`Exhibit #
`
`1023
`
`1027
`
`1030
`
`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
`
`Mitchell, A., “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., “The Effects of -Hydroxybutyrate on the
`Sleep of Narcolepsy Patients: A Double-Blind Study,” Sleep,
`13:479-490 (1990).
`
`6.
`
`Generally,
`
`the ’107 patent claims are directed to a method of
`
`distributing a prescription drug using an exclusive central pharmacy that
`
`comprises: (1) controlling with a computer processor the distribution of said
`
`prescription drug via an exclusive central pharmacy that maintains a central
`
`database that tracks all prescriptions of said prescription drug and analyzes for
`
`potential abuse situations; (2) receiving in the computer processor all prescription
`
`requests, for any and all patients being prescribed the prescription drug, only at the
`
`exclusive central pharmacy, from any and all medical doctors allowed to prescribe
`
`the prescription drug; (3) processing with the computer processor all prescriptions
`
`for the prescription drug only by the exclusive central pharmacy using only the
`
`central database; (4) determining with the computer processor current and
`
`4
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`anticipated patterns of potential prescription abuse of said prescription drug from
`
`periodic reports generated only by the central database based on prescription
`
`request data from a particular medical doctor and further based on filling of
`
`prescriptions by a particular patient, wherein said request data contain information
`
`identifying the patient, the drug prescribed, and credentials of the medical doctor;
`
`(5) selecting with the computer processor multiple controls for distribution by said
`
`exclusive central pharmacy, the controls comprising communicating prescriptions
`
`from a physician to the central pharmacy;
`
`identifying the physician's name,
`
`license, and DEA (Drug Enforcement Agency) registration information; verifying
`
`the prescription; obtaining patient information; verifying the physician is eligible
`
`to prescribe the prescription drug by consulting the National Technical
`
`Information Services to determine whether the physician has an active DEA
`
`number and to check on whether any actions are pending against the physician;
`
`providing comprehensive printed materials to the physician; contacting the
`
`patient's insurance company if any; verifying patient
`
`registry information;
`
`providing comprehensive education information to the patient; verifying the
`
`patient has reviewed the educational materials; verifying the home address of the
`
`patient; shipping via US postal service or a commercial shipping service;
`
`receiving the name of an at least 18 year old designee to receive the drug;
`
`5
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`confirming receipt of an initial shipment of the drug to the patient returning the
`
`drug to the pharmacy after two attempts to deliver; launching an investigation
`
`when a shipment is lost; shipping to another pharmacy for delivery; requiring
`
`manufacture at a single location; releasing inventory in a controlled manner to the
`
`central pharmacy; questioning early refills; flagging repeat
`
`instances of lost,
`
`stolen, destroyed, or spilled prescriptions; limiting the prescription to a one month
`
`supply; requiring rewriting of the prescription periodically; and making the
`
`database available to the DEA for checking for abuse patterns in the data, for cash
`
`payments, and for inappropriate questions.
`
`7.
`
`It
`
`is my opinion that the methods recited in claims 1-6 can be
`
`performed simply through mental ability and the use of a pen and paper-based
`
`registry. Moreover, it is my opinion that the claimed steps of controlling with a
`
`computer processor the distribution of the prescription drug via a pharmacy that
`
`maintains a central database, receiving in the computer processor all prescription
`
`requests, processing with the computer processor all prescriptions using only the
`
`central database, determining with the computer processor current and anticipated
`
`patterns of potential prescription abuse from periodic reports generated only by
`
`the central database, and selecting with the computer processor multiple controls
`
`for distribution are no more than the common place procedures a pharmacist
`
`6
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`Declaration of Robert J. Valuck, Ph.D., R.Ph. (Exhibit 1007)
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`would employ when using a basic pharmacy computer and database to fill a
`
`prescription.
`
`8.
`
`It is my opinion that the Advisory Committee Art (“ACA”) (i.e.,
`
`ROX1003-ROX1006) either explicitly or implicitly discloses and enables each
`
`and every limitation in claims 1-6 of the ‘107 patent, arranged as claimed.
`
`9.
`
`It
`
`is also 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 1-6 of the ‘107 patent in view of the ACA, as discussed in
`
`this declaration below, with a reasonable expectation of success.
`
`10.
`
`In formulating my opinions, I have relied upon my experience in the
`
`relevant art. In formulating my opinions, I have also considered the viewpoint of
`
`a POSA (i.e., a person of ordinary skill as set forth below in ¶22) as of December
`
`17, 2002.
`
`II. My background and qualifications
`
`11. My qualifications and credentials are fully set forth in my curriculum
`
`vitae, attached as ROX1008.
`
`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
`
`7
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`Declaration of Robert J. Valuck, Ph.D., R.Ph. (Exhibit 1007)
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`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.
`
`12.
`
`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.
`
`13.
`
`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.
`
`14.
`
`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, 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
`
`8
`
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`Declaration of Robert J. Valuck, Ph.D., R.Ph. (Exhibit 1007)
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`reports, maintaining controlled substance inventory records, and other duties as
`
`needed to operate the pharmacy.
`
`15.
`
`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 other duties as needed to serve the patient
`
`population.
`
`16.
`
`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 13 and 14 above—with use of a variety of computer systems
`
`(varying by location, but common in their purpose and uses).
`
`17.
`
`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
`
`9
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`and customary duties of a home health care (aka “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.
`
`18.
`
`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
`
`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.
`
`19.
`
`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,
`
`10
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`
`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.
`
`20.
`
`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
`
`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
`
`11
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`Covered Business Method Patent Review of USPN 7,765,107
`Declaration of Robert J. Valuck, Ph.D., R.Ph. (Exhibit 1007)
`
`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.
`
`21. 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.
`
`III.
`
`Person of ordinary skill in the art
`
`22.
`
`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
`
`12
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`Covered Business Method Patent Review of USPN 7,765,107
`Declaration of Robert J. Valuck, Ph.D., R.Ph. (Exhibit 1007)
`
`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 ‘107
`
`patent, including knowledge about methods employed in the art. Accordingly, a
`
`POSA would have been well aware of techniques related to the mitigation of the
`
`risk associated with the distribution of potentially hazardous, but therapeutically
`
`beneficial prescription drugs.
`
`IV.
`
`State of the art
`
`23.
`
`The mitigation of the risks associated with the distribution of
`
`potentially hazardous prescription drugs was well-known in the art before the
`
`earliest effective filing date of ‘107 patent. For example, in 1982, Hoffmann-La
`
`13
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`
`Roche (“Roche”) gained approval for Accutane® (isotretinoin).
`
`(See ROX1009,
`
`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.)
`
`Under pressure to respond, 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 negative for pregnancy
`
`at least two weeks prior to beginning treatment. (Id.)
`
`24.
`
`Following in the footsteps of Accutane®,
`
`in 1990 Clozaril®
`
`(clozapine) entered the United States market for the treatment of treatment-
`
`resistant schizophrenia. (ROX1011, 52:1, ¶1 and 53:2, ¶1.) However, Clozaril®
`
`use was associated with agranulocytosis, a potentially fatal blood disorder
`
`resulting in white blood cell loss. (Id., 52:1, ¶1 and 53:1, ¶1.) To mitigate these
`
`risks and to control the distribution of Clozaril®, the manufacturer implemented a
`
`national registry system that limited the distribution of the drug.
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`(Id., 52:2, ¶2.)
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`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 and re-educating the prescribing physician and/or discontinuing
`
`supplying of the prescription to the patient. (Id., 53:1, ¶1 and 3, ¶3.) Overall, the
`
`Clozaril® distribution system resulted in 97% patient/physician compliance over
`
`its first five years of implementation. (Id., 53:3, ¶2.)
`
`25. And while the use of a computer differentiated the Clozaril® system
`
`from the Accutane® system, the use of a computer was not novel to prescription
`
`drug distribution, especially distribution of hazardous drugs, because by 1990 the
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`pharmaceutical industry had long been using computers when filling prescriptions.
`
`(See, e.g., ROX1012, 53:1 and 56:2, ¶1-61:1, ¶3.)
`
`26.
`
`Based on the experiences of patients and doctors with Accutane® and
`
`Clozapine®, the manufacturers of prescription thalidomide—a known teratogen—
`
`developed a hybrid system, taking the computerized registry system of Clozaril®
`
`and the pregnancy monitoring, pregnancy prevention steps, and informed consent
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`requirements of Accutane®.
`
`(ROX1017, 319:1, ¶1, 320:2, ¶1, 324:1, ¶2, 325:1,
`
`¶1-2:¶3, and 327:2, ¶¶3, 4.) Additionally, attempts at early re-fills were blocked.
`
`(Id.) This computerized registry system and preventative testing served to monitor
`
`and control the distribution of the drug. (Id., 328:2, ¶1, 2 and 329:2, ¶2.)
`
`27. As such, by 1999, at
`
`least three systems for the distribution of
`
`effective, yet hazardous prescription drugs were known in the art and implemented
`
`in the industry. Realizing the necessity of developing “[a] better understanding of
`
`risks and a more integrated risk management system [to] enable more effective
`
`risk interventions,” the FDA convened a task force to develop a framework for
`
`risk management of medical products. (ROX1014, 2: ¶1.) Part of the task force’s
`
`recommendation was to increase “postmarketing risk interventions for products
`
`with special risks, such as restricted distribution of products or
`
`requiring
`
`mandatory educational programs for healthcare professionals and patients.” (Id.,
`
`13: ¶3.) For example, the task force pointed to the restricted computer-based
`
`distribution of thalidomide as an example of a successful risk management
`
`program, and noted that restricted distribution can be favorable for certain drugs.
`
`(Id., 83: ¶1.)
`
`28. Moreover, while risk management programs were developing during
`
`the 1980s through 1990s, pharmacies were also making use of computerized
`
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`Covered Business Method Patent Review of USPN 7,765,107
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`systems to track and control the distribution of controlled substances, i.e., drugs
`
`with potential for abuse. (ROX1012, 56:2, ¶1-57:1, ¶1.) Because of the need to
`
`reduce time commitment to dispensing, improve accuracy and accountability, and
`
`streamline record keeping, the distribution of controlled substances veered toward
`
`automation via the implementation of computerized systems of distribution. (Id.,
`
`56:2, ¶1.) Computerized systems were helpful in accelerating the process of
`
`generating reports that notified pharmacists if patients were receiving excessive
`
`supplies of controlled substances.
`
`(Id., 56:2, ¶2, 3.) Distribution of controlled
`
`substances could be tied to information identifying the patient, the prescribing
`
`doctor, the quantity of the drug dispensed, and hospital inventory of a drug. (Id.,
`
`56:2, ¶3.)
`
`In addition, the systems could be queried to provide data, such as,
`
`prescriptions by doctor and patient.
`
`(Id.) Ultimately, these systems allowed for
`
`detecting patterns of abuse. (Id., 56:2, ¶1-57:1, ¶1.)
`
`29.
`
`Consequently, by December of 2002, multiple sources existed in the
`
`art that would have led a POSA to develop centralized distribution systems to
`
`minimize
`
`the
`
`risks
`
`associated with the distribution of hazardous, but
`
`therapeutically beneficial prescription drugs.
`
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`Covered Business Method Patent Review of USPN 7,765,107
`Declaration of Robert J. Valuck, Ph.D., R.Ph. (Exhibit 1007)
`
`V.
`
`The ‘107 patent and its claims
`
`30.
`
`I understand that this declaration is being submitted together with a
`
`petition for CBM review of claims 1-6 of the ‘107 patent.
`
`31.
`
`I have considered the disclosure of the ‘107 patent in light of the
`
`general knowledge in the art as of the earliest possible priority date of the ‘107
`
`patent, which I understand to be December 17, 2002.
`
`32.
`
`The ‘107 patent specification is generally directed towards “[a] drug
`
`distribution system and method utiliz[ing] a central pharmacy and database to
`
`track all prescriptions for a sensitive drug.” (ROX1001, Abstract.) According to
`
`the ‘107 specification, multiple controls are imposed on the distribution of the
`
`prescription drug.
`
`(Id., 1:56-58.) Physician and patient prescription patterns are
`
`monitored for abuse using an exclusive central database. Physician eligibility to
`
`prescribe the drug is verified via a database,
`
`including determining whether
`
`disciplinary actions have been brought against the physician. (Id., 1:48-56.) Prior
`
`to shipping the prescription drug, the central pharmacy confirms whether the
`
`patient has been educated about the prescription, and only ships the prescription
`
`drug when no abuse is found related to the patient and prescribing doctor.
`
`(Id.,
`
`1:59-67.) The prescription drug is then shipped to the patient. (Id., 1:59-2:3.)
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`Covered Business Method Patent Review of USPN 7,765,107
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`
`33.
`
`I have been informed that claim terms are given their broadest
`
`reasonable interpretation, as understood by a POSA, in view of their specification.
`
`After reading the ‘107 patent’s specification, it is my opinion that a POSA reading
`
`the ‘107 patent would have understood that all the terms of claims 1-6 should be
`
`given their ordinary meaning except as discussed below.
`
`It
`
`is also my
`
`understanding that a dependent claim contains all the limitations of the claim from
`
`which it depends.
`
`A.
`
`34.
`
`Claim 1
`
`Claim 1 of the ‘107 patent, from which claims 2 and 3 depend, in
`
`general claims a method to control abuse of a prescription drug. (ROX1001, 8:36-
`
`9:25.)
`
`35.
`
`In particular, claim 1 requires controlling with a computer processor
`
`the distribution of said prescription drug via an exclusive central pharmacy that
`
`maintains a central database that tracks all prescriptions of said prescription drug
`
`and analyzes for potential abuse situations (claim 1, clause 1). (ROX1001, 8:38-
`
`42.) Next,
`
`the method requires receiving in the computer processor all
`
`prescription requests,