UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`AMNEAL PHARMACEUTICALS LLC, PAR PHARMACEUTICAL, INC. and
`WOCKHARDT BIO AG,
`
`Petitioners,
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.
`
`Patent Owner
`
`________________
`
`Case IPR2015-005541
`Patent 7,668,730
`________________
`
`
`
`DECLARATION OF BRYAN BERGERON, MD, FACMI
`
`
`
`1 Case IPR2015-01818 has been joined with this proceeding.
`
`JAZZ EXHIBIT 2047
`Amneal Pharms. et al. (Petitioners) v. Jazz Pharms., Inc. (Patent Owner)
`Case IPR2015-00554
`
`Page 1 of 55
`
`
`
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`AMNEAL PHARMACEUTICALS LLC, PAR PHARMACEUTICAL, INC. and
`WOCKHARDT BIO AG,
`
`Petitioners,
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.
`
`Patent Owner
`
`________________
`
`Case IPR2015-005541
`Patent 7,668,730
`________________
`
`
`
`DECLARATION OF BRYAN BERGERON, MD, FACMI
`
`
`
`1 Case IPR2015-01818 has been joined with this proceeding.
`
`JAZZ EXHIBIT 2047
`Amneal Pharms. et al. (Petitioners) v. Jazz Pharms., Inc. (Patent Owner)
`Case IPR2015-00554
`
`Page 1 of 55
`
`
`
`
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`TABLE OF CONTENTS
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`Page
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`I.
`
`QUALIFICATIONS ........................................................................................ 1
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`II. MATERIALS CONSIDERED ........................................................................ 4
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`III. LEGAL STANDARDS ................................................................................... 5
`
`IV. THE CHALLENGED PATENT AND THE RELEVANT PERSON
`OF ORDINARY SKILL IN THE ART ........................................................... 7
`
`V.
`
`CLAIM CONSTRUCTION ............................................................................ 9
`
`A.
`
`B.
`
`“exclusive central pharmacy” and “exclusive computer
`database”.............................................................................................. 10
`
`“generating with the computer processor periodic reports via
`the exclusive computer database to evaluate potential diversion
`patterns” ............................................................................................... 10
`
`VI. A POSA WOULD NOT HAVE BEEN FAMILIAR WITH THE
`FEDERAL REGISTER AND WOULD NOT HAVE BEEN
`MOTIVATED TO LOOK TO THE FEDERAL REGISTER ...................... 13
`
`VII. THE ACA MATERIALS WOULD NOT HAVE DISCLOSED,
`TAUGHT, OR SUGGESTED “GENERATING WITH THE
`COMPUTER PROCESSOR PERIODIC REPORTS VIA THE
`EXCLUSIVE COMPUTER DATABASE TO EVALUATE
`POTENTIAL DIVERSION PATTERNS” .................................................... 15
`
`VIII. SUPPLEMENTAL OR AMENDED OPINIONS ......................................... 21
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`
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`Page 2 of 55
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`I, Bryan Bergeron, MD, FACMI, hereby declare and state as follows:
`
`1.
`
`I submit this declaration on behalf of Jazz Pharmaceuticals, Inc.
`
`(“Jazz”), Patent Owner of U.S. Patent No. 7,668,730 (the “’730 patent”) in
`
`connection with this inter partes review (“IPR”), Case IPR2015-00554.
`
`I.
`
`QUALIFICATIONS
`
`2.
`
`I am currently the President of Archetype Technologies, Inc. which
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`specializes in the development and evaluation of new technologies. Archetype
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`Technologies, Inc. specifically focuses on medical and healthcare computer
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`hardware and software systems, for academia, governmental and commercial
`
`customers.
`
`3.
`
`I obtained my B.S. degree in Psychology, with honors, with additional
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`emphases in physics and chemistry, from Tulane University in 1980. I obtained
`
`my Doctor of Medicine (M.D.) degree from Louisiana State University Medical
`
`Center in 1984.
`
`4.
`
` Following medical school, I was a post-doctoral research fellow in
`
`medical informatics at Brigham & Women’s Hospital, a Harvard Medical School
`
`teaching hospital. Medical informatics—also referred to as healthcare
`
`informatics—is a discipline at the intersection of information science, computer
`
`science, and health care. It deals with the resources, devices, and methods for
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`optimizing the acquisition, storage, retrieval, and use of information in various
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`Page 3 of 55
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`
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`medical environments. During the fellowship, I studied computer science at
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`Harvard University.
`
`5.
`
`Following my post-doctoral fellowship, I began working as an
`
`instructor at Harvard Medical School, as well as an Assistant Director of the post-
`
`doctoral fellowship program in medical informatics at Brigham & Women’s
`
`Hospital and Harvard University. In addition to these positions, I have held
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`multiple academic positions at Harvard Medical School, Massachusetts Institute of
`
`Technology (“MIT”), the Harvard-MIT Division of Health Sciences and
`
`Technology, and Massachusetts General Hospital Institute for Healthcare
`
`Professionals. I have taught in the Harvard/MIT system for over 30 years,
`
`including courses on both medicine and medical informatics. For the past decade,
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`I have taught a course on medical informatics that includes lessons on systems to
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`address medical errors, including those that occur in the pharmacy. For a more
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`comprehensive list of my work experience, please see my curriculum vitae,
`
`attached hereto as Exhibit 1.
`
`6.
`
`As a result of my academic and non-academic work, I have extensive
`
`experience with Electronic Medical Record (EMR) and Electronic Health Record
`
`(EHR) systems. I have worked with, studied, or been exposed to a variety of EMR
`
`and EHR systems—including at LDS Hospital in Salt Lake City, Utah, Duke
`
`University, Indiana University Medical Center, and Massachusetts General
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`Page 4 of 55
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`Hospital. I have also served as faculty advisor to many Masters and Ph.D. students
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`on projects or theses that included EMR systems and large database design.
`
`7.
`
`Over my career, I have designed and helped implement multimedia
`
`patient simulator systems, including those with EMR functionality. The EMR
`
`components of the simulators have included medical history, physician orders,
`
`pharmacy, laboratory, and progress notes.
`
`8. My EMR and EHR experience includes an ongoing project (2004 to
`
`present) to help develop and extend an enterprise-wide data warehouse. The data
`
`warehouse provides a central repository of EMR data from a variety of clinical and
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`administrative systems, including pharmacy, radiology, and ER. The system
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`provides tools for analytics, forecasting, and diagnostic support that enable
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`physicians to provide high quality, affordable health care in a timely fashion. My
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`work on the data warehouse project has been documented in three books.
`
`9.
`
`I also have extensive experience with computer hardware and
`
`software programming, especially as used and implemented in the medical
`
`industry. I have held a variety of posts in organizations that focus on the
`
`application of computing to the practice of medicine. For example, I have served
`
`as Chairman of the Mathematical Modeling & Simulation Committee for the
`
`Symposium on Computer Applications in Medical Care (SCAMC), Chairman of
`
`the SCAMC Human-Computer Interfacing Committee. I was also Chairman of the
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`Page 5 of 55
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`Healthcare Information and Management Systems Society (HIMSS) Conference
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`on Innovative Informatics for Reducing Medical Errors, which included a
`
`discussion on controlling patient injury through pharmaceutical intervention. For a
`
`more comprehensive list of my affiliations, please see my curriculum vitae.
`
`10.
`
`I have also served on fourteen editorial boards for various publications
`
`related to medical informatics, including e.MD (Founding Editor-in-Chief),
`
`Physicians Home Page, Healthstream, Medical Software Reviews,
`
`WebMD/Medscape Tech Med, and Healthcare Informatics. For a more
`
`comprehensive list of my editorial experience, please see my curriculum vitae.
`
`11.
`
`I am also a frequent contributor to the field of medical informatics. I
`
`am the sole or primary author on over 24 books and over 500 articles, most of
`
`which deal with medical informatics and computer technology. I have given
`
`hundreds of lectures and courses on topics regarding computer technology,
`
`computer-assisted training, medical informatics, clinical database issues, and
`
`emerging technologies in healthcare. For a more comprehensive list of my
`
`publications and invited lectures, please see my curriculum vitae.
`
`II. MATERIALS CONSIDERED
`
`12.
`
`I have reviewed Amneal Pharmaceuticals LLC and Par
`
`Pharmaceutical, Inc.’s (“Petitioners”) IPR petition concerning the ’730 patent. I
`
`have also reviewed the declaration submitted by Robert J. Valuck, Ph.D., R.Ph in
`
`Page 6 of 55
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`
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`support of Petitioners’ IPR petition (Ex. 1007), as well as the ACA materials cited
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`in the Petition and Dr. Valuck’s declaration (Exs. 1003-1006). Additional
`
`materials considered in connection with this declaration are set forth in Exhibit 2.
`
`III. LEGAL STANDARDS
`
`13.
`
`I have been informed by counsel of the following legal standards. I
`
`set forth my opinions in the context of my understanding of these standards.
`
`14.
`
`I have been informed by counsel that a patent claim may be invalid
`
`under 35 U.S.C. § 103 if the claim, when considered as a whole, would have been
`
`obvious to a person of ordinary skill (“POSA”) as of the date of the claimed
`
`invention. For the purposes of the obviousness analysis in this report, I have been
`
`asked to use December 17, 2002 as the date of invention.
`
`15.
`
`I have been informed by counsel that this analysis is objective, and
`
`requires consideration of: (1) the scope and content of the prior art; (2) the
`
`differences between the prior art and the claims at issue; (3) the level of ordinary
`
`skill; and (4) secondary considerations of nonobviousness.
`
`16.
`
`I have been informed by counsel that the prior art must be considered
`
`as a whole, including disclosures that would have taught a POSA away from the
`
`claimed invention. I also understand that the prior art must be viewed from the
`
`perspective of a POSA as of the date of the invention and that it is impermissible to
`
`view the prior art with the benefit of hindsight provided by the claimed invention.
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`Page 7 of 55
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`17.
`
`I understand that for a claim to be obvious, there must be some
`
`teaching or suggestion in one or more prior art references of each and every
`
`element of the claim.
`
`18.
`
`I have also been informed by counsel that a patent claim that has
`
`several elements is not proved obvious merely by demonstrating that each of its
`
`individual elements was individually known in the prior art. Instead, I understand
`
`that in order to prove obviousness, there must be a showing that a POSA, as of the
`
`date of the invention, would have had a reason or motivation to combine two or
`
`more references or to modify a reference to achieve the claimed invention as a
`
`whole. I understand that common sense and the general knowledge of a POSA can
`
`be relied on to identify a reason why a POSA would have combined or modified
`
`prior art references to come up with the claimed invention as a whole. I also
`
`understand, however, that the mere recitation of the words “common sense,” with
`
`no explanation or reasoning, is insufficient to show a motivation to combine or
`
`modify prior art references. I further understand that if the prior art teaches away
`
`from the combination or modification that is relied on, then that indicates non-
`
`obviousness.
`
`19.
`
`I have also been informed by counsel that to prove obviousness, one
`
`must show that a POSA would have had a reasonable expectation of success in
`
`making the claimed inventions from the combination or modification of the prior
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`Page 8 of 55
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`art. I understand that an invention is not obvious if it is more than the combination
`
`of well-known components/elements to achieve an expected outcome.
`
`IV. THE CHALLENGED PATENT AND THE RELEVANT
`PERSON OF ORDINARY SKILL IN THE ART
`
`20.
`
`I understand that Petitioners have challenged the ’730 patent in this
`
`IPR. I have reviewed the ’730 patent and its claims. See Ex. 1001. The ’730
`
`patent claims methods of preventing abuse, misuse, and diversion of prescription
`
`drugs, like GHB, by implementing various controls. See id. 1001 at 8:36-12:44;
`
`see also id. at Abstract, 1:41-45.
`
`21. The independent claims of the ’730 patent require:
`
`• (i) receiving in a computer processor, at an exclusive central
`
`pharmacy, all prescription requests of all patients being prescribed the
`
`prescription drug, with the prescription requests containing information
`
`identifying the patient and various credentials of the prescriber;
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`• (ii) entering the information into an exclusive computer database for
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`an analysis of potential abuse situations;
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`• (iii) checking the prescriber’s credentials to ensure he/she is eligible to
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`prescribe the drug;
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`• (iv) confirming with the patient that he/she has read educational
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`materials prior to shipping or providing the prescription drug;
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`• (v) checking with the exclusive computer database to determine any
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`Page 9 of 55
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`potential abuse by the patient and/or prescriber;
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`• (vi) mailing or providing the prescription drug to the patient only if
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`the information in the exclusive computer database is not indicative of
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`potential abuse or if no abuse is found by the patient and prescriber;
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`• (vii) confirming receipt by the patient of the prescription drug; and
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`• (viii) generating periodic reports with the exclusive computer database
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`to evaluate potential prescription drug diversion patterns.
`
`See id. at Claims 1, 2, and 7-11.
`
`22. The dependent claims add further limitations for preventing possible
`
`abuse, misuse, or diversion of pharmaceuticals, including GHB. Id. at Claims 3-6.
`
`23.
`
`I have been informed by counsel that Dr. Valuck offers three different
`
`POSAs: the first “POSA would hold a Bachelors or Doctor of Pharmacy degree
`
`and a license as a registered pharmacist with 3-5 years of relevant work
`
`experience” (Ex. 2044 at 38:20-25) (“Pharmacist POSA”); the second POSA
`
`would have “a computer science undergraduate degree or equivalent work
`
`experience and work experience relating to business applications, for example,
`
`including familiarity with drug distribution procedures” (id. at 39:8-21)
`
`(“Computer POSA”); and the third POSA would “have a blend of computer
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`science and pharmacy drug distribution knowledge and/or experience. For
`
`example, such a POSA may have computer science education qualifications and
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`Page 10 of 55
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`experience relating to computerized drug distribution systems” (id. at 40:22-41:1)
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`(“Blended POSA”). See also id. at 37:23-41:5; Ex. 1007 ¶ 20.
`
`24.
`
`In my opinion, Dr. Valuck’s three POSAs account for the fact that the
`
`’730 patent’s claims are directed to both pharmacy distribution elements and
`
`computer elements. See Ex. 1001 at claims. I have expertise as both a Computer
`
`POSA and a Blended POSA. See supra at ¶¶ 2-11. Although my expertise
`
`exceeds the level of ordinary skill, for the purposes of this declaration, I offer my
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`opinions from the vantage point of a Computer POSA and a Blended POSA. In
`
`this declaration, I address only those opinions relevant to these two POSAs. Any
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`reference to “POSA” herein should be understood to mean “Computer POSA” and
`
`“Blended POSA.”
`
`V. CLAIM CONSTRUCTION
`
`25.
`
`I have been informed by counsel that, in IPRs, claims are to be given
`
`their broadest reasonable interpretation in light of the patent’s specification.
`
`26.
`
`I have also been informed by counsel the tribunal in this IPR (the
`
`“Board”) issued a Decision in which it adopted preliminary claim constructions for
`
`the terms: (1) “exclusive central pharmacy” and “exclusive computer database”;
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`and (2)“generating with the computer processor periodic reports via the exclusive
`
`computer database to evaluate potential diversion patterns.” Paper 19 at 21-23. I
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`Page 11 of 55
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`have reviewed the portion of the Decision that addresses these claim constructions.
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`I address these terms below.
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`A.
`
`“exclusive central pharmacy” and “exclusive computer database”
`
`27. As stated above, I have been informed by counsel that the Board
`
`provided a preliminary construction for the terms “exclusive central pharmacy”
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`and “exclusive computer database.” Because the preliminary construction does not
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`affect my opinions, I do not address that construction in my declaration.
`
`B.
`
`“generating with the computer processor periodic
`reports via the exclusive computer database
`to evaluate potential diversion patterns”
`
`28.
`
`In the Decision, the Board defined “generating with the computer
`
`processor periodic reports via the exclusive computer database to evaluate
`
`potential diversion patterns” to mean “querying the exclusive computer database
`
`via the exclusive computer processor to generate periodic reports containing
`
`prescriber, patient, and/or prescription related information that permits evaluation
`
`of potential diversion, misuse, or abuse of a prescription drug.” Paper 19 at 23.
`
`29.
`
`I agree with the Board that the claim term requires “querying the
`
`exclusive computer database via the exclusive computer processor . . . [for]
`
`information that permits evaluation of potential diversion, misuse, or abuse of a
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`prescription drug.” In my opinion, this understanding is supported by the ’730
`
`patent’s disclosure of “reports obtained by querying a central database having the
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`Page 12 of 55
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`fields represented in Fig. 7.” Ex. 1001 at 8:22-24; see also id. at 8:27-28 (“The
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`reports are obtained by running queries against the database. . . .”). Indeed, the
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`fields in Fig. 7 contain the “prescriber, patient, and/or prescription related
`
`information” already included in the Board’s construction. See Ex. 1001 at Fig. 7;
`
`Paper 19 at 23.
`
`30.
`
`In my opinion, however, the claim term also requires that the reports
`
`to evaluate diversion be periodic reports. In other words, the claim term requires
`
`that the reports be generated on a periodic basis—specifically, at regular
`
`frequencies or intervals, as opposed to intermittently or upon request.
`
`31.
`
`I understand that Dr. Valuck testified at his deposition that reports to
`
`evaluate diversion can be generated on either “an ad hoc basis or on a regular
`
`basis.” Ex. 2044 at 184:8-16. A POSA would agree with Dr. Valuck. Computer
`
`reports can be generated either at set frequencies or intervals, or intermittently or
`
`upon request. In my opinion, a POSA would understand that “ad hoc” reports are
`
`generated in response to specific requests or prompts—for example, if requested
`
`by a federal or state agency to support an investigation. See, e.g., Ex. 1004 at 110
`
`(discussing generating ad hoc reports for diversion investigations “upon request”).
`
`In my opinion, a POSA would not equate “ad hoc” reports with periodic reports
`
`because “ad hoc” reports are not generated with any regular frequency. See also
`
`Ex. 2044 at 184:8-16.
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`Page 13 of 55
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`32. My understanding of periodic reports, and the distinction between
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`periodic reports and “ad hoc” reports, is supported by the ’730 patent’s
`
`specification. Specifically, the specification discloses Figs. 13A-C as “reports
`
`obtained by querying a central database having fields represented in Fig. 7.” Ex.
`
`1001 at 8:22-26; Figs. 13A-C. The specification makes clear that: “Each report
`
`has an associated frequency or frequencies.” Id. at 8:26-27 (emphasis added);
`
`See also id. at Figs. 13A-C (showing that reports regarding prescriber, patient,
`
`and/or prescription related information—that allow evaluations for potential
`
`diversion, misuse, and abuse—are run at regular frequencies or intervals, as
`
`opposed to intermittently or upon request). Id. These reports are periodic reports.
`
`33. The specification also discloses “ad hoc” reports. Specifically, Fig.
`
`4B describes “ad hoc” reports that are run only for the specific purpose of
`
`evaluating “possible product diversion, misuse or over-use” when a patient
`
`requests an early refill of the prescription drug. Ex. 1001 at 6:36-40; Fig. 4B. As
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`mentioned above, Dr. Valuck explained at his deposition that diversion reports can
`
`be generated on either “an ad hoc basis or on a regular basis.” Ex. 2044 at 184:8-
`
`16. In my opinion, a POSA would understand that the reports generated in Figure
`
`4B are “ad hoc” reports done for the particular purpose of investigating specific
`
`early refill requests, and not regular or “periodic” reports as set forth in the ’730
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`Page 14 of 55
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`patent claims. Indeed, the reports in Fig. 4B are generated only in response to
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`early refill requests. See Ex. 1001 at Fig. 4B.
`
`34. My opinion regarding the meaning of “periodic reports” is also
`
`supported by the plain and ordinary mean of the word periodic. Specifically,
`
`Merriam-Webster’s Collegiate Dictionary defines the word “periodic” as:
`
`
`
`Ex. 2043 at 3.
`
`35. Accordingly, it is my opinion that the phrase “generating with the
`
`computer processor periodic reports via the exclusive computer database to
`
`evaluate potential diversion patterns,” means: querying the exclusive computer
`
`database via the exclusive computer processor to generate, at regular frequencies
`
`or intervals, as opposed to intermittently or upon request, reports containing
`
`prescriber, patient, and/or prescription related information that permits evaluation
`
`of potential diversion, misuse, or abuse of a prescription drug.
`
`VI. A POSA WOULD NOT HAVE BEEN FAMILIAR WITH THE
`FEDERAL REGISTER AND WOULD NOT HAVE BEEN
`MOTIVATED TO LOOK TO THE FEDERAL REGISTER
`
`36. Dr. Valuck opines that “a POSA exercising reasonable diligence
`
`would have been able to locate the [ACA materials]” because “[n]otice of the
`
`Advisory Committee Meeting was posted in the Federal Register” and “the Federal
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`Page 15 of 55
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`Register also points a POSA to [an Internet address] where the ACA would be
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`publicly accessible before and after the meeting.” Ex. 1007 ¶ 47. I understand that
`
`Dr. Valuck also testified at his deposition, that it was only through the Federal
`
`Register notice that a POSA could locate the Internet address allegedly leading to
`
`the ACA materials. Ex. 2044 at 57:13-18 (Dr. Valuck testifying that he found the
`
`ACA materials by “search[ing] for the . . . website that was indicated in the Federal
`
`Register announcement”); 60:9-61:16 (Dr. Valuck testifying that he “can’t confirm
`
`without, again, going . . . to the Federal Register to verify which website [he] went
`
`to, which is where [he] then obtained all of . . . those materials that are included in
`
`[his] exhibits”). In my opinion, Dr. Valuck is wrong to rely on the Federal
`
`Register. In my opinion, a POSA would not have even been familiar with the
`
`Federal Register, let alone motivated to look to it.
`
`37.
`
`I understand that Dr. Valuck testified at his deposition that a POSA
`
`would have become familiar with the Federal Register:
`
`[E]ither in their education. If they’re a pharmacist, we teach them
`
`about it and expect them to learn how to use it. If they’re working in
`
`the practice setting, whether – as I mentioned, the POSA may come
`
`from – different aspects of a team but would find out about it and
`
`learn about it in those practice settings where it’s typical that a POSA
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`would – would have access to and see the Federal Register.
`
`Ex. 2045 at 293:24-294:11. I disagree.
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`Page 16 of 55
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`38.
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`In my opinion, neither a Computer POSA nor a Blended POSA would
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`have been familiar with the Federal Register. Further, neither a Computer POSA
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`nor a Blended POSA would have been motivated to look to the Federal Register or
`
`Advisory Committee Meetings for guidance on how to develop systems to control
`
`access to drugs subject to abuse, misuse, or diversion. I am not familiar with the
`
`Federal Register and never had any cause to use it.
`
`VII. THE ACA MATERIALS WOULD NOT HAVE DISCLOSED,
`TAUGHT, OR SUGGESTED “GENERATING WITH THE
`COMPUTER PROCESSOR PERIODIC REPORTS VIA THE
`EXCLUSIVE COMPUTER DATABASE TO EVALUATE
`POTENTIAL DIVERSION PATTERNS”2
`
`39. As discussed above, a POSA would understand this claim term to
`
`mean: querying the exclusive computer database via the exclusive computer
`
`processor to generate, at regular frequencies or intervals, as opposed to
`
`intermittently or upon request, reports containing prescriber, patient, and/or
`
`prescription related information that permits evaluation of potential diversion,
`
`misuse, or abuse of a prescription drug. See supra at ¶¶ 28-35. For this claim term
`
`to be met, the ACA materials must disclose that the reports to evaluate diversion be
`
`generated: (1) on a periodic basis, i.e., at regular frequencies or intervals, as
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`2 This limitation appears in claims 1-10 of the ’730 patent.
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`Page 17 of 55
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`
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`opposed to intermittently or upon request; and (2) by querying the exclusive
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`computer database.
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`40. Dr. Valuck opines that the ACA materials disclose “generating with
`
`the computer processor periodic reports via the exclusive computer database to
`
`evaluate potential diversion patterns.” See Ex. 1007 ¶¶ 79-83. I disagree.
`
`Specifically, Dr. Valuck fails to show that both of the requirements of the claim
`
`term (set forth above) are met.
`
`41. First, Dr. Valuck opines that “the [ACA] describes using the central
`
`data repository to identify patterns of abuse and diversion.” Ex. 1007 ¶ 81 (citing
`
`Ex. 1003 at 184:24-185:7, Slides at 158; Ex. 1005 at 306, 307, 311). A POSA
`
`reviewing the cited disclosures would have understood, however, that the ACA
`
`materials’ disclosures of the specific information available in the “central data
`
`repository,” do not disclose, teach, or suggest running queries on that data to
`
`generate any types of reports, much less periodic reports. See Ex. 1003 at 184:24-
`
`185:7, Slides at 158; Ex. 1005 at 306, 307, 311.
`
`42. Second, Dr. Valuck opines that “the [ACA] discloses preventing
`
`diversion and illicit use, as well as providing assistance to ‘law enforcement for
`
`investigation and prosecution efforts,’ as a goal of its distribution system.” Ex.
`
`1007 ¶ 81 (citing Ex. 1003 at 15:6-8; Ex. 1004 at 110; Ex. 1005 at 298, 301, 306-
`
`308). Dr. Valuck also opines that “[f]rom the prescription information entered into
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`Page 18 of 55
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`
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`the database, the database can be queried to provide information such as
`
`‘[p]rescriptions by physician specialty . . . by patient name . . by volume
`
`(frequency) . . . [and] by dose.” Ex. 1007 ¶ 82 (citing Ex. 1004 at 110). Dr.
`
`Valuck further opines that “[a] POSA would have appreciated that such data
`
`generation and querying via the central data repository is equivalent to the claimed
`
`generating periodic reports via the exclusive computer database to evaluate
`
`potential diversion patterns using a computer.” See Ex. 1007 ¶¶ 82-83 (citing Ex.
`
`1006 at 10 n.42; V5 00:10-00:27, V13 00:17-00:31; Ex. 1003 at 24:21-24; Ex.
`
`1005, cover letter at 1.1).
`
`43. A POSA reviewing these above-cited disclosures would have
`
`understood, however, that they do not disclose, teach, or suggest generating
`
`periodic reports. See Ex. 1003 at 15:6-8, 24:21-24; Ex. 1004 at 110; Ex. 1005 at
`
`cover letter, 1.1, 298, 301, 306-308; Ex. 1006 at 10 n.42; V5 00:10-00:27, V13
`
`00:17-00:31. Rather, the evidence cited discloses that “[t]he database will be made
`
`available for review by the DEA as well as other federal and state agencies upon
`
`request.” Ex. 1004 at 110 (emphasis added). In my opinion, a POSA would have
`
`understood the DEA reviews are “ad hoc” and “upon request” as opposed to
`
`“periodic.” See Ex. 1004 at 110.
`
`44. Third, Dr. Valuck opines that “the [ACA] discloses generating data by
`
`‘recording prescribers, patients, and dosing that could provide information for any
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`Page 19 of 55
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`
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`possible investigations and prosecutions for state and federal authorities’ using a
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`computer.” Ex. 1007 ¶ 82 (citing Ex. 1006 at 4 n.13-14; V5 00:10-00:27). Dr.
`
`Valuck also opines that the ACA discloses that “[a]ll data collected will be
`
`available to state and federal authorities, on whatever timeframe they determine to
`
`be appropriate,” and that “[a] POSA would immediately appreciate that the
`
`‘timeframe’ referred to implies a periodic reporting.” Ex. 1007 ¶ 82 (citing Ex.
`
`1005 at 307). I disagree with Dr. Valuck’s understanding of “timeframe.”
`
`45. Based on the ACA disclosures, it is my opinion that a POSA would
`
`have understood that “[g]enerating data . . . for any possible investigations and
`
`prosecutions” is not the same as generating periodic reports. In my opinion, the
`
`ACA’s full disclosure teaches a POSA that any reports generated for state or
`
`federal agencies are done so “upon request” to assist the authorities with an
`
`investigation for diversion “should one become necessary,” and that cases of
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`diversion are expected to be “rare.” (Ex. 1004 at 110; Ex. 1005 at 306 (“Available
`
`data … will assist appropriate authorities in an investigation, should one become
`
`necessary. The centralized, real-time nature of these data will allow for rapid
`
`identification in the rare case of diversion.”) (emphasis added). Thus, it is my
`
`opinion that the ACA materials only disclose generating retrospective “ad hoc”
`
`reports to aid in diversion investigations once those investigations have already
`
`been initiated. The ACA materials would not have disclosed, taught, or suggested
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`Page 20 of 55
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`
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`the claimed prospective periodic reports that will aid the central pharmacy in
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`evaluating potential diversion patterns.
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`46. Moreover, Dr. Valuck does not offer any cites to support his opinion
`
`that the “timeframe” referenced in Ex. 1005 at 307 “implies a periodic reporting.”
`
`See Ex. 1007 ¶ 82. Based on the ACA materials’ disclosures, it is my opinion that
`
`a POSA would have understood the “timeframe” referenced in Ex. 1005 at 307 to
`
`be referring to the statement in Ex. 1005 at 306 that the centralized data “allow[s]
`
`for rapid identification in the rare case of diversion.” Ex. 1005 at 306 (emphasis
`
`added). In other words, “timeframe” means how long it takes the pharmacy to run
`
`a query and compile data.
`
`47. Specifically, it is my opinion that a POSA would have understood that
`
`the disclosure of generating data on whatever “timeframe [the authorities]
`
`determine to be appropriate” emphasizes the benefit of centralized data being
`
`available in real-time, which is that potential investigations will be able to proceed
`
`without delay from the pharmacy. In my opinion, the “timeframe” is contingent on
`
`a particular request—specifically, the timeframe refers to how long it will take the
`
`pharmacy to generate the data in response to a request. In my opinion,
`
`“timeframe” is not equivalent to periodic reporting.
`
`48.
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`In addition to disagreeing with Dr. Valuck’s opinions, I also disagree
`
`that the Board was correct in relying on Ex. 1005 at 306 in reaching its preliminary
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`Page 21 of 55
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`
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`conclusion that the ACA materials disclose “generating with the computer
`
`processor periodic reports via the exclusive computer database to evaluate
`
`potential diversion patterns.”
`
`49. Specifically, the Board stated “[p]age 306 of the Briefing Booklet
`
`states ‘database checks (AMA, NPD and State Medical Boards available on-line)
`
`will periodically occur to ensure that physician eligibility has not changed.’” Paper
`
`19 at 35. In my opinion, however, this disclosure expressly teaches a POSA that
`
`the AMA, NPD, and State Medical Board online databases are external databases,
`
`not the exclusive computer database. Dr. Valuck agrees with my opinion. See
`
`Ex. 1007 ¶ 68 (Dr. Valuck referencing Ex. 1005 at 306 and noting that the ACA
`
`discloses “utilizing the external DEA[] . . . database, as well as other external on-
`
`line databases”) (emphasis added). Because the claim term requires that the
`
`periodic reports are generated by “querying the exclusive computer database,” not
`
`external databases (Paper 19 at 23 (emphasis added)), it is my opinion that the
`
`cited disclosure in Ex. 1005 at 306 does not disclose the claimed periodic report.
`
`50.
`
`In my opinion, a POSA also would not have been motivated to
`
`substitute the exclusive computer database for the disclosed external databases.
`
`The ACA materials disclose that the external database checks are performed to
`
`provide the central pharmacy with consistently updated information about the
`
`physicians’ licenses and disciplinary records that the exclusive computer database
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`Page 22 of 55
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`does not have access to until the external database checks are performed. Ex. 1005
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`at 306. Indeed, the ACA materials disclose to a POSA that the entire purpose of
`
`checking the external databases “periodically” is “to ensure that physician
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`eligibility has not changed.” Id.
`
`51. Accordingly, it is my opinion that the ACA materials would not have
`
`disclosed, taught, or suggested “generating with the computer processor periodic
`
`reports via the exclusive computer database to evaluate potential diversion
`
`patterns.”
`
`VIII. SUPPLEMENTAL OR AMENDED OPINIONS
`
`52.
`
`I reserve t
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