UNITED STATES PATENT AND TRADEMARK OFFICE
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`________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`________________
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`AMNEAL PHARMACEUTICALS LLC and PAR PHARMACEUTICAL, INC.
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`Petitioners,
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`v.
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`JAZZ PHARMACEUTICALS, INC.
`
`Patent Owner
`
`________________
`
`Case IPR2015-01903
`Patent 8,731,963
`________________
`
`DECLARATION OF BRYAN BERGERON, MD, FACMI
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`
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`
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`
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`JAZZ EXHIBIT 2006
`Amneal Pharms. et al. (Petitioners) v. Jazz Pharms., Inc. (Patent Owner)
`Case IPR2015-01903
`
`Page 1 of 55
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`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`AMNEAL PHARMACEUTICALS LLC and PAR PHARMACEUTICAL, INC.
`
`Petitioners,
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.
`
`Patent Owner
`
`________________
`
`Case IPR2015-01903
`Patent 8,731,963
`________________
`
`DECLARATION OF BRYAN BERGERON, MD, FACMI
`
`
`
`
`
`
`
`JAZZ EXHIBIT 2006
`Amneal Pharms. et al. (Petitioners) v. Jazz Pharms., Inc. (Patent Owner)
`Case IPR2015-01903
`
`Page 1 of 55
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`TABLE OF CONTENTS
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`Page
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`I.
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`QUALIFICATIONS ............................................................................................................1
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`II.
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`MATERIALS CONSIDERED ............................................................................................4
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`III.
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`LEGAL STANDARDS .......................................................................................................5
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`IV.
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`THE CHALLENGED PATENT AND THE RELEVANT PERSON OF
`ORDINARY SKILL IN THE ART .....................................................................................7
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`V.
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`CLAIM CONSTRUCTION .................................................................................................8
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`VI.
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`THE ACA MATERIALS WOULD NOT HAVE DISCLOSED, TAUGHT, OR
`SUGGESTED THE LIMITATION IN CLAIM 27: “WHEREIN THE
`CURRENT PATTERN OR THE ANTICIPATED PATTERN [OF ABUSE] ARE
`IDENTIFIED USING PERIODIC REPORTS GENERATED FROM THE
`SINGLE COMPUTER DATABASE” ..............................................................................12
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`VII. A POSA WOULD NOT HAVE BEEN MOTIVATED TO COMBINE THE ACA
`WITH KORFHAGE TO ARRIVE AT THE CLAIMED “CENTRAL
`COMPUTER DATABASE BEING DISTRIBUTED OVER MULTIPLE
`COMPUTERS” ..................................................................................................................17
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`VIII. SUPPLEMENTAL OR AMENDED OPINIONS .............................................................21
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`I, Bryan Bergeron, MD, FACMI, hereby declare and state as follows:
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`1.
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`I submit this declaration on behalf of Jazz Pharmaceuticals, Inc.
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`(“Jazz”), Patent Owner of U.S. Patent No. 8,731,963 (the “’963 patent”) in
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`connection with this inter partes review (“IPR”), Case IPR2015-01903.
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`I.
`
`QUALIFICATIONS
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`2.
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`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
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`customers.
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`3.
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`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
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`my Doctor of Medicine (M.D.) degree from Louisiana State University Medical
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`Center in 1984.
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`4.
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` Following medical school, I was a post-doctoral research fellow in
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`medical informatics at Brigham & Women’s Hospital, a Harvard Medical School
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`teaching hospital. Medical informatics—also referred to as healthcare
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`informatics—is a discipline at the intersection of information science, computer
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`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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`medical environments. During the fellowship, I studied computer science at
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`Harvard University.
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`5.
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`Following my post-doctoral fellowship, I began working as an
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`instructor at Harvard Medical School, as well as an Assistant Director of the post-
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`doctoral fellowship program in medical informatics at Brigham & Women’s
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`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
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`Technology (“MIT”), the Harvard-MIT Division of Health Sciences and
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`Technology, and Massachusetts General Hospital Institute for Healthcare
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`Professionals. I have taught in the Harvard/MIT system for over 30 years,
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`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,
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`attached hereto as Exhibit 1.
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`6.
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`As a result of my academic and non-academic work, I have extensive
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`experience with Electronic Medical Record (EMR) and Electronic Health Record
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`(EHR) systems. I have worked with, studied, or been exposed to a variety of EMR
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`and EHR systems—including at LDS Hospital in Salt Lake City, Utah, Duke
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`University, Indiana University Medical Center, and Massachusetts General
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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.
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`7.
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`Over my career, I have designed and helped implement multimedia
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`patient simulator systems, including those with EMR functionality. The EMR
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`components of the simulators have included medical history, physician orders,
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`pharmacy, laboratory, and progress notes.
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`8. My EMR and EHR experience includes an ongoing project (2004 to
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`present) to help develop and extend an enterprise-wide data warehouse. The data
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`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.
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`9.
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`I also have extensive experience with computer hardware and
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`software programming, especially as used and implemented in the medical
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`industry. I have held a variety of posts in organizations that focus on the
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`application of computing to the practice of medicine. For example, I have served
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`as Chairman of the Mathematical Modeling & Simulation Committee for the
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`Symposium on Computer Applications in Medical Care (SCAMC), Chairman of
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`the SCAMC Human-Computer Interfacing Committee. I was also Chairman of the
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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
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`discussion on controlling patient injury through pharmaceutical intervention. For a
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`more comprehensive list of my affiliations, please see my curriculum vitae.
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`10.
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`I have also served on fourteen editorial boards for various publications
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`related to medical informatics, including e.MD (Founding Editor-in-Chief),
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`Physicians Home Page, Healthstream, Medical Software Reviews,
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`WebMD/Medscape Tech Med, and Healthcare Informatics. For a more
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`comprehensive list of my editorial experience, please see my curriculum vitae.
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`11.
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`I am also a frequent contributor to the field of medical informatics. I
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`am the sole or primary author on over 24 books and over 500 articles, most of
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`which deal with medical informatics and computer technology. I have given
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`hundreds of lectures and courses on topics regarding computer technology,
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`computer-assisted training, medical informatics, clinical database issues, and
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`emerging technologies in healthcare. For a more comprehensive list of my
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`publications and invited lectures, please see my curriculum vitae.
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`II. MATERIALS CONSIDERED
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`12.
`
`I have reviewed Amneal Pharmaceuticals LLC and Par
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`Pharmaceutical, Inc.’s (“Petitioners”) IPR petition concerning claims 24, 26, and
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`27 of the ’963 patent. I have also reviewed the declaration submitted by Robert J.
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`Valuck, Ph.D., R.Ph in support of the petition (Ex. 1007) concerning the same
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`claims, as well as the ACA materials and Korfhage reference cited in the Petition
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`and Dr. Valuck’s declaration. Additional materials considered in connection with
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`this declaration are set forth in Exhibit 2.
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`III. LEGAL STANDARDS
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`13.
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`I have been informed by counsel of the following legal standards. I
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`set forth my opinions in the context of my understanding of these standards.
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`14.
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`I have been informed by counsel that a patent claim may be invalid
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`under 35 U.S.C. § 103 if the claim, when considered as a whole, would have been
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`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
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`asked to use December 17, 2002 as the date of invention.
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`15.
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`I have been informed by counsel that this analysis is objective, and
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`requires consideration of: (1) the scope and content of the prior art; (2) the
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`differences between the prior art and the claims at issue; (3) the level of ordinary
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`skill; and (4) secondary considerations of nonobviousness.
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`16.
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`I have been informed by counsel that the prior art must be considered
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`as a whole, including disclosures that would have taught a POSA away from the
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`claimed invention. I also understand that the prior art must be viewed from the
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`perspective of a POSA as of the date of the invention and that it is impermissible to
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`view the prior art with the benefit of hindsight provided by the claimed invention.
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`17.
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`I understand that for a claim to be obvious, there must be some
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`teaching or suggestion in one or more prior art references of each and every
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`element of the claim.
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`18.
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`I have also been informed by counsel that a patent claim that has
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`several elements is not proved obvious merely by demonstrating that each of its
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`individual elements was individually known in the prior art. Instead, I understand
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`that in order to prove obviousness, there must be a showing that a POSA, as of the
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`date of the invention, would have had a reason or motivation to combine two or
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`more references or to modify a reference to achieve the claimed invention as a
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`whole. I understand that common sense and the general knowledge of a POSA can
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`be relied on to identify a reason why a POSA would have combined or modified
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`prior art references to come up with the claimed invention as a whole. I also
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`understand, however, that the mere recitation of the words “common sense,” with
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`no explanation or reasoning, is insufficient to show a motivation to combine or
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`modify prior art references. I further understand that if the prior art teaches away
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`from the combination or modification that is relied on, then that indicates non-
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`obviousness.
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`19.
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`I have also been informed by counsel that to prove obviousness, one
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`must show that a POSA would have had a reasonable expectation of success in
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`making the claimed inventions from the combination or modification of the prior
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`art. I understand that an invention is not obvious if it is more than the combination
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`of well-known components/elements to achieve an expected outcome.
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`IV. THE CHALLENGED PATENT AND THE RELEVANT
`PERSON OF ORDINARY SKILL IN THE ART
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`20.
`
`I understand that Petitioners have challenged the ’963 patent in this
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`IPR. I have reviewed the ’963 patent and the relevant claims. See Ex. 1001.
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`Claims 24, 26, and 27 of the ’963 patent claim computer-implemented systems for
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`treating a narcoleptic patient with a prescription drug that has a potential for
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`misuse, abuse, or diversion, while preventing that misuse, abuse, and diversion by
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`means of various controls. See id. 1001 at 11:7-12:10, 12:23-33; see also id. at
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`Abstract, 1:41-45.
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`21.
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`I have been informed by counsel that Dr. Valuck offers three different
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`POSAs: the first “POSA would hold a Bachelors or Doctor of Pharmacy degree
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`and a license as a registered pharmacist with 3-5 years of relevant work
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`experience” (Ex. 2007 at 38:20-25) (“Pharmacist POSA”); the second POSA
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`would have “a computer science undergraduate degree or equivalent work
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`experience and work experience relating to business applications, for example,
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`including familiarity with drug distribution procedures” (id. at 39:8-21)
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`(“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
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`example, such a POSA may have computer science education qualifications and
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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 ¶ 21.
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`22.
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`In my opinion, Dr. Valuck’s three POSAs account for the fact that
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`claims 24, 26, and 27 of the ’963 patent are directed to both pharmacy distribution
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`elements and computer elements. See Ex. 1001 at 11:7-12:10, 12:23-33. I have
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`expertise as both a Computer POSA and a Blended POSA. See supra at ¶¶ 2-11.
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`Although my expertise exceeds the level of ordinary skill, for the purposes of this
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`declaration, I offer my opinions from the vantage point of a Computer POSA and a
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`Blended POSA. In this declaration, I address only those opinions relevant to these
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`two POSAs. Any reference to “POSA” herein should be understood to mean
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`“Computer POSA” and “Blended POSA.”
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`V. CLAIM CONSTRUCTION
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`23.
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`I have been informed by counsel that, in IPRs, claims are to be given
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`their broadest reasonable interpretation in light of the patent’s specification.
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`24.
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`I have also been informed by counsel that the tribunal in this IPR (the
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`“Board”) determined that no claim terms require a construction in its Institution
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`Decision. See Paper 10 at 8.
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`25.
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`In my opinion, the phrase “wherein the current pattern or the
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`anticipated pattern [of abuse] are identified using periodic reports generated from
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`the single computer database” in claim 27 requires construction. Based on the
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`’963 patent’s specification, the phase should be construed to mean: querying the
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`single computer database to generate, at regular frequencies or intervals, as
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`opposed to intermittently or upon request, reports containing prescriber, patient,
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`and/or prescription related information to identify a current pattern or an
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`anticipated pattern of abuse of the prescription drug.
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`26. The ’963 patent’s specification discloses “reports obtained by
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`querying a central database having the fields represented in Fig. 7.” Ex. 1001 at
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`8:24-26; see also id. at 8:29-30 (“The reports are obtained by running queries
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`against the database. . . .”). The fields in Fig. 7 contain “prescriber, patient, and/or
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`prescription related information.” See Ex. 1001 at Fig. 7.
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`27.
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`I understand that Dr. Valuck testified at his deposition that reports to
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`evaluate abuse can be generated on either “an ad hoc basis or on a regular basis.”
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`Ex. 2007 at 184:8-16. A POSA would agree with Dr. Valuck. Computer reports
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`can be generated either at set frequencies or intervals, or intermittently or upon
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`request. In my opinion, a POSA would understand that “ad hoc” reports are
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`generated in response to specific requests or prompts—for example, if requested
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`by a federal or state agency to support an investigation. See, e.g., Ex. 1004 at 110
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`(discussing generating ad hoc reports for diversion investigations “upon request”).
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`In my opinion, a POSA would not equate “ad hoc” reports with periodic reports
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`because “ad hoc” reports are not generated with any regular frequency. See also
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`Ex. 2007 at 184:8-16. Here, the claims require the reports to be periodic. The
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`’963 patent shows the distinction between periodic reports and “ad hoc” reports.
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`28.
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` Specifically, the specification discloses Figs. 13A-C as “reports
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`obtained by querying a central database having fields represented in Fig. 7.” Ex.
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`1001 at 8:23-30; Figs. 13A-C. The specification makes clear that: “Each report
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`has an associated frequency or frequencies.” Id. at 8:28-29 (emphasis added);
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`see also id. at Figs. 13A-C (showing that reports regarding prescriber, patient,
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`and/or prescription related information—that allow evaluations for potential
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`diversion, misuse, and abuse—are run at regular frequencies or intervals, as
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`opposed to intermittently or upon request). Id. These reports are periodic reports.
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`29. The specification also discloses “ad hoc” reports. Specifically, Fig.
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`4B describes “ad hoc” reports that are run only for the specific purpose of
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`evaluating “possible product diversion, misuse or over-use” when a patient
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`requests an early refill of the prescription drug. Ex. 1001 at 6:40-44; Fig. 4B. As
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`mentioned above, Dr. Valuck explained at his deposition that reports used to
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`investigate abuse can be generated on either “an ad hoc basis or on a regular
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`basis.” Ex. 2007 at 184:8-16. In my opinion, a POSA would understand that the
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`reports generated in Figure 4B are “ad hoc” reports done for the particular purpose
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`of investigating specific early refill requests, and not regular or “periodic” reports
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`as set forth in the ’963 patent claims. Indeed, the reports in Fig. 4B are generated
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`only in response to early refill requests. See Ex. 1001 at Fig. 4B.
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`30. My opinion regarding the meaning of “periodic reports” is also
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`supported by the plain and ordinary mean of the word periodic. Specifically,
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`Merriam-Webster’s Collegiate Dictionary defines the word “periodic” as:
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`
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`Ex. 2010 at 3.
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`31. Accordingly, it is my opinion that the phrase “wherein the current
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`pattern or the anticipated pattern [of abuse] are identified using periodic reports
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`generated from the single computer database” means: querying the single
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`computer database to generate, at regular frequencies or intervals, as opposed to
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`intermittently or upon request, reports containing prescriber, patient, and/or
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`prescription related information to identify a current pattern or an anticipated
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`pattern of abuse of the prescription drug.
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`VI. THE ACA MATERIALS WOULD NOT HAVE DISCLOSED,
`TAUGHT, OR SUGGESTED THE LIMITATION IN CLAIM 27:
`“WHEREIN THE CURRENT PATTERN OR THE ANTICIPATED
`PATTERN [OF ABUSE] ARE IDENTIFIED USING PERIODIC
`REPORTS GENERATED FROM THE SINGLE COMPUTER
`DATABASE”
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`32. As discussed above, a POSA would understand this claim term to
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`mean: querying the single computer database to generate, at regular frequencies or
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`intervals, as opposed to intermittently or upon request, reports containing
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`prescriber, patient, and/or prescription related information to identify a current
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`pattern or an anticipated pattern of abuse of the prescription drug. See supra at ¶¶
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`25-31. For this claim term to be met, the ACA materials must disclose that the
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`reports to identify abuse are generated: (1) on a periodic basis, i.e., at regular
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`frequencies or intervals, as opposed to intermittently or upon request; and (2) by
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`querying the single computer database.
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`33. Dr. Valuck opines that the ACA materials teach the claim 27
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`limitation: “wherein the current pattern or the anticipated pattern [of abuse] are
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`identified using periodic reports generated from the single computer database.”
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`See Ex. 1007 ¶¶ 120-122. I disagree. Specifically, Dr. Valuck fails to show that
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`both of the requirements of the claim term (set forth above) are met.
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`34. First, Dr. Valuck opines that “the ACA discloses using the central
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`data repository to identify patterns of abuse and diversion.” Ex. 1007 ¶ 121 (citing
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`Ex. 1003 at 184:24-185:7, Slides at 158; Ex. 1005 at 304, 310, 311). A POSA
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`reviewing the cited disclosures would have understood, however, that the ACA
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`materials’ disclosures of the specific information available in the “central data
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`repository,” do not disclose, teach, or suggest running queries on that data to
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`generate any types of reports, much less periodic reports. See Ex. 1003 at 184:24-
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`185:7, Slides at 158; Ex. 1005 at 304, 310, 311.
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`35. Second, Dr. Valuck opines that “the ACA describes preventing
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`diversion and illicit use, as well as providing assistance to ‘law enforcement for
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`investigation and prosecution efforts,’ as a goal of the system.” Ex. 1007 ¶ 121
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`(citing Ex. 1003 at 15:6-8; Ex. 1004 at 110; Ex. 1005 at 298, 301, 306-308).
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`Dr. Valuck also opines that the central pharmacy “employs numerous mechanisms,
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`controls, and verification procedures to ensure that Xyrem is not obtained
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`fraudulently or abused or diverted by the patient or prescriber.” Ex. 1007 ¶ 120
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`(citing Ex. 1003 at 184:24-185:7, Slides at 158; Ex. 1004 at 110; Ex. 1005 at 304,
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`310, 311; Ex. 1006 at 4 n.14, 8 nn. 29, 33 and 9 n.38). Dr. Valuck further opines
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`that “[i]t would have been obvious to a POSA to recognize that for the database to
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`determine such abuse or patterns of abuse . . . that the database must be generating
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`periodic reports” and that a POSA “would have understood that such data
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`generation obtained through querying via the central data repository is
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`synonymous with generating periodic reports via the exclusive computer database
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`to evaluate potential diversion pattern claimed, using a computer.” See Ex. 1007
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`¶¶ 120, 122 (citing Ex. 1003 at 24:21-24; Ex. 1004 at 110, 115; Ex. 1005 at cover
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`letter, 304, 310, 311; Ex. 1006 at 4 n.14, 7 n.25, 8 nn.29, 33, 9 n.38, 10 nn.41-42;
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`V5 00:10-00:27, V13 00:17-00:31; Ex. 1003 at 24:21-24).
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`36. A POSA reviewing these above-cited disclosures would have
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`understood, however, that they do not disclose, teach, or suggest generating
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`periodic reports. See Ex. 1003 at 15:6-8, 24:21-24, 184:24-185:7, Slides at 158;
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`Ex. 1004 at 110, 115; Ex. 1005 at cover letter, 298, 301, 304, 306-308, 310, 311;
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`Ex. 1006 at 4 n.14, 7 n.25, 8 nn.29, 33, 9 n.38, 10 nn.41-42; V5 00:10-00:27, V13
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`00:17-00:31; Ex. 1003 at 24:21-24. Rather, the evidence cited discloses that “[t]he
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`database will be made available for review by the DEA as well as other federal and
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`state agencies upon request.” Ex. 1004 at 110 (emphasis added). In my opinion, a
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`POSA would have understood the DEA reviews are “ad hoc” and “upon request”
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`as opposed to “periodic.” See Ex. 1004 at 110.
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`37.
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`In addition, Dr. Valuck opines that “[t]he ACA discloses generating
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`data by ‘recording prescribers, patients, and dosing that could provide information
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`for any possible investigations and prosecutions for state and federal authorities’
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`using a computer.” Ex. 1007 ¶ 122 (citing Ex. 1006 at 4 nn.13-14; V5 00:10-
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`00:27). Dr. Valuck also opines that the ACA discloses that “[a]ll data collected
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`will be available to state and federal authorities, on whatever timeframe they
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`determine to be appropriate,” and implies that “timeframe” means periodic
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`reporting. Ex. 1007 ¶ 122 (citing Ex. 1005 at 307). I disagree with Dr. Valuck’s
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`understanding of “timeframe.”
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`38. Based on the ACA disclosures, it is my opinion that a POSA would
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`have understood that “[g]enerating data . . . for any possible investigations and
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`prosecutions” is not the same as generating periodic reports. In my opinion, the
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`ACA’s full disclosure teaches a POSA that any reports generated for state or
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`federal agencies are done so “upon request” to assist the authorities with an
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`investigation for abuse “should one become necessary,” and that cases of abuse are
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`expected to be “rare.” (Ex. 1004 at 110; Ex. 1005 at 306 (“Available data … will
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`assist appropriate authorities in an investigation, should one become necessary.
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`The centralized, real-time nature of these data will allow for rapid identification in
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`the rare case of diversion.”) (emphasis added). Thus, it is my opinion that the
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`ACA materials only disclose generating retrospective “ad hoc” reports to aid in
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`abuse investigations once those investigations have already been initiated. The
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`ACA materials would not have disclosed, taught, or suggested the claimed
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`prospective periodic reports that will aid the central pharmacy in identifying a
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`current pattern or an anticipated pattern of abuse of the prescription drug.
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`39. Moreover, Dr. Valuck does not offer any cites to support his opinion
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`that the “timeframe” referenced in Ex. 1005 at 307 implies a periodic reporting.
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`See Ex. 1007 ¶ 122. Based on the ACA materials’ disclosures, it is my opinion
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`that a POSA would have understood the “timeframe” referenced in Ex. 1005 at 307
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`to be referring to the statement in Ex. 1005 at 306 that the centralized data
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`“allow[s] for rapid identification in the rare case of diversion.” Ex. 1005 at 306
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`(emphasis added). In other words, “timeframe” means how long it takes the
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`pharmacy to run a query and compile data.
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`40. Specifically, it is my opinion that a POSA would have understood that
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`the disclosure of generating data on whatever “timeframe [the authorities]
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`determine to be appropriate” emphasizes the benefit of centralized data being
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`available in real-time, which is that potential investigations will be able to proceed
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`without delay from the pharmacy. In my opinion, the “timeframe” is contingent on
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`a particular request—specifically, the timeframe refers to how long it will take the
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`pharmacy to generate the data in response to a request. In my opinion,
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`“timeframe” is not equivalent to periodic reporting.
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`41. Accordingly, it is my opinion that the ACA materials would not have
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`disclosed, taught, or suggested the claims 27 limitation: “wherein the current
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`pattern or the anticipated pattern [of abuse] are identified using periodic reports
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`generated from the single computer database.”
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`Page 18 of 55
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`VII. A POSA WOULD NOT HAVE BEEN MOTIVATED TO COMBINE
`THE ACA WITH KORFHAGE TO ARRIVE AT THE CLAIMED
`“CENTRAL COMPUTER DATABASE BEING DISTRIBUTED
`OVER MULTIPLE COMPUTERS”
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`42. Dr. Valuck opines that for claims 24, 26, and 27, the requirement that
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`the “central computer database being distributed over multiple computers” would
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`have been obvious over the ACA materials in view of Korfhage. Ex. 1007 at ¶
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`144. I disagree.
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`43.
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`I have reviewed Dr. Valuck’s declaration and he does not identify
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`anything in the ACA materials that would have disclosed, taught, or suggested a
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`central computer database being distributed over multiple computers. See
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`generally Ex. 1007. In fact, he admits that this limitation does not appear in the
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`ACA materials. See id. ¶ 144. Instead, Dr. Valuck opines that a POSA would
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`have combined the ACA materials with Korfhage to arrive at the inventions of
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`claims 24, 26, and 27. Ex. 1007 ¶ 144. I disagree.
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`44.
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`In my opinion, unless a POSA started with the claimed inventions and
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`knew that they were looking for a distributed computer database architecture, a
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`POSA would not have had any reason to look to Korfhage, much less single out
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`the one page discussion of distributed computer database architectures.
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`45. Korfhage is a treatise on Information Storage and Retrieval within
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`computer systems. I have reviewed the 349 page treatise and nothing in it relates
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`to drug distribution or pharmacy practice. See generally Ex. 1037. Likewise,
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`nothing in Korfhage relates to drug abuse, misuse, or diversion. Id. Thus, nothing
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`in Korfhage relates to anything discussed in the ACA materials. In my opinion,
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`there is no way that a POSA would have happened upon Korfhage when
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`attempting to design a system for controlling access to dangerous pharmaceuticals,
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`while protecting against abuse, misuse, and diversion.
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`46. Dr. Valuck acknowledges that the “ACA discloses a central data
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`repository” and that queries can be performed on the central data repository. See
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`Ex. 1007 ¶ 138. Nonetheless, Dr. Valuck opines that “a POSA would have had
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`ample motivation to distribute the single database of the ACA among multiple
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`computers as taught by Korfhage to increase the efficiency of the distribution of
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`Xyrem.” Id. ¶ 144. I note, however, that earlier in his declaration, Dr. Valuck
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`opines that that the large number of prescription requests can be handled using a
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`“conventional computer,” and that the ACA materials disclose the use of such
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`conventional computer. Id. ¶ 72.
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`47.
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`In my opinion, a POSA would have understood, just as Dr. Valuck did
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`(see id.), that any computer database would sufficiently accommodate drug
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`distribution by the central pharmacy. Dr. Valuck has not identified any problem
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`with the centralized (non-distributed) database disclosed in the ACA materials that
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`would have provided a POSA with a reason to look for any other computer
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`database architecture to use in the system disclosed in the ACA materials, much
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`less the specific distributed computer database architecture discussed in Korfhage.
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`48. Further, a POSA would understand that there were many different
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`computer database architectures that could be employed to accommodate
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`efficiency. Indeed, I understand that Dr. Valuck testified repeatedly at his
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`deposition about the large number of computer database architectures and that they
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`were all available to a POSA. See Ex. 2008 at 286:11-17 (Dr. Valuck testifying
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`that Korfhage “would suggest a lot of possibilities”), 316:23-317:8 (Dr. Valuck
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`testifying that distributed database document systems are not the only database
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`architecture for handling documents for pharmacies), 317:12-14 (Dr. Valuck
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`testifying that Korfhage “covers a host of possibilities for systems”), 318:3-15 (Dr.
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`Valuck testifying that there are “various forms and different architectures for
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`accomplishing the same tasks in different ways”), 317:16-23 (Dr. Valuck testifying
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`that “all these different forms were . . . existing in the art and existing in practice
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`for many years in various systems and various permutations and forms”), 320:3-4
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`(Dr. Valuck testifying that “there are different architectures and [] a POSA would
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`know that”).
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`49.
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`In my opinion a POSA would have no reason to select the distributed
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`computer database architecture discussed in Korfhage, and Dr. Valuck has not
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`provided one.
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`50. Rather, in my opinion, Korfhage would have taught a POSA against
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`modifying the system disclosed in the ACA materials to include a distributed
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`computer database architecture. Specifically, Korfhage expressly discloses to a
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`POSA that “three major problems arise” when a user tries to “locat[e] and obtain[]
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`a document regardless of where it resides” by “accessing a single logical database
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`in response to a query, even when the system must consult multiple physical
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`databases.” Ex. 1037 at 276-77. In other words, Korfhage expressly discloses to a
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`POSA that “three major problems arise” when a user tries to have a single query
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`operate over multiple physical databases. See id.
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`51.
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`In my opinion, a POSA would have understood that the second “major
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`problem” expressly disclosed in Korfhage would have been particularly troubling
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`if it arose in connection with the distribution system disclosed in the ACA
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`materials. Specifically, Korfhage explains that “[t]he second problem is that of
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`data redundancy. Different databases may include copies of the same or equivalent
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`document.” Ex. 1037 at 276. Korfhage suggests that “eliminating the duplication
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`requires relatively little work,” but “in some instances the documents may be
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`sufficiently different to cause problems.” Id. Dr. Valuck explains elsewhere in his
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`declaration, and the ACA clearly discloses to a POSA, however, that one of the
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`“benefits of central data repository” is “identification of [d]uplicate prescriptions.”
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`Ex. 1007 at p. 43 (claim chart); see also Ex. 1003 at 184:24-185:7, Slide 158.
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`52.
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`In my opinion, the return of redundant data in a distribution system
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`for a drug prone to abuse, misuse, and diversion would create two competing
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