`
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`AMNEAL PHARMACEUTICALS LLC and PAR PHARMACEUTICAL, INC.
`
`Petitioner,
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.
`
`Patent Owner
`
`________________
`
`Case IPR2015-01903
`Patent 8,731,963
`________________
`
`DECLARATION OF JOSEPH T. DIPIRO, PHARM.D.
`
`
`
`
`
`
`
`JAZZ EXHIBIT 2005
`Amneal Pharms. et al. (Petitioners) v. Jazz Pharms., Inc. (Patent Owner)
`Case IPR2015-01903
`
`Page 1 of 54
`
`
`
`TABLE OF CONTENTS
`
`
`
`Page
`
`I.
`
`QUALIFICATIONS ............................................................................................................1
`
`II.
`
`MATERIALS CONSIDERED ............................................................................................2
`
`III.
`
`LEGAL STANDARDS .......................................................................................................3
`
`IV.
`
`BACKGROUND .................................................................................................................5
`
`V.
`
`PERSON OF ORDINARY SKILL IN THE ART ...............................................................6
`
`VI.
`
`CLAIM CONSTRUCTION .................................................................................................7
`
`VII. THE ACA MATERIALS DO NOT RENDER CLAIM 27 OF THE ’963
`PATENT OBVIOUS .........................................................................................................11
`
`VIII. SUPPLEMENTAL OR AMENDED OPINIONS .............................................................15
`
`
`
`
`
`Page 2 of 54
`
`
`
`
`
`I, Joseph T. DiPiro, Pharm.D, 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. 8,731,963 (the “’963 patent”) in
`
`connection with this inter partes review, Case IPR2015-01903.
`
`I.
`
`QUALIFICATIONS
`
`2.
`
`I have been a registered pharmacist for over 37 years. I am currently
`
`Dean and the Archie O. McCalley Chair and Professor at Virginia Commonwealth
`
`University School of Pharmacy.
`
`3.
`
`Prior to holding my current position, I was Executive Dean and
`
`Professor at South Carolina College of Pharmacy, the University of South
`
`Carolina, and the Medical University of South Carolina. Before that, I held
`
`various academic positions at the University of Georgia College of Pharmacy
`
`including Assistant Dean, Head of the Department of Clinical and Administrative
`
`Sciences, and Professor of Pharmacy. I also held various academic positions at the
`
`Medical College of Georgia, including Assistant Dean for Pharmacy Programs and
`
`Director of Surgical Research. A full description of my work history is provided in
`
`my curriculum vitae, a copy of which is attached hereto as Exhibit 1.
`
`4.
`
`I received a Bachelor of Science degree in pharmacy from the
`
`University of Connecticut in 1978, and a Doctorate in Pharmacy from the
`
`University of Kentucky, College of Pharmacy in 1981. While obtaining my
`
`
`
`Page 3 of 54
`
`
`
`
`
`
`
`
`
`
`
`doctorate degree, I spent three years of residency at the Albert B. Chandler
`
`Medical Center, Lexington, Kentucky. In 1990, I completed one year of
`
`postdoctoral research in clinical immunology at Johns Hopkins University. A full
`
`description of my formal education is provided in my curriculum vitae.
`
`5.
`
`I have given over 100 presentations in the field of pharmacy. I am the
`
`author or co-author of over 130 papers, over 25 book chapters, and 39 books in the
`
`field of pharmacy. I am also the author of numerous letters and book reviews
`
`concerning various aspects of pharmacy, which are described in my curriculum
`
`vitae.
`
`6.
`
`I was the editor of the American Journal of Pharmaceutical Education,
`
`which is the primary journal of pharmacy education in the U.S., from 2002 to
`
`2014. I am also the President-elect of the American Association of Colleges of
`
`Pharmacy.
`
`7.
`
`I am an expert in the practice of pharmacy, including the education
`
`and training of pharmacists.
`
`II. MATERIALS CONSIDERED
`
`8.
`
`I have reviewed Amneal Pharmaceuticals LLC and Par
`
`Pharmaceutical, Inc.’s (“Petitioners”) Petition for inter partes review regarding
`
`claims 24, 26, and 27 of the ’963 patent, as well as the supporting declaration of
`
`Robert J. Valuck, Ph.D., R.Ph. (Ex. 1007) regarding the same claims. I have also
`
`
`
`
`- 2 -
`
`
`
`Page 4 of 54
`
`
`
`
`
`
`
`
`
`
`
`reviewed the ACA materials (Exs. 1003-1006) cited in the Petition and
`
`Dr. Valuck’s declaration. A list of any additional materials that I have reviewed in
`
`connection with the preparation of this declaration is attached as Exhibit 2.
`
`III. LEGAL STANDARDS
`
`9.
`
`I have been advised by counsel for Jazz of the following legal
`
`standards and set forth my opinions in the context of my understanding of these
`
`standards.
`
`10.
`
`I understand 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.
`
`11.
`
`I understand that the obviousness 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.
`
`12.
`
`I understand 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
`
`
`
`
`- 3 -
`
`
`
`Page 5 of 54
`
`
`
`
`
`
`
`
`
`
`
`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.
`
`13.
`
`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.
`
`14.
`
`I also understand 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
`
`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.
`
`15.
`
`I also understand that to prove obviousness, one must show that a
`
`POSA would have had a reasonable expectation of success in making the claimed
`
`
`
`
`- 4 -
`
`
`
`Page 6 of 54
`
`
`
`
`
`
`
`
`
`
`
`inventions from the combination or modification of the prior 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. BACKGROUND
`
`16. Claims 24, 26, and 27 of the ’963 patent claim computer-implemented
`
`systems for treating a narcoleptic patient with a prescription drug that has a
`
`potential for misuse, abuse, or diversion, while preventing that misuse, abuse, and
`
`diversion by means of various controls. See id. 1001 at 11:7-12:10, 12:23-33; see
`
`also id. at Abstract, 1:41-45.
`
`17. The ’963 patent is listed in the U.S. Food and Drug Administration’s
`
`publication entitled, “Approved Drug Products with Therapeutic Equivalence
`
`Evaluations” (the “Orange Book”) for Jazz’s Xyrem® drug product. Ex. 2013.
`
`18. Xyrem is the only FDA-approved treatment for both cataplexy and
`
`excessive daytime sleepiness. Ex. 2001 at 1; Ex. 2002 at 1.
`
`19. Xyrem is also a unique drug product because its active ingredient is a
`
`sodium salt of gammahydroxybutryic acid (“GHB”). GHB has been legislatively
`
`defined as a “date rape” drug due to its illicit use in committing sexual assaults.
`
`Ex. 2003 at 1; Ex. 2004 at 3. As a result of its combination of benefits and risks,
`
`Xyrem is one of the few prescription drugs to be subject to a bifurcated schedule.
`
`In its approved form, Xyrem is a Schedule III drug. See Ex. 2003 at 2. All other
`
`
`
`
`- 5 -
`
`
`
`Page 7 of 54
`
`
`
`
`
`
`
`
`
`
`
`forms of GHB, however, are placed on Schedule I. See id. Schedule I is the
`
`DEA’s most stringent schedule, reserved for the most dangerous types of drugs,
`
`such as heroin.
`
`20. The FDA made clear that it would not approve Xyrem without an
`
`adequate method of restricting access to the drug that the FDA considered capable
`
`of ensuring that the benefit of Xyrem would outweigh the risks to patients and
`
`third parties. When the FDA approved Xyrem in 2002, it did so under a special
`
`regulation, 21 CFR § 314.520 (“Subpart H”), which allows the FDA to approve
`
`drugs that are shown to be effective but that can only be used safely under
`
`restricted conditions. Ex. 2001 at 1; Ex. 2002 at 1.
`
`21. The solution to the challenging requirement of having to develop a
`
`system that adequately protects individuals from potential abuse, misuse, and
`
`diversion of Xyrem, while still allowing patient’s access to Xyrem’s efficacious
`
`effects, is claimed in the ’963 patent, and other related patents owned by Jazz.
`
`V.
`
`PERSON OF ORDINARY SKILL IN THE ART
`
`22.
`
`I understand 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. 2007 at
`
`38:20-25) (the “Pharmacist POSA”); the second POSA would have “a computer
`
`science undergraduate degree or equivalent work experience and work experience
`
`
`
`
`- 6 -
`
`
`
`Page 8 of 54
`
`
`
`
`
`
`
`
`
`
`
`relating to business applications, for example, including familiarity with drug
`
`distribution procedures” (id. at 39:8-21) (the “Computer POSA”); and the third
`
`POSA would “have a blend of computer science and pharmacy drug distribution
`
`knowledge and/or experience. For example, such a POSA may have computer
`
`science education qualifications and experience relating to computerized drug
`
`distribution systems” (id. at 40:22-41:1) (the “Blended POSA”). See also id. at
`
`37:23-41:5; Ex. 1007 at ¶ 21.
`
`23. Although my experience exceeds the requirements, I offer my
`
`opinions from the viewpoint of a Pharmacist POSA. All references to “POSA”
`
`herein should be understood to mean “Pharmacist POSA.” I had at least the level
`
`of skill of a POSA as of the ’963 patent’s December 17, 2002 priority date.
`
`VI. CLAIM CONSTRUCTION
`
`24.
`
`I have been advised by counsel for Jazz that in this proceeding, claims
`
`are given their broadest reasonable interpretation in light of the patent’s
`
`specification.
`
`25.
`
`I understand that the Patent Trial and Appeal Board (the “Patent
`
`Board”) in this proceeding issued an Institution Decision in which it determined
`
`that no claim terms require express construction for the purposes of the Institution
`
`Decision. See Paper 10 at 8.
`
`
`
`
`- 7 -
`
`
`
`Page 9 of 54
`
`
`
`
`
`
`
`
`
`
`
`26.
`
`In my opinion, the phrase “wherein the current pattern or the
`
`anticipated pattern [of abuse] are identified using periodic reports generated from
`
`the single computer database” in claim 27 requires construction. Specifically,
`
`“wherein the current pattern or the anticipated pattern [of abuse] are identified
`
`using periodic reports generated from the single computer database” should be
`
`construed to mean: querying the single computer database to generate, at regular
`
`frequencies or intervals, as opposed to intermittently or upon request, reports
`
`containing prescriber, patient, and/or prescription related information to identify a
`
`current pattern or an anticipated pattern of abuse of the prescription drug.
`
`27.
`
`In my opinion, the ’963 patent describes “querying the exclusive
`
`computer database . . . [for] information that permits evaluation of potential
`
`diversion, misuse, or abuse of a prescription drug.” Specifically, the specification
`
`explains Figures 13A-C are “reports obtained by querying a central database
`
`having the fields represented in Fig. 7.” Ex. 1001 at 8:23-25; see also id. at 8:29-
`
`30 (“The reports are obtained by running queries against the database. . . .”). The
`
`fields in Fig. 7 contain “prescriber, patient, and/or prescription related
`
`information.” See Ex. 1001 at Fig. 7.
`
`28.
`
`In my opinion, a POSA would understand that reports to identify a
`
`current pattern or an anticipated pattern of abuse of the prescription drug can either
`
`be run at set intervals or frequencies, or intermittently or upon request. I
`
`
`
`
`- 8 -
`
`
`
`Page 10 of 54
`
`
`
`
`
`
`
`
`
`
`
`understand that Dr. Valuck testified at his deposition that reports to evaluate abuse
`
`can be generated on either “an ad hoc basis or on a regular basis.” Ex. 2007 at
`
`184:8-16. In my opinion, a POSA would understand that ad hoc reports are done
`
`for a particular purpose—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 investigations “upon request”). A POSA would not consider “ad hoc”
`
`reports to be “periodic” because they are not generated with any regular frequency.
`
`See also Ex. 2007 at 184:8-16.
`
`29. My opinions are supported by the ’963 patent’s specification. The
`
`’963 patent distinguishes between periodic reports (those that are run at set
`
`frequencies or intervals), and reports run intermittently or upon request for a
`
`specific purpose.
`
`30. Specifically, as stated above, the specification discloses Figs. 13A-C
`
`as “reports obtained by querying a central database having fields represented in
`
`Fig. 7.” Ex. 1001 at 8:23-25; Figs. 13A-C. The specification makes clear that:
`
`“Each report has an associated frequency or frequencies.” Id. at 8:28-29
`
`(emphasis added); See also id. at Figs. 13A-C (showing that reports regarding
`
`prescriber, patient, and/or prescription related information—that allow for
`
`identification of a current pattern or an anticipated pattern of abuse of the
`
`
`
`
`- 9 -
`
`
`
`Page 11 of 54
`
`
`
`
`
`
`
`
`
`
`
`prescription drug—are run at regular frequencies or intervals, as opposed to
`
`intermittently or upon request). Id.
`
`31. On the other hand, Fig. 4B of the specification describes ad hoc
`
`reports that are run only for the specific purpose of evaluating “possible product
`
`diversion, misuse” such as when a patient requests an early refill of the
`
`prescription drug. Ex. 1001 at 6:40-44; Fig. 4B. As mentioned above, Dr. Valuck
`
`explained at his deposition that reports to investigate abuse can be generated on
`
`either “an ad hoc basis or on a regular basis.” Ex. 2007 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 claim 27. Indeed, the
`
`reports in Fig. 4B are generated only in response to early refill requests. See Ex.
`
`1001 at Fig. 4B.
`
`32. Further, in my opinion, a POSA would understand that the plain and
`
`ordinary meaning of the word periodic supports an interpretation of “periodic
`
`reports” that requires set-frequency or set-interval reports. Specifically, Merriam-
`
`Webster’s Collegiate Dictionary defines the word “periodic” as:
`
`Ex. 2010 at 3.
`
`
`
`
`
`
`- 10 -
`
`
`
`Page 12 of 54
`
`
`
`
`
`
`
`
`
`
`
`33. Thus, it is my opinion that the phrase “wherein the current pattern or
`
`the anticipated pattern [of abuse] are identified using periodic reports generated
`
`from the single computer database” means: querying the single computer database
`
`to generate, at regular frequencies or intervals, as opposed to intermittently or upon
`
`request, reports containing prescriber, patient, and/or prescription related
`
`information to identify a current pattern or an anticipated pattern of abuse of the
`
`prescription drug.
`
`VII. THE ACA MATERIALS DO NOT RENDER
`CLAIM 27 OF THE ’963 PATENT OBVIOUS1
`
`34. Dr. Valuck opines that the ACA materials render claim 27 obvious. I
`
`disagree.
`
`35.
`
`In my opinion, the ACA materials would not have disclosed, taught,
`
`or suggested the claim limitation: “wherein the current pattern or the anticipated
`
`pattern [of abuse] are identified using periodic reports generated from the single
`
`computer database.”
`
`36. As discussed above, a POSA would understand this limitation to
`
`mean: querying the single computer database to generate, at regular frequencies or
`
`intervals, as opposed to intermittently or upon request, reports containing
`
`
`
`
`1 My opinions on nonobviousness are limited to claim 27. I have no opinions on
`
`the elements of claims 24 and 26.
`
`
`
`
`- 11 -
`
`
`
`Page 13 of 54
`
`
`
`
`
`
`
`
`
`
`
`prescriber, patient, and/or prescription related information to identify a current
`
`pattern or an anticipated pattern of abuse of the prescription drug. See supra at ¶¶
`
`26-33. Thus, for this limitation 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 opposed to intermittently or upon request; and
`
`(2) by querying the single computer database. Dr. Valuck’s cited evidence does
`
`not satisfy both of these requirements.
`
`37. Before addressing Dr. Valuck’s specific opinions regarding this claim
`
`element, however, I note that it is my opinion that the claim element requires the
`
`knowledge of both a Pharmacist POSA and a Computer POSA. In other words,
`
`the claim element requires the knowledge of a Blended POSA. My opinions below
`
`only address Dr. Valuck’s opinions relevant to the Pharmacist POSA. I understand
`
`that Bryan Bergeron, M.D. will be addressing Dr. Valuck’s opinions relevant to the
`
`Computer POSA and Blended POSA.
`
`38. Dr. Valuck opines that “[t]he ACA discloses generating data by
`
`‘recording prescribers, patients, and dosing that could provide information for any
`
`possible investigations and prosecutions for state and federal authorities’ using a
`
`computer.” Ex. 1007 at ¶ 122 (citing Ex. 1006 at 4 nn.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
`
`
`
`
`- 12 -
`
`
`
`Page 14 of 54
`
`
`
`
`
`
`
`
`
`
`
`appropriate.” Ex. 1007 at ¶ 122 (citing Ex. 1005 at 307). I understand that it is
`
`Dr. Valuck’s opinion that “timeframe” implies periodic reporting. I disagree with
`
`Dr. Valuck’s understanding of “timeframe.”
`
`39.
`
`In my opinion, based on the ACA disclosures, 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 information provided to state or federal
`
`agencies is done so “upon request” to assist the authorities with an investigation for
`
`abuse “should one become necessary,” and that cases of abuse 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 disclose, at most, generating retrospective reports to aid in specific
`
`investigations of abuse. The ACA materials do not disclose, teach, or suggest the
`
`claimed prospective periodic reports that will aid the central pharmacy in
`
`identifying a current pattern or an anticipated pattern of abuse of the prescription
`
`drug.
`
`40.
`
`In my opinion, the ACA materials disclose to a POSA that the
`
`pharmacy can only assist with an investigation once it becomes necessary and once
`
`
`
`
`- 13 -
`
`
`
`Page 15 of 54
`
`
`
`
`
`
`
`
`
`
`
`the investigation has already begun. Specifically, the ACA materials disclose that
`
`“[t]he practicalities of how prescriptions are filled in the U.S. do not allow for a
`
`specialty pharmacy to ‘police’ the practice of medicine.” Ex. 1005 at 307.
`
`Instead, “the current system used in the U.S. for managing the risks associated with
`
`controlled substances allows for appropriate stakeholders to police individual
`
`physician and patient behavior. The Xyrem system preserves this important
`
`feature.” Id.; see also id. (discussing how the pharmacy will cooperate with the
`
`appropriate stakeholders—“state and federal authorities, including State Medical
`
`Boards, DEA and FDA, in any investigation dealing with physician or patient
`
`behavior”).
`
`41. Further, Dr. Valuck does not offer any support for his opinion that the
`
`“timeframe” referenced in Ex. 1005 at 307 implies a periodic reporting. See Ex.
`
`1007 at ¶ 122. Based on the ACA materials’ disclosures, it is my opinion that a
`
`POSA would have understood that the “timeframe” referenced on page 307 of
`
`Ex. 1005 is similar to the statement on page 306 of Ex. 1005 that the centralized
`
`data “allow[s] for rapid identification in the rare case of diversion.” Ex. 1005 at
`
`306 (emphasis added). In other words, in my opinion, “timeframe” refers to how
`
`long it takes the pharmacy to generate data in response to a request for information.
`
`In my opinion, a POSA would have understood that the disclosure of generating
`
`data on whatever “timeframe [the authorities] determine to be appropriate”
`
`
`
`
`- 14 -
`
`
`
`Page 16 of 54
`
`
`
`
`
`
`
`
`
`
`
`signifies 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” mentioned in the ACA materials is relating to how
`
`long it takes the pharmacy to respond to an agency’s request for information, i.e.,
`
`how long it takes for a pharmacist to query the system when questioning the
`
`legitimacy of a prescription. It is not, in my opinion, an implication of periodic
`
`reporting.
`
`42. Accordingly, it is my opinion that the ACA materials would not have
`
`disclosed, taught, or suggested the claim limitation: “wherein the current pattern
`
`or the anticipated pattern [of abuse] are identified using periodic reports generated
`
`from the single computer database.”
`
`VIII. SUPPLEMENTAL OR AMENDED OPINIONS
`
`43.
`
`I reserve the right to supplement or amend my opinions in response to
`
`opinions expressed by Petitioners’ experts, or in light of any additional evidence,
`
`testimony, discovery, Patent Board order, or other information that may be
`
`provided to me after the date of this report.
`
`- 15 -
`
`
`
`
`
`
`
`
`Page 17 of 54
`
`
`
`
`
`
`
`
`
`
`
`Executed this 3rd day of June 2016. I declare under penalty of perjury
`
`that the foregoing is true and correct.
`
`
`
`
`
`_______________________________
`Joseph T. DiPiro, Pharm.D
`
`
`
`
`- 16 -
`
`
`
`Page 18 of 54
`
`
`
`Exhibit 1
`Exhibit 1
`
`
`
`
`
`Page 19 of 54
`
`
`Page 19 of 54
`
`
`
`Curriculum Vitae
`June 2016
`
`
`
`
`
`
`JOSEPH THOMAS DIPIRO
`
`School of Pharmacy
`Virginia Commonwealth University
`410 N. 12th Street, Suite 540K
`P.O. Box 980581
`Richmond, VA 23298
`
`804-828-3006
`
`jtdipiro@vcu.edu
`
`
`
`
`
`OFFICE:
`
`
`
`
`
`
`
`
`TEL:
`
`
`
`
`ACADEMIC RANK AND APPOINTMENTS
`
`July 2014 - present
`
`Dean and Archie O. McCalley Chair and Professor, School of Pharmacy, Virginia
`Commonwealth University
`
`
`June 2014
`
`
`2005 to 2014
`
`
`2005
`
`2001 to 2005
`
`
`
`
`
`
`
`
`
`Dean Emeritus, Medical University of South Carolina, South Carolina College of
`Pharmacy
`
`Executive Dean and Professor, South Carolina College of Pharmacy, the
`University of South Carolina and the Medical University of South Carolina
`
`Professor Emeritus, University of Georgia College of Pharmacy
`
`
`
`Assistant Dean for Pharmacy Programs, Medical College of Georgia School of
`Medicine, Augusta
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1998 to 2005
`
`Assistant Dean, University of Georgia College of Pharmacy
`
`1997 to 2005
`
`Head, Department of Clinical and Administrative Sciences
`University of Georgia College of Pharmacy
`
`1994 to 1997
`
`Head, Department of Pharmacy Practice
`University of Georgia College of Pharmacy
`
`1991 to 2005
`
`
`
`Professor of Pharmacy
`University of Georgia College of Pharmacy
`
`1990 to 2000
`
`Director, Surgical Research
`Medical College of Georgia
`
`1992 to 2005
`
`
`
`Clinical Professor of Surgery
`Medical College of Georgia
`
`1981 to 2005
`
`
`
`Consulting Clinical Pharmacist
`
`Page 20 of 54
`
`
`
`
`
`
`
`
`
`
`
`
`
`Department of Pharmacy
`Medical College of Georgia Hospital & Clinics
`
`1981 to 2000
`
`Research Investigator (WOC)
`Veterans Administration Medical Center
`Augusta, Georgia
`
`1986 to 1991
`
`Associate Professor of Pharmacy
`University of Georgia College of Pharmacy
`
`1986 to 1992
`
`Associate Clinical Professor of Surgery
`Medical College of Georgia
`
`1981 to 1986
`
`
`
`Assistant Professor of Pharmacy
`University of Georgia College of Pharmacy
`
`1982 to 1986
`
`
`
`Assistant Adjunct Professor of Surgery
`Medical College of Georgia
`
`
`LICENSE
`
`
`Pharmacist:
`
`Kentucky #8016
`
`Georgia #13683
`
`South Carolina #14,318 (inactive)
`
`
`
`EDUCATION
`
`
`
`
`Doctor of Pharmacy: University of Kentucky, College of Pharmacy under the Supervisory Committee of
`Ann B. Amerson, Pharm.D. (Chairman) and Thomas S. Foster, Pharm.D. completed in May, 1981.
`
`Bachelor of Science (Pharmacy, Honors College): University of Connecticut completed in June, 1978.
`(Magna Cum Laude)
`
`Notre Dame High School, West Haven, Connecticut (1969-1973)
`
`
`
`
`
`POSTGRADUATE EDUCATION AND TRAINING
`
`
`Pharmacy Residency: American Society of Hospital Pharmacists accredited, three year residency at the
`Albert B. Chandler Medical Center, Lexington, Kentucky, under the preceptorship of Paul F. Parker, M.S.,
`Sc.D. completed in June, 1981.
`
`Post-Doctoral Research Fellowship in Clinical Immunology: under direction of Dr. N. Franklin Adkinson,
`Division of Clinical Immunology, Johns Hopkins University, Baltimore, Maryland, July, 1989 to June, 1990.
`
`Management Development Program: Harvard University Graduate School of Education, June 1997.
`
`Certificate Course in Health Care Evaluation: Medical College of Georgia Center for Healthcare
`Improvement, September-December, 1999.
`
`Medical Informatics Certificate - Marine Biological Laboratory, Woods Hole, MA. Sponsored by the
`National Library of Medicine. Fall Course, October 2000.
`
`
`
`
`
`
`
`
`
`
`
`TEACHING EXPERIENCE
`
`
`University of Kentucky
`
`Page 21 of 54
`
`
`
`CURRICULUM VITAE
`JOSEPH T. DIPIRO
`
`
`
`Page 3
`
`Disease Processes and Advanced Pharmacotherapeutics (PHR 876)
`Clinical Orientation Clerkship for Senior Pharmacy Students (PHR 870)
`Medical Surgical Nursing Pharmacology (NUR 833)
`Anesthesiology Staff Conferences
`Pharmacy Teaching Rounds
`
`
`University of Georgia
`Undergraduate Pharmacy Clerkship (PHR 500)
`Advanced Therapeutics III (PHR 587, 588, 589)
`Doctor of Pharmacy Clerkship (PHR 572)
`Doctor of Pharmacy Project (PHR 577, 578, 579)
`Applied Pharmacokinetics (PHR 554)
`Medical Writing (PHR 521)
`Human Anatomy and Physiology (PHRM 3410)
`Pathophysiology (PHRM 3480)
`Disease Management (PHRM 4860)
`Pharmacotherapy (PHRM 5860, 5870)
`Pharmacy Skills Lab (PHRM 5150)
`
`Medical College of Georgia
`Basic Clerkship in Surgery (SUR 500)
`
`South Carolina College of Pharmacy
`
`Introduction to Pharmacy
`
`Residency Academic Preparation Program
`
`Academic Rotation, advanced pharmacy practice experience
`
`Virginia Commonwealth University
`
`Academic rotation, advanced pharmacy practice experience
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`AWARDS
`
`
`1979
`
`1981
`1992
`
`1998
`
`2001
`
`2002
`
`
`
`
`
`
`
`
`
`
`
`
`2004
`
`2004
`2007
`2010
`
`2010
`2013
`2014
`
`
`
`
`
`
`
`
`American Society of Hospital Pharmacists Research and Education Foundation
`Student Award
`Outstanding Resident Award, University of Kentucky Medical Center
`Named recipient of American Society of Hospital Pharmacists Research and Education
`Foundation Award for sustained contributions to the pharmacy literature.
`Named recipient of Russell R. Miller Award from the American College of Clinical
`Pharmacy for contributions to the literature of clinical pharmacy.
`Named recipient of Paul F. Parker Award from the University of Kentucky College of
`Pharmacy
`Selected as recipient of the Robert K. Chalmers Distinguished Pharmacy Educator Award
`from the American Association of Colleges of Pharmacy
`Received the Roland T. Lakey Award from Wayne State University in recognition of
`contributions to the profession of pharmacy and pharmaceutical education.
`Education Award from the American College of Clinical Pharmacy
`Named Phi Lambda Sigma National Leadership Award winner
`Received the Martin Luther King Diversity Award from the Intercollegiate Black History
`Consortium
`MUSC Excellence Leadership Award
`Selected as National Rho Chi Distinguished Lecturer
`Paul Parker Medal Award from the American College of Clinical Pharmacy in recognition
`
`Page 22 of 54
`
`
`
`CURRICULUM VITAE
`JOSEPH T. DIPIRO
`
`Page 4
`
`of outstanding and sustained contributions to improving or expanding the profession of
`pharmacy
`
`
`
`
`
`HONORS
`
`
`1975-1978
`1978
`
`1989
`
`1990
`
`1991
`
`
`1995
`1997
`1998
`1999
`2002
`2003
`
`2004
`
`2004
`2004
`
`2005
`2005
`2005
`2005
`2006
`2006
`2006
`2008
`2009
`2009
`2010
`
`2010
`2010
`2011
`2011
`
`2011
`
`2011
`2013
`
`2013
`
`2013
`2013
`2015
`
`2015
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`University of Connecticut Honors College
`Bachelor of Science, Magna Cum Laude (University of Connecticut)
`Elected as Fellow to American College of Clinical Pharmacy
`Elected to Board of Regents of American College of Clinical Pharmacy
`Awarded Pfeiffer Memorial Research Fellowship, American Foundation for
`Pharmaceutical Education
`Georgia Pharmacist Magazine dedication by 1995 graduating Pharm.D. class.
`Panoz Professor of Pharmacy (Endowed Professorship)
`Elected as Trustee, American College of Clinical Pharmacy Research Institute
`Ferguson Memorial Lecturer, University of North Carolina, School of Pharmacy
`Distinguished Alumnus of the University of Connecticut School of Pharmacy
`Selected as Rho Chi Lecturer by students at the University of Kentucky College of
`Pharmacy
`Walker Scholar by Auburn University, Harrison School of Pharmacy "in recognition of
`outstanding leadership in pharmacy.”
`Kremers Memorial Lecturer at the University of Wisconsin School of Pharmacy.
`Named the Robert G. Leonard Memorial Lecturer by the University of Texas
`College of Pharmacy and the Texas Society of Health-System Pharmacists.
`Rho Chi Lecturer. Mercer University, Southern School of Pharmacy
`Rho Chi Lecturer. University of South Carolina
`Phi Lambda Sigma Speaker. Medical University of South Carolina
`Elected to Phi Lambda Sigma
`Elected to National Academies of Practice in Pharmacy
`Named the Parpia Lecturer, Faculty of Pharmacy, University of British Columbia
`Commencement speaker, North Dakota State University College of Pharmacy
`Commencement speaker, University of Georgia College of Pharmacy
`James T. McCarty Phi Lambda Sigma Lecturer, University of Houston
`Albert Ebert Rho Chi Lecturer, University of Illinois-Chicago
`First Tennessee Chair of Excellence Distinguished Visiting Professor, University of
`Tennessee – Memphis
`Graduation speaker, University of Connecticut School of Pharmacy
`White Coat Ceremony speaker, Irma Rangel Texas A&M College of Pharmacy, Kingsville
`G. Van Greene Distinguished Lecturer, Mercer University, March 2011