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, PAR PHARMACEUTICAL, INC. and
`WOCKHARDT BIO AG,
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`Petitioners,
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`v.
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`JAZZ PHARMACEUTICALS, INC.
`
`Patent Owner
`
`________________
`
`Case IPR2015-005541
`Patent 7,668,730
`________________
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`
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`DECLARATION OF JOSEPH T. DIPIRO, PHARM.D.
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`
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`1 Case IPR2015-01818 has been joined with this proceeding.
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`Page 1 of 82
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`JAZZ EXHIBIT 2046
`Amneal Pharms. et al. (Petitioners) v. Jazz Pharms., Inc. (Patent Owner)
`Case IPR2015-00554
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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. MATERIALS CONSIDERED ........................................................................ 2
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`III. LEGAL STANDARDS ................................................................................... 3
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`IV. BACKGROUND ............................................................................................. 5
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`V.
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`PERSON OF ORDINARY SKILL IN THE ART .......................................... 7
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`VI. CLAIM CONSTRUCTION ............................................................................ 8
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`A.
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`B.
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`C.
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`D.
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`“exclusive central pharmacy” and “exclusive computer
`database”................................................................................................ 9
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`“generating with the computer processor periodic reports via
`the exclusive computer database to evaluate potential diversion
`patterns” ............................................................................................... 10
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`“the prescription requests [for GHB] containing information
`identifying patients” ............................................................................ 13
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`“the prescription requests [for GHB] containing information
`identifying . . . various credentials of the any and all [medical
`doctors/authorized prescribers]” ......................................................... 16
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`VII. A POSA WOULD NOT HAVE BEEN MOTIVATED TO LOOK
`TO THE FEDERAL REGISTER .................................................................. 19
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`VIII. THE ACA MATERIALS DO NOT RENDER CLAIMS 1-11 OF
`THE ’730 PATENT OBVIOUS .................................................................... 23
`
`The ACA materials would not have disclosed, taught, or
`suggested “prescription requests [for GHB] containing
`information identifying patients . . . and various credentials of
`the any and all [medical doctors/authorized prescribers] ................... 23
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`The ACA materials would not have disclosed, taught, or
`suggested “generating with the computer processor periodic
`
`A.
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`B.
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`reports via the exclusive computer database to evaluate
`potential diversion patterns” ................................................................ 29
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`C. A POSA would not have been motivated to modify the risk
`management system proposed by Orphan Medical to require
`“confirming with a patient that [GHB] educational material has
`been read prior to [shipping/providing the prescription
`drug/GHB],” instead of after shipping the prescription drug,
`with a reasonable expectation of success ............................................ 35
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`IX. SUPPLEMENTAL OR AMENDED OPINIONS ......................................... 42
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`I, Joseph T. DiPiro, Pharm.D, 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. 7,668,730 (the “’730 patent”) in
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`connection with this inter partes review, Case IPR2015-00554.
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`I.
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`QUALIFICATIONS
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`2.
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`I have been a registered pharmacist for 37 years. I am currently Dean
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`and the Archie O. McCalley Chair and Professor at Virginia Commonwealth
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`University School of Pharmacy.
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`3.
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`Prior to holding my current position, I was Executive Dean and
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`Professor at South Carolina College of Pharmacy, the University of South
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`Carolina, and the Medical University of South Carolina. Before that, I held
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`various academic positions at the University of Georgia College of Pharmacy
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`including Assistant Dean, Head of the Department of Clinical and Administrative
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`Sciences, and Professor of Pharmacy. I also held various academic positions at the
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`Medical College of Georgia, including Assistant Dean for Pharmacy Programs and
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`Director of Surgical Research. A full description of my work history is provided in
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`my curriculum vitae, a copy of which is attached hereto as Exhibit 1.
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`4.
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`I received a Bachelor of Science degree in pharmacy from the
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`University of Connecticut in 1978, and a Doctorate in Pharmacy from the
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`University of Kentucky, College of Pharmacy in 1981. While obtaining my
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`doctorate degree, I spent three years of residency at the Albert B. Chandler
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`Medical Center, Lexington, Kentucky. In 1990, I completed one year of
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`postdoctoral research in clinical immunology at Johns Hopkins University. A full
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`description of my formal education is provided in my curriculum vitae.
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`5.
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`I have given over 100 presentations in the field of pharmacy. I am the
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`author or co-author of over 130 papers, over 25 book chapters, and 39 books in the
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`field of pharmacy. I am also the author of numerous letters and book reviews
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`concerning various aspects of pharmacy, which are described in my curriculum
`
`vitae.
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`6.
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`I was the editor of the American Journal of Pharmaceutical Education,
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`which is the primary journal of pharmacy education in the U.S., from 2002 to
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`2014. I am also the President-elect of the American Association of Colleges of
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`Pharmacy.
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`7.
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`I am an expert in the practice of pharmacy, including the education
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`and training of pharmacists.
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`II. MATERIALS CONSIDERED
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`8.
`
`I have reviewed Amneal Pharmaceuticals LLC and Par
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`Pharmaceutical, Inc.’s (“Petitioners”) Petition for inter partes review regarding the
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`’730 patent, as well as the supporting declaration of Robert J. Valuck, Ph.D., R.Ph.
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`(Ex. 1007). I have also reviewed the ACA materials (Exs. 1003-1006) cited in the
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`Petition and Dr. Valuck’s declaration. A list of any additional materials that I have
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`reviewed in connection with the preparation of this declaration is attached as
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`Exhibit 2.
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`III. LEGAL STANDARDS
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`9.
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`I have been advised by counsel for Jazz of the following legal
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`standards and set forth my opinions in the context of my understanding of these
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`standards.
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`10.
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`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
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`ordinary skill (“POSA”) as of the date of the claimed invention. For the purposes
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`of the obviousness analysis in this report, I have been asked to use December 17,
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`2002 as the date of invention.
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`11.
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`I understand that the obviousness analysis is objective, and requires
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`consideration of: (1) the scope and content of the prior art; (2) the differences
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`between the prior art and the claims at issue; (3) the level of ordinary skill; and (4)
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`secondary considerations of nonobviousness.
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`12.
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`I understand that the prior art must be considered as a whole,
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`including disclosures that would have taught a POSA away from the claimed
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`invention. I also understand that the prior art must be viewed from the perspective
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`of a POSA as of the date of the invention and that it is impermissible to view the
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`prior art with the benefit of hindsight provided by the claimed invention.
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`13.
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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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`14.
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`I also understand that a patent claim that has several elements is not
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`proved obvious merely by demonstrating that each of its individual elements was
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`individually known in the prior art. Instead, I understand that in order to prove
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`obviousness, there must be a showing that a POSA, as of the date of the invention,
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`would have had a reason or motivation to combine two or more references or
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`modify a reference to achieve the claimed invention as a whole. I understand that
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`common sense and the general knowledge of a POSA can be relied on to identify a
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`reason why a POSA would have combined or modified prior art references to come
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`up with the claimed invention as a whole. I also understand, however, that the
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`mere recitation of the words “common sense,” with no explanation or reasoning, is
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`insufficient to show a motivation to combine or modify prior art references. I
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`further understand that if the prior art teaches away from the combination or
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`modification that is relied on, then that indicates non-obviousness.
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`15.
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`I also understand that to prove obviousness, one must show that a
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`POSA would have had a reasonable expectation of success in making the claimed
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`inventions from the combination or modification of the prior art. I understand that
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`an invention is not obvious if it is more than the combination of well-known
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`components/elements to achieve an expected outcome.
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`IV. BACKGROUND
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`16. The ’730 patent recites and claims methods of preventing abuse,
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`misuse, and diversion of prescription drugs, such as GHB, by means of various
`
`controls. See Ex. 1001 at 8:36-12:44; see also id. at Abstract, 1:41-45.
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`17. More specifically, the independent claims of the ’730 patent claim
`
`methods of:
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`• (i) receiving in a computer processor, at an exclusive central
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`pharmacy, all prescription requests of all patients being prescribed the
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`prescription drug, with the prescription requests containing information
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`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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`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.
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`See id. at Claims 1, 2, and 7-11.
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`18. The dependent claims add limitations for further preventing any
`
`possible abuse, misuse, or diversion of pharmaceuticals, including GHB. Id. at
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`Claims 3-6.
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`19. The ’730 patent is listed in the U.S. Food and Drug Administration’s
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`publication entitled, “Approved Drug Products with Therapeutic Equivalence
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`Evaluations” (the “Orange Book”) for Jazz’s Xyrem® drug product. Ex. 2051.
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`20. Xyrem is the only FDA-approved treatment for both cataplexy and
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`excessive daytime sleepiness. Ex. 2013 at 1; Ex. 2014 at 1.
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`21. Xyrem is also a unique drug product because its active ingredient is a
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`sodium salt of gammahydroxybutryic acid (“GHB”). GHB has been legislatively
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`defined as a “date rape” drug due to its illicit use in committing sexual assaults.
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`Ex. 2011 at 1; Ex. 2012 at 3. As a result of its combination of benefits and risks,
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`Xyrem is one of the few prescription drugs to be subject to a bifurcated schedule.
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`In its approved form, Xyrem is a Schedule III drug. See Ex. 2011 at 2. All other
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`forms of GHB, however, are placed on Schedule I. See id. Schedule I is the
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`DEA’s most stringent schedule, reserved for the most dangerous types of drugs,
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`such as heroin.
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`22. The FDA made clear that it would not approve Xyrem without an
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`adequate method of restricting access to the drug that the FDA considered capable
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`of ensuring that the benefit of Xyrem would outweigh the risks to patients and
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`third parties. When the FDA approved Xyrem in 2002, it did so under a special
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`regulation, 21 CFR § 314.520 (“Subpart H”), which allows the FDA to approve
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`drugs that are shown to be effective but that can only be used safely under
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`restricted conditions. Ex. 2013 at 1; Ex. 2014.
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`23. The solution to the challenging requirement of having to develop an
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`system that adequately protects individuals from potential abuse, misuse, and
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`diversion of Xyrem, while still allowing patient’s access to Xyrem’s efficacious
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`effects, is claimed in the ’730 patent, and other related patents owned by Jazz.
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`V.
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`PERSON OF ORDINARY SKILL IN THE ART
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`24.
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`I understand that Dr. Valuck offers three different POSAs: the first
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`“POSA would hold a Bachelors or Doctor of Pharmacy degree and a license as a
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`registered pharmacist with 3-5 years of relevant work experience” (Ex. 2044 at
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`38:20-25) (the “Pharmacist POSA”); the second POSA would have “a computer
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`science undergraduate degree or equivalent work experience and work experience
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`relating to business applications, for example, including familiarity with drug
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`distribution procedures” (id. at 39:8-21) (the “Computer POSA”); and the third
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`POSA would “have a blend of computer science and pharmacy drug distribution
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`knowledge and/or experience. For example, such a POSA may have computer
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`science education qualifications and experience relating to computerized drug
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`distribution systems” (id. at 40:22-41:1) (the “Blended POSA”). See also id. at
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`37:23-41:5; Ex. 1007 at ¶ 20.
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`25. Although my experience exceeds the requirements, I offer my
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`opinions from the viewpoint of a Pharmacist POSA. All references to “POSA”
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`herein should be understood to mean “Pharmacist POSA.” I had at least the level
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`of skill of a POSA as of the ’730 patent’s December 17, 2002 priority date.
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`VI. CLAIM CONSTRUCTION
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`26.
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`I have been advised by counsel for Jazz that in this proceeding, claims
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`are given their broadest reasonable interpretation in light of the patent’s
`
`specification.
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`27.
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`I understand that the Patent Trial and Appeal Board (the “Patent
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`Board”) in this proceeding issued a Decision in which it adopted preliminary claim
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`constructions for the terms: (1) “exclusive central pharmacy” and “exclusive
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`computer database”; and (2)“generating with the computer processor periodic
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`reports via the exclusive computer database to evaluate potential diversion
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`patterns.” Paper 19 at 21-23. I have read the portion of the Decision that
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`addresses these claim constructions.
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`28. Below I address the terms in the Decision as well as the additional
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`terms: (1) “the prescription requests containing information identifying patients”
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`and “the prescription requests for GHB containing information identifying
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`patients” (together, “the prescription requests [for GHB] containing information
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`identifying patients”); and (2) “the prescription requests containing information
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`identifying . . . various credentials of the any and all medical doctors,” “the
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`prescription requests containing information identifying . . . various credentials of
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`the any and all authorized prescribers,” and “the prescription requests for GHB
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`containing information identifying . . . various credentials of the any and all
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`authorized prescribers” (collectively, “the prescription requests [for GHB]
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`containing information identifying . . . various credentials of the any and all
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`[medical doctors/authorized prescribers]”).
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`A.
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`“exclusive central pharmacy” and “exclusive computer database”
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`29. As part of the Decision, I understand that the Patent Board gave a
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`preliminary construction of the terms “exclusive central pharmacy” and “exclusive
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`computer database.” I do not address this preliminary construction because it does
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`not affect my opinions in this expert declaration.
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`B.
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`“generating with the computer processor periodic
`reports via the exclusive computer database
`to evaluate potential diversion patterns”
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`30. As part of the Decision, I understand that the Patent Board
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`preliminarily interpreted “generating with the computer processor periodic reports
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`via the exclusive computer database to evaluate potential diversion patterns” to
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`mean “querying the exclusive computer database via the exclusive computer
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`processor to generate periodic reports containing prescriber, patient, and/or
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`prescription related information that permits evaluation of potential diversion,
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`misuse, or abuse of a prescription drug.” Paper 19 at 23.
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`31.
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`In my opinion, the ’730 patent does describe “querying the exclusive
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`computer database via the exclusive computer processor . . . [for] information that
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`permits evaluation of potential diversion, misuse, or abuse of a prescription drug.”
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`Specifically, the specification explains Figures 13A-C are “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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`8:22-24; see also id. at 8:27-28 (“The reports are obtained by running queries
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`against the database. . . .”). The fields in Fig. 7 contain the “prescriber, patient,
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`and/or prescription related information” already included in the Patent Board’s
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`construction. See Ex. 1001 at Fig. 7; Paper 19 at 23.
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`32.
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`In my opinion, however, the phrase interpreted by the Patent Board
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`also requires that the reports to evaluate diversion be periodic reports. Thus, to be
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`consistent with the claimed “periodic reports,” it is my opinion that the reports
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`must be generated periodically, i.e., at regular frequencies or intervals, as opposed
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`to intermittently or upon request.
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`33.
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`In my opinion, a POSA would understand that reports to evaluate
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`diversion can either be run at set intervals or frequencies, or intermittently or upon
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`request. I understand that Dr. Valuck testified at his deposition that reports to
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`evaluate diversion can be generated on either “an ad hoc basis or on a regular
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`basis.” Ex. 2044 at 184:8-16. In my opinion, a POSA would understand that ad
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`hoc reports are done for a particular purpose—for example, if requested by a
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`federal or government agency to support an investigation. See, e.g., Ex. 1004 at
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`110 (discussing generating ad hoc reports for diversion investigations “upon
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`request”). A POSA would not consider “ad hoc” reports to be “periodic” because
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`they are not generated with any regular frequency. See also Ex. 2044 at 184:8-16.
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`34. My opinions are supported by the ’730 patent’s specification. The
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`’730 patent distinguishes between periodic reports (those that are run at set
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`frequencies or intervals), and reports run intermittently or upon request for a
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`specific purpose.
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`35. Specifically, as stated above, the specification discloses Figs. 13A-C
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`as “reports obtained by querying a central database having fields represented in
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`Fig. 7.” Ex. 1001 at 8:24-26; Figs. 13A-C. The specification makes clear that:
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`“Each report has an associated frequency or frequencies.” Id. at 8:26-27
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`(emphasis added); See also id. at Figs. 13A-C (showing that reports regarding
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`prescriber, patient, and/or prescription related information—that permit evaluations
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`for potential diversion, misuse, and abuse—are run at regular frequencies or
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`intervals, as opposed to intermittently or upon request). Id.
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`36. On the other hand, Fig. 4B of the specification describes ad hoc
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`reports that are run only for the specific purpose of evaluating “possible product
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`diversion, misuse or over-use” such as when a patient requests an early refill of the
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`prescription drug. Ex. 1001 at 6:36-40; Fig. 4B. As mentioned above, Dr. Valuck
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`explained at his deposition that diversion reports can be generated on either “an ad
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`hoc basis or on a regular basis.” Ex. 2044 at 184:8-16. In my opinion, a POSA
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`would understand that the reports generated in Figure 4B are “ad hoc” reports done
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`for the particular purpose of investigating specific early refill requests, and not
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`regular or “periodic” reports as set forth in the ’730 patent claims. Indeed, the
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`reports in Fig. 4B are generated only in response to early refill requests. See Ex.
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`1001 at Fig. 4B.
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`37. Further, in my opinion, a POSA would understand that the plain and
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`ordinary meaning of the word periodic supports an interpretation of “periodic
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`reports” that requires set-frequency or set-interval reports. Specifically, Merriam-
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`Webster’s Collegiate Dictionary defines the word “periodic” as:
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`
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`Ex. 2043 at 3.
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`38. Thus, it is my opinion that the phrase “generating with the computer
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`processor periodic reports via the exclusive computer database to evaluate
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`potential diversion patterns,” means: querying the exclusive computer database via
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`the exclusive computer processor to generate, at regular frequencies or intervals,
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`as opposed to intermittently or upon request, reports containing prescriber,
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`patient, and/or prescription related information that permits evaluation of potential
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`diversion, misuse, or abuse of a prescription drug.
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`C.
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`“the prescription requests [for GHB] containing
`information identifying patients”
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`39.
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`I understand that the Patent Board did not provide a preliminary
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`construction for the term “the prescription requests [for GHB] containing
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`information identifying patients.” In my analysis below, I apply the plain and
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`ordinary meaning of the term in the context of the ’730 patent.
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`40. The above-recited term appears in the claim element:
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`Receiving in a computer processor all prescription requests [for
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`GHB], for any and all patients being prescribed [the prescription
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`drug/GHB], only at the [exclusive] central pharmacy from any and all
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`[medical doctors/authorized prescribers] allowed to prescribe [the
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`prescription drug/GHB], the prescription requests containing
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`information identifying patients [, the prescription drug,] and various
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`credentials of the any and all [medical doctors/authorized prescribers].
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`See Ex. 1001 at Claims 1-11 (emphasis added).
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`41. Read in the context of the ’730 patent, a POSA would understand the
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`term “the prescription requests [for GHB] containing information identifying
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`patients” to mean, at a minimum: the prescription requests [for GHB] containing
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`the patient’s name, social security number, date of birth, sex, and complete address
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`information, including city, state and zip code. This construction is consistent with
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`the information sufficient to identify the patient who is receiving the prescription
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`drug, which allows the ’730 patent’s overall goal—to control access to a
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`prescription drug and guard against potential abuse, misuse, and diversion—to be
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`successfully completed.
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`42.
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`In my opinion, the ’730 patent makes clear that a central pharmacy
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`will receive all prescription requests for a sensitive prescription drug like GHB.
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`See, e.g., Ex. 1001 at 8:40-44, 10:20-23; see also id. at 4:8-11 (describing “a
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`medical doctor (MD) sending an RX/enrollment form” to the central pharmacy).
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`The specification also explains that “[t]he enrollment form . . . contains patient
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`information.” Id. at 4:13-17. The specification discloses that the patient
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`information includes the patient’s “name, social security number, date of birth,
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`gender, [and] contact information.” Id. at 4:20-22. The specification also refers a
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`POSA to the prescription and enrollment form in Fig. 9 (id. at 8:4-5), which
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`requires the same patient information. See id. at Fig. 9.
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`43.
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`In my opinion, a POSA would understand that the “patient
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`information” on the enrollment form is information that permits the pharmacist to
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`be able to sufficiently identify that the patient to whom the drug is prescribed is
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`actually the patient receiving the drug. Indeed, I understand that Dr. Valuck shares
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`the same opinion. See Ex. 2044 at 97:11-98:5 (Dr. Valuck testifying that the
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`necessary patient information “would include for the pharmacist or pharmacy to be
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`able to verify – sufficiently identify that the patient for whom the drug is
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`prescribed is actually the patient”).
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`44.
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`I also understand that Dr. Valuck agreed that a POSA would
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`understand that the information sufficient to identify the patient who is receiving
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`the prescription drug includes all of the information identified in Fig. 9 of the ’730
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`patent:
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`Q. So what pieces of information is sufficient to identify the
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`narcoleptic patient?2
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`2 Xyrem is used to treat narcolepsy. See Ex. 2044 at 82:22-24.
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`A. And then Figure 9 specifies required information for a
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`prescription and enrollment form that contains both prescriber
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`information, prescription form, and patient information. So across
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`these different tables, different information is – is specified as far as
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`the patient identification requirements for the – for this program.
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`Q. So what specific fields do you consider through the eyes of a
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`person of ordinary skill in the art to be sufficient to identify the
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`narcoleptic patient?
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`A. These would include the elements specified; patient name, Social
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`Security number, date of birth, sex, complete address information,
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`city, state, zip.
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`Ex. 2044 at 99:18-100:10 (emphasis added); see also id. at 97:11-23 (Dr. Valuck
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`testifying that he “interprets [information sufficient to identify the narcoleptic
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`patient] to mean the information specified . . . in the patent”).
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`D.
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`“the prescription requests [for GHB] containing
`information identifying . . . various credentials of the
`any and all [medical doctors/authorized prescribers]”
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`45.
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`I understand that the Patent Board did not provide a preliminary
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`construction for the term “the prescription requests [for GHB] containing
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`information identifying . . . various credentials of the any and all [medical
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`doctors/authorized prescribers].” In my analysis below, I apply the plain and
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`ordinary meaning of the term in the context of the ’730 patent.
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`46. The above-recited term appears in the claim element:
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`Receiving in a computer processor all prescription requests [for
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`GHB], for any and all patients being prescribed [the prescription
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`drug/GHB], only at the [exclusive] central pharmacy from any and all
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`[medical doctors/authorized prescribers] allowed to prescribe [the
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`prescription drug/GHB], the prescription requests containing
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`information identifying patients [, the prescription drug,] and various
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`credentials of the any and all [medical doctors/authorized
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`prescribers].
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`See Ex. 1001 at Claims 1-11 (emphasis added).
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`47. Read in the context of the ’730 patent, a POSA would understand the
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`term “the prescription requests [for GHB] containing information identifying . . .
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`various credentials of the any and all [medical doctors/authorized prescribers]” to
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`mean, at a minimum: the prescription requests [for GHB] containing the
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`prescriber’s name, license number, DEA number, and physician specialty. This
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`construction is consistent with the information sufficient to ensure that the medical
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`doctor/authorized prescriber is eligible to prescribe the prescription drug, which
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`allows the ’730 patent’s overall goal—to control access to a prescription drug and
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`guard against potential abuse, misuse, and diversion—to be successfully
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`completed.
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`48.
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`In my opinion, the ’730 patent makes clear that a central pharmacy
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`will receive all prescription requests for a sensitive prescription drug like GHB.
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`See, e.g., Ex. 1001 at 8:40-44, 10:20-23; see also id. at 4:8-11 (describing “a
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`medical doctor (MD) sending an RX/enrollment form” to the central pharmacy).
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`The specification explains that “[t]he enrollment form contains prescriber
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`information.” Id. at 4:13-14. The specification discloses that “[t]he prescriber
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`information contains standard contact information as well as license number, DEA
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`number and physician specialty.” Id. at 4:20-22. The specification also refers a
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`POSA to the prescription and enrollment form in Fig. 9 (id. at 8:4-5), which
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`requires the prescriber’s “various credentials” that are set forth in my
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`understanding of the term. See id. at Fig. 9.
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`49.
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`I also understand that Dr. Valuck shares my understanding of the
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`“various credentials” that would be included in the “information identifying the . . .
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`various credentials of the any and all [medical doctors/authorized prescribers]:
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`Q. In the context of the Jazz patents, what is meant by “credentials of
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`the medical doctor”?
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`. . .
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`A. A POSA would understand the credentials of the physician to be
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`the – inclusive of their training, licensure, certifications; all of those
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`qualifications that relate to their training, licensure and ability to
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`practice medicine.
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`Q. Would you include DEA numbers as part of the licensure?
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`A. I would include DEA as part of credentialing. It’s not explicitly
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`medical licensure per se, but DEA registration is a form of
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`credentialing for physicians and pharmacies.
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`Ex. 2044 at 181:1-23.
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`VII. A POSA WOULD NOT HAVE BEEN MOTIVATED
`TO LOOK TO THE FEDERAL REGISTER
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`50. Dr. Valuck opines that “a POSA exercising reasonable diligence
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`would have been able to locate the [ACA materials]” because “[n]otice of the
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`Advisory Committee Meeting was posted in the Federal Register” and “the Federal
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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 at ¶ 47. I understand
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`that Dr. Valuck also testified at his deposition that it was only through the Federal
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`Register notice that a POSA could locate the Internet address allegedly leading to
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`the ACA materials. Ex. 2044 at 57:13-18 (Dr. Valuck testifying that he found the
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`ACA materials by “search[ing] for the . . . website that was indicated in the Federal
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`Register announcement”); 60:9-61:16 (Dr. Valuck testifying that he “can’t confirm
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`without, again, going . . . to the Federal Register to verify which website [he] went
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`to, which is where [he] then obtained all of . . . those materials that are included in
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`[his] exhibits”). In my opinion, a POSA would not have been motivated to look to
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`the Federal Register as Dr. Valuck opines.
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`51.
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`In my opinion, a POSA would not be monitoring the Federal Register
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`for general updates regarding the practice of pharmacy. In my opinion, a POSA
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`also would not consult the Federal Register with sufficient thoroughness or
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`regularity to find the specific Advisory Committee notice identified by Dr. Valuck.
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`Indeed, the notice was one of nearly 29,000 notices published in 2001. See Ex.
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`2050 at 2 (statistics for 2001).
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`52.
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`I understand that Dr. Valuck testified at his deposition that a POSA
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`would have become familiar with the Federal Register:
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`[E]ither in their education. If they’re a pharmacist, we teach them
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`about it and expect them to learn how to use it. If they’re working in
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`the practice setting, whether – as I mentioned, the POSA may come
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`from – different aspects of a team but would find out about it and
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`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.
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`Ex. 2045 at 293:24-294:11. I understand he further testified that a POSA would
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`have been motivated to look to the Federal Register because:
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`[A] varie