`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`HIKMA PHARMACEUTICALS USA INC.,
`HIKMA PHARMACEUTICALS PLC,
`Petitioner,
`
`v.
`
`AMARIN PHARMACEUTICALS IRELAND LIMITED,
`Patent Owner.
`
`Case IPR2022-00215
`Patent 8,642,077 B2
`Issued: February 4, 2014
`
`Title: STABLE PHARMACEUTICAL
`COMPOSITION AND METHODS OF USING SAME
`
`DECLARATION OF SYLVIA D. HALL-ELLIS, PH.D.
`
`Hikma Pharmaceuticals
`
`IPR2022-00215
`
`Ex. 1013, p. 1 of 852
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`
`
`I.
`
`INTRODUCTION
`1. My name is Sylvia D. Hall-Ellis. I have been retained as an expert by
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`Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals PLC (together,
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`“Hikma”), the Petitioner.
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`2.
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`I have written this declaration at the request of Hikma to provide my
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`expert opinion regarding the authenticity and public availability of several journal
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`publications, books, and documents. My declaration sets forth my opinions in detail
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`and provides the basis for my opinions regarding the authenticity and public
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`availability of these publications.
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`3.
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`I reserve the right to supplement or amend my opinions, and bases for
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`them, in response to any additional evidence, testimony, discovery, argument, and/or
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`other additional information that may be provided to me after the date of this
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`declaration.
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`4.
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`I am being compensated for my time spent working on this matter at
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`my normal consulting rate of $325 per hour, plus reimbursement for any additional
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`reasonable expenses. My compensation is not in any way tied to the content of this
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`declaration, the substance of my opinions, or the outcome of this proceeding. I have
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`no other interests in this proceeding or with any of the parties.
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`5.
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`All of the materials that I considered are discussed explicitly in this
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`declaration.
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`1
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`Hikma Pharmaceuticals
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`IPR2022-00215
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`Ex. 1013, p. 2 of 852
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`
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`II. QUALIFICATIONS
`6.
`I am currently an Adjunct Professor in the School of Information at San
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`José State University. I obtained a Master of Library Science from the University
`
`of North Texas in 1972 and a Ph.D. in Library and Information Science from the
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`University of Pittsburgh in 1985. Over the last fifty years, I have held various
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`positions in the field of library and information resources. I was first employed as a
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`librarian in 1966 and have been involved in the field of library sciences since,
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`holding numerous positions.
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`7.
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`I am a member of the American Library Association (ALA) and its
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`Association for Library Collections & Technical Services (ALCTS) Division, and I
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`served on the Committee on Cataloging: Resource and Description (which wrote the
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`new cataloging rules) and as the chair of the Committee for Education and Training
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`of Catalogers and the Competencies and Education for a Career in Cataloging
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`Interest Group. I also served as the Chair of the ALCTS Division’s Task Force on
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`Competencies and Education for a Career in Cataloging. Additionally, I have served
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`as the Chair for the ALA Office of Diversity’s Committee on Diversity, as a member
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`of the national Board of Directors for REFORMA, and as a member of the Editorial
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`Board for the ALCTS premier cataloging journal, Library Resources and Technical
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`Services. Currently I serve as a Co-Chair for the Library Research Round Table of
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`the American Library Association.
`
`2
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`Hikma Pharmaceuticals
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`IPR2022-00215
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`Ex. 1013, p. 3 of 852
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`8.
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`I have also given over one hundred presentations in the field, including
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`several on library cataloging systems and Machine-Readable Cataloging (“MARC”)
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`standards. My current research interests include library cataloging systems,
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`metadata, and organization of electronic resources.
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`9. My full curriculum vitae is attached hereto as Attachment 9 to this
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`declaration.
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`III. LIBRARY CATALOGING PRACTICES
`10.
`I am fully familiar with the library cataloging standard known as the
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`MARC standard, which is an industry-wide standard method of storing and
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`organizing library catalog information.1 MARC was first developed in the 1960s by
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`the Library of Congress. A MARC-compatible library is one that has a catalog
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`consisting of individual MARC records for each of its items. Today, MARC is the
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`primary communications protocol for the transfer and storage of bibliographic
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`metadata in libraries.2
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`
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`1 The full text of the standard is available from the Library of Congress at
`http://www.loc.gov/marc/bibliographic/.
`2 Almost every major library in the world is MARC-compatible. See, e.g., MARC
`Frequently Asked Questions (FAQ), Library of Congress,
`https://www.loc.gov/marc/faq.html (last visited October 18, 2021) (“MARC is the
`acronym for MAchine-Readable Cataloging. It defines a data format that emerged
`from a Library of Congress-led initiative that began nearly fifty years ago. It
`provides the mechanism by which computers exchange, use, and interpret
`bibliographic information, and its data elements make up the foundation of most
`3
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`Hikma Pharmaceuticals
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`IPR2022-00215
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`Ex. 1013, p. 4 of 852
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`11. A MARC record comprises several fields, each of which contains
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`specific data about the work. Each field is identified by a standardized, unique,
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`three-digit code corresponding to the type of data that follow. For example, a work’s
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`title is recorded in field 245, the primary author of the work is recorded in field 100,
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`an item’s International Standard Book Number (“ISBN”) is recorded in field 020,
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`an item’s International Standard Serial Number (“ISSN”) is recorded in field 022,
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`an item’s Library of Congress call number is recorded in field 050, and the
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`publication date is recorded in field 260 under the subfield “c.” If a work is a
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`periodical, then its publication frequency is recorded in field 310, and the publication
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`dates (e.g., the first and last publication) are recorded in field 362, which is also
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`referred to as the enumeration/chronology field.
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`12. The library that created the record is recorded in field 040 in subfield
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`“a” with a unique library code. When viewing the MARC record online via Online
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`Computer Library Center’s (“OCLC”) bibliographic database, hovering over this
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`code with the mouse reveals the full name of the library. I used this method of
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`“mousing over” the library codes in the OCLC database to identify the originating
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`library for the MARC records discussed in this declaration. Where this “mouse
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`over” option was not available, I consulted the Directory of OCLC Libraries in order
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`
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`library catalogs used today.”). MARC is the ANSI/NISO Z39.2-1994 (reaffirmed
`2016) standard for Information Interchange Format.
`4
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`Hikma Pharmaceuticals
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`IPR2022-00215
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`Ex. 1013, p. 5 of 852
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`to identify the institution that created the MARC record.3
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`13. MARC records also include several fields that include subject matter
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`classification information. An overview of MARC record fields is available through
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`the Library of Congress.4 For example, 6XX fields are termed “Subject Access
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`Fields.”5 Among these, for example, is the 650 field; this is the “Subject Added
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`Entry – Topical Term” field.6 The 650 field is a “[s]ubject added entry in which
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`the entry element is a topical term.” These entries “are assigned to a bibliographic
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`record to provide access according to generally accepted thesaurus-building rules
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`(e.g., Library of Congress Subject Headings (LCSH), Medical Subject Headings
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`(MeSH)).” Further, MARC records include call numbers, which themselves include
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`a classification number. For example, the 050 field is the “Library of Congress Call
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`Number.” 7 A defined portion of the Library of Congress Call Number is the
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`classification number, and “source of the classification number is Library of
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`Congress Classification and the LC Classification-Additions and Changes.” Thus,
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`included in the 050 field is a subject matter classification. Each item in a library has
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`a single classification number. A library selects a classification scheme (e.g., the
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`
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`3 https://www.oclc.org/en/contacts/libraries.html.
`4 http://www.loc.gov/marc/bibliographic/.
`5 http://www.loc.gov/marc/bibliographic/bd6xx.html.
`6 http://www.loc.gov/marc/bibliographic/bd650.html.
`7 http://www.loc.gov/marc/bibliographic/bd050.html.
`5
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`Hikma Pharmaceuticals
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`IPR2022-00215
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`Ex. 1013, p. 6 of 852
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`Library of Congress Classification scheme just described or a similar scheme such
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`as the Dewey Decimal Classification scheme) and uses it consistently. When the
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`Library of Congress assigns the classification number, it appears as part of the 050
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`field. If a local library assigns the classification number, it appears in a 090 field.
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`In either scenario, the MARC record includes a classification number that represents
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`a subject matter classification.
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`14. The OCLC was created “to establish, maintain and operate a
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`computerized library network and to promote the evolution of library use, of libraries
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`themselves, and of librarianship, and to provide processes and products for the
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`benefit of library users and libraries, including such objectives as increasing
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`availability of library resources to individual library patrons and reducing the rate of
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`rise of library per-unit costs, all for the fundamental public purpose of furthering
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`ease of access to and use of the ever-expanding body of worldwide scientific, literary
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`and educational knowledge and information.”8 Among other services, OCLC and
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`its members are responsible for maintaining the WorldCat database, 9 used by
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`independent and institutional libraries throughout the world.
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`15. OCLC also provides its members online access to MARC records
`
`
`
`8 Third Article, Amended Articles of Incorporation of OCLC Online Computer
`Library Center, Incorporated (available at
`https://www.oclc.org/content/dam/oclc/membership/articles-of-incorporation.pdf).
`9 http://www.worldcat.org/.
`
`6
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`Hikma Pharmaceuticals
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`IPR2022-00215
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`Ex. 1013, p. 7 of 852
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`
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`through its OCLC bibliographic database. When an OCLC member institution
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`acquires a work, it creates a MARC record for this work in its computer catalog
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`system in the ordinary course of its business. MARC records created at the Library
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`of Congress are directly uploaded or may be tape-loaded into the OCLC database
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`through a subscription to MARC Distribution Services daily or weekly. Once the
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`MARC record is created by a cataloger at an OCLC member institution or is tape-
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`loaded from a participating institution, the MARC record is then made available to
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`any other OCLC members online, and therefore made available to the public.
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`Accordingly, once the MARC record is created by a cataloger at an OCLC member
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`institution or is tape-loaded from the Library of Congress or another library
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`anywhere in the world, any publication corresponding to the MARC record has been
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`cataloged and indexed according to its subject matter such that a person interested
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`in that subject matter could, with reasonable diligence, locate and access the
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`publication through any library with access to the OCLC bibliographic database or
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`through the Library of Congress.
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`16. When an OCLC member institution creates a new MARC record,
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`OCLC automatically supplies the date of creation for that record. The date of
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`creation for the MARC record appears in the fixed field (008), characters 00 through
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`05. The MARC record creation date reflects the date on which, or shortly after
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`which, the item was first acquired or cataloged. Initially, field 005 of the MARC
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`7
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`Ex. 1013, p. 8 of 852
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`record is automatically populated with the date the MARC record was created in
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`year, month, day format (YYYYMMDD) (some of the newer library catalog systems
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`also include hour, minute, second (HHMMSS)). Thereafter, the library’s computer
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`system may automatically update the date in field 005 every time the library updates
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`the MARC record (e.g., to reflect that an item has been moved to a different shelving
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`location within the library). Field 005 is visible when viewing a MARC record via
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`an appropriate computerized interface, but when a MARC record is printed to
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`hardcopy, no “005” label appears. The initial field 005 date (i.e., the date the MARC
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`record was created) does appear, however, next to the label “Entered.”10 The date
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`upon which the most recent update to field 005 occurred also appears, next to the
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`label “Replaced.” Thus, when an item’s MARC record has been printed to
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`hardcopy—as is the case with the exhibits to this declaration—the date reflected next
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`to the label “Entered” is necessarily on or after the date the library first cataloged
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`and indexed the underlying item.
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`17. Once one library has cataloged and indexed a publication by creating a
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`MARC record for that publication, other libraries that receive the publication do not
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`
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`10 In this declaration, I sometimes refer to the “Entered” entry as Field 008,
`characters 00-05. Field 005 is visible when viewing a MARC record via an
`appropriate computerized interface. But when a MARC record is printed directly
`to hardcopy from the OCLC database, the “005” label is not shown. The date in
`the 005 field instead appears next to the label “Replaced.”
`8
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`Hikma Pharmaceuticals
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`Ex. 1013, p. 9 of 852
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`
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`create additional MARC records—the other libraries instead rely on the original
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`MARC record. They may update or revise the MARC record to ensure accuracy,
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`but they do not replace or duplicate it. This practice does more than save libraries
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`from duplicating labor. It also enhances the accuracy of MARC records. Further, it
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`allows librarians around the world to know that a particular MARC record is
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`authoritative (in contrast, a hypothetical system wherein duplicative records were
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`created would result in confusion as to which record is authoritative).
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`18. The date of creation of the MARC record by a cataloger at an OCLC
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`member institution reflects when the underlying item is accessible to the public.
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`Upwards of two-thirds to three-quarters of book sales to libraries come from a jobber
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`or wholesaler for online and print resources. These resellers make it their business
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`to provide books to their customers as fast as possible, often providing turnaround
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`times of only a single day after publication. Libraries purchase a significant portion
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`of the balance of their books directly from publishers themselves, which provide
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`delivery on a similarly expedited schedule. In general, libraries make these
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`purchases throughout the year as the books are published and shelve the books as
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`soon thereafter as possible in order to make the books available to their patrons.
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`Thus, books are generally available at libraries across the country within just a few
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`days of publication.
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`19. Catalogers can create MARC records for all types of print, online, and
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`9
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`Hikma Pharmaceuticals
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`Ex. 1013, p. 10 of 852
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`digital resources. For example, MARC records cover serial publications, including
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`both serially-published monographs and journals. OCLC hosts MARC records for
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`more than 320 million serial publications. Serial publications are those publications
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`that have the same collective title but are intended to be continued indefinitely with
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`enumeration such as a volume or issue number (e.g., magazines, journals, etc.). In
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`the OCLC bibliographic database, the first issue or volume of the monographic serial
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`is typically cataloged (i.e., a corresponding MARC record is created), but the date is
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`left open-ended with the use of a punctuation mark such as a dash. MARC records
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`for serial publications represent the entire run of the title. With knowledge of the
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`first issue or volume published, future issues or volumes can be predicted based on
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`the information provided in the MARC record, for example in field 362. In my
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`extensive professional experience, is it highly unusual for a library to stop collecting
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`and shelving a serial publication prior to the time of its cessation. If a subscription
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`to a serial publication ends or is cancelled, the library will denote that it has stopped
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`receiving new issues or volumes by filling in the end date in the MARC record.
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`20. The handling of printed journal subscriptions is shown on the covers of
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`individual issues. As was the best practice among libraries, issues arrived at a central
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`facility and were immediately received, verified as part of a subscription, checked
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`in, and stamped with the institution’s name and date. Determining that the issue was
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`part of the library subscription ensured that the entire set of publications for the year
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`10
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`Ex. 1013, p. 11 of 852
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`had been received so that they could be professionally bound and retained. This
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`process also verified that each of the published issues arrived so that the library staff
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`did not have to request or claim an issue that did not arrive as expected. In large
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`public libraries with branches and multi-campus libraries within academic
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`institutions, the journals were sorted and delivered to the subscribing unit. The
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`issues were frequently stamped again to acknowledge receipt. The new issue was
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`placed in the public area; the older issue was stored so that it remained available.
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`21. The foregoing process has been standard library practice longer than I
`
`have been working in the profession. I first learned the steps in the process in the
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`late 1970s and later supervised it. Although the checking in process has become
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`automated and now links electronically to holdings records for the MARC record
`
`for each serial title, the manual stamping and placing the issue in a public area has
`
`not changed for 50 years. Unless I note otherwise below in reference to a specific
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`serial publication, it is my expert opinion that this standard protocol was followed
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`for each of the serial publications discussed below.
`
`22.
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`In preparing this declaration, I used authoritative databases, such as the
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`OCLC bibliographic database and the Library of Congress Online Catalog, to
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`confirm citation details of the various publications discussed.
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`23.
`
`Indexing. A researcher may discover material relevant to his or her
`
`topic in a variety of ways. One common means of discovery is to search for relevant
`
`11
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`Hikma Pharmaceuticals
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`Ex. 1013, p. 12 of 852
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`
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`information in an index of periodical and other publications. Having found relevant
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`material, the researcher will then normally obtain it online, look for it in libraries, or
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`purchase it from the publisher, a bookstore, a document delivery service, or other
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`provider. Sometimes, the date of a document’s public accessibility will involve both
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`indexing and library date information. However, date information for indexing
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`entries is often unavailable. This is especially true for online indices.
`
`24.
`
`Indexing services use a wide variety of controlled vocabularies to
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`provide subject access and other means of discovering the content of documents.
`
`The formats in which these access terms are presented vary from service to service.
`
`25. Online indexing services commonly provide bibliographic information,
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`abstracts, and full-text copies of the indexed publications, along with a list of the
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`documents cited in the indexed publication. These services also often provide lists
`
`of publications that cite a given document. A citation of a document is evidence that
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`the document was publicly available and in use by researchers no later than the
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`publication date of the citing document.
`
`26. Before the widespread development of online databases to index
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`articles in journals, magazines, conference papers, and technical reports, libraries
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`purchased printed volumes of indices. Graduate library school education mandated
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`that students learn about the bibliographic control of disciplines, the prominent
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`indexing volumes, and searching strategies required to use them effectively and
`
`12
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`Hikma Pharmaceuticals
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`Ex. 1013, p. 13 of 852
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`efficiently. Half of the courses that I studied in library school were focused on the
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`bibliography and resources in academic disciplines.
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`27. Librarians consulted with information seekers to verify citations, check
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`availability in union catalogs, printed books catalogs, the OCLC database, and make
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`formal requests for materials (e.g., books, conference proceedings, journal articles).
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`Requests were transmitted using Telex machines, rudimentary email systems, and
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`the United States Postal Service. During my career, I have performed and supervised
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`staff who handled these resource sharing tasks.
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`28. A major firm known for the breadth of subjects and comprehensive
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`treatment in the preparation of index volumes, the H. W. Wilson Company offered
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`these reference resources since the firm was founded in 1898. The Reader’s Guide
`
`to Periodical Literature is one of the best-known titles available from H. W. Wilson.
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`Each volume includes a comprehensive index for 300 of the most popular and
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`important periodicals in the United States and Canada. Information seekers have
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`subject access expressed in plain language terminology, author access, and cross
`
`references to find the desired results from their searches. The family of index titles
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`included Science & Technology Index, Business Periodicals, Applied Science &
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`Technology Index, Humanities Index, Biological & Agricultural Index, and
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`Industrial Arts Index. These printed indices have been superseded by digital
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`database offerings available to information seekers through Ebsco.
`
`13
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`Ex. 1013, p. 14 of 852
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`29.
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`Information seekers also used printed versions of Chemical Abstracts
`
`and Index Medicus to locate articles, scientific reports, and research papers.
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`Chemical Abstracts began publication in 1907 and by 2007 its databases “contained
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`more than 27 million records of journal and patent literature.”11 In 2010, Chemical
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`Abstracts discontinued the print index. Access is now available through two
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`electronic databases: CAplus and Registry. 12 Index Medicus is a bibliographic
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`index to medical science information, started in 1879. 13 Currently, PubMed
`
`includes the content that had been published as Index Medicus.14
`
`30. Established in 1836 as part of the Surgeon General of the Army’s
`
`Office, the National Library of Medicine (NLM) has been instrumental in the
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`development of access to medical books, journals, and research publications. In the
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`
`
`11 Chemical Abstracts Service, “CAS History,” available at
`https://www.cas.org/about/cas-history (last accessed October 18, 2021); American
`Chemical Society, “Chemical Abstracts Service,” available at
`https://www.acs.org/content/acs/en/education/whatischemistry/landmarks/cas.html
`(last accessed October 18, 2021).
`12 American Chemical Society, “Chemical Abstracts Service,” available at
`https://www.acs.org/content/acs/en/education/whatischemistry/landmarks/cas.html
`(last accessed October 18, 2021).
`13 Stephen Greenberg and Patricia Gallagher, “The great contribution: Index
`Medicus, Index-Catalogue, and IndexCast,” Journal of Medical Library
`Association, April 2009, available at
`https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2670211/ (last accessed October
`18, 2021).
`14 U.S. National Library of Medicine, “List of All Journals Cited in PubMed®,”
`https://www.nlm.nih.gov/bsd/serfile_addedinfo.html (last accessed October 18,
`2021).
`
`14
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`Ex. 1013, p. 15 of 852
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`1970s, NLM introduced MEDLINE, followed by “the establishment of the National
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`Center for Biotechnology Information in 1988, the introduction of free MEDLINE
`
`in 1997, the creation of consumer-friendly MedlinePlus in 1998, and the introduction
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`of ClinicalTrials.gov in 2000.”15
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`31. Online indexing services such as Google Scholar16 or ScienceDirect17
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`commonly provide bibliographic information, abstracts, and full-text copies of the
`
`indexed publications, along with a list of the documents cited in the indexed
`
`publication. These services also often provide lists of publications that cite a given
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`document.
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`32. A citation of a document by another is evidence that the document was
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`publicly available and in use no later than the publication date of the citing
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`document.
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`IV. PRELIMINARIES
`33.
`Scope of this declaration. I am not an attorney and will not offer
`
`opinions on the law. I am, however, rendering my expert opinion on the authenticity
`
`of the documents referenced herein and when and how each of these documents was
`
`disseminated or otherwise made publicly available to the extent that persons
`
`
`
`15 U.S. National Library of Medicine, “A Brief History of NLM,” available at
`https://www.nlm.nih.gov/about/briefhistory.html.
`16 https://scholar.google.com/.
`17 https://www.sciencedirect.com/.
`
`15
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`Hikma Pharmaceuticals
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`Ex. 1013, p. 16 of 852
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`interested and ordinarily skilled in the subject matter or art, exercising reasonable
`
`diligence, could have located the documents before April 29, 2008.
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`34.
`
`I am informed by counsel that a printed publication qualifies as publicly
`
`accessible as of the date it was disseminated or otherwise made available such that
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`a person interested in and ordinarily skilled in the relevant subject matter could
`
`locate it through the exercise of ordinary diligence.
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`35. While I understand that the determination of public accessibility under
`
`the foregoing standard rests on a case-by-case analysis of the facts particular to an
`
`individual publication, I also understand that a printed publication is rendered
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`“publicly accessible” if it is cataloged and indexed by a library such that a person
`
`interested in the relevant subject matter could locate it exercising reasonable
`
`diligence (i.e., I understand that cataloging and indexing by a library in a manner
`
`that permits a person of ordinary skill in the relevant subject matter to locate the
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`publication is sufficient, though there are other ways that a printed publication may
`
`qualify as publicly accessible). One manner of sufficient indexing is indexing
`
`according to subject matter category. I understand that the cataloging and indexing
`
`by a single library of a single instance of a particular printed publication is sufficient,
`
`even if the single library is in a foreign country. I understand that, even if access to
`
`a library is restricted, a printed publication that has been cataloged and indexed
`
`therein is publicly accessible so long as a presumption is raised that the portion of
`
`16
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`Ex. 1013, p. 17 of 852
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`the public concerned with the relevant subject matter would know of the printed
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`publication. I also understand that the cataloging and indexing of information that
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`would guide a person interested in the relevant subject matter to the printed
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`publication, such as the cataloging and indexing of an abstract for the printed
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`publication, is sufficient to render the printed publication publicly accessible.
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`36.
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`I understand that routine business practices, such as general library
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`cataloging and indexing practices, can be used to establish an approximate date on
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`which a printed publication became publicly accessible.
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`37. Persons of ordinary skill in the art. I am told by counsel that the subject
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`matter of this proceeding relates generally to the field of treating cardiovascular-
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`related diseases and lipid disorders.
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`38.
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`I have been informed by counsel that a person of ordinary skill in the
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`art (“POSA”) is a hypothetical person who is presumed to be familiar with the
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`relevant field and its literature at the time of the alleged invention. This hypothetical
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`person is also a person of ordinary creativity, capable of understanding the scientific
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`principles applicable to the pertinent field.
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`39.
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`I am informed by counsel that a POSA for purposes of this proceeding
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`would have had (1) a medical degree; (2) several years of experience in the
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`development and/or clinical use of fatty acids to treat cardiovascular, endocrine,
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`and/or lipid disorders, including fish-oil-based fatty acids, i.e., EPA and/or DHA,
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`17
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`and their dosage forms; and (3) access to a team including one or more of an
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`analytical chemist, pharmaceutical chemist, formulator, or biostatistician.
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`40.
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` It is my opinion that such a person would have been engaged in
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`research, learning through study and practice in the field and possibly through formal
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`instruction the bibliographic resources relevant to his or her research. In the late-
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`1990s such a person would have had access to a vast array of long-established print
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`resources in cardiology and/or lipidology and/or endocrinology as well as to a rich
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`set of online resources providing indexing information, abstracts, and full text
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`services for cardiology and/or lipidology and/or endocrinology references.
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`41. Based on my experience working in research libraries with researchers
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`having the qualifications described above, or even lesser qualifications, it is my
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`opinion that such researchers would have been able to locate the material discussed
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`herein on their own or with the assistance of a research librarian with relative ease
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`using the tools and resources described herein.
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`V.
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`PUBLICATIONS
`A. Document 1: Exhibit 1008 (“ATP-III”)
`42. Attached hereto as Attachment 1 is a copy of a report from Volume
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`106, Number 25 of the journal Circulation found in the National Agricultural
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`Library (Beltsville, Maryland). The “Third Report of the National Cholesterol
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`Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment
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`of High Blood Cholesterol in Adults (Adult Treatment Panel III) Final Report”
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`(hereafter “ATP-III”) appears beginning on page 3143 of this issue dated December
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`17, 2002. Attachment 1 is a true and correct copy of the nine-part report.
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`Attachment 1 is a true and correct copy of the issue cover, table of contents, and the
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`nine parts (pages 3157-3421). I obtained copies of Parts 1 through 8 from the
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`National Agricultural Library and downloaded Part 9 from the journal website.
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`Specifically, the text of the column is complete; no pages are missing, and the text
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`on each page appears to flow seamlessly from one page to the next; further, there are
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`no visible alterations to the document. Attachment 1 was found within the custody
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`of a library and/or the publisher itself – places where, if authentic, a copy of this
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`journal would likely be. Attachment 1 is a true and correct copy in a condition that
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`creates no suspicion about its authenticity.
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`43. The cover of the December 17, 2002, issue of the journal Circulation
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`has a stamp affixed at the National Agricultural Library which shows that it was
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`received, verified, and checked in on December 28, 2002. This date stamp has the
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`general appearance of date stamps that libraries have long affixed to periodicals to
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`show when a reference was received, verified, and checked. Therefore, in my
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`experience, the issue of the journal Circulation in which ATP-III appears would
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`have been available to users at the National Agricultural Library on that date.
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`19
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`44. Attached hereto as Attachment 1a is a true and correct copy of the
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`MARC record for the journal Circulation in the National Agricultural Library online
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`catalog. The library ownership is indicated by the presence of the library’s code
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`(AGL) in the 049 field. The most recent enhancement to Attachment 1a occurred on
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`June 26, 2020, as shown in field 005 (“20200626”). I personally identified and
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`retrieved the MARC record that is Attachment 1a. Attachment 1a also shows that
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`ATP-III was catalogued with three descriptor terms reading “Cardiology $v
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`Periodicals”
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`(see Attachment 1b, Library of Congress subject heading
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`sh2008117649), “Cardiovascular system $v Periodicals” (see Attachment 1c,
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`National Library of Congress subject heading sh85020226 and Attachment 1d,
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`Library of Congress subject heading sh85099890), and “Hypertension $v
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`Periodicals” (see Attachment 1