UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________________
`
`PAR PHARMACEUTICAL, INC.
`
`Petitioner
`
`v.
`
`NOVARTIS AG.
`
`Patent Owner
`
`_______________________
`
`U.S. Patent No. 9,006,224
`
`_______________________
`
`DECLARATION OF SCOTT BENNETT, Ph.D.
`15 July 2016
`
`1
`
`Par Pharm., Inc.
`Exhibit 1061
`Page 001
`
`
`
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________________
`
`PAR PHARMACEUTICAL, INC.
`
`Petitioner
`
`v.
`
`NOVARTIS AG.
`
`Patent Owner
`
`_______________________
`
`U.S. Patent No. 9,006,224
`
`_______________________
`
`DECLARATION OF SCOTT BENNETT, Ph.D.
`15 July 2016
`
`1
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`Par Pharm., Inc.
`Exhibit 1061
`Page 001
`
`
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`I, Scott Bennet, Ph.D., resident of Urbana, Illinois, hereby declare as
`
`follows:
`
`Introduction and Qualifications
`1.
`I have been retained by Latham & Watkins LLP to provide my
`
`opinions concerning the public availability of certain documents at issue in inter
`
`partes review proceedings for U.S. Patent Nos. 9,006,224.
`
`2.
`
`My curriculum vitae is appended to this document as Appendix A.
`
`From 1956 to 1960, I attended Oberlin College, where I received an A.B. in
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`English. I then attended Indiana University, where I received an M.A. in 1966 and
`
`a Ph.D. in 1967, both in English. In 1976, I received a M.S. in Library Science
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`from the University of Illinois. I also served at the University of Illinois at
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`Urbana‐Champaign in two capacities. First, from 1967 to 1974, I was an Assistant
`
`Professor of English; then from 1974 to 1981, I was an Instructor, Assistant
`
`Professor, and Associate Professor of Library Science.
`
`3.
`
`From 1981 to 1989, I served as the Assistant University Librarian for
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`Collection Management, Northwestern University. From 1989 to 1994, I served as
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`the Director of The Milton S. Eisenhower Library at The Johns Hopkins
`
`University. From 1994 to 2001, I served as the University Librarian at Yale
`
`University. In 2001, I retired from Yale University.
`
`2
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`Par Pharm., Inc.
`Exhibit 1061
`Page 002
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`
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`4.
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`Since then, I have served in multiple capacities for various
`
`organizations, including as a consultant on library space planning from 2004 to the
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`present, as a Senior Advisor for the library program of the Council of Independent
`
`Advisory Board from 2004 to the present, and as a Visiting Professor at the
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`Graduate School of Library and Information Science, University of Illinois at
`
`Colleges from 2001to 2009, as a member of the Wartburg College Library
`Urbana‐Champaign, in the Fall of 2003. I was a founding partner of Prior Art
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`Documentation Services, LLC, in 2015.
`
`5.
`
`Over the course of my work as a librarian, professor, researcher, and
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`author of numerous publications, I have had extensive experience with cataloging
`
`and online library management systems built around Machine-Readable
`
`Cataloging (MARC) standards. As a consultant, I have substantial experience in
`
`authenticating documents and establishing the date when they were available to
`
`persons exercising reasonable diligence.
`
`6.
`
`In the course of more than fifty years of academic life, I have myself
`
`been an active researcher. I have collaborated with many individual researchers
`
`and, as a librarian, worked in the services of thousands of researchers at four
`
`prominent research universities. Members of my family are university researchers.
`
`Over the years, I have read some of the voluminous professional literature on the
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`information seeking behaviors of academic researchers. And as an educator, I
`
`3
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`Par Pharm., Inc.
`Exhibit 1061
`Page 003
`
`
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`have a broad knowledge of the ways in which students in a variety of disciplines
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`learn to master the bibliographic resources used in their disciplines. In all of these
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`ways, I have a general knowledge of the how researchers work.
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`7.
`
`My work in this matter is being billed at my standard consulting rate
`
`of $88 per hour. My compensation is not in any way contingent upon the outcome
`
`of this or any other inter partes review. I have no financial or personal interest in
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`the outcome of this proceeding or any related litigation.
`
`Scope of this Declaration
`8.
`I am not a lawyer and I am not rendering an opinion on the legal
`
`question that any particular document is, or is not, a “printed publication” under
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`the law.
`
`9.
`
`I am, however, rendering my expert opinion on when and how each of
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`the documents addressed herein was disseminated or otherwise made available to
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`the extent that persons interested and ordinarily skilled in the subject matter or art,
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`exercising reasonable diligence, could have located the documents before
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`November 2004 or November 2005.
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`10.
`
`I reserve the right to supplement my opinion in the future to respond
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`to any arguments that the parties to this case raise and to take into account new
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`information as it becomes available.
`
`4
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`Par Pharm., Inc.
`Exhibit 1061
`Page 004
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`
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`Materials Considered in Forming My Opinion
`11.
`In forming the opinions expressed in this declaration, I have relied on
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`the Documents and the Attachments created for this declaration, as listed below.
`
`Document 1 (Exhibit 1027). Öberg, K. “Treatment of neuroendocrine tumours
`
`of the gastrointestinal tract.” Oncologia, 27,4 (2004): 57-61.
`
`Document 2 (Exhibit 1005). Boulay, Anne, et al. “Antitumor Efficacy of
`
`Intermittent Treatment Schedules with the Rapamycin Derivative RAD001
`
`Correlates with Prolonged Inactivation of Ribosomal Protein S6 Kinase 1 in
`
`Peripheral Blood Mononuclear Cells.” Cancer Research, 65, 1 (January
`
`2004): 252-261.
`
`Document 3 (Exhibit 1029). O’Donnell, S. et al. “A phase 1 study of the oral
`
`mTOR inhibitor RAD001 as monotherapy to identify the optimal
`
`biologically effective dose using toxicity, pharmacokinetic (PK) and
`
`pharmacodynamics (PD) endpoints in patients with solid tumors.” Abstract
`
`803 of a poster discussion. Meeting Proceedings. American Society of
`
`Clinical Oncology. Thirty-Ninth Annual Meeting, May 31 – June 3, 2003,
`
`Chicago, Illinois, 22 (2003): 200.
`
`Document 4 (Exhibit 1038). Tabernero, J., et al. “A phase 1 study with tumor
`
`molecular pharmacodynamics (MPD) evaluation of dose and schedule of the
`
`oral mTOR-inhibitor Everolimus (RAD001) in patents (pts) with solid
`
`5
`
`Par Pharm., Inc.
`Exhibit 1061
`Page 005
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`
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`tumors.” Abstract 3007 of an oral presentation. Journal of Clinical
`
`Oncology. Supplement. 2005 ASCO Annual Meeting Proceedings. 41st
`
`Annual Meeting, May 13-17, 2005. Orlando, FL. 23, 16, Supplement (1
`
`June 2005): 193s.
`
`Document 5 (Exhibit 1011). Duran, I., et al. “A phase II trial of temsirolimus
`
`in metastatic neuroendocrine carcinomas (NECs).” Publication only abstract
`
`3097. Journal of Clinical Oncology. Supplement. 2005 ASCO Annual
`
`Meeting Proceedings. 41st Annual Meeting, May 13-17, 2005. Orlando, FL.
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`23, 16, Supplement (1 June 2005): 215s.
`
`12.
`
`The following Attachments are true and accurate representations of
`
`library material and online documents and records, as they are identified below.
`
`Unless otherwise indicated, all Attachments are records made in the regular course of
`
`business and available to the public. All attachments were created on 26 June – 14
`
`June 2016, and all URLs referenced in this declaration were available on 15 July
`
`2016.
`
`Attachment 1a: Illinois Statewide Library Catalog record for Oncologia
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`Attachment 1b: Copy of Öberg from the SciELO Web site
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`Attachment 1c: British Library catalog record for Oncologia
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`Attachment 1d: British Library holdings record for Oncologia
`
`6
`
`Par Pharm., Inc.
`Exhibit 1061
`Page 006
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`
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`Attachment 1e: Copy of the table of contents for Oncologia, volume 27, issue
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`4, from the British Library
`
`Attachment 1f: Copy of Öberg from the British Library
`
`Attachment 1g: Web of Science index record for Öberg
`
`Attachment 2a: Statewide Illinois Library Catalog record for Cancer Research
`
`Attachment 2b: University of Illinois at Urbana-Champaign Library catalog
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`record for Cancer Research
`
`Attachment 2c: Copy of Boulay from the University of Illinois at Urbana-
`
`Champaign Library
`
`Attachment 2d: Copy of Boulay from the University of Wisconsin Library
`
`Attachment 2e: PubMed record for Boulay
`
`Attachment 2f: Copy of Boulay from the AACR Publications Web site
`
`Attachment 3a: Program for the 2003 ASCO Annual Meeting
`
`Attachment 3b: Copy of O’Donnell from the University of Minnesota Library
`
`Attachment 3c: University of Minnesota Library monograph catalog record for
`
`the 2003 ASCO Annual Meeting proceedings
`
`Attachment 3d: Statewide Illinois Library Catalog record for the 2003 ASCO
`
`Annual Meeting proceedings
`
`Attachment 3e: Google Scholar list of documents citing O’Donnell
`
`Attachment 3f: Index record for a documenting citing O’Donnell
`
`7
`
`Par Pharm., Inc.
`Exhibit 1061
`Page 007
`
`
`
`Attachment 4a: Copy of Tabernero from the University of Illinois at Urbana-
`
`Champaign Library
`
`Attachment 4b: Copy of Tabernero from the University of Minnesota Library
`
`Attachment 4c: University of Illinois at Urbana-Champaign Library catalog
`
`record for the Journal of Clinical Oncology
`
`Attachment 4d: Statewide Illinois Library Catalog record for the Journal of
`
`Clinical Oncology
`
`Attachment 4e: Google Scholar list of documents citing Tabernero
`
`Attachment 4f: Index record for a documenting citing Tabernero
`
`Attachment 5a: Copy of Duran from the University of Illinois at Urbana-
`
`Champaign Library
`
`Attachment 5b: Copy of Duran from the University of Minnesota Library
`
`Attachment 5c: Google Scholar list of documents citing Duran
`
`Attachment 5d: Copy of document citing Duran
`
`Background Information
`13.
`Persons of ordinary skill in the art. I am told by counsel that the
`
`subject matter of this proceeding relates to oncology and the treatment of specific
`
`tumors.
`
`14.
`
`I am told by counsel that persons of ordinary skill in this subject
`
`matter or art have an understanding of cancer and the medical treatment of tumors.
`
`8
`
`Par Pharm., Inc.
`Exhibit 1061
`Page 008
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`
`
`I am told by counsel that such a person typically has, at the minimum, a Ph.D. in
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`cancer biology, molecular biology, medicinal chemistry, or a related field with
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`several years of experience in chemotherapeutic drug development, including
`
`evaluating cancer therapeutics in in vitro and/or in vivo assays; or an MD with
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`several years of specific experience in oncology and clinical pharmacology.
`
`15.
`
`It is my opinion that such a person would have been engaged in
`
`advanced research starting at least in graduate or medical school, learning though
`
`study and practice in the field and possibly through formal instruction the
`
`bibliographic resources relevant to his or her research. In the mid-2000s, such a
`
`person would have had access to a vast array of long-established print resources in
`
`chemistry, biology, and the health sciences as well as to a rich set of online
`
`resources providing indexing information, abstracts, and full text services for those
`
`disciplines.
`
`16. Conference papers. Conference papers are typically presented at a
`
`conference. The circumstances of such presentation may vary, especially as
`
`regards the prominence of the conference, the number of conference participants,
`
`and the organization and conduct of the conference. Sometimes, only posters of
`
`research findings are presented. Formal publication of papers presented at
`
`conferences also varies. Sometimes, the papers are published before the
`
`conference so as to be available to conference participants. Sometimes, papers are
`
`9
`
`Par Pharm., Inc.
`Exhibit 1061
`Page 009
`
`
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`published only after the conference, and in some cases only abstracts of the papers
`
`are published.
`
`17. Because of this variability, detailed information about the conference
`
`may often be used to establish the public accessibility of conference papers. The
`
`availability of such information, especially for long past conferences, varies.
`
`18.
`
`Library catalog records. Some background on MARC formatted
`
`records, OCLC, WorldCat, and OCLC’s Connexion is needed to understand the
`
`library catalog records used in this declaration.
`
`19.
`
`Libraries world-wide use the MARC format for catalog records; this
`
`machine readable format was developed at the Library of Congress in the 1960s.
`
`20. MARC formatted records use numerous tags and codes. For instance,
`
`they provide a variety of subject access points based on the content of the
`
`document being cataloged. All may be found in the MARC Fields 6XX. MARC
`
`Field 600, for instance, identifies personal names used as subjects, and the MARC
`
`Field 650 identifies topical terms. An ordinarily skilled researcher might discover
`
`material relevant to his or her topic by a search using the terms employed in the
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`MARC Fields 6XX.
`
`21.
`
`The MARC Field 040, subfield a, identifies the library or other entity
`
`that created the original catalog record for a given document and transcribed it into
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`machine readable form. The MARC Field 008 identifies the date when this first
`
`10
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`Par Pharm., Inc.
`Exhibit 1061
`Page 010
`
`
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`catalog record was entered on the file. This date persists in all subsequent uses of
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`the first catalog record, although newly created records for the same document,
`
`separate from the original record, will show a new date.
`
`22. WorldCat is the world’s largest public online catalog, maintained by
`
`the Online Computer Library Center, Inc., or OCLC, and built with the records
`
`created by the thousands of libraries that are members of OCLC. WorldCat
`
`provides a user-friendly interface for the public to use MARC records; it requires
`
`no knowledge of MARC tags and codes. WorldCat records appear in many
`
`different catalogs, including the Statewide Illinois Library Catalog. The date a
`
`given catalog record was created (corresponding to the MARC Field 008) appears
`
`in some detailed WorldCat records as the Date of Entry.
`
`23. When an OCLC participating institution acquires a document for
`
`which it finds no previously created record in OCLC, or when the institution
`
`chooses not to use an existing record, it creates a record for the document using
`
`OCLC’s Connexion, the bibliographic system used by catalogers to create MARC
`
`records. Connexion automatically supplies the date of record creation in the
`
`MARC Field 008.
`
`24. Once the MARC record is created by a cataloger at an OCLC
`
`participating member institution, it becomes available to other OCLC participating
`
`members in Connexion and to the public in WorldCat.
`
`11
`
`Par Pharm., Inc.
`Exhibit 1061
`Page 011
`
`
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`25.
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`The public availability of MARC formatted catalog records and
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`detailed WorldCat records showing the Date of Entry varies.
`
`26. When a book has been cataloged, it will normally be made available
`
`to readers soon thereafter—normally within a few days or (at most) within a few
`
`weeks of cataloging.
`
`27.
`
`Publications in series. A library typically creates a MARC catalog
`
`record for a series of publications, such as the proceedings of an annual
`
`conference, when the library receives its first issue. When the institution receives
`
`subsequent issues/volumes of the series, the issues/volumes are checked in
`
`(sometimes using a date stamp), added to the institution’s holdings records, and
`
`made available very soon thereafter—normally within a few days of receipt or (at
`
`most) within a few weeks of receipt.
`
`28.
`
`The initial serials record will often not reflect all of the subsequent
`
`changes in publication details (including minor variations in title, etc.).
`
`29. When a library does not intend systematically to acquire a series, but
`
`adds individual volumes of a series to its collections, the library will typically treat
`
`each such volume as an individual book, or monograph. In this case, the MARC
`
`Field 008 will record the date when the record for that individual volume, not the
`
`series, was created.
`
`12
`
`Par Pharm., Inc.
`Exhibit 1061
`Page 012
`
`
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`30.
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`It is sometimes possible to find both a series and a monograph library
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`catalog record for the same publication.
`
`31.
`
`Periodical publications. A library typically creates a MARC catalog
`
`record for a periodical publication when the library receives its first issue;
`
`subsequent issues will be entered under the same record and therefore do not
`
`receive a new date in MARC field 008. When the institution receives subsequent
`
`issues/volumes of the periodical, the issues/volumes are checked in (often using a
`
`date stamp), added to the institution’s holdings records, and made available very
`
`soon thereafter—normally within a few days of receipt or (at most) within a few
`
`weeks of receipt.
`
`32.
`
`The initial periodicals record will sometimes not reflect all of the
`
`subsequent changes in publication details (including minor variations in title, etc.).
`
`33.
`
`Internet Archive. The Internet Archive is a non-profit digital library
`
`founded in 1996.
`
`34.
`
`The Internet Archive maintains an archive of Web pages collected
`
`from the Internet using software called a crawler. Crawlers automatically create a
`
`snapshot of Web pages as they existed at a certain point in time. The WayBack
`
`Machine is an application created by the Internet Archive to search its archive of
`
`Web pages and to represent, graphically, the date of each crawler capture.
`
`The
`
`Internet Archive, now with about 50 petabytes of data, collects only Web material
`
`13
`
`Par Pharm., Inc.
`Exhibit 1061
`Page 013
`
`
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`that is publicly available. Some sites are “not archived because they were
`
`password protected, blocked by robots.txt, or otherwise inaccessible to our
`
`automated systems. Site owners might have also requested that their sites be
`
`excluded from the WayBack Machine” (see the WayBack Machine FAQ,
`
`https://archive.org/about/faqs.php#The_Wayback_Machine).
`
`35.
`
`Indexing. An ordinarily skilled 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 information in an index of periodical and other
`
`publications. Having found relevant material, the researcher will then normally
`
`obtain it online, look for it in libraries, or purchase it from the publisher, a
`
`bookstore, a document delivery service, or other provider.
`
`36.
`
`Indexing services use a wide variety of controlled vocabularies to
`
`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.
`
`37.
`
`Indexing services commonly provide bibliographic information,
`
`abstracts, and access to 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 document. A citation of a document
`
`is evidence that the document was publicly available and in use by researchers no
`
`later than the publication date of the citing document.
`
`14
`
`Par Pharm., Inc.
`Exhibit 1061
`Page 014
`
`
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`38.
`
`Sometimes, the date of a document’s public accessibility will involve
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`both indexing and library date information. Date information for indexing entries
`
`is, however, often unavailable, especially for online indexes. Nonetheless,
`
`indexing services enhance their value to researchers by reporting on publications as
`
`promptly as possible. Generally, one may reasonably assume that index entries—
`
`especially those in online services—become available to researchers in reasonably
`
`near proximity to the listed publication date of the documents indexed.
`
`39.
`
`Prominent indexing services include:
`
`40. Web of Science. Like its print predecessors Science Citation Index,
`
`Social Science Citation Index, and Arts and Humanities Citation Index, Web of
`
`Science provides thorough coverage of a broad set of disciplines. A Thomson
`
`Reuters product, Web of Science indexes 1,700 arts and humanities journals from
`
`1975 to the present, 8,500 scientific journals from 1900 to the present, and some
`
`300 social science journals from 1900 to the present.
`
`41.
`
`Scopus. Produced by Elsevier, a major publisher, Scopus is the
`
`largest database of abstracts and citations of peer-reviewed literature. Its scope
`
`includes the social sciences, science, technology, medicine, and the arts. It
`
`includes 60 million records from more than 21,500 titles from some 5,000
`
`international publishers. Coverage includes 360 trade publications, over 530 book
`
`15
`
`Par Pharm., Inc.
`Exhibit 1061
`Page 015
`
`
`
`series, more than 7.2 million conference papers, and 116,000 books. Records date
`
`from 1823.
`
`42. Google Scholar. Google Scholar indexes the texts and metadata of
`
`scholarly publications across a wide range of disciplines. It includes most peer-
`
`reviewed online academic journals, conference papers, theses, technical reports,
`
`and other material. Google does not publish the size of the Google Scholar
`
`database, but researchers have estimated that it contained approximately 160
`
`million items in 2014 (Enrique Oduna-Malea, et al., “About the size of Google
`
`Scholar: playing the numbers,” Scientometrics, 104,3 (September 2015): 931-949,
`
`available at https://arxiv.org/ftp/arxiv/papers/1407/1407.6239.pdf ).
`
`43. MEDLINE/PubMed. Produced by the National Library of Medicine,
`
`MEDLINE provides access to journal articles in the life sciences and biomedicine.
`
`The NLM Medical Subject Headings (MeSH®) are used to provide subject access.
`
`More than 22 million records are included in the database from some 5,600
`
`publications issued from 1950 to the present. The database is freely available via
`
`the PubMed interface and is one of the most heavily used medical databases.
`
`Consideration of individual documents
`
`16
`
`Par Pharm., Inc.
`Exhibit 1061
`Page 016
`
`
`
`Document 1 (Exhibit 1027). Öberg, K. “Treatment of neuroendocrine
`
`tumours of the gastrointestinal tract.” Oncologia, 27,4 (2004): 57-61.
`
`Hereafter referred to as Öberg.
`
`44. Document 1 is a research paper by K. Öberg published in 2004 in
`
`Volume 27, Issue 3 of the journal Oncologia.
`
`45. Based on the evidence presented below—print and online publication,
`
`library date stamp, and indexing—it is my opinion that Öberg was available to
`
`researchers no later than June 2004.
`
`46. Attachment 1a is a true and accurate copy of the Illinois Statewide
`
`Library Catalog for Oncologia, showing that the periodical began publication in
`
`1976 and that 44 libraries world-wide hold the title. Most of these libraries hold
`
`the online version of Oncologia, available through SciELO, the Scientific
`
`Electronic Library Online.
`
`47. Attachment 1b is a true and accurate copy of Öberg in the online
`
`version available from a search for Öberg at the SciELO Web site
`
`(http://scielo.isciii.es/scielo.php?script=sci_home&lng=en&nrm=iso ),
`
`48. Öberg is available in print as well, although relatively few libraries
`
`hold print copies of Oncologia. The British Library is one of these libraries.
`
`Attachment 1c is a true and accurate copy of the British Library catalog record for
`
`17
`
`Par Pharm., Inc.
`Exhibit 1061
`Page 017
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`
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`Oncologia. Attachment 1d is a true and accurate copy of the British Library
`
`holdings record for Oncologia, showing volume 27, issue 4 as available.
`
`49. Attachments 1e and 1f are true and accurate copies of material
`
`relating to Öberg obtained from the British Library. These materials are in a
`
`condition that creates no suspicion about their authenticity. They were found
`
`within the custody of a library – a place where if authentic they would likely be.
`
`50. Attachment 1e is a true and accurate copy of the table of contents for
`
`volume 27, issue 4 of Oncologia obtained from the British Library. The Table of
`
`Contents is in Spanish, but Öberg is listed in English and shown to begin on p. 57.
`
`51. Attachment 1f is a true and accurate copy of the print version of
`
`Öberg obtained from the British Library. It includes the cover for this issue of
`
`Oncologia and some preliminary matter. Attachment 1f bears a British Library
`
`(Boston Spa) date stamp of 24 May 2004. Based on my experience, I affirm this
`
`date stamp has the general appearance of date stamps that libraries have long
`
`affixed to periodicals in processing them. I do not see any indications or have any
`
`reason to believe this date stamp was affixed by anyone other than library
`
`personnel on or about the date indicated by the stamp.
`
`52.
`
`I infer from this 24 May 2004 date stamp that this issue of Oncologia
`
`had been cataloged and was made accessible to readers at the British Library
`
`shortly after it was processed, no later than June 2004.
`
`18
`
`Par Pharm., Inc.
`Exhibit 1061
`Page 018
`
`
`
`53. An ordinarily skilled researcher could also have discovered Öberg
`
`through the Web of Science. Attachment 1g is a true and accurate copy of that
`
`service’s index record for Öberg, drawn from the BIOSIS database. BIOSIS is a
`
`major indexing and abstracting service founded in 1926 and now, since its
`
`purchase by Thompson Reuters, part of the Web of Science. Attachment 1g shows
`
`the bibliographic details for Öberg and the variety of search terms by which the
`
`paper might be found. The Web of Science is a reliable indexing service, listing
`
`articles such as Öberg soon after their listed publication date.
`
`Document 2 (Exhibit 1005). Boulay, Anne, et al. “Antitumor Efficacy
`
`of Intermittent Treatment Schedules with the Rapamycin Derivative RAD001
`
`Correlates with Prolonged Inactivation of Ribosomal Protein S6 Kinase 1 in
`
`Peripheral Blood Mononuclear Cells.” Cancer Research, 65, 1 (January
`
`2004): 252-261. Hereafter referred to as Boulay.
`
`54. Document 2 is a research paper by Anne Bouley and others and
`
`published in the January 2004 issue of the Cancer Research, Volume 65, Number
`
`1, pages 252-261. This paper is herein referred to as Boulay.
`
`55. Based on the evidence presented below—publication in a widely held
`
`periodical, library processing, and indexing—it is my opinion that Boulay was
`
`publicly accessible to an ordinarily skilled researcher by mid-February 2004.
`
`19
`
`Par Pharm., Inc.
`Exhibit 1061
`Page 019
`
`
`
`56. Attachment 2a is a true and accurate copy of the Statewide Illinois
`
`Library Catalog showing that Cancer Research began publication in 1941 and is
`
`held by 694 libraries world-wide. An ordinarily skilled researcher would have had
`
`no difficulty locating copies of this periodical.
`
`57.
`
`The University of Illinois at Urbana-Champaign is one library where
`
`an ordinarily skilled researcher could have found Boulay in 2004. Attachment 2b
`
`is a true and accurate copy of that library’s catalog record for Cancer Research,
`
`showing its holdings of volume 65. Attachment 2c is a true and accurate copy of
`
`Boulay from the University of Illinois at Urbana-Champaign Library’s copy of
`
`Cancer Research. This attachment shows the periodical cover, preliminary matter,
`
`the table of contents showing Boulay, and Boulay. This copy of Boulay is in a
`
`condition that creates no suspicion about its authenticity. It was found within the
`
`custody of a library – a place where if authentic it would likely be.
`
`58.
`
`The cover shown in Attachment 2c includes a date stamp indicating
`
`that the January 2004 issue of Cancer Research was processed at the University of
`
`Illinois at Urbana-Champaign Library on 30 January 2004. Based on my
`
`experience, I affirm this date stamp has the general appearance of date stamps that
`
`libraries have long affixed to periodicals in processing them. I do not see any
`
`indications or have any reason to believe this date stamp was affixed by anyone
`
`other than library personnel on or about the date indicated by the stamp.
`
`20
`
`Par Pharm., Inc.
`Exhibit 1061
`Page 020
`
`
`
`59.
`
`I infer from this 30 January 2004 date stamp that this issue of Cancer
`
`Research had been cataloged and was made accessible to readers at the University
`
`of Illinois at Urbana-Champaign Library shortly after it was processed, no later
`
`than mid-February 2004.
`
`60.
`
`This date stamp indicates the January 2004 issue of the Cancer
`
`Research had been mailed to this library and to other subscribers (including other
`
`library subscribers) sometime before 30 January 2004, because it takes some time
`
`for the item to arrive at and to be processed by the library. I therefore conclude
`
`that the January 2004 issue of Cancer Research would have been received by other
`
`subscribers, and that other subscribing libraries would have processed and made
`
`this issue available to their readers at about the same time.
`
`61. As an example, Attachment 2d is a true and accurate copy of Boulay
`
`from the University of Wisconsin Library, with a date stamp of 23 January 2004
`
`indicating that it was processed by this library on that date. This copy of Boulay is
`
`in a condition that creates no suspicion about its authenticity. It was found within
`
`the custody of a library – a place where if authentic it would likely be. Based on
`
`my experience, I affirm the date stamp in Attachment 2d has the general
`
`appearance of date stamps that libraries have long affixed to periodicals in
`
`processing them. I do not see any indications or have any reason to believe this
`
`date stamp was affixed by anyone other than library personnel on or about the date
`
`21
`
`Par Pharm., Inc.
`Exhibit 1061
`Page 021
`
`
`
`indicated by the stamp. One may reasonably infer from this 23 January 2004 date
`
`stamp that this issue of Cancer Research had been catalogued and was made
`
`accessible to readers at the University of Wisconsin Library shortly after
`
`processing, no later than mid-February 2004. This is within the general time frame
`
`of access documented in Attachment 2c.
`
`62. An ordinarily skilled researcher could also have discovered Boulay
`
`through MEDLINE/PubMed. Attachment 2e is a true and accurate copy of the
`
`MEDLINE/PubMed item record for Boulay, showing the MeSH terms that an
`
`ordinarily skilled researcher could have used to discover Boulay.
`
`MEDLINE/PubMed is a reliable indexing service, listing articles such as Boulay
`
`soon after their publication. Attachment 2f is a true and accurate copy of Boulay,
`
`available from a link in the MEDLINE/PubMed record to the American
`
`Association for Cancer Research (AACR) Publications Web site. This online
`
`copy bears, on the first page, information about the journal title and the publication
`
`date of 1 January 2004.
`
`Document 3 (Exhibit 1029). O’Donnell, A. et al. “A phase 1 study of
`
`the oral mTOR inhibitor RAD001 as monotherapy to identify the optimal
`
`biologically effective dose using toxicity, pharmacokinetic (PK) and
`
`pharmacodynamics (PD) endpoints in patients with solid tumors.” Abstract
`
`803 of a poster discussion. Meeting Proceedings. American Society of
`
`22
`
`Par Pharm., Inc.
`Exhibit 1061
`Page 022
`
`
`
`Clinical Oncology. Thirty-Ninth Annual Meeting, May 31 – June 3, 2003,
`
`Chicago, Illinois, 22 (2003): 200. Hereafter referred to as O’Donnell.
`
`63. Document 3 is an abstract of a research paper by A. O’Donnell and
`
`others presented as a poster discussion at the 2003 annual meeting of the American
`
`Society of Clinical Oncology (ASCO) and published in the ASCO meeting
`
`proceedings in 2003. This abstract is herein referred to as O’Donnell.
`
`64. Based on the evidence presented below—poster presentation at a
`
`prominent conference, publication in a widely held periodical, library cataloging,
`
`and citation—it is my opinion that O’Donnell was publicly accessible to an
`
`ordinarily skilled researcher by no later than mid-August 2003 and was in actual
`
`use by researchers by November 2003.
`
`65. O’Donnell was presented at the ASCO meeting on Tuesday, 3 June
`
`2003. Attachment 3a is a true and accurate copy of the meeting’s program
`
`(available at
`
`https://web.archive.org/web/20050113192755/http:/www.asco.org/asco/downloads
`
`/asco_final_program.pdf ). It describes the broad scope of the meeting and reports
`
`that “nearly 2,100 abstracts, representing the latest advances in cancer research,
`
`will be presented in oral and poster sessions” and that “one hundred sessions in the
`
`2003 ASCO Annual Meeting program are certified for pharmacy and/or nursing
`
`continuing education credit.”
`
`23
`
`Par Pharm., Inc.
`Exhibit 1061
`Page 023
`
`
`
`66. Attachment 3b is a true and accurate copy of O’Donnell from the
`
`University of Minnesota Library. This copy of O’Donnell is in a condition that
`
`creates no suspicion about its authenticity. It was found within the custody of a
`
`library – a place where if authentic it would likely be. Attachment 3b shows that
`
`O’Donnell was presented as a poster discussion on Tuesday [3 June 2003].
`
`Attachment 3b has a library processing date stamp of 29 July 2004. Based on my
`
`experience, I affirm this date stamp has the general appearance of date stamps that
`
`libraries have long affixed to periodicals in processing them, and this date
`
`represents a common interval between a conference presentation and the
`
`publication of the conference proceedings. I do not see any indications or have any
`
`reason to believe this date stamp was affixed by anyone other than library
`
`personnel on or about the date indicated by the stamp.
`
`67.
`
`I infer from this date stamp that the 2003 ASCO Annual Meeting
`
`proceedings wer
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