PaperNo._
`Filed: November 24, 2015
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`NEPTUNE GENERICS, LLC
`
`PETITIONER
`
`V.
`
`ELI LILLY & COMPANY
`
`PATENT OWNER
`
`CASE NO.: UNASSIGNED
`PATENT NO. 7,772,209
`FILED: JULY 11,2007
`ISSUED: AUGUST 10, 2010
`INVENTOR: CLET NIYIKIZA
`
`TITLE: ANTIFOLATE COMBINATION THERAPIES
`
`DECLARATION OF SCOTT BENNETT, Ph.D.
`
`NEPTUNE GENERICS 1029- 00001
`
`APOTEX 1029 - 0001
`
`
`Filed: November 24, 2015
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`NEPTUNE GENERICS, LLC
`
`PETITIONER
`
`V.
`
`ELI LILLY & COMPANY
`
`PATENT OWNER
`
`CASE NO.: UNASSIGNED
`PATENT NO. 7,772,209
`FILED: JULY 11,2007
`ISSUED: AUGUST 10, 2010
`INVENTOR: CLET NIYIKIZA
`
`TITLE: ANTIFOLATE COMBINATION THERAPIES
`
`DECLARATION OF SCOTT BENNETT, Ph.D.
`
`NEPTUNE GENERICS 1029- 00001
`
`APOTEX 1029 - 0001
`
`
`
`I, Scott Bennett, hereby declare as follows:
`
`I.
`
`PROFESSIONAL BACKGROUND AND QUALIFICATIONS
`
`1.
`
`I make this declaration based on my personal knowledge,
`
`consideration of the materials I discuss herein, and my expert opinions.
`
`2.
`
`I am a retired academic librarian working as a Managing Partner in
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`Prior Art Documentation Services LLP, at 711 South Race Street, Urbana, IL,
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`61801-4132. I have over 27 years of research librarian experience.
`
`3.
`
`From 1974-1981, I was employed as an Instructor, Assistant, and
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`Associate Professor of Library Administration at the University of Illinois at
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`Urbana-Champaign, Urbana, IL.
`
`4.
`
`From 1981-1989, I was employed as the Assistant University
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`Librarian for Collection Management at Northwestern University, Evanston, IL.
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`5.
`
`From 1989-1994, I was employed as the Director of the Milton S.
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`Eisenhower Library at the Johns Hopkins University, Baltimore, MD.
`
`6.
`
`From 1994-2001, I was employed as the University Librarian at Yale
`
`University, New Haven, CT.
`
`7.
`
`I received an A.B. in English from Oberlin College (1960), a Ph.D. in
`
`English from Indiana University (1967), and an M.A. in Library Science from the
`
`University oflllinois (1976)
`
`1
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`NEPTUNE GENERICS 1029- 00002
`
`APOTEX 1 029 - 0002
`
`
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`8.
`
`Additional details of my education and experience are set forth in my
`
`curriculum vitae, a copy of which is attached as Exhibit 10028. Information about
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`my company is available at http://www.priorartdocumentation.com.
`
`II.
`
`SCOPE OF THIS REPORT
`
`9.
`
`I have been asked to authenticate the following documents and
`
`establish their availability prior to the earliest priority date of June 30, 1999, and
`
`prior to June 30, 2000 (the filing date of the Provisional Application for the U. S.
`
`Patent No. 7,772,209):
`
`a. Rusthoven, James J., et al. Multi targeted antifolate L Y231514 as
`
`first-line chemotherapy for patients with advanced non-small-celllung
`
`cancer: A phase II study, National Cancer Institute of Canada Clinical
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`Trials. Journal ofClinical Oncology, 17.4 (April1999): 1194-1198
`
`(hereinafter "Rust hoven").
`
`b. Carrasco, M., et al. Acute megaloblastic anemia: homocysteine levels
`
`are useful for diagnosis and follow-up. Haematologica, 84.8 (August
`
`1999): 767-768 (hereinafter "Carrasco").
`
`10.
`
`I reserve the right to supplement my opinion and/or this declaration in
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`the future to respond to any arguments that the Patent Owner raises and to take into
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`account new information as it becomes available.
`
`2
`
`NEPTUNE GENERICS 1029- 00003
`
`APOTEX 1 029 - 0003
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`
`
`III. FEES
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`11. My compensation for time spent working on this matter is based on a
`
`rate of $85 per hour. This compensation is not contingent on my opinions, my
`
`performance or the outcome of the inter partes review, or any issues in or related
`
`to this inter partes review.
`
`IV.
`
`INTRODUCTORY INFORMATION
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`12.
`
`Library catalog records. Libraries world-wide use the MARC format
`
`for catalog records; this format was developed at the Library of Congress in the
`
`1960s. WorldCat is the world's largest public online catalog (see
`
`https:/ /en. wikipedia.org/wiki/OCLC ). Its records appear in many different
`
`catalogs, including the Statewide Illinois Library Catalog.
`
`13.
`
`Library management of periodicals. For periodical publications, a
`
`library will typically create a catalog record for the periodical when the library
`
`orders or receives its first issue. 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 publicly
`
`accessible very soon thereafter-normally within a few days of receipt or (at most)
`
`within a few weeks of receipt.
`
`14.
`
`Indexing. An ordinarily skilled researcher will typically begin his or
`
`her search for relevant information in an index of periodical and other publications.
`
`3
`
`NEPTUNE GENERICS 1029- 00004
`
`APOTEX 1 029 - 0004
`
`
`
`Having found relevant material, the researcher will then obtain it online, look for it
`
`in libraries, or purchase it from the publisher, a bookstore, or other provider.
`
`V.
`
`DOCUMENTS REPRESENTED AS PRIOR ART
`
`A.
`
`Rusthoven
`
`1.
`
`Authentication
`
`15. Rust hoven is a research paper published in the Journal of Clinical
`
`Oncology, an online copy of which is available from Cadmus Article Works (Ex.
`
`1 030). Ex. 1031 is the relevant entry from University of Illinois at Urbana(cid:173)
`
`Champaign Library directory to electronic journals.
`
`2.
`
`Public accessibility
`
`16. Rusthoven was published in the Journal of Clinical Oncology, which
`
`is held by 798libraries world-wide, as indicated in the Statewide Illinois Library
`
`Catalog record for this journal (Ex. 1 032). Ex. 1033 is a copy of Rust hoven, and of
`
`the cover and relevant table of contents for the Journal of Clinical Oncology, from
`
`the University of Illinois at Chicago Library. A somewhat difficult to read date
`
`stamp (Ex. 1033 at 9) shows that Rusthoven was processed at that library in April
`
`1999 and was therefore publicly accessible soon thereafter.
`
`17. Rusthoven was indexed in the widely used Web of Science abstracting
`
`and indexing service (Ex. 1034).
`
`4
`
`NEPTUNE GENERICS 1029- 00005
`
`APOTEX 1 029 - 0005
`
`
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`18. Based on the evidence presented here-online availability of the
`
`document, the indexing record for it, wide spread availability of the journal
`
`title, and a library processing date stamp-it is my opinion that Rusthoven is
`
`an authentic document that was publicly accessible to ordinarily skilled
`
`researchers no later than May 1999.
`
`B. Carrasco
`
`1.
`
`Authentication
`
`19. Carrasco is a research paper, an online copy of which is available
`
`from the Highwire Press (Ex. 1035). Ex. 1036 is the relevant entry from
`
`University of Illinois at Urbana-Champaign Library directory to electronic
`
`journals.
`
`2.
`
`Public accessibility
`
`20. Carrasco was published in Haematologica, a journal that is held by
`
`118 libraries world-wide, as indicated in the Statewide Illinois Library Catalog
`
`record for this journal (Ex. 1037). Ex. 1038 is a copy of Carrasco, and of the
`
`cover and relevant table of contents for the Haematologtca, from the University of
`
`Michigan Taubman Medical Library. A date stamp (Ex. 1038 at 6) shows that
`
`Carrasco was processed at that library on 27 October 1999 and was therefore
`
`publicly accessible soon thereafter.
`
`5
`
`NEPTUNE GENERICS 1029- 00006
`
`APOTEX 1 029 - 0006
`
`
`
`21. Carrasco was indexed in the widely used Web of Science abstracting
`
`and indexing service (Ex. 1039).
`
`22. Based on the evidence presented here-online availability of the
`
`document, the indexing record for it, and wide spread availability of the
`
`journal title, and a library processing date stamp -it is my opinion that
`
`Carrasco is an authentic document that was publicly accessible to ordinarily
`
`skilled researchers no later than November 1999.
`
`VI.
`
`SUMMARY
`
`23.
`
`The evidence described above and supported by the attachments to
`
`this declaration conclusively indicates that Rust hoven was available to diligent
`
`researchers ordinarily skilled in the relevant art substantially before June 30, 1999,
`
`and Carrasco was available to diligent researchers ordinarily skilled in the relevant
`
`art substantially before June 30, 2000.
`
`VII. CERTIFICATION:
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`24.
`
`I declare that all statements made herein of my own knowledge are
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`true and that all statements made on information and belief are believed to be true;
`
`and further that these statements were made with the knowledge that willful false
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`statements and the like so made are punishable by fine or imprisonment, or both,
`
`under Section 1001 ofTitle 18 ofthe United States Code.
`
`Executed on this 23rd day ofNovember, 2015.
`
`6
`
`NEPTUNE GENERICS 1029- 00007
`
`APOTEX 1 029 - 0007
`
`
`
`Respectfully submitted,
`
`Scott Bennett
`Managing Partner
`Prior Art Documentation Services LLC
`
`7
`
`NEPTUNE GENERICS 1029- 00008
`
`APOTEX 1 029 - 0008
`
`
`
`ATTACHMENTS
`
`The following attachments are true and accurate representations oflibrary material
`
`and online documents and records, as they are identified above. All attachments
`
`were created on 17-23 November 2015, and all URLs referenced in this declaration
`
`were available on 18 November 2015.
`
`Exhibit No.
`1030
`
`1031
`
`1032
`
`1033
`
`1034
`1035
`1036
`
`1037
`1038
`
`1039
`
`DESCRIPTION:
`Online copy of Rusthoven from the Web site of the Journal of
`Clinical Oncology
`University of Illinois at Urbana-Champaign Library directory
`entry for the Journal of Clinical Oncology
`Statewide Illinois Library Catalog record for the Journal of
`Clinical Oncology
`Copy of Rusthoven from the University of Illinois at Chicago
`Library
`Web of Science entry for Rusthoven
`Online copy of Carrasco from the High wire Press
`University of Illinois at Urbana-Champaign Library directory
`entry for Haematologica
`Statewide Illinois Library Catalog record for Haematologica
`Copy of Carrasco from the University of Michigan Taubman
`Medical Library
`Web of Science entry for Carrasco
`
`8
`
`NEPTUNE GENERICS 1029- 00009
`
`APOTEX 1 029 - 0009
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