UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_______________________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________________
`
`
`PAR PHARMACEUTICAL, INC.
`Petitioner
`
`v.
`
`SUMITOMO DAINIPPON PHARMA CO., LTD.
`Patent Owner
`_______________________
`
`U.S. Patent No. 9,555,027
`
`Title: Pharmaceutical Composition
`_______________________
`
`
`Inter Partes Review Case No. Unassigned
`
`
`
`
`DECLARATION OF SCOTT BENNETT, Ph.D.
`13 April, 2017
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 001
`
`
`
`_______________________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________________
`
`
`PAR PHARMACEUTICAL, INC.
`Petitioner
`
`v.
`
`SUMITOMO DAINIPPON PHARMA CO., LTD.
`Patent Owner
`_______________________
`
`U.S. Patent No. 9,555,027
`
`Title: Pharmaceutical Composition
`_______________________
`
`
`Inter Partes Review Case No. Unassigned
`
`
`
`
`DECLARATION OF SCOTT BENNETT, Ph.D.
`13 April, 2017
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 001
`
`
`
`TABLE OF CONTENTS
`
`Page
`
`I.
`
`II.
`
`INTRODUCTION .......................................................................................... 1
`
`BACKGROUND AND QUALIFICATIONS ................................................ 1
`
`III.
`
`PRELIMINARIES .......................................................................................... 3
`
`IV. OPINIONS REGARDING INDIVIDUAL DOCUMENTS ........................10
`
`V.
`
`ATTACHMENTS ........................................................................................18
`
`VI.
`
`CONCLUSION ............................................................................................19
`
`
`
`i
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 002
`
`
`
`I, Scott Bennett, hereby declare under penalty of perjury:
`
`I.
`
`INTRODUCTION
`
`1.
`
`I have personal knowledge of the facts and opinions set forth in this
`
`declaration, I believe them to be true, and if called upon to do so, I would testify
`
`competently to them. I have been warned that willful false statements and the like
`
`are punishable by fine or imprisonment, or both.
`
`2.
`
`I am a retired academic librarian working as a Managing Partner of
`
`the firm Prior Art Documentation LLC at 711 South Race Street, Urbana, IL,
`
`61801-4132. Exhibit 1005 is a true and correct copy of my Curriculum Vitae
`
`describing my background and experience. Further information about my firm is
`
`available at www.priorartdocumentation.com.
`
`3.
`
`I have been retained by Latham & Watkins LLP to authenticate and
`
`establish the dates of public accessibility of certain documents in an inter partes
`
`review proceeding for U.S. Patent No. 9,555,027 (Exhibit 1001, “the ’027
`
`Patent”). For this service, I am being paid my usual hourly fee of $88/hour. My
`
`compensation in no way depends on the substance of my testimony or the
`
`outcome of this proceeding.
`
`II. BACKGROUND AND QUALIFICATIONS
`
`4.
`
`I was previously employed as follows:
`
`
`
`University Librarian, Yale University, New Haven, CT, 1994-2001;
`
`
`
`1
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 003
`
`
`
`
`
`Director, The Milton S. Eisenhower Library, The Johns Hopkins
`
`University, Baltimore, MD, 1989-1994;
`
`
`
`Assistant University Librarian for Collection Management,
`
`Northwestern University, Evanston, IL, 1981-1989;
`
`
`
`Instructor, Assistant, and Associate Professor of Library
`
`Administration, University of Illinois at Urbana-Champaign, Urbana,
`
`IL, 1974-1981; and
`
`
`
`Assistant Professor of English, University of Illinois at Urbana-
`
`Champaign, 1967-1974.
`
`5.
`
`Over the course of my work as a librarian, professor of English,
`
`researcher, and author of nearly fifty scholarly papers and other publications, I
`
`have had extensive experience with cataloging records and online library
`
`management systems built around Machine-Readable Cataloging (MARC)
`
`standards. I also have substantial experience in authenticating printed documents
`
`and establishing the date when they were accessible to researchers.
`
`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
`
`
`
`2
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 004
`
`
`
`literature on the information seeking behaviors of academic researchers. And as
`
`an educator, I have a broad knowledge of the ways in which students in a variety
`
`of disciplines learn to master the bibliographic resources used in their disciplines.
`
`In all of these ways, I have a general knowledge of how researchers work.
`
`III. PRELIMINARIES
`
`7.
`
`Scope of this declaration. I am not a lawyer and I am not rendering
`
`an opinion on the legal question of whether any particular document is, or is not, a
`
`“printed publication” under the law.
`
`8.
`
`I am, however, rendering my expert opinion on the authenticity of the
`
`documents referenced herein and on when and how each of these documents was
`
`disseminated or otherwise made available to the extent that persons interested and
`
`ordinarily skilled in the subject matter or art, exercising reasonable diligence,
`
`could have located the documents before 26 May 2005.
`
`9. Materials considered. In forming the opinions expressed in this
`
`declaration, I have reviewed the documents and attachments referenced herein.
`
`These materials are records created in the ordinary course of business by
`
`publishers, libraries, indexing services, and others. From my years of experience,
`
`I am familiar with the process for creating many of these records, and I know
`
`these records are created by people with knowledge of the information in the
`
`record. Further, these records are created with the expectation that researchers
`
`
`
`3
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 005
`
`
`
`and other members of the public will use them. All materials cited in this
`
`declaration and its attachments are of a type that experts in my field would
`
`reasonably rely upon and refer to in forming their opinions.
`
`10. Persons of ordinary skill in the art. I am told by counsel that the
`
`subject matter of this proceeding relates to pharmaceutical compositions.
`
`11.
`
`I have been informed by counsel that the “person of ordinary skill in
`
`the art at the time of the invention” is a hypothetical person who is presumed to be
`
`familiar with the relevant field and its literature at the time of the invention. This
`
`hypothetical person is also a person of ordinary creativity, capable of
`
`understanding the scientific principles applicable to the pertinent field.
`
`12.
`
`I am told by counsel that a person of ordinary skill in this art as of
`
`May 26, 2005, would be a formulator with a Ph.D. in pharmaceutics, or in a drug
`
`delivery-relevant field of a related discipline such as physical chemistry, or could
`
`have a bachelor’s degree in pharmaceutics or in a related field, plus two to five
`
`years of relevant experience in developing solid oral drug formulations. This
`
`description is approximate, and a higher level of education or skill might make up
`
`for less experience, and vice versa. This person of ordinary skill may also consult
`
`with others from an interdisciplinary team, such as a clinician with experience in
`
`treating and/or dosing schizophrenic patients.
`
`
`
`4
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 006
`
`
`
`13.
`
`It is my opinion that such a person would have been engaged in
`
`advanced research starting at least in university or graduate school, learning
`
`though study and practice in the field and possibly through formal instruction
`
`from the bibliographic resources relevant to his or her research. In the 1990s and
`
`2000s such a person would have had access to a vast array of long-established
`
`print resources in pharmacology as well as to a rich and fast changing set of online
`
`resources providing indexing information, abstracts, and full text services for
`
`pharmacology.
`
`14. Library catalog records. 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 records appear in many different catalogs, including the
`
`Statewide Illinois Library Catalog.
`
`15. 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 catalog
`
`records.
`
`
`
`5
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 007
`
`
`
`16. 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.
`
`17. 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.
`
`18. Periodical publications. A library typically creates a catalog record
`
`for a periodical publication when the library 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 available very soon thereafter—normally
`
`within a few days of receipt or (at most) within a few weeks of receipt.
`
`19. The initial periodicals record will sometimes not reflect all of the
`
`subsequent changes in publication details (including minor variations in title, etc.).
`
`20.
`
`Internet Archive. The Internet Archive is a non-profit digital library
`
`founded in 1996.
`
`21. The Internet Archive maintains an archive of webpages collected
`
`from the Internet using software called a crawler. Crawlers automatically create a
`
`snapshot of webpages 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
`
`
`
`6
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 008
`
`
`
`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
`
`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” (Internet Archive Frequently Asked
`
`Questions – The Wayback Machine,
`
`https://archive.org/about/faqs.php#The_Wayback_Machine (last visited April 5,
`
`2017)) (Attachment 5).
`
`22. Many Internet Archive captures made by the Wayback Machine have
`
`a banner at the top with the capture date prominently displayed. Other dates when
`
`captures of the same URL have been made are indicated to the right and left of the
`
`date provided in the banner. Some captures may lack this banner. In any case, the
`
`URL for the capture begins with the identification of the Internet Archive (e.g.,
`
`http://web.archive.org/web/) followed by information that dates and time stamps
`
`the capture as follows: year in yyyy, month in mm, day in dd, time code in
`
`hh:mm:ss (e.g., 20041208081749, or 8 December 2004 at 8:17:49 a.m.). These
`
`elements are then followed by the URL of the original capture site.
`
`23.
`
`Internet Archive captures often include links to other, related
`
`documents. Sometimes these links have become inactive. Where they remain
`
`
`
`7
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 009
`
`
`
`active, the Wayback Machine is programmed to produce the archived file with the
`
`closest available date (not the closest available prior date) to the page upon which
`
`the link appeared and was clicked.
`
`24.
`
`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 information in an index of periodicals 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. Sometimes, the date of a document’s public
`
`accessibility will involve both indexing and library date information. Date
`
`information for indexing entries is, however, often unavailable. This is especially
`
`true for online indices.
`
`25.
`
`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.
`
`26. Online indexing services 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 document. A citation of a document
`
`
`
`8
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 010
`
`
`
`is evidence that the document was publicly available and in use by researchers no
`
`later than the publication date of the citing document.
`
`27. Prominent indexing services include:
`
`28. 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
`
`series, more than 7.2 million conference papers, and 116,000 books. Records date
`
`from 1823.
`
`29. Science Direct. Science Direct, provided by Elsevier, is a database of
`
`abstracts and articles in the physical sciences and engineering, the life and health
`
`sciences, and the social sciences and humanities. It has over 12 million items from
`
`3,500 journals and 34,000 books.
`
`30. 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 Oduña-Malea et al., About the Size of Google
`
`
`
`9
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 011
`
`
`
`Scholar: Playing the Numbers, 18 EC3 WORKING PAPERS 1 (Jul. 2014), available
`
`at https://arxiv.org/ftp/arxiv/papers/1407/1407.6239.pdf (Attachment 4).
`
`IV. OPINIONS REGARDING INDIVIDUAL DOCUMENTS
`
`Document 1. K.P.R. Chowdary & N. Rama Rao, Formulation and
`Evaluation of Dispersible Tablets with Pregelatinized Starch, 35 INDIAN
`DRUGS 368 (1998)
`
`1.
`
`Authentication
`
`31. Document 1 is a research paper by K. P. R. Chowdary and N. Rama
`
`Rao published in the June 1998 issue of Indian Drugs.
`
`32. Attachment 1a is a true and correct copy of Document 1 (along with
`
`the volume cover, contents pages, and a page listing other IDMA publications)
`
`from the National Library of Medicine. Attachment 1b is a true and correct copy
`
`of the National Library of Medicine catalog record for Indian Drugs, showing the
`
`holdings for volume 35, no. 4 through volume 37, no. 6 issues of this periodical,
`
`including therefore volume 35, no. 6, in which Document 1 was published.
`
`33. Attachment 1a is in a condition that creates no suspicion about its
`
`authenticity. Specifically, Document 1 in Attachment 1a is not missing any
`
`intermediate pages of the article’s text, the text on each page appears to flow
`
`seamlessly from one page to the next, and there are no visible alterations to the
`
`document. Attachment 1a was found within the custody of a library—a place
`
`where, if authentic, it would likely be found.
`
`
`
`10
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 012
`
`
`
`34. Attachment 1c is a true and accurate copy of the Scopus index record
`
`for Document 1, showing the many keywords under which Document 1 might be
`
`found.
`
`35. Attachment 1d is a true and accurate copy of the entry for Indian
`
`Drugs from Ulrichsweb, the most complete, authoritative, and commonly used
`
`online directory of periodical publications. This record reports an International
`
`Standard Serial Number (ISSN) of 0019-462X, the same as the ISSN number on
`
`the cover of Indian Drugs in Attachment 1a and in the Attachment 1b catalog
`
`record for Indian Drugs.
`
`36.
`
`I have compared Attachment 1a, a copy of Document 1 from the
`
`National Library of Medicine, with Exhibit 1011, a copy of Document 1 provided
`
`by counsel. I find them to be substantively the same document.
`
`37.
`
`I conclude, based on finding Document 1 in a library and on finding
`
`library catalog records and an online index record for Document 1, that
`
`Attachment 1a and Exhibit 1011 are authentic copies of Document 1.
`
`2.
`
`Public Accessibility
`
`38. Attachment 1e is a true and correct copy of the Statewide Illinois
`
`Library Catalog record for Indian Drugs, showing this periodical was first
`
`published in 1963 and is held by 22 libraries world-wide. Researchers would have
`
`had no difficulty finding copies of Indian Drugs.
`
`
`
`11
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 013
`
`
`
`39. Attachment 1a, from the National Library of Medicine, includes a
`
`library date label indicating that the June 1998 issue of Indian Drugs was
`
`processed on 3 December 1998. Based on my experience, I affirm this date label
`
`has the general appearance of date labels that libraries have long affixed to
`
`periodicals in processing them. I do not see any indications or have any reason to
`
`believe this date label was affixed by anyone other than library personnel on or
`
`about the date indicated by the label.
`
`40. Allowing for some time between affixing the date label of 3
`
`December 1998 and the appearance of the June 1998 issue of Indian Drugs on
`
`library shelves, where it would be publicly available, it is my opinion that
`
`Document 1 was publicly available at least by January 1999.
`
`3.
`
`Conclusion
`
`41. Based on the evidence presented here—publication in periodical,
`
`ISSN number, library processing and cataloging, online indexing—it is my
`
`opinion that Document 1 is an authentic document that was publicly
`
`available to researchers by January 1999.
`
`Document 2. Colorcon, Starch 1500: Partially Pregelantinized Maize Starch
`(1999)
`
`1.
`
`Authentication
`
`42. Document 2 is a product description brochure copyrighted by
`
`Colorcon in 1999.
`
`
`
`12
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 014
`
`
`
`43. Attachment 2a is a true and correct copy of an Internet Archive
`
`capture with a banner date of 07 December 2004, as explained in paragraphs 22
`
`and 23 above. Attachment 2a shows various documents relating to Starch 1500®
`
`available from Colorcon. The Sales Brochure listed here is available in 7
`
`languages. I obtained Attachment 2b, the English language version of the Sales
`
`Brochure, from the Internet Archive at
`
`http://web.archive.org/web/20041208081749/http://www.colorcon.com/pharma/ex
`
`cipients/starch/lit/sales_brochures/english.pdf. I note that the URL for
`
`Attachment 2b indicates it was captured by the Wayback Machine on 8 December
`
`2004, as explained in paragraphs 22 and 23, above.
`
`44.
`
` Attachment 2c is a true and correct copy of another Internet Archive
`
`capture of Document 2, which I obtained at
`
`https://web.archive.org/web/20050501004036/http://www.colorcon.com/pharma/e
`
`xcipients/starch/lit/sales_brochures/english.pdf. I note that the URL for
`
`Attachment 2c indicates it was captured by the Wayback Machine on 4 May 2005,
`
`as explained in paragraphs 22-23 above.
`
`45.
`
`I have examined Attachments 2b and 2c and find them to be
`
`substantively identical to one another. For instance, the design elements and text
`
`blocks are the same in Attachments 2b and 2c; both Attachments bear the same
`
`1999 copyright date and the same printing abbreviation, EX/STAR/PB1199. I
`
`
`
`13
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 015
`
`
`
`conclude there is no evidence of any substantive change to Document 2 between 8
`
`December 2005 and 4 May 2005.
`
`46.
`
`I have compared Attachments 2b and 2c with Exhibit 1025, a copy of
`
`Document 2 provided by counsel. I find them to be substantively the same
`
`document.
`
`47. Based on these findings, I have confirmed that Attachments 2b and
`
`2c and Exhibit 1025 are authentic copies of Document 2.
`
`2.
`
`Public Accessibility
`
`48. As discussed in Paragraph 43 and Paragraphs 21-23 above,
`
`Document 2 is accessible through the Internet Archive webcrawlers at least as
`
`early as 8 December 2004. Further, it is self-evident that Colorcon would have
`
`wished to make Document 2 readily available to customers. Therefore, the
`
`reasonable conclusion is that (1) internet search engines circa 2004 would have
`
`been able to find and index Document 2, and (2) a person of ordinary skill in the
`
`art in 2004 using typical internet search tools would have readily found a copy of
`
`Document 2.
`
`49. Attachment 2a lists a number of other documents related to
`
`Starch 1500® as being available on the banner date of this capture, 07 December
`
`2004. Included are Attachment 2d, a poster reprint relating to Low Dose Drugs
`
`presented at the November 2000 AAPS meeting; Attachment 2e, an article by two
`
`
`
`14
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 016
`
`
`
`Colorcon authors relating to Moisture Sensitive Drugs published in the May 2001
`
`issue of Pharmaceutical Technology Europe; and Attachment 2f, a poster reprint
`
`relating to Moisture Sensitive Drugs presented at the October 2001 AAPS
`
`meeting. I conclude from these supporting Colorcon documents that various
`
`attributes of Starch 1500® were well documented before 26 May 2005.
`
`3.
`
`Conclusion
`
`50. Based on the evidence presented here—Internet Archive captures—it
`
`is my opinion that Document 2 is an authentic document that was publicly
`
`available to researchers by at least 8 December 2004.
`
`Document 3. PHARMACEUTICS: THE SCIENCE OF DOSAGE FORM DESIGN 136
`(Michael E. Aulton ed., 1988)
`
`1.
`
`Authentication
`
`51. Document 3 is a book by Michael Aulton published by Churchill
`
`Livingston in 1988. Attachment 3a is a true and accurate copy of the book’s title
`
`page, title page verso, table of contents, and Chapters 9, 13, 18, and 39 from the
`
`Rutgers University Library. Attachment 3b is a true and accurate copy of that
`
`library’s catalog record, in MARC format, for Document 3.
`
`52. Attachment 3a is in a condition that creates no suspicion about its
`
`authenticity. Specifically, Chapters 9, 13, 18, and 39 in Document 3 are not
`
`missing any intermediate pages, the text on each page appears to flow seamlessly
`
`from one page to the next, and there are no visible alterations to the document
`
`
`
`15
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 017
`
`
`
`(other than a few highlighted items in Chapters 13 and 39). Attachment 3a was
`
`found within the custody of a library – a place where, if authentic, it would likely
`
`be found.
`
`53.
`
`I have compared Attachment 3a, a copy from the Rutgers University
`
`Library, with Exhibit 1009, a copy of Document 3 provided by counsel. I find
`
`them to be substantively the same document.
`
`54.
`
`I conclude, based on finding Document 3 in a library and on finding
`
`library catalog records for Document 3, that Attachment 3a and Exhibit 1009 are
`
`authentic copies of Document 3.
`
`2.
`
`Public accessibility
`
`55. Attachment 3c is a Statewide Illinois Library Catalog record for
`
`Document 3, showing that Document 3 is held by 88 libraries world-wide and was
`
`cataloged or indexed in a meaningful way—including being cataloged by subject.
`
`In Attachment 3c, the date of entry, corresponding to the MARC Field 008,
`
`subfield a, indicates that Document 3 was first cataloged on 12 September 1986,
`
`well before the publication of Document 3. This was a cataloging-in-publication
`
`record, as evident from the verso of the title page in Attachment 3a, which
`
`displays cataloging-in-publication information from both the British Library and
`
`the Library of Congress. I conclude from this catalog record that Document 3 was
`
`bibliographically identifiable by 12 September 1986.
`
`
`
`16
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 018
`
`
`
`56.
`
`In Attachment 3b, the Rutgers University Library catalog record for
`
`Document 3, the MARC Field 040 indicates this record was created jointly by the
`
`National Library of Medicine and the Library of Congress (OCLC codes = DNLM
`
`and DLC). The MARC Field 008, subfield 8, indicates this record was created on
`
`3 February 1988.
`
`57. Attachment 3d is a true and accurate copy of a second Statewide
`
`Illinois Library catalog record for Document 3, showing the book is held by
`
`another 10 libraries world-wide. The date of entry in Attachment 3d,
`
`corresponding to the MARC Field 008, indicates this catalog record was created
`
`on 17 February 1988.
`
`58. Given this cataloging evidence, it is my opinion that Document 3 was
`
`sufficiently accessible to the public interested in the art; and an ordinarily skilled
`
`researcher, exercising reasonable diligence, would have had no difficulty finding
`
`copies of Document 3 in at least one library by March 1988.
`
`59. Attachment 3e is a true and accurate copy of a Google Scholar list of
`
`publications citing Document 3. One document citing Document 3 is by Hak-Kim
`
`Chan & Igor Gondoa, Serendipitous Preparation of Crystals of Methotrexate and
`
`Attempts to Modify its Crystal Habit, 94 JOURNAL OF CRYSTAL GROWTH 488
`
`(1988). Attachment 3f is a true and accurate copy of the Science Direct record for
`
`the Chan and Gondoa paper; it shows that the paper was received by the Journal
`
`
`
`17
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 019
`
`
`
`of Crystal Growth on 15 September 1988 and that Document 3 is the fifth item in
`
`its list of references.
`
`3.
`
`Conclusion
`
`60. Based on the evidence presented here—book publication, library
`
`cataloging, and citations—it is my opinion that Document 3 is an authentic
`
`document that was bibliographically identifiable by 12 September 1986 and
`
`was publicly available in at least one library at least by March 1988. The
`
`citation evidence presented here indicates that Document 3 was in actual use by
`
`researchers at least by September 1988.
`
`V. ATTACHMENTS
`
`61. The attachments attached hereto are true and correct copies of the
`
`materials identified above. Helen Sullivan is a Managing Partner in Prior Art
`
`Documentation Services LLC (see http://www.priorartdocumentation.com/helen-
`
`sullivan/ ). One of her primary responsibilities in our partnership is to secure the
`
`bibliographic documentation used in attachments to our declarations.
`
`62. Ms. Sullivan and I work in close collaboration on the bibliographic
`
`documentation needed in each declaration. I will sometimes request specific
`
`bibliographic documents or, more rarely, secure them myself. In all cases, I have
`
`carefully reviewed the bibliographic documentation used in my declaration. My
`
`
`
`18
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 020
`
`
`
`signature on the declaration indicates my full confidence in the authenticity,
`
`accuracy, and reliability of the bibliographic documentation used.
`
`63. Each Attachment has been marked with an identifying label on the
`
`top of each page. No alterations other than these noted labels appear in these
`
`attachments. All attachments were created on 11 January 2017 – 5 April 2017 and
`
`all URLs referenced in this declaration were available 28 March 2017.
`
`VI. CONCLUSION
`
`64.
`
`In summary, I conclude that Documents 1, 2, and 3 discussed above
`
`are all authentic documents that were publicly accessible before 26 May 2005.
`
`65.
`
`I reserve the right to supplement my opinions in the future to respond
`
`to any arguments that the Patent Owner or its expert(s) may raise and to take into
`
`account new information as it becomes available to me.
`
`
`
`I declare under penalty of perjury that the foregoing is true and correct.
`
`
`
`Executed this 13th day of April, 2017 in Urbana, Illinois.
`
`
`
`
`____________________________
`Scott Bennett
`
`
`
`19
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 021
`
`
`
`ATTACHMENT 1a
`ATTACHMENTla
`
`hibit 1004
`Page 022
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 022
`
`
`
`Attachment 1a: Copy of Document 1 from the National Library of Medicine
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 023
`
`
`
`Attachment 1a: Copy of Document 1 from the National Library of Medicine
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 024
`
`
`
`Attachment 1a: Copy of Document 1 from the National Library of Medicine
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 025
`
`
`
`Attachment 1a: Copy of Document 1 from the National Library of Medicine
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 026
`
`
`
`Attachment 1a: Copy of Document 1 from the National Library of Medicine
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 027
`
`
`
`Attachment 1a: Copy of Document 1 from the National Library of Medicine
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 028
`
`
`
`Attachment 1a: Copy of Document 1 from the National Library of Medicine
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 029
`
`
`
`ATTACHMENT 1b
`ATTACHMENT 1b
`
`
`
`hibit 1004
`Page 030
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 030
`
`
`
`Attachment 1b: National Library of Medicine catalog record for Indian Drugs
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 031
`
`
`
`ATTACHMENT 1c
`ATTACHMENTIc
`
`
`
`hibit 1004
`Page 032
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 032
`
`
`
`Attachment 1c: Scopus index record for Document 1
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 033
`
`
`
`Attachment 1c: Scopus index record for Document 1
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 034
`
`
`
`ATTACHMENT 1d
`ATTACHMENTId
`
`
`
`hibit 1004
`Page 035
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 035
`
`
`
`Attachment 1d: Ulrichsweb record for Indian Drugs
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 036
`
`
`
`ATTACHMENT 1e
`ATTACHMENTle
`
`
`
`hibit 1004
`Page 037
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 037
`
`
`
`Attachment 1e: Statewide Illinois Library Catalog record for Indian Drugs
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 038
`
`
`
`Attachment 1e: Statewide Illinois Library Catalog record for Indian Drugs
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 039
`
`
`
`ATTACHMENT 2a
`ATTACHMENT2a
`
`
`
`hibit 1004
`Page 040
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 040
`
`
`
`Attachment 2a: List of Colorcon publications relating to Starch 1500
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 041
`
`
`
`Attachment 2a: List of Colorcon publications relating to Starch 1500
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 042
`
`
`
`ATTACHMENT 2b
`ATTACHMENT 2b
`
`
`
`hibit 1004
`Page 043
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 043
`
`
`
`STARCH 1500®
`
`P A R T I A L L Y P R E G E L A T I N I Z E D M A I Z E S T A R C H
`
`Flexibility for performance
`
`C
`
`O
`
`L
`
`O
`
`R
`
`C
`
`O
`
`N
`
`®
`
`Attachment 2b: Copy of Document 2 (1)
`
`Par Pharm., Inc.
`Exhibit 1004
`Page 044
`
`
`
`DIRECT COMPACTION
`
`Starch 1500 performs key functions in
`direct compaction formulations as a binder,
`disintegrant, flow-aid and self-lubricant.
`It also promotes formulation f lexibility
`by complementing and enhancing the
`functionality of other excipients.
`
`B I N D E R
`
`As a dr y binder, it compresses well,
`predominately deforming plastically. Starch
`1500 can be used with other excipients,
`such as microcrystalline cellulose, lactose,
`and dicalcium phosphate, to produce
`tablets with excellent hardness and low
`friability at compaction forces typically
`used in tableting operations.
`
`D I S I N T E G R A N T
`
`Starch 1500 performs the actions of two
`disintegrants; maize starch and free amylose
`in dry processes. In some applications, 2%
`to 10% of Starch 1500 provides disintegrant
`action as effective as super disintegrants,
`greatly reducing costs. (See Figure 1)
`
`Figure 1
`
`DISINTEGRATION PROFILE FOR HYDROCHLOROTHIAZIDE TABLETS, 50 MG **
`
`DISINTEGRATIONTIME(MINUTES)
`
`The combination of maize starch and
`free amylose has a positive impact on
`drug dissolution. Supporting the tablet
`disintegration data in Figure 1, the
`resulting drug dissolution data
`in
`Figure 2 compares Starch 1500 with
`more costly disintegrants.
`
`STARCH 1500 ®
`PARTIALLY PREGELATINIZED MAIZE STARCH
`T H E S U P E R I O R M U LT I F U N C T I O N A L E X C I P I E N T F O R
`
`S O L I D D O S A G E D E V E L O P M E N T
`
`Starch 1500 is a unique pharmaceutical excipient combining
`
`several properties in a single product. Only Starch 1500
`
`performs the multiple functions of a binder, disintegrant,
`
`flow-aid and self-lubricant. It is extremely versatile, being
`
`effective in a variety of processing methods for solid oral
`
`dosage form
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