IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`Mylan Laboratories Ltd.
`Petitioner,
`
`v .
`
`Janssen Pharmaceutica NV
`Patent Owner.
`
`U.S. Patent No. 9,439,906 to Vermeulen et al.
`Issue Date: September 13, 2016
`Title: Dosing Regimen Associated with Long
`Acting Injectable Paliperidone Esters
`
`
`
`Inter Partes Review No.: IPR2020-00440
`
`
`
`
`
`
`
`
`
`Declaration of Alys Tryon
`
`
`
`
`
`
`
`
`
`
`
`
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1042 p. 001
`
`

`

`
`
`
`I, Alys Tryon, state and declare as follows:
`
`
`1.
`
`I have prepared this Declaration in connection with the Petition
`
`of Mylan Laboratories Ltd. (“Petitioner”) for inter partes review of U.S.
`
`Patent No. 9,439,906 (“the ’906 patent”). I understand that December 5, 2008
`
`is a date that is relevant for determining what is prior art to the ’906 patent.
`
`2.
`
`I am currently a Research Analyst contractor at Katten Muchin
`
`Rosenman LLP, 525 W. Monroe Street, Chicago, IL 60661-3693. My
`
`employer is the LAC Group.
`
`3.
`
`I am over 18 years of age and am competent to make this
`
`Declaration. I make this Declaration based on my own personal knowledge
`
`and based on my knowledge of library sciences practices.
`
`4.
`
`I earned a Master’s of Library and Information Services
`
`(“MLIS”) from San José State University in 2011.
`
`5.
`
`I have used and become familiar with WorldCat, which is an
`
`online catalog that itemizes the collections of 17,900 libraries in 123 countries
`
`and territories. It is the most comprehensive index of library holdings
`
`worldwide and largest online public access catalog. I am familiar with the
`
`searching features of WorldCat, and I have used WorldCat to conduct
`
`research. WorldCat is a well-known research tool known to those in the field
`
`
`
`1
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1042 p. 002
`
`

`

`
`
`
`
`of research since 2001. WorldCat operates by combining the library
`
`collections of numerous libraries into a single searchable database. This is
`
`accomplished by OCLC (a non-profit organization that was formed in 1967
`
`to help catalog member library’s collections) member libraries uploading
`
`information on their collections to the OCLC System. When a library uploads
`
`information related to the library’s reference collection, OCLC stores
`
`information identifying a date when the information was uploaded.
`
`6.
`
`I have been asked to search for the circulation information
`
`regarding the following scientific journals: (1) Clinical Pharmacology &
`
`Therapeutics; (2) International Journal of Clinical Practice; (3) European
`
`Neuropsychopharmacology; and (4) Hospital Pharmacy.
`
`7.
`
`All of the titles I was asked to search had at least one record
`
`associated with a reputable publisher, and they are all in at least several
`
`hundred individual academic library catalogs worldwide.
`
`8.
`
`I conducted this search on January 13, 2020. My findings are
`
`attached as Exhibits A-D.
`
`9.
`
`I accessed and searched WorldCat Clinical Pharmacology &
`
`Therapeutics, and WorldCat returned two catalog entries: (1) Clinical
`
`Pharmacology & Therapeutics; and
`
`(2) Clinical Pharmacology &
`
`2
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1042 p. 003
`
`

`

`
`
`
`
`Therapeutics: Official Publication of the American Therapeutic Society. A
`
`copy of the report summary is attached as Exhibit A.
`
`10. Clinical Pharmacology & Therapeutics is authored by the
`
`American Society of Pharmacology and Therapeutics. The WorldCat search
`
`returned a total of 695 library results between the two catalog entries.
`
`11.
`
`I accessed and searched WorldCat for the International Journal
`
`of Clinical Practice, and WorldCat returned two catalog entries: (1)
`
`International Journal of Clinical Practice; and (2) The International Journal of
`
`Clinical Practice IJCP. A copy of the report summary is attached as Exhibit
`
`B.
`
`12. The International Journal of Clinical Practice is published by
`
`Wiley-Blackwell. The WorldCat search returned a total of 575 library results
`
`between the two catalog entries.
`
`13.
`
`I accessed and searched WorldCat for Hospital Pharmacy, and
`
`WorldCat returned three catalog entries: (1) Hospital Pharmacy; (2) Hospital
`
`Pharmacy Europe HPE; and (3) Hospital Pharmacy: A Peer-Reviewed Journal
`
`for Hospital and Organized Health Care Systems Pharmacists. A copy of the
`
`report summary is attached as Exhibit C.
`
`14. The WorldCat search returned a total of 609 library results
`
`between the three catalog entries.
`
`3
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1042 p. 004
`
`

`

`
`
`
`
`15.
`
`I
`
`accessed
`
`and
`
`searched WorldCat
`
`for European
`
`Neuropsychopharmacology and WorldCat returned four catalog entries: (1)
`
`European
`
`Neuropsychopharmacology;
`
`(2)
`
`European
`
`Neuropsychopharmacology : ENP; The Journal of the European College of
`
`Neuropsychopharmacology; (3) European Neuropsychopharmacology : ENP:
`
`The Journal of the European College of Neuropsychopharmacology; and (4)
`
`European Neuropsychopharmacology. A copy of the report summary is
`
`attached as Exhibit D.
`
`16. The WorldCat search returned a total of 907 results between the
`
`four catalog entries.
`
`17. To the best of my knowledge and based on my experience, all
`
`titles that I was asked to search are academic in nature and the results indicate
`
`that these references are widespread.
`
`18. For example, European Neuropsychopharmacology was located
`
`in the Stanford University Lane Medical Library and the University of
`
`California, Riverside. Exhibit D at 6-9. Hospital Pharmacy was located in the
`
`University of Florida library and the National Library of Medicine. Exhibit C
`
`at 3. The International Journal of Medicine was located in several universities
`
`within California alone: University of California, Irvine; The Claremont
`
`Colleges; and the University of Southern California, Norris Medical Library.
`
`4
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1042 p. 005
`
`

`

`
`
`
`
`
`
`
`Exhibit B at 1-2. Clinical Pharmacology & Therapeutics was also located
`
`several times within California: University of California, Irvine; University of
`
`California, Riverside; and Western University of Health Sciences. Exhibit A
`
`at 1.
`
`19.
`
`I hereby declare that all statements made herein of my own
`
`knowledge are 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 statements and the like so made are punishable
`
`by fine or imprisonment, or both, under Section 1001 of Title 18 of the United
`
`States Code.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`________________
`Alys Tryon
`
`5
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1042 p. 006
`
`

`

`Mylan v. Janssen (IPR2020-00440) Ex. 1042 p. 007
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`1532-6535
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`M.i.v. 2007 uitgegeven door: New York : Nature Publishing Group; m.i.v. 2015 uitgegeven door: Chichester
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`Zeitschrift
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`Erscheint auch als
`
`International journal of clinical practice / Supplement. Supplement.
`Oxford : Wiley-Blackwell, 1997-2013
`Druck-Ausgabe, 1997-2013
`(DE-605)HT012701708
`
`
`
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`Mylan v. Janssen (IPR2020-00440) Ex. 1042 p. 016
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`Mylan v. Janssen (IPR2020-00440) Ex. 1042 p. 020
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