`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________
`
`MYLAN LABORATORIES LTD.
`Petitioner
`
`v.
`
`JANSSEN PHARMACEUTICA NV
`Patent Owner
`____________________
`
`Case IPR2020-00440
`Patent 9,439,906
`____________________
`
`
`DECLARATION OF JOONG YOUN (JAY) CHO
`
`
`
`Janssen Ex. 2012
`Mylan v. Janssen
`IPR2020-00440
`
`
`
`
`
`I, Joong Youn (Jay) Cho, hereby attest to the following:
`
`1. I am an attorney at the law firm of Patterson Belknap Webb & Tyler LLP. I
`
`am licensed to practice law in the State of New York (Bar No. 5322771) and also
`
`before the United States Patent and Trademark Office (Reg. No. 75,052). I have
`
`personal knowledge of the facts set forth in this declaration.
`
`2. Exhibit 2009 contains accurate reproductions of the text from:
`
`a. Ex. 1016 (U.S. Provisional Application No. 61/014,918) at p. 22 ll. 9
`
`– p. 23 ll. 18 (“Example 2”); Ex. 1016 at p. 23 ll. 20 – p. 24 ll. 27
`
`(“Example 3”); and
`
`b. Ex. 1003 (Abstracts of the Annual Meeting of the American Society
`
`for Clinical Pharmacology and Therapeutics, 83 Supp. 1 Clin.
`
`Pharmacol. & Therapeutics S31, PI-74 and PI-75 (Mar. 2008)) at
`
`p.003 PI-74 (heading, title, authors, background, methods, results, and
`
`conclusion) (“PI-74”); Ex. 1003 at p.003 PI-75 (heading, title, authors,
`
`background, methods, results, and conclusion) (“PI-75”).
`
`3. The text font and size of Exhibit 2009 was set to be Times New Roman 12
`
`point. In the first table of Exhibit 2009, the text of Example 2 was placed into the
`
`left-hand column and the text of PI-75 was placed into the right-hand column. In
`
`the second table of Exhibit 2009, the text of Example 3 was placed into the left-
`
`hand column and the text of PI-74 was placed into the right-hand column. For ease
`
`
`
`2
`
`Janssen Ex. 2012
`Mylan v. Janssen
`IPR2020-00440
`
`
`
`
`
`of comparison between the text on the left-hand side and the text on the right-hand
`
`side, line spacing adjustments were made and highlighting was added. No other
`
`alterations were made to the text.
`
`4. Exhibit 2010 is a complete list of FDA-approved drugs containing
`
`paliperidone palmitate that was generated by performing a search using the term
`
`“paliperidone palmitate” on the FDA-Approved Drugs website
`
`(https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm). Each entry in the
`
`search result list was expanded to show additional information about the drug. A
`
`copy of the information displayed was generated by using the print function on the
`
`webpage and saving the resulting image as a PDF file and made to bear the label
`
`Exhibit 2010.
`
`5. Exhibit 2011 is the “Summary Review” for Invega Trinza® obtained from
`
`the FDA website. The FDA webpage for Invega Trinza® was accessed by clicking
`
`the “INVEGA TRINZA (PALIPERIDONE PALMITATE)” hyperlink in the search
`
`results webpage shown in Exhibit 2010. On the FDA webpage for Invega Trinza®,
`
`the hyperlink “Summary Review” was selected. A copy of the resulting document
`
`was saved as a PDF file and made to bear the label Exhibit 2011.
`
`6. I hereby declare that all statements made herein of my own knowledge are
`
`true, and further that these statements were made with the knowledge that willful
`
`
`
`3
`
`Janssen Ex. 2012
`Mylan v. Janssen
`IPR2020-00440
`
`
`
`
`
`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.
`
`
`Dated this 18th day of June, 2020.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`By:
`Joong Youn (Jay) Cho
`Reg. No. 75,052
`jcho@pbwt.com
`Patterson Belknap Webb & Tyler LLP
`1133 Avenue of the Americas
`New York, New York 10036
`
`4
`
`Janssen Ex. 2012
`Mylan v. Janssen
`IPR2020-00440
`
`