throbber

`
`
`
`
`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
`
`

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket