`
`
`
`
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`_________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_________________
`
`LUPIN LTD. and LUPIN PHARMACEUTICALS INC.
`
`Petitioners,
`
`v.
`
`HORIZON THERAPEUTICS, LLC.
`
`Patent Owner.
`_________________
`
`DECLARATION OF TIFFANY MAHMOOD
`
`LUPIN EX. 1024
`1 of 3
`
`
`
`
`
`I, Tiffany Mahmood, declare under penalty of perjury as follows:
`
`1.
`
`2.
`
`I am an associate at the law firm Goodwin Procter LLP.
`
`I make this Declaration in support of Lupin’s petition for inter partes
`
`review of U.S. Patent No. 9,561,197.
`
`3.
`
`Exhibit 1013 is a true and correct copy of a document I downloaded
`
`on December 11, 2017 from the Drugs@FDA section of the U.S. Food and Drug
`
`Administration’s website, relating to the Drug Approval Package for RAVICTI
`
`(glycerol phenylbutyrate) Oral Liquid, NDA 203284. Specifically, I navigated to
`
`the Drugs@FDA: FDA Approved Drug Products database, available at
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm. At this page, I ran a
`
`search for “Ravicti” which returned a page of information relating to RAVICTI,
`
`available at https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=
`
`BasicSearch.process. On this page, I navigated to the section for “Approval
`
`Date(s) and History, Letters, Labels, Reviews for NDA 203284.” Under the
`
`header for “Original Approvals or Tentative Approvals,” I clicked on “Review,”
`
`which led me to the Drug Approval Package for RAVICTI , available at
`
`https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203284Orig1s000TOC.
`
`cfm. On this page, I clicked on “Summary Review,” which returned a pdf of a
`
`document, a true and correct copy of which is marked as Ex. 1013.
`
`
`
`LUPIN EX. 1024
`2 of 3
`
`
`
`4.
`
`Exhibit 1020is a true and correct copy of the prosecution history of
`
`U.S Patent No. 9,561,197 which I downloaded on December11, 2017 from the
`
`U.S. Patent and Trademark Office’s Patent Application Information Retrieval
`
`website, at https://portal.uspto.gov/pair/PublicPair. Specifically, I ran a search on
`
`the Public Pair portal for U.S. Patent No. 9,561,197 which providedall patent
`
`information for U.S. Patent No. 9,561,197.
`
`I then navigatedto the “ImageFile
`
`Wrapper”tab. I sorted all documentslisted in a chronological order, and selected
`
`for download all documents marked as “PROSECUTION.”Atrue and correct
`
`copy of the compilation of all documents downloaded is marked as Ex 1020.
`
`5.
`
`I declarethatall statements made herein of my knowledgeare true
`
`andthat all statements made on information andbelief are believed to be true; and
`
`further that these statements were made with the knowledgethat willful false
`
`statements and the like so madeare punishable by fine or imprisonment, or both,
`
`under Section 1001 of Title 18 of the United States Code.
`Dated: December !4, 2017
`By:
`| a
`a Mahmoed—
`
`ee
`
`LUPIN EX. 1002
`3 of 3
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
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.
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.
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
