throbber
UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`TEVA PHARMACEUTICALS USA, INC.
`Petitioner
`
`V.
`
`CORCEPT THERAPEUTICS, INC.
`Patent Owner
`
`Case No: Unassigned
`US. Patent No. 10,195,214
`
`Title: CONCOMITANT ADMINISTRATION OF GLUCOCORTICOID
`
`RECEPTOR MODULATORS AND CYP3A INHIBITORS
`
`DECLARATION OF ATUL KAUSHIK
`
`TEVA1 054
`
`TEVA1054
`
`

`

`Petition for Post-Grant Review
`
`US. Patent No. 10,195,214
`Declaration of Atul Kaushik
`
`I, Atul Kaushik, hereby declare as follows:
`
`1.
`
`I am over the age of eighteen (18) and competent to make this
`
`declaration.
`
`2.
`
`I understand that this Declaration accompanies a petition for PGR
`
`involving US. Patent No. 10,195,214 (“the ’214 patent”) (TEVA1001).
`
`'3.
`
`I have personal knowledge of all the facts contained in this
`
`declaration.
`
`4.
`
`I am Senior Director at Teva Pharmaceuticals USA, Inc. My business
`
`address is Plot No. K-7, MIDC, Additional Ambernath (E), Dist-Thane, India—
`
`421506. In this role, I am leading Formulation Research and Development
`
`Department. As part of my duties, I routinely review FDA approval packages for
`
`branded drugs for which Teva seeks FDA approval to manufacture and distribute a
`
`generic equivalent. 1, or one of my colleagues at Teva, access these materials by
`
`downloading them from the FDA’s website.
`
`5.
`
`On December 15, 2017, Teva filed Abbreviated New Drug
`
`Application No. 211436 seeking to market a generic version of Korlym®
`
`(mifepristone) Tablets, 300 mg. Korlym is the subject of Corcept Therapeutic,
`
`Inc.’s New Drug Application No. 202107, which was approved by the FDA on
`
`February 17, 2012.
`
`

`

`Petition for Post-Grant Review
`
`US. Patent No. 10,195,214
`Declaration of Atul Kaushik
`
`6.
`
`In April 2016, in connection with Teva’s preparation of ANDA No.
`
`211436, my colleague Pritesh Jain downloaded all the materials in the Drug \
`
`Approval Package for Korlym from the FDA’s website. See
`
`https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202107_korlym_toc.cf
`
`m. This webpage’s “Date created” is listed as July 6, 2012. I know that Mr. Jain
`
`downloaded the material in early 2016 because it was part of our preparation of
`
`ANDA No. 211436. The documents from the Korlym Drug Approval Package
`
`Were electronically saved on Teva’s internal network in April 2016, as shown in
`
`the screenshot below, which I took on April 26, 2019.
`
` om v
`
`3': anm
`I Dump
`3 Downloads
`’5‘ Rennntpllcu
`
`‘3' Limn'u
`*1 Documents
`Jr Music
`g Plcmlu
`I Wdem
`fl Computzv
`L OSan (ca
`g Corp_QA (\\Tm.Cc
`fi Nth-ark
`
`, 7
`
`v”
`
`mum um
`\\1U,m§3,2|\v|bfi:\PUBLIE\FRD\..
`24mm
`EDI/2016450554
`W’N‘S‘EW
`"
`31:“
`WWW
`102029321
`
`‘
`‘;
`E
`i
`
`;
`'
`
`Print
`lapmwmummnuaum7 v
`”"ne
`
`5 REMS Rawxfiles
`7—"??5- .
`7
`,, 3"“ .
`1‘ ZUZWTOIIgleflAdm.........pdf
`'1’ 2121010dgb000Chemedf
`fizz-11M ”*5" swim; ..
`'1‘ 2021Mo¢iglxfloflcIinpharmnpdf
`’
`'
`'
`3‘ ZJZlfllOngbUWClouR-pdf
`'1’ Zfll‘flYOnghflflOMszpdf
`1' 202m10n51xoflflNamedef
`'1‘ 2021010ri9b|7000fllstpdf
`{1‘ ZflZmTOIighWflOthuflqadf
`3f ZDZLDTOIiglsfllehamRPdf
`'1‘ ZflZmlOnglsflfloRirklpdf
`5‘ 2021070rig130005hlkpdf
`'1' lflZmTOngbVflDSuprdf
`1' lflllflhflflfllblpdf
`'1‘ 2nziovsanom.paf
`'1‘ Dairy med L:be|.pcf
`1‘ Pllpdf
`8:: “EMS sumsmm
`
`
`
`
`..
`
`x
`
`,
`..
`
`2'4
`
`iIl
`
`mum 4.50 PM
`urea/2
`'~ '
`
`
`
`.5
`
`m VILpdf
`cm meadim BAN/2016 4:50 ”A
`On: :reoLett zmmois .250 PM
`}».
`c 2 ‘:m
`, m
`34:? no KB
`C’fflmeaxafizbilfif. Notwiflable
`A._,
`
`
`Offlin: mm: On‘m
`
`I
`
`

`

`Petition for Post-Grant Review
`
`US. Patent No. 10,195,214
`
`Declaration of Atul Kaushik
`
`7.
`
`The file named “202107sOOOlbl.pdf” is a copy of the original FDA-
`
`approved label for Korlym that was downloaded from the FDA website. I confirm
`
`that Mr. Jain downloaded “202107sOOOlbl.pdf” in April 2016 as a part of the
`
`preparation for Teva’s filing ANDA No. 211436. This document is attached to
`
`Teva’s petition as Exhibit TEVA1004.
`
`8.
`
`The file named “202107orig1sOOOclinpharmrpdf’ is copy of the
`
`Clinical Pharmacology Review for Korlym, Office of Clinical Pharmacology
`
`Review NDA 20687 (Addendum, KorlymTM, Mifepristone) (2012) that was
`
`downloaded from the FDA website. I confirm that Mr. Jain downloaded
`
`“202107orig1sOOOclinpharmrpdf’ in April 2016 as a part of the preparation for
`
`Teva’s filing ANDA No. 211436. This document is attached to Teva’s petition as
`
`Exhibit TEVA1005.
`
`9.
`
`The file named “20210730001tr.pdf” is a copy of FDA’s approval
`
`letter for Korlym that was downloaded from the FDA website. I confirm that Mr.
`
`Jain downloaded “20210730001tr'.pdf’ in April 2016 as a part of the preparation for
`
`Teva’s filing ANDA No. 211436. This document is attached to Teva’s petition as
`
`Exhibit TEVAl 006.
`
`

`

`Petition for Post-Grant Review
`
`US. Patent No. 10,195,214
`Declaration of Atul Kaushik
`
`10.
`
`I accordingly have personal knowledge that the documents attached to
`
`Teva’s petition as Exhibits TEVA1004, TEVA1005, and TEVA1006 were publicly
`
`available on the FDA’s website no later than April 2016.
`
`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.
`
`Respectfully submitted,
`
`OW/
`
`Atul Kaushik
`
`[Senior Director-FRD]
`
`Date: May 7, 2019
`
`

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