UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`APOTEX INC., APOTEX CORP., ARGENTUM PHARMACEUTICALS LLC,
`ACTAVIS ELIZABETH LLC, TEVA PHARMACEUTICALS USA, INC., SUN
`PHARMACEUTICAL INDUSTRIES, LTD., SUN PHARMACEUTICAL
`'
`INDUSTRIES, INC., AND SUN PHARMA GLOBAL FZE,
`
`Petitioners,
`
`V.
`
`NOVARTIS AG,
`
`Patent Owner.
`
`
`
`Case IPR2017-008541
`
`US Patent No. 9,187,405
`
`DECLARATION OF PETER J. WAIBEL, ESQ. IN SUPPORT OF
`
`EVIDENCE
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`US. Patent and Trademark Office
`
`PO. Box 1450
`
`ALEXANDRIA, VA 22313—1450.
`
`1 Cases IPR2017-01550, IPR2017—01946, and IPR2017—01929 have been joined
`with this proceeding.
`
`Apotex v. Novartis
`lPR2017-00854
`
`NOVARTIS 2078
`
`Apotex v. Novartis
`IPR2017-00854
`NOVARTIS 2078
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`APOTEX INC., APOTEX CORP., ARGENTUM PHARMACEUTICALS LLC,
`ACTAVIS ELIZABETH LLC, TEVA PHARMACEUTICALS USA, INC., SUN
`PHARMACEUTICAL INDUSTRIES, LTD., SUN PHARMACEUTICAL
`'
`INDUSTRIES, INC., AND SUN PHARMA GLOBAL FZE,
`
`Petitioners,
`
`V.
`
`NOVARTIS AG,
`
`Patent Owner.
`
`
`
`Case IPR2017-008541
`
`US Patent No. 9,187,405
`
`DECLARATION OF PETER J. WAIBEL, ESQ. IN SUPPORT OF
`
`EVIDENCE
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`US. Patent and Trademark Office
`
`PO. Box 1450
`
`ALEXANDRIA, VA 22313—1450.
`
`1 Cases IPR2017-01550, IPR2017—01946, and IPR2017—01929 have been joined
`with this proceeding.
`
`Apotex v. Novartis
`lPR2017-00854
`
`NOVARTIS 2078
`
`Apotex v. Novartis
`IPR2017-00854
`NOVARTIS 2078
`
`
`
`I, Peter J. Waibel declare as follows:
`
`I am Head of’ US Patent Litigation for Novartis Pharmaceuticals
`l'
`1.
`Corporation (“Novartis”), the assignee ofU.S. Patent No. 9,187,405 and a real party—
`
`in—interest in these proceedings. . I have been employed by Novartis since 2002, as a
`
`Senior Patent Attorney until 2007, when I assumed my current role as Head of US
`
`Patent Litigation.
`
`2.
`
`_ As head of US Patent Litigation, I have access to certain NoVartis’
`
`business records, including Novartis’ regulatory communications and filings with
`
`FDA regarding clinical trials.
`
`I have knowledge of Novartis’ product development
`
`efforts, including with respect to Novartis’ Gilenya product.
`
`I have personal knowledge of Novartis’ businesspractices regarding
`3.
`the maintenance of e-mail and internal data systems and the practices and protocols
`
`for ensuring the accuracy of the date and time stamps reflected on e—mails sent from
`
`Novartis’ e—mail system.
`
`a
`
`4.
`
`In the ordinary course of business, the e-mail system used by Novartis
`
`automatically affixes a date and time stamp on each e—mail received and sent on
`
`Novartis’ internal servers. It is Novartis" practice to institute security safeguards to
`
`prevent tampering with its e—mail systems.
`
`5.
`
`I have personal knowledge of Novartis’ business practices regarding
`
`the drafting and maintenance‘of communications with the FDA. Novartis is in the
`
`
`
`IPR2017-00854.
`
`US. Patent No. 9,187,405
`
`business of selling branded pharmaceuticals. Accordingly, Novartis regulatory
`
`personnel draft communications with FDA in the Ordinary course of business and as
`
`a regularly conducted business activity. Novartis continuously maintains copies of
`
`communications with the FDA and any documents
`
`included in those
`
`communications in the ordinary course of business. Novartis maintains its
`
`communications with FDA in a centraliZed computerized filing system, to which I
`
`can gain access as part of my job.
`
`6.
`
`I have personal knowledge of Novartis’ business practices regarding
`
`the drafting and maintenance of communications regarding clinical trials. Novartis
`
`personnel draft and maintain records of all communications with third parties
`
`regarding clinical trials in the ordinary course of business and as a regularly
`
`conducted business
`
`activity.
`
`- Novartis
`
`continuously maintains
`
`copies of
`
`' communications with third parties regarding clinical trials in the ordinary course of
`
`business.
`
`7.
`I have reviewed the records filed as Exhibits 2037, 2040, 2057, and
`2063-2066 (the “Records”), and I confirm that the Records are true and accurate .
`copies of original records created and/or maintained by Novaitis personnel in the
`
`manner described above in the ordinary course of business.
`
`I confirm that the time
`
`
`
`IPR2017-00854
`
`US Patent No. 9,187,405 v
`
`stamps on the Records saved on Novartis’ internal servers accurately reflect the date
`the Records were last modified on Novartis’ internal- servers.
`8».
`The document identified as EX. 2037 is a copy of letter sent by FDA to
`
`Novartis on September 21, 2010 approving NoVartis’ new drug application (“NDA”)
`
`No. 022-527. This letter was received in the ordinary} course of business, and filed
`in Novartis’s electronic filing system for FDA correspondence.
`I confirm that
`
`Novartis made a post-marketing commitment to FDA to undertake a 0.25 mg daily
`
`dose trial of fingolimod, as is shown on page 7 of Ex. 2037. Furthermore, this
`
`approval
`
`A
`
`letter
`
`is
`
`publicly
`
`V
`
`'
`
`available
`
`at
`
`https ://www.accessdata.fda. gov/drugsatfda docs/nda/2010/0225270rig1s0001trpd
`
`r.
`
`>
`
`V
`
`i
`
`The document identified as EX. 2040 is a copy of the Gilenya label
`9.»
`revised in February 2016 and sent to and approved by FDA. This Gilenya label was
`prepared in the ordinary course of business by an employee in Novartis? regulatory-
`
`department. According to Novartis" routine V business practice, a copy of the
`
`approved Gilenya label as revised in February 2016’ was made and filed, and'I was
`
`able to access this file for inclusion in these proceedings. Furthermore, the'Gilenya
`
`label
`
`is
`
`.
`
`publicly
`
`available
`
`I
`
`j at
`
`
`
`IPR2017—00854
`
`US. Patent No. 9,187,405
`
`htt s://www. harma.us.novartis.com/sites/www. harrna.us.novartis.com/files/
`
`
`
`
`
`ilen '
`
`ya.p_df.
`
`The document identified as EX. 2057 is a copy of aninternal report
`10.
`prepared by, the inventors of the ’405 patent—Novartis scientists Christian Schnell
`
`and Peter Hiestand. This report was submitted to FDA‘as part of Novartis’ NDA
`
`No. 022—527. According to Novartis’ routine business practice, a copy of this-report
`
`was made and filed, and I was able to access this file for inclusion in these
`
`proceedings.
`
`ll.
`
`The document identified as EXI. 2063 is a redacted copy of e-mail
`
`correspondence between‘Novartis personnel and personnel at Mount Sinai School
`
`of Medicine regarding Mount Sinai’s potential participation in Gilenya clinical
`
`trials.
`
`I can confirm that Novartis personnelsent and received the correspondence
`
`represented in Ex. 2063.
`_ Sylvia Burns worked for Novartis from 2004-2010.‘
`Valentina Curovic—Perisic worked for Novartis from 2005§present. These emails
`came from Novartis’s email system, specifically from the email box of Mr. Tom
`Watson, a former Novartis employee. I confirm that the data identifying the senders,
`
`recipients, date, and time of delivery reflected in EX. 2063 matches the data collected
`in Novartis’ internal system that is automatically affixed to these emails and saved
`
`at the time of delivery and/or receipt.
`
`I also confirm that the redacted portion of the
`
`
`
`lPR2017—00854
`
`US Patent No. 9,187,405
`
`email constitutes internal conversation at Novartis only and does not
`
`include
`
`additional communication with any personnel at Mount Sinai School of Medicine.
`
`12.
`
`The document identified as Ex. 2064 is an authentic copy of letter sent
`
`to FDA from Novartis personnel on March 3, 2008 concerning clinical trials of
`
`I Gilenya. This letter was sent to FDA in the ordinary course of business. On
`
`information and belief, the individual who prepared this letter on behalf ofNovartis,
`
`Tom Watson, possessed personal knowledge of its content. Mr. Watson was
`
`Novartis’s head of regulatory affairs in March, 2008, and he was personally involved
`
`in matters related to Gilenya. According to Novartis" routine business practice, a
`
`copy of this was made and filed, and I was able to access this file for inclusion in .
`these proceedings.
`13.
`The decument identified asEx. 2065 is an authentic copy of e-mail, ‘
`
`correspondence between Novartis personnel and personnel at Mount Sinai School
`
`, of Medicine regarding Mount Sinai’s potential participation in Gilenya clinical
`
`trials.
`I can confirm that Novartis personnel sent and received the correspondence
`represented inEx. 2065. Tom. Watsonworked for Novartis from 2002-2017, SylVia
`Burns worked for Novartis from 2004—2010. Valentina Curovic—Perisic worked for
`
`Novartis from 2005-present.
`
`James [Prodafikas worked for Novartis from 2004-
`
`2008.. Karen Webster worked for Novartis from 2007-2008. We reviewed these
`
`
`
`IPR2017-00854
`
`'U.S. Patent No. 9,187,405
`
`emails frOm Novartis’s email system, specifically from the email box of Mr. Tom
`
`Watson, a former Novartis employee. I confirmthat the data identifying the senders,
`
`recipients, and date and time of delivery reflected in EX. 2065 matches the data
`collected in-Novartis’ internal system that is automatically affixed to these emails
`
`and Saved at the time of delivery and/or receipt.
`
`»- 14.
`
`The document identified as Ex. 2066 is an authentic copy of a letter
`
`from Novartis personnel to personnel at Mount Sinai School of Medicine regarding
`
`Mount Sinai’s potential participatiOn in Gilenya clinical trials. The document
`
`identified as EX. 2066 was also attached to the email correspondence represented in
`
`Ex. 2065. Novartis head of regulatory affairs Tom Watson sent this letter in the
`
`ordinary course of business as part of his involvement with FDA regarding Gilenya.
`
`According to Novartis” routine business practice, a copy of this letter was made and
`
`filed, and I was able to access this file for inclusion in these proceedings.
`
`15. Under penalty 'of perjury, all statements made herein of my own
`
`knowledge are true, and I believe all statements made herein on information and
`
`belief to be true. I have been warned and am aware that willful false statements and
`
`the like are punishable by fine or imprisonment 01' both under Section 1001 of Title
`
`18 of the United States Code.
`
`
`
`IPR2017-00854
`
`US. Patent No. 9,187,405
`
`16.
`
`In signing this Declaration, I understand that it will be filed as evidence
`
`in a contested case before the Patent Trial and Appeal Board of the United States
`Patent and Trademark Office.
`I acknowledge that I may be subject. to cross-
`
`7 examination in the case and that cross-examination will take place in the United
`
`States. If cross-examination is required of me, I will appear for cross—examination
`
`within the United States during the time allotted.
`
`Dated: December 5, 2017
`
`
`
`Peter J. Waibel I
`
`
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