UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PA TENT TRIAL AND APPEAL BOARD
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`APOTEX IN.C., APOTEX CORP., ARGENTUM PHARMACEUTICALS LLC,
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`ACTA VIS ELIZABETH LLC, TEVA PHARMACEUTICALS USA, INC., SUN
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`PHARMACEUTICAL INDUSTRIES., LTD.,. SUN PHARMACEUTICAL
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`INDUSTRIES, INC., AND SUN PHARJ.\1A GLOBAL FZE,
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`Petitioners,
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`V.
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`NOVARTIS AG,
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`Patent Owner.
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`Case IPR2017-00854
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`1
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`U.S. Patent
`No. 9,187,405
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`SECOND DECLARATION OF PETER J. WAIBEL, ESQ.
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`Mail Stop Patent Board
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`Patent Trial and Appeal Board
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`U ,S. Patent and Trade1nark Office
`P.O. Box 1450
`ALEXANDRIA, VA 22313-1450
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`1 Cases IPR2017-01550, IPR2017-01946,
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`with this proceeding.
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`and IPR2017-01929 have been joined
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`Apotex v. Novartis
`IPR2017-00854
`NOVARTIS 2088
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`
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`BEFORE THE PA TENT TRIAL AND APPEAL BOARD
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`APOTEX IN.C., APOTEX CORP., ARGENTUM PHARMACEUTICALS LLC,
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`
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`ACTA VIS ELIZABETH LLC, TEVA PHARMACEUTICALS USA, INC., SUN
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`PHARMACEUTICAL INDUSTRIES., LTD.,. SUN PHARMACEUTICAL
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`INDUSTRIES, INC., AND SUN PHARJ.\1A GLOBAL FZE,
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`Petitioners,
`
`V.
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`NOVARTIS AG,
`
`
`
`Patent Owner.
`
`Case IPR2017-00854
`
`1
`
`U.S. Patent
`No. 9,187,405
`
`SECOND DECLARATION OF PETER J. WAIBEL, ESQ.
`
`Mail Stop Patent Board
`
`
`Patent Trial and Appeal Board
`
`
`U ,S. Patent and Trade1nark Office
`P.O. Box 1450
`ALEXANDRIA, VA 22313-1450
`
`
`1 Cases IPR2017-01550, IPR2017-01946,
`
`with this proceeding.
`
`and IPR2017-01929 have been joined
`
`Apotex v. Novartis
`IPR2017-00854
`NOVARTIS 2088
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`I, Peter J. Waibel declare as fol Lows:
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`1. I am head of US Patent Litigation for Novartis Pharmaceuticals
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`Corporation, the assignee of U.S. Patent No. 9,.187,405.
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`I previously executed a
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`declaration in this matter on December 5
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`Ex. ) 2017. (My "First Declaration/'
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`2078.) This is m,y second declaration in this matter.
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`request for "the phase2. I submit this declaration to address Petitioners'
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`III protocol referenced in Exhibit 2065 ('Protocol')." (Paper 3:5 at 1.) Here I
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`describe the burden, if not the impossibility
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`the ) of identifying and producing
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`specific Protocol version Mo\lllt Sinai discussed in the emails as of Match 2007.
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`3. I have reviewed Exhibit 2065, a March 2007 email chain between
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`Novartis personnel and representatives of Mount Sinai hospit�l in New York City
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`about Mount Sinai's possible participation in the TRANSFORMS clinical trial fot
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`Gilertya.
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`Dr. Lublin describes that trial in his Second Declaration. {Ex. 2025 if1
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`43-63.)
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`I
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`1
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`IPR20l 7-00854
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`U.S. Patent No, 9,187,405
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`5, I have investigated whether and how Novartis Would be able to
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`identify and produce the specific version of the Ptotocol mentioned in Exhibit
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`to do so if not impossible 2065. I have concluded that it would be very difficult
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`because there is no single protocol for the TRANSFORMS study,
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`I
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`-----
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`Mount Sinai had in March7. I do not know what version of the Protocol
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`for responsible 2007. That would depend on the last version Novartis personnel
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`interacting with Mount Sinai had sent
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`I do not believe that would be practicably
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`attainable on any reasonabletime frame, if at all.
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`2
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`IPR2017-00854
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`U.S. Patent No. 9,L87,405
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`with Mount Sinai was over ten years ago.9. Moreover, the. interaction
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`Only one of the Novartis employees on Exhibit 2065 is still with the company,
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`Valentina Cutovic-Perisic. (See my First Declaration, Ex. 2078 ,i 13 (identifying
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`identified in Exhibit employment beginning and end dates for employees 2065).) I
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`understand from Ms. Curovic-.Perisic that We cannot find the emails and
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`of the Protocol attachments we would need to identify which version Mount Sinai
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`had as of March 2007,
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`10.Novartis
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`located Exhibit 2065 only due to the happenstance that the
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`had emails of Mr. To1n Watson, another ex-employee mentioned in the emails,
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`been retained from late 2014 onward under a litigation document hold in another
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`case. I understand that we have been unable to locate any emails in his retained
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`Mount Sinai had as of of the Protocol collection that would identify which version
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`3
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`IPR2017-00854
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`U.S. Patent No. 9,187,405
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`identified 2065 had on Exhibit Match 2007. Every other Nova1tis employee
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`already left the company before the 2014 litigation hold that preserved Mr.
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`Watson's
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`emails. (See my First Declaration, Exhibit 2078 ,r 13 (identifying
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`departure dates for Sylvia Bums (2010), James Prodafikas (2008), and Karen
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`Webster (2008)).)
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`As a result, their emails would not have been subject to that
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`hold.
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`version11.There is a remote chancethat emails reflecting which Protocol
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`Mount Sinai had as of March 2007 might be in other employees' email files.
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`However,
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`burden, identifying those emails would be a substantial if not
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`impossible.
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`So far as. I am aware_, it would at least entail a comprehensive
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`to determine
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`inves.tiga,tion of any remaining old records
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`who was responsible for
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`Then, if that person's emails
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`disseminating protocol amendments. to Mount Sinai.
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`still exist in the company, those .emails would have to be collected and reviewed to
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`of determine if they reveal the last version of the protocol sent to Mount Sinai as
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`record March 2007. Based on my experience in working with Novartis's
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`keeping
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`systems, this project would likely take months with at best a remote chance of
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`success.·
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`12.I of course do not know if Mount Sinai's IRB would have kept
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`confidential records related to a trial
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`, But
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`even if they did, Novartis has no power to compel Mount Sinai to provide any of
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`4
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`those records.
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`IPR20J7 .. 00854
`U.S. Patent
`No. 9,187,405
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`13.Accordingly,
`I believe
`the burden in
`trying
`to produce
`a correct
`and
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`specific
`version
`of the Protocol
`would be substantial;
`the time involved
`would be
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`extensive;
`and the likelihood ofsuccess
`would be low.
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`*
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`*
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`*
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`*
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`*
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`*
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`14.Under penalty
`of perjury,
`all statements
`made herein of 1ny own
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`knowledge are. true, and
`l believe
`all statements
`made herein
`oh information
`and
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`to be true. I have been warned and a m aware that willful false
`statements
`belief
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`and the like
`are punishable
`by fine or imprisonment
`or both under Section
`1001 of
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`Title 18 of the United
`States Code.
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`15.In signing this
`Declaration,
`I understand
`that it will
`be tiled as
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`evidence
`in a contested
`case before the Patent Ti'iaL and
`Appeal Board of the
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`United
`States
`Patent
`and Trademark
`Office. I acknowledge
`that I may be subject
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`to cross-examination
`in the case and that crOs$-examination
`will take place in the
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`If cross--examination
`is required
`of me, I will appear for cross
`United States.
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`examination
`within
`the United States
`during
`the time allotted.
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`I declare under penalty
`of perjury
`that the foregoing is true and correct.
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`5
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`Dated: January 29, 2018
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`IPR2017-00854
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`•U.S. Patent No. 9,187,405
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`(,�t:�
`
`Peter J. Waibel
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`6
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