`
`From:
`Sent:
`To:
`Cc:
`
`Subject:
`
`Mills, Jad <jmills@wsgr.com>
`Monday, December 11, 2017 6:02 PM
`Love, Jane M.
`Parmelee, Steve; Rosato, Michael; trea@crowell.com; dyellin@crowell.com;
`slentz@crowell.com; SPark@winston.com; CKlein@winston.com; SNaqi@winston.com;
`amanda.hollis@kirkland.com; egoryunov@kirkland.com; Springsted, Gregory;
`Trenchard, Robert W.
`RE: IPR2017-00854
`
`•
`
`Hi Jane,
`
`Thank you for your response. Just to be clear, we have asked you to produce as routine discovery complete copies of
`documents relied upon in your papers. This includes:
`•
`“the FDA’s minutes of the February 2, 2005 face‐to‐face meeting between FDA and Novartis” referenced in
`Exhibit 2066 and in paragraph 55 of Exhibit 2025 (Second Lublin Declaration)
`the “briefing book” for the “March 26, 2007 End‐of‐Phase II meeting” referenced in Exhibit 2064 and in
`paragraph 46 of Exhibit 2025 (Second Lublin Declaration)
`•
`An unredacted copy of Exhibit 2063
`We will inform the Board that you oppose.
`
`If our request is considered as additional discovery, we will request authorization to file appropriate briefing. We intend
`to abide by the Board’s prohibition against unauthorized email briefing and would ask you to do the same.
`
`Regards,
`
`Jad A. Mills
`Wilson Sonsini Goodrich & Rosati
`701 5th Ave., Suite 5100
`Seattle, WA 98104
`Direct: (206) 883-2554
`Main: (206) 883-2500
`Fax: (206) 883-2699
`Email: jmills@wsgr.com
`
`
`From: Love, Jane M. [mailto:JLove@gibsondunn.com]
`Sent: Monday, December 11, 2017 12:18 PM
`To: Mills, Jad
`Cc: Parmelee, Steve; Rosato, Michael; trea@crowell.com; dyellin@crowell.com; slentz@crowell.com;
`SPark@winston.com; CKlein@winston.com; SNaqi@winston.com; amanda.hollis@kirkland.com; egoryunov@kirkland.com;
`Springsted, Gregory; Love, Jane M.; Trenchard, Robert W.
`Subject: RE: IPR2017-00854
`
`Hi Jad,
`
`You have given neither “evidence” nor “reasoning” that would meet the Garmin factors, which are required in seeking
`additional discovery, for your first two requests. You have said “production of the full documents will be useful to
`evaluate Novartis’s contentions.” This is per se speculative, and fails Garmin factor 1. By seeking discovery into
`“Novartis’s contentions,” you improperly seek discovery of Novartis’s litigation positions. This is also unlawful under
`Garmin.
`
`1
`
`Apotex v. Novartis
`IPR2017-00854
`NOVARTIS 2086
`
`
`
`
`This afternoon, you have included two new requests for additional discovery. You give no basis for your entitlement to
`this additional discovery under Garmin. What is your basis for making these two additional requests under Garmin?
`
`We disagree with you that we “should have served the meeting minutes and briefing books.” You are again inaccurate
`in your email below. These two documents were not “expressly cited” in Dr. Lublin’s Second Declaration.
`
`To clarify the record, in ¶ 55 of Dr. Lublin’s Second Declaration, he quotes from Exhibit 2066 (Novartis Letter to Dr.
`Miller dated June 5, 2007 regarding Protocol CFTY720D2302). Exhibit 2066 was served along with Dr. Lublin’s Second
`Declaration.
`
`In ¶ 46, Dr. Lublin references Exhibit 2064 (Novartis Letter to Dr. Katz dated March 3, 2008 re DSMB's benefit/risk
`analysis of 0.5 mg dose). Exhibit 2064 was served along with Dr. Lublin’s Second Declaration.
`
`Also, as a practical matter, we do not think it is feasible to produce the documents you request prior to Friday, Dr.
`Lublin’s deposition date. We explained this in our last email and reiterate it here. This is true also for your new
`requests.
`
`Are you going to include the email correspondence to date along with your request to the Board? We would like the
`email chain, including this email, attached to your email to the Board requesting the conference call.
`
`We agree to make ourselves available during the Schnell deposition on Wednesday for a conference call with the Board.
`
`Best,
`Jane and Bob
`
`Jane M. Love, Ph.D.
`
`GIBSON DUNN
`
`Gibson, Dunn & Crutcher LLP
`200 Park Avenue, New York, NY 10166-0193
`Tel +1 212.351.3922 • Fax +1 212.351.6322
`JLove@gibsondunn.com • www.gibsondunn.com
`
`
`
`From: Mills, Jad [mailto:jmills@wsgr.com]
`Sent: Monday, December 11, 2017 1:54 PM
`To: Trenchard, Robert W. <RTrenchard@gibsondunn.com>; Love, Jane M. <JLove@gibsondunn.com>
`Cc: Parmelee, Steve <sparmelee@wsgr.com>; Rosato, Michael <mrosato@wsgr.com>; trea@crowell.com;
`dyellin@crowell.com; slentz@crowell.com; SPark@winston.com; CKlein@winston.com; SNaqi@winston.com;
`amanda.hollis@kirkland.com; egoryunov@kirkland.com; Springsted, Gregory <greg.springsted@kirkland.com>
`Subject: RE: IPR2017‐00854
`
`Hi Bob,
`
`Thanks for your email. We are a bit confused by your response. You should have served the meeting minutes and
`briefing book together with your Patent Owner Response because they were expressly cited in your witness’s testimony
`relied upon in your Patent Owner Response. 37 C.F.R. §§ 42.51(b)(1)(i), 42.65. Even if characterized as “additional
`discovery” our request satisfies the Garmin factors and the documents should be produced under 37 C.F.R. §§
`42.51(b)(2).
`
`
`2
`
`
`
`Besides the FDA minutes, we ask that you serve any appropriate documents under 37 C.F.R. § 42.51(b)(1)(iii) that
`contain relevant information that is inconsistent with the positions you have advanced in this proceeding.
`
`We will be asking the Board today for a conference call on Wednesday. As both parties should be present on
`Wednesday during the Schnell deposition, I will inform the Board that we are available that day at their convenience.
`We can simply break from the deposition when the Board decides to hold the call. We will be asking the Board to order
`production of the following:
`• “the FDA’s minutes of the February 2, 2005 face‐to‐face meeting between FDA and Novartis” referenced in
`Exhibit 2066 and in paragraph 55 of Exhibit 2025 (Second Lublin Declaration)
`• the “briefing book” for the “March 26, 2007 End‐of‐Phase II meeting” referenced in Exhibit 2064 and in
`paragraph 46 of Exhibit 2025 (Second Lublin Declaration)
`• Documents sufficient to show all correspondence between Novartis and FDA regarding the decision to include
`the 0.5 mg dose in the phase III trials
`• An unredacted copy of Exhibit 2063
`
`
`Regards,
`
`Jad A. Mills
`Wilson Sonsini Goodrich & Rosati
`701 5th Ave., Suite 5100
`Seattle, WA 98104
`Direct: (206) 883-2554
`Main: (206) 883-2500
`Fax: (206) 883-2699
`Email: jmills@wsgr.com
`
`
`From: Trenchard, Robert W. [mailto:RTrenchard@gibsondunn.com]
`Sent: Thursday, December 07, 2017 7:24 PM
`To: Mills, Jad; Love, Jane M.
`Cc: Parmelee, Steve; Rosato, Michael; trea@crowell.com; dyellin@crowell.com; slentz@crowell.com;
`SPark@winston.com; CKlein@winston.com; SNaqi@winston.com; amanda.hollis@kirkland.com; egoryunov@kirkland.com;
`Springsted, Gregory
`Subject: RE: IPR2017-00854
`
`Hi Jad. Thanks for your email explaining Petitioners’ views. We do not see how Petitioner’s request meets the Garmin
`factors.
`
`For instance, Garmin Factor 1 requires “evidence or reasoning tending to show beyond speculation that something
`useful will be uncovered[,]” where “’useful’ means favorable in substantive value to a contention of the party moving for
`discovery.” Your email does not identify any “evidence or reasoning” to suggest that anything of “substantive value” to
`Petitioners’ position exists in the documents you seek. We are aware of none. To the contrary, the quotations in the
`exhibits Dr. Lublin reviewed support Novartis, not Petitioners. As your email states, Petitioners seek this information
`merely to “evaluate” Novartis’s positions—exactly the “speculation” Garmin prohibits. An abstract interest in
`“evaluating” an adversary’s position does not make a request “necessary in the interests of justice,” nor does it go
`“beyond speculation.”
`
`Petitioners are also mistaken in assuming that this request is not burdensome, and that information relevant to
`“evaluating” Novartis’s positions is not available from other sources. With respect to burden, identifying, reviewing, and
`possibly redacting the briefing book is a substantial undertaking. Many Novartis personnel are involved in preparing
`briefing books and meeting with FDA. Identifying a definitive, clean, final version of the book would require significant
`effort. The book, potentially hundreds of pages long, then would have to be reviewed and possibly redacted prior to any
`production. Dr. Lublin’s deposition is only eight (8) days from today. As a practical matter, this process may not be
`
`3
`
`
`
`possible in that short timeframe. With respect to other sources of information, Petitioners will have the opportunity to
`examine Dr. Lublin, and he can provide testimony about the bases of his opinions.
`
`Your email says that Novartis has provided “excerpts” of the documents Petitioners seek. That is inaccurate. Novartis
`has provided full and complete copies of each of the documents Dr. Lublin used to form his opinion. They were
`produced to you already as Exhibits 2048, 2063, 2064, 2065, and 2066 and are referred to in his Declaration. Some of
`those Exhibits do quote or refer to other documents, but that does not mean that Novartis provided “excerpts” of any
`documents. Novartis served full copies of each document it produced. Following Petitioners’ reasoning, if one of the
`current exhibits quotes or refers to other documents, then Petitioners would say they are entitled to those too, and so
`on. That is exactly the sort of expansive discovery forbidden in an IPR.
`
`If Petitioners intend to present the issue to the Board, we ask that Petitioners submit this email chain to assist the Board
`deciding the matter. We may also wish to make other points beyond those made here if the Board orders a hearing on
`the issue.
`
`Best, Bob and Jane.
`
`
`Robert Trenchard
`
`GIBSON DUNN
`
`Gibson, Dunn & Crutcher LLP
`200 Park Avenue, New York, NY 10166-0193
`Tel +1 212.351.3942 • Fax +1 212.351.5242
`RTrenchard@gibsondunn.com • www.gibsondunn.com
`
`
`
`From: Mills, Jad [mailto:jmills@wsgr.com]
`Sent: Wednesday, December 6, 2017 7:59 PM
`To: Trenchard, Robert W. <RTrenchard@gibsondunn.com>; Love, Jane M. <JLove@gibsondunn.com>
`Cc: Parmelee, Steve <sparmelee@wsgr.com>; Rosato, Michael <mrosato@wsgr.com>; trea@crowell.com;
`dyellin@crowell.com; slentz@crowell.com; SPark@winston.com; CKlein@winston.com; SNaqi@winston.com;
`amanda.hollis@kirkland.com; egoryunov@kirkland.com; Springsted, Gregory <greg.springsted@kirkland.com>
`Subject: RE: IPR2017‐00854
`
`Hi Bob,
`
`Thank you for considering our request. Your email below asks for additional explanation of (1) why the five factors
`discussed in Garmin support production of the requested documents as additional discovery; and (2) why 37 CFR §42.65
`is relevant to production of the requested documents if, as you say, Dr. Lublin never reviewed the underlying
`documents. Without any limitation on the arguments we may provide to the Board supporting our production request,
`below is some additional discussion addressing your inquiries.
`
`Garmin Factors
`I begin with whether the discovery request is easily understandable and whether the requests are not overly
`burdensome to answer. My email below requests two documents specifically identified by name, date and locations
`where these documents are described in your evidence and witness testimony. The references to these documents in
`your exhibits suggest that they are easily‐identifiable documents within Novartis’s possession. The request is easy to
`understand, narrowly targeted, and not overly burdensome. If you do not understand the request or believe that there
`would be a significant burden on Novartis to produce these documents, please explain your confusion or the nature of
`the burden.
`
`
`4
`
`
`
`Regarding whether the party requesting discovery is merely asking for the other party’s litigation positions, that is
`clearly not the case. As discussed above, the production request is narrowly targeted to specific documents partially
`quoted in exhibits already submitted by Novartis.
`
`Regarding whether the requesting party is able to obtain the requested information without discovery, we have
`performed a search of the FDA web site and have been unable to locate the requested documents. If you are aware of a
`source from which Petitioners may obtain the requested documents without discovery, please identify it.
`
`Regarding whether it is merely speculative that the something useful will be found, the existence of the requested
`documents does not appear to be in dispute. Your papers allege that the requested documents were communicated
`between FDA and Novartis, and provided the justification for the inclusion of the 0.5 mg dose and the futility analysis in
`the Phase III trial. Novartis has provided only excerpts of these documents. Novartis has placed at issue, among other
`things, whether the FDA required Novartis to include the 0.5 mg dose in the Phase III trial, whether it did so despite
`Novartis’s alleged concerns that the 0.5 mg dose would lack efficacy, and whether FDA would have requested the 0.5 mg
`dose be administered to RR‐MS patients if the 0.5 mg dose had been obvious. Production of the full documents will be
`useful to evaluate Novartis’s contentions.
`
`37 CFR §42.65
`Dr. Lublin relies upon alleged quotations from these documents to establish the details of “the final study plan Novartis
`submitted to the FDA” and that the FDA required Novartis to include the 0.5 mg dose in the phase III trial. See, e.g.,
`EX2025 ¶¶46, 55. Regardless of whether Dr. Lublin personally examined the underlying documents or simply took
`Novartis’s word for their contents as you suggest, the documents themselves are the “underlying facts” on which his
`opinion is based.
`
`Please confirm by the close of business on December 7, 2017 whether Novartis agrees to produce the requested
`documents.
`
`Regards,
`
`Jad A. Mills
`Wilson Sonsini Goodrich & Rosati
`701 5th Ave., Suite 5100
`Seattle, WA 98104
`Direct: (206) 883-2554
`Main: (206) 883-2500
`Fax: (206) 883-2699
`Email: jmills@wsgr.com
`
`
`From: Trenchard, Robert W. [mailto:RTrenchard@gibsondunn.com]
`Sent: Wednesday, December 06, 2017 12:23 PM
`To: Mills, Jad; Love, Jane M.
`Cc: Parmelee, Steve; Rosato, Michael; trea@crowell.com; dyellin@crowell.com; slentz@crowell.com;
`SPark@winston.com; CKlein@winston.com; SNaqi@winston.com; amanda.hollis@kirkland.com; egoryunov@kirkland.com;
`gregory.springsted@kirkland.com
`Subject: RE: IPR2017-00854
`
`Hi Jad. We are considering your request. To help us in discussing the issue with our client, please explain in writing for
`each document you request why Petitioners believe they meet each of the five Garmin factors for additional
`discovery. In addition, please explain the relevance of 37 CFR 42.65 cited in your email, which pertains to documents
`considered by an expert in forming his opinion. Dr. Lublin has never seen these materials and had no role in creating
`them. Best, Bob and Jane.
`
`
`5
`
`
`
`Robert Trenchard
`
`GIBSON DUNN
`
`Gibson, Dunn & Crutcher LLP
`200 Park Avenue, New York, NY 10166-0193
`Tel +1 212.351.3942 • Fax +1 212.351.5242
`RTrenchard@gibsondunn.com • www.gibsondunn.com
`
`
`
`From: Mills, Jad [mailto:jmills@wsgr.com]
`Sent: Tuesday, December 5, 2017 7:05 PM
`To: Trenchard, Robert W. <RTrenchard@gibsondunn.com>; Love, Jane M. <JLove@gibsondunn.com>
`Cc: Parmelee, Steve <sparmelee@wsgr.com>; Rosato, Michael <mrosato@wsgr.com>; trea@crowell.com;
`dyellin@crowell.com; slentz@crowell.com; SPark@winston.com; CKlein@winston.com; SNaqi@winston.com;
`amanda.hollis@kirkland.com; egoryunov@kirkland.com; gregory.springsted@kirkland.com
`Subject: IPR2017‐00854
`
`PROTECTIVE ORDER MATERIAL
`
`Counsel,
`
`Pursuant to 37 C.F.R. §§ 42.51(b)(1), (2), 42.65 and F.R.E. 106, I write on behalf of Petitioners in the above‐referenced
`IPR to request production of the following documents:
`
`
` “the FDA’s minutes of the February 2, 2005 face‐to‐face meeting between FDA and Novartis” referenced in
`Exhibit 2066 and in paragraph 55 of Exhibit 2025 (Second Lublin Declaration)
`
`
`
` the “briefing book” for the “March 26, 2007 End‐of‐Phase II meeting” referenced in Exhibit 2064 and in
`paragraph 46 of Exhibit 2025 (Second Lublin Declaration)
`
`
`We request that production of these documents occur in advance of the scheduled deposition of Dr. Lublin on
`December 15. Please confirm by the close of business on December 7, 2017 whether Novartis agrees to produce these
`documents.
`
`Regards,
`
`Jad A. Mills
`Wilson Sonsini Goodrich & Rosati
`701 5th Ave., Suite 5100
`Seattle, WA 98104
`Direct: (206) 883-2554
`Main: (206) 883-2500
`Fax: (206) 883-2699
`Email: jmills@wsgr.com
`
`
`
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`6
`
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`
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`7
`
`