`From: Love, Jane M. <JLove@gibsondunn.com>
`Sent: Wednesday, March 28, 2018 11:48 AM
`To: Trials <Trials@USPTO.GOV>
`Cc: Mills, Jad <jmills@wsgr.com>; Rosato, Michael <mrosato@wsgr.com>; TRea@Crowell.com;
`DYellin@Crowell.com; TLiu@agpharm.com; 'SPark@winston.com' <SPark@winston.com>;
`'CKlein@winston.com' <CKlein@winston.com>; 'amanda.hollis@kirkland.com'
`<amanda.hollis@kirkland.com>; 'egoryunov@kirkland.com' <egoryunov@kirkland.com>;
`'greg.springsted@kirkland.com' <greg.springsted@kirkland.com>; Trenchard, Robert W.
`<RTrenchard@gibsondunn.com>; Love, Jane M. <JLove@gibsondunn.com>; Parmelee, Steve
`<sparmelee@wsgr.com>
`Subject: RE: IPR2017-00854 Conference Call Request
`
`
`Good Morning Your Honors. We represent Patent Owner Novartis and write in response to Mr.
`Parmelee’s email from this morning. We can be available for a conference call Thursday, March 29,
`2018. We oppose Petitioners’ requests, about which we were not given a chance to confer before
`Petitioners’ email to the Board. We lay out our position here in comparable length to Petitioners’
`submission.
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`
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`First, Novartis’s sur-reply and supporting declarations were authorized in Paper 45. They specifically
`respond to the new, 60-page pharmacology declaration from Dr. Leslie Benet that Petitioners submitted
`on reply (Ex. 1047), and Petitioners’ arguments in their reply brief based on Dr. Benet’s testimony (Paper
`49).
`
`
`
`The Board defined a person of skill in the Institution Decision to include an MS physician and a
`pharmacologist. (Paper 11 at 8-9.) Petitioners submitted no pharmacologist testimony with the
`Petition. Instead, they only submitted pharmacologist testimony on reply, depriving Novartis the
`opportunity to rebut this evidence at all. Novartis objected, moved to strike, or in the alternative for
`leave to respond to Dr. Benet’s testimony. The Board received emails and held a teleconference on the
`issue on February 21, 2018. (Exs. 3004 (email requesting conference) and 2084 (transcript of
`proceedings).) Rather than strike Dr. Benet’s declaration, the Board granted Novartis’s request for a sur-
`reply with supporting evidence. (Paper 54.)
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`
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`Novartis’s sur-reply and supporting evidence are limited to responding to Dr. Benet’s opinions. Dr.
`Benet cites many pharmacologic and other facts in support of his views as a pharmacologist. Novartis’s
`expert testimony responds in comparable total length and level of detail, including the following:
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`

`

`• Dr. Jusko’s declaration (Ex. 2095) responds to Dr. Benet’s argument that the animal dose
`scaling methods would have pointed a person of skill toward the dose method claimed in the
`‘405 Patent.
`
`• Dr. Steinman’s declaration (Ex. 2096) responds to Dr. Benet’s claim construction arguments,
`and his argument that Webb, Kahan 2003, and Park 2005 point toward the dose claimed in the
`‘405 Patent.
`
`• Dr. Chun is a co-author of Webb and his declaration (Ex. 2098) responds to Dr. Benet’s
`argument that Webb does not mean what it says.
`
`• Dr. Lublin’s declaration (Ex. 2097) responds to Dr. Benet’s various arguments about the Phase
`III clinical trials.
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`Petitioners’ effort to limit the Board’s authorization to only “pharmacokinetic” arguments takes the
`Board’s order out of context. In authorizing Novartis to file a sur-reply (rather than strike Dr. Benet’s
`testimony entirely), the Board referred to a passage from the Institution Decision in which the Board
`explained its reasoning for including a pharmacologist in the definition of a person of skill. That passage
`identifies pharmacokinetic information in the prior art as relevant in this case.
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`
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`The Board’s Order does not require parsing Dr. Benet’s opinion into “pharmacokinetic” and “non-
`pharmacokinetic” bits, requiring a response only to the first. Nor would such parsing be practical—all of
`Dr. Benet’s opinions on pharmacokinetics are informed and, in his view, corroborated by the other parts
`of his declaration. As we explained at the conference on the sur-reply (Ex. 2094 at 23), the Board’s rules
`and the Administrative Procedure Act required that Novartis be given a chance to respond to Dr. Benet’s
`full evidence. Proceeding otherwise would be prejudicial to Novartis. Novartis properly limited our sur-
`reply and supporting declarations to those opinions.
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`
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`Petitioners will of course have the opportunity to cross-examine Novartis’s witnesses, who currently are
`scheduled for testimony per prior agreement on April 5, 6, 9, and 10. Petitioners can also file
`observations based on those cross-examinations. If Petitioners believe that any of Novartis’s evidence is
`improper, Petitioners can move to exclude.
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`It was Petitioners’ failure to properly support the Petition in the first place and the effort to back-fill on
`reply that prompted Novartis’s sur-reply. The Board should not permit the Petitioners to file another
`round of papers and extend the proceedings even further.
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`

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`Second, as for Petitioners’ request for a sur-reply on the motion to amend, that argument has been
`waived.
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`In October 2017, Novartis raised with Petitioners the exact issue they raise in their email of today (see
`highlighted portions of attached email correspondence). When seeking to adjust the schedule to
`account for In re Aqua, Novartis invited Petitioners to discuss whether that decision’s shifting of burdens
`would require a different order of briefs on the motion to amend, including by giving Petitioners the
`final brief.
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`Petitioners never took up that suggestion, and since then have agreed to an order of briefing in multiple
`adjusted schedules that does not provide for a sur-reply in connection with the motion to
`amend. (Papers 25, 46, 58) Novartis and the Board have relied on that schedule and altering it at this
`late stage of the proceeding would be prejudicial.
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`Moreover, notwithstanding the shifted burdens of In re Aqua, the Board has issued a guidance stating
`that the order of briefing on motions to amend should generally remain the same. (“Guidance on
`Motions to Amend in view of Aqua Products,” at 2 (November 21, 2017).)
`
`
`Respectfully submitted,
`
`
`
`Jane M. Love, Ph.D.
`
`Lead Counsel for Patent Owner
`
`
`
`
`
`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
`
`
`