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`IPR2017-00854
`U.S. Patent No. 9,187,405
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`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
`U.S. Patent No. 9,187,405
`______________________
`PATENT OWNER NOVARTIS’S REPLY IN SUPPORT OF
`MOTION TO EXCLUDE
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
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`1 Cases IPR2017-01550, IPR2017-01946, and IPR2017-01929 have been joined
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`with this proceeding.
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`IPR2017-00854
`U.S. Patent No. 9,187,405
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`TABLE OF CONTENTS
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`Page
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`A. Dr. Giesser’s Testimony Is Inadmissible .............................................. 1
`1.
`Dr. Giesser Did Not Do Her Own Review of the Art ................. 1
`2.
`Dr. Giesser Is Not A Pharmacologist .......................................... 3
`Exhibits 1032, 1035, 1037, 1041, and 1051 Are Irrelevant .................. 3
`Petitioners New References Should Be Excluded ................................ 4
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`B.
`C.
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`IPR2017-00854
`U.S. Patent No. 9,187,405
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`Petitioners have largely ignored Novartis’s motion to exclude, and instead
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`used their brief as a platform to address merits arguments. The Board should
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`disregard this naked end-run around the Board’s order prohibiting any further merits
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`briefing from Petitioners (Paper 66), and grant Novartis’s motion to exclude.
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`A. Dr. Giesser’s Testimony Is Inadmissible
`1.
`Dr. Giesser Did Not Do Her Own Review of the Art
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`Petitioners still do not dispute that putative expert opinions about obviousness
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`based only on counsel’s handpicked references are per se hindsight and thus
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`unlawful. (See cases cited in Paper 26 at 42–43; Paper 80 at 4–5.) Nor do they
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`dispute that hindsight-driven opinions are inadmissible under Rule 702. (Paper 80
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`at 3–5.) Dr. Giesser’s opinion accordingly should be excluded under FRE 702.2
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`In her deposition, Dr. Giesser testified that, other than looking up one longer
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`version of a study counsel had already provided, she conducted no independent
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`research for her declaration: “Q. Other than that, have you performed any searches
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`for literature? A. No. Q. Okay. How did you get the references that are cited in
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`your declaration? A. References were supplied by counsel.” (Ex. 2039 50:4-9
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`2 Petitioners complain (at 1) that Novartis did not cite this objection in the motion to
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`exclude, though Petitioners claim no prejudice from that fact or that the objection is
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`untimely. Nor could they. Novartis objected under Rule 702 in Paper 13 at 1–2.
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`1
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`(emphasis added).) Nor did Dr. Giesser provide a reply declaration to address what
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`IPR2017-00854
`U.S. Patent No. 9,187,405
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`she missed initially. Her opinion is thus per se hindsight and unlawful.
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`The most Petitioners say in response is that Dr. Giesser already knew about
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`some of the references counsel supplied. (Paper 94 at 3.) That is irrelevant. She
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`indisputably was not aware of the full scope of the prior art, and conducted no
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`independent research to bring herself up to speed. And even when Novartis
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`submitted references she did not consider, Petitioners submitted no reply declaration
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`to address those references and try to fix her omissions. That ends the analysis.
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`Petitioners bizarrely try to change the subject by discussing their deposition
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`of Dr. Jerold Chun, a co-author of the Webb reference (Ex. 2014). Apart from being
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`a non-sequitur and improper subject matter for a motion about Dr. Giesser,
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`Petitioners’ brief grossly mischaracterizes Dr. Chun’s testimony. He never once said
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`that Novartis’s points about Webb are incorrect, as Petitioners claim (Paper 94 at 5).
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`To the contrary, he affirmed that he and his co-authors concluded that 70%
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`lymphocyte suppression was needed for clinical efficacy that is “replicable,”
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`“consistent,” and “predominant” (Ex. 1063 at 185:10–20)—just as he said in his
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`declaration (Ex. 2098 ¶¶ 38–40). Novartis has never moved to exclude this
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`testimony. Why would it? The testimony helps Novartis. Dr. Chun indeed
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`specifically refused to agree that lesser suppression would be just as likely to be
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`effective; he said the opposite. (Ex. 1063 at 275:3–276:21.)
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`IPR2017-00854
`U.S. Patent No. 9,187,405
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`In other words, Dr. Chun stood by his refutation of Petitioners’ effort to
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`rewrite Webb. Petitioners’ effort to distract from Dr. Giesser’s testimony with
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`mischaracterizations about Dr. Chun just bespeaks their desperation.
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`2.
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`Dr. Giesser Is Not A Pharmacologist
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`In addition to challenging her methodology, Novartis challenged Dr. Giesser’s
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`lack of any expertise in pharmacology. (Paper 80 at 2–3, 6.) As Petitioners do not
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`dispute, “Dr. Giesser’s ‘pharmacologic testimony was beset with error.’” (Opp. at
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`7.) But Petitioners pretend, without any citation to the record, that Dr. Benet
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`somehow resuscitated Dr. Giesser. (Id.) He did not. In fact, even after
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`pharmacologist Dr. Jusko pointed out the errors in Dr. Giesser’s pharmacology
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`analysis, and even after Dr. Benet acknowledged those criticisms in his declaration,
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`he did not contest them or come to Dr. Giesser’s defense. (Ex. 2024 ¶¶ 118–23; Ex.
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`1047 ¶¶ 31–37.) Dr. Giesser simply is not qualified as a pharmacologist, and thus is
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`unable to support the Petition from the perspective of a full person of skill.
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`B.
`Exhibits 1032, 1035, 1037, 1041, and 1051 Are Irrelevant
`Novartis showed that Petitioners’ exhibits about the ’283 IPR (Ex. 1032,
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`1035, 1037, 1041) are irrelevant here. (Paper 80 at 7–8.) 3 Petitioners barely
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`respond, asserting that the references could be relevant for “preclusion or estoppel”
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`3 Novartis objected to these exhibits as irrelevant in Papers 13 at 9–12, and 55 at 4.
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`3
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`purposes, but without explaining how. (Opp. at 7.) Given that the Exhibits involve
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`IPR2017-00854
`U.S. Patent No. 9,187,405
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`a different patent on a different technology relevant to a different person of skill,
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`Petitioners are manifestly wrong and the Exhibits should be excluded.
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`Novartis showed also that a confidential clinical trial document (Ex. 1051) is
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`irrelevant. It is not prior art and does not reflect the views of ordinary skill in the
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`art. (Paper 80 at 9–10.) This document is not evidence to rebut that those of ordinary
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`skill without knowledge of the invention were skeptical that a 0.5 mg would work,
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`precisely because it reflects the internal knowledge of individuals at Novartis. (Id.)
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`Petitioners have no response. The exhibit should be excluded.
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`C.
`Petitioners New References Should Be Excluded
`Petitioners tried to inject new articles into the record at the last minute in the
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`depositions of Drs. Chun and Jusko (Exs. 1054–1060).4 These exhibits were outside
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`the scope of both witnesses’ testimony, and the witnesses had nothing relevant to
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`say about them. (Paper 80 at 10–14.) Novartis thus moved to exclude the exhibits
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`4 Novartis objected to the questioning on these exhibits in the depositions of Drs.
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`Chun and Jusko ((Ex. 1063 at 278:3–318:20 (passim); Ex. 1064 at 130:25–163:9
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`(passim)), and further filed the present motion within 5 business days after service
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`of the documents, which were first cited in and filed along with Petitioner’s
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`observations (Papers 78–79).
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`4
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`because no expert has ever addressed them or laid a foundation for their relevance.
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`IPR2017-00854
`U.S. Patent No. 9,187,405
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`(Id.) Petitioners do not rebut that basic fact anywhere in the opposition.
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`Petitioners instead again use this section of their brief to try to rewrite Webb
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`and to resuscitate their obviousness case in ways that are wholly unrelated to
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`Novartis’s motion. (Paper 94 at 10–11.) Petitioners wrongly say, for example, that
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`Novartis is trying to distance itself from Dr. Chun because he disagreed with
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`Novartis’s views about Webb’s 70% threshold. (Id.) That is false. Novartis did not
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`even bother to try to exclude the testimony Petitioners tout. As discussed above, Dr.
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`Chun’s testimony is entirely in line with his declaration rebutting Petitioners’ effort
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`through Dr. Benet to rewrite Webb.
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`Respectfully submitted,
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`Dated: April 30, 2018
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`
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`/Jane M. Love, Ph.D./
`Jane M. Love, Ph.D.
`Reg. No. 42,812
`Lead Counsel for Patent Owner
`Gibson, Dunn & Crutcher LLP
`200 Park Avenue
`New York, New York 10166-0193
`jlove@gibsondunn.com
`Tel: 212-351-3922
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`IPR2017-00854
`U.S. Patent No. 9,187,405
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6, I hereby certify that on April 30, 2018, true and
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`accurate copies of the foregoing PATENT OWNER NOVARTIS’S REPLY IN
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`SUPPORT OF MOTION TO EXCLUDE for IPR2017-00854 were served via
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`electronic mail, on the following counsel of record for Petitioners:
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`For Apotex:
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`For Argentum:
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`For Sun:
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`Steven W. Parmelee: sparmelee@wsgr.com
`Michael T. Rosato: mrosato@wsgr.com
`Jad A. Mills: jmills@wsgr.com
`Wilson Sonsini Goodrich & Rosati
`701 Fifth Avenue, Suite 5100
`Seattle, WA 98104
`Telephone: 206-883-2542
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`Teresa Stanek Rea: trea@crowell.com
`Deborah H. Yellin: dyellin@crowell.com
`Shannon M. Lentz: slentz@crowell.com
`Tyler C. Liu: TLiu@agpharm.com
`Crowell & Moring LLP
`Intellectual Property Group
`1001 Pennsylvania Ave, NW
`Washington, DC 20004-2595
`(202) 624-2620
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`Samuel Park: SPark@winston.com
`Charles B. Klein: CKlein@winston.com
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`For Teva:
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`IPR2017-00854
`U.S. Patent No. 9,187,405
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`Winston & Strawn LLP
`35 W. Wacker Drive
`Chicago, IL 60601
`Telephone: (312) 558-7931
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`Amanda Hollis: amanda.hollis@kirkland.com
`Eugene Goryunov: egoryunov@kirkland.com
`Gregory Springsted: greg.springsted@kirkland.com
`Kirkland & Ellis LLP
`300 North LaSalle
`Chicago, IL 60654
`Telephone: (312) 862-2000
`(202) 624-2620
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`Respectfully submitted,
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`
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`/Jane M. Love, Ph.D./
`Jane M. Love, Ph.D.
`Reg. No. 42,812
`Lead Counsel for Patent Owner
`Gibson, Dunn & Crutcher LLP
`200 Park Avenue
`New York, New York 10166-0193
`jlove@gibsondunn.com
`Tel: 212-351-3922
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`Dated: April 30, 2018
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`7
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