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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 ITS
`SUPPLEMENTAL 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
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`joined with this proceeding.
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`IPR2017-00854
`U.S. Patent No. 9,187,405
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`Petitioners begin their defense of admissibility of Exhibits 1065-1069 with a
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`straw man, knocking down an authenticity argument under Fed. R. Evid. 901 that
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`Novartis never made. (Paper 101 at 1–2.) As for the untimeliness of these Exhibits,
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`that is an objection under the Board’s rules, which some Board panels have permitted
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`in a motion to exclude. See, e.g., Toshiba Corp. v. Optical Devices, LLC, IPR2014-
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`01447, Paper 34 at 44–47 (Mar. 9, 2016) (excluding evidence improperly first
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`submitted in reply as untimely).
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`In the remainder of their opposition, Petitioners do not dispute the reasons
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`these exhibits lack relevance and would be prejudicial under Fed. R. Evid. 401-403.
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`Two of the exhibits post-date the ’405 Patent (Exhibits 1068 and 1069), and none
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`has anything to do with neurological disease, multiple sclerosis, or fingolimod drug
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`dosing regimens. (Mot. at 1–2.) Without expert evidence linking these documents
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`to the facts that matter in this case, the Exhibits are plainly irrelevant and prejudicial
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`and should be excluded. The meaning of terms in the proposed amended claims
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`must be evaluated from the perspective of a person of ordinary skill, as must the
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`meaning of supposedly invalidating prior art. Trustees of Columbia Univ. in City of
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`New York v. Symantec Corp., 811 F.3d 1359, 1362 (Fed. Cir. 2016) (“Claim
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`construction requires a determination as to how a person of ordinary skill in the art
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`would understand a claim term ‘in the context of the entire patent, including the
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`specification.’”) (quoting Phillips v. AWH Corp., 415 F.3d 1303, 1313
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`(Fed.Cir.2005) (en banc)); Pre-AIA 35 U.S.C. § 103(a) (inquiry whether the claimed
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`IPR2017-00854
`U.S. Patent No. 9,187,405
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`“subject matter as a whole would have been obvious at the time the invention was
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`made to a person having ordinary skill in the art to which said subject matter
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`pertains.”) (emphasis added); Mintz v. Dietz & Watson, Inc., 679 F.3d 1372, 1376-
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`78 (Fed. Cir. 2012) (vacating summary judgment of obviousness in part because
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`district court considered prior art from perspective other than that of a POSA).
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`Petitioners could have supplied an expert declaration with their sur-reply to provide
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`that meaning if they had chosen to do so. They did not, rendering these documents
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`unusable here.
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`Unable to contest these facts, Petitioners seize the opportunity to make a brand
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`new merits argument, contending that the ’405 Patent specification lacks written
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`description support for the proposed amended claims’ use of the term “dosing
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`regimen.” The Board should disregard this new argument in a motion to exclude.
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`In any event, it is plainly wrong.
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`The ’405 Patent repeatedly uses the word “dose” and uses the word “regimen”
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`too when describing the methods of administering fingolimod. (Ex. 1001 at 10:63,
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`11:25, 11:37, 12:30.) The ’405 patent describes multiple embodiments of dosing
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`regimens. (Id. at 9:48-51, 11:3-19.) Both experts have also testified that a person
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`of ordinary skill in the art at the time reading the patent specification would have
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`understood that the inventors had possession of the claimed invention. (Ex. 2022 ¶¶
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`2
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`182–89; Ex. 2024 ¶¶ 171–76.) Written description is found in the specification.
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`IPR2017-00854
`U.S. Patent No. 9,187,405
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`Nothing more is needed for written description support. Ariad Pharm., Inc. v. Eli
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`Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (“[T]he test for sufficiency is
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`whether the disclosure of the application relied upon reasonably conveys to those
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`skilled in the art that the inventor had possession of the claimed subject matter as of
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`the filing date.) (emphasis added).
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`Terms must be given the broadest reasonable interpretation to a person of
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`ordinary skill in the art in the context of the patent. Here, that hypothetical “person”
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`has been defined by the Board, the parties have not disputed that definition, and
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`Novartis has offered testimony from experts about how such persons would read the
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`specification. (Paper 11 at 9.) Yet Petitioners offered no testimony from a person
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`of skill about Exhibits 1065-69; they offered only attorney argument. (Mot. at 1.)
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`The Board should disregard this improper attempt at further merits briefing, and
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`exclude the Exhibits 1065-1069 under Fed. R. Evid. 401-403.
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`Dated: May 5, 2018
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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
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`IPR2017-00854
`U.S. Patent No. 9,187,405
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`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
`Pursuant to 37 C.F.R. § 42.6, I hereby certify that on May 5, 2018, true and
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`accurate copies of the foregoing PATENT OWNER NOVARTIS’S REPLY IN
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`SUPPORT OF ITS SUPPLEMENTAL MOTION TO EXCLUDE for IPR2017-
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`00854 was served via electronic mail, on the following counsel of record for
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`Petitioners:
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`For Apotex:
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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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`For Argentum:
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`For Sun:
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`For Teva:
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`IPR2017-00854
`U.S. Patent No. 9,187,405
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`Samuel Park: SPark@winston.com
`Charles B. Klein: CKlein@winston.com
`Sharick Naqi: SNaqi@winston.com
`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
`
`Dated: May 5, 2018
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`6
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