UNITED STTES PATENT AND TRADEMARK OFFICE
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`____________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`____________
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`STEADYMED LTD.,
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`Petitioner,
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`v.
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`UNITED THERAPEUTICS CORPORATION
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`Patent Owner.
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`Case IPR2016-00006
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`Patent No. 8,497,393
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`____________
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`PETITIONER'S REPLY IN SUPPORT OF
`PETITIONER'S MOTION TO EXCLUDE
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`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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`WEST\274368865.2
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`TABLE OF CONTENTS
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`Page
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`INTRODUCTION .......................................................................................... 1
`I.
`II. ARGUMENT .................................................................................................. 2
`A. Dr. Ruffolo must understand enough of the long-felt-need legal
`standard to have a reliable methodology. ............................................. 2
`B. Dr. Ruffolo's testimony showed that he did not understand what
`a long-felt but unsolved need was. ....................................................... 3
`C. All of Dr. Ruffolo's testimony concerned long-felt need. .................... 5
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`WEST\274368865.2
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`CASES
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`TABLE OF AUTHORITIES
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`Page(s)
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`DSU Med. Corp. v. JMS Co.,
`471 F. 3d 1293 (Fed. Cir. 2006) ........................................................................................2
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`Meds. Co. v. Mylan Inc.,
`No. 11-CV-1285, 2014 WL 1227214 (N.D. Ill. Mar. 25, 2014) ...............................2
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`OTHER AUTHORITIES
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`37 C.F.R. § 42.64(c) ...................................................................................................................1
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`WEST\274368865.2
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`Petittioner, SteaadyMed Lttd. ("Petitiooner"), resspectfully ssubmits thiis reply in
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`support of its Mottion to Excclude Patennt Owner's
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`Pursuant tto 37 C.F.RR.
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`§ 42.64
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`r No. 62.
`(c) ("Motioon" or "Moot."), Pape
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`I.
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`INNTRODUUCTION
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`Expeert testimony must bee excludedd when an eexpert ignoores the rellevant legaal
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`standardd in reaching his or hher conclussion. Patennt Owner ddoes not disspute that DDr.
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`Ruffoloo was entireely unawarre of the coorrect standdard suppoorting his oopinion on
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`long-fellt need. Raather, Patennt Owner ppremises itss Oppositi
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`arguingg that Petitiioner's Mottion shouldd be deniedd because
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`on on falsee grounds,
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`"Petitionerr does not
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`attack DDr. Ruffoloo's qualifications, the factual baasis of his oopinions, oor the
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`methodology empployed, including its rreliability.
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`" (Opp. at
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`1, 4). Pateent Owner
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`wrong:
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`because DDr. Ruffolo was unawware of the
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`correct leggal standarrd requiredd to
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`s opinion, the factuall basis of hhis opinionn, his methoodology, aand his opinnion
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`are all uunreliable, and shouldd be excludded. Dr. RuRuffolo wass specificallly asked bby
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`Patent OOwner to oopine whethher there wwas a "longg-felt, unmmet need" thhat the '3933
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`Patent ssatisfied; yet, Dr. Rufffolo had nno understaanding of tthe legal reequirementts to
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`establishh a long-feelt, unmet nneed, and uused the wwrong factss and methoodology.
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`Accordiingly, Dr. RRuffolo's oopinions shhould be exxcluded.
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` AII. ARGUME
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`standdard to haave a reliabble methoodology.
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`AA. Dr. RRuffolo muust undersstand enouugh of thee long-felt--need legaal
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`Patennt Owner ppremises itts Oppositiion ("Opp.
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`" [Paper NNo. 66]) onn its contenntion
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`that therre is no reqquirement that expertts need to kknow the llegal standdard that
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`inform ttheir opinions becausse experts are not "reequired to bbe fluent inn the law
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`…prior to makingg [their] op
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`inions." (OOpp. at 8).
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`Numerouss courts, hoowever, haave
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`excludeed expert teestimony wwhere, as hhere, an exppert complletely ignorres the leg
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`11-CV-1285, 20144 WL 12277214, at *55 (N.D. Ill.. Mar. 25, 22014) ("Beecause Mr
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`standardd in reaching his or hher conclussion. See, ee.g., Meds.
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`Flammiia applies tthe wrong llegal standdard regardding commmercial succcess ... his
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`law on commmercial ssuccess. Acccordinglyy, the
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`methodology failss to complyy with the
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`Court sttrikes his oopinions onn commerccial successs because tthey are leegally flaw
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`and willl not be heelpful to thee trier of faact."); see aalso DSU MMed. Corpp. v. JMS CCo.,
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`471 F. 33d 1293, 13308 (Fed. CCir. 2006) (affirmingg exclusionn of expertt's "proffereed
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`methodology ... [bbecause it] is not grouunded on eestablishedd legal prinnciple and iis
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`tually to bfar too rremote fac
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`e within thhe line drawwn for legaally compeensable pattent
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`injuries."). Any asssertions too the contraary are wroong.
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`BB. Dr. RRuffolo's ttestimony showed thhat he did
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`long--felt but unsolved neeed was.
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`not underrstand whhat a
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`Patennt Owner aargues Petiitioner "miischaracterrizes" Dr. RRuffolo's t
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`estimony oon
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`the legaal standardss relating tto secondarry consideerations, a ""topic outsside his
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`expertise." (Opp. at 1, 4). A review of the cited testimony confirms that Patent
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`Owner's characterizations of Dr. Ruffolo's testimony and statements are
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`unsupported by the record, and support exclusion.
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`First, Patent Owner argues that the FDA identified the long-felt need for higher
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`purity treprostinil, because "[r]egulatory agents have…sought to increase levels of
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`purity." (Opp., at 5, citing Ex. 2022, at ¶ 36). Patent Owner does not dispute,
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`however, that the relevant standard required to support a conclusion of non-
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`obviousness is that the alleged long-felt need must have been a persistent one that
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`was recognized by those of ordinary skill in the art and have a nexus to the patent
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`claims. Further, Patent Owner does not dispute that Dr. Ruffolo had no idea if the
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`FDA had even asked for a change in purity of treprostinil (Ex. 2058, at 45:15-22),
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`and had no idea if anyone had ever expressed a specific desire for greater purity of
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`treprostinil (id., 130:16-25). Dr. Ruffolo's bare assertions that the FDA has an
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`overall interest in purity with no tie to the actual patent claims or even treprostinil
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`itself, combined with his ignorance of the requisite legal standard, renders his
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`opinion fatally flawed.
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`Second, Patent Owner takes issue with Dr. Ruffolo's concession that there were
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`no differences between the '393 Patent product and the Moriarty prior art (Opp. at
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`6), citing to portions of Dr. Ruffolo's Declaration where he discussed the alleged
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`change in purity profile for the '393 Patent and his reliance on Dr. Williams'
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`analysis. But, a review of the cited testimony reveals that neither Dr. Ruffolo nor
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`Dr. Williams provided any testimony on the importance of the impurity profile of
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`treprostinil. See Motion, at 8.
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`Third, Patent Owner concedes that Dr. Ruffolo failed to provide any opinion
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`regarding the thousands of other compounds encompassed by '393 Patent claims.
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`Nonetheless, Patent Owner argues that the Board should: (1) consider an unrelated
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`decision involving another expert’s analysis of secondary considerations for
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`Moriarty's U.S. Patent No. 6,765,117 which does not discuss long-felt need
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`specific to any of the claims of the '393 Patent; and (2) rely on Dr. Williams'
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`testimony and analysis with respect to only claim 1 of the '393 Patent. (Opp. at 8).
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`This, too, does not salvage Dr. Ruffolo's testimony, and does nothing to rebut the
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`fact that Dr. Ruffolo's analysis was not tied to the claims themselves.
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`Lastly, Patent Owner argues that Dr. Ruffolo understood that the
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`commercialized treprostinil product was covered by the '393 Patent. (Opp. at 8).
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`Yet, Patent Owner does not dispute Dr. Ruffolo was unaware that he had to draw a
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`nexus between the alleged long-felt need and the claims themselves. See Motion,
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`at 9-10. This, too, merits exclusion.
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`C. All of Dr. Ruffolo's testimony concerned long-felt need.
`Patent Owner argues that many of the statements that Petitioner seeks to
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`exclude have "relevance beyond long-felt, unmet need," (Opp. at 11), contending
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`that Dr. Ruffolo provided testimony related to other issues unrelated to long-felt
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`need, such as issues related to structural and functional differences between the
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`'393 Patent and the prior art. (Opp. at 12). This is incorrect, and belied by Dr.
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`Ruffolo's own testimony:
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`I don’t recall that there are other opinions. I was asked to
`deal with long-felt need and that was pretty much what
`my -- my task was and so that's what I focused on.
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`(Ex. 2058, at 37:7-11). The record is replete with Dr. Ruffolo's repeated assertions
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`that his opinion was limited to issues of long-felt need. (See id., 37:14-38:5; 64:16-
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`20; 84:11-13; 87:13-19; 100:23-101:3; 110:7-10; 113:2-4; 202:25-203:2). Even
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`assuming, arguendo, that Dr. Ruffolo provided testimony beyond long-felt need,
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`Paragraphs 66-75 of the Ruffolo Declaration fail to show that Dr. Ruffolo followed
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`the requisite analysis required to show long-felt need by tying the claims of the
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`'393 Patent to the alleged need.
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`Date: November 22, 2016
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`/s Stuart E. Pollack /
`Stuart E. Pollack, J.D. Ph.D.
`Reg. No. 43,862
`DLA Piper LLP (US)
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`Respectfully submitted,
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`/s Lisa A. Haile /
`Lisa A. Haile, J.D., Ph.D.
`Reg. No. 38,347
`DLA Piper LLP (US)
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`5
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`CERTIFICATE OF SERVICE
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`The undersigned certifies that a copy of the attached PETITIONER'S
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`REPLY IN SUPPORT OF PETITIONER'S MOTION TO EXCLUDE was served
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`via electronic mail to the following:
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`Stephen B. Maebius
`George Quillin
`FOLEY & LARDNER LLP
`UT393-IPR@foley.com
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`Shaun R. Snader
`UNITED THERAPEUTICS CORP.
`ssnader@unither.com
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`Douglas Carsten
`Richard Torczon
`Robert Delafield
`WILSON, SONSINI, GOODRICH & ROSATI
`dcarsten@wsgr.com
`rtorczon@wsgr.com
`bdelafield@wsgr.com
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`Respectfully submitted,
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`/s Lisa A. Haile /
`Lisa A. Haile, J.D., Ph.D.
`Reg. No. 38,347
`DLA Piper LLP (US)
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`6
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`Date: November 22, 2016
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`
`/s Stuart E. Pollack /
`Stuart E. Pollack, J.D., Ph.D.
`Reg. No. 43,862
`DLA Piper LLP (US)