CONTAINS PROTECTIVE ORDER MATERIAL
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`____________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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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 B2
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`____________
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`PETITIONER'S MOTION TO EXCLUDE EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64(C)
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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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`TABLE OF CONTENTS
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`Page
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`I.
`II.
`III.
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`INTRODUCTION .......................................................................................... 1
`STATEMENT OF THE PRECISE RELIEF REQUESTED ......................... 3
`IDENTIFICATION OF OBJECTIONS IN THE RECORD, AND
`WHERE IN THE RECORD THE EVIDENCE SOUGHT TO BE
`EXCLUDED WAS RELIED UPON .............................................................. 3
`IV. STATEMENT OF THE REASONS FOR THE RELIEF
`REQUESTED ................................................................................................. 3
`A.
`LEGAL STANDARD .......................................................................... 3
`B. DR. RUFFOLO DID NOT UNDERSTAND WHAT A LONG-
`FELT BUT UNRESOLVED NEED WAS .......................................... 4
`C. DR. RUFFOLO DID NOT KNOW THAT THE NEED MUST
`BE UNMET AT THE TIME THE '393 PATENT WAS FILED ........ 7
`D. DR. RUFFOLO DID NOT KNOW THAT THERE MUST BE
`A NEXUS BETWEEN THE NEED AND THE CLAIMS ................. 9
`DR. RUFFOLO DID NOT KNOW HIS EVIDENCE MUST
`BE COMMENSURATE IN SCOPE WITH THE CLAIMS ............. 10
`CONCLUSION ............................................................................................. 12
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`V.
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`CASES
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`TABLE OF AUTHORITIES
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`Page(s)
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`Allergan, Inc. v. Apotex Inc.,
`754 F.3d 952 (Fed. Cir. 2014) .........................................................................................11
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`AstraZeneca LP v. Breath Ltd.,
`88 F. Supp. 3d 326, 389 (D.N.J. 2015), aff'd 603 F. App'x 999 (Fed. Cir.
`2015) .......................................................................................................................................12
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`Cardiocom, LLC v. Robert Bosch Healthcare Sys., Inc.,
`IPR2013-00468, 2015 WL 395462 (PTAB Jan. 27, 2015), aff'd 2016 WL
`3545685 (Fed. Cir. June 29, 2016) ...............................................................................5, 7
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`Daubert v. Merrell Dow Pharms., Inc.,
`509 U.S. 579 (1993) ................................................................................................... passim
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`Ecolochem, Inc. v. S. Cal. Edison Co.,
`227 F.3d 1361 (Fed. Cir. 2000) .........................................................................................7
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`General Elec. Co. v. Joiner,
`522 U.S. 136 (1997) .............................................................................................................4
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`Geo. M. Martin Co. v. Alliance Mach. Sys. Int'l LLC,
`618 F.3d 1294 (Fed Cir. 2010) ..........................................................................................8
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`In re Greenfield,
`571 F.2d 1185 (C.C.P.A. 1978) .......................................................................................12
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`In re Huai-Hung Kao,
`639 F.3d 1057 (Fed. Cir. 2011) .........................................................................................7
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`In re Paoli R.R. Yard PCB Litig.,
`35 F.3d 717 (3d Cir. 1994) .................................................................................................4
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`Iron Grip Barbell Co. v. USA Sports, Inc.,
`392 F.3d 1317 (Fed. Cir. 2004) .....................................................................................6, 9
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`Kumho Tire Co. v. Carmichael,
`526 U.S. 137 (1999) .............................................................................................................4
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`Ormco Corp. v. Align Tech., Inc.,
`463 F.3d 1299 (Fed. Cir. 2006) .........................................................................................9
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`Perfect Web Techs., Inc. v. InfoUSA, Inc.,
`587 F.3d 1324 (Fed. Cir. 2009) .........................................................................................4
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`Therasense, Inc. v. Becton, Dickinson and Co.,
`593 F.3d 1325 (Fed. Cir. 2010) .......................................................................................12
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`L ATERIALRDER MACTIVE ORCOONTAINS PROTEC
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`I.
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`INNTRODUUCTION.
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`Petittioner SteaadyMed LLtd. ("Petittioner") mmoves to eexclude thhe opinionns of
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`Owner Unnited Therrapeutics' eexpert Roobert Ruffoolo regardding seconndary
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`consideerations, foound in EEx. 2022
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`(the "Rufffolo Decclaration").
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` The Rufffolo
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`Declaraation offerss the conclusion thatt there waas a long-ffelt need fofor the claiimed
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`inventioons. But DDr. Ruffoloo was unawware of thee correct leegal standaard requireed to
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`show aa long-felt
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`need for
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`standardd. His opinnions thus
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`a claimed inventioon, and innstead, appplied a wwrong
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`are not reelevant to tthe questioon of longg-felt need.. For
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`that reason, these
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`opinions aare unreliaable, confuusing, and nnot helpfull to the trieer of
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`fact. Thhey should be excludeed under FFederal Rulles of Eviddence 702 aand Daubeert v.
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`Merrelll Dow Pharrms., Inc., 509 U.S. 5579 (1993)).
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`Dr. RRuffolo waas asked bby United TTherapeutiics' counseel to opine
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`that there
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`"a longg-felt unmmet need"
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`that the
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`"'393 pattent satisffied ... byy providinng a
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`commerrcial scale
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`synthesis
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`of treprosttinil that reesults in a
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`treprostiniil product
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`with
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`higher ooverall purrity and loower level
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`of individdual impurrities." (Exx. 2022, ¶
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`31.)
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`But Dr.. Ruffolo wwas not toold that thee "long-fellt unmet neeed" must
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`be one thhat is
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`art, such thhat others
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`were tryinng to pursuue it. He waas not toldd that
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`the needd was one
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`that was nnot being mmet by thee prior art.
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`He was noot told thaat the
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`long-fellt need hadd to have aa nexus too the patennt claims. AAnd he waas not toldd that
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`the longg-felt need had to be commensuurate in scoope with thhe claims.
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`Because of counsel's failure to advise Dr. Ruffolo of the correct legal standard,
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`Dr. Ruffolo did not inquire whether anyone in the art felt a long-standing need for
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`the '393 invention. He did not know if this alleged need had been recognized
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`before the patent had been filed.
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`In fact, treprostinil made by the prior-art Moriarty method had been an
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`approved drug for years before the '393 patent was filed, and as Dr. Ruffolo
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`explained at his deposition, this prior-art treprostinil was "highly, highly pure." But
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`Dr. Ruffolo did not know that he needed to compare the long-felt need he
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`articulated with the prior-art solution to this alleged problem.
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`Dr. Ruffolo also did not know that there needed to be a nexus between the
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`claims and the long-felt unmet need he identified. Dr. Ruffolo did not even know
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`whether United Therapeutics' current commercial product practiced the '393 patent
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`claims. Moreover, the claims are not limited to the commercial scale synthesis
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`identified by Dr. Ruffolo in his long-felt need, but cover any synthesis.
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`Finally, Dr. Ruffolo did not know that his long-felt-unmet-need evidence
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`needed to be commensurate in scope with the claims. When confronted with this
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`legal standard at his deposition, Dr. Ruffolo conceded that many of the claims
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`contained at least hundreds of thousands of compounds, and others contained
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`numerous compounds, but that his opinion was confined to treprostinil. He
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`conceded on cross-examination that he was not opining that there was a long-felt
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`L ATERIALRDER MACTIVE ORCOONTAINS PROTEC
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`need foor any of
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`those claiims, and eexcept forr those claaims that
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`are limiteed to
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`an opiniion on anyy other claimms despitee his Declaaration.
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`treprosttinil alone
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`(only claaims 10 aand 15), oor treprosttinil diethaanolamine
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`(claims
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`14 and 177) (an opiniion not exppressed in
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`his Declarration), he
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`is not offeering
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`SSTATEMEENT OF TTHE PRECCISE RELLIEF REQQUESTEDD.
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`II.
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`The
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`Purssuant to 377 C.F.R. §
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`42.64(c),
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`Petitionerr moves too exclude pparagraphss 26,
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`27, 31, 32-57, 58-65, andd 66-75 off the Rufffolo Declaaration (Exx. 2022).
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`Ruffoloo Declaratiion is inaadmissible
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`under Feed. R. Eviid. 702 annd Dauberrt v.
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`Merrelll Dow Phaarms., Inc.,, 509 U.S. 579 (199
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`3), becausse the Dec
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`for exammple, baseed upon reeliable prinnciples andd methods.. Accordinngly, Petitiioner
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`moves tto exclude the above--referencedd paragrapphs of the RRuffolo Deeclaration.
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`IDDENTIFICATION OF OBJEECTIONSS IN THE
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`WHERE INN THE REECORD TTHE EVIDDENCE S
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`OUGHT TTO BE
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`EXCLUDEED WAS RRELIED UUPON.
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`III.
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`Petittioner objeected to thiis evidencee on July 113, 2016. ((Paper 43,
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`Petitionner objected to the RRuffolo Deeclaration ppursuant too Fed. R.
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`at 3-4.) Thhere,
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`Evid. 702
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`Dauberrt. (Id.) Thiis evidencee was usedd in Patentt Owner's RResponse ((Paper No
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`throughhout, and esspecially aat pages 1-33, 6-8, 12,
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`26, 31, 344, and 47-4
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`8.
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`IV.
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` SSTATEMEENT OF TTHE REASSONS FOOR THE RRELIEF REEQUESTEED.
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`AA. LEGGAL STANNDARD.
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`Fedeeral Rule oof Evidencce 702 govverns expeert-testimoony admisssibility. Exxpert
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`testimonny must bbe helpful
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`in undersstanding thhe evidencce or
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`determining a fact in issue. Fed. R. Evid. 702. And the court must be convinced
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`that the expert testimony is reliable. Id. Reliable testimony must be (1) "based on
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`sufficient facts or data," (2) "the product of reliable principles and methods," and
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`(3) a sound application of the principles to the facts. Id. The party offering expert
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`testimony must show by a preponderance of the evidence that its expert's opinions
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`are reliable. In re Paoli R.R. Yard PCB Litig., 35 F.3d 717, 743-44 (3d Cir. 1994).
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`"[T]he Rules of Evidence—especially Rule 702—do assign to the trial judge
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`the task of ensuring that an expert's testimony both rests on a reliable foundation
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`and is relevant to the task at hand." Daubert, 509 U.S. at 597. While the Board has
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`discretion in deciding whether that standard has been met, the Board cannot shirk
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`its gatekeeper duties. See General Elec. Co. v. Joiner, 522 U.S. 136, 142 (1997);
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`compare with id. at 148 (Breyer, J., concurring). This gatekeeping ensures "that an
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`expert ... employs in the courtroom the same level of intellectual rigor" as he would
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`outside. Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152 (1999).
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`B. DR. RUFFOLO DID NOT UNDERSTAND WHAT A LONG-
`FELT BUT UNRESOLVED NEED WAS.
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`To support a case for "a long-felt, unmet need alleviated by the patent," United
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`Therapeutics and Dr. Ruffolo must, as a predicate showing, provide "evidence to
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`explain how long this need was felt, or when the problem first arose," since "long-
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`felt need is analyzed as of the date of an articulated identified problem." Perfect
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`quotations omitted). As the Board has stated, "[t]o support a conclusion of
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`nonobviousness, an alleged long-felt need must have been a persistent one that was
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`recognized by those of ordinary skill in the art, must not have been satisfied by
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`another before the challenged patent, and must have been satisfied by the claimed
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`invention." Cardiocom, LLC v. Robert Bosch Healthcare Sys., Inc., IPR2013-
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`00468, 2015 WL 395462, at *21 (PTAB Jan. 27, 2015), aff'd 2016 WL 3545685
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`(Fed. Cir. June 29, 2016) (Final Written Decision Paper No. 72). But Dr. Ruffolo
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`had no idea whether the art ever recognized a problem with treprostinil's purity.
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`Dr. Ruffolo's Declaration is addressed solely to long-felt need. (Ex. 2058 37:7-
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`38:3.) But Dr. Ruffolo's understanding of long-felt need was deficient:
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`Q. What's your understanding of long-felt need? What is that?
`A. Well, again, not being an attorney, my understanding of long-felt
`need is something that results in an improvement in a product that has a
`significance and something that other people hadn't done. That's my
`simple layman's understanding.
`Q. You said it had a significance. A significance to whom?
`A. Well, I'm assuming to anybody. I don't know that it applies to any
`individual case in terms of your general question.
`Q. Well, do you know, does -- does a long-felt need to be something that
`was recognized or understood in the art?
`A. I don't understand.
`(Id. 38: 4-20.)
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`Rather than looking for recognition of the need in the art, Dr. Ruffolo merely
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`looked for an improvement that had not been done before, and relied on the
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`absence of treprostinil made by the '393 patented method in the market. But this
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`approach to long-felt need has been explicitly rejected by the Federal Circuit:
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`Iron Grip places significant emphasis on the fact that, before it filed for
`the '015 patent, there was no three-grip plate being offered in the retail
`market. It argues that the absence of such a three-grip plate in light of the
`prior art speaks to the nonobviousness of its invention. However, Iron
`Grip has presented no evidence of a long-felt need for three-grip weight
`plates or the failure of others. Absent a showing of long-felt need or the
`failure of others, the mere passage of time without the claimed invention
`is not evidence of nonobviousness.
`Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1324-25 (Fed. Cir.
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`2004).
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`Regarding recognition by others in the art of an alleged purity problem with
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`treprostinil that had not been solved, Dr. Ruffolo conceded that he had no idea if
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`FDA had asked for a change in purity, (Ex. 2058 45:15-22), nor could he identify
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`anyone who expressed a particular desire for greater purity, (id., 130:16-25). He
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`also recognized that one could usually purify a drug further by running purification
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`procedures repeatedly, (id., 46:9-18), which Dr. Williams confirmed was true for
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`treprostinil (Ex. 2059, 94:8-12), which proves that there was no need for the
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`"invention" at the time of filing.
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`C. DR. RUFFOLO DID NOT KNOW THAT THE NEED MUST BE
`UNMET AT THE TIME THE '393 PATENT WAS FILED.
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`"Where the offered secondary consideration actually results from something
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`other than what is both claimed and novel in the claim, there is no nexus to the
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`merits of the claimed invention." In re Huai-Hung Kao, 639 F.3d 1057, 1068 (Fed.
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`Cir. 2011) (italics in original). Needs that are already solvable by the prior art are
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`not long-felt and unmet needs, and typically "an unsolved problem is not evidence
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`of non-obviousness unless skilled workers in the art have tried and failed to solve
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`the problem." Ecolochem, Inc. v. S. Cal. Edison Co., 227 F.3d 1361, 1377, 1378
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`(Fed. Cir. 2000). "[A]n alleged long-felt need ... must not have been satisfied by
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`another before the challenged patent ...." Cardiocom, 2015 WL 395462, at *21.
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`Dr. Ruffolo apparently did not understand that the need—here, supposedly for
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`"treprostinil product with higher overall purity and lower level of individual
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`impurities"—needed to be unmet at the time of the '393 Patent's filing. To the
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`contrary, Dr. Ruffolo conceded that: (1) the FDA requires only a
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` purity level,
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`which is much lower than any levels produced by the prior art, (id.,159:20-161:7);
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`(2) the FDA would allow batches of treprostinil produced by the Moriarty process
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`to be sold, (id.,179:23-180:17), since Moriarty products are "highly, highly pure,"
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`(id., 217:11-218:5); (3) one could usually purify a drug further by running
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`purification procedures repeatedly, (id., 46:9-18), which Dr. Williams confirmed
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`was true for treprostinil, (Ex. 2059, 94:8-12), thus showing no need at the time of
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`filing; and (4) there is no clinical difference between the prior-art Moriarty product
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`and the '393 Patent product (id. 315:15-23).
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`In regard to the precise impurities supposedly found using the prior-art Moriarty
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`process (assuming, incorrectly but for the sake of argument, that the Moriarty
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`process produced a unique impurity profile, which the data shows is not the case),
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`Dr. Ruffolo conceded that he had no information regarding whether the impurity
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`profile of treprostinil mattered:
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`Q. Is there a difference between the approved Moriarty treprostinil
`product that was shown clinically that's different from the '393 product?
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`THE WITNESS: Not -- not to my knowledge.
`(Ex. 2058, 315:15-23; see also 257:22-258:5; Ex. 2059, 47:4-13 (Dr. Williams).)
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`Dr. Ruffolo's concessions regarding the fact that there were no differences
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`between the prior art Moriarty-process and the '393 Patent product in regard to
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`patient needs shows that he was unaware that the need must be unmet. "Where the
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`differences between the prior art and the claimed invention are as minimal s they
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`are here ... it cannot be said that any long-felt need was unsolved." Geo. M. Martin
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`Co. v. Alliance Mach. Sys. Int'l LLC, 618 F.3d 1294, 1304 (Fed Cir. 2010). Thus,
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`his opinion, which ignored the "unmet need" standard, is not based on reliable
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`principles, will not help the trier of fact, and should be excluded under Daubert.
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`D. DR. RUFFOLO DID NOT KNOW THAT THERE MUST BE A
`NEXUS BETWEEN THE NEED AND THE CLAIMS.
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`A "nexus must be established between the merits of the claimed invention and
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`evidence of commercial success before that evidence may become relevant to the
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`issue of obviousness." Iron Grip Barbell, 392 F.3d at 1324. This rule applies to the
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`other secondary considerations as well. See Ormco Corp. v. Align Tech., Inc., 463
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`F.3d 1299, 1311-12 (Fed. Cir. 2006) ("Evidence of commercial success, or other
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`secondary considerations, is only significant if there is a nexus between the
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`claimed invention and the commercial success."). "[I]f the commercial success is
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`due to an unclaimed feature of the device, the commercial success is irrelevant. So
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`too if the feature that creates the commercial success was known in the prior art,
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`the success is not pertinent." Id. at 1312.
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`In addition to not understanding that the need must be "long-felt" and "unmet,"
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`Dr. Ruffolo was unaware that he had to draw a nexus between the supposed long-
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`felt need and the claims. In fact, Dr. Ruffolo did not even know if the commercial
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`treprostinil he discussed in his opinion was covered by the '393 Patent's claims:
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`Did you analyze claim 9 and determine whether it covers United
`Therapeutics' Remodulin product?
`...
`THE WITNESS: I -- again, I'm still not quite sure what you mean but,
`you know, that wasn't what I was asked to do, and I don't believe I did
`make any comparison like that.
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`Q. Do you know if anyone else in this case made that comparison?
`A. No.
`(Ex. 2058, 292:15-293:2.)
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`The '393 Patent is not addressed to specific impurities in treprostinil, as Dr.
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`Ruffolo conceded. (Ex. 2058, 234:16-235:12). He testified: "I see primarily
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`purities of the parent compound, which is what I believe the invention is related to"
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`and "so I see comparisons between the old process and new process with purities,
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`but – but I don't see, unless I've missed it, I don't see the impurities." (Ex. 2058,
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`235:6-12.) UT maintains the specific identity of these impurities as a trade secret
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`requiring a protective order. (Ex. 2058, 93:19-94:24, 233:5-12.) These secret
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`impurities, not even identified in the '393 patent for the hundreds of thousands of
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`compounds claimed, cannot be connected with any supposed long-felt need.
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`Moreover, Dr. Ruffolo did not know if the purity of the commercial product he
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`was describing was due to the '393 Patent, or to other changes in process between
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`the Moriarty-process product and the '393-Patent product, including purification of
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`the nitrile, or change in solvents. (Ex. 2058, 239:8-241:14.) These process changes
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`are not features of the claims.
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`E. DR. RUFFOLO DID NOT KNOW HIS EVIDENCE MUST BE
`COMMENSURATE IN SCOPE WITH THE CLAIMS.
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`"It is the established rule that 'objective evidence of non-obviousness must be
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`commensurate in scope with the claims which the evidence is offered to support.'"
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`Allergan, Inc. v. Apotex Inc., 754 F.3d 952, 965 (Fed. Cir. 2014).
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`Dr. Ruffolo concedes that the claims are not limited to treprostinil, nor
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`treprostinil salt, but include hundreds of thousands of other compounds, for which
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`he provides no evidence regarding long-felt need or impurities. (Ex. 2059, 71:17-
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`72:17; Ex. 2058, 234:16-235:17.) Dr. Ruffolo testified that there is nothing he can
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`say about any long-felt need connected with any claims not limited to treprostinil,
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`including, for example, claim 1 ("there's nothing I can tell you about the long-felt
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`need for those other compounds [of claim 1],") (Ex. 2058, 65:4-13); claim 9 (Ex.
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`2058, 69:20-70:11); claims 12, 13, 16, 17, 21, or 22 (Ex. 2058, 110:17-111:9,
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`114:16-117:3, 118:2-5; 118:23-119:23, 121:5-23); or of any claim that was not
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`limited to treprostinil and treprostinil diethanolamine salt, (Ex. 2058, 68:14-25).
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`Only claims 10, 14, 15, and 17 are limited to treprostinil or its salt.
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`Moreover, Dr. Ruffolo's Declaration never offers any opinion regarding
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`treprostinil diethanolamine salt, but only addresses treprostinil. (Ex. 2022; see e.g.,
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`¶ 31("a long felt need ... in a treprostinil product".) Except for those claims that are
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`limited to treprostinil alone (only claims 10 and 15), Dr. Ruffolo cannot show that
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`his opinion is commensurate in scope with the broad claims containing numerous
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`compounds in the '393 Patent. (Ex. 2058, 109:18-121:23.)
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`Dr. Ruffolo's so-called "evidence as to the long-felt, unmet need is not
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`reasonably commensurate with the scope of the claims as it goes to only a single
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`embodimment of thhe claims," treprostinnil. See AsttraZeneca
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`LP v. Breeath Ltd., 888 F.
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`also
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`Supp. 3d 326, 3899 (D.N.J. 22015), aff'dd 603 F. AApp'x 999 ((Fed. Cir. 22015); see
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`In re GGreenfield,, 571 F.2dd 1185, 11189 (C.CC.P.A. 197
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`8) ("[T]hee specificaation
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`disclosees test resuults of the sstabilizing
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`effects of f only one
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`... of a claiimed subg
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`enus
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`which cconsists off several hhundred coompounds.
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` Establishhing that o
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`ne (or a ssmall
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`numberr of) speciees gives unnexpected rresults is iinadequatee proof, forr 'it is the vview
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`of this ccourt that oobjective eevidence oof non-obviiousness mmust be commmensuraate in
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`scope wwith the claaims whichh the evideence is offfered to suupport.'"). AAs the Fedderal
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`Circuit
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`has held, wwhere, as
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`here, the cclaims covver numeroous emboddiments thaat do
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`regardingg commeercial
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`not so
`lve a
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`long-felt-neeed—here,
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`an allegged need
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`treprosttinil, but
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`not any
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`other emmbodimennts—the
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`llong-felt
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`need "is
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`not
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`commennsurate in
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`scope withh the claimms which tthe evidencce is offereed to suppport."
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`Theraseense, Inc.
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`v. Becton, Dickinsonn and Co.., 593 F.3
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`d 1325, 1
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`336 (Fed.
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`Cir.
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`
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`2010) (iinternal quuotations ommitted).
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`Becaause Dr. RRuffolo waas unawaree that his eevidence rregarding
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`a long-feltt but
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`unmet nneed must
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`be commeensurate in
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`scope withh the claimms, his opinnion testimmony
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`should bbe excludeed under Daubert as nnot based oon reliablee principless.
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`V.
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` CCONCLUSSION.
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`Dr. RRuffolo's DDeclarationn, Ex. 20222, was nott "the prodduct of reli
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`and metthods." Drr. Ruffolo wwas not addvised thatt a "long-ffelt unmet
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`able princiiples
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`need" musst be
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`CONTAINS PROTECTIVE ORDER MATERIAL
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`one that is recognized in the art, not being met by the prior art, needed a nexus to
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`the patent claims, and must be commensurate in scope with the claims. Because his
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`Ex. 2022 was written without these principles in mind, Dr. Ruffolo's opinion
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`testimony should be excluded under Daubert.
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`Date: November 1, 2016
`
`
`/s Stuart E. Pollack /
`Stuart E. Pollack, J.D. Ph.D.
`Reg. No. 43,862
`DLA Piper LLP (US)
`
`
`
`Respectfully submitted,
`
`/s Lisa A. Haile / __________
`Lisa A. Haile, J.D., Ph.D.
` Reg. No. 38,347
`DLA Piper LLP (US)
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`
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`WEST\273894032.5
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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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`MOTION TO EXCLUDE EVIDENCE PURSUANT TO 37 C.F.R. § 42.64(C) was
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`served via electronic mail to the following:
`
`Stephen B. Maebius
`George Quillin
`FOLEY & LARDNER LLP
`UT393-IPR@foley.com
`
`Shaun R. Snader
`UNITED THERAPEUTICS CORP.
`ssnader@unither.com
`
`Douglas Carsten
`Richard Torczon
`Robert Delafield
`WILSON, SONSINI, GOODRICH & ROSATI
`dcarsten@wsgr.com
`rtorczon@wsgr.com
`bdelafield@wsgr.com
`
`
`
`
`/s Lisa A. Haile /
`Lisa A. Haile, J.D., Ph.D.
`Reg. No. 38,347
`DLA Piper LLP (US)
`
`
`
`
`
`Date: November 1, 2016
`
`
`/s Stuart E. Pollack /
`Stuart E. Pollack, J.D., Ph.D.
`Reg. No. 43,862
`DLA Piper LLP (US)
`
`
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`WEST\273894032.5
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