Paper _____
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`STEADYMED LTD.
`Petitioner
`
`v.
`
`UNITED THERAPEUTICS CORPORATION
`Patent Owner
`
`
`
`U.S. Patent No. 8,497,393
`Issue Date: Jul. 30, 2013
`Title: PROCESS TO PREPARE TREPROSTINIL, THE ACTIVE INGREDIENT IN
`REMODULIN®
`_______________
`
`Case IPR2016-00006
`_______________
`
`
`
`PATENT OWNER’S MOTION TO EXCLUDE
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`
`
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`4850-9319-7872.1
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`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`STEADYMED LTD.
`Petitioner
`
`v.
`
`UNITED THERAPEUTICS CORPORATION
`Patent Owner
`
`
`
`U.S. Patent No. 8,497,393
`Issue Date: Jul. 30, 2013
`Title: PROCESS TO PREPARE TREPROSTINIL, THE ACTIVE INGREDIENT IN
`REMODULIN®
`_______________
`
`Case IPR2016-00006
`_______________
`
`
`
`PATENT OWNER’S MOTION TO EXCLUDE
`
`
`
`
`4850-9319-7872.1
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`
`
`IPR2016-00006
`Patent 8,497,393
`
`
`Patent Owner Docket No. 080618-1601
`
`
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`INTRODUCTION
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`I.
`Under 37 C.F.R. § 42.64(c) and the Scheduling Order (Paper 13), United
`
`Therapeutics Corporation (“Patent Owner”) moves to exclude Petitioner’s Exhibit
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`1022 and the objected-to portions of Exhibits 1009, 1022 and 2059 on the
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`following grounds:
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`Exhibit
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`Description
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`Reason to Exclude
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`Ex. 1009
`
`Declaration of Jeffrey D.
`
`Expert not qualified to make these
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`Winkler, Ph.D. (¶¶3, 31, 46, 48,
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`conclusory statements
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`54, 57, 63, 71, and 72)
`
`Ex. 1017
`
`A website printout entitled
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`Hearsay and not authenticated
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`“Getting Started in HPLC,’
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`Section 4D: Precision and
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`Accuracy”
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`Ex. 1022
`
`Dr. Robin D. Rogers
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`Exceeds scope of PO Response
`
`Declaration
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`and does not rely on facts and data
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`Ex. 2059
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`Certain portions of Deposition
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`Likely to create confusion and
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`in the record
`
`Transcript of Dr. Robert M.
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`mislead
`
`Williams, Ph.D
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`4850-9319-7872.1
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`2
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`IPR2016-00006
`Patent 8,497,393
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`Patent Owner Docket No. 080618-1601
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`
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`Petitioner relied on these exhibits as pointed out below in its Petition (Paper
`
`No. 1) and Petitioner’s Reply (Paper No. 52). Patent Owner also moves to exclude
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`the portions of Petitioner’s Petition and Reply, which rely on these exhibits.
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`II.
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`PATENT OWNER TIMELY OBJECTED
`
`Patent Owner timely objected, on April 22, 2016, to Exhibits 1009 and 1017,
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`which were submitted with the Petition, which was instituted on April 12, 2016.
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`See Paper 19. Likewise, Patent Owner timely objected, on October 3, 2016, to
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`Exhibits 1022 and 2059, which were submitted with the Reply, which was filed on
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`September 27, 2016. See Paper 55. Petitioner did not supplement or authenticate
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`any of its evidence in response to these specific objections.
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`A. Ex. 1009
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`Specifically, Patent Owner objected to Ex. 1009 in Paper No. 19 for the
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`following reasons:
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`Exhibit 1009 is described as “Declaration of Jeffrey D. Winkler, Ph.D.” Patent
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`Owner objects to Exhibit 1009, under FRE 701, because the opinion testimony
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`contained in this exhibit reaches legal conclusions for which the declarant has not
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`established that he is capable of providing, for example, paragraphs 3, 31, 46, 48,
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`4850-9319-7872.1
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`IPR2016-00006
`Patent 8,497,393
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`Patent Owner Docket No. 080618-1601
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`54, 57, 63, 71, and 72 each recite an unsupported legal conclusion and, thus,
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`should not be considered by the Board is this proceeding.
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`B. Ex. 1017
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`Patent Owner objected to Ex. 1017 in Paper No. 19 for the following reasons:
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`Exhibit 1017 is described as “‘Getting Started in HPLC,’ Section 4D: Precision
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`and Accuracy, available at http://www.lcresources.com/resources/getstart/
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`4d01.htm (accessed Sept. 29, 2015).” Patent Owner objects to Exhibit 1017 under
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`FRE 901 as not being properly authenticated. Petitioner relies on the exhibit to
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`prove the truth of the matter asserted therein, but the exhibit fails to meet the
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`requirements of any hearsay exception or exemption under FRE 803-807.
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`C. Ex. 1022
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`Patent Owner objected to Ex. 1022 in Paper No. 55 for the following reasons:
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`Exhibit 1022 is described as “Dr. Robin D. Rogers Declaration.”
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`(a) Patent Owner objects to Exhibit 1022 under 37 CFR 42.23 because the
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`opinion testimony contained in this exhibit contains opinions, including
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`paragraphs 44-48, that are not responsive to the Patent Owner Response and,
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`thus, should not be considered by the PTAB in this proceeding. See 37
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`C.F.R. § 41.41(b);
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`4850-9319-7872.1
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`4
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`IPR2016-00006
`Patent 8,497,393
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`Patent Owner Docket No. 080618-1601
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`(b) Patent Owner objects to Exhibit 1022 under FRE 702-703 as including
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`opinions, including paragraphs 84-86, that rely on facts and data that are not
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`in the record as to how a melting point was calculated;
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`(c) Patent Owner objects to Exhibit 1022 under FRE 702-703 as including
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`opinions, including paragraph 87, that rely on facts and data that are not in
`
`the record to conclude that a melting point range is narrow.
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`D. Ex. 2059
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`Patent Owner objected to Ex. 2059 in Paper No. 55 for the following reasons:
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`Patent Owner objects to the Reply at pages 2, 3, 4, 7, 8, and 24 for citing
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`portions of Ex. 2059 (Williams deposition transcript at 112-113 and 217-219)
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`under FRE 402-403 as being likely to cause confusion pursuant to the objection
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`made at the deposition at p. 112 of the transcript that the questions
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`mischaracterized earlier testimony and documents shown to the witness.
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`Patent Owner objects to the Reply at page 15 for citing portions of Ex. 2059
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`(Williams deposition transcript at 180) under FRE 402-403 as being likely to cause
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`confusion pursuant to the objection made at the deposition at p. 181 of the
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`transcript that the earlier questions misrepresented the document shown to the
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`witness.
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`4850-9319-7872.1
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`IPR2016-00006
`Patent 8,497,393
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`III. ARGUMENT
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`Patent Owner Docket No. 080618-1601
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`
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`A. The Conclusory Statements of Dr. Winkler (Ex. 1009) Should be
`Excluded
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`Under FRE 702, a witness may be qualified to testify as an expert if “the
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`expert’s scientific, technical, or other specialized knowledge will help the trier of
`
`fact to understand the evidence or to determine a fact in issue.” In paragraphs 3,
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`31 46, 48, 54, 57, 63, 71, and 72 of his declaration (Ex. 1009), Dr. Winkler gives
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`opinions for which he lacks the requisite expertise.
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`While Dr. Winkler may be qualified in organic chemistry, Dr. Winkler offers
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`several opinions that are purely legal conclusions or otherwise unsupported
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`conclusory statements about subjects that he is not qualified to make. For
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`example, in each of the paragraphs cited above, Dr. Winker concludes that a prior
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`art reference either “anticipates,” “inherently” discloses or renders “obvious”
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`claim limitations. Anticipation, inherency and obviousness are legal concepts that
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`are beyond Dr. Winker’s expertise. Rather, Dr. Winker’s declaration should be
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`limited to his opinions that are within the field of organic chemistry. Accordingly,
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`paragraphs 3, 31, 46, 48, 54, 57, 63, 71, and 72 of Exhibit 1017 should be
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`excluded. See The Medicines Co. v. Mylan Inc., No. 11-CV-1285, 2014 WL
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`1758135, at *6 (N.D. Ill. May 2, 2014) (“expert testimony that contains a legal
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`conclusion that determines the outcome of a case is inadmissible.”).
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`4850-9319-7872.1
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`IPR2016-00006
`Patent 8,497,393
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`Patent Owner Docket No. 080618-1601
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`These conclusory statements of Dr. Winkler are relied upon in the Petition at
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`pp. 21, 24, and 25 and in the Petitioner’s Reply at p. 11, which accordingly, should
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`also be excluded.
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`B.
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`Exhibit 1017 Should be Excluded as Inadmissible Hearsay and
`Not Properly Authenticated Evidence
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`Exhibit 1017 should be excluded because it contains hearsay under FRE 802.
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`The asserted copyright date and asserted revision date on page 3 of the exhibit are
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`hearsay (as are the purported web address and the date in the footer of the
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`document). See Hilgraeve, Inc. v. Symantec Corp., 271 F. Supp. 2d 964, 974 (E.D.
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`Mich. 2003) (copyright “dates imprinted on . . . documents are hearsay when
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`offered to prove the truth of the matter asserted”). In his declaration (Ex. 1009),
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`Dr. Winkler relies on Exhibit 1017 for the proposition that “the literature on
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`HPLC's precision indicates that the ‘RSD’ or ‘relative standard deviation’ for a
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`typical instrument is about 1%.” Exhibit 1009 at ¶ 70. It appears that Dr.
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`Winkler’s statement at ¶ 70 is referencing the text of Ex. 1017 which reads: “[f]or
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`most purposes, HPLC methods are expected to have CV values on the order of
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`1%” (see Winkler Deposition Transcript, Ex. 2051 at pp. 97-98). This statement in
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`Ex. 1017 (relied upon by Dr. Winkler at ¶ 70 of his Declaration) is simply hearsay
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`for which no exception applies and should be excluded. See FRE 802.
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`4850-9319-7872.1
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`IPR2016-00006
`Patent 8,497,393
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`Patent Owner Docket No. 080618-1601
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`Exhibit 1017 should also be excluded because it has not been authenticated
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`pursuant to FRE 901, and it is not a self-authenticating document pursuant to FRE
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`902. Petitioner offers it as a print-out from a web site (Petition, Paper 1 at ii) but
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`has made no attempt to authenticate the exhibit following Patent Owner’s
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`objection. Petitioner provided no testimony from any witness about when, where,
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`or how this document was obtained. Petitioner could have provided supplemental
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`evidence directed to authentication, but Petitioner provided no testimony from any
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`witness that Ex. 1017 is what Petitioner purports it to be. Printouts from web sites
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`are not self-authenticating. See Veeam Software Corp. v. Symantec Corp.,
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`IPR2013-00142, Paper 11 at 9 (P.T.A.B. Aug. 7, 2013) (“under the Federal Rules
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`of Evidence, authentication of [website printouts] is required”). Accordingly,
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`Exhibit 1017 has not been properly authenticated and should be excluded.
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`The Winkler Declaration (Ex. 1009) relies upon Ex. 1017 in paragraph 70. In
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`addition, the Petition relies upon these portions of the Winkler Declaration and Ex.
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`1017 at pp. 21, 29, 44, 45, and 56, and the Petitioner’s Reply relies upon them at
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`pp. 12, 13, and 15.
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`C. Certain Portions of Dr. Rogers’ Declaration (Ex. 1022) Should be
`Excluded
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`First, paragraphs 44-48 of Dr. Roger’s declaration (Ex. 1022) do not respond to
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`the Patent Owner Response and should be excluded under 37 C.F.R. § 41.41(b). In
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`4850-9319-7872.1
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`IPR2016-00006
`Patent 8,497,393
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`Patent Owner Docket No. 080618-1601
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`paragraphs 44-48 of his declaration, Dr. Rogers provides opinions about Form A’s
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`melting point range and also thermogravimetric analysis. However, these opinions
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`do not rebut any portion of the Patent Owner Response. Accordingly, such
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`opinions are new opinions, which are not proper for an expert declaration
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`submitted with a Petitioner Reply brief, and should be excluded under 37 C.F.R. §
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`41.41(b).
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`Second, paragraphs 84-86 rely on facts and data that are not in the record and
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`are improper under FRE 702-703. Paragraphs 84-87 offer opinions as to how a
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`melting point is calculated by an unspecified piece of software and also the relative
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`breadth of a melting point range without any reference being cited against which to
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`judge the breadth of the range. These paragraphs are not supported by citation to
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`any reference and merely conclusory statements made by Dr. Rogers.
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`Accordingly, such opinions should be excluded.
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`These paragraphs of Dr. Roger’s Declaration are relied upon in Petitioner’s
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`Reply at p. 15, which accordingly, should also be excluded.
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`D. The Portions of Dr. Williams’ Testimony That Were
`Mischaracterized Should be Excluded
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`Petitioner’s Reply to Patent Owner’s Response includes a number of
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`statements and references that misrepresent certain testimony from the deposition
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`transcript of Dr. Williams (Ex. 2059). In particular, in these pages of the Reply,
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`4850-9319-7872.1
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`IPR2016-00006
`Patent 8,497,393
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`Patent Owner Docket No. 080618-1601
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`Petitioner mischaracterizes portions of Dr. Williams’ testimony despite the
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`objections of Patent Owner’s counsel (Ms. Hasper), who objected that Petitioner’s
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`counsel (Mr. Pollack) had mischaracterized earlier testimony and various exhibits
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`(Ex. 2059 at 112:22-113:20, 180:9-25, 217:11-219:20), which renders Dr.
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`Williams testimony confusing, misleading, and more prejudicial than probative,
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`and, therefore, inadmissible under FRE 403.
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`First, Patent Owner objects to the Petitioner’s Reply at pages 2, 3, 4, 7, 8, and
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`24 for citing portions of Ex. 2059 (Williams deposition transcript at pp. 112-113
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`and 217-219) under FRE 402-403 as being likely to cause confusion pursuant to
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`the objection made at the deposition at p. 112 of the Williams deposition transcript
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`that the questions in those sections mischaracterized his earlier testimony and
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`documents shown to the witness.
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`Second, Patent Owner objects to the Petitioner’s Reply at page 15 for citing
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`portions of Ex. 2059 (Williams deposition transcript at p. 180) under FRE 402-403
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`as being likely to cause confusion pursuant to the objection made at the deposition
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`at p. 181 of the transcript that the earlier questions misrepresented the document
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`shown to the witness.
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`4850-9319-7872.1
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`10
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`IPR2016-00006
`Patent 8,497,393
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`Patent Owner Docket No. 080618-1601
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`These mischaracterized portions of Dr. Williams’ testimony are relied upon in
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`Petitioner’s Reply at pp. 2, 3, 4, 7, 8, 15, and 24, which accordingly, should also be
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`excluded.
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`IV. CONCLUSION
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`For at least the reasons provided above, Patent Owner urges the Board to grant
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`this motion and exclude exhibits Exhibit 1017, the objected-to portions of Exhibits
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`1009, 1022 and 2059, as well as the arguments of Petitioner that rely on these
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`exhibits in the Petition and in Petitioner’s Reply as set forth above.
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`Respectfully submitted,
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`/Stephen B. Maebius/
`Stephen B. Maebius
`Registration No. 35,264
`Counsel for Patent Owner
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`Date: Nov. 1, 2016
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`4850-9319-7872.1
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`IPR2016-00006
`Patent 8,497,393
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`Attorney Docket No. 080618-1601
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing Patent Owner’s Motion to
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`Exclude was served on counsel of record on Nov. 1, 2016, by filing this document through the
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`PTAB E2E System as well as delivering a copy via email to the counsel of record for the
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`Petitioner at the following address: Steadymed-IPR@dlapiper.com.
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`/Stephen B. Maebius/
`Stephen B. Maebius
`Foley & Lardner LLP
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`Date: Nov. 1, 2016
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`4850-9319-7872.1
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