UNITED STTES PATENT AND TRADEMARK OFFICE
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________
`
`STEADYMED LTD.,
`
`Petitioner,
`
`v.
`
`UNITED THERAPEUTICS CORPORATION
`
`Patent Owner.
`
`
`
`Case IPR2016-00006
`
`Patent No. 8,497,393
`
`____________
`
`PETITIONER'S OPPOSITION TO PATENT OWNER'S
`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
`
`
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________
`
`STEADYMED LTD.,
`
`Petitioner,
`
`v.
`
`UNITED THERAPEUTICS CORPORATION
`
`Patent Owner.
`
`
`
`Case IPR2016-00006
`
`Patent No. 8,497,393
`
`____________
`
`PETITIONER'S OPPOSITION TO PATENT OWNER'S
`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
`
`
`
`TABLE OF CONTENTS
`
`
`Page
`
`
`INTRODUCTION .......................................................................................... 1
`I.
`II. ARGUMENT .................................................................................................. 2
`A.
`The Objected-to Portions of Dr. Winkler's Declaration (Ex.
`1009) Are Admissible Because an Expert Can Properly Opine
`on the Ultimate Conclusion of Invalidity. ............................................ 2
`Exhibit 1017 Does Not Constitute Inadmissible Hearsay and Is
`Properly Authenticated. ........................................................................ 4
`The Objected-to Portions of Dr. Rogers' Declaration (Ex. 1022)
`Are Directly Responsive to Patent Owner's Response. ....................... 8
`Patent Owner's Allegations Regarding Mischaracterization of
`Dr. Williams' Testimony Are Yet Another Attempt to Strike
`Petitioner's Reply. ................................................................................. 9
`III. CONCLUSION ............................................................................................. 10
`
`B.
`
`C.
`
`D.
`
`
`
`i
`
`
`
`TABLE OF AUTHORITIES
`
`
`Page
`
`
`CASES
`Binder v. Disability Grp., Inc.,
`772 F. Supp. 2d 1172 (C.D. Cal. 2011) ................................................................ 5
`
`Branovations, Inc. v. Ontel Prods. Corp.,
`No. 12-cv-00306, 2014 WL 407577 (M.D. Fla. Feb. 3, 2014) ............................ 2
`
`Daubert v. Merrell Dow,
`509 U.S. 579 (1993) .............................................................................................. 5
`
`Ericsson Inc. v. Intellectual Ventures I LLC,
`IPR2014-01149, Paper No. 68 (P.T.A.B. Dec. 9, 2015) ...................................... 6
`
`Hopkins Manufacturing Co., et al., v. Cequent Performance Products, Inc.,
`IPR2015-00609, Paper 32 (P.T.A.B. July 28, 2016) ............................................ 9
`
`In re Rambus, Inc.,
`753 F.3d 1253 (Fed. Cir. 2014) ............................................................................ 3
`
`Inline Connection Corp. v. AOL Time Warner Inc.,
`470 F. Supp. 2d 435 (D. Del. 2007) ...................................................................... 5
`
`Interwoven, Inc. v. Vertical Computer Sys.,
`No. 10-cv-04645, 2013 WL 3786633 (N.D. Cal. Jul. 18, 2013) .......................... 5
`
`Leo Pharm. Prods., Ltd. v. Rea,
`726 F.3d 1346 (Fed. Cir. 2013) ............................................................................ 3
`
`Marine Polymer Technologies, Inc. v. HemCon, Inc.,
`2009 WL 801826 (D.N.H. Mar. 24, 2009) ........................................................... 3
`
`SDI Tech., Inc. v. Bose Corp.,
`IPR2013-00465, Paper 40 (P.T.A.B. Nov. 7, 2014) ............................................. 6
`
`Sundance, Inc. v. DeMonte Fabricating Ltd.,
`550 F.3d 1356 (Fed. Cir. 2008) ............................................................................ 2
`
`The Medicines Co. v. Mylan Inc.,
`No. 11-cv-1285, 2014 WL 1758135 (N.D. Ill. May 2, 2014) .......................... 3, 4
`
`ii
`
`
`
`TABLE OF AUTHORITIES
`(continued)
`
`Page
`
`
`Veeam Software Corp. v. Symantec Corp.,
`IPR2013-00142, Paper 11 (P.T.A.B. Aug. 7, 2013) ......................................... 7, 8
`
`OTHER AUTHORITIES
`
`37 C.F.R. § 42.53(f)(8) ............................................................................................ 10
`
`37 C.F.R. § 42.64(c) ................................................................................................... 1
`
`Fed. R. Evid. 702(a) ................................................................................................... 3
`
`Fed. R. Evid. 703 ....................................................................................................... 4
`
`Fed. R. Evid. 704 ....................................................................................................... 4
`
`Fed. R. Evid. 704(a) ................................................................................................... 2
`
`Fed. R. Evid. 901(b)(1) .............................................................................................. 6
`
`Fed. R. Evid. 901(b)(4) .............................................................................................. 7
`
`
`
`iii
`
`
`
`
`
`Petitioner, SteadyMed Ltd. ("Petitioner"), respectfully submits this response in
`
`opposition to Patent Owner's Motion to Exclude Petitioner's Evidence Pursuant to
`
`37 C.F.R. § 42.64(c) ("Motion" or "Mot.").
`
`INTRODUCTION
`
`I.
`Patent Owner's Motion seeks to expunge relevant evidence from the record
`
`simply because it is not favorable to Patent Owner's positions in this inter partes
`
`review proceeding. This is not the standard, nor is this permissible. Patent Owner
`
`seeks to exclude nearly every position that Petitioner has taken in this proceeding:
`
` Exhibits 1009 (Winkler Declaration) and Exhibit 1017: Dr. Winkler's
`
`conclusions that the '393 Patent is invalid for anticipation and obviousness
`
`based on prior art references Moriarty, Phares, and Kawakami and his
`
`underlying support for the precision of HPLC instrumentation;
`
` Exhibit 1022 (Rogers Declaration): Dr. Rogers' opinions responding to
`
`Patent Owner's challenge on melting point, specifically, why the melting
`
`point of treprostinil diethanolamine salt Form B can be compared between
`
`the '393 Patent and the Phares reference; and
`
` Exhibit 2059 and Petitioner's Reply: Portions of Petitioner's Reply and Dr.
`
`Williams' deposition that support the fact that the Moriarty method produces
`
`the same product as the product of the '393 Patent, a product with a purity
`
`of
`
`, and that Petitioner and its counsel cherry-picked 10 batches of
`
`1
`
`
`
`
`
`data to drive down the average purity value of the Moriarty product from
`
` to
`
`.
`
`The Federal Rules of Evidence and the wealth of case law establish that Exhibit
`
`1022 and the objected-to portions of Exhibits 1009, 1022 and 2059 are fully
`
`admissible. Patent Owner has failed to show otherwise, and thus, its motion must
`
`be denied.
`
`II. ARGUMENT
`A. The Objected-to Portions of Dr. Winkler's Declaration (Ex. 1009)
`Are Admissible Because an Expert Can Properly Opine on the
`Ultimate Conclusion of Invalidity.
`
`The Board should reject Patent Owner's request to exclude Paragraphs 3, 31,
`
`46, 48, 54, 57, 63, 71, and 72 of Dr. Winkler's Declaration (Ex. 1009) for at least
`
`two independent reasons.
`
`First, far from being "purely legal conclusions," Dr. Winkler's opinions on the
`
`ultimate conclusions of anticipation and obviousness are entirely permissible. It is
`
`black-letter law that an expert's "opinion is not objectionable just because it
`
`embraces an ultimate issue." Fed. R. Evid. 704(a). Numerous courts, including the
`
`Federal Circuit, "ha[ve] approved expert testimony regarding the ultimate issues
`
`of…validity provided that the expert is qualified to testify in the relevant field."
`
`Branovations, Inc. v. Ontel Prods. Corp., No. 12-cv-00306, 2014 WL 407577, at
`
`*4 (M.D. Fla. Feb. 3, 2014), citing Sundance, Inc. v. DeMonte Fabricating Ltd.,
`
`2
`
`
`
`
`
`550 F.3d 1356, 1361 (Fed. Cir. 2008); see also Marine Polymer Technologies, Inc.
`
`v. HemCon, Inc., No. 06-cv-100, 2009 WL 801826, at *3-*4 (D.N.H. Mar. 24,
`
`2009) (denying accused infringer's motion to strike expert testimony because it
`
`opined on the overall conclusion of validity). Therefore, expert testimony from a
`
`qualified expert, such as Dr. Winkler, whom Patent Owner does not dispute is
`
`qualified to opine in this proceeding, is permissible and well within the province of
`
`expert opinion. Notably, Patent Owner does not object to any of Dr. Winkler's
`
`supporting testimony related to his ultimate conclusions on validity. Dr. Winkler's
`
`opinion is not objectionable simply because Patent Owner takes issue with his
`
`overall conclusions on anticipation and obviousness.
`
`Second, the Federal Rules of Evidence permit expert testimony to "help the
`
`trier of fact to understand the evidence or to determine a fact in issue." Fed. R.
`
`Evid. 702(a). "Anticipation is a question of fact ...." In re Rambus, Inc., 753 F.3d
`
`1253, 1246 (Fed. Cir. 2014) (citations omitted). "Obviousness is a question of law
`
`based on underlying findings of fact." Leo Pharm. Prods., Ltd. v. Rea, 726 F.3d
`
`1346, 1353 (Fed. Cir. 2013). Thus, the issues of obviousness and anticipation are
`
`entirely within the bounds of appropriate subject matter for expert testimony.
`
`In light of this authority, Patent Owner's reliance on The Medicines Co. v.
`
`Mylan Inc., No. 11-cv-1285, 2014 WL 1758135, at *6 (N.D. Ill. May 2, 2014) is
`
`entirely misplaced. In The Medicines Co., the Court was ruling on a motion to
`
`3
`
`
`
`
`
`preclude the testimony of an expert, a patent attorney, offered to support an
`
`inequitable conduct claim. The expert was testifying about the ultimate issue of
`
`inequitable conduct, a discretionary issue for the judge. Id. at *6. While the expert
`
`was permitted to explain certain legal concepts related to inequitable conduct, she
`
`could not speculate regarding the ultimate conclusion of inequitable conduct. Id. at
`
`*7.
`
`Since Dr. Winkler did not provide his testimony as a patent law expert, and is
`
`not a patent attorney, The Medicines Co. is entirely inapposite. Dr. Winkler
`
`provides his testimony to inform about his obviousness and anticipation analysis
`
`based on his review of the relevant art, and as a qualified expert in the field.
`
`Because the objected-to paragraphs merely summarize Dr. Winkler's final
`
`positions on anticipation and obviousness, Patent Owner has no basis to object to
`
`the inclusion of these paragraphs in the Winkler Declaration, and these opinions
`
`are explicitly permitted under Fed. R. Evid. 704.
`
`B. Exhibit 1017 Does Not Constitute Inadmissible Hearsay and Is
`Properly Authenticated.
`
`Patent Owner objects to Exhibit 1017 on two grounds: (1) it constitutes
`
`inadmissible hearsay; and (2) it is not properly authenticated.
`
`As a threshold matter, even if Exhibit 1017 is considered inadmissible hearsay
`
`(which it is not), Federal Rule of Evidence Rule 703 allows an expert to consider
`
`inadmissible hearsay if it contains facts or data "of a type reasonably relied upon
`
`4
`
`
`
`
`
`by experts in the particular field." See Daubert v. Merrell Dow, 509 U.S. 579, 595
`
`(1993); see also Interwoven, Inc. v. Vertical Computer Sys., No. 10-cv-04645,
`
`2013 WL 3786633, at *7 (N.D. Cal. Jul. 18, 2013) ("Experts are, however,
`
`permitted to rely on hearsay evidence in coming to their conclusions, so long as an
`
`expert in the field would reasonably rely on that information"); Binder v. Disability
`
`Grp., Inc., 772 F. Supp. 2d 1172, 1180 n.8 (C.D. Cal. 2011) ("experts are allowed
`
`to rely on hearsay"); Inline Connection Corp. v. AOL Time Warner Inc., 470 F.
`
`Supp. 2d 435, 442 (D. Del. 2007) (same). Dr. Winkler relies on Exhibit 1017 to
`
`support his assessment that HPLC instruments have a relative standard deviation of
`
`about 1%, based on his knowledge as an expert in the field. Because Exhibit 1017
`
`was properly relied upon as a basis for an expert opinion and Patent Owner has not
`
`raised any issues with Dr. Winkler's qualifications, Exhibit 1017 is admissible.
`
`Further, notwithstanding the admissibility of Exhibit 1017, Patent Owner's
`
`arguments regarding hearsay also fail. (Motion, at 7). Dr. Winkler did not rely on
`
`Exhibit 1017 for its copyright date or as prior art, but rather, as support for his
`
`opinion regarding precision of HPLC instrumentation:
`
`Q. Now, you rely on [Exhibit 1017] for the argument you
`make that HPLC has 1 percent error; is that right?
`
`A. I think what I -- excuse me -- what I stated here was
`that HPLC methods are expected to have CV values, and
`the CV is…sta[t]ed at coefficient of variance, which is an
`
`5
`
`
`
`
`
`equivalent of the RSD of the relative standard deviation,
`and that [] number is on the order of 1 percent for HPLC.
`[…] I think I only know that the HPLC methods are
`expected to have CV values on the order of 1 percent.
`
`(Ex. 2059, 98:7-17; 100:18-20). As a qualified expert, Dr. Winkler can opine on
`
`the statements in Exhibit 1017 and provide his opinion.
`
`Second, Exhibit 1017 is properly authenticated, and nothing more is required.
`
`See, e.g., SDI Tech., Inc. v. Bose Corp., IPR2013-00465, Paper 40 at 13-16
`
`(P.T.A.B. Nov. 7, 2014) (denying motion to exclude webpages where "an affidavit
`
`would not have added materially to the record."). Here, in support of Exhibit 1017,
`
`Petitioner submitted the declaration of Dr. Winkler (Ex. 1009), who has personal
`
`knowledge regarding this exhibit's presence on the listed website. See Ex. 2051, at
`
`97:9-23; Fed. R. Evid. 901(b)(1). Exhibit 1017 identifies the uniform resources
`
`locator ("URL") from which the exhibit was pulled. The parties and the Board can
`
`access the URL to verify its contents, and confirm that Exhibit 1017 is authentic.
`
`Patent Owner has not offered any reason to believe that this exhibit is in any way
`
`inauthentic, as Patent Owner identifies no evidence or even argument casting doubt
`
`on the authenticity of Exhibit 1017. See Ericsson Inc. v. Intellectual Ventures I
`
`LLC, IPR2014-01149, Paper 68, at *12-13 (PTAB Dec. 9, 2015) (rejecting
`
`authenticity objection concerning "document that appears to be internally
`
`consistent with no obvious indication of having been fabricated or altered," and
`
`6
`
`
`
`
`
`
`
`where ""[movant] ppresents noo affirmative evidencce that castts doubt onn the
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`authentiicity of thee exhibit")..
`
`
`
`Exhiibit 1017 ccontains othher distinctive characcteristics, ssuch as a loogo from tthe
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
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`source wwebsite (deepicted bellow), furthher indicati
`
`
`
`
`
`
`
`
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`ng its authhenticity. SSee Fed. R.
`
`
`
`
`
`
`
`Evid. 9001(b)(4).
`
`
`
`
`
`Accordiingly, the ccombinatioon of Dr. WWinkler's teestimony aand the disttinctive
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`characteeristics of tthe exhibitt sufficienttly demonsstrates that
`
`
`
`
`
`
`
`
`
`it is authe
`
`
`
`ntic. See SSDI,
`
`
`
`IPR2013-00465, PPaper 40 att 15-16 (deetermining g that webppages faciaally appeareed
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
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`authentiic and were "authentiicated furthher by acceessing the
`
`
`
`
`
`
`
`
`
`
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`website").. Patent Owwner
`
`
`
`
`
`presentss no conflicting evideence of autthenticity,
`
`
`
`
`
`
`
`
`
`would ggo to weighht, not admmissibility.
`
`
`
`
`
`
`
`While Patent OOwner reliees on Veeaam Softwarre Corp. v.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`and, in anyy event, suuch evidencce
`
`Symantec
`
`Corp.,
`
`IPR201
`
`
`
`
`
`
`
`
`
`
`3-00142, PPaper 11 (PP.T.A.B. AAug. 7, 20113), to arguue that webbsite print--outs
`
`
`
`
`
`are not
`
`
`
`
`self-authennticating, PPatent Ownner relies oon inappos
`
`
`
`
`
`
`
`the Boaard found thhe challengged websitte to be autthentic for
`
`
`
`
`
`
`
`
`
`ite authori
`
`
`
`ty. In Veeaam,
`
`the purpo
`
`ses of
`
`
`
`institutiion. Id. at **9. As Pateent Owner had createed the veryy documentt it was
`
`
`
`
`
`
`
`
`
`
`
`
`
`
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`challengging, the BBoard warnned the Patent Ownerr to check iits own reccords for
`
`
`
`
`
`
`
`
`
`
`
`
`
`nticity. Id.
`informaation regardding authe
`
`
`
`
` at *10. Thhe case is eentirely inaapposite.
`
`
`
`
`
`
`
`7
`
`
`
`
`
`C. The Objected-to Portions of Dr. Rogers' Declaration (Ex. 1022)
`Are Directly Responsive to Patent Owner's Response.
`
`Patent Owner's arguments regarding Dr. Rogers' Declaration are simply a re-
`
`hash of its failed attempt to request authorization to strike Dr. Rogers' Declaration,
`
`which was already ruled on and denied by the Board. (Paper 56). Yet again, Patent
`
`Owner raises the same issues it raised in its failed attempt to strike Dr. Rogers'
`
`Declaration. As Patent Owner puts forth no new issues than what is set forth in its
`
`Itemized List (Paper 59), Petitioner incorporates its response to Patent Owner's
`
`Itemized List (Paper 60), and further responds as follows:
`
`Objected-to
`Portions of Dr.
`Rogers'
`Declaration
`Paragraphs 44-48
`
`Petitioner Response
`
`Paragraphs 44-48 are directly responsive to Patent Owner's
`
`challenges on melting point, as found in Patent Owner
`
`Response, at 22-24, and the Williams' Declaration (Ex. 2020),
`
`at ¶¶ 72-78.
`
`Paragraphs 84-86
`
`Paragraphs 84, 85, and 86 are directly responsive to Patent
`
`Owner's challenges on the narrowness of melting point, and
`
`rely on data from the Phares reference (Ex. 1005), which is
`
`already in the record. Dr. Rogers provides information about
`
`the equipment used to generate the Phares data, as provided in
`
`8
`
`
`
`
`
`the Phares reference itself. See Ex. 1005, at 121.
`
`Paragraph 87
`
`Paragraph 87 is directly responsive to Patent Owner's
`
`challenges regarding melting point, and recites data from the
`
`Phares reference itself. Dr. Rogers can properly opine on this
`
`data and provide his assessment, as an expert in the field on
`
`these issues.
`
`
`
`D. Patent Owner's Allegations Regarding Mischaracterization of Dr.
`Williams' Testimony Are Yet Another Attempt to Strike
`Petitioner's Reply.
`
`Despite the Board's denial of Patent Owner’s request to file a motion to strike
`
`(Paper 56, at 3, noting "[w]e determine that neither a motion to strike, nor sur-reply
`
`is warranted in this instance"), Patent Owner again attempts to exclude portions of
`
`Petitioner's Reply that rely on Dr. Williams' testimony. This is improper; the
`
`"[r]eply brief is not itself evidence, and a motion to exclude is not a proper vehicle
`
`for a party to argue that the other party’s arguments are incorrect." See Hopkins
`
`Manufacturing Co., et al., v. Cequent Performance Products, Inc., IPR2015-
`
`00609, Paper 32, at *23 (P.T.A.B. July 28, 2016). Patent Owner's arguments
`
`seeking to exclude alleged mischaracterizations of Dr. Williams' testimony are also
`
`improper, as they go to the weight, not the admissibility, of the evidence. As this
`
`Board has already recognized, "the panel can identify and disregard…any
`
`misrepresentations of UTC’s expert’s testimony in the Reply" (Paper 56, at 3).
`
`9
`
`
`
`
`
`Further, no objections were made to the questioning at pages 180 and 217-219,
`
`and only one question was objected to in the section from 112:22-113:20, of the
`
`Williams Deposition (Ex. 2059), which are the only sections Patent Owner seeks to
`
`exclude. Patent Owner has waived any objection by not making these objections
`
`during the deposition. See 37 C.F.R. § 42.53(f)(8) ("[a]ny objection to the content,
`
`form, or manner of taking the deposition…is waived unless made on the record
`
`during the deposition and preserved in a timely filed motion to exclude")
`
`(emphasis added). As Patent Owner raises issue with the questioning of Mr.
`
`Williams (i.e., the "content, form, or manner of taking the deposition") and failed
`
`to raise any objection during the deposition itself, its argument is waived. Even if
`
`this challenge were sustained, there is no basis to exclude the testimony.
`
`III. CONCLUSION
`For the reasons set forth above, Patent Owner's Motion to Exclude should be
`
`denied.
`
`Date: November 15, 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)
`
`
`
`
`
`
`
`10
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that a copy of the attached PETITIONER'S
`
`OPPOSITION TO PATENT OWNER'S MOTION TO EXCLUDE was 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
`
`
`
`Respectfully submitted,
`
`
`
`/s Lisa A. Haile /
`Lisa A. Haile, J.D., Ph.D.
`Reg. No. 38,347
`DLA Piper LLP (US)
`
`
`
`11
`
`
`Date: November 15, 2016
`
`
`/s Stuart E. Pollack /
`Stuart E. Pollack, J.D., Ph.D.
`Reg. No. 43,862
`DLA Piper LLP (US)
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