IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`ARGENTUM PHARMACEUTICALS LLC, MYLAN PHARMACEUTICALS
`INC., BRECKENRIDGE PHARMACEUTICAL, INC., and ALEMBIC
`PHARMACEUTICALS, LTD.,
`
`Petitioners,
`
`RESEARCH CORPORATION TECHNOLOGIES, INC.,
`Patent Owner.
`
`Case No. IPR2016-002041
`
`Patent No. RE 38,551
`
`PATENT OWNER’S OBJECTIONS TO EVIDENCE
`
`UNDER 37 C.F.R. § 42.64(b)(1)
`
`1 Case IPR2016-01101, Case IPR2016—01242, and Case IPR2016-01245 have been
`
`joined with this proceeding.
`
`DC: 6275406-2
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`ARGENTUM PHARMACEUTICALS LLC, MYLAN PHARMACEUTICALS
`INC., BRECKENRIDGE PHARMACEUTICAL, INC., and ALEMBIC
`PHARMACEUTICALS, LTD.,
`
`Petitioners,
`
`RESEARCH CORPORATION TECHNOLOGIES, INC.,
`Patent Owner.
`
`Case No. IPR2016-002041
`
`Patent No. RE 38,551
`
`PATENT OWNER’S OBJECTIONS TO EVIDENCE
`
`UNDER 37 C.F.R. § 42.64(b)(1)
`
`1 Case IPR2016-01101, Case IPR2016—01242, and Case IPR2016-01245 have been
`
`joined with this proceeding.
`
`DC: 6275406-2
`
`
`
`IPR2016—00204
`
`Patent Owner, Research Corporation Technologies,
`
`Inc.,
`
`submits
`
`the
`
`following objections to evidence filed by Petitioners with their Reply (Paper 52).
`
`Although none of the exhibits was timely served on the November 14, 2016 due
`
`date (see objection to Exhibits 1048-1213 infra), these objections are timely as
`
`being filed within five (5) business days from the service date (November 14,
`
`2016) of Petitioner’s Reply.
`
`Exhibits 1048-1213
`
`Exhibits 1048-1213 are inadmissible because they were not served on Patent
`
`Owner with the Reply as required by 37 C.F.R. § 42.51(b)(1)(i). None of the
`
`exhibits was timely served with the Reply on the November 14, 2016 due date as
`
`set forth in the Joint Notice of Stipulation Concerning Schedule (Paper 50). See
`
`Ex. 2189 (email communication from Matthew Dowd at 11:50 PM on November
`
`14, 2016 indicating that the exhibits would be served the following day); see also
`
`Ex. 2190 (letter dated November 15, 2016 for hand delivery of USB drive with
`
`“documents as filed yesterday”). The November 14, 2016 email communication
`
`(Ex.
`
`2189)
`
`included
`
`attachments
`
`identified
`
`as
`
`“Final Draft Davis
`
`Declaration_signed.pdf,” “McDuff Declaration - 20161114.pdf,” and “Wang
`
`Declaration Final Declaration-11—14—16[2].pdf,” However, none of the documents
`
`attached to Ex. 2189 included any exhibit labels or markings, and it is not Patent
`
`
`
`IPRZO16-00204
`
`Owner’s burden or responsibility to determine whether these documents are the
`
`same as those marked as exhibits and served the following day.
`
`Exhibit 1085 — CAS Registry FAg ls
`
`Exhibit 1085 is also inadmissible for at
`
`least
`
`the following reasons,
`
`including under the Federal Rules of Evidence (“FRE”).
`
`Patent Owner objects to Exhibit 1085 as lacking authentication, and thus
`
`inadmissible under FRE 901.
`
`Exhibit 1085 purports to be a copy of the
`
`“Frequently Asked Questions” section from the Chemical Abstracts Service (CAS)
`
`Registry website. However, Petitioner may not rely on the content of an alleged
`
`website printout without proper authentication. Petitioner has offered no evidence
`
`establishing that Exhibit 1085 is a true and correct printout from the CAS Registry
`
`website.
`
`Petitioner also has not provided the testimony of any witness with
`
`personal knowledge of the website. See Neste Oil OYJ v. Reg Synthetic Fuels,
`
`LLC, IPR2013—0O578, Paper 53 at 3-4 (P.T.A.B. Mar. 12, 2015). Consequently,
`
`Petitioner has not provided evidence sufficient to support a finding that Exhibit
`
`1085 “is what [Petitioner] claims it is.” See FRE 901(a).
`
`Exhibit 1104 —— Summary of PI Values
`
`Exhibit 1104 is also inadmissible for at
`
`least
`
`the following reasons,
`
`including under the Federal Rules of Evidence (‘fFRE”).
`
`
`
`IPR2016—00204
`
`Patent Owner objects to Exhibit 1104 as lacking authentication, and thus
`
`inadmissible under FRE 901. Exhibit 1104 purports to be a table compiling the
`
`protective indices
`
`(“PI Values”) “of all FAA [c]ompounds in Dr. Kohn’s
`
`[r]eferences.” Ex. 1104 p. 1. However, the exhibit’s author and its date of creation
`
`are not reported. Exhibit 1104 does not even provide citations for its purported PI
`
`Values beyond vague listings of alleged source documents. Thus, Petitioner has
`
`not provided evidence sufficient to support a finding that Exhibit 1156 is an
`
`accurate compilation of PI Values for all FAAs in Dr. Kohn’s publications. See
`
`FRE 901(a).
`
`Exhibit 1104 is also inadmissible under FRE 1001(e) and FRE 1003 as an
`
`inappropriate “duplicate.”
`
`First, Exhibit 1104 does not
`
`include all PI values
`
`reported in the alleged source documents. As one example, Conley 1987
`
`(Ex. 2004) contains a PI Value for N—acetyl—DL—alanine N-m—fluorobenzylamide
`
`(compound lm), but this information is omitted from Exhibit 1104. See Conley
`
`1987 (Ex. 2004) at 571, Table VI.
`
`Second, certain PI Values reported in Exhibit 1104 are incorrect. As one
`
`example, Exhibit 1104 reports a PI value for Compound 3t of 1.81, but Kohn 1991
`
`(Ex. 1012) shows that the correct PI Value for that compound is > 1.81. See Kohn
`
`1991 (Ex. 1012) at 2445 (reporting an ED50 of 62.0 and a TD50 of > 112).
`
`
`
`IPR20l6—0O204
`
`Exhibits 1136 to 1144 —— Drug Labels
`
`Exhibits 1136 to 1144 are also inadmissible for at
`
`least
`
`the following
`
`reasons, including under the Federal Rules of Evidence (“FRE”).
`
`Patent Owner objects to Exhibit 1136, Exhibit 1137, Exhibit 1138, Exhibit
`
`1139, Exhibit 1140, Exhibit 1141, Exhibit 1142, Exhibit 1143 and Exhibit 1144 as
`
`lacking authentication, and thus inadmissible under FRE 901. Each of these
`
`exhibits purports to be a copy of a drug label. However, not one identifies the
`
`source of the exhibit. Petitioner’s Exhibit List suggests that these drug labels may
`
`be from the FDA’s website, see Paper 51 pp. [l3—14], but the Exhibit List offers
`
`no specifics.
`
`Petitioner may not rely on the content of the alleged website printouts
`
`without proper authentication. Petitioner has offered no evidence establishing that
`
`the exhibits are true and correct printouts from specific websites, or even evidence
`
`identifying the individual who downloaded the exhibits. Petitioner also has not
`
`provided the testimony of any witness with personal knowledge of the websites.
`
`See Neste Oil OYJ v. Reg Synthetic Fuels, LLC, IPR2013—OO578, Paper 53 at 3-4
`
`(P.T.A.B. Mar. 12, 2015). Consequently, Petitioner has not provided evidence
`
`sufficient to support the authenticity of Exhibits 1136 to 1144 under FRE 901.
`
`
`
`IPR2016—O0204
`
`Exhibit 1147 — FBI UCB Keppra Off-label Uses 2011
`
`Exhibit 1147 is also inadmissible for at
`
`least
`
`the following reasons,
`
`including under the Federal Rules of Evidence (“FRE”).
`
`Patent Owner objects to Exhibit 1147 as lacking authentication, and thus
`
`inadmissible under FRE 901. Exhibit 1147 purports to be a copy of a 2011 FBI
`
`press release from a website. Ex. 1147 p. 1. However, Petitioner may not rely on
`
`the content of
`
`the alleged website printout without proper authentication.
`
`Petitioner has offered no evidence establishing that the exhibit is a true and correct
`
`printout from the identified website, or even evidence identifying the individual
`
`who downloaded the exhibit. Petitioner also has not provided the testimony of any
`
`witness with personal knowledge of the website. See Neste Oil OYJ v. Reg
`
`Synthetic Fuels, LLC, IPR2013—O0578, Paper 53 at 3-4 (P.T.A.B. Mar. 12, 2015).
`
`Consequently, Petitioner has not provided evidence sufficient to support a finding
`
`that Exhibit 1147 “is what [Petitioner] claims it is.” See FRE 901(a).
`
`Patent Owner further objects to Exhibit 1147 as being inadmissible under
`
`FRE 402 as lacking relevance.
`
`Exhibit 1156 — Transcript, Deposition of Dr. Lehner
`
`Exhibit 1156 is also inadmissible for at
`
`least
`
`the following reasons,
`
`including under the Federal Rules of Evidence (“FRE”).
`
`
`
`IPR2016-00204
`
`Patent Owner objects to Exhibit 1156 as being inadmissible under FRE 402
`
`as lacking relevance.
`
`Exhibit 1156 purports to be the transcript of a 2014
`
`deposition of John Lehner. Petitioner’s Reply cites 17 pages of Exhibit 1156 to
`
`argue that the LeGall thesis (Ex. 1008) was publicly available as of the priority
`
`date of the ’55l Patent. See Reply (Paper 52), pp. 28-29. However, the Board has
`
`already determined that Petitioner failed to provide “threshold evidence’ that
`
`justifies going forward with a trial on any ground that relies on the LeGall thesis as
`
`‘printed publication’ prior art.”
`
`Institution Decision (Paper 19), p. 12. Thus,
`
`Exhibit 1156 has no relevance to either of the instituted grounds.
`
`Exhibit 1158 ——- McDuff Declaration Attachments
`
`Exhibit 1158 is also inadmissible for at
`
`least
`
`the following reasons,
`
`including under the Federal Rules of Evidence (“FRE”).
`
`Patent Owner objects to Exhibit 1158 as lacking authentication, and thus
`
`inadmissible under FRE 901. Exhibit 1158 purports to be a series of tables
`
`containing anti—epileptic drug information, including sales data. However,
`
`the
`
`exhibit’s author and its date of creation are not reported. Moreover, the cited
`
`sources for much of the information in Exhibit 1158 also lack authentication under
`
`FRE 901.
`
`See infra Exhibits 1194 to 1203 and Exhibits 1206 to 1213.
`
`Consequently, Petitioner has not provided evidence sufficient to support a finding
`
`that Exhibit 1156 “is what [Petitioner] claims it is.” See FRE 901(a).
`
`
`
`IPR2016—00204
`
`Exhibits 1194 to 1203 and Exhibits 1206 to 1213 — Drug Labels
`
`Exhibits 1194 to 1203 and Exhibits 1206 to 1213 are also inadmissible for at
`
`least
`
`the following reasons,
`
`including under the Federal Rules of Evidence
`
`(“FRE”).
`
`Patent Owner objects to Exhibit 1194, Exhibit 1195, Exhibit 1196, Exhibit
`
`1197, Exhibit 1198, Exhibit 1199, Exhibit 1200, Exhibit 1201, Exhibit 1202,
`
`Exhibit 1203, Exhibit 1206, Exhibit 1207, Exhibit 1208, Exhibit 1209, Exhibit
`
`1210, Exhibit 1211, Exhibit 1212 and Exhibit 1213 as lacking authentication, and
`
`thus inadmissible under FRE 901. Each of these exhibits purports to be a copy of a
`
`drug label. Petitioner’s Exhibit List indicates that these drug labels were obtained
`
`from various websites nearly 1 and 1/2 years ago. See Paper 51, pp. [20—23].
`
`However, Petitioner may not rely on the content of the website printouts
`
`without proper authentication. Petitioner has offered no evidence establishing that
`
`the exhibits are true and correct printouts from the identified websites, or even
`
`evidence identifying who downloaded the exhibits in May 2015. Petitioner also
`
`has not provided the testimony of any witness with personal knowledge of the
`
`websites. See Neste Oil OYJ v. Reg Synthetic Fuels, LLC, IPR2013—00578, Paper
`
`53 at 3-4 (P.T.A.B. Mar. 12, 2015). Consequently, Petitioner has not provided
`
`evidence sufficient
`
`to support
`
`the authenticity of Exhibits 1194 to 1203 and
`
`Exhibits 1206 to 1213 under FRE 901.
`
`
`
`
`
`Date: November 21 2016 Respectfully submitted,
`
`IPR2016~00204
`
` ,<
`
`Andrea G. Reister /
`
`Registration No.: 36,253
`
`Jennifer L. Robbins
`
`Registration No.: 61,163
`
`Enrique D. Longton
`
`Registration No.: 47,304
`
`COVINGTON & BURLING LLP
`
`One CityCenter, 850 Tenth Street, NW
`
`Washington, DC 20001
`
`(202) 662—6000
`
`Attorneys for Patent Owner
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6, I hereby certify that on this 21st day of
`
`November 2016, the foregoing Patent Owner’s Objections to Evidence under 37
`
`C.F.R. § 42.64(b)(l) was served by electronic mail, by agreement of the parties on
`
`the following counsel of record for Petitioners.
`
`PETITIONER (IPR2016-00204)
`Matthew J. Dowd (mjdowd@dowdpllc.com)
`DOWD PLLC
`
`William G. Jenks (wjenks@jenksiplaw.Corn)
`JENKS IP LAW
`
`PETITIONER (IPR2016-O1 101)
`Steven W. Parmelee (sparmalee@wsgr.com)
`Michael T. Rosato (mrosato@wsgr.com)
`Jad A. Mills (jmills@wsgr.com)
`WILSON SONSINI GOODRICH & ROSATI
`
`PETITIONER (IPR2016—01242)
`Matthew L. Fedowitz (mfedowitz@rnerChantgou1d.com)
`Daniel R. Evans (devans@merChantgould.com)
`MERCHANT & GOULD P.C.
`
`PETITIONER (IPR2016-01245)
`Gary J . Speier (gspeier@carlsoncaspers.com)
`Jeffer Ali (jali@carlsoncaspers.com)
`CARLSON, CASPERS, VANDENBURGH, LINDQUIST & SCHUMAN, P.A.
`
`Date: November 21, 2016
`
`Registration No.: 36,253
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