IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
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`AMERIGEN PHARMACEUTICALS LIMITED
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`and
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`ARGENTUM PHARMACEUTICALS LLC,
`
`Petitioners
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`v.
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`JANSSEN ONCOLOGY, INC.,
`
`Patent Owner
`_______________
`
`Case IPR2016-002861
`
`Patent 8,822,438 B2
`_______________
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`
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`PETITIONERS’ OPPOSITION TO PATENT OWNER’S
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`MOTION TO EXCLUDE EVIDENCE
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`1 Case IPR2016-01317 has been joined with this proceeding.
`
`
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`AMERIGEN PHARMACEUTICALS LIMITED
`
`and
`
`ARGENTUM PHARMACEUTICALS LLC,
`
`Petitioners
`
`v.
`
`JANSSEN ONCOLOGY, INC.,
`
`Patent Owner
`_______________
`
`Case IPR2016-002861
`
`Patent 8,822,438 B2
`_______________
`
`
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`PETITIONERS’ OPPOSITION TO PATENT OWNER’S
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`MOTION TO EXCLUDE EVIDENCE
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`
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`
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`1 Case IPR2016-01317 has been joined with this proceeding.
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`
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`Petitioners’ Opposition To Patent Owner’s Motion To Exclude Evidence
`Petition for Inter Partes Review 2016-00286
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`Petitioners, Amerigen Pharmaceuticals Limited and Argentum
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`Pharmaceuticals LLC, oppose Patent Owner’s, Janssen Oncology, Inc., Motion to
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`Exclude Evidence submitted by Petitioners.
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`I. Declarations and related Exhibits of Deforest McDuff (economic
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`expert).
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`Patent Owner argues that all the evidence submitted by Petitioners
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`concerning commercial success should be excluded. As Patent Owner correctly
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`points out, commercial success can be relevant to the issue of obviousness of a
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`patent claim. In this instance, the Patent Owner itself attempted to claim
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`commercial success as an objective indicia of non-obviousness in Patent Owner’s
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`Response. (See Patent Owner’s Response at p. 60).
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`There is no basis in law or common sense suggesting that Patent Owner can
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`attempt to establish non-obviousness with evidence of commercial success in the
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`course of prosecuting a patent, and then again during an IPR proceeding, but that
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`Petitioners are prohibited from addressing such, commenting upon, and offering its
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`own evidence on the issue. Tellingly, Patent Owner cites to no regulation or case
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`law on the issue.
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`Patent Owner’s issue with Dr. McDuff’s first declaration (Exh. 1017) seems
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`to be that it was offered prior in time to Patent Owner’s Response and is therefore
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`not technically a “rebuttal.” Dr. McDuff’s first declaration was necessitated by the
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`2
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`Petitioners’ Opposition To Patent Owner’s Motion To Exclude Evidence
`Petition for Inter Partes Review 2016-00286
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`original prosecution record leading to the issuance of the ‘438 Patent in the first
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`instance. Patent Owner overlooks that critically, in the case of the ‘438 Patent,
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`patentees were only able to overcome compelling prior art rejections based on
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`“commercial showings.” Dr. McDuff’s Declaration necessarily addresses the
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`original prosecution record. Patent Owner cannot expect Petitioners and the Board
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`to not consider the grounds on which the ‘438 patent issued in the first instance.
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`Again, Patent Owner offers no case law to support this notion that such evidence
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`must be offered in the Reply as opposed to the Petition itself.
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`Finally, Patent Owner claims that Dr. McDuff’s second declaration
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`(currently labeled Exh. 1152) is not cited in Petitioners’ Reply. As is known to the
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`Patent Owner, Dr. McDuff’s second declaration was inadvertently labeled as
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`Exhibit 1152. However, the second McDuff Declaration is cited as Exhibit 1096 in
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`Petitioners’ Reply brief and Exhibits 1149, 1150, 1151 and 1190 are cited in the
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`second McDuff declaration. Petitioners have approached the Board to correct the
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`clerical error. There has been no prejudice to Patent Owner in this regard, as
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`counsel fully considered Dr. McDuff’s second declaration and exhibits, and indeed
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`deposed him on it. Exh. 1191. During the deposition of Dr. McDuff the Patent
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`Owner did not make any objections that the testimony was irrelevant. It is illogical
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`3
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`Petitioners’ Opposition To Patent Owner’s Motion To Exclude Evidence
`Petition for Inter Partes Review 2016-00286
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`that Patent Owner has objected to Dr. McDuff’s Declaration but did not object to
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`Dr. McDuff’s deposition based upon his declaration.
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`II. Certain of Petitioners’ Exhibits to Its Reply Brief Filed and
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`Served After Midnight.
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`
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`Patent Owner admits that Petitioners’ Reply brief and four expert
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`declarations accompanying its Reply brief were timely filed but complains that the
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`exhibits were filed after midnight. Patent Owner relies solely on Teva
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`Pharmaceuticals USA, Inc. v. Monosol RX, LLC, IPR2016- 00281, -00282, Papers
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`21 and 19 (PTAB May 23, 2016) for the notion that the exhibits should be stricken.
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`Patent Owner fails to mention that Teva however missed a statutory bar for the
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`filing of a Petition. There is no such bar here, and in the interest of justice the
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`exhibits should not be stricken.
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`The Patent Owner does not make an actual claim of prejudice and there was
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`none. First, Petitioners note that January 16, 2017 was a national holiday, the
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`USPTO was officially closed, and Patent Owner received all exhibits prior to open
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`of business on the morning of the first business day following the holiday. Second,
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`the Patent Owner took all of the depositions of Petitioners’ experts as scheduled.
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`Patent Owner did not request additional time to prepare or otherwise object until
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`after it took each of the depositions. Further, Patent Owner elected not to use more
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`than half of its allotted time for each deposition.
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`4
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`Petitioners’ Opposition To Patent Owner’s Motion To Exclude Evidence
`Petition for Inter Partes Review 2016-00286
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`Finally, Patent Owner’s subtle suggestion of gamesmanship is unwarranted.
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`Petitioners experienced technical problems during the filing which caused the
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`delay. Petitioners have always cooperated with Patent Owner including giving
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`Patent Owner two extensions totaling approximately five weeks (August 31 to
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`October 4) to file its Preliminary Response and working with Patent Owner to
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`schedule depositions of the four experts relied upon in Petitioners’ Reply in
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`advance of filing the Reply. With regard to the five hour delay in filing the
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`exhibits to the Petitioners’ Reply, Petitioners, in response to Patent Owner’s
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`Objection served on January 23, 2017, have requested that the Patent Owner
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`stipulate to an extension of the deadline from January 16 to January 17 but Patent
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`Owner rejected such a stipulation.
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`III. Paragraphs of Petitioners’ Reply Declarations Not Explicitly
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`Recited in Petitioners’ Reply.
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`
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`Patent Owner, citing no statute, regulation, or case law, complains that any
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`paragraph of an expert declaration not explicitly cited in Petitioners’ Reply brief
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`should be stricken. There is simply no legal basis for striking these paragraphs.
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`Patent Owner’s sole basis for arguing irrelevance is the lack of citation in the
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`Reply brief. Patent Owner did not examine the substance of any paragraphs it
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`moved to exclude. That is, Patent Owner failed to consider that the paragraphs at
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`5
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`Petitioners’ Opposition To Patent Owner’s Motion To Exclude Evidence
`Petition for Inter Partes Review 2016-00286
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`issue are relevant to the portions of the expert declarations that are cited in the
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`Reply brief.
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`It is extremely common for expert declarations to contain information that is
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`not directly cited in a party’s brief. Expert declarations almost always contain
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`information relevant to the expert’s opinions that are not cited by paragraph
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`number in the brief. In fact, Patent Owner’s own expert declarations are replete
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`with paragraphs that are not cited in Patent Owner’s own Response brief.
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`With regard to Dr. McDuff’s second declaration, as explained above, this
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`was inadvertently labeled as Exhibit 1152. However, the second McDuff
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`Declaration is cited as Exhibit 1096 in Petitioners’ Reply brief. Patent Owner has
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`denied Petitioners’ request to correct this clerical error. Patent Owner has denied
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`this request in spite of Petitioners previous consent for Patent Owner to correct not
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`just clerical errors, but changes more substantive in nature to its own expert’s
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`declaration. Accordingly Petitioner has approached the Board to correct the
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`clerical error.
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`
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`IV. Petitioners Exhibits Objected to Due to Lack of Authenticity and
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`Hearsay.
`A. Authenticity
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`Patent Owner initially objected to Exhibits 1040, 1041, 1048, 1049, 1051-
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`1053, 1055-1057, 1088, 1128, 1130, 1140, and 1166 as lacking authenticity.
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`6
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`Petitioners’ Opposition To Patent Owner’s Motion To Exclude Evidence
`Petition for Inter Partes Review 2016-00286
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`Petitioner timely responded to each objection and timely served supplemental
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`evidence authenticating each of these exhibits2. In particular, Petitioners provided
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`the declarations of DeForest McDuff and Scott Serels as Exhibits 1068 and 1069,
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`respectively, that authenticated the objected-to exhibits. Yet, in its motion, Patent
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`Owner fails to identify any alleged deficiency in the authentication contained in the
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`supplemental evidence (or address the supplemental evidence at all).
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`Patent Owner similarly complains that Exhibits 1017 [B-1 and B-2], 1032,
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`1042-1044, 1058-1063, 1067, and 1140 lack authentication. Again, Petitioners
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`timely responded to each objection and timely served supplemental evidence
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`authenticating each of these exhibits.3 In particular, Petitioners provided the
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`declarations of DeForest McDuff, Scott Serels, and Jayesh Bindra as Exhibits
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`1068, 1069 and 1070, respectively, authenticating the exhibits. In its motion,
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`Patent Owner again failed to identify any the alleged deficiency in the
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`authentication contained in the supplemental evidence (or address the supplemental
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`evidence at all).
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`
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`2 Due to the schedule Petitioners will timely file supplemental evidence
`authenticating Exhibits 1088, 1128, 1130, 1140, and 1166.
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` 3
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` Due to the schedule Petitioners will timely file supplemental evidence
`authenticating Exhibit 1140.
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`7
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`Petitioners’ Opposition To Patent Owner’s Motion To Exclude Evidence
`Petition for Inter Partes Review 2016-00286
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`For example, Patent Owner complains that Exhibit 1032, “purports to be the
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`‘Taxotere® Prescribing Information’, but this exhibit lacks proper authentication
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`and foundation at least because the circumstances surrounding the source and the
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`accuracy of the ‘Taxotere® Prescribing Information’ have not been established.”
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`Yet the declaration of Scott Serels describes in detail where the document is found
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`on the Food and Drug Administration website and swears it is a true and correct
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`copy of such document. See Exh. 1069 at 7.
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`Patent Owner makes similar complaints about the other documents while
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`seemingly ignoring the Petitioners’ supplemental evidence, i.e., Exhibits 1068,
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`1069 and 1070. Instead Patent Owner makes general conclusory statements about
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`Petitioners’ exhibits while failing to address the actual statements in Petitioners’
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`declarations. Tellingly, the supplemental evidence provided by Patent Owner to
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`authenticate exhibits provides less information than Petitioners have provided in
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`their supplemental evidence.
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`B. Hearsay
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`Patent Owners assert that Exhibits 1042-1044, 1055, 1056, 1058-1063, and
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`1067 are hearsay. All the objected to exhibits fall into an exception under Federal
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`Rules of Evidence 803.
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`8
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`Petitioners’ Opposition To Patent Owner’s Motion To Exclude Evidence
`Petition for Inter Partes Review 2016-00286
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`Patent Owner objects to Exhibits 1042-1044, 1056, and 1058-1063 and
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`correctly characterize these as investment analyst reports. These documents
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`clearly fall within the exception to the hearsay Rule 803(17), which states:
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`“Market Reports and Similar Commercial Publications. Market quotations, lists,
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`directories, or other compilations that are generally relied on by the public or by
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`persons in particular occupations.” Dr. McDuff relied on these commercial
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`publications as a person in the occupation of consulting in applied business
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`economics. Dr. McDuff explicitly identifies these documents as research material
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`in his Declaration (Exh. 1017, attachment A2). Patent Owner fails to prove or
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`even argue that the documents are not generally relied on by the public or by
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`persons in Dr. McDuff’s occupational field.
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`Additionally, Exhibits 1055 and 1067 are similarly reports of the type
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`generally relied on by persons in Dr. McDuff’s occupation. For example, Patent
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`Owner’s own economics expert, Dr. Christopher Vellturo, relied on both
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`documents in the formation of his opinion. See Exh. 2044, Appendix A. Further,
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`while Dr. Vellturo’s declaration purports to evaluate Dr. McDuff’s analysis, Dr.
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`Vellturo failed to assert that any of the objected to exhibits were not generally
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`relied on by the public or by persons in particular occupations.
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`None of the exhibits should be excluded as hearsay.
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`9
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`Petitioners’ Opposition To Patent Owner’s Motion To Exclude Evidence
`Petition for Inter Partes Review 2016-00286
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`Dated: February 3, 2017
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`Respectfully Submitted,
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`/William D. Hare/
`William D. Hare
`Reg. No. 44,739
`McNeely Hare & War, LLP
`12 Roszel Road, Suite C104
`Princeton, NJ 08540
`(202) 640-1801
`bill@miplaw.com
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`10
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`Petitioners’ Opposition To Patent Owner’s Motion To Exclude Evidence
`Petition for Inter Partes Review 2016-00286
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that the foregoing Petitioners’ Opposition
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`to Patent Owner’s Motion to Exclude Evidence was served on February 3, 2017 by
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`delivering copies via electronic mail on the following attorneys of record for the
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`Patent Owner:
`
`Dianne B. Elderkin
`Barbara L. Mullin
`Ruben H. Munoz
`delderkin@akingump.com
`bmullin@akingump.com
`rmunoz@akingump.com
`JANS-ZYTIGA@akingump.com
`AKIN GUMP STRAUSS HAUER & FELD LLP
`
`David T. Pritikin
`Bindu Donovan
`Paul J. Zegger
`Todd Krause
`Isaac Olson
`Alyssa B. Monsen
`dpritikin@sidley.com
`bdonovan@sidley.com
`pzegger@sidley.com
`tkrause@sidley.com
`iolson@sidley.com
`amonsen@sidley.com
`ZytigaIPRTeam@sidley.com
`SIDLEY AUSTIN LLP
`
`Jennifer H. Roscetti
`Anthony C. Tridico
`jennifer.roscetti@finnegan.com
`anthony.tridico@finnegan.com
`FINNEGAN HENDERSON FARABOW GARRETT & DUNNER
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`11
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`Petitioners’ Opposition To Patent Owner’s Motion To Exclude Evidence
`Petition for Inter Partes Review 2016-00286
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`Teresa Stanek Rea
`Shannon M. Lentz
`TRea@Crowell.com
`SLentz@Crowell.com
`CROWELL & MORING LLP
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`Date: February 3, 2017
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`/William D. Hare/
`William D. Hare
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`12
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