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`Paper No. ___
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`Date Filed: February 6, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
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`AMERIGEN PHARMACEUTICALS LIMITED,
`ARGENTUM PHARMACEUTICALS LLC,
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`Petitioner
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`v.
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`JANSSEN ONCOLOGY, INC.,
`Patent Owner
`________________
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`Case IPR2016-002861
`________________
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`Patent No. 8,822,438 B2
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`PATENT OWNER’S REPLY TO PETITIONERS’ OPPOSITION TO
`PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64(C)
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`1 Case IPR2016-01317 has been joined with this proceeding.
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`IPR2016-00286
`U.S. Patent 8,822,438
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`Patent Owner, Janssen Oncology, Inc., set forth four independent grounds
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`for excluding evidence relied upon by Petitioners. (Paper 70). As discussed below,
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`Petitioners have failed to refute those grounds. The exhibits should be excluded.
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`A.
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`Petitioners Offer No Legitimate Basis for Ignoring the Statutory
`Limitations on the Grounds for Cancellation
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`Petitioners do not dispute that the governing statute, § 311(b), clearly and
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`unambiguously states that IPRs may seek cancellation of a claim “only on the basis
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`of prior art consisting of patents or printed publications.” Nor do Petitioners
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`dispute that the declaration of their economist Dr. McDuff (Exh. 1017) offers
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`opinions on “commercial success,” which are outside the ambit of “patents or
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`printed publications.” Instead, Petitioners make several arguments, but none
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`justifies ignoring the statute, which Petitioners do not even mention.
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`First, Petitioners point out that Patent Owner relied on commercial success
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`in its Patent Owner’s Response, as if that had any bearing on what was permissible
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`as grounds for seeking cancellation in the petition. (Paper 76 at 2). On the
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`contrary, whether a patent owner chooses to rely on evidence of commercial
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`success in its response to an IPR is completely irrelevant to what the explicit
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`statute permits in an IPR petition in the first instance. Second, Petitioners criticize
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`Patent Owner for not citing to regulations or case law on the issue at hand. (Paper
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`76 at 2). But this amounts to nothing more than misdirection by Petitioners, since
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`1
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`IPR2016-00286
`U.S. Patent No. 8,822,438
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`the basis of the instant motion is the governing statute. Petitioners’ position is akin
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`to requiring case law as a condition precedent to enforcing any statute, which is
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`clearly not correct. Third, Petitioners urge that “commercial success” belonged in
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`their petition, because the issue played a part in the course of the ‘438 patent
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`prosecution. (Paper 76 at 2-3). However, Petitioners provide no authority for even
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`suggesting that the prosecution history is a legitimate reason for departing from
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`clear limits placed by § 311(b) on the grounds that can be raised in an IPR petition.
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`As for Dr. McDuff’s second declaration (Exh. 1152), Petitioners concede
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`that it was not cited anywhere in their reply brief. (Paper 76 at 3). Thus, even if
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`Dr. McDuff’s second declaration on “commercial success” were regarded as proper
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`rebuttal, it is not connected to anything in Petitioners’ reply. Petitioners’ excuse
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`that this was an inadvertent clerical error is unpersuasive. Petitioners do not
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`explain how Patent Owner was supposed to know that Exhibit 1096 in the reply
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`was in reality Exhibit 1152. Nor is there any merit to Petitioners’ illogical
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`argument that Patent Owner should have objected to its own deposition of Dr.
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`McDuff. (Paper 76 at 3-4). Both declarations of Dr. McDuff should be stricken.
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`B.
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`Petitioners’ Attempts to Excuse Their Failure to File Reply
`Exhibits on Time are Unavailing
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`Petitioners claim that their failure to file and serve their reply exhibits on
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`time was due to “technical problems” during the filing. (Paper 76 at 5). But that is
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`2
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`IPR2016-00286
`U.S. Patent No. 8,822,438
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`the same excuse that the Board rejected in Teva. See Patent Owner Motion to
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`Exclude (Paper 70) at 6. Petitioner tries to distinguish Teva on the grounds that
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`Petitioners here are not faced with a statutory deadline. (Paper 76 at 5). Yet that
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`only weakens Petitioners’ position. In Teva, the penalty for filing late (by just a
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`few hours) was denial of the petition, while here Petitioners face a less draconian
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`loss of only the late filed exhibits.
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`Like the petitioner in Teva, Petitioners here offer no explanation whatsoever
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`as to why they waited so long (until 11:59 pm on January 16, 2017) to file and
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`serve their reply and expert declarations.
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`Petitioners also argue that the Patent Office was officially closed on the
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`January 16, 2017 deadline (a date chosen by Petitioners). But the date on which
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`the Patent Office had access to the exhibits is utterly irrelevant to the issue here.
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`Petitioners’ resort to arguments based on prior extensions of time and the length of
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`depositions taken by Patent Owner in the days after the January 16, 2017 deadline
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`(Paper 76 at 4-5) are likewise irrelevant.
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`C.
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`Petitioners Have Not Shown that the Materials Omitted from
`Their Reply Meet the Standards for Relevance
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`
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`Petitioners do not dispute that the subject matter in entire portions of their
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`expert reply declarations of Drs. Ratain and Dorin (and the entirety of Dr.
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`McDuff’s reply declaration) are not cited anywhere in Petitioners’ reply brief.
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`3
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`IPR2016-00286
`U.S. Patent No. 8,822,438
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`(Paper 76 at 5-6). Without any support, Petitioners contend that their practice of
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`including topics in expert declarations but not citing those portions of their expert
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`reports is “extremely common.” (Paper 76 at 6). True or not, this essentially
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`amounts to a defense of “everyone does it,” which does not address the issue of
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`relevance under the governing Federal Rules of Evidence. See FRE 401-402.
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`In addition, even accepting Petitioners’ explanation that the failure to cite Dr.
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`McDuff’s second declaration was a clerical error, Petitioners only cited to one page
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`(page 21) of “Exhibit 1096,” his supposed declaration. (Paper 60 at 23). Thus, in
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`any event, the remaining pages of his second declaration should be stricken, along
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`with the uncited portions of the reply declarations of Drs. Ratain and Dorin.
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`D.
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`Petitioners Have Not Shown that the Challenged Exhibits Meet
`the Requirements for Authenticity and Hearsay
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`Petitioners concede that many of their exhibits have not been authenticated,
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`but pledge to provide supplemental declarations for that purpose in the future. But
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`even for those exhibits that Petitioners contend have already been authenticated,
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`the showing is still lacking. For example, for the website documents, Petitioners
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`offer conclusory statements that the document was downloaded from a particular
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`website, without providing any information about the source of the underlying
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`information contained in the document. In this regard, Exhibit 1056, a document
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`apparently taken from www.barrons.com, can no longer be accessed at the
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`4
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`IPR2016-00286
`U.S. Patent No. 8,822,438
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`provided link, and Petitioners’ assertion that Barron’s Online is a “leading third-
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`party publisher of financial information” fails to provide the source of the
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`underlying information.
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`Petitioners’ attempt to shoehorn investment analyst reports into hearsay
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`exception 803(17) is unavailing. Petitioner offers no case in which that exception
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`has been applied to such reports. The Notes of the Advisory Committee on
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`exception 17 indicate that one rationale underlying the exception is the motivation
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`of the compiler to foster reliance by being accurate. However, the analyst reports
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`at issue here expressly warn against investor reliance, stating that they are not
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`necessarily accurate. For example, the disclaimer in Exhibit 1043 (at 2) states:
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`“Each author of this research report hereby certifies that (i) the views expressed in
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`the research report accurately reflect his or her personal views about any and all of
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`the subject securities or issuers,” and “Other than disclosures relating to Cowen
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`and Company, LLC, the information herein is based on sources we believe to be
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`reliable but is not guaranteed by us and does not purport to be a complete statement
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`or summary of the available data.” The analyst report Exhibit 1058 (at 9) contains
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`a similar disavowal of accuracy and objectivity. And Exhibit 1060 (at 1) flat out
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`warns investors that the firm providing the report may have a conflict of interest.
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`The reports do not fall under hearsay exception 803(17) and should be stricken.
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`5
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`IPR2016-00286
`U.S. Patent No. 8,822,438
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`Date: February 6, 2017
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`Respectfully submitted,
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`
`/Dianne B. Elderkin/
`Dianne B. Elderkin (Lead Counsel)
`Reg. No. 28,598
`Barbara L. Mullin (Back-up Counsel)
`Reg. No. 38,250
`Ruben H. Munoz (Back-up Counsel)
`Reg. No. 66,998
`AKIN GUMP STRAUSS HAUER
`& FELD LLP
`Two Commerce Square
`2001 Market Street, Suite 4100
`Philadelphia, PA 19103
`Tel.: (215) 965-1340
`Fax: (215) 965-1210
`
`David T. Pritikin (pro hac vice)
`dpritikin@sidley.com
`Bindu Donovan (pro hac vice)
`bdonovan@sidley.com
`Paul J. Zegger (Reg. No. 33,821)
`pzegger@sidley.com
`Todd Krause (Reg. No. 48,860)
`tkrause@sidley.com
`Isaac Olson (pro hac vice)
`iolson@sidley.com
`Alyssa B. Monsen (pro hac vice)
`amonsen@sidley.com
`SIDLEY AUSTIN LLP
`787 Seventh Avenue
`New York, NY 10019
`Tel.: (212) 839-5300
`Fax: (212) 839-5599
`
`Counsel for Patent Owner
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`
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`6
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing Patent
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`Owner’s Reply to Petitioners’ Opposition to Patent Owner’s Motion to Exclude
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`Evidence Pursuant to 37 C.F.R. § 42.64(c) was served on counsel of record on
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`February 6, 2017 by filing this document through the End-to-End System, as well
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`as delivering a copy via electronic mail to counsel of record for the Petitioners and
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`Patent Co-Owner at the following addresses:
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`
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`William Hare - bill@miplaw.com
`Gabriela Materassi - materassi@miplaw.com
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`Teresa Stanek Rea - TRea@Crowell.com
`Shannon M. Lentz - SLentz@Crowell.com
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`Anthony C. Tridico - anthony.tridico@finnegan.com
`Jennifer H. Roscetti - jennifer.roscetti@finnegan.com
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`Date: February 6, 2017
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`Respectfully submitted,
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`
`/Dianne B. Elderkin/
`Dianne B. Elderkin
`Registration No. 28,598
`Counsel for Patent Owner
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`7
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