Paper No. ___
`Date Filed: Dec. 22, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`___________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`___________________
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`WOCKHARDT BIO AG,
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`Petitioner
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`v.
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`JANSSEN ONCOLOGY, INC.,
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`Patent Owner.
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`___________________
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`CASE IPR2016-01582
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`Patent 8,822,438
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`___________________
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`JANSSEN ONCOLOGY INC.’S SURREPLY TO PATENT OWNER
`PRELIMINARY RESPONSE
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`Date Filed: Dec. 22, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`___________________
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`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`___________________
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`WOCKHARDT BIO AG,
`
`Petitioner
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`
`
`v.
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`
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`JANSSEN ONCOLOGY, INC.,
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`Patent Owner.
`
`___________________
`
`CASE IPR2016-01582
`
`Patent 8,822,438
`
`___________________
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`
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`JANSSEN ONCOLOGY INC.’S SURREPLY TO PATENT OWNER
`PRELIMINARY RESPONSE
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`IPR2016-01582
`Patent No. 8,822,438
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`Wockhardt’s reply fails to acknowledge – much less address – the
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`discussions between Patent Owner’s counsel, Ms. Reda, and Wockhardt’s V.P. of
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`Global IP, Dr. Dhanorkar, that demonstrate that Wockhardt and Amerigen are
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`jointly controlling their IPR filings for their mutual benefit. Wockhardt does not
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`dispute that Dr. Dhanorkar touted Wockhardt’s
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` Instead, Wockhardt relies on the declaration of a different person
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`from a different Wockhardt company in New Jersey – Wockhardt USA’s V.P. of
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`Business Development, Mr. Venkatesan. But his conclusory and irrelevant
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`statements fail to refute Janssen’s showing. Moreover, there is no indication of
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`what (if any) investigation Mr. Venkatesan undertook, or whether he even bothered
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`to talk with Dr. Dhanorkar or anyone at Amerigen.
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`Wockhardt also attempts to evade the admissions of Dr. Dhanorkar by
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`attempting to invoke Fed. R. Evid. 408, even though that rule does not apply to the
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`RPI issue present here.
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`Wockhardt bears the burden of justifying its omission of Amerigen as an
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`RPI, but has not done so. Given the undisputed statements of Dr. Dhanorkar,
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`1
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`IPR2016-01582
`Patent No. 8,822,438
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`Wockhardt should not be allowed to avoid identifying Amerigen as an RPI. To do
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`so would create a loophole for others to exploit, thereby encouraging the very
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`behavior the RPI requirements were intended to deter – harassment and “second
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`bites.”
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`I. Wockhardt Does Not Credibly Contradict its Own Statements
`Demonstrating that Amerigen Is an RPI
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`At this preliminary stage, the “petitioner bears the burden of showing
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`compliance with the threshold requirement of § 315(b).” Johnson Health Tech Co.
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`Ltd. v. Icon Health & Fitness, Inc., IPR2014-01242, Paper 16 at 4 (Feb. 11, 2015).
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`But Wockhardt has not done so. Instead, Wockhardt counters with a host of
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`largely irrelevant and unsupported allegations about formal corporate relationships
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`and the supposed absence of “financial dealings” or contracts between itself and
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`Amerigen. But this ignores the fact that “control” with respect to the RPI inquiry
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`need not be “overt.” Instead, “control” can be established by circumstantial
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`evidence. See Patent Owner Prelim. Response (Paper 13) at 9.
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`Here the undisputed evidence demonstrates that Wockhardt and Amerigen
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`are more than just “codefendants” (Reply to Prelim. Response (Paper 22) at 1) in a
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`patent lawsuit. Dr. Dhanorkar’s own statements indicate that Wockhardt and
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` Ex. 2003 (Reda Dec.) at ¶¶ 3-10.
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`2
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`Amerigen
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`IPR2016-01582
`Patent No. 8,822,438
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`, Amerigen clearly
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`exercised control over the present proceeding. Whether the relationship between
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`Amerigen and Wockhardt was formalized in a written agreement is irrelevant.
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`Indeed, the declaration of Wockhardt USA’s1 Mr. Venkatesan raises more
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`questions than it answers. It fails to explain the nature of Wockhardt’s
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`, or why Dr. Dhanorkar
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` if there were no relationship
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`between the parties with respect to this IPR. Mr. Venkatesan’s declaration also
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`fails to explain what sort of investigation he conducted before signing the
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`declaration, and whether he even spoke to Dr. Dhanorkar. And noticeably absent
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`from Wockhardt’s submission is any declaration from Dr. Dhanorkar himself.
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`Dr. Dhanorkar’s e-mails and communications with Patent Owner’s counsel
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`are clear on their face and show that Amerigen is an RPI that should have been
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`identified in this proceeding. Mr. Venkatesan’s declaration fails to refer to these
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`communications or even acknowledge them. The declaration should therefore be
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`accorded no weight.
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`II.
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` Wockhardt’s Attempts to Evade the Impact of its Statements to the
`Patent Owner Are Unavailing
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`None of Wockhardt’s three excuses has any merit.
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`1 http://www.healthnetworkcommunications.com/conference/affordable-
`medicines/speaker-gopalakrishnan-VENKATESAN.stm.
`3
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`IPR2016-01582
`Patent No. 8,822,438
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`First, Wockhardt’s reliance on Fed. R. Evid. 408 is misguided. (Paper 22 at
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`6). As previously pointed out (Paper 13 at 5, n. 4), Patent Owner is not offering
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`the communications “to prove or disprove the validity or amount of a disputed
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`claim,” as proscribed by Rule 408. Nor are the communications being offered for
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`purposes of impeachment of the testimony of Dr. Dhanorkar or anyone else.
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`Instead, the sole purpose here is to demonstrate Wockhardt’s noncompliance with
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`the RPI requirement. Rule 408 simply does not apply. See Amneal Pharms. LLC
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`v. Jazz Pharms., Inc., IPR2015-00545, Paper 38 at 5-6 (Sept. 18, 2015).
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`Second, Wockhardt argues that the communications between Dr. Dhanorkar
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`and Ms. Reda do not demonstrate that Amerigen and Wockhardt “funded” each
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`other’s IPRs. (Paper 22 at 6). But this is irrelevant. Financing an IPR is not the
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`same as controlling one. Evidence of financing is not a requirement for
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`determining that an unidentified party is an RPI. See Paramount Home
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`Entertainment Inc. v. Nissim Corp., IPR2014-00961, Paper 11 at 7-11 (Dec. 29,
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`2014). Likewise, the argument that Amerigen and Wockhardt are “separate
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`corporate entities” is irrelevant. The RPI inquiry does not turn on the “relationship
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`between parties.” Aruze Gaming Macau, Ltd. v. MGT Gaming, Inc., IPR2014-
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`01288, Paper 13 at 11 (Feb. 20, 2015). What matters is control. Wockhardt’s bald
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`denial of control, supported only by Mr. Venkatesan’s declaration, is simply not
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`4
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`IPR2016-01582
`Patent No. 8,822,438
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`credible in view of the undisputed contrary evidence found in Dr. Dhanorkar’s
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`undisputed statements.
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`Third, Wockhardt’s attempt to cast Dr. Dhanorkar’s role as merely
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`presenting a settlement proposal on behalf of Amerigen and Wockhardt (Paper 22
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`at 7) is belied by the actual communications. While settlement may have been the
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`ultimate goal, the facts show that
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` for the mutual benefit of
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`both parties, as Patent Owner has already explained. See Patent Owner Prelim.
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`Resp. (Paper 13) at 5-7 and 10-15.
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`, Amerigen
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`exercised control over this IPR. If it were otherwise, then Dr. Dhanorkar could not
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`have
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` means
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`that Amerigen indeed was exercising control.
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`As Patent Owner has explained, Wockhardt’s petition is an attempt to
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`“game” the system in order to take a “second bite at the apple.” Wockhardt has
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`failed to meet its burden of establishing otherwise.
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`III. Conclusion
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`The Board should deny institution of the Wockhardt Petition for failure to
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`5
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`comply with §312(a)(2).
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`IPR2016-01582
`Patent No. 8,822,438
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`Dated: December 22, 2016
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`Respectfully submitted,
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`
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`By: /Dianne B. Elderkin/
`Dianne B. Elderkin (Reg. No. 28,598)
`delderkin@akingump.com
`Barbara L. Mullin (Reg. No. 38,250)
`bmullin@akingump.com
`Ruben H. Munoz (Reg. No. 66,998)
`rmunoz@akingump.com
`AKIN GUMP STRAUSS HAUER
`& FELD LLP
`Two Commerce Square
`2001 Market Street, Suite 4100
`Philadelphia, PA 19103
`Tel: (215) 965-1200
`Fax: (215) 965-1210
`
`David T. Pritikin (pro hac vice)
`Bindu Donovan (pro hac vice)
`SIDLEY AUSTIN LLP
`787 Seventh Avenue
`New York, NY 10019
`Tel.: (212) 839-5300
`Fax: (212) 839-5599
`ZytigaIPRTeam@sidley.com
`
`Counsel for Patent Owner
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`6
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`IPR2016-01582
`Patent No. 8,822,438
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing Janssen
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`Oncology, Inc.’s Surreply to Patent Owner Preliminary Response was served on
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`counsel of record on December 22, 2016 by filing this document through the End-
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`to-End System, as well as delivering a copy via electronic mail to counsel of record
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`for the Petitioner and Patent Co-Owner at the following addresses:
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`Dennies Varughese - dvarughe-PTAB@skgf.com
`Deborah A. Sterling - dsterlin-PTAB@skgf.com
`Christopher M. Gallo - cgallo-PTAB@skgf.com
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`Anthony C. Tridico - anthony.tridico@finnegan.com
`Jennifer H. Roscetti - jennifer.roscetti@finnegan.com
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`Respectfully submitted,
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`By: /Dianne B. Elderkin/
`Dianne B. Elderkin
`Registration No. 28,598
`Counsel for Patent Owner
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`7
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`Date: Dec. 22, 2016
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