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`Paper No. ___
`Date Filed: May 17, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`MYLAN PHARMACEUTICALS INC., ACTAVIS
`LABORATORIES FL, INC., AMNEAL
`PHARMACEUTICALS LLC, AMNEAL
`PHARMACEUTICALS OF NEW YORK, LLC, DR.
`REDDY’S LABORATORIES, INC., DR. REDDY’S
`LABORATORIES, LTD., SUN PHARMACEUTICALS
`INDUSTRIES, LTD, SUN PHARMACEUTICALS
`INDUSTRIES, INC., TEVA PHARMACEUTICALS
`USA, INC., WEST-WARD PHARMACEUTICAL
`CORP., AND HIKMA PHARMACEUTICALS, LLC,
`
`Petitioner
`
`v.
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`JANSSEN ONCOLOGY, INC.,
`Patent Owner.
`________________
`
`Case IPR2016-013321
`________________
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`Patent No. 8,822,438 B2
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`PATENT OWNER’S REPLY IN SUPPORT OF ITS
`MOTION TO EXCLUDE EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64(C)
`
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`1 Case IPR2016-00853 has been joined with this proceeding.
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`IPR2016-01332
`U.S. Patent 8,822,438
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`Patent Owner, Janssen Oncology, Inc., submits this Reply in support of its
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`Motion to Exclude Evidence (Paper 69).2
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`I.
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`Petitioners’ Request to Ignore § 311(b) Should Be Rejected
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`Petitioners do not dispute that the governing statute, 35 U.S.C. § 311(b),
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`states that Petitioners may challenge a claim “only on the basis of prior art
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`consisting of patents or printed publications.” Nor do Petitioners dispute that their
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`economic expert Mr. Hofmann offers opinions on “commercial success” as part of
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`the petition, going beyond the scope of “patents or printed publications.” None of
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`Petitioners’ arguments justify ignoring the express limitations in the statute.
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`First, Petitioners argue that they complied with the statute by requesting
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`cancellation of the ’438 patent claims by asserting grounds based on “three patents
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`or printed publications.” Paper 76 at 3. But if that were the case, there would have
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`been no need to submit the Hofmann Declaration as part of the Petition.
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`According to Petitioners, Mr. Hofmann addresses the “prosecution history and the
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`Examiner’s decision to allow the ’438 patent on the basis of commercial success.”
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`Paper 76 at 4-5. Thus, by their own admission, Petitioners used the Hofmann
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`Declaration in order to attack validity on grounds other than prior art patents or
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`2 Patent Owner withdraws authentication objections to Exhibits 1017 [B-1], 1048,
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`1053, 1055, 1057, 1092 and 1125; relevance objections to Exhibits 1050, 1055,
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`1100, 1102, and 1103; and hearsay objections to Exhibits 1055 and 1095.
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`1
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`IPR2016-01332
`U.S. Patent 8,822,438
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`printed publications. Petitioners’ contention that they do not seek to cancel the
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`’438 patent on the basis of commercial success but only to show that the patent
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`should not have been allowed on this ground (Paper 76 at 3) is no distinction at all.
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`Second, Petitioners urge that § 311(b) places no limit on the scope of
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`evidence permitted in a petition. Paper 76 at 3-4. But Petitioners’ incorrect
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`reading would open a loophole allowing petitioners to assail patentability with any
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`evidence, including commercial success, as long as the formal grounds relate to
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`prior art patents or printed publications. Petitioners find no support for their
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`erroneous position in Meadwestvaco Packaging Sys., LLC v. Lingamfelter, 2011
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`WL 901354 (B.P.A.I. Mar. 14, 2011). There, evidence on secondary
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`considerations was submitted after institution. Id. at *11 (“[r]eexamination was
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`instituted based on prior art consisting of patents or printed publications”). Here,
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`in contrast, the commercial success evidence submitted with the Petition was not
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`rebuttal evidence and was therefore contrary to § 311(b). Petitioners’ reliance on
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`the parallel Amerigen IPR (Paper 76 at 4) is misleading because Patent Owner has
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`a similar pending motion to exclude based on § 311(b) in that IPR.
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`Third, Petitioners argue that commercial success belonged in the Petition
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`because the issue is “relevant” to whether the Examiner erred in allowing the ’438
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`patent. Paper 76 at 5. However, Petitioners provide no authority for substituting
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`this standard for the express provisions of § 311(b).
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`2
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`IPR2016-01332
`U.S. Patent 8,822,438
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`Finally, Petitioners’ complaint that Janssen’s argument would prohibit
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`Petitioners from rebutting Patent Owner’s contentions of commercial success is
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`untrue. Paper 76 at 5. Rather, the issue here is Petitioners’ inclusion of prohibited
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`matter in their Petition. Petitioners’ fallback position––requesting that the Board
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`treat the opening Hofmann Declaration and exhibits as filed with the Reply—
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`should also be rejected, as it would reward Petitioners for disregarding § 311(b).
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`The initial Hofmann Declaration (Ex. 1017) and associated Exhibits 1040,
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`1041, 1046-1051, 1053-1055, 1057, and 1064-1066 should be excluded.
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`II.
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`Petitioners’ Uncited Evidence Is Irrelevant and Unfairly Prejudicial
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`Petitioners’ evidence that is untethered from any paper should be excluded.
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`Microsoft Corp. v. Parallel Networks Licensing, LLC, IPR2015-00485, Paper 81 at
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`24 (Aug. 11, 2016). Petitioners’ reliance on Activision Blizzard, Inc. v.
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`Acceleration Bay, LLC is unpersuasive because Petitioners not only failed to cite
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`the exhibits themselves, but also any portion of their expert declarations discussing
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`the exhibits. IPR2015-01953, Paper 107 at 75 (Mar. 23, 2017). Activision also
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`relied on 37 C.F.R. § 42.64(b)(2), but that provision pertains to the special case of
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`supplemental evidence and is not germane.
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`In addition, whether Petitioners can now articulate reasons to justify the
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`relevance of the uncited material is entirely immaterial. Paper 76 at 6-11. Any
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`explanation belonged in the Petition or the Reply, not at this late date shortly
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`3
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`IPR2016-01332
`U.S. Patent 8,822,438
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`before the hearing. 37 C.F.R. § 42.104(b)(5).
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`Having admittedly failed to cite in their Petition, Reply, or the paragraphs of
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`its expert declarations cited therein, any of Exhibits 1002 ¶ 30; 1040; 1041; 1046;
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`1049; 1064; 1066; 1086; 1089; 1091 ¶¶ 17-29, 31; 1092-1094; 1097 ¶¶ 11-16, 95;
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`1104 ¶¶ 5-9, 11-13, 88-90, 92-95, 119-122; and 1139, the evidence should be
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`excluded as irrelevant and unduly prejudicial. At a minimum the Board should
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`give this evidence no weight. 37 C.F.R. § 42.104(b)(5).
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`III. Petitioners’ Unexplained Authentication Arguments Fail
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`Petitioners claim their supplemental evidence overcomes all authenticity
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`objections but provide no explanation as to why. As explained in Patent Owner’s
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`Motion, and fatally unrebutted, a declaration testifying to retrieving a website
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`printout is insufficient when website contents are offered as proof. Paper 69 at 7.
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`Exhibit 1028 is a purported 1989 publication concerning ketoconazole. Ex.
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`1002 (Garnick) at 13, ¶ 78 (citing Ex. 1028). Petitioners’ supplemental evidence
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`provides only an insufficient statement that this and other exhibits “are publicly
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`available, or derived from documents that are publicly available.” Ex. 1153 ¶ 3.
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`Exhibit 1049 is purportedly a Jevtana website, and is wrongly treated by Mr.
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`Hofmann as prior art when his declarations reflect only knowledge of a 2016
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`printout. Ex. 1017 ¶ 33; Ex. 1154 ¶ 5. Exhibit 1088 is supposedly a BTG press
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`release allegedly offered to prove that statements were made by BTG in 2004.
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`4
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`IPR2016-01332
`U.S. Patent 8,822,438
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`Paper 76 at 13. However, the authenticity of Exhibit 1088, including the date, is
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`supported only by a Mylan lawyer’s description of retrieving it from a website in
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`2017. Ex. 1152 (Beel) ¶ 4.
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`While not apparent on their faces, the supplemental Beel Declaration (Ex.
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`1152 ¶¶ 11, 13) makes clear that Exhibits 1095 and 1117 are also purportedly
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`printouts from a website, and Exhibit 1117 was troublingly altered with an
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`annotation. Petitioners offer Exhibits 1095 and 1117 to prove the website’s
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`contents. Ex. 1097 (McKeague) ¶ 36 (citing Ex. 1095, discussing reported data);
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`Ex. 1104 (Garnick) ¶¶ 56-58 (citing Ex. 1117). But the Beel Declaration only
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`verifies how the printouts were obtained. Accordingly, none of the foregoing
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`exhibits are authenticated.
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`IV. Petitioners’ Hearsay Rebuttal Fails
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` Petitioners state they use Exhibit 1088 to demonstrate what BTG
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`“represented to the public in 2004 . . . .” Paper 76 at 13. Thus the 2004 date of
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`Exhibit 1088 is offered for its truth, and thus is classic hearsay. Exhibit 1088 is not
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`a party admission or a business record because Petitioners failed to lay any
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`foundation for a Rule 801(d)(2) or Rule 803(6) exception relating to BTG’s
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`statements regarding the ’213 patent.
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`V. Conclusion
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`For the foregoing reasons, the Board should grant Patent Owner’s Motion.
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`5
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`IPR2016-01332
`U.S. Patent 8,822,438
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`Dated: May 17, 2017
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`Respectfully submitted,
`
`/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)
`Paul J. Zegger (Reg. No. 33,821)
`Todd L. Krause (Reg. No. 48,860)
`Alyssa B. Monsen (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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`IPR2016-01332
`U.S. Patent 8,822,438
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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 in Support of its Motion to Exclude Evidence Pursuant 37 C.F.R. §
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`42.64(c) was served on counsel of record on May 17, 2017 by filing this document
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`through the End-to-End System, as well as delivering a copy via electronic mail to
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`counsel of record for the Petitioners at the following addresses:
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`Brandon M. White – bmwhite@perkinscoie.com
`Crystal R. Canterbury – ccanterbury@perkinscoie.com
`Bryan D. Beel – bbeel@perkinscoie.com
`Shannon Bloodworth – sbloodworth@perkinscoie.com
`Emily J. Greb – egreb@perkinscoie.com
`Robert D. Swanson – rswanson@perkinscoie.com
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`Samuel S. Park – spark@winston.com
`Ryan B. Hauer – rhauer@winston.com
`Jovial Wong – jwong@winston.com
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`
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`Date: May 17, 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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