Paper No. ___
`
`Date Filed: May 19, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`WOCKHARDT BIO AG,
`
`Petitioner
`
`v.
`
`JANSSEN ONCOLOGY, INC.,
`Patent Owner.
`________________
`
`Case IPR2016-01582
`________________
`
`Patent No. 8,822,438 B2
`
`
`
`PATENT OWNER’S REPLY IN SUPPORT OF ITS
`MOTION TO EXCLUDE EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64(C)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Date Filed: May 19, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`WOCKHARDT BIO AG,
`
`Petitioner
`
`v.
`
`JANSSEN ONCOLOGY, INC.,
`Patent Owner.
`________________
`
`Case IPR2016-01582
`________________
`
`Patent No. 8,822,438 B2
`
`
`
`PATENT OWNER’S REPLY IN SUPPORT OF ITS
`MOTION TO EXCLUDE EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64(C)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`IPR2016-01582
`U.S. Patent 8,822,438
`
`Patent Owner, Janssen Oncology, Inc., submits this Reply in support of its
`
`Motion to Exclude Evidence (Paper 63 (“Mot.”)).1
`
`I.
`
`Petitioner’s Request to Ignore 35 U.S.C. § 311(b) Should Be Rejected
`
`Petitioner does not dispute that the governing statute, § 311(b), clearly and
`
`unambiguously states that petitions may seek cancellation of a claim “only on the
`
`basis of prior art consisting of patents or printed publications.” Nor does Petitioner
`
`dispute that the declaration of its economist Dr. Stoner (Ex. 1077) offers opinions
`
`on “commercial success” as part of the Petition, going beyond “patents or printed
`
`publications.” Petitioner’s arguments do not justify ignoring the statute.
`
`First, Petitioner points out that Patent Owner relied on commercial success
`
`in its Patent Owner’s Response, and that commercial success was an issue in the
`
`’438 patent prosecution history. Paper 66 at 1-2. Neither point has any bearing on
`
`the statutorily prescribed grounds for seeking cancellation in the petition, nor
`
`would Patent Owner’s Motion preclude rebuttal evidence and argument in a reply.
`
`Second, Petitioner argues that exhibits post-dating the ’438 patent should not
`
`be excluded because evidence of commercial success would be expected to post-
`
`date the ’438 patent. Paper 66 at 3. This is just an admission that the Stoner
`
`
`1 Patent Owner withdraws authentication objections to Exhibits 1050, 1077
`
`Attachment B-1, 1114, and 1116. Patent Owner objects to Petitioner’s replacement
`
`exhibits for the same reasons (Ex. 1127 replaces 1112; Ex. 1131 replaces 1070).
`
`1
`
`
`
`IPR2016-01582
`U.S. Patent 8,822,438
`
`Declaration (Ex. 1077) and associated exhibits relate to commercial success, not
`
`“prior art consisting of patents or printed publications,” in violation of § 311(b).
`
`II.
`
`Petitioner’s Uncited Evidence Is Irrelevant and Unfairly Prejudicial
`
`Petitioner does not deny that it failed to cite in its papers any of the evidence
`
`challenged on this ground, or even declarations discussing the evidence. Mot.,
`
`Paper 63 at 6-7. Evidence that is untethered from the papers should be excluded.
`
`Microsoft Corp. v. Parallel Networks Licensing, LLC, IPR2015-00485, Paper 81 at
`
`24 (Aug. 11, 2016). First Quality Baby Prods. v. Kimberly-Clark Worldwide is
`
`inapposite as it addressed a motion to exclude for failure of proof, not a failure to
`
`cite documents in the papers. IPR2014-01023, Paper 56 at 35 (Dec. 10, 2015).2
`
`Whether Petitioner can now articulate any relevance for uncited matter is
`
`immaterial as that explanation belonged in the Petition or the Reply, not at this late
`
`date shortly before the hearing. 37 C.F.R. § 42.104(b)(5). The Board should
`
`exclude Petitioner’s uncited evidence, or at a minimum give it no weight. Id.
`
`III. Petitioner Has Failed to Authenticate the Challenged Exhibits
`
`As explained in Patent Owner’s Motion, a declaration testifying to retrieving
`
`a website printout is insufficient when the website’s contents are offered as proof.
`
`
`2 Ericsson Inc. v. Intellectual Ventures II LLC, IPR2014-00915, Paper 37 at 11
`
`(Dec. 7, 2015), did not address entirely uncited exhibits. The Board should follow
`
`the more recent Microsoft decision and exclude all of Petitioner’s uncited matter.
`
`
`
`2
`
`
`
`IPR2016-01582
`U.S. Patent 8,822,438
`
`Paper 63 at 8-9. Exhibit 1034 is allegedly prior art Taxotere prescribing
`
`information. Ex. 1002 (Godley) at 9, ¶ 102. Dr. Godley’s declaration reflects only
`
`knowledge of a website printout accessed in 2016, not knowledge of the 2004
`
`contents. Ex. 1129 ¶ 4. Similarly, Exhibit 1063 is purportedly a Jevtana website,
`
`and is wrongly treated by Dr. Stoner as prior art when his declarations reflect only
`
`knowledge of a 2016 printout. Ex. 1077 ¶ 47; Ex. 1130 ¶ 10.
`
`Dr. Stoner asserts that Exhibits 1057, 1060, 1061, and 1066-1073 are “copies
`
`of investment reports” from various entities, but offers no testimony regarding how
`
`the exhibits were obtained and relies on another’s testimony from a different IPR.
`
`Ex. 1130 ¶¶ 7-8. Exhibits 1065 and 1074 are also alleged “investment reports” but
`
`Dr. Stoner’s declaration details only knowledge of website printouts. Ex. 1130 ¶¶
`
`7, 9. Exhibit 1080 is allegedly a compilation of IMS data and is summarized in
`
`Exhibit 1077 [B-2]. Dr. Stoner’s declaration provides no indication where the
`
`“compilation” in Exhibit 1080 came from, and he relies on declarations from a
`
`parallel IPR instead of his personal knowledge. Ex. 1130 ¶ 12. Exhibit 1087 is an
`
`alleged 2004 BTG press release, offered as proof of 2004 actions by BTG. Ex.
`
`1103 (Stoner) ¶ 23. Exhibit 1087 is insufficiently described by Dr. Stoner as “a
`
`document” he downloaded from a particular website in 2017. Ex. 1124 ¶¶ 4-5.
`
`Exhibit 1094 is allegedly a 2016 paper by Attard et al. Dr. Godley states, “to
`
`the best of my knowledge the exhibits cited in my initial declaration––including
`
`
`
`3
`
`
`
`IPR2016-01582
`U.S. Patent 8,822,438
`
`Exhibit[] . . . 1094––are true and accurate copies of what they purport to be . . . .”
`
`Ex. 1123 ¶ 4. But Exhibit 1094 was never cited in Dr. Godley’s initial declaration
`
`(Ex. 1002), and when addressing Exhibit 1094 specifically, Dr. Godley meekly
`
`asserts that it is “a true and correct copy of a document” he downloaded from a
`
`website in April 2017. Ex. 1123 ¶ 5 (emphasis added). Similarly, Dr. Stoner
`
`insufficiently describes each of Exhibits 1100 and 1102 as “a document” he
`
`downloaded from locations on certain websites. Ex. 1124 ¶¶ 6-7.
`
`Exhibit 1109 is purportedly a webpage regarding an abiraterone acetate
`
`clinical trial. Exhibit 1109 bears a stamp from another IPR, showing it cannot be a
`
`true copy obtained by Dr. Stoner. Ex. 1124 (Stoner) ¶ 13. Exhibit 1112 is
`
`purportedly EMA Product Information for ZYTIGA®. Ex. 1103 (Stoner) at 4,
`
`¶ 39. Dr. Stoner states that he downloaded the exhibit from another IPR and has
`
`only an “understanding” that a true and correct copy is available online. Ex. 1124
`
`¶ 15. While not obvious on its face, Exhibit 1119 is allegedly a website printout of
`
`a clinical study report, offered to prove its contents. Ex. 1106 (McKeague) ¶ 36. It
`
`is only supported by a lawyer’s description of accessing the website. Ex. 1125
`
`(Kenton) ¶ 6. None of the foregoing exhibits are authenticated.
`
`IV. Petitioner’s Hearsay Rebuttals Have No Merit
`
`Petitioner represents to the Board that all exhibits challenged for hearsay are
`
`solely offered for their effect on a person of ordinary skill, not their truth. Paper 66
`
`
`
`4
`
`
`
`IPR2016-01582
`U.S. Patent 8,822,438
`
`at 10-11. Yet Petitioner admitted that these exhibits relate to the declarations of
`
`Petitioner’s economic expert (id.), who is incompetent to make any proclamations
`
`about what a person of ordinary skill would think. If not excluded as hearsay,
`
`these exhibits should be given no weight because they are useless for their stated
`
`non-truth purpose. Petitioner also argues that Rule 703 allows disclosure of
`
`hearsay relied on by an expert, but fails to address Rule 703’s requirement that
`
`“experts in the particular field would reasonably rely on those kinds of facts or data
`
`in forming an opinion on the subject.” Petitioner thus fails to show Rule 703 is
`
`satisfied, as is required to consider inadmissible hearsay relied on by an expert.
`
`Finally, Petitioner attempts to shoehorn Exhibits 1057, 1060-1061, 1065, and
`
`1067-1073 into the market reports hearsay exception. But Rule 803(17) is
`
`intended for reliable factual documents such as newspaper stock quotes. Fed. R.
`
`Evid. 803, Notes of Advisory Committee. In contrast, these exhibits reflect the
`
`subjective views of analysts, often accompanied by warnings about conflicts of
`
`interest and reliance by the public. E.g., Ex.1057 at 1; Ex. 1060 at 2; Ex. 1061 at
`
`1, 3-4; Ex. 1065 at 8; Ex. 1067 at 1; Ex. 1068 at 1; Ex. 1069 at 1; Ex. 1071 at 1, 4,
`
`6; Ex. 1072 at 1, 5, 7; Ex. 1073 at 1; Ex. 1131 at 1 (replacement for Ex. 1070,
`
`“important disclosures” not included).
`
`V. Conclusion
`
`For the foregoing reasons, the Board should grant Patent Owner’s Motion.
`
`
`
`5
`
`
`
`IPR2016-01582
`U.S. Patent 8,822,438
`
`
`Dated: May 19, 2017
`
`Respectfully Submitted,
`
`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)
`dpritikin@sidley.com
`Bindu Donovan (pro hac vice)
`bdonovan@sidley.com
`Paul Zegger (Reg. No. 33,821)
`pzegger@sidley.com
`Todd Krause (Reg. No. 48,860)
`tkrause@sidley.com
`Alyssa B. Monsen (pro hac vice)
`amonsen@sidleyaustin.com
`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
`
`
`
`6
`
`
`
`
`
`
`
`IPR2016-01582
`U.S. Patent 8,822,438
`
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing Patent
`
`Owner’s Reply in Support of Its Motion to Exclude Evidence Pursuant to 37 C.F.R.
`
`§ 42.64(c) was served on counsel of record on May 19, 2017 by filing this
`
`document through the End-to-End System, as well as delivering a copy via
`
`electronic mail to counsel of record for the Petitioner and Patent Co-Owner at the
`
`following addresses:
`
`Dennies Varughese – dvarughe-PTAB@skgf.com
`Deborah A. Sterling – dsterlin-PTAB@skgf.com
`Lestin L. Kenton Jr. – lkenton-PTAB@skgf.com
`Ralph W. Powers III – tpowers-PTAB@skgf.com
`
`Anthony C. Tridico – anthony.tridico@finnegan.com
`Jennifer H. Roscetti – jennifer.roscetti@finnegan.com
`
`
`
`
`
`
`
`Date: May 19, 2017
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`By: /Dianne B. Elderkin/
`Dianne B. Elderkin
`Registration No. 28,598
`Counsel for Patent Owner
`
`
`
`
`
`7
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
