Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`
`
`Paper 16
`Entered: October 26, 2016
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`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`JANSSEN ONCOLOGY, INC.,
`Patent Owner.
`____________
`
`Case IPR2016-01332
`Patent 8,822,438 B2
`____________
`
`Before LORA M. GREEN, RAMA G. ELLURU, and
`KRISTINA M. KALAN, Administrative Patent Judges.
`
`KALAN, Administrative Patent Judge.
`
`
`
`ORDER
`Conduct of the Proceeding
`37 C.F.R. § 42.5
`
`
`
`
`

`
`IPR2016-01332
`Patent 8,822,438 B2
`
`
`On October 20, 2016, Petitioner sent an electronic message to the
`Board requesting leave to file a Reply to Patent Owner’s Preliminary
`Response “to allow Petitioner to respond to Patent Owner’s irreconcilable
`positions set forth in Patent Owner’s recent submissions to the Board.”
`Ex. A, 1. According to Petitioner, Patent Owner’s Preliminary Response
`asserts that Petitioner’s Petition is a “copy of” an earlier-filed petition in a
`proceeding involving the same patent. Id. However, according to Petitioner,
`Patent Owner “told the Board the opposite thing in no uncertain terms”
`when opposing Petitioner’s Motion for Joinder. Id. Patent Owner has not
`made us aware of its position on whether Petitioner should be granted leave
`to file a Reply.
`Based on the facts of this case, we are not persuaded that Petitioner
`has shown good cause to file a Reply. See 37 C.F.R. § 42.108(c). As
`indicated by Petitioner, in pointing what it believes to be Patent Owner’s
`inconsistent positions, Patent Owner’s allegedly inconsistent statements are
`already in the record in at least Paper 9 and Paper 14. The Board is capable
`of evaluating the parties’ proposed positions relative to the asserted
`inconsistencies and related issues in this case based on the information
`already in the record.
`
`
`ORDER
`
`
`In view of the foregoing, it is hereby:
`ORDERED that Petitioner’s request to file a Reply to Patent Owner’s
`Preliminary Response is denied.
`
`
`
`

`
`IPR2016-01332
`Patent 8,822,438 B2
`
`FOR PETITIONER:
`
`Brandon M. White
`Crystal Canterbury
`bmwhite@perkinscoie.com
`CCanterbury@perkinscoie.com
`
`FOR PATENT OWNER:
`
`Dianne Elderkin
`delderkin@akingump.com
`Ruben Munoz
`rmunoz@akingump.com
`Barbara Mullin
`bmullin@akingump.com
`
`
`
`
`

`
`EXHIBIT A
`
`EXHIBIT A
`
`IPR2016—01332
`
`IPR2016-01332
`Patent 8,822,438 B2
`Patent 8,822,438 B2
`
`
`
`
`From: White, Brandon {Perkins Coie} [mailto:BMWhite@'perl<inscoie.com]
`Sent: Thursday, October 20, 2016 11:28 AM
`To: Trials <Tria|s@U5PTO.GOV:.v-
`Cc: JAN5—ZYTlGA@akingump.com; 2ytiga|PRTeam@sidle'p'.com; Abiraterone@ perl<inscoie.com; Beel, Bryan D. [Perkins
`Coie] -:BBeel@perkinscoie.com>; Canterbury, Crystal R. {Perkins Coie) <CCanterbury@perkinscoie.oom>
`Subject: Mylan V. Janssen, |PR2{]1Er{]13-32: Request for Reply
`
`Dear Board.
`
`Petitioner respectfully requests leave to file a reply in support of its Petition. As explained
`below. good cause exists as required by 37 C.F.R. § 42.l'U8(c) to allow Petitioner to respond to
`Patent Owner's irreconcilable positions set forth in Patent Owner's recent submissions to the
`Board.
`
`In its prel_irninary response. Patent Owner Janssen Oncology. Inc. asserts that the Board should
`
`not institute Petitioner Mylan Pharmaceuticals lnc.'s [PR because it is a "copy of” and "mere|]
`repetition" of an allegedly identical earlier—filed Amerigen petition. Paper No. 14 at 1-2. Janssen
`further cla_i_1ns that M3rlan's declarant. Dr. Garnick. offers "substantially the same" declaration as
`Dr. Serels (who submitted a declaration in support of Amerigens instituted petition for
`IPR). Id.
`
`However. about two months ago when opposing Mylans motion for jo:i_nder. Janssen told the
`Board the opposite thing in no uncertain terms. At that time. Janssen asserted in relevant part:
`
`1)
`
`2)
`
`3)
`
`"[T]he Mylan [PB petition does not advance ‘identical grounds’ to those
`instituted by the Board i_n Arnerigens IPR." Paper No. 9 at 5 {einphasis
`added).
`
`"Mylan relies on new evidence and new expert testimony not presented in
`the Ainerigen IPR." Id. {emphasis added).
`
`Criticism of Mylan's description of its petition as "congruent" with Ainerigens. Id.
`at 8.
`
`Thus. Janssen argued it would face substantial burden and prejudice if joi_nder were allowed. Id.
`at l. 8. The Board accepted Janssen's arguments. issuing an Order refusing to expedite
`1
`
`
`
`
`
`

`
`IPR2016—01332
`
`IPR2016-01332
`Patent 8,822,438 B2
`Patent 8,822,438 B2
`
`
`Janssen's preliminary response because of "the additional evidence and testimony relied upon by
`[lU.[ylan] in its Petition." Paper No. 11 at 3.
`
`In View of Janssenis about face i_n its preliminary response. Mylan respectfully submits that good
`cause exists to allow Mylan a reply to address (1) Janssen's inconsistent positions. and (2) more
`particularly. Janssen's claim that the Board should deny institution of Mylanis [PR because the
`"sanie or substantially the same prior art or arguments previously [were] presented to the
`Ufliioe." Paper No. 14 at 1. Accordingly. Mylan respectfully requests leave to file a 5—page reply
`within one week of the Board's decision on this request.
`
`Brandon White | Perkins Coie LLP
`PARTNER
`TDCI Thirteenth Street, N.W. Suite BDCI
`‘Washington, DC 2l]DE]5—396D
`D. +1_2D2.65-'vl.E2DE
`F. +1_2lJ2_654.EIEB1
`E. E§MWnite@gerlcinscoie.oom
`
`NOTICE: This communication may contain privileged or oll1er confidential information. If you have received it in en'or, please advise the sender by reply email and
`immediately delete the message and any attachments without copying or disclosing the contents. Thanlt you.