`
`
`
`IPR2019-00400
`Patent 8,633,194
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
`
`APOTEX INC.
`Petitioner,
`
`v.
`
`UCB BIOPHARMA SPRL,
`Patent Owner.
`______________
`
`Case IPR2019-00400
`Patent 8,633,194
`______________
`
`
`PATENT OWNER’S SUR-REPLY PURSUANT TO ORDER [PAPER 15]
`
`
`
`
`
`
`
`
`IPR2019-00400
`Patent 8,633,194
`
`TABLE OF CONTENTS
`
`I.
`II.
`
`INTRODUCTION ......................................................................................... 1
`INSTITUTION SHOULD BE DENIED UNDER § 325(d). ...................... 1
`A.
`Petitioner Fails to Explain How Its Arguments, or Its Prior Art,
`Differs From The Examiner’s Rejections During Prosecution. ............ 1
`The Board Can, and Should, Consider Declarations Submitted During
`Prosecution and the Examiner’s Reliance On Them. ............................ 2
`INSTITUTION SHOULD BE DENIED UNDER § 314(a). ....................... 4
`III.
`IV. PATENT OWNER HAS PREVIEWED ITS SUBSTANTIVE
`ARGUMENTS BUT CAN, AND WILL, FULLY ADDRESS THE
`MERITS IF INSTITUTION IS GRANTED. .............................................. 4
`
`B.
`
`
`
`
`
`
`
`-i-
`
`
`
`
`
`
`
`TABLE OF AUTHORITIES
`
`IPR2019-00400
`Patent 8,633,194
`
` Page(s)
`
`Cases
`Actavis LLC v. Abraxis Bioscience LLC,
`IPR2017-01103, Paper 7 (PTAB Oct. 10, 2017) .................................................. 3
`Apotex Inc. v. Celgene Corp.,
`IPR2018-00685, Paper 8 (PTAB Sept. 27, 2018) ................................................. 3
`Hologic, Inc. v. Biomérieux, Inc.,
`IPR2018-00567, Paper 9 (PTAB Aug. 4, 2018) ................................................... 3
`Intel Corp. v. Godo Kaisha IP Bridge 1,
`IPR2018-00753, Paper 11 (PTAB Oct. 9, 2018) .................................................. 2
`
`Koios Pharms. LLC v. medac Gesellschaft für klinische Spezialpräparate
`mbH,
`IPR2016-01370, Paper 13 (PTAB Feb. 8, 2017) .................................................. 3
`Quanergy Systems, Inc. v. Velodyne Lidar, Inc.,
`IPR2018-00256, Paper 14 (PTAB May 25, 2018) ............................................... 3
`Valve Corp. v. Electronic Scripting Products, Inc.,
`IPR2019-00062, Paper 11 (PTAB Apr. 2, 2019) ................................................. 4
`Statutes
`35 U.S.C. § 314(a) ..................................................................................................... 4
`35 U.S.C. § 325(d) ..................................................................................................... 1
`Other Authorities
`Patent Trial and Appeal Board, Trial Practice Guide Update (August 2018) .......... 1
`U.S. Patent No. 8,633,194 ...................................................................................... 1, 3
`
`
`-ii-
`
`
`
`
`
`I.
`
`
`
`IPR2019-00400
`Patent 8,633,194
`
`INTRODUCTION
`Section 325(d) empowers the Board to decline institution when “the same or
`
`substantially the same prior art or arguments were presented previously.” See
`
`Patent Trial and Appeal Board, Trial Practice Guide Update (August 2018) at 11
`
`(emphasis added). The Board should exercise such discretion here given Petitioner’s
`
`decision to ignore the prosecution of U.S. Patent No. 8,633,194. The POPR
`
`explained how the Petition repeated substantially the same arguments raised in
`
`prosecution rejections, albeit based on art the Examiner only “considered” and did
`
`not “discuss,” yet made no attempt to address the Examiner’s reasons for
`
`withdrawing these rejections, including his consideration of an inventor declaration.
`
`Petitioner’s Reply fails to cure these defects and the Board should deny institution.
`
`II.
`
`INSTITUTION SHOULD BE DENIED UNDER § 325(d).
`A.
`Petitioner Fails to Explain How Its Arguments, or Its Prior Art,
`Differs From The Examiner’s Rejections During Prosecution.
`Petitioner spends nearly half of its Reply trying to prove that its references are
`
`not cumulative to the Examiner’s prior art. See Reply at 2-7. This distinction misses
`
`the mark and improperly attempts to reduce the first four Becton Dickinson factors
`
`to the single question of whether the art is cumulative.
`
`Petitioner’s argument centers around distinguishing prior art “discussed”
`
`during prosecution from prior art that is merely “considered.” Reply at 2. To the
`
`extent such a distinction matters for these purposes, it merely affects the weight
`
`-1-
`
`
`
`IPR2019-00400
`Patent 8,633,194
`attributed to the prosecution discussion or consideration, as the Board has previously
`
`
`
`exercised its discretion not to institute solely because prior art references were
`
`similarly only “considered”. POPR at 9 citing Neil Ziegmann, N.P.Z., Inc. v.
`
`Stephens, IPR2015-01860, Paper 11 at 7, 9-10 (PTAB Feb. 24, 2016).
`
`Moreover, consistent with multiple of the Becton Dickinson factors, the
`
`underlying reasons why the references were discussed during prosecution should
`
`also be considered. See, e.g., Intel Corp. v. Godo Kaisha IP Bridge 1, IPR2018-
`
`00753, Paper 11 at 14-15, 18-20 (PTAB Oct. 9, 2018). Patent Owner spent nearly
`
`half of its petition comparing these reasons (see POPR at 8-12, 13-22), yet Petitioner
`
`provides no meaningful response to this detailed explanation at all.
`
`B.
`
`The Board Can, and Should, Consider Declarations Submitted
`During Prosecution and the Examiner’s Reliance On Them.
`In an attempt to explain away its decision to ignore the Examiner’s reasons
`
`for allowing the claims, and reliance on an inventor declaration in so doing, (see
`
`POPR at 22-25), Petitioner makes no attempt to address the issues on the merits and,
`
`instead, conjures two new PTAB rules. See Reply at 7-8. There is no precedent for
`
`these rules and they should not be adopted now. Moreover, institution should be
`
`denied because Petitioner still has not distinguished or explained how it can
`
`overcome the inventor declaration evidence that the Examiner considered and found
`
`fatal to the same arguments Petitioner presents now. See POPR at 22-23.
`
`First, Petitioner attempts to persuade the Board it need not consider
`
`-2-
`
`
`
`IPR2019-00400
`Patent 8,633,194
`unexpected results until after institution. See Reply at 7 (citing Koios Pharms. LLC
`
`
`
`v. medac Gesellschaft für klinische Spezialpräparate mbH, IPR2016-01370, Paper
`
`13 (PTAB Feb. 8, 2017) and Quanergy Systems, Inc. v. Velodyne Lidar, Inc.,
`
`IPR2018-00256, Paper 14 (PTAB May 25, 2018)). Neither Koios nor Quanergy
`
`have any bearing here. In both, the Board was considering evidence presented for
`
`the first time in Patent Owner’s Preliminary Response. See Koios Pharms., Paper
`
`11 at 35-36 (PTAB Nov. 10, 2016); Quanergy Systems, Inc., Paper 10 at 39-59
`
`(PTAB Mar. 7, 2018). Here, Patent Owner points only to evidence submitted during
`
`prosecution of the ’194 patent, a record fully available to Petitioner, and that
`
`Petitioner should have addressed in its Petition. See POPR at 22-25.
`
`Second, Patent Owner relies on a single sentence of dicta for the proposition
`
`that prosecution declarations need not be considered, while ignoring the more recent
`
`decisions cited in Patent Owner’s POPR on the same issue. Compare Reply at 7-8
`
`citing Actavis LLC v. Abraxis Bioscience LLC, IPR2017-01103, Paper 7 at 8, 35
`
`(PTAB Oct. 10, 2017) with POPR at 24-25 citing Apotex Inc. v. Celgene Corp.,
`
`IPR2018-00685, Paper 8 at 17-18, 24-26 (PTAB Sept. 27, 2018) and Hologic, Inc.
`
`v. Biomérieux, Inc., IPR2018-00567, Paper 9 at 23-26 (PTAB Aug. 4, 2018). As
`
`Apotex and Hologic explain, Petitioner must sufficiently point out how the Examiner
`
`erred in relying on a declaration. See Apotex at 26; Hologic at 24. Conversely, at
`
`most, Actavis makes the unremarkable statement that lack of cross-examination
`
`-3-
`
`
`
`IPR2019-00400
`Patent 8,633,194
`should be considered in assessing the weight of testimonial evidence.
`
`
`
`III.
`
` INSTITUTION SHOULD BE DENIED UNDER § 314(a).
`Petitioner dismisses the applicability of section 314(a) because “[t]he instant
`
`petition is not a follow-on petition.” Reply at 10. As this Board recently confirmed
`
`in a “precedential” decision, the General Plastics factors are not limited to instances
`
`when multiple petitions are filed by the same petitioner. Valve Corp. v. Electronic
`
`Scripting Products, Inc., IPR2019-00062, Paper 11 (PTAB Apr. 2, 2019). Patent
`
`Owner’s analysis cannot be so simply dismissed, and there is no reason Petitioner’s
`
`strategic and prejudicial use of district court litigation should not be considered. See
`
`POPR at 27-33. For the reasons explained in the POPR, institution should be denied.
`
`IV. PATENT OWNER HAS PREVIEWED ITS SUBSTANTIVE
`ARGUMENTS BUT CAN, AND WILL, FULLY ADDRESS THE
`MERITS IF INSTITUTION IS GRANTED.
`From the outset of its Reply, Petitioner tries to fault Patent Owner for
`
`supposedly not addressing the merits of Petitioner’s arguments. See, e.g., Reply at
`
`1. This argument is not only irrelevant, as Petitioner acknowledges that Patent
`
`Owner may wait to address the merits if IPR is ever instituted (Reply at 7), but also
`
`inaccurate. While the merits were not central to Patent Owner’s POPR, Patent
`
`Owner did in fact raise multiple merits-focused arguments. See POPR at 19-24. In
`
`its Reply, Petitioner does not attempt to cure any of these fatal defects from its
`
`Petition and thus provides another reason the Board should deny its Petition.
`
`-4-
`
`
`
`Dated: May 21, 2019
`
`
`
`
`
`
`
`
`
`IPR2019-00400
`Patent 8,633,194
`
`Respectfully submitted,
`
`/s/ James S. Trainor (Electronically signed)
`James S. Trainor, Reg. No. 52,297
`Lead Counsel
`
`Robert E. Counihan, Reg. No. 61,382
`Back-Up Counsel
`
`Fenwick & West LLP
`902 Broadway, Suite 14
`New York, NY 10010
`(212) 921-2001
`jtrainor@fenwick.com
`rcounihan@fenwick.com
`
`Erica R. Sutter, Reg. No. 77,450
`801 California Street
`Mountain View, CA 94041
`(650) 988-8500
`esutter@fenwick.com
`
`
`Counsel for Patent Owner UCB Biopharma
`Sprl
`
`
`
`-5-
`
`
`
`
`
`IPR2019-00400
`Patent 8,633,194
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e), I hereby certify that on May 21, 2019, the
`
`foregoing document is being served by filing this document through the Patent Trial
`
`and Appeal Board End to End System, as well as by delivering a copy via electronic
`
`mail upon the following counsel of record for the Petitioner:
`
`
`
`
`
`
`
`
`
`jitty.malik@kattenlaw.com
`alissa.pacchioli@kattenlaw.com
`joe.janusz@kattenlaw.com
`lance.soderstrom@kattenlaw.com
`
`
`Date: May 21, 2019
`
`
`Respectfully submitted,
`
`/s/ James S. Trainor (Electronically signed)
`James S. Trainor
`Reg. No. 52,297
`Phone: (212) 921-2001
`
`-6-
`
`
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
