Paper No. ____
`Date filed: December 15, 2014
`
`Filed On Behalf Of:
`
`Novartis AG and LTS Lohmann Therapie-Systeme AG
`
`By:
`
`Raymond R. Mandra
`ExelonPatchIPR@fchs.com
`(212) 218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`
`NOVARTIS AG AND LTS LOHMANN THERAPIE-SYSTEME AG,
`Patent Owners
`
`Inter Partes Review No. 2015-00268
`
`U.S. Patent 6,335,031
`
`PATENT OWNERS’ OPPOSITION TO PETITIONER’S
`MOTION FOR JOINDER
`
`
`Date filed: December 15, 2014
`
`Filed On Behalf Of:
`
`Novartis AG and LTS Lohmann Therapie-Systeme AG
`
`By:
`
`Raymond R. Mandra
`ExelonPatchIPR@fchs.com
`(212) 218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`
`NOVARTIS AG AND LTS LOHMANN THERAPIE-SYSTEME AG,
`Patent Owners
`
`Inter Partes Review No. 2015-00268
`
`U.S. Patent 6,335,031
`
`PATENT OWNERS’ OPPOSITION TO PETITIONER’S
`MOTION FOR JOINDER
`
`
`
`Patent Owners Novartis AG and LTS Lohmann Therapie-Systeme AG
`
`(collectively “Novartis”) respectfully oppose the Motion For Joinder (“Motion”)
`
`by Mylan Pharmaceuticals Inc. (“Mylan”) to join this inter partes review
`
`proceeding, IPR 2015-00268, with that brought by Noven Pharmaceuticals Inc.
`
`(“Noven”), Noven Pharmaceuticals Inc. v. Novartis AG and LTS Lohmann
`
`Therapie-Systeme AG, IPR2014-00550 (“the Noven IPR”) on the terms proposed
`
`by Mylan. However, Novartis would not oppose joinder if the Board were to order
`
`that (a) all filings by Mylan in the joined proceeding be consolidated with
`
`Noven’s, unless a filing solely concerns issues that do not involve Noven; (b)
`
`Mylan shall not be permitted to raise any new grounds not already instituted by the
`
`Board in the Noven IPR, or introduce any argument or discovery not already
`
`introduced by Noven; (c) Mylan shall be bound by any agreement between
`
`Novartis and Noven concerning discovery and/or depositions; and (d) Mylan at
`
`deposition shall not receive any direct, cross-examination or redirect time beyond
`
`that permitted for Noven alone under either 37 C.F.R. § 42.53 or any agreement
`
`between Novartis and Noven. As set forth below, Novartis’s requests in this regard
`
`are consistent with the Board’s prior orders on motions for joinder.
`
`I.
`
`THE NOVEN IPR
`
`On April 2, 2014, Noven filed a petition to institute inter partes review of
`
`U.S. Patent No. 6,335,031 (“the ’031 Patent”). Noven Pharmaceuticals Inc. v.
`
`1
`
`
`
`Novartis AG and LTS Lohmann Therapie-Systeme AG, IPR2014-00550 (Apr. 2,
`
`2014) (Paper 1). The Board instituted review of the ’031 Patent on October 14,
`
`2014. Noven Pharmaceuticals, IPR2014-00550 (Oct. 14, 2014) (Paper 10).
`
`Novartis’s response to Noven’s petition is due on January 20, 2015. Noven
`
`Pharmaceuticals, IPR2014-00550 (Nov. 4, 2014) (Paper 16). Novartis and
`
`Noven have stipulated that the cross-examination of Noven’s declarants will occur
`
`no earlier than January 2, 2015. Id.
`
`II.
`
`ARGUMENT
`
`The Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284
`
`(2011) permits joinder of like review proceedings. The Board, acting on behalf of
`
`the Director, has the discretion to join an inter partes review with another inter
`
`partes review when warranted. See 35 U.S.C. § 315(c); 37 C.F.R. § 42.122. The
`
`Board has indicated that it will determine whether to grant joinder on a case-by-
`
`case basis, taking into account the particular facts of each case, substantive and
`
`procedural issues, and other considerations. See 157 CONG. REC. S1376 (daily ed.
`
`Mar. 8, 2011) (statement of Sen. Kyl). In the exercise of this discretion, the Board
`
`should consider that patent trial regulations, including the rules for joinder, must be
`
`construed to secure the just, speedy, and inexpensive resolution of every
`
`proceeding. See 35 U.S.C. § 316(b); 37 C.F.R. § 42.1(b).
`
`2
`
`
`
`As the moving party, Mylan has the burden of proving that it is entitled to
`
`join its IPR to the Noven IPR. 37 C.F.R. §§ 42.20(c), 42.122(b). Mylan’s Motion
`
`for joinder should have: (1) set forth the reasons why joinder is appropriate; (2)
`
`identified any new ground of unpatentability asserted in Mylan’s petition; (3)
`
`explained what impact (if any) joinder would have on the trial schedule for the
`
`Noven IPR; and (4) addressed specifically how briefing and discovery may be
`
`simplified. See Kyocera Corp. v. SoftView LLC, IPR2013-00004 (Apr. 24, 2013)
`
`(Paper 15 at 4). Mylan has failed to meet this burden.
`
`First, Mylan has failed to explain clearly how joinder would simplify
`
`briefing. Although Mylan in its Motion “agree[s] to consolidated filings on the
`
`existing briefing schedule, for which Noven will maintain responsibility” (Motion
`
`at 7), Mylan has provided no assurance that it will refrain from introducing
`
`additional, unconsolidated filings that are not on the existing briefing schedule. If
`
`Mylan is not required to consolidate all of its filings with Noven’s upon joinder,
`
`Mylan potentially may force Novartis and the Board to respond to numerous
`
`additional papers. However, Novartis would not oppose joinder if the Board were
`
`to order that all filings by Mylan in the joined proceeding be consolidated with
`
`Noven’s, unless a filing solely concerns issues that do not involve Noven.
`
`Novartis’s request in this regard is consistent with the Board’s order in SAP
`
`3
`
`
`
`America Inc. v. Clouding IP, LLP, IPR2014-00306 (May 19, 2014) (Paper 13 at 5),
`
`cited by Mylan in support of its motion. (Motion at 8.)
`
`Second, Mylan has failed to explain clearly how joinder would simplify
`
`discovery. For example, although Mylan states that it “does not anticipate the
`
`need for new expert depositions following joinder” (Motion at 6) and does not
`
`“anticipate” that it will introduce new argument or discovery (id.), Mylan has
`
`provided no assurance that it will not, in fact, introduce new experts, argument or
`
`discovery in any joined proceeding. However, Novartis would not oppose joinder
`
`if the Board were to order that (1) Mylan shall not be permitted to introduce any
`
`experts, argument or discovery not already introduced by Noven; (2) Mylan shall
`
`be bound by any agreement between Novartis and Noven concerning discovery
`
`and/or depositions; and (3) Mylan at deposition shall not receive any direct, cross-
`
`examination or redirect time beyond that permitted for Noven alone under either
`
`37 C.F.R. § 42.53 or any agreement between Novartis and Noven. Novartis’s
`
`requested limitation on Mylan’s deposition time is consistent with the Board’s
`
`order in SAP America Inc., IPR2014-00306 (Paper 13 at 6).
`
`Third, Mylan has proposed that in a joined proceeding, Mylan should be
`
`permitted “separate filings” of no more than seven pages directed to points of
`
`disagreement with Noven’s asserted positions in any consolidated filing. (Motion
`
`at 7.) Mylan’s proposal, however, does not give Novartis an opportunity to
`
`4
`
`
`
`respond to these “separate filings.” In the event that the Board permits Mylan such
`
`“separate filings,” which Novartis opposes, Novartis respectfully requests that in
`
`addition to having the opportunity to respond to any consolidated filing, Novartis
`
`should be permitted to respond concurrently to any “separate filing” by Mylan in a
`
`responsive paper of up to seven pages. Novartis’s request in this regard again is
`
`consistent with the Board’s order in SAP America Inc., IPR2014-00306 (Paper 13
`
`at 5).
`
`Finally, although Mylan’s motion represents that “Mylan’s Petition asserts,
`
`verbatim, the arguments that the Board has already instituted in the Noven IPR,”
`
`(Motion at 6), Mylan has not expressly confirmed that it will not create new issues
`
`for the Board and Novartis to address. Furthermore, Mylan’s assertion that “there
`
`are no new arguments for the Board to consider or to which the Patent Owners
`
`need to respond” (Motion at 6) may not be correct. In the Noven IPR, the Board
`
`declined to proceed on ground 1 challenging claim 15 and ground 2 challenging
`
`claims 16 and 18. Noven Pharmaceuticals, IPR2014-00550 (Oct. 14, 2014) (Paper
`
`10 at 26-27). Contrary to Mylan’s assertion that there are no new issues, Mylan
`
`petitioned the Board to institute review of the identical grounds previously rejected
`
`by the Board in the Noven IPR. (Petition at 19-23, 25-31.) Novartis therefore
`
`respectfully requests that the Board expressly prohibit Mylan from raising any new
`
`5
`
`
`
`grounds or arguments beyond those already instituted by the Board in the Noven
`
`IPR. Noven Pharmaceuticals, IPR2014-00550(Oct. 14, 2014) (Paper 10).
`
`III. CONCLUSION
`
`For the foregoing reasons, Novartis opposes Mylan’s Motion to join its inter
`
`partes review proceeding 2015-00268 with Noven’s inter partes review
`
`proceeding 2014-00550.
`
`Respectfully submitted,
`
`Dated: December 15, 2014
`
`/Raymond R. Mandra/
`Raymond R. Mandra
`Registration No. 34,382
`Lead Counsel for Patent Owners
`FITZPATRICK, CELLA, HARPER
`& SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel. 212-218-2100
`
`6
`
`
`
`CERTIFICATE OF SERVICE
`
`I certify that a copy of the Patent Owners’ Opposition To Petitioner’s
`
`Motion For Joinder was served on December 15, 2014 by causing it to be sent by
`
`email to counsel for Petitioner at the following email address:
`
`BoxMylan2@knobbe.com
`
`Dated: December 15, 2014
`
`/Raymond R. Mandra/
`Raymond R. Mandra
`Registration No. 34,382
`FITZPATRICK, CELLA, HARPER
`& SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel. 212-218-2100
`
`FCHS_WS 10948514v2.doc
`
`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
