UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________
`
`APOTEX INC.,
`Petitioner
`
`v.
`
`NOVO NORDISK A/S,
`PATENT OWNER
`_____________________
`
`CASE IPR2024-00631
`U.S. PATENT NO. 10,335,462
`ISSUED: JULY 2, 2019
`
`TITLE:
`USE OF LONG-ACTING GLP-1 PEPTIDES
`
`
`APOTEX’S REPLY TO PATENT OWNER’S OPPOSITION TO
`PETITIONER’S MOTION FOR JOINDER
`
`PROTECTIVE ORDER MATERIAL
`
`
`
`PROTECTIVE ORDER MATERIAL
`
`
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________
`
`APOTEX INC.,
`Petitioner
`
`v.
`
`NOVO NORDISK A/S,
`PATENT OWNER
`_____________________
`
`CASE IPR2024-00631
`U.S. PATENT NO. 10,335,462
`ISSUED: JULY 2, 2019
`
`TITLE:
`USE OF LONG-ACTING GLP-1 PEPTIDES
`
`
`APOTEX’S REPLY TO PATENT OWNER’S OPPOSITION TO
`PETITIONER’S MOTION FOR JOINDER
`
`PROTECTIVE ORDER MATERIAL
`
`
`
`PROTECTIVE ORDER MATERIAL
`
`
`
`Apotex replies to Novo’s opposition to Apotex’s motion for joinder or
`
`alternatively, consolidation. See Paper Nos. 5, 9. As for joinder, Novo principally
`
`contends that Apotex failed to show good cause for its motion and improperly
`
`waited to file it.
`
`
`
`
`
`
`
`
`
`And Novo has shown
`
`no strategic advantage or improper purpose relating to the timing of Apotex’s
`
`filings, because, quite simply, there was none. As for consolidation, Novo oddly
`
`asserts that scheduling issues preclude merging this proceeding with Mylan’s, even
`
`though Apotex will serve as an understudy and follow the Mylan proceeding’s
`
`schedule. Overall, Novo has not disputed that joinder or consolidation would
`
`promote efficient resolution of the cases or identified any prejudice resulting from
`
`either approach. The Board should thus grant Apotex’s motion.
`
`NOVO DOES NOT DISPUTE THAT KYOCERA FAVORS JOINDER
`To begin, Novo does not dispute that the following Kyocera factors favor
`
`joinder: Apotex’s petition presents no new unpatentability grounds, joinder will
`
`not impact the lead case’s schedule, and briefing and discovery may be simplified.
`
`
`PROTECTIVE ORDER MATERIAL
`
`-1-
`
`
`
`Mot. 6-9. Novo even acknowledges that Apotex agreed to essentially the same
`
`conditions that resolved Novo’s opposition to DRL’s and Sun’s motions for joinder
`
`to the Mylan proceeding. Opp. 7-9 n.5. Moreover, Novo has identified no
`
`prejudice that would result from joinder. In sum, the fact that these factors
`
`undisputedly favor Apotex, coupled with the absence of prejudice, compel joinder.
`
`THE BOARD SHOULD WAIVE THE JOINDER TIMING REQUIREMENT
`Novo argues that Petitioner has not shown “special” circumstances to justify
`
`waiving the joinder deadline. Opp. 1-3. But Apotex has shown exactly such
`
`circumstances.
`
`
`1
`
`
`
`PROTECTIVE ORDER MATERIAL
`
`-2-
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`2 In light of these efforts, Novo’s assertion that preparing a copycat petition
`
`“required no substantive work” is unfounded. Opp. 5-6.
`
`3 The “waiting” cases Novo cites are off point. In Roche, petitioner relied upon an
`
`acquisition to explain its delay despite filing its joinder motion over 4 months
`
`after publicly announcing the acquisition. Roche, IPR2015-01091, Paper No. 18,
`
`at 10-11. In Shaw, petitioner strategically waited for a Board rehearing decision
`
`prior to filing its motion. Shaw, IPR2013-00584, Paper No. 20, at 4-5.
`
`
`
`PROTECTIVE ORDER MATERIAL
`
`-3-
`
`
`
`
`
`4
`
`Novo attempts to distinguish GlobalFoundries and Sony, cases in which the
`
`Board waived the filing deadline, on the basis that the petitioners in those cases
`
`attempted to join the earlier IPR proceeding within the filing deadline. Opp. 6-7.
`
`
`
`
`
`. And critically,
`
`Novo ignores the key similarities between those cases and this one, viz., that the
`
`petitions raised no new unpatentability grounds, the trial schedule did not need to
`
`be adjusted, and the petitioners agreed to serve as silent understudies. Id. at 10.
`
`As a throwaway, Novo asserts that Apotex’s motion was unauthorized.
`
`Opp. 1 n.1, 9. But seeking authorization was unnecessary, because Apotex filed its
`
`motion with its petition. See Trial Practice Guidelines at 37 (providing that prior
`
`
`4
`
`
`PROTECTIVE ORDER MATERIAL
`
`-4-
`
`
`
`
`
`
`
`
`
`
`
`authorization is unnecessary for “motions where it is impractical for a party to seek
`
`prior Board authorization,” which include “motions filed with a petition”).
`
`ALTERNATIVELY, CONSOLIDATION IS APPROPRIATE
`Novo first contends, without a shred of support, that Apotex’s motion to
`
`consolidate is “an improper attempt to end-run the joinder deadline without
`
`justification.” Opp. 9. But Novo has provided no evidence of anything improper
`
`in Apotex’s consolidation motion, and the ample justification Apotex has provided
`
`for joinder applies with equal force to consolidation. Moreover, Novo curiously
`
`argues that the schedules of the Apotex and Mylan proceedings are incompatible,
`
`thus precluding consolidation. Id. at 9, 11. But if consolidation were granted,
`
`Apotex has agreed to serve as Mylan’s silent understudy, such that the case will
`
`proceed on the Mylan proceeding’s schedule. Mot. 8, 11. Lastly, Novo weakly
`
`attempts to distinguish Apotex’s Sony and ZTE cases based on the timing of co-
`
`pending joinder motions, institution decisions, and/or consolidation decisions in
`
`those cases. Opp. 10. But these distinctions fail for the same simple reason: there
`
`is no timing requirement for consolidation. Mot. 11. As such, Apotex has
`
`properly availed itself of the consolidation procedure.
`
`For these reasons, and those set forth in Apotex’s motion, Apotex
`
`respectfully requests joinder, or in the alternative, consolidation.
`
`
`PROTECTIVE ORDER MATERIAL
`
`-5-
`
`
`
`Dated: April 15, 2024
`STEPTOE LLP
`1114 Avenue of the Americas
`New York, NY 10036
`Telephone: 212-506-3900
`Fax: 212-506-3950
`Email: Semaglutide@Steptoe.com
`
`Respectfully submitted,
`
`
`
`/John J. Molenda/
`John J. Molenda
`Reg. No. 47,804
`Lead Counsel for Apotex
`
`
`PROTECTIVE ORDER MATERIAL
`
`-6-
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that, in accordance with 37 C.F.R. § 42.6(e) and 37
`
`C.F.R. § 42.105, and with Patent Owner’s consent, electronic service of APOTEX’S
`
`REPLY TO PATENT OWNER’S OPPOSITION TO PETITIONER’S MOTION
`
`FOR JOINDER was made on Patent Owner to the following email addresses:
`
`J. Steven Baughman
`Megan Raymond
`Michael F. Milea
`Joshua Reich
`
`GROOMBRIDGE, WU, BAUGHMAN & STONE LLP
`steve.baughman@groombridgewu.com
`megan.raymond@groombridgewu.com
`mike.milea@groombridgewu.com
`Joshua.reich@groombridgewu.com
`Novo-Semaglutide-IPR@groombridgewu.com
`
`
`
`/s/ John J. Molenda
`John J. Molenda (Reg. No. 47,804)
`Lawrence Kass (Reg. No. 40,671)
`Tyler Doh (Reg. No. 80,274)
`Michael I. Green (Reg. No. 80,436)
`STEPTOE LLP
`1114 Avenue of the Americas
`New York, NY 10036
`Tel: (212) 506-3900
`
`Counsel for Apotex
`
`Dated: April 15, 2024
`
`
`
`
`
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
