Trials
`White, Brandon (WDC); Trials
`J. Steven Baughman; Novo-Semaglutide-IPR@groombridgewu.com; Megan Raymond; Tietz, Jonathan (WDC);
`Greb, Emily J. (MSN); Beel, Bryan D. (POR); Lembo, Matthew (NYC); *Semaglutide-Ozempic
`RE: IPR2023-00724 | request for leave to file reply to POPR
`Thursday, August 3, 2023 8:29:17 AM
`
`From:
`To:
`Cc:
`
`Subject:
`Date:
`
`Counsel:
`
`From the Board –
`
`Petitioner’s request for authorization to file a Reply to Patent Owner’s Preliminary Response is
`granted solely to address the specific issues set forth in Petitioner’s e-mail. Patent Owner’s request
`for authorization to file a Sur-reply is also granted.
`
`The Reply and Sur-reply shall be no longer than 5 pages each. The Reply should be filed no later
`than 5 business days after the date of this e-mail. The Sur-reply should be filed no later than 5
`business days after the date the Reply is filed.
`
`No conference call is necessary at this time.
`
`Regards,
`
`Esther Goldschlager
`Supervisory Paralegal Specialist
`Patent Trial & Appeal Board
`U.S. Patent & Trademark Office
`
`From: White, Brandon (WDC) <BMWhite@perkinscoie.com>
`Sent: Tuesday, August 1, 2023 5:17 PM
`To: Trials <Trials@USPTO.GOV>
`Cc: J. Steven Baughman <steve.baughman@groombridgewu.com>; Novo-Semaglutide-
`IPR@groombridgewu.com; Megan Raymond <megan.raymond@groombridgewu.com>; Tietz,
`Jonathan (WDC) <JTietz@perkinscoie.com>; Greb, Emily J. (MSN) <EGreb@perkinscoie.com>; White,
`Brandon (WDC) <BMWhite@perkinscoie.com>; Beel, Bryan D. (POR) <BBeel@perkinscoie.com>;
`Lembo, Matthew (NYC) <MLembo@perkinscoie.com>; *Semaglutide-Ozempic <Semaglutide-
`Ozempic@perkinscoie.com>
`Subject: IPR2023-00724 | request for leave to file reply to POPR
`
`CAUTION: This email has originated from a source outside of USPTO. PLEASE CONSIDER THE SOURCE before
`responding, clicking on links, or opening attachments.
`
`Dear Board,
`
`Pursuant to 37 C.F.R. § 42.108(c), Petitioner Mylan Pharmaceuticals Inc. requests
`authorization to file an eight-page reply to Patent Owner’s Preliminary Response in IPR2023-
`00724. Petitioner has good cause for this request. Petitioner intends to address issues of claim
`
`Exhibit 3001
`
`

`

`construction and discretionary non-institution under §325(d). These issues could have been
`previously addressed
`
`On July 20, 2023, the District Court entered a claim construction order construing, inter alia,
`the preamble of the ’462 patent that is the subject of this proceeding. See In re Ozempic
`(Semaglutide) Patent Litigation, No. MDL No. 22-cv-3038 (D. Del.), ECF No. 148. Petitioner
`contends that arguments regarding the degree of efficacy allegedly required by the claims in
`the POPR are inconsistent with that order and the positions taken by Patent Owner during
`claim construction proceedings. The District Court’s construction could not have been
`previously addressed. Accordingly, good cause exists.
`
`Concerning §325(d), the POPR makes arguments regarding discretionary noninstitution based
`on interpretations of the prosecution history and the prior art that were not previously
`disclosed and could not have been foreseen. Accordingly, good cause exists.
`
`Petitioner proposes to file a reply of no more than eight pages within seven business days of
`an order authorizing the reply.
`
`Petitioner met and conferred with Patent Owner.
`
`Patent Owner Novo Nordisk A/S opposes Petitioner’s requests. To the extent Mylan is
`granted reply briefing, however, Patent Owner Novo requests an equal number of pages in sur-
`reply. As Patent Owner indicated to Petitioner, solely to avoid burdening the Board with a
`dispute, Patent Owner would be agreeable to Petitioner having 3 pages to address issues
`limited to 325(d) if Patent Owner receives a reply of the same length. Petitioner disagrees
`with Petitioner’s assertions about claim construction and Petitioner’s assertions about the
`foreseeability of Patent Owner’s arguments and is prepared to address those arguments on any
`call that the Board may schedule. Pursuant to the Board’s guidance regarding conference
`calls, Patent Owner indicates it is available for a call on Wednesday 10am-3pm, Thursday 3-
`5pm, or Monday 3-5pm or otherwise at the Board's convenience.
`
`If necessary, the Petitioner is available for a call to discuss its request at the Board’s
`convenience.
`
`
`Brandon White | Perkins Coie LLP
`PARTNER
`700 Thirteenth Street, N.W. Suite 600
`Washington, DC 20005-3960
`D. +1.202.654.6206
`F. +1.202.654.9681
`E. BMWhite@perkinscoie.com
`
`
`
`NOTICE: This communication may contain privileged or other confidential information. If you have received it in error, please advise the
`sender by reply email and immediately delete the message and any attachments without copying or disclosing the contents. Thank you.
`
`