From:
`To:
`Cc:
`
`Subject:
`Date:
`
`Sodikoff, Brian
`Wong, Jovial; J. Steven Baughman; Ferenc, Christopher B.; White, Brandon (Perkins Coie)
`White-ptab@perkinscoie.com; Beel, Bryan D. (Perkins Coie); Greb-ptab@perkinscoie.com; prochnow-
`ptab@perkinscoie.com; jones-ptab@perkinscoie.com; tietz-ptab@perkinscoie.com; lembo-ptab@perkinscoie.com;
`Bloodworth, Shannon (Perkins Coie); kelley_nathan-ptab@perkinscoie.com; RSwartz@perkinscoie.com;
`Semaglutide-Ozempic@perkinscoie.com; Border, Scott; Lin, Sharon; Novo-Semaglutide-
`IPR@groombridgewu.com; Anstaett, David L. (Perkins Coie)
`RE: IPR2023-00724 - Service of draft proposed motion for sanctions
`Monday, July 8, 2024 4:07:06 PM
`
`Counsel,
`
`As promised, we write to follow up on our email of Friday July 5 on the issue of discovery on Sun.
` Sun’s position echoes that of DRL, provided below. The only authority you have cited to, and
`generally at that, is the Garmin case and enunciated factors. The questions you provided as an
`alternative to document discovery are appreciated. But, none of the Garmin factors (alone or in
`combination) support seeking the requested discovery (or any discovery relating to Patent Owner’s
`sanctions motion) from Sun.
`
`As such, Sun declines to provide any additional discovery to Patent Owner and will oppose any
`efforts by Novo to seek the same.
`
`Regards,
`
`Brian
`
`Brian Sodikoff
`Partner, Co-Chair, Patent Litigation
`Katten
`Katten Muchin Rosenman LLP
`525 W. Monroe Street | Chicago, IL 60661-3693
`direct +1.312.902.5462
`brian.sodikoff@katten.com | katten.com
`
`From: Wong, Jovial <JWong@winston.com>
`Sent: Monday, July 8, 2024 12:52 PM
`To: J. Steven Baughman <steve.baughman@groombridgewu.com>; Ferenc, Christopher B.
`<christopher.ferenc@katten.com>; White, Brandon (Perkins Coie) <BMWhite@perkinscoie.com>
`Cc: White-ptab@perkinscoie.com; Beel, Bryan D. (Perkins Coie) <BBeel@perkinscoie.com>; Greb-
`ptab@perkinscoie.com; prochnow-ptab@perkinscoie.com; jones-ptab@perkinscoie.com; tietz-
`ptab@perkinscoie.com; lembo-ptab@perkinscoie.com; Bloodworth, Shannon (Perkins Coie)
`<SBloodworth@perkinscoie.com>; kelley_nathan-ptab@perkinscoie.com;
`RSwartz@perkinscoie.com; Semaglutide-Ozempic@perkinscoie.com; Border, Scott
`<SBorder@winston.com>; Lin, Sharon <SLin@winston.com>; Sodikoff, Brian
`<brian.sodikoff@katten.com>; Novo-Semaglutide-IPR@groombridgewu.com; Anstaett, David L.
`(Perkins Coie) <DAnstaett@perkinscoie.com>
`Subject: RE: IPR2023-00724 - Service of draft proposed motion for sanctions
`
`
`Novo Nordisk Exhibit 2653
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`

`

`EXTERNAL EMAIL – EXERCISE CAUTION
`Counsel,
`
`As discussed on our meet and confers, DRL continues to believe that Novo’s requested
`discovery of DRL (including the documents and questions identified below) would be
`improper, overbroad and duplicative, and unduly burdensome, especially given Novo’s
`proposed motion for sanctions is directed only at alleged conduct by Mylan and not DRL. To
`date, Novo has also not identified any authority supporting the discovery that it seeks of DRL.
`
`As such, DRL opposes Novo’s requested discovery should it raise the issue and seek relief
`from the Board. We will send our edits to the draft email shortly.
`
`Regards,
`Jovial
`
`
`Jovial Wong
`Partner
`Winston & Strawn LLP
`1901 L Street, N.W.
`Washington, D.C. 20036-3506
`D: +1 202-282-5867
`M: +1 202-352-5509
`Bio | VCard | Email | winston.com
`
`
`From: J. Steven Baughman <steve.baughman@groombridgewu.com>
`Sent: Friday, July 5, 2024 10:13 AM
`To: Ferenc, Christopher B. <christopher.ferenc@katten.com>; White, Brandon (Perkins Coie)
`<BMWhite@perkinscoie.com>
`Cc: White-ptab@perkinscoie.com; Beel, Bryan D. (Perkins Coie) <BBeel@perkinscoie.com>; Greb-
`ptab@perkinscoie.com; prochnow-ptab@perkinscoie.com; jones-ptab@perkinscoie.com; tietz-
`ptab@perkinscoie.com; lembo-ptab@perkinscoie.com; Bloodworth, Shannon (Perkins Coie)
`<SBloodworth@perkinscoie.com>; kelley_nathan-ptab@perkinscoie.com;
`RSwartz@perkinscoie.com; Semaglutide-Ozempic@perkinscoie.com; Wong, Jovial
`<JWong@winston.com>; Border, Scott <SBorder@winston.com>; Lin, Sharon <SLin@winston.com>;
`Sodikoff, Brian <brian.sodikoff@katten.com>; Novo-Semaglutide-IPR@groombridgewu.com;
`Anstaett, David L. (Perkins Coie) <DAnstaett@perkinscoie.com>
`Subject: RE: IPR2023-00724 - Service of draft proposed motion for sanctions
`
`
`Following up on our Wednesday call, we understand counsel for Sun and DRL may be open to the possibility of agreeing to narrow our discovery disputes—and, in particular, may be open to the possibility of Sun and/or DRL answering an agreed set of questions in a way that can be pre ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌ ‌
`
`
`Following up on our Wednesday call, we understand counsel for Sun and DRL may be open to
`the possibility of agreeing to narrow our discovery disputes—and, in particular, may be open to
`
`Novo Nordisk Exhibit 2653
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
`
`

`

`the possibility of Sun and/or DRL answering an agreed set of questions in a way that can be
`presented to the Board as a factual representation from such petitioner, in exchange for
`Patent Owner’s agreement to defer seeking the document discovery of that petitioner that we
`previously identified (in our requests concerning all petitioners) until after Patent Owner has
`sought equivalent discovery from Mylan and determined what further discovery, if any, might
`then be needed. During our call, Mylan’s counsel confirmed Mylan’s position that it will not
`agree to any discovery of any kind, so (as indicated in our draft email to the Board) Patent
`Owner will be pursuing discovery before the Board as to at least Mylan (and, absent
`agreement, as to Sun and DRL, as well).
`
`As I stated in our June 14 meet and confer, the discovery requests we are pursuing are limited
`to the ‘462 patent, and here are those original requests with revisions in red to reflect that
`limitation explicitly:
`
`
`1. All documents consisting of or reflecting communications (including
`without limitation any actual or potential agreements, drafts, or other
`documents communicated) between or among Mylan and any other
`litigation co-defendant about the actual or potential retention of Mylan's
`IPR experts, Drs. William Jusko, John Bantle and/or Paul Dalby, by any of
`the co-defendants other than Mylan in the parallel Delaware litigation, In
`re: Ozempic (Semaglutide) Patent Litigation, No. 1:22-cv-01040-CFC (D.
`Del.), in connection with the ‘462 patent. To the extent you assert any
`such documents are privileged, please provide a privilege log
`substantiating the basis for your assertion.
`
`
`
`2. All documents reflecting any communications (including without
`limitation any drafts or other documents communicated) between or
`among any litigation co-defendant and any of Mylan's IPR experts Drs.
`William Jusko, John Bantle and/or Paul Dalby, relating to or reflecting any
`direction, instruction, or consultation of such expert(s) in connection with
`arguments that claims 1-3 of the ‘462 patent are invalid as anticipated by
`WO ‘421, that claims 1-3 of the ‘462 patent invalid as anticipated by
`Lovshin 2009, and/or that claims 1-10 are invalid as obvious over WO ‘537
`in view of Lovshin 2009 (“the repeated ‘462 arguments”) in the parallel
`Delaware litigation. To the extent you assert any such documents are
`privileged, please provide a privilege log substantiating the basis for your
`assertion.
`
`
`
`Novo Nordisk Exhibit 2653
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`

`

`3. All documents and things relating to or reflecting the retention and
`payment of Mylan's IPR experts, Drs. William Jusko, John Bantle and/or
`Paul Dalby, in connection with the repeated ‘462 arguments in the parallel
`Delaware litigation, including without limitation all actual or draft retention
`agreements, invoices, and payment confirmations. To the extent you
`assert any such documents are privileged, please provide a privilege log
`substantiating the basis for your assertion.
`
`
`Per Brian’s inquiry on behalf of Sun, given Mylan’s refusal to give any meaningful response
`regarding its conduct at any time following institution we do not have in mind a workable
`temporal limitation in connection with these requests (although if you propose one we would
`be open to considering it).
`
`Patent Owner proposes the following set of factual questions as a possible basis for narrowing
`Patent Owner’s discovery disputes as to the Sun petitioner and the DRL petitioner (each of
`which, together with its employees, counsel, and other representatives and agents, would be
`“petitioner” as used in the questions below).
`
`
`1. Retention of Experts. Separately, for each of Dr. Bantle, Dr. Jusko, and Dr. Dalby
`(each, “the expert”):
`a. When did petitioner retain the expert for purposes of the ‘462 patent in the
`parallel district court action (In re Ozempic (Semaglutide) Patent Litigation,
`No. 1:22-cv-01040-CFC (D.Del.) (“the Delaware district court action”))?
`b. When did petitioner first discuss with Mylan the possibility of petitioner
`retaining the expert for purposes of the ‘462 patent in the Delaware district
`court action, and when did Mylan agree to share the expert with petitioner for
`this purpose?
`2. Direction of Experts. Separately, for each of Dr. Bantle, Dr. Jusko, and Dr. Dalby
`(each, “the expert”):
`a. Did petitioner have any role in directing the expert’s work relating to
`arguments that claims 1-3 of the ‘462 patent are invalid as anticipated by
`WO ‘421, that claims 1-3 of the ‘462 patent are invalid as anticipated by
`Lovshin 2009, and/or that claims 1-10 are invalid as obvious over WO ‘537 in
`view of Lovshin 2009 (“the ‘462 arguments”) in connection with the expert’s
`report served on March 19, 2024 (“March 19 report”)? If so, what role?
`b. Does petitioner know whether Mylan had any role in directing the expert’s
`work relating to the ‘462 arguments in connection with the expert’s March 19
`report? If so, did Mylan have any such role and, if yes, what role?
`c. [Please answer separately for (1), (2), and (3)] Did petitioner take any part in
`(1) drafting, (2) revising, and/or (3) reviewing any portion of the expert’s
`March 19 report (or any draft thereof) relating to the ‘462 arguments?
`d. [Please answer separately for (1), (2), and (3)] Does petitioner know whether
`Mylan took any part in (1) drafting, (2) revising, and/or (3) reviewing any
`portion of the expert’s March 19 report (or any draft thereof) relating to the
`‘462 arguments? If so, did Mylan take part in (1), (2), and/or (3)?
`
`Novo Nordisk Exhibit 2653
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
`
`

`

`e. To petitioner’s knowledge, has Mylan ever specified that it will not interact
`with the expert concerning portions of his work in the Delaware district court
`action having to do with the ‘462 arguments? If so, when?
`3. Compensation of Experts. Separately, for each of Dr. Bantle, Dr. Jusko, and Dr.
`Dalby (each, “the expert”):
`a. [Please answer separately for (1) and (2)] Has petitioner paid the expert for
`work in connection with (1) IPR2023-00724, and/or (2) the ‘462 arguments in
`the Delaware district court action? How are expenses for the expert in
`connection with the ‘462 arguments in the Delaware district court action
`shared, if at all, among the codefendants?
`b. To petitioner’s knowledge, did Mylan specify that it was not compensating
`the expert for portions of the March 19 report having to do with the ‘462
`arguments?
`c. To petitioner’s knowledge, has Mylan ever specified that it will not
`compensate the expert for portions of his work in the Delaware district court
`action having to do with the ‘462 arguments? If so, when?
`
`
`Please let us know if Sun and/or DRL would be amenable to answering this set of questions
`(or, if you have a counterproposal, some other set you identify) as the basis for a possible
`agreement. If so, we are open to discussing on Monday afternoon. Absent agreement, we will
`pursue the needed discovery before the Board as previously stated.
`
`Best regards,
`Steve
`
`
`
`J. Steven Baughman
`Groombridge, Wu, Baughman & Stone LLP
`O +1 202-505-5832, M +1 617-378-5548
`steve.baughman@groombridgewu.com
`
`From: Ferenc, Christopher B. <christopher.ferenc@katten.com>
`Sent: Tuesday, July 2, 2024 3:14 PM
`To: J. Steven Baughman <steve.baughman@groombridgewu.com>; White, Brandon (Perkins Coie)
`<BMWhite@perkinscoie.com>
`Cc: White-ptab@perkinscoie.com; Beel, Bryan D. (Perkins Coie) <BBeel@perkinscoie.com>; Greb-
`ptab@perkinscoie.com; prochnow-ptab@perkinscoie.com; jones-ptab@perkinscoie.com; tietz-
`ptab@perkinscoie.com; lembo-ptab@perkinscoie.com; Bloodworth, Shannon (Perkins Coie)
`<SBloodworth@perkinscoie.com>; kelley_nathan-ptab@perkinscoie.com;
`RSwartz@perkinscoie.com; Semaglutide-Ozempic@perkinscoie.com; Wong, Jovial
`(jwong@winston.com) <jwong@winston.com>; Border, Scott <SBorder@winston.com>;
`slin@winston.com; Sodikoff, Brian <brian.sodikoff@katten.com>; Novo-Semaglutide-
`IPR@groombridgewu.com; Anstaett, David L. (Perkins Coie) <DAnstaett@perkinscoie.com>
`Subject: RE: IPR2023-00724 - Service of draft proposed motion for sanctions
`
`
`Novo Nordisk Exhibit 2653
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00005
`
`

`

`Steve,
`
`That time works for petitioners. Please circulate a dial-in.
`
`Best,
`Chris
`
`Christopher B. Ferenc
`Partner
`Katten
`Katten Muchin Rosenman LLP
`1919 Pennsylvania Ave., NW., Suite 800 | Washington, DC 20006
`direct +1.202.625.3647
`christopher.ferenc@katten.com | katten.com
`
`From: J. Steven Baughman <steve.baughman@groombridgewu.com>
`Sent: Tuesday, July 2, 2024 2:54 PM
`To: Ferenc, Christopher B. <christopher.ferenc@katten.com>; White, Brandon (Perkins Coie)
`<BMWhite@perkinscoie.com>
`Cc: White-ptab@perkinscoie.com; Beel, Bryan D. (Perkins Coie) <BBeel@perkinscoie.com>; Greb-
`ptab@perkinscoie.com; prochnow-ptab@perkinscoie.com; jones-ptab@perkinscoie.com; tietz-
`ptab@perkinscoie.com; lembo-ptab@perkinscoie.com; Bloodworth, Shannon (Perkins Coie)
`<SBloodworth@perkinscoie.com>; kelley_nathan-ptab@perkinscoie.com;
`RSwartz@perkinscoie.com; Semaglutide-Ozempic@perkinscoie.com; Wong, Jovial
`(jwong@winston.com) <jwong@winston.com>; Border, Scott <SBorder@winston.com>;
`slin@winston.com; Sodikoff, Brian <brian.sodikoff@katten.com>; Novo-Semaglutide-
`IPR@groombridgewu.com; Anstaett, David L. (Perkins Coie) <DAnstaett@perkinscoie.com>
`Subject: Re: IPR2023-00724 - Service of draft proposed motion for sanctions
`
`EXTERNAL EMAIL – EXERCISE CAUTION
`Thanks, Chris-
`
`We can talk at 4pm tomorrow ET; if that works I can circulate a link.
`
`Best,
`Steve
`
`J. Steven Baughman
`Groombridge, Wu, Baughman & Stone LLP
`801 17th Street, NW, Suite 1050
`Washington, DC 20006
`O +1 202-505-5832, M +1 617-378-5548
`steve.baughman@groombridgewu.com
`Pronouns: he/his
`
`
`From: Ferenc, Christopher B. <christopher.ferenc@katten.com>
`
`Novo Nordisk Exhibit 2653
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00006
`
`

`

`Sent: Tuesday, July 2, 2024 12:15:53 PM
`To: J. Steven Baughman <steve.baughman@groombridgewu.com>; White, Brandon (Perkins Coie)
`<BMWhite@perkinscoie.com>
`Cc: White-ptab@perkinscoie.com <White-ptab@perkinscoie.com>; Beel, Bryan D. (Perkins Coie)
`<BBeel@perkinscoie.com>; Greb-ptab@perkinscoie.com <Greb-ptab@perkinscoie.com>; prochnow-
`ptab@perkinscoie.com <prochnow-ptab@perkinscoie.com>; jones-ptab@perkinscoie.com <jones-
`ptab@perkinscoie.com>; tietz-ptab@perkinscoie.com <tietz-ptab@perkinscoie.com>; lembo-
`ptab@perkinscoie.com <lembo-ptab@perkinscoie.com>; Bloodworth, Shannon (Perkins Coie)
`<SBloodworth@perkinscoie.com>; kelley_nathan-ptab@perkinscoie.com <kelley_nathan-
`ptab@perkinscoie.com>; RSwartz@perkinscoie.com <RSwartz@perkinscoie.com>; Semaglutide-
`Ozempic@perkinscoie.com <Semaglutide-Ozempic@perkinscoie.com>; Wong, Jovial
`(jwong@winston.com) <jwong@winston.com>; Border, Scott <SBorder@winston.com>;
`slin@winston.com <slin@winston.com>; Sodikoff, Brian <brian.sodikoff@katten.com>; Novo-
`Semaglutide-IPR@groombridgewu.com <Novo-Semaglutide-IPR@groombridgewu.com>; Anstaett,
`David L. (Perkins Coie) <DAnstaett@perkinscoie.com>
`Subject: RE: IPR2023-00724 - Service of draft proposed motion for sanctions
`
`Steve,
`
`Counsel for DRL and Sun are available for a call tomorrow to discuss the e-mail below. Please suggest
`some times that work on your end.
`
`Best,
`Chris
`
`Christopher B. Ferenc
`Partner
`Katten
`Katten Muchin Rosenman LLP
`1919 Pennsylvania Ave., NW., Suite 800 | Washington, DC 20006
`direct +1.202.625.3647
`christopher.ferenc@katten.com | katten.com
`
`From: J. Steven Baughman <steve.baughman@groombridgewu.com>
`Sent: Monday, July 1, 2024 3:58 PM
`To: White, Brandon (Perkins Coie) <BMWhite@perkinscoie.com>
`Cc: White-ptab@perkinscoie.com; Beel, Bryan D. (Perkins Coie) <BBeel@perkinscoie.com>; Greb-
`ptab@perkinscoie.com; prochnow-ptab@perkinscoie.com; jones-ptab@perkinscoie.com; tietz-
`ptab@perkinscoie.com; lembo-ptab@perkinscoie.com; Bloodworth, Shannon (Perkins Coie)
`<SBloodworth@perkinscoie.com>; kelley_nathan-ptab@perkinscoie.com;
`RSwartz@perkinscoie.com; Semaglutide-Ozempic@perkinscoie.com; Wong, Jovial
`(jwong@winston.com) <jwong@winston.com>; Border, Scott <SBorder@winston.com>;
`slin@winston.com; Sodikoff, Brian <brian.sodikoff@katten.com>; Ferenc, Christopher B.
`<christopher.ferenc@katten.com>; Novo-Semaglutide-IPR@groombridgewu.com; Anstaett, David L.
`(Perkins Coie) <DAnstaett@perkinscoie.com>
`Subject: RE: IPR2023-00724 - Service of draft proposed motion for sanctions
`
`Novo Nordisk Exhibit 2653
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00007
`
`

`

`
`EXTERNAL EMAIL – EXERCISE CAUTION
`Counsel,
`
`Please find below our draft email to the Board requesting a call to authorize a motion for
`sanctions and a motion for additional discovery. Could you please confirm your
`availability for a call with the Board next Thursday and Friday, July 10 and 11, and
`Monday, July 15? Given the holiday on Thursday, we intend to write to the Board on
`Monday, July 8.
`
`We have not heard from you on this topic since our email last Tuesday and assume
`Petitioner's positions remain the same, including regarding Petitioner's refusal to answer
`our questions below or to provide any discovery.
`
`Regarding counsel for Sun's query about the possibility of deferring potentially
`overlapping discovery as to the joining petitioners (and without waiver of or prejudice to
`Petitioner's position that, per the representations of Sun and DRL in connection with
`joinder, Patent Owner is entitled to rely on the positions of Petitioner Mylan on behalf of
`all joined petitioners), Patent Owner is open to further discussion in advance of the call
`with the Board to try to narrow this aspect of the dispute. If Sun and/or DRL may be open
`to answering some basic questions about participation in the March 2024 expert reports
`as a possible basis for deferring aspects of Patent Owner's discovery requests as to Sun
`and DRL, please let us know and we are happy to arrange a discussion.
`
`Best regards,
`Steve
`
`
`--DRAFT
`
`Patent Owner respectfully requests a call with the Board to seek permission to file a
`motion for sanctions, pursuant to Rule 42.12, based on Petitioner Mylan's violation of its
`promise to the Board and Patent Owner that, upon institution, Mylan "will not pursue in
`the district court any instituted grounds against the originally-issued claims" (Pet. 66), by
`actively litigating three instituted grounds in district court--including in three expert
`reports expressly made on behalf of Mylan and its co-defendants and served by Mylan.
` The 21-day period specified in Rule 42.11(d)(2) has passed, and Patent Owner seeks
`sanctions that are not available in the district court. Counsel for Petitioner Mylan
`confirms that Petitioner opposes this request.
`
`Novo Nordisk Exhibit 2653
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00008
`
`

`

`
`Because Petitioner has refused any discovery regarding its conduct in connection with
`the expert reports noted above, Patent Owner--in order to understand the extent of
`Petitioner's violation--further requests leave to file a motion for limited additional
`discovery from Petitioners regarding their respective retention, direction, and payment
`of these three experts in connection with the instituted '462 grounds who, prior to
`institution, were experts in this IPR and only for Mylan. Counsel for Petitioner Mylan has
`stated that Mylan believes no discovery is appropriate and opposes this request.
`
`Counsel for both parties are available to discuss their respective positions with the
`Board on Thursday, July 11, between 3 and 5pm ET, Friday, July 12, between 3 and
`5pm ET, or Monday, July 15, between 1 and 5pm ET, or as the Board otherwise directs.
`
`Respectfully submitted,
`
`
`J. Steven Baughman
`Groombridge, Wu, Baughman & Stone LLP
`O +1 202-505-5832, M +1 617-378-5548
`steve.baughman@groombridgewu.com
`
`From: J. Steven Baughman <steve.baughman@groombridgewu.com>
`Sent: Tuesday, June 25, 2024 1:23 PM
`To: White, Brandon (Perkins Coie) <BMWhite@perkinscoie.com>
`Cc: White-ptab@perkinscoie.com; Beel, Bryan D. (Perkins Coie) <BBeel@perkinscoie.com>; Greb-
`ptab@perkinscoie.com; prochnow-ptab@perkinscoie.com; jones-ptab@perkinscoie.com; tietz-
`ptab@perkinscoie.com; lembo-ptab@perkinscoie.com; Bloodworth, Shannon (Perkins Coie)
`<SBloodworth@perkinscoie.com>; kelley_nathan-ptab@perkinscoie.com;
`RSwartz@perkinscoie.com; Semaglutide-Ozempic@perkinscoie.com; Wong, Jovial
`(jwong@winston.com) <jwong@winston.com>; Border, Scott <SBorder@winston.com>;
`slin@winston.com; Sodikoff, Brian <brian.sodikoff@katten.com>; West, Christopher W.
`<christopher.west@katten.com>; Ferenc, Christopher B. <christopher.ferenc@katten.com>; Novo-
`Semaglutide-IPR@groombridgewu.com; Anstaett, David L. (Perkins Coie)
`<DAnstaett@perkinscoie.com>
`Subject: RE: IPR2023-00724 - Service of draft proposed motion for sanctions
`
`Brandon,
`
`We are, first, surprised by Mylan’s conspicuous attempt to alter and limit Mylan's
`commitment to the Board to pursuing the instituted grounds only “by motion or at
`trial.” As you know, in its petition Mylan explicitly promised it would not pursue those
`instituted grounds in district court litigation at all upon institution (Pet.66):
`
`Novo Nordisk Exhibit 2653
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00009
`
`

`

`
`
`In addition, Petitioner stipulates that if the Board institutes, Petitioner will not
`pursue in the district court any instituted grounds against the originally-issued
`claims unless a change in law otherwise permits. This further weighs in favor of
`institution.
`
`
`Far from “reaffirm[ing]” or “reiterat[ing]” its promise, Mylan now tries to rewrite it going
`forward—all the while refusing to answer any questions in the IPR about what Mylan has
`already done.
`
`There is no basis for Mylan’s suggestion that, so long as it stops short of doing so in a
`“motion or… trial,” Mylan is somehow entitled to pursue these foresworn grounds in
`litigation in other ways—such as by submitting reports asserting and detailing those
`improper grounds on Mylan’s own behalf and on behalf of its co-defendants (organized
`and prepared by Mylan to carry on even if Mylan is eventually forced, going forward, to
`follow Mylan’s petition stipulation). Indeed, the point of making a Fintiv-related
`stipulation like Mylan’s is to assure the Board that wasteful, duplicative litigation by the
`petitioner will stop in full and immediately at institution—not at some future time or only
`in pre-trial motions or arguments at trial.
`
`Mylan’s attempt to recast its promise also calls into question what Mylan now concedes
`it won’t do, going forward, at trial or in motion practice. It is apparent that Mylan, after
`institution, agreed to share with its litigation co-defendants Mylan’s three IPR experts,
`who not only copied vast swaths of their IPR declarations but also, with Mylan’s
`apparent sponsorship and participation, included further additional opinions responding
`to specific arguments raised by Patent Owner in the IPR. Mylan then formally submitted
`these three reports to Patent Owner in litigation on behalf of Mylan and all of its
`codefendants. This is certainly an example of Mylan “pursu[ing] in the district court [the
`three] instituted grounds,” contrary to its stipulation. Does Mylan agree that, going
`forward, it will not pursue these grounds, whether alone or in collaboration (openly or
`“behind the scenes”) with its codefendants? Or, is it Mylan’s position that Mylan need
`only refrain from officially signing on to arguments Mylan helps to prepare on those
`foresworn grounds when they are advanced against Patent Owner in the district court?
`
`While Mylan argues it was “forced… to participate in coordinated and consolidated pre-
`trial proceedings,” Mylan’s characterization of the litigation history (even if it were
`accepted, arguendo) would not absolve Mylan of its obligations to follow its
`commitments to the Board or any other requirements—whether in the interests of
`Mylan’s “convenience” or otherwise. (Notably, Mylan’s reliance on Patent Owner’s
`
`Novo Nordisk Exhibit 2653
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00010
`
`

`

`arguments for consolidated pre-trial proceedings in the MDL ignore that these were
`made nearly a year prior to the filing of Mylan’s petition, and that Mylan’s promise came
`after consolidation was ordered and Mylan was fully aware it would be involved in pre-
`trial proceedings with defendants not bound by Mylan’s promise. Similarly, the October
`31, 2023 joint stipulation was entered into after institution was granted and Mylan’s
`promise was in force, and did not relieve Mylan of its promise—"coordinating []
`discovery efforts” does not mean Mylan can substantively assist those other
`defendants.) For example, the suggestion that Mylan is somehow incapable of funding
`and sharing experts only on permissible topics, and not on the grounds Mylan promised
`the Board and Patent Owner it would not pursue, is nonsensical—and it is, of course,
`belied by the conduct of Mylan’s own co-petitioners, Sun and DRL, who (as Sun noted in
`our June 14 meet and confer) have expressly stated they are not joining certain aspects
`of the co-defendants’ shared expert reports following institution of their joined
`petitions. E.g., Responsive Expert Report of Arthur Z. Schwartzbard, M.D., F.A.C.C., at 1
`n.1 (“I understand that Dr. Reddy’s Laboratories, Ltd., Dr. Reddy’s Laboratories, Inc.,
`Sun Pharmaceutical Industries Ltd., and Sun Pharmaceutical Industries, Inc. do not
`adopt my opinions as they relate to anticipation or obviousness of the ’462 patent.”).
`
`Finally, Mylan’s attempt to rewrite its stipulation to the Board going forward notably
`omits any comment on what Mylan has already done, including in the March 19, 2024,
`expert reports it joined and served for all the defendants months after institution. While
`Mylan has yet to acknowledge it did anything to violate its stipulation, Mylan has not
`explained its conduct or disputed any of the facts presented in our draft motion for
`sanctions, and we intend to seek the Board’s assistance. Notwithstanding Mylan’s
`stated refusal in our meet and confer to consider any discovery on any aspect of this
`matter, we also intend to seek the Board’s permission for related discovery, and will
`follow up on that topic in separate correspondence. But in the meantime, we ask again:
`can Mylan represent to Patent Owner that (other than completed work Mylan had
`already performed solely in connection with the IPR) Mylan had no substantive
`involvement in the preparation, discussion, or other development of the invalidity
`theories in the March 19, 2024 expert reports of Drs. Bantle, Jusko, and Dalby that Mylan
`promised it would not pursue in the district court?
`
`Regarding Mylan’s repeated threat that—if Patent Owner seeks the Board’s assessment
`of and assistance with Mylan’s conduct here—Mylan will “seek its own sanctions,” we
`respectfully submit this is facially improper and unfounded, as confirmed by Mylan’s
`conduct in our June 14 meet and confer. During that discussion, Mylan’s counsel
`repeatedly suggested he had in mind controlling legal authority that a sanctions motion
`against Mylan would be impermissible and improper—but in response to our repeated,
`
`Novo Nordisk Exhibit 2653
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00011
`
`

`

`explicit requests, he flatly refused to identify any such authority. We are not aware of
`any, and we ask again that Mylan either identify it to us so that we may consider it, or
`cease making improper threats of retaliation.
`
`Respectfully,
`Steve
`
`
`
`J. Steven Baughman
`Groombridge, Wu, Baughman & Stone LLP
`O +1 202-505-5832, M +1 617-378-5548
`steve.baughman@groombridgewu.com
`
`From: White, Brandon (Perkins Coie) <BMWhite@perkinscoie.com>
`Sent: Friday, June 21, 2024 10:51 AM
`To: J. Steven Baughman <steve.baughman@groombridgewu.com>
`Cc: White-ptab@perkinscoie.com; Beel, Bryan D. (Perkins Coie) <BBeel@perkinscoie.com>; Greb-
`ptab@perkinscoie.com; prochnow-ptab@perkinscoie.com; jones-ptab@perkinscoie.com; tietz-
`ptab@perkinscoie.com; lembo-ptab@perkinscoie.com; Bloodworth, Shannon (Perkins Coie)
`<SBloodworth@perkinscoie.com>; kelley_nathan-ptab@perkinscoie.com;
`RSwartz@perkinscoie.com; Semaglutide-Ozempic@perkinscoie.com; Wong, Jovial
`(jwong@winston.com) <jwong@winston.com>; Border, Scott <SBorder@winston.com>;
`slin@winston.com; Sodikoff, Brian <brian.sodikoff@katten.com>; West, Christopher W.
`<christopher.west@katten.com>; Ferenc, Christopher B. <christopher.ferenc@katten.com>; Novo-
`Semaglutide-IPR@groombridgewu.com; Anstaett, David L. (Perkins Coie)
`<DAnstaett@perkinscoie.com>
`Subject: RE: IPR2023-00724 - Service of draft proposed motion for sanctions
`
`Steve,
`
`Attached is a copy of a letter provided to counsel in In re Ozempic (Semaglutide) Patent
`Litigation, MDL No. 22-MD-3038 (CFC). MPI reaffirms in this letter that it will not pursue
`by motion or at trial in the district court litigation any grounds of invalidity instituted in Mylan
`Pharmaceuticals Inc. v. Novo Nordisk A/S, No. IPR2023-00724 (PTAB), against the
`originally-issued claims of U.S. Patent No. 10,335,462, unless a change in law otherwise
`permits.
`
`While Novo Nordisk now appears to take issue with the Defendants in the district court
`litigation sharing experts and serving common expert reports, that is exactly what Novo
`Nordisk expected and relied upon before the JPML to force MPI to litigate in Delaware. Novo
`Nordisk understood and expected that there would be overlapping invalidity issues and shared
`experts between the cases it filed in Delaware and the case it filed against MPI in the Northern
`District of West Virginia and leveraged that expectation to compel MPI’s transfer from