Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 1 of 25 PageID #: 1294
`Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 1 of 25 PageID #: 1294
`
`Exhibit A
`
`

`

`Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 2 of 25 PageID #: 1295
`Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 2 of 25 PagelD #: 1295
`
`Hache, Gu Iaine
`
`From:
`
`Sent:
`
`To:
`
`Cc:
`
`Subject:
`
`Bowers, Seth <SBowers@wc.corn>
`
`Friday, June 5, 2020 12:35 PM
`
`Soderstrorn, Lance A.; Grossman, Dov; Mukerjee, Deepro R.; Malik, Jitty; Hache, Guylaine;
`Scott, Ian; pkouyoumdjian@taftlaw.com; kdorsney@morrisjames.com
`Genderson, Bruce; Berl, David; Picozzi, Ben; Farha, Griffin; Jack B. Blumenfeld
`
`RE: Activity in Case 1:16-cv-01221-LPS Bayer Healthcare LLC et al v. Apotex Inc. et al.
`Order
`
`Attachments:
`
`Status Report re 107 Discovery (DRAFT 2020.06.05}.docx
`
`EXTERNAL EMAIL — EXERCISE CAUTION
`
`All,
`
`I have attached a draft Joint Status Report regarding Apotex’s non-enablement theory. Please let us know promptly if
`you have proposed changes or would like to discuss so that we can get this on file on Monday.
`
`sbowers@wc.com | www.wc.com(sbowers
`
`Best,
`Seth
`
`Seth R. Bowers
`
`Associate | Williams 8: Connolly LLP
`725 Twelfth Street, N.W., Washington, DC 20005
`
`(P) 202-434-5457 | (F) 202-434-5029
`
`From: Soderstrom, Lance A. <lance.soderstrom@katten.com>
`
`Sent: Thursday, June 04, 2020 10:13 AM
`
`To: Grossman, Dov <DGrossman@wc.com>; Bowers, Seth <SBowers@wc.com>; Mukerjee, Deepro R.
`
`<deepro.mukerjee@katten.com>; Malik, Jitty <jitty.malik@katten.com>; Hache, Guylaine
`
`<guylaine.hache@katten.com>; Scott, Ian <iscott@taftlaw.com>; pkouyoumdjian@taftlaw.com;
`
`kdorsney@morrisjames.com
`Cc: Genderson, Bruce <BGenderson@wc.com>; Berl, David <DBerl@wc.com>; Picozzi, Ben <BPicozzi@wc.com>; Farha,
`
`Griffin <GFarha@wc.com>; Jack B. Blumenfeld <jblumenfeld@mnat.com>
`
`Subject: RE: Activity in Case 1:16-cv-01221-LPS Bayer Healthcare LLC et al v. Apotex Inc. et aI. Order
`
`Dov —
`
`Just to close the loop below, we do plan to raise the parties’ discussion from Monday related to Plaintiffs’ MIL. We
`
`obviously will defer to the Court’s preferences, but do note the points you and Bruce raised and think it worthwhile to
`raise it and leave it to the Court.
`
`Lance A. Soderstrom
`Partner
`
`Katten
`Katten Muchin Rosenman LLP
`
`575 Madison Avenue | New York, NY 10022—2585
`direct +1.212.940.6330 mobile +1.810.252_4827
`
`lance.soderstrom@katten.com | kattencom
`
`

`

`Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 3 of 25 PageID #: 1296
`Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 3 of 25 PagelD #: 1296
`
`From: Soderstrom, Lance A.
`
`Sent: Wednesday, June 3, 2020 2:30 PM
`
`To: 'Grossman, Dov' <DGrossman@wc.com>; Bowers, Seth <SBowers@wc.com>; Mukerjee, Deepro R.
`<deepro.mukerieeratten.com>; Malik, Jitty <‘itt
`.malik katten.com>; Hache, Guylaine
`<guy|aine.hache@katten.com>; Scott, Ian <iscott@taftlaw.com>; pkouyoumdiian@taftlaw.com;
`
`kdorsneyQmorrisiames.com
`
`Cc: Genderson, Bruce <BGenderson@wc.com>; Berl, David <DBerl@wc.com>; Picozzi, Ben <BPicozzi@wc.com>; Farha,
`Griffin <GFarha@wc.com>; Jack B. Blumenfeld <ib|umenfeld@mnat.com>
`
`Subject: RE: Activity in Case 1:16-cv-01221-LPS Bayer Healthcare LLC et al v. Apotex Inc. et al. Order
`
`Thanks Dov. As I understand it, Plaintiffs’ proposal was that Plaintiffs’ MIL be adjudicated early and Plaintiffs would raise
`
`it with the Court.
`
`I understand now Plaintiffs will not be raising that on their own. As I noted on the call, we’re not
`
`interested in any sort of ambush tomorrow and will do our best to get back to you on whether we will separately raise
`
`it. But we are in depositions today and tomorrow, so please bear with us.
`
`Lance A. Soderstrom
`Partner
`
`Katten
`Katten Muchin Rosenman LLP
`
`575 Madison Avenue | New York, NY 10022—2585
`direct +1.2’l2.940.6330 mobile +1.810.252_4827
`
`lance.soderstrom@katten.com | kattencom
`
`From: Grossman, Dov <DGrossman wc.com>
`
`Sent: Wednesday, June 3, 2020 2:24 PM
`
`To: Soderstrom, Lance A. <lance.soderstrom @katten.com>; Bowers, Seth <SBowers@wc.com>; Mukerjee, Deepro R.
`
`(deegro.mukeriee@katten.com>; Malik, Jitty <iitty.malik@katten.com>; Hache, Guylaine
`<guylaine.hache@katten.com>; Scott, Ian <iscott@taftlaw.com>; Qkouyoumdiiathaftlaw.com;
`kdorsne morris‘ames.com
`
`Cc: Genderson, Bruce <BGenderson@wc.com>; Berl, David <DBerl@wc.com>; Picozzi, Ben <BPicozzi@wc.com>; Farha,
`
`Griffin <GFarha@wc.com>; Jack B. Blumenfeld <‘blumenfeld mnat.com>
`
`Subject: RE: Activity in Case 1:16-cv-01221-LPS Bayer Healthcare LLC et al v. Apotex Inc. et al. Order
`
`EXTERNAL EMAIL — EXERCISE CA UTION
`
`Lance — as we discussed earlier today, that wasn’t what we proposed, but in any event we do not intend to raise early
`
`adjudication of any motion in limine with the Court tomorrow.
`
`Regards,
`Dov
`
`Dov P. Grossman
`
`Williams 8: Connolly LLP
`
`725 Twelfth St., N.W., Washington, DC 20005
`
`(P) 202-434-5812 | (F) 202-434-5029
`
`dgrossman@wc.com | www.wc.com(dgrossman
`
`From: Soderstrom, Lance A. <|ance.soderstrom@katten.com>
`
`Sent: Wednesday, June 03, 2020 10:48 AM
`
`To: Bowers, Seth <SBowers@wc.com>; Mukerjee, Deepro R. <deepro.mukeriee@katten.com>; Malik, Jitty
`
`<iitty.malik@katten.com>; Hache, Guylaine <guylaine.hache@katten.com>; Scott, lan <iscott@taft|aw.com>;
`
`Qkouyoumdiian@taftlaw.com; kdorsnemeorrisiames.com
`Cc: Genderson, Bruce <BGenderson@wc.com>; Berl, David <DBerl@wc.com>; Grossman, 00v <DGrossman wc.com>;
`2
`
`

`

`Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 4 of 25 PageID #: 1297
`Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 4 of 25 PagelD #: 1297
`
`Picozzi, Ben <BPicozzi@wc.com>; Farha, Griffin <GFarha@wc.com>; Jack B. Blumenfeld <iblumenfeld@mnat.com>
`
`Subject: RE: Activity in Case 1:16-cv-01221-LPS Bayer Healthcare LLC et al v. Apotex Inc. et aI. Order
`
`Dov —
`
`To follow up on our call, we do not oppose Plaintiffs raising earlier adjudication of the MlLs with the Court tomorrow,
`but will of course defer to whatever the Court deems fit.
`
`Lance A. Soderstrom
`Partner
`
`Katten
`Katten Muchin Rosenman LLP
`
`575 Madison Avenue | New York, NY 10022—2585
`direct +1.212.940.6330 mobile +1.810.252_4827
`
`lance.soderstrom@katten.com | kattencom
`
`From: Bowers, Seth <SBowers@wc.com>
`
`Sent: Wednesday, May 27, 2020 11:40 AM
`
`To: Soderstrom, Lance A. <lance.soderstrom @katten.com>; Mukerjee, Deepro R. <dee9ro.mukeriee@katten.com>;
`
`Malik, Jitty <iittv.malik@katten.com>; Hache, Guylaine <guvlaine.hache@katten.com>; Scott, Ian <iscott@taftlaw.com>;
`
`Qkouyoumdiian@taftlaw.com; kdorsnermorrisiamesLom
`
`Cc: Genderson, Bruce <BGenderson@wc.com>; Berl, David <DBerl@wc.com>; Grossman, Dov <DGrossman wc.com>;
`Picozzi, Ben <BPicozzi@wc.com>; Farha, Griffin <GFarha@wc.com>; Jack B. Blumenfeld (“blumenfeld mnat.com>
`Subject: RE: Activity in Case 1:16-cv-01221-LPS Bayer Healthcare LLC et al v. Apotex Inc. et aI. Order
`
`EXTERNAL EMAIL — EXERCISE CAUTION
`
`Thanks, Lance. We can use the dial-in below.
`
`Dial-in: 8887596037
`
`Passcode: 2024345457
`
`Seth R. Bowers
`
`Associate | Williams 8: Connolly LLP
`725 Twelfth Street, N.W., Washington, DC 20005
`
`(P) 202-434-5457 | (F) 202-434-5029
`
`sbowers@wc.com | www.wc.comgsbowers
`
`From: Soderstrom, Lance A. <|ance.soderstrom katten.com>
`
`Sent: Wednesday, May 27, 2020 11:35 AM
`
`To: Bowers, Seth <SBowers@wc.com>; Mukerjee, Deepro R. <dee9ro.mukerieeratten.com>; Malik, Jitty
`<iittv.malik@katten.com>; Hache, Guylaine <guylaine.hache@katten.com>; Scott, Ian <iscott@taft|aw.com>;
`
`Qkouyoumdiian@taftlaw.com; kdorsnermorrisiamesLom
`
`Cc: Genderson, Bruce <BGenderson@wc.com>; Berl, David <DBerl@wc.com>; Grossman, Dov <DGrossman wc.com>;
`
`Picozzi, Ben <BPicozzi@wc.com>; Farha, Griffin <GFarha@wc.com>; Jack B. Blumenfeld <'blumenfeld mnat.com>
`Subject: RE: Activity in Case 1:16-cv-01221-LPS Bayer Healthcare LLC et al v. Apotex Inc. et aI. Order
`
`Yes, that’s fine. Thank you.
`
`Lance A. Soderstrom
`Partner
`
`Katten
`Katten Muchin Rosenman LLP
`
`

`

`Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 5 of 25 PageID #: 1298
`Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 5 of 25 PagelD #: 1298
`
`575 Madison Avenue | New York, NY 10022—2585
`direct +1.2’l2.940.6330 mobile +1.810.252.4827
`
`lance.soderstrom@katten.com | kattencom
`
`From: Bowers, Seth <SBowers@wc.com>
`
`Sent: Wednesday, May 27, 2020 11:34 AM
`
`To: Soderstrom, Lance A. <lance.soderstrom @katten.com>; Mukerjee, Deepro R. <dee9ro.mukeriee@katten.com>;
`
`Malik, Jitty <iittv.malik@katten.com>; Hache, Guylaine <guvlaine.hache@katten.com>; Scott, Ian <iscott@taftlaw.com>;
`
`Qkouyoumdiian@taftlaw.com; kdorsnermorrisiamesLom
`
`Cc: Genderson, Bruce <BGenderson@wc.com>; Berl, David <DBerl@wc.com>; Grossman, Dov <DGrossman wc.com>;
`Picozzi, Ben <BPicozzi@wc.com>; Farha, Griffin <GFarha@wc.com>; Jack B. Blumenfeld (“blumenfeld mnat.com>
`
`Subject: RE: Activity in Case 1:16-cv-01221-LPS Bayer Healthcare LLC et al v. Apotex Inc. et al. Order
`
`EXTERNAL EMAIL — EXERCISE CA UTION
`
`Lance,
`
`Would 2:30pm on Monday work?
`
`Best,
`Seth
`
`Seth R. Bowers
`
`Associate | Williams 8; Connolly LLP
`
`725 Twelfth Street, N.W., Washington, DC 20005
`
`(P) 202-434-5457 | (F) 202-434-5029
`
`sbowersch.com | www.wc.comgsbowers
`
`From: Soderstrom, Lance A. <lance.soderstrom katten.com>
`
`Sent: Wednesday, May 27, 2020 10:48 AM
`
`To: Bowers, Seth <530wers@wc.com>; Mukerjee, Deepro R. (deegro.mukeriee@katten.com>; Malik, Jitty
`<iittv.malik@katten.com>; Hache, Guylaine <guylaine.hache@katten.com>; Scott, Ian <iscott@taftlaw.com>;
`
`Qkouyoumdiian@taftlaw.com; kdorsnermorrisiamesLom
`
`Cc: Genderson, Bruce <BGenderson@wc.com>; Berl, David <DBerl@wc.com>; Grossman, Dov <DGrossman wc.com>;
`
`Picozzi, Ben <BPicozzi@wc.com>; Farha, Griffin <GFarha@wc.com>; Jack B. Blumenfeld <'blumenfeld mnat.com>
`Subject: RE: Activity in Case 1:16-cv-01221-LPS Bayer Healthcare LLC et al v. Apotex Inc. et al. Order
`
`Seth —
`
`Does 2pm EST on Monday work? If so, please circulate a calendar invite.
`
`Thanks,
`
`Lance A. Soderstrom
`Partner
`
`Katten
`Katten Muchin Rosenman LLP
`
`575 Madison Avenue | New York, NY 10022—2585
`direct +1.2‘|2.940.6330 mobile +‘l 810.252.4827
`
`lance.soderstrom@katten.com | kattencom
`
`From: Bowers, Seth (SBowers wc.com>
`
`Sent: Tuesday, May 26, 2020 7:46 PM
`
`

`

`Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 6 of 25 PageID #: 1299
`Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 6 of 25 PagelD #: 1299
`
`To: Soderstrom, Lance A. <lance.soderstrom @katten.com>; Mukerjee, Deepro R. <deepro.mukeriee@katten.com>;
`
`Malik, Jitty <iitty.malik@katten.com>; Hache, Guylaine <guylaine.hache@katten.com>; Scott, Ian <iscott@taftlaw.com>;
`
`Qkouyoumdiian@taftlaw.com; kdorsnemeorrisiames.com
`Cc: Genderson, Bruce <BGenderson@wc.com>; Berl, David <DBerl@wc.com>; Grossman, Dov <DGrossman wc.com>;
`
`Picozzi, Ben <BPicozzi@wc.com>; Farha, Griffin <GFarha@wc.com>; Jack B. Blumenfeld <‘blumenfeld mnat.com>
`
`Subject: FW: Activity in Case 1:16-cv-01221-LPS Bayer Healthcare LLC et al v. Apotex Inc. et al. Order
`
`EXTERNAL EMAIL — EXERCISE CAUTION
`
`Lance,
`
`In light of the Court’s order, we should find a time in the next couple of days to discuss trial logistics in advance of our
`June 4 conference with the court.
`
`With respect to the software platform, our current view is that Zoom for Business provides the best functionality. We
`
`can discuss on our call whether that platform will work for your team and, if so, can propose it to the Court. We expect
`that our respective trial techs will coordinate to ensure everything runs smoothly.
`
`Let’s also discuss the timing for exchanging documents. We don’t anticipate any issue with exchanging documents
`
`among counsel, but should discuss how best to handle providing cross-examination materials to remote
`
`witnesses. Relatedly, we will need to determine the Court’s preferences for receiving demonstratives and callouts.
`
`Finally, we should consider whether to ask the Court to adjust start times for trial days to accommodate witnesses in
`different time zones.
`
`We are of course happy to discuss any other issues you have identified.
`
`Best,
`Seth
`
`Seth R. Bowers
`
`Associate | Williams 8: Connolly LLP
`725 Twelfth Street, N.W., Washington, DC 20005
`
`(P) 202-434-5457 | (F) 202-434-5029
`
`sbowers@wc.com | www.wc.com(sbowers
`
`From: ded nefreplyQded.uscourts.gov <ded nefre l
`Sent: Thursday, May 21, 2020 5:46 PM
`
`ded.uscourts. ov>
`
`To: ded ecf@ded.uscourts.gov
`
`Subject: Activity in Case 1:16-cv-01221-LPS Bayer Healthcare LLC et al v. Apotex Inc. et al. Order
`
`This is an automatic e-mail message generated by the CWECF system. Please DO NOT RESPOND to
`this e-mail because the mailbox is unattended.
`
`***NOTE TO PUBLIC ACCESS USERS*** Judicial Conference of the United States policy permits
`attorneys of record and parties in a case (including pro se litigants) to receive one free electronic copy of
`all documents filed electronically, if receipt is required by law or directed by the filer. PACER access fees
`apply to all other users. To avoid later charges, download a copy of each document during this first
`viewing. However, if the referenced document is a transcript, the free copy and 30 page limit do not
`apply.
`
`US. District Court
`
`

`

`Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 7 of 25 PageID #: 1300
`Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 7 of 25 PagelD #: 1300
`
`District of Delaware
`
`Notice of Electronic Filing
`
`The following transaction was entered on 5i21r’2020 at 5:45 PM EDT and filed on 5i21r’2020
`Case Name:
`Bayer Healthcare LLC et a] V. Apotex Inc. et a].
`Case Number:
`1:16-cv-01221-LPS
`
`Filer:
`
`Document Number: 150(No document attached)
`
`Docket Text:
`
`ORAL ORDER: Having reviewed the parties' May 15, 2020 joint status report (D.l. 148), IT IS
`HEREBY ORDERED that trial will be held on September 8-11, 2020. At this time, the Court
`believes that because not all counsel and witnesses are likely to be able to attend trial in
`person, it is likely that the entire trial will proceed remotely by video. The parties shall be
`prepared to discuss how the trial will proceed during a teleconference which will be held on
`June 4, 2020 at 3:45 pm. The parties shall provide to the Court the dial-in information for the
`call. IT IS FURTHER ORDERED that the final pretrial order shall be submitted by no later than
`August 19, 2020 and the pretrial conference will be held on August 26, 2020 at 4:30 pm. (in
`whatever format trial will proceed in). ORDERED by Judge Leonard P. Stark on 521120. (ntl)
`
`1:16-cv-01221-LPS Notice has been electronically mailed to:
`
`Jack B. Blumenfeld
`
`’bbefilin mnat.com
`
`Kenneth Laurence Dorsney
`
`kdorsneygcgmorrisjames.com, ipparagcgmorrisjamescom
`
`Derek James Fahnestock
`
`dfahnestock@mnat.com
`
`Bruce R. Genderson
`
`bgendersongcgwccom
`
`Dov P. Grossman
`
`dgrossman@wc.com
`
`Ian Scott
`
`iscott@taftlaw.com, schang@taftlaw.com
`
`Anthony David Raucci
`
`arauccigcgmnatcom
`
`Philip Y. Kouyoumdjian
`
`pkouyoumdjian@taftlaw.com, pskinner@taftlaw.com
`
`
`Lance A. Soderstrom lance.soderstrom@katten.com
`
`Jessica B. Rydstrom jrydstrom@wc.com
`
`Jitendra Malik
`
`jitty.malik@katten.com
`
`Seth R. Bowers
`
`sbowersgcgwccom
`
`BenV.Picozzi
`
`b icozzi wc.com
`
`

`

`Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 8 of 25 PageID #: 1301
`Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 8 of 25 PagelD #: 1301
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`1:16-cv-01221-LPS Filer will deliver document by other means to:
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`Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 9 of 25 PageID #: 1302
`Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 9 of 25 PagelD #: 1302
`
`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DI STRICT OF DELAWARE
`
`CA. No. 16-1221 (LPS')
`CONSOLIDATED
`
`) ) '
`
`) ) ) ) )
`
`) '
`
`) ) ) )
`
`BAYER HEALTHCARE LLC and BAYER
`
`HEALTHCARE PHARMACEUTICALS INC,
`
`Plaintiffs,
`
`v.
`
`APOTEX, CORP. and APOTEX, INC, et al.,
`
`De fendants.
`
`W
`
`Pursuant to the Court’s oral order dated April 20, 2020, the parties provide the following
`
`Joint Status Report regarding the above-captioned consolidated case:
`
`1.
`
`Bayer intends to move in limine to preclude a new non-enablement theory regarding
`
`US. Patent No. 9,458,107 (“the ’10? patent”) that was raised by Apotex at the close of expert
`
`discovery.
`
`2.
`
`Should the Court deny Bayer’s motion, Bayer expects that it will seek to rely on
`
`additional documents and testimony in response to Apotex’s theory. To allow for the disclosure
`
`of such information in an orderly fashion prior to trial, and subject to Bayer’s motion, the parties
`
`can be produced by July 10, 2020.
`
`agree to the following discovery procedure:
`
`a.
`
`Bayer will work expeditiously to produce any additional documents that
`
`Bayer may rely upon at trial in response to Apotex’s new theory should the
`
`Court deny Bayer’s motion. Bayer currently expects that such documents
`
`

`

`Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 10 of 25 PageID #: 1303
`Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 10 of 25 PageID #: 1303
`
`In addition,
`
`to the extent
`
`that Bayer intends to introduce at
`
`trial
`
`the
`
`witnesses available after the production of documents in July or August 2020 to provide deposition testimony. Any such deposition(s) will be
`
`testimony of any additional fact witnesses, Bayer will make those fact
`
`conducted remotely. Apotex will have 1.5 hours on the record to question
`
`each witness, and such testimony will be limited to topics of (i) the synthetic
`
`examples disclosed in the ’107 patent in the Working Examples, (ii) any of
`
`the newly produced dOCuments, and (iii) regulatory dOCuments describing
`
`Bayer’s process for manufacturing regorafenib. Also, Bayer will have the
`
`opportunity (up to 1.0 hours on the record per witness) to adduce any
`
`deposition testimony.
`
`If a party believes that a small
`
`increase in the
`
`deposition time is needed, the parties will meet and confer about that issue.
`
`0.
`
`In the event that Apotex is permitted to pursue its non-enablement theory at
`
`trial, Bayer’s expert Dr. Allan Myerson may address the issue, including by
`
`relying on the documents to be produced, as well as any deposition
`
`testimony identified in subsection (b') and any documents used at those
`
`depositions. Apotex’s experts will not address the new non-enablement
`
`theory at trial.
`
`June 8, 2020
`
`

`

`Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 11 of 25 PageID #: 1304
`Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 11 of 25 PageID #: 1304
`
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`
`MORRIS JAMES LLP
`
`
`
`
`
`Kenneth L. Dorsney-
`500 Delaware Avenue, Suite 1500
`Wilmington, DE. 19801
`kdorsney@momsgames.com
`Attorneyfor Defendant‘s Apotex Corp. and
`Apotex Inc.
`
`Jack B. Blumenfeld (#1014)
`Derek J. Fahnestock (#4705)
`Anthony D. Raucci (#5948)
`1201 North Market Street
`PO, Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@mnat.com
`dfahnestock@mnat.com
`araucci@mnat.com
`Afton: eys for Plainrjffi
`Bayer Health Care LLC and
`Bayer Health Care Pharmaceuticals Inc.
`
`

`

`Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 12 of 25 PageID #: 1305
`Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 12 of 25 PageID #: 1305
`
`Exhibit B
`
`

`

`Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 13 of 25 PageID #: 1306
`Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 13 of 25 PagelD #: 1306
`
`CONFIDENTIAL
`
`Allan Myerson, Ph D. - October 21, 2019
`
`UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`Page 1
`
`BAYER HEALTHCARE LLC and BAYER
`
`HEALTHCARE PHARMACEUTICALS,
`
`|NC.,
`
`Plaintiff,
`
`Case No.
`
`16-1221(LPS)
`
`- USDC-DDE
`
`TEVA PHARMACEUTICALS USA,
`
`INC.,
`
`APOTEX, CORP. AND APOTEX INC.,
`
`Defendants.
`
`C 0 N
`
`F
`
`|
`
`D
`
`E
`
`N
`
`T
`
`|
`
`A L
`
`DEPOSITION OF ALLAN MYERSON,
`
`Ph D.
`
`Washington, D.C.
`
`October 21, 2019
`
`REPORTED BY:
`
`Tina Alfaro, RPR, CRR,
`
`RMR
`
`GregoryEdwards, LLC I Worldwide Court Reporting
`GregoryEdwards com I 866-4Team GE
`
`
`
`
`
`

`

`Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 14 of 25 PageID #: 1307
`Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 14 of 25 PagelD #: 1307
`
`CONFIDENTIAL
`
`Allan Myerson, Ph.D. - October 21, 2019
`
`Page 77
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`11
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`:02:
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`d.
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`stipulate to infringement that says you're
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`infringing the claims, and if you say you infringe
`
`something that
`
`implies you understand what the
`
`claims mean.
`
`If you tell me that Apotex wanted to
`
`stipulate to infringement but they don't understand
`
`the claims, you can tell me that, but a reasonable
`
`person would agree to what
`
`I
`
`just said. Why would
`
`you stipulate to infringement of something you
`
`didn't understand?
`
`0. Let's go to paragraph 87 of your report.
`
`There you say "A POSA would understand reducing the
`
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`\OCDMO‘Cfl-L‘LQJM
`A. Right.
`
`levels of AF-PMA and 4-amino-3-fluorophenol
`
`to
`
`within the ranges required by the '10? Patent would
`
`require optimization of a wide variety of
`
`variables," and you go ahead and list some
`
`variables, correct?
`
`18
`
`19
`
`20
`
`21
`
`22
`
`0. Let's go back -- bear with me. Let's go
`
`back to Myerson Exhibit 3, which is the file
`
`history excerpt that
`
`l directed your attention to,
`
`going to Bayer-361.
`
`A. Yes.
`
`GregoryEdwards, LLG I Worldwide Court Reporting
`GregoryEdwards.com I 866-4Team GE
`
`
`
`

`

`Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 15 of 25 PageID #: 1308
`Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 15 of 25 PagelD #: 1308
`
`CONFIDENTIAL
`
`Allan Myerson, Ph.D. - October 21, 2019
`
`Page 82
`
`11
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`:11:
`
`14
`
`that.
`
`0. Well,
`
`let's just kind of break that up.
`
`So there are four stages in the example, correct?
`
`A. Correct.
`
`0.
`
`And looking at stage 3, which is on
`
`column 14, what amount of
`
`impurities do you
`
`achieve?
`
`A.
`
`It doesn't say.
`
`0. Certainly doesn't tell you whether
`
`0.0001 percent was ever achieved, correct?
`
`A.
`
`It doesn't say, but, of course, a POSA
`
`could perform this example and do the analysis and
`
`they would know.
`
`0.
`
`Stage 4 also measures the amount of
`
`impurities, correct?
`
`A. Correct.
`
`11
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`:25
`\OCDMO‘Cfl-L‘LQJM
`
`
`0.
`
`And it does not tell you whether
`
`0.0001 percent was ever achieved, correct?
`
`A.
`
`The data's not
`
`in there,
`
`that's correct.
`
`The POSA would have to perform example 4 and
`
`determine if it was achieved.
`
`11
`
`:12
`
`22
`
`0.
`
`To achieve 0.001 percent can you show me
`
`GregoryEdwards, LLC I Worldwide Court Reporting
`GregoryEdwards.com I 866-4Team GE
`
`
`
`

`

`Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 16 of 25 PageID #: 1309
`Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 16 of 25 PagelD #: 1309
`
`CONFIDENTIAL
`
`Allan Myerson, Ph.D. - October 21, 2019
`
`Page 85
`
`11
`
`:14:48
`
`d.
`
`PPM.
`
`I would agree it doesn't say that anywhere.
`
`11
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`\OCDMO‘Cfl-L‘LQJM
`CDHO‘Ln-ih-OJMHC)
`
`19
`
`20
`
`21
`
`22
`
`0.
`
`Do you have an opinion as to which would
`
`be more challenging,
`
`reaching a composition with
`
`1 PPM's or 100 PPM's?
`
`A.
`
`1 PPM is certainly more difficult than a
`
`hundred PPM.
`
`0.
`
`Is there anything in the patent,
`
`the
`
`'10? Patent that teaches what changes need to be
`
`made to the reaction conditions at each stage of
`
`the synthesis to achieve 1 PPM versus 100 PPM's?
`
`MR. BOWERS: Object to the form of the
`
`
`
`question.
`
`A.
`
`No,
`
`it does not. Certainly a POSA could
`
`practice the invention and see what purity levels
`
`they did achieve, but
`
`it doesn't tell you -- and it
`
`would -- it would be,
`
`in my opinion, within the
`
`claimed range, but
`
`it doesn't tell you how to
`
`achieve 1 versus 100.
`
`0.
`
`Is there anything in the patent that
`
`you're aware of that would teach what changes to
`
`the intermediate work -- sorry -- to the
`
`intermediate purification that needs to be made to
`
`GregoryEdwards, LLG I Worldwide Court Reporting
`GregoryEdwards.com I 866-4Team GE
`
`
`
`

`

`Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 17 of 25 PageID #: 1310
`Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 17 of 25 PagelD #: 1310
`
`CONFIDENTIAL
`
`Allan Myerson, Ph.D. - October 21, 2019
`
`Page 86
`
`achieve 1 PPM versus 100 PPM's?
`
`A.
`
`0.
`
`Same answer as |
`
`just gave.
`
`Is there anything in the patent that
`
`teaches what specific changes need to be made to
`
`the final
`
`isolation to achieve 1 PPM versus
`
`100 PPM's?
`
`A.
`
`No. Again,
`
`if you practice the invention,
`
`it's my opinion you would get a result
`
`in the
`
`range, but you wouldn't know how to do 1 PPM versus
`
`100 PPM.
`
`In paragraph -- turn to paragraph 85 of
`
`\OCDMO‘Cfl-L‘LQJM
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`H H H H H 1
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`1
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`
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`0.
`
`your report.
`
`A. Yes.
`
`0.
`
`Paragraph 85 of your report you state that
`
`"Dr. Hansen has not provided any opinion or
`
`analysis explaining how the POSA would have
`
`reasonably expected a ten-fold reduction from
`
`1,000 PPM to 100 PPM (i e.
`
`the highest
`
`level
`
`allowed in the asserted claims of the '10? Patent)
`
`to be successful"; do you see that sentence?
`
`A. Yes.
`
`0. You're saying in that paragraph that even
`
`GregoryEdwards, LLG I Worldwide Court Reporting
`GregoryEdwards.com I 866-4Team GE
`
`
`
`

`

`Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 18 of 25 PageID #: 1311
`Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 18 of 25 PagelD #: 1311
`
`CONFIDENTIAL
`
`Allan Myerson, Ph.D. - October 21, 2019
`
`Page 87
`
`11
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`1
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`A. Yes.
`
`0.
`
`And a 100-fold reduction would be even
`
`harder, correct?
`
`A.
`
`0.
`
`Turn to paragraph 83 of your report.
`
`I'm
`
`sorry.
`
`Paragraph -- strike that -- 80 of your
`
`report.
`
`Let me know when you're there.
`
`A. Yes.
`
`:59
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`a ten-fold reduction would be difficult to achieve, correct?
`To go from a thousand to one, certainly that's correct.
`\OCDMO‘Cfl-L‘LQJM
`NM-x-x-x-L-L-L-L-L-L-LdO‘OCDNO‘Ln-h-WMHD
`
`0.
`
`Paragraph 80 there's a sentence "To the
`
`contrary,
`
`the POSA would have recognized that
`
`reducing regorafenib anilinic impurities and in
`
`particular the impurity AF-PMA to the levels
`
`required by the asserted claims would be especially
`
`challenging"; do you see that?
`
`A. Yes.
`
`0.
`
`Do you have an understanding -- strike
`
`that.
`
`Now,
`
`in that paragraph you use the term
`
`22
`
`"especially challenging," correct?
`
`GregoryEdwards, LLG I Worldwide Court Reporting
`GregoryEdwards.com I 866-4Team GE
`
`
`
`

`

`Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 19 of 25 PageID #: 1312
`Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 19 of 25 PagelD #: 1312
`
`CONFIDENTIAL
`
`Allan Myerson, Ph D. - October 21, 2019
`
`Page 240
`
`1706:57
`
`1
`
`BY MR. BOWERS:
`
`0.
`
`Is there information in the HPLC method
`
`disclosed in lines 44 to 62 of column 14 of the
`
`'10? Patent that would provide information to the
`
`POSA regarding the level of
`
`impurities that might
`
`be expected if following the method of the
`
`'10? Patent to make regorafenib?
`
`A. Yes.
`
`0.
`
`And what
`
`is that
`
`information?
`
`impurity listed as
`
`\OCDMO‘Cfl-L‘LQJM
`
`_|. C)
`
`_|. ‘
`
`_|. M
`
`_|. O.)
`
`J3.
`
`U1
`
`ON
`
`«.4
`
`CO
`
`‘0
`
`N C)
`
`IND _L
`
`IN) N
`
`A. Well,
`
`if we start on,
`
`let's see,
`
`line 52
`
`approximately, starting with the term "relevant
`
`potential byproducts," then it says
`
`"4-amino-3-fluorophenol at R0 -- RRT (relative
`
`retention time) of 0.1,
`
`typically less than
`
`0.01 percent
`
`(2.6 minutes), 4-(4—Amino-3-
`
`fIourophenony-N-methylpyridine-2-oarboxamide RRT
`
`0.37,
`
`typically less than 0.01 percent
`
`(9.5
`
`minutes), RRT 0.46 of 4(3-fluoro—4{[2-
`
`(methylcarbamoyl)pyridine-4-[amino1-phenoxy)-N-
`
`methylpyridine-2—carboxamide),
`
`typically less than
`
`0.15 percent
`
`(11.? minutes) RRT .6 ," and then
`
`there's another one -- another
`
`GregoryEdwards, LLG I Worldwide Court Reporting
`GregoryEdwards.com I 866-4Team GE
`
`

`

`1?
`
`:19:
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`Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 20 of 25 PageID #: 1313
`Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 20 of 25 PagelD #: 1313
`
`CONFIDENTIAL
`
`Allan Myerson, Ph D. - October 21, 2019
`
`Page 241
`
`welL
`
`0.
`
`Okay.
`
`The impurity listed beginning at
`
`line 52 --
`
`Yes.
`
`-- 4-amino-3-fluorophenol --
`
`Yes.
`
`-- is that one of the two impurities
`
`specified in the asserted claims?
`
`A. Yes.
`
`0.
`
`And the statement "typically less than
`
`0.01 percent" --
`
`A. Yes.
`
`MR. MALIK: Object to form.
`
`Go ahead.
`
`MR. BOWERS:
`
`I'd appreciate if you'd let
`
`me finish my question before you state your
`
`objection.
`
`BY MR. BOWERS:
`
`0.
`
`The statement "typically less than
`
`0.01 percent," how does that amount relate to the
`
`level of fluoroaminc-3-fluorophenol permitted by
`
`
`the asserted claims?
`\OCDMO‘Cfl-L‘LQJM
`M—LCJ‘OCD‘JO‘Ln-h-WMHD
`
`A.
`
`It's certainly within the permitted claim
`
`GregoryEdwards, LLG I Worldwide Court Reporting
`GregoryEdwards.com I 866-4Team GE
`
`
`
`

`

`Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 21 of 25 PageID #: 1314
`Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 21 of 25 PagelD #: 1314
`
`CONFIDENTIAL
`
`Allan Myerson, Ph.D. - October 21, 2019
`
`Page 242
`
`because it's between -- that's upper
`
`limit and it's
`
`less than the upper
`
`limit.
`
`0.
`
`And beginning in line 54,
`
`is the impurity
`
`specified 4-(4-amino-3-flourophenoxy) and so on the
`
`impurity that we discussed today as AFP-PMA?
`
`A. Yes.
`
`0.
`
`And same question with respect to AFP-PMA
`
`as disclosed in this passage. What does the
`
`reference to less than -- "typically less than
`
`0.01 percent" indicate?
`
`A.
`
`It
`
`indicated it would be within the
`
`claimed range, which is between -- is where 0.01 is
`
`it's less than that.
`
`d.
`
`2 3 4 5 6 7 8 9
`
`_L_L_L_LWM‘D
`
`17:
`
`20:
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`17:
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`20:
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`17:
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`20:
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`17:
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`20:
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`17:
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`17:
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`
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`:32
`
`0. All right.
`
`I have a hypothetical question
`
`regarding "and/or" in the context of the asserted
`
`claims.
`
`Suppose you have 4-amino-3-fluorophenol
`
`present at a level of 0.005 percent or 50 PPM and
`
`GregoryEdwards, LLG I Worldwide Court Reporting
`GregoryEdwards.com I 866-4Team GE
`
`the upper
`
`limit,
`
`0.
`
`Thank you.
`
`Dr. Myerson, do you recall testifying
`
`today regarding the asserted claims recitation of
`
`the phrase "and/or"?
`
`A. Yes.
`
`:59
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`:09
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`:10
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`:15
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`:17
`
`:18
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`:21
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`:25
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`17:
`
`20
`
`17:
`
`21
`
`17:
`
`21
`
`17:
`
`21
`
`17:
`
`21
`
`17:
`
`21
`
`17:
`
`21
`
`17:
`
`21
`
`17:
`
`21
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`14
`
`15
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`16
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`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`
`
`

`

`Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 22 of 25 PageID #: 1315
`Case 1:16-cv-01221-LPS Document 159-1 Filed 07/02/20 Page 22 of 25 PageID #: 1315
`
`Exhibit C
`
`

`

`Case 1:16-cv-01221-LP