Case 1:23-cv-00089-TSK Document 43-5 Filed 12/22/23 Page 1 of 5 PageID #: 3728
`
`Exhibit C
`
`
`
`Exhibit C
`
`
`
`Case 1:23-cv-00089-TSK Document 43-5 Filed 12/22/23 Page 2 of 5 PageID #: 3729
`
`Van Horn, Shaun M.
`Fletcher, Thomas; Tuchman, Haley B.
`Fogel, Louis E.; DL FYB203Internal; Eylea; Eylea Biosimilars
`RE: FYB 203: Regeneron"s (l)(3)(A) List
`Friday, November 10, 2023 12:41:31 PM
`
`From:
`To:
`Cc:
`Subject:
`Date:
`
`Tom,
`
`Thanks for the proposal below. We have discussed it with Formycon and are hoping you might have time this
`afternoon or Monday to discuss how this would work in a bit more detail, e.g., which court we’d file in, how it
`would relate to any parallel biosimilar proceedings, how we’d deal with the court’s schedule/input, and what we’d
`do about the remainder of the case schedule. Let us know what works for you.
`
`Best,
`Shaun
`
`From: Fletcher, Thomas <TFletcher@wc.com>
`Sent: Thursday, November 9, 2023 8:49 AM
`To: Tuchman, Haley B. <HTuchman@jenner.com>
`Cc: Fogel, Louis E. <LFogel@jenner.com>; Van Horn, Shaun M. <SVanHorn@jenner.com>; DL_FYB203Internal
`<DL_FYB203Internal@jenner.com>; Eylea <Eylea@wc.com>; Eylea Biosimilars <Eylea.Biosimilars@weil.com>
`Subject: RE: FYB 203: Regeneron's (l)(3)(A) List
`
`External Email - Do Not Click Links or Attachments Unless You Know They Are Safe
`
`Counsel,
`
`With the end of regulatory exclusivity approximately 6 months away, please let us know if Formycon would be
`willing to proceed on the below schedule for preliminary injunction proceedings once an infringement action has
`been filed.
`
`Note that we have included a date to suggest to the Court when a ruling is necessary based on our estimate of when
`FDA might approve your BLA—if you believe that date is inaccurate, please let us know. In any event, to give the
`Court the opportunity to evaluate the parties’ position, this proposal assumes that you will promise to the Court that
`you will not commercialize your aflibercept biosimilar product prior to the Court’s decision on the preliminary
`injunction motion.
`
`Best,
`
`Tom
`
`
`
`Case 1:23-cv-00089-TSK Document 43-5 Filed 12/22/23 Page 3 of 5 PageID #: 3730
`
`Date
`
`Event
`
`November 16, 2023
`
`Regeneron to identify list of no more than 4 patents to include in motion for preliminary injunction
`
`November 22, 2023
`
`Parties exchange targeted requests for production
`
`December 22, 2023
`
`Formycon to identify no more than 3 invalidity arguments per patent for purpose of the PI hearing only —for clarity,
`each prior art combination or anticipatory reference is one argument
`
`January 19, 2024
`
`Document production complete
`
`February 23, 2024
`
`Regeneron to file motion for preliminary injunction
`
`March 8, 2024
`
`Depositions of Regeneron declarants complete
`
`March 22, 2024
`
`Formycon to file opposition
`
`April 5, 2024
`
`Deposition of Formycon declarants complete
`
`April 19, 2024
`
`Regeneron Reply ISO preliminary injunction
`
`Week of May 13, 2024
`
`Proposed hearing
`
`June 25, 2024
`
`Estimated date of decision on preliminary injunction
`
`
`
`Case 1:23-cv-00089-TSK Document 43-5 Filed 12/22/23 Page 4 of 5 PageID #: 3731
`
`---
`
`Thomas S. Fletcher
`Williams & Connolly LLP
`680 Maine Ave. SW
`Washington, DC 20024
`(202) 434-5497
`
`From: Fletcher, Thomas <TFletcher@wc.com<mailto:TFletcher@wc.com>>
`Sent: Tuesday, November 7, 2023 4:40 PM
`To: 'Tuchman, Haley B.' <HTuchman@jenner.com<mailto:HTuchman@jenner.com>>
`Cc: Fogel, Louis E. <LFogel@jenner.com<mailto:LFogel@jenner.com>>; Van Horn, Shaun M.
`<SVanHorn@jenner.com<mailto:SVanHorn@jenner.com>>; DL_FYB203Internal
`<DL_FYB203Internal@jenner.com<mailto:DL_FYB203Internal@jenner.com>>; Eylea
`<Eylea@wc.com<mailto:Eylea@wc.com>>; Eylea Biosimilars
`<Eylea.Biosimilars@weil.com<mailto:Eylea.Biosimilars@weil.com>>
`Subject: FYB 203: Regeneron's (l)(3)(A) List
`
`Counsel,
`
`Please see the attached letter with Regeneron’s list of patents pursuant to 42 U.S.C. § 262(l)(3)(A), and if you have
`any trouble with the attached, please let me know.
`
`Regards,
`
`Tom
`
`---
`
`Thomas S. Fletcher
`Williams & Connolly LLP
`680 Maine Ave. SW
`Washington, DC 20024
`(202) 434-5497
`
`From: Tuchman, Haley B. <HTuchman@jenner.com<mailto:HTuchman@jenner.com>>
`Sent: Friday, September 8, 2023 12:37 PM
`To: Fletcher, Thomas <TFletcher@wc.com<mailto:TFletcher@wc.com>>
`Cc: Fogel, Louis E. <LFogel@jenner.com<mailto:LFogel@jenner.com>>; Van Horn, Shaun M.
`<SVanHorn@jenner.com<mailto:SVanHorn@jenner.com>>
`Subject: FYB 203 Production
`
`
`
`Case 1:23-cv-00089-TSK Document 43-5 Filed 12/22/23 Page 5 of 5 PageID #: 3732
`
`Tom,
`
`Please see the attached correspondence regarding Formycon AG’s production of BLA No. 761378.
`
`Regards,
`
`Haley
`
` _____
`
`Haley B. Tuchman
`
`Jenner & Block LLP
`1099 New York Avenue, NW
`Suite 900, Washington, DC 20001-4412 | jenner.com<http://www.jenner.com>
`+1 202 639 5351 | TEL
`+1 771 215 0622 | MOBILE
`Pronouns: She / Her
`HTuchman@jenner.com<mailto:HTuchman@jenner.com>
`Download V-Card<https://svcs.jenner.com/JBvCard/vcardhandler/getcardbypid/76453> | View
`Biography<http://www.jenner.com/people/HaleyTuchman>
`
`CONFIDENTIALITY WARNING: This email may contain privileged or confidential information and is for the sole
`use of the intended recipient(s). Any unauthorized use or disclosure of this communication is prohibited. If you
`believe that you have received this email in error, please notify the sender immediately and delete it from your
`system.
`
` _____
`
` _____
`
`This message and any attachments are intended only for the addressee and may contain information that is
`privileged and confidential. If you have received this message in error, please do not read, use, copy, distribute, or
`disclose the contents of the message and any attachments. Instead, please delete the message and any attachments
`and notify the sender immediately. Thank you.
`
`
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