Case 1:23-cv-00089-TSK Document 95-1 Filed 02/13/24 Page 1 of 17 PageID #: 4030
`Case 1:23-cv-00089-TSK Document 95-1 Filed 02/13/24 Page 1of17 PagelD #: 4030
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`EXHIBIT A
`EXHIBIT A
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`EXHIBIT A
`EXHIBIT A
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`Case 1:23-cv-00089-TSK Document 95-1 Filed 02/13/24 Page 2 of 17 PageID #: 4031
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`UNITED STATES DISTRICT COURT
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`NORTHERN DISTRICT OF WEST VIRGINIA
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`Regeneron Pharmaceuticals, Inc.
` Plaintiff,
` VS. CIVIL ACTION NO.
` 1:23-cv-89
`Celltrion, Inc.
` Defendant.
`
`- - -
`
`Regeneron Pharmaceuticals, Inc.
` Plaintiff,
` VS. CIVIL ACTION NOS.
` 1:23-cv-94
`Samsung Bioepis Co., Ltd. 1:23-cv-106
`Defendant.
`
`- - -
`
`Regeneron Pharmaceuticals, Inc.
` Plaintiff,
` VS. CIVIL ACTION NO.
` 1:23-cv-97
`Formycon AG,
`Defendant.
`
`- - -
`
`Proceedings had in the status conference of the
`above-styled action on January 5, 2024, before Honorable Thomas
`S. Kleeh, District Judge, at Clarksburg, West Virginia.
`
`- - -
`
` APPEARANCES:
`
` On behalf of the Plaintiff:
`
`David I. Berl
`Ellen E. Oberwetter
`Renee Griffin
`Thomas S. Fletcher
`Williams & Connolly, LLP
`680 Maine Avenue, SW
`Washington, D.C. 20024
`202.434.5000
`
`
`APPEARANCES CONTINUED ON NEXT PAGE
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`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
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`On behalf of the Plaintiff (continued):
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`Elizabeth S. Weiswasser
`Weil, Gotshal & Manges, LLP
`767 Fifth Avenue
`New York, NY 10153
`212.310.8022
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`Jake E. Harman
`Kellogg, Hansen, Todd, Figel & Frederick
`1615 M Street NW, Suite 1400
`Washington, DC 20036
`202.326.7989
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`Steven Robert Ruby
`Carey, Douglas, Kessler & Ruby, PLLC
`797 Virginia Street, East, Suite 901
`Charleston, WV 25301
`304.345.1234
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`Also appearing: Petra Scamborova, James Evans, in-house
`counsel for Regeneron
`
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`On behalf of Defendant Celltrion:
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`Max Gottlieb
`Michael Hissam
`Andrew C. Robey
`Hissam, Forman, Donovan & Ritchie
`700 Virginia Street East, Suite 210
`Charleston, WV 25301
`304.543.4893
`
`
`
`Robert Cerwinski
`Michael B. Cottler
`Gemini Law, LLP
`40 West 24th Street, Suite 6N
`New York, NY 10010
`917.915.8832
`
`
`
`
`Michael W. Johnson
`Willkie, Farr & Gallagher, LLP
`787 Seventh Avenue
`New York, NY 10019
`212.720.8000
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`APPEARANCES CONTINUED ON NEXT PAGE
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`On behalf of Defendant Formycon AG:
`
`M. David Griffith
`Thomas, Combs & Spann
`PO Box 3824
`Charleston, WV 25338
`304.414.1810
`
`Louis Fogel
`Shaun M. VanHorn
`Jenner & Block, LLP
`353 N. Clark Street
`Chicago, IL 60654
`312.923.2661
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`On behalf of Defendant Samsung Bioepis Co., Ltd:
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`Sandra K. Law
`Schrader, Companion, Duff & law, PLLC
`401 Main Street
`Wheeling, WV 26003
`304.233.3390
`
`Matthew A. Traupman
`Raymond N. Nimrod
`Quinn, Emanuel, Urquhart & Sullivan, LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`212.849.7322
`
`
`Chad L. Taylor
`Simmerman Law Office, PLLC
`254 East Main Street
`Clarksburg, WV 26301
`304.623.4900
`
`
`
` Proceedings recorded utilizing realtime translation.
` Transcript produced by computer-aided transcription.
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`THE COURT: Good morning, everyone.
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`And then, my apologies if I mispronounce it,
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`Formycon, specially or otherwise. Mr. Griffith.
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`MR. GRIFFITH: Good morning, Your Honor. David
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`Griffith with Thomas Combs & Spann in Charleston, West
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`Virginia, on behalf of Formycon AG, appearing specially today,
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`as indicated in our response to the motion for alternative
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`service, preserving all rights to jurisdiction, venue, and
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`12(b) defenses.
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`With me today in the courtroom is Louis Fogel and
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`Shaun VanHorn, both with the Jenner Block firm in Chicago.
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`THE COURT: Good morning. Anyone else? Good to see
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`everybody. I hope you had safe travels, if you had to travel.
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`I wanted to get -- the Court's certainly aware of the
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`pressing issues and the ticking clock that exists. I know we
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`do already have a motion to dismiss, raising jurisdictional
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`issues on behalf of Samsung in cases 94 and 106. Is that
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`right? In 94 and 106.
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`Mr. Berl, I'll ask you, sir, any idea when Regeneron
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`may respond to that motion, sir?
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`MR. BERL: Yes. Your Honor, I think your question
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`goes to a few issues here that we think should be discussed,
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`which is what is the overall schedule here with respect to a
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`motion for preliminary injunction, and resolution of that, as
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`well as resolution of the motions that one defendant has filed,
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`the other two defendants have indicated that they will file on
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`January 17th, contesting jurisdiction.
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`We set out a schedule that sets forth when we think
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`all of that should happen, including our opposition to the
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`motions for personal jurisdiction, which would be due on
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`February 19th. I can address just that piece, if you'd like,
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`Your Honor.
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`Samsung filed first, the fastest. It took them 44
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`days between the day we filed the complaint and the day that
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`they filed their motion yesterday. I leave it to Your Honor to
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`figure out why they waited 44 days to file that motion, but
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`obviously doesn't take 44 days to prepare a motion for lack of
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`personal jurisdiction.
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`For their part, Celltrion is waiting 69 days between
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`the time of the complaint and the time to file the motion, and
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`Formycon is somewhere in between 44 and 69. Their motion --
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`we've seen one of the three. I think it makes sense, to be
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`honest, to respond to all three of the motions together.
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`They're going to raise, as we understand it, overlapping issues
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`with very similar legal principles at stake. And so we think
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`we should respond to all of them together at the same time.
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`In terms of when, their motion -- and I don't want to
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`get into the details, especially because it was filed under
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`seal. In our view, it's defective legally for various reasons
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`and, we think, contrary to controlling Federal Circuit
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`authority. But it also raises various factual allegations that
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`we think are both incomplete and, as far as we can tell, not
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`correct.
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`And so on the basis of having seen one of those three
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`motions, it's our view that we think we should have some
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`discovery as to that motion. Again, I don't want to get into
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`the details that they raised on agreement between two parties.
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`They did not furnish to us other agreements between those
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`parties that we think are relevant to the relationship and to
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`the issues, again, even if we're wrong as to the threshold
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`legal question. And so in our view, if we can get that
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`discovery rather quickly.
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`THE COURT: How long would that discovery take
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`ideally from, your perspective?
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`MR. BERL: I think we want the agreements themselves.
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`I think those should be able to be furnished within 24 hours,
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`and then take a deposition of someone with knowledge of the
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`agreements and the relationships between the parties that are
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`at issue in their motion. So I think with those documents and
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`a deposition, I think that would be sufficient.
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`Again, we'll see the other motions on January 17th.
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`I'd imagine we'd probably want something like that with respect
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`to the Celltrion motion and the Formycon motion, and if we were
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`to get that discovery quickly, we think we'd be in a position
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`to respond to that on February 19th.
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`THE COURT: Okay. All right.
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`MR. BERL: One issue that this raises, however, is
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`something that Samsung raised yesterday in their opposition to
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`our motion for the emergency conference, which is Samsung takes
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`the view that somehow their jurisdictional motion should be
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`decided before anyone moves forward with preliminary injunction
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`proceedings. And I think that's, to be honest, Your Honor, the
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`threshold issue that you'll have to decide.
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`We've been proposing to do them all together, in
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`parallel. Honestly, we've already started down that road. A
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`couple weeks ago we gave the defendants categories of documents
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`we think we need in order to file the preliminary injunction
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`motion. Two of the three defendants, Formycon and Celltrion,
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`are starting to work with us on that, saying which documents
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`should we prioritize first, and we're going down that road with
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`two out of the three in a cooperative and productive way.
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`Honestly, with Samsung, we're not. We've heard
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`nothing in response to our categories from the production with
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`Samsung, and as I read the papers yesterday, their position is
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`we can just ignore everything until our jurisdictional motion
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`is decided.
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`Respectfully, we don't think that's the correct
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`approach here. We prepared a slide, if you want, of cases
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`where courts have entertained discovery in parallel proceedings
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`while jurisdictional motions are pending. In this district,
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`whole story, because of course there's a second lawsuit that
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`was filed last week, December 28th. And we knew that lawsuit
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`was coming. So we waited till that second lawsuit was filed to
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`move to dismiss, because we knew the issues were going to be
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`the same, and we were honestly hopeful that we could engage in
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`dialogue with Regeneron so they would file that second lawsuit
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`here in West Virginia, for the reasons that we've stated on the
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`record. We asked them repeatedly to work cooperatively with us
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`to talk about jurisdiction, figure out the right place where
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`this lawsuit can be filed. And we're not trying to play a game
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`of gotcha here, Your Honor. We told --
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`THE COURT: There's cross accusations of gotcha that
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`have already been made.
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`MR. TRAUPMAN: My point is it's not like we're trying
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`to say there's no personal jurisdiction anywhere. We told the
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`Court and Regeneron where they could file suit and where we're
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`not going to contest personal jurisdiction. The 20-odd-plus
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`lawyers, I'm confident, could get a complaint on file on
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`Monday, if they wanted to, in a different jurisdiction where
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`there won't be issues of personal jurisdiction. But that's not
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`what happens here, Your Honor. We're here on what we think is
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`a meritorious personal jurisdiction motion.
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`And under the default local rules -- two points under
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`the local rules. Our motion to dismiss is supposed to be given
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`priority. And we think certainly, given the threshold
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`jurisdictional issues that are presented in our motion, that
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`makes a lot of sense here, and the Court should follow what's
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`already in the local rules.
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`And the second point --
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`THE COURT: To that point, counsel, let me ask, any
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`objection from Samsung's perspective in either -- I should have
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`the numbers memorized by now -- Cases 94 and 106, Mr. Berl's
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`suggestion that Regeneron be given until February 19th,
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`Mr. Berl?
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`MR. BERL: Yes, Your Honor.
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`THE COURT: February 19th, and basically just do an
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`omnibus response to all of the pending anticipated motions to
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`dismiss?
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`MR. TRAUPMAN: The answer to that question, Your
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`Honor, depends on whether or not we're moving in parallel. We
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`don't think we should move in parallel. We think it's
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`improper. We don't think we're subject to the Court's
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`jurisdiction, and I could get into the reasons we think moving
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`forward with discovery is improper.
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`If we're not moving forward with other parts of the
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`proceeding while the motion for personal jurisdiction issues
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`are pending, February 19th is, I guess, okay with us. If
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`that's not the case, then I think we have some issues, but with
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`the proposed schedule, I guess what really just strikes me,
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`from what I've heard counsel for Regeneron state, is I thought
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`this was a legal issue.
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`They stated pretty clearly, both in our conversations
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`and again in the brief for the emergency motion they filed last
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`week, that their view of Acorda is the simple act of making
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`that FDA submission submits the filer to jurisdiction in all 50
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`states. There's no dispute we've made -- that one single fact
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`is, I don't think, in dispute. I think it's pretty clear from
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`our brief that it's not in dispute.
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`And it seems to me that the personal jurisdiction
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`issues are largely legal in nature. And Regeneron has their
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`view of the Acorda decision. We have our view of the Acorda
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`decision. Obviously, it shouldn't take so long to write a
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`brief to explain the basis of why we're wrong in our reading of
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`Acorda, and it shouldn't be that complex.
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`THE COURT: So you're in a hurry as well then, sounds
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`like.
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`MR. TRAUPMAN: To be clear, we are anxious to get
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`resolution of that, Your Honor, but again, we think there's
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`jurisdictions that there won't be any personal jurisdiction
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`issues, and we'd just as soon get moving forward in those
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`jurisdictions as promptly as we can. But again, that's not our
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`choice, and we're dealing with the hand that we've been dealt.
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`And so now we've heard for the first time that there
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`might be other agreements. I don't know exactly what
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`agreements they're talking about. If it's simple, simply some
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`other agreements between SB and its public commercialization
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`partner is Biogen, so I don't think there's any problem saying
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`that on the record. This is the first I've heard from
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`Regeneron that they want some other agreements that they think
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`exist between Biogen and Samsung Bioepis. I don't know exactly
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`what they are. I'm happy to take those requests.
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`THE COURT: That was going to be my next question,
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`counsel. And we'll take it in two parts. But with respect to
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`jurisdictional discovery, is there any objection to that
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`proposal?
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`MR. TRAUPMAN: Without seeing the exact discovery
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`request, I can't say for sure, but in the theory of asking for
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`some additional agreements, I think they said a deposition, on
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`that level I don't think there's any strenuous objections.
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`Again, the devil's in the details, but standing here today,
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`nothing I heard at that high level is problematic, Your Honor.
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`THE COURT: Okay. What about dual-track discovery,
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`both jurisdictional and merits? I'll let you state that
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`officially on the record.
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`MR. TRAUPMAN: As I think you've alluded to, you know
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`the answer to the question, which is Samsung objects to that
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`and does not believe it would be appropriate to move forward
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`with merits-based discovery, any sort of merits-based action,
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`while our personal jurisdiction motion is pending.
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`THE COURT: Understood. Anything else, counsel?
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`Case 1:23-cv-00089-TSK Document 95-1 Filed 02/13/24 Page 13 of 17 PageID #: 4042
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`MR. TRAUPMAN: Not unless Your Honor has any
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`questions.
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`THE COURT: Thank you, sir.
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`MR. TRAUPMAN: Thank you.
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`THE COURT: Celltrion.
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`MR. GOTTLIEB: Thank you, Your Honor.
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`THE COURT: Good morning.
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`MR. GOTTLIEB: First, with respect to the
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`jurisdictional breaching issue, we absolutely are in agreement
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`with Samsung that this should be taken, first, a schedule as to
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`the briefing on the motion to dismiss, or the jurisdictional
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`and venue issues, and then deal with the merits scheduling.
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`And part of that, Your Honor -- I know Regeneron proposed a
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`February 19th date. We think it's more appropriate in this
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`instance to simply follow the local rules and the briefing
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`schedule under it, which, based on Celltrion's filing of the
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`17th, would make their response due roughly on the 31st, if my
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`math is to be trusted, but we think that's appropriate.
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`And additionally, going to the secondary issue of
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`whether jurisdictional discovery is necessary, one, admittedly
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`they've seen Samsung's. We think we'll be similarly situated
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`with respect to some of the legal arguments, but to order
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`discovery prior to Celltrion's filing is preliminary and is too
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`preemptive, Your Honor. And additionally, the other issue with
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`it --
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`Case 1:23-cv-00089-TSK Document 95-1 Filed 02/13/24 Page 14 of 17 PageID #: 4043
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`THE COURT: Making the chosen date of January 17th
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`for this coming motion the fly in the ointment, yes, sir, I
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`would agree. Go ahead.
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`MR. GOTTLIEB: Your Honor, I mean, it is important to
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`note that jurisdictional discovery is, in and of itself, an
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`exception to the rule. And I think it only should be in the
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`instance in which there are serious factual issues, which, as
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`Samsung's counsel pointed out, this should largely be a legal
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`issue, Your Honor, so we think that is preemptive, not the
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`least of which is Regeneron has already received hundreds of
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`thousands of pages of discovery from Celltrion months and
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`months ago, without going into anything confidential, Your
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`Honor, so the contention that kind of more is needed for this
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`immediate process is -- it just doesn't -- it doesn't land,
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`Your Honor.
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`Moving to the timing elements of this, Celltrion's
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`not opposed to moving forward. We think it would be more
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`efficient and easier to move forward in a different venue, Your
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`Honor. In fact, we think that is part of the reason why the
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`venue and personal jurisdiction arguments from an efficiency
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`reason have weight. Like Samsung, Your Honor, Celltrion has
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`made clear to Regeneron that we are happy to make Celltrion
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`available to the personal jurisdiction and venue elsewhere. It
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`will be easier. It will be quicker. We all recognize there's
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`a time crunch, Your Honor, and we're happy to do that, but
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`Case 1:23-cv-00089-TSK Document 95-1 Filed 02/13/24 Page 15 of 17 PageID #: 4044
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`there's another venue that's appropriate to do so.
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`Your Honor, to the extent that the Court would --
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`does not opt for the motion to dismiss solely schedule, we
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`reserve the ability to talk through some of the other issues,
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`but we do think that's most important, because unlike in other
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`situations, this is not your run-of-the-mill litigation, Your
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`Honor. And we think it really is appropriate to deal with
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`these --
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`THE COURT: We get this crowd every day, every day,
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`standing room only, out in the hallway.
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`MR. GOTTLIEB: Absolutely, Your Honor, but unless the
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`Court has any other questions, we're happy to sit for the time
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`being.
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`THE COURT: I get it. Thank you so much.
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`MR. GOTTLIEB: Thank you, Your Honor.
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`THE COURT: Thank you.
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`Formycon. Mr. Griffith, sir.
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`MR. GRIFFITH: Good morning, Your Honor. David
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`Griffith from Thomas, Combs & Spann for Formycon. I don't want
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`to take up much more of the Court's time with that. I'll say
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`that Formycon's position on all of these issues is virtually
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`identical to what Celltrion just presented to the Court.
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`THE COURT: Understood. And let me ask you, just for
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`the record, counsel, any opposition or objection to the
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`proposal of a unified briefing schedule, if you will, and an
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`Case 1:23-cv-00089-TSK Document 95-1 Filed 02/13/24 Page 16 of 17 PageID #: 4045
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`omnibus response from -- obviously defendants should have the
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`opportunity to submit any reply briefs on their own, but any
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`objection to that?
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`MR. GRIFFITH: On the motions to dismiss?
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`THE COURT: Yes, sir.
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`MR. GRIFFITH: No, Your Honor. Although we agree
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`with Celltrion's position that the local rules do provide a
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`schedule for that briefing, that we don't believe there's
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`really any reason to diverge from that.
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`THE COURT: Understood. Thank you, counsel.
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`You actually get a reply, Mr. Berl, but it's early in
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`the year. I'm still --
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`MR. BERL: Christmas spirit.
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`THE COURT: Go ahead.
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`MR. BERL: Christmas spirit still holds.
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`THE COURT: Actually, due to a blue and gold victory,
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`probably more accurate.
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`MR. BERL: I saw that. Congratulations.
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`THE COURT: Thank you. Big year for Mountaineers.
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`MR. BERL: So, Your Honor, as you noted, there's a
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`ticking clock here, and so the notion that the parties should
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`have 69 days after the complaint to file a motion to dismiss
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`for lack of jurisdiction and then we have to await preliminary
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`injunction proceedings to begin until all of that is resolved,
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`that just doesn't make any sense. As I said -- and we'll
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`Case 1:23-cv-00089-TSK Document 95-1 Filed 02/13/24 Page 17 of 17 PageID #: 4046
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`submit it in the papers, but we can flash it up -- case after
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`case after case holds that you can do discovery at the same
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`time.
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`THE COURT: One second. One second. Mr. Berl, if
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`you wouldn't mind filing those.
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`MR. BERL: Why don't I hand up -- those are two
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`copies, with Your Honor's permission to approach. And these
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`cases are on page 10 and 11. They look like docket entries,
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`scheduling orders, that are entered while motions for personal
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`jurisdiction are pending, including the second case that you
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`see in this district that's a case from Judge Bailey clarifying
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`his scheduling order that discovery continues and proceeds
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`while any motions to dismiss for lack of personal jurisdiction
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`is pending.
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`And as I said, districts throughout the land
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`recognize this. It is discretionary. It is discretionary.
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`But in the cases where there's a stay of the merits, the theme
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`of those cases is there's no burden. And here, the notion that
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`we're not burdened is not tenable. They've waited 69 days to
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`file a personal jurisdiction motion. We can't wait. We have a
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`ticking clock. And I think Formycon and Celltrion respectfully
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`recognize that. That's why they're proposing to give us
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`documents pursuant to the schedule that we propose.
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`And so in our view, you should enter the schedule
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`that we proposed. We proposed a schedule -- and if we can look
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