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`UNITED STATES DISTRICT COURT
`
`NORTHERN DISTRICT OF WEST VIRGINIA
`
`Regeneron Pharmaceuticals, Inc.
`
` Plaintiff,
`
` VS. CIVIL ACTION NO.
`
` 1:22-cv-61
`
`Mylan Pharmaceuticals, Inc., et al.,
`
` Defendants.
`
`- - -
`
`Proceedings had in the pretrial conference of the
`above-styled action on May 30, 2023, before Honorable Thomas S.
`Kleeh, District Judge, at Clarksburg, West Virginia.
`
`- - -
`
` APPEARANCES:
`
` On behalf of the Plaintiff:
`
`David I. Berl
`Ellen E. Oberwetter
`Arthur J. Argall, III
`Kathryn S. Kayali
`Williams & Connolly, LLP
`680 Maine Avenue, SW
`Washington, D.C. 20024
`202.434.5000
`
`
`
`
`
`Andrew E. Goldsmith
`Kellogg, Hansen, Todd, Figel & Frederick, PLLC
`1615 M. Street NW, Suite 400
`Washington, DC 20036
`202.326.7945
`
`APPEARANCES CONTINUED ON NEXT PAGE
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`UNITED STATES DISTRICT COURT
`
`NORTHERN DISTRICT OF WEST VIRGINIA
`
`Regeneron Pharmaceuticals, Inc.
`
` Plaintiff,
`
` VS. CIVIL ACTION NO.
`
` 1:22-cv-61
`
`Mylan Pharmaceuticals, Inc., et al.,
`
` Defendants.
`
`- - -
`
`Proceedings had in the pretrial conference of the
`above-styled action on May 30, 2023, before Honorable Thomas S.
`Kleeh, District Judge, at Clarksburg, West Virginia.
`
`- - -
`
` APPEARANCES:
`
` On behalf of the Plaintiff:
`
`David I. Berl
`Ellen E. Oberwetter
`Arthur J. Argall, III
`Kathryn S. Kayali
`Williams & Connolly, LLP
`680 Maine Avenue, SW
`Washington, D.C. 20024
`202.434.5000
`
`
`
`
`
`Andrew E. Goldsmith
`Kellogg, Hansen, Todd, Figel & Frederick, PLLC
`1615 M. Street NW, Suite 400
`Washington, DC 20036
`202.326.7945
`
`APPEARANCES CONTINUED ON NEXT PAGE
`
`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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`
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`Case 1:22-cv-00061-TSK-JPM Document 517 Filed 06/02/23 Page 2 of 87 PageID #: 41333
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`On behalf of the Plaintiff, continued:
`
`
`
`Steven Robert Ruby
`Carey, Douglas, Kessler & Ruby, PLLC
`797 Virginia Street, East, Suite 901
`Charleston, WV 25301
`304.345.1234
`
`
`Petra Scamborova
`Regeneron Pharmaceuticals, Inc.
`777 Old Saw Mill River Road
`Tarrytown, NY 10591-6717
`914.847.7611
`
`On behalf of the Defendant:
`
`Deanne M. Mazzochi
`William A. Rakoczy
`Heinz J. Salmen
`Eric R. Hunt
`Lauren M. Lesko
`Neil B. McLaughlin
`Rakoczy, Molino, Mazzochi & Siwik, LLP
`6 W. Hubbard Street, Suite 500
`Chicago, IL 60654
`312.527.2157
`
`
`
`
`
`
`
`
`
`William J. O'Brien
`Steptoe & Johnson
`400 White Oaks Blvd.
`Bridgeport, WV 26330
`304.933.8162
`
`
`
`Also attending: from Mylan Pharmaceuticals, Matthew
`Greinert; from Biocon Biologics, Subhashini Karra.
`
`
` Proceedings recorded utilizing realtime translation.
` Transcript produced by computer-aided transcription.
`
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`Tuesday Morning Session,
`
`May 30, 2023, 10:26 a.m.
`
`- - -
`
`THE CLERK: Regeneron Pharmaceuticals, Inc.,
`
`plaintiff, versus Mylan Pharmaceuticals, Inc., et al.,
`
`defendants, Civil Action Number 1:22-CV-61.
`
`Will counsel please note your appearance for the
`
`record.
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`MR. RUBY: Your Honor, Steve Ruby.
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`THE COURT: Good morning, Mr. Ruby. I didn't realize
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`you were all the way back there.
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`MR. RUBY: Good morning, Your Honor. Steve Ruby for
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`the plaintiff, and joined at counsel table by David Berl, Ellen
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`Oberwetter, Arthur Argall of Williams & Connolly.
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`MR. O'BRIEN: Good morning. William O'Brien for
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`defendant Mylan Pharmaceuticals. With us at counsel table are
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`Deanne Mazzochi, Bill Rakoczy, Neil McLaughlin, Heinz Salmen,
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`Lauren Lesko, and Eric Hunt.
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`MR. HUNT: Excuse me, Your Honor. We also have
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`in-house representatives that would like to be introduced to
`
`the Court today. From Mylan Pharmaceuticals, Matthew Greinert;
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`and from Biocon Biologics, Subhashini Karra.
`
`MR. RUBY: I neglected to introduce our in-house
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`representative from Regeneron, Petra Scamborova.
`
`THE COURT: Anyone else?
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`MR. RUBY: I think that's it, Your Honor.
`
`THE COURT: Apologies for being on judge time this
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`morning.
`
`We have convened for our pretrial conference. Trial
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`remains scheduled for June 12th, as the parties are quite well
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`aware, I'm sure. A couple developments since I believe the
`
`last time we spoke that word is out that we can discuss it for
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`purposes of our record. Our courthouse will be closed starting
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`July 3rd. There's an asbestos abatement project that needs to
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`begin here in Clarksburg; in particular, just on the other side
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`of that wall to counsel's right.
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`We've been assured repeatedly by our landlords at GSA
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`that our air quality tests are fine and nothing is friable and
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`all the rest, but as part of an overall larger project,
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`including replacing the two roofs on this now antique structure
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`of a building, that asbestos needs abated.
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`The abatement, as I mentioned, is scheduled to start
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`the week of the 3rd. We, as in my chambers and this courtroom
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`in particular, have to vacate by June 27th for the mobilization
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`to prepare for that abatement.
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`So we don't have extraneous time available to us from
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`a physical structure. And we kind of need to stay on that
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`schedule, given the contractors and the rest.
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`Presently, the courthouse is closed for 30 days
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`starting July 3rd. When I say "the courthouse," the courthouse
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`will be closed. As I mentioned, my chambers, we're being
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`kicked out that week of the 26th so they can prepare, but the
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`courthouse itself will be closed for at least 30 days starting
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`on July 3rd.
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`GSA assures us they can get it done in less than 30
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`days. Our district's informal polling of our asbestos
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`abatement projects around the country indicate that may be
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`wishful thinking, so we're going to play that by ear. We do
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`anticipate other parts of the courthouse being able to be
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`opened, but our shop, which includes the only suitable
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`courtroom in this building, might be a little behind.
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`I mention that for everyone's general edification to
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`highlight two things: We've got the week of the 12th and the
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`week of the 19th, with the 19th being a holiday, scheduled for
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`trial. I know we need to discuss closing arguments, briefing,
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`and proposed findings of fact and conclusions of law as well.
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`I would anticipate not being in the Clarksburg
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`courthouse for closings. We can talk about where and how we do
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`those. Our docket has been divvied up. Trials during this
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`period where we're going to be displaced, the criminal trials
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`will take place in Wheeling; civil trials in Elkins. There's
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`space in both locations that we can use largely at our need at
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`both courthouses. So we can talk about when and where all of
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`that occurs.
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`Let me start here, given that sort of background.
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`Mr. Berl, are you confident we can complete trial in the time
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`we have allotted at this point, sir?
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`MR. BERL: Yes.
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`THE COURT: Counsel?
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`MS. MAZZOCHI: Yes, we are, Your Honor.
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`THE COURT: I saw this morning a notice of mootness
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`on a motion in limine for Dr. Russell and the rest. Are the
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`parties having ongoing discussions about coming to some
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`consensus of what our trial presentations will look like?
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`MR. BERL: I don't think so, Your Honor. I think we
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`need help on some of that. That's, frankly, the main thing, in
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`our view, that needs to get resolved today is what the scope of
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`the trial will be. There has been some narrowing. We can get
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`into the details of that, but I don't think that there are
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`ongoing discussions now that will bear fruit in terms of
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`further resolving the scope of the trial.
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`THE COURT: Okay. All right.
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`Counsel.
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`MS. MAZZOCHI: Sure. Your Honor, we actually
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`provided several proposals to Regeneron based on some of the
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`issues that we think they're not really contesting at trial or
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`based on some of the particular positions that they've taken in
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`this case, again, to try to streamline or narrow issues. We
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`didn't really get much response on that, so -- but I think that
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`the parties are seasoned trial lawyers. We understand how
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`we're going to be able to get it done. I think as long as we
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`know the target number of hours that we're going to have on
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`each side to get our presentation done, recognizing we're
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`dealing with clinicians who may have scheduling issues, but
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`that we're going to try to work through independently.
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`THE COURT: If any of those clinicians or others need
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`reminded of the import and impact of subpoenas from the United
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`States District Court, I'm happy to provide that as necessary.
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`I'll mention that with all due candor and respect to those
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`folks.
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`I give everyone that background, again, for what
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`we're dealing with in terms of a physical space here. It's
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`been a heavy lift trying to get a plan together going forward,
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`and we, through intensive and lengthy negotiations with our
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`landlord, insisted that their project begin after this trial,
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`so with respect to everyone's clients, witnesses, experts, and
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`the rest, they need to be made aware that we've got sort of a
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`hard stop that looms toward the end here.
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`There is already in place a standing order outlining
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`all of this. I know it's available on the court's
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`public-facing website, but at this juncture it doesn't say
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`anything other than what I've noted here, other than our
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`chambers and this courtroom will be displaced a week ahead of
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`the entire building being closed. So that -- I'll put it
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`politely -- presents issues and we continue to work through
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`those.
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`I've got a list, let's kind of check through those,
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`of pending matters. Motion 175, which is Regeneron's motion
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`for judgment on the pleadings, is that mooted at this point, or
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`is that a remaining dispute that needs addressed?
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`MR. BERL: That remains.
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`THE COURT: Okay. All right, Mr. Berl, go right
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`ahead then. I'm sorry. Whomever.
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`MR. BERL: So this relates in some way to what
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`happened Thursday night, which I don't know if it's on your
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`list, might have missed it in the torrent of filings.
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`THE COURT: "Torrent" is on outstanding word.
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`MR. BERL: But Mylan on Thursday night filed a motion
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`to amend its answer to add various new defenses, and that
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`motion to amend its answer interfaces in some regard to our
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`motions on the pleading. If you'd like to address that first,
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`Your Honor, my cocounsel, Ms. Oberwetter, is prepared to do
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`that.
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`THE COURT: Yes, counsel. Thank you.
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`MS. OBERWETTER: Your Honor, we have a set of
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`PowerPoints to address the amended answer. This does not
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`appear to be connected here, but we're happy to hand those out
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`at this point.
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`THE COURT: I see our title slide -- never mind. One
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`of the other things we need to talk about is intervener motion.
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`"Inventorship." Different word. We will come to
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`intervenorship later.
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`MS. OBERWETTER: We will, I'm sure, come to that
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`later.
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`So, Your Honor, to talk about sort of what Mr. Berl
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`alluded to, which is concern about the scope of the case, last
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`Thursday night at about 11:56 p.m. Mylan filed a motion to
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`amend, rather substantially, its answer.
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`THE COURT: From Regeneron's standpoint, what are, as
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`I think you mentioned, counsel, substantial revisions to their
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`answer or counterclaims?
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`MS. OBERWETTER: So we have hard copies. They did
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`not supply a red line when they put that in. It is dozens of
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`pages of new allegations that were not previously in the
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`complaint. They really fall into two categories. I'm happy to
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`hand those out to you -- we have red line copies -- at whatever
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`point is convenient for Your Honor.
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`So there really are two components of what they
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`included in their motion to amend, which I'm sure, as you can
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`anticipate, our position will be it is drastically too late to
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`do that in a case two weeks out from trial, trying to figure
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`out who our witnesses are going to be, how much time they're
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`going to take, all of those kinds of things.
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`So the two components that they included really go
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`point one, to an effort, as we understand it, to moot our
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`pending 12(c) motion on the pleadings with respect to
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`inequitable conduct. So we have divided up the substantive
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`issues in Mylan's motion. My cocounsel and colleague, Andy
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`Goldsmith, at Kellogg Hansen, who's here today, is prepared to
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`address any issues related to the inequitable conduct
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`allegations and the 12(c) motion.
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`The second part of what they included in the motion
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`to amend is basically a brand-new defense going to the question
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`of proper inventorship on the patents in the case. They are
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`citing new statutes. They put in dozens of new allegations,
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`albeit deficient, we believe, from a Rule 9(b) standpoint, and
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`I will get to that.
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`There's no basis for this. So there's really two
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`parts of the argument I'm going to make, the first from a
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`timing standpoint. We are way too late to be doing this. The
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`second is, their amendments would be futile in any event.
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`Either of those is a basis for denying the motion at this point
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`and saying the parties should be going about their business and
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`getting ready for trial without the interjection of dozens of
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`new pages of allegations.
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`I'd like to start just with a brief time line of the
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`case and how their allegations now fit into it. The case has
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`been pending since August 2nd. The deadline to amend pleadings
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`was December 9th of 2022. We are well past that at this point.
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`Fact discovery closed basically toward the end of January.
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`Basically the only thing that we have heard from Mylan as a
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`justification for this is that we have continued to narrow our
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`claims. Those claims have been in since the beginning. And
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`what that argument essentially boils down to is an argument
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`that our compliance with the scheduling order means they get to
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`amend late. It is absolutely nonsensical.
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`Many of the claims that they are complaining about,
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`these are not one-offs. They're all over the patents. So I've
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`put up on the -- put them in the slide presentation. Slide 3,
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`there are multiple versions of the claims that they are
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`complaining about as somehow having been imperceptible to them
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`during the entire pendency of this case. The only other thing
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`they've attempted to say in their brief is that there has
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`been -- they say recent discovery which causes the need to add
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`some of the new allegations they're making.
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`There hasn't been any new, recent discovery.
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`Discovery closed at the end of January. The motion that they
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`put in with their motion to amend, bereft of anything that is a
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`recently discovered fact.
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`They also say that the discovery period recently
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`closed. That just isn't accurate. Discovery closed at the end
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`of January. So whether it's a matter of our claim narrowing or
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`whether it's a matter of something being a newly discovered
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`fact, neither of those is accurate.
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`They have mentioned at various points in their
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`brief -- and I'm not going to put this one up on the screen
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`because it's at least nominally confidential, but they did make
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`a point -- and this is Slide 4 in what I handed up -- they did
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`make a point that inventorship was in their patent disclosures
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`before the case was filed. It is not. So we have outlined at
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`Slide 4 exactly where you would have expected to see it. It
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`isn't there.
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`They don't satisfy the tests -- so let me go forward.
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`They don't satisfy the test for doing an amendment at this
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`point in time. So I think they cited in their brief, and we
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`would agree, that the leading Fourth Circuit case on this
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`p0oint is this Nourison Rug case. You have to have a real
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`reason. It can't just be you get to the point of trial, look
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`at your defenses, and say, I have one more that I didn't think
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`of before.
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`That doesn't allow anybody to plan. That doesn't
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`allow anybody to prepare witnesses, to figure out who their
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`experts are going to be and what their expert opinions are
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`going to be, and this falls precisely into that category. Both
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`the Fourth Circuit and courts within the Fourth Circuit have
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`made abundantly clear you have to demonstrate diligence in
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`order to amend a pleading after the time provided in the
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`scheduling order, which, again, at this point was back in
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`December.
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`This is not just a one-off rule. This is multiple
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`courts within the Fourth Circuit who make this point over and
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`over again that you have to demonstrate diligence.
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`I want to pause for a minute on one particular case
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`out of the District of New Jersey which is in the relatively
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`recent past, involved a very similar situation. This is the
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`Eagle View Technologies case that we have put an excerpt of up
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`on the screen, which involved an effort to add a late
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`inventorship defense shortly before trial. The Court had no
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`patience for it and denied the effort to do it, and --
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`THE COURT: The courts lacking patience. Huh.
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`MS. OBERWETTER: Maybe the right way to put it is
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`denied the motion, Your Honor, because there was no basis for
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`it. There was -- there had not been -- first of all, there
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`hadn't even been an effort by the party that wanted to add the
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`late amendment to come in and say, we actually need more time
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`to amend our pleadings, so I don't know at what point this
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`first started bubbling over there that maybe they would want to
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`add an inventorship defense to the case. I highly doubt it was
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`just last Thursday. They never came to us and said they were
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`going to do it. They never asked for more time to amend the
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`pleadings.
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`The other thing that the Eagle View case is
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`particularly useful for is that it recognizes a new
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`inventorship defense is not a minor thing. It went through the
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`litany of ways that that could affect the parties' defenses,
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`that that could affect the parties' expert presentations, so
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`this is a significant thing that they are seeking to do two
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`weeks before trial, with nobody having developed testimony on
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`it, with nobody having developed expert opinions on it, as we
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`are all sort of headed up to our June 12, which is, as we know,
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`quickly upon all of us.
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`There are other courts within the Fourth Circuit who
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`have made the point that prejudice to a party in the face of a
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`belated amendment is likely to occur where the amendment is
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`happening after a significant amount of discovery already has
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`been conducted. That's obviously the situation. Discovery
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`concluded back in January.
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`THE COURT: Let's get to the futility argument. I
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`think Mylan is going to have a difficult time on the timeliness
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`issue, but let's talk about futility.
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`MS. OBERWETTER: Yes, Your Honor. So a couple of
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`things on futility. If we just talk about the record that has
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`already been developed, the point I'm about to make goes both
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`to diligence and to futility. They had witnesses in front of
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`them during the discovery period who, if they had wanted to ask
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`any question whatsoever, they could have done it it. They
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`didn't do it.
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`There is now nothing in the record to support what
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`they want to do on inventorship, so just -- they had -- this is
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`illustrative. They had Regeneron's outside counsel, an
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`individual named Karl Bozicevic, who worked on the patent
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`prosecutions, they had him for as much time as they needed.
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`They asked no questions about how inventorship was assessed.
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`It didn't happen.
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`I'll skip a couple slides so I can keep getting to
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`more of what you're interested in. But it didn't happen. They
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`had one of Regeneron's in-house counsel in front of them where
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`they could have asked, how did you go about assessing
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`inventorship for any of the patents that we're talking about in
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`this case. They didn't ask the question.
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`So I think the absence of evidence goes both to the
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`diligence issue and to the fact that an amendment at this point
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`would be futile. I don't know what the record is that they
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`think would support it. They certainly don't talk about it
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`their pleadings.
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`So let's go just briefly to -- I don't want to wade
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`too much into the substance of inventorship principles for
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`today's purposes, because we have multiple layers of arguments
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`as to why this is a futile undertaking. But first of all, they
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`just get the law of inventorship wrong in some of the points
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`they make in their motion.
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`There's not really a question that inventions can be
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`a combination of known elements and it cannot be that you have
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`to list everybody who ever contributed to an element of a
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`patent as a coinventor. That just isn't what the law provides.
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`And I'll give you an example with reference to one of the
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`claims in the case that they are pointing to is something where
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`they now say they have discovered there's an inventorship
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`problem.
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`So if you take Claim 6 of the '572 patent, which
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`depends back to Claim 1, and we've cut out the intervening two
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`claims, but it goes back to Claim 1, this is where they're
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`saying there needed to be a coinventor, and it simply misstates
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`the law.
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`Dr. Yancopoulos didn't have to invent independently
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`every aspect of this claim. He didn't have to invent the
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`concept of a week for weekly dosing. He didn't have to invent
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`the concept of an intravitreal injection that some guy back in
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`1911, I think we've determined, actually is the one who came up
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`with. All he has to have done is take elements and combine
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`them in a way that patent law recognizes. So they're simply
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`misstating the law of inventorship.
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`I will also note their inventorship arguments are
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`futile because improper inventorship can be cured. That's very
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`clear under 35 U.S.C. 256(a). They make an argument, and I'm
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`going to try to just move through this, Your Honor, but 256(a)
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`permits correction even of intentional inventorship errors,
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`which we didn't have here, but even if we did, it would allow
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`that correction. And that's the Egenera 2020 Federal Circuit
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`case. What the Federal Circuit said in that case is if you're
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`in a situation where there's an intentional or deceptive
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`inventorship area, you're back in the land of inequitable
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`conduct. There's no problem with actually correcting
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`inventorship.
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`I'll speed through this one. This is a now
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`25-year-old Federal Circuit case making clear that the
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`inventorship correction statute is a savings provision and you
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`can correct inventorship.
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`So let me go -- skip past this Janssen slide. Let me
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`go to the bigger problem, apart from we don't have to wade into
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`the merits of inventorship for you to see why the new amendment
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`is futile.
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`Futility is also demonstrated by fact that they are
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`subject to the 9(b) pleading requirements for claiming
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`intentional misnaming of an inventor or a failure to name an
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`inventor. That's the inequitable conduct. The Federal Circuit
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`and other courts have been very clear, when you're talking
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`about inequitable conduct, you have to apply the Rule 9(b)
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`standards, because you're accusing people of fraud, is what
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`you're really doing.
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`So in anything that Mylan filed last Thursday, where
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`is the classic 9(b) formulation, the who, what, where, when, of
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`somebody associated with Regeneron who put in a false
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`intentional statement about inventorship to the Patent Office.
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`Where is it? You can read the memo. You can read the dozens
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`of pages of allegations they've put in. It isn't in there.
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`They don't have it, because there is no evidence to support
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`that that's what actually happened. Who is the person that
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`they're saying did that? Who is the person? They haven't
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`said.
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`So under the standards of Rule 9(b), they have no
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`well-pleaded Rule 9(b) inventorship deception theory. None
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`would be plausible. Even if they come up with one, they have
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`absolutely no motive they have pointed to why someone would
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`have left someone off intentionally here or what it would
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`matter to.
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`To the extent they're trying to suggest that somebody
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`did this intentionally -- I will add there's also lots of cases
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`that talk about how generally, as in other 9(b) contexts,
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`security fraud or whatever else, you can't just have general
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`and conclusory allegations from the standpoint of your
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`inequitable conduct allegations, including those that relate to
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`inventorship.
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`So the last point I want to make, just to give you
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`some additional comfort on all of this, although we feel very
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`strongly the timing alone should suffice here, is that there's
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`lots of room in inventorship case law for differences of
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`opinion about who should be an inventor, and the fact that they
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`disagree about who should be an inventor is not proof of
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`anything. Lots of people under even Federal Circuit
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`standards -- the Federal Circuit has acknowledged there can be
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`room for disagreement, because it's a complicated legal issue.
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`So those are the points that I wanted to make, both
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`from a timing standpoint; the volume of allegations alone
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`should be enough to shut this down at this point.
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`THE COURT: Understood. Thank you, counsel.
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`Counsel? Within reason I'll give you a chance to say
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`whatever you'd like, but there is no question in my mind,
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`subject to that changing, that it's untimely, so what is the
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`good cause to excuse the untimely nature of this motion?
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`MS. MAZZOCHI: I will give you exactly the good
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`cause. So from the beginning of this case, Your Honor, when it
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`comes to the dosing patents, Regeneron was really focusing on
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`three issues they said caused their claims to be differentiated
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`from the prior art. They were focusing on efficacy issues,
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`they were focusing on the BCVA claim element, and they were
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`focusing on the exclusion criteria.
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`So they've got hundreds of pages in their expert
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`reports where they're going on and on about how this is new,
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`this is novel, this is nonobvious. After the Court's claim
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`construction and we filed our motion for summary judgment, all
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`of a sudden Regeneron turned on a dime. Now they're pointing
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`to this isotonic solution claim element as this is somehow the
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`nirvana of the invention that is going to save it from
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`invalidity.
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`They have all of two paragraphs in their Dr. Trout
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`expert report, didn't even talk about anticipation, only
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`focused on obviousness, and they had two conclusory paragraphs
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`from Dr. Czaky who started saying this. Even then that's part
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`of our summary judgment motion on Claim 6, that we don't think
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`they've actually even created a genuine dispute of material
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`fact that these particular claims can survive summary judgment.
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`Now, in their summary judgment motions, so all of a
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`sudden we start seeing in these summary judgment motions that
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`they're going to be elevating this isotonic solution claim
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`element. Here's the problem, Your Honor. Back during fact
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`discovery, when we did ask them, what's your story of the
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`invention, who did what, when they were focusing on
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`Dr. Yancopolous and what he did, they were focusing on the
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`dosing regimen. They've now conceded that's invalid.
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`When it came to any formulation issues, they were
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`focusing on a different group who had created the invention of
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`Eylea and the formulation and all that sort of t
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