throbber
Case 1:22-cv-00061-TSK-JPM Document 90 Filed 11/02/22 Page 1 of 46 PageID #: 2249
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`1 UNITED STATES DISTRICT COURT
` NORTHERN DISTRICT OF WEST VIRGINIA
`
` REGENERON PHARMACEUTICALS, INC.,
`
`2 3
`
`4 Plaintiff,
`
`5 vs. CASE NO.:
` 1:22-CV-61
`6 MYLAN PHARMACEUTICALS INC.,
`
`7 Defendant.
`
`8 - - -
`
`9 Proceedings had in the status conference of the
` above-styled action on Wednesday, September 28, 2022, before
`10 the Honorable Thomas S. Kleeh, Chief District Judge, at
` Clarksburg, West Virginia.
`11
` - - -
`12
` APPEARANCES:
`13
` On behalf of the Plaintiff via Zoom:
`14
` David I. Berl
`15 Williams & Connolly LLP - Washington
` 680 Maine Avenue, SW
`16 Washington, DC 20024
` dberl@wc.com
`17
` Steven Robert Ruby
`18 Carey, Douglas, Kessler & Ruby, PLLC
` 707 Virginia Street, East
`19 Suite 901
` Charleston, WV 25301
`20 sruby@cdkrlaw.com
`
`21 James Evans
` Petra Scamborova
`22 Regeneron Pharmaceuticals, Inc.
` 777 Old Saw Mill River Road
`23 Tarrytown, NY 10591-6717
` james.evans@regeneron.com
`24 petra.scamborova@regeneron.com
`
`25 APPEARANCES CONTINUED ON NEXT PAGE
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`1 On behalf of the Defendant via Zoom:
`
`2 Gordon H. Copland
` William J. O'Brien
`3 Steptoe & Johnson PLLC - Bridgeport
` 400 White Oaks Boulevard
`4 Bridgeport, WV 26330
` gordon.copland@steptoe-johnson.com
`5 william.obrien@steptoe-johnson.com
`
`6 William Rakoczy
` Neil B. McLaughlin
`7 Rakoczy, Molino, Mazzochi & Siwik, LLP
` 6 W. Hubbard Street, Suite 500
`8 Chicago, IL 60654
` wrakoczy@rmmslegal.com
`9 nmclaughlin@rmmslegal.com
`
`10 Matthew Greinert
` Thomas Jenkins
`11 Viatris Inc.
` 1000 Mylan Boulevard
`12 Canonsburg, PA 15317
` matthew.greinert@viatris.com
`13
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`14 Proceedings recorded utilizing realtime translation.
` Transcript produced by computer-aided transcription.
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`Case 1:22-cv-00061-TSK-JPM Document 90 Filed 11/02/22 Page 3 of 46 PageID #: 2251
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`1 Wednesday Afternoon Session
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`2 September 28, 2022, 2:59 PM
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`3 - - -
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`4 THE COURT: Madam Clerk, would you be kind enough to
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`5 call our next case, please.
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`6 THE CLERK: Regeneron Pharmaceuticals, Inc., versus
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`7 Mylan Pharmaceuticals, Inc. Civil Action Number 1:22-cv-61.
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`8 Will counsel, beginning with Plaintiff's counsel,
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`9 please note your appearance for the record.
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`10 MR. RUBY: Good afternoon, Your Honor. Steve Ruby --
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`11 Carey, Douglas, Kessler & Ruby -- for Plaintiff, Regeneron.
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`12 And also with me I have David Berl of Williams & Connolly,
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`13 who's been admitted pro hac vice and will be primarily handling
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`14 the matter for Plaintiff today.
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`15 We also have a couple of Plaintiff representatives
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`16 from in-house counsel with Regeneron, Petra Scamborova and
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`17 James Evans, Your Honor.
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`18 THE COURT: All right. Good afternoon, counsel.
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`19 MR. COPLAND: Good afternoon, Your Honor. This is
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`20 Gordon Copland, Steptoe & Johnson, appearing for the
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`21 Defendants.
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`22 Also appearing are William Rakoczy of the Rakoczy
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`23 Molino firm. Mr. Rakoczy will be addressing the Court on the
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`24 issues we expect.
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`25 Furthermore, Mylan is also appearing through two
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`1 in-house attorneys, Thomas Jenkins and Matthew Greinert, who
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`2 are attending the hearing.
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`3 THE COURT: All right. Understood. Good afternoon
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`4 to you as well, counsel. And, again, my apologies collectively
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`5 to everyone for being a bit behind schedule here today.
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`6 We convene to discuss some scheduling issues as there
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`7 seems to be quite a divergence as to not only when we should
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`8 set trial but also under what statutory vehicle we proceed.
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`9 Plaintiff's counsel, the floor is yours first.
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`10 MR. BERL: Thank you very much, Your Honor.
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`11 David Berl of Williams & Connolly representing Regeneron.
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`12 Your Honor, in our view this is not a garden variety
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`13 patent infringement case. In particular, there are two
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`14 important differences between this case and the typical case
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`15 that comes before Your Honor in terms of patent infringement.
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`16 The first key difference is that this case, a BPCIA
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`17 case -- BPCIA is an acronym for the biosimilar statute passed
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`18 as part of Obamacare -- includes with it a series of voluminous
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`19 exchanges that occur before the case is filed, colloquially
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`20 referred to as the "patent dance." And that patent dance
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`21 includes Regeneron's assertions about what claims are infringed
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`22 and why, Mylan's assertions about why its product and
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`23 manufacturing process don't infringe those claims, Mylan's
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`24 assertions for why the claims are invalid, and Regeneron's
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`25 responses as to why it believes its claims are valid.
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`1 That all happened via an exchange of many hundreds of
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`2 pages of information going both ways all before this case was
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`3 filed. And that's important in our view because this case does
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`4 not begin at the same posture as most cases. We're part of the
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`5 way down the runway -- I would submit much of the way down the
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`6 runway -- toward knowing what we would generally not know until
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`7 that discovery has occurred.
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`8 We've seen their aBLA -- that's their FDA
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`9 application -- to sell their biosimilar version of Regeneron's
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`10 flagship Eylea product. We've seen additional information as
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`11 well. And we are prepared to move forward, given that
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`12 information, on an accelerated schedule.
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`13 Which brings me to the second distinction between
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`14 this case and the typical patent infringement case is that this
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`15 case, pursuant to the BPCIA, provides more particular statutory
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`16 relief that Congress included when it passed the BPCIA. And
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`17 that statutory relief is a mandatory injunction precluding the
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`18 Defendant, here Viatris, from marketing and selling its product
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`19 in the United States until expiry of any patent that Your Honor
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`20 finds to be valid and infringed following trial as long as
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`21 there's what's called in the statue a final court decision,
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`22 which is defined as a judgment that is either not appealed or
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`23 appealed and then ruled on by the court of appeals, here the
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`24 Court of Appeals for the Federal Circuit.
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`25 So we can be flexible, Your Honor, with respect to
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`1 how this case proceeds and even with respect to how many
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`2 patents move forward at this juncture. But we cannot be
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`3 flexible -- because the statute does not permit us to be
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`4 flexible -- as to the timing of the case, as to the timing of
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`5 the trial and the ultimate disposition of the case, which in
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`6 our view needs to occur before May 18th, 2024, in order to
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`7 avail ourselves of the statutory relief that Congress provided.
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`8 So that's why, in our view, we've proposed a schedule
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`9 we think is feasible. We think it's reasonable. We think it's
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`10 within the scope and balance of what other courts and
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`11 administrative bodies have ordered in circumstances that we
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`12 view are -- as analogous.
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`13 But the fundamental point here is that it is not
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`14 appropriate for Viatris, the defendant, to moot our claim for
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`15 statutory relief, our primary request for relief, simply by
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`16 running out the clock. But irrespective of the merits of
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`17 opposition on validity and infringement, we are not permitted
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`18 to obtain statutory relief. So that's why we provided the
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`19 schedule we've provided.
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`20 The Defendant, Viatris/Mylan, has provided a few
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`21 responses, largely that our schedule isn't feasible. We don't
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`22 believe that to be true. They are a large company as Your
`
`23 Honor knows. Eleven lawyers on their side already have entered
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`24 an appearance. And we think we can move forward, given what we
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`25 already know, on the schedule that we have provided for.
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`1 Their second primary response --
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`2 THE COURT: Mr. Berl.
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`3 MR. BERL: -- is the fact --
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`4 Yes.
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`5 THE COURT: If I could interrupt you there before you
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`6 transition.
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`7 What would Plaintiff's position be on the remaining
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`8 discovery or other issues necessary to occur before trial
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`9 given -- and I'll borrow your phrase -- the patent dance work
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`10 that's already occurred?
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`11 MR. BERL: Yes. So, Your Honor, there are no
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`12 documents for us to produce. Mylan has already produced its
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`13 FDA application. There are some additional documents that we'd
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`14 like them to produce. We provided them requests back in August
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`15 for those documents. So they understand what we need. And
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`16 that's largely what we need. There may be a few follow-ups,
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`17 but that largely is what we need.
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`18 In terms of what needs to happen from our
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`19 perspective, from what we need to produce, we have prepared a
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`20 substantial document production that includes the most
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`21 important documents in my client's possession; that is the
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`22 relevant portions of its FDA application for its Eylea product,
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`23 the laboratory notebooks that reflect the conception of the
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`24 invention at issue, scientific reports that reflect information
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`25 about the research and development that led to the inventions
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`Case 1:22-cv-00061-TSK-JPM Document 90 Filed 11/02/22 Page 8 of 46 PageID #: 2256
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`1 that are disclosed in claims here, as well as the patents and
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`2 their file histories. We will be prepared to furnish all of
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`3 that information, all of those documents to Mylan within 48
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`4 hours of Your Honor's entry of a protective order.
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`5 And by way of update, we have received a response
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`6 from Mylan. We're conferring with Mylan tomorrow. And we're
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`7 hopeful that by the end of the week the parties will be able to
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`8 present for Your Honor's signature a stipulated protective
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`9 order. And within 48 hours of that being executed by The
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`10 Court, as I said, we will produce the lion's share of the
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`11 information that Mylan would need.
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`12 At that point, obviously, they would review the
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`13 documents; we would review the documents they have produced;
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`14 and we would proceed to depositions.
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`15 We're mindful, Your Honor, of the fact that we are
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`16 requesting an accelerated schedule. And what that means is
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`17 that this should not be a case in which 50 depositions happen
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`18 on both sides. This is not a four-year schedule. This is a
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`19 nine-month schedule. Again, starting from today nine months
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`20 rather than from the date of the exchanges that have preceded
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`21 the filing of the complaint.
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`22 And so we will obviously have depositions. They will
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`23 be able to learn about the discoveries and the research and
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`24 development that led to them. We'll need to take depositions
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`25 to understand a little more of what their FDA application means
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`Case 1:22-cv-00061-TSK-JPM Document 90 Filed 11/02/22 Page 9 of 46 PageID #: 2257
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`1 and their product. And following that we would proceed to
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`2 expert discovery.
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`3 Mylan has suggested that the expert discovery will be
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`4 unwieldy, that we'll have innumerable experts. Just to be
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`5 clear, Your Honor, that's not the case. We will not present to
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`6 Your Honor anything like the boogeyman of a case that Mylan has
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`7 presented in its papers. I've been doing this for two decades
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`8 now. I have never presented to The Court 655 claims, or
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`9 whatever the number is, for adjudication at trial. I would be
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`10 shocked if we present more than a dozen claims to Your Honor
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`11 for adjudication at trial.
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`12 No fact finder, no matter how experienced and how
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`13 intelligent, can keep 655 claims straight in his or her mind.
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`14 And we don't pretend that you should be the first. So we will
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`15 narrow the case substantially before trial. We think that
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`16 should be done in a reasonable manner. We shouldn't have to
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`17 pick and choose at this point, essentially playing roulette,
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`18 before we have a claim construction proceeding and we have
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`19 discovery. But following that fact discovery and claim
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`20 construction proceeding, we will be prepared to narrow the case
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`21 substantially, down to a small number of patents, somewhere in
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`22 the range of four patents. And at that point we can proceed to
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`23 trial on a small number of claims. Nowhere close to the
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`24 hundreds of claims. Somewhere in the range of a dozen or two
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`25 claims at that point. And we'll further narrow before trial.
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`1 So we think this can be done and managed, given what
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`2 we already know, in an efficient manner. We will litigate the
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`3 case in recognition of the schedule. We're not going to have
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`4 25 experts come in in a nine-month schedule. That's
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`5 unreasonable. We wouldn't do that upon asking Your Honor for
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`6 this schedule. It has to be litigated in a commensurate and
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`7 reasonable way. And we're prepared to do that.
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`8 THE COURT: All right. Thank you, Counsel.
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`9 Mr. Rakoczy. And I'm sorry if I'm not pronouncing
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`10 your name correctly, sir. Is that -- am I close?
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`11 MR. RAKOCZY: That is correct, Your Honor.
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`12 Mr. Rakoczy. William Rakoczy.
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`13 THE COURT: All right. Thank you, sir. Go right
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`14 ahead.
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`15 MR. RAKOCZY: Thank you, Your Honor.
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`16 I'd like to start first with the remedy issue. So
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`17 point one, Your Honor: Regeneron will not be left without a
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`18 remedy here. There's no dispute that they can seek a
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`19 preliminary injunction if the emergent need arises and that
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`20 they can seek a permanent injunction under the patent laws,
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`21 just like any litigant can do, and under Supreme Court case
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`22 law.
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`23 As for the statutory issue, Your Honor, they are not
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`24 interpreting it how the statute has been applied. For one
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`25 thing --
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`1 THE COURT: And, Mr. Rakoczy, you're speaking
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`2 specifically about the BPCIA? Is that right?
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`3 MR. RAKOCZY: Yes, Your Honor.
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`4 THE COURT: Okay.
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`5 MR. RAKOCZY: I want to speak about that issue.
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`6 So the first issue is there's no dispute they can
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`7 seek a permanent injunction if they win it. All patent
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`8 applicants can do that. All people that sue as a patent owner
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`9 can do that.
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`10 On that specific statutory issue, Your Honor,
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`11 mentioned, my point is this: The majority of all BLAs, or
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`12 biosimilars, in the past have been approved years before there
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`13 was ever a District Court, much less a Federal Circuit appeal,
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`14 decision. And the only courts to redress this issue have, in
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`15 fact, granted the permanent injunctive relief under that
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`16 statute even though the BLA was approved years before those
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`17 final judgments. So this interpretation of Regeneron just does
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`18 not come to pass.
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`19 Beyond that, Your Honor, the interpretation doesn't
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`20 make sense. Because under their view of the world of this
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`21 statute whether that relief is available is based on things
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`22 like court schedules, the vagaries of litigation, appellate
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`23 schedules, when applicants filed their applications. And so
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`24 this is a great case in point. In this case they're saying
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`25 they need a superfast schedule against Mylan to get that
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`1 relief. But there's a dozen other filers coming down the pipe
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`2 after Mylan who will be nowhere near court decisions before
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`3 they get BLA approval. And yet they would say it wouldn't
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`4 apply to them. That makes no sense.
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`5 So point one, Your Honor, they do have a remedy.
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`6 They will not be left without a remedy.
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`7 But number two, putting all that aside, that issue
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`8 should not be used to deprive Mylan of the due process and a
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`9 full and fair opportunity to defend itself with full discovery,
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`10 Your Honor. A full and fair discovery. And the schedule that
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`11 they are proposing is not feasible, it's not fair, and it's
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`12 unprecedented.
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`13 We're talking about 24 patents, Your Honor, they've
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`14 sued us on. Twenty-four patents, hundreds of claims,
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`15 11 different patent families, numerous subject matter like
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`16 protein purification, recombinant manufacturing methods,
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`17 formulations, indications. I can go on. Thirty-three unique
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`18 inventors.
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`19 And here we hear from Regeneron today that maybe if
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`20 we go through all this discovery we'll have all of this somehow
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`21 reduced. Well, it hasn't been reduced, Your Honor. And this
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`22 is an unprecedented schedule. In all of the biologic
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`23 litigation of this type to date, we're talking about 24-month
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`24 to 41 1/2-month schedules for two patents. Not 24, not
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`25 hundreds of claims, not 33 unique inventors. No one has done a
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`1 biologic case like this in this amount of time, and for good
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`2 reason, because it prejudices the defendant in a huge, huge
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`3 way. We don't think this remedy should override that.
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`4 Now, something else I want to mention -- point three,
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`5 Your Honor -- is the futility of the proposal from Regeneron.
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`6 Even if we mapped out their proposal, we're talking about one
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`7 and a half months for Markman proceedings. And let's think
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`8 about that. Twenty-four patents in suit. Briefing on Markman,
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`9 hearing on Markman, and Your Honor writing up an opinion on
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`10 Markman in one and a half months. Let's just assume even that
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`11 was feasible. Then we're talking about three months of fact
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`12 discovery on 24 patents. In Your Honor's other patent actions,
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`13 Hatch-Waxman actions, we're talking over 24-month schedules for
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`14 two to six patents. And again, as I said, in other biologic
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`15 actions it's gone years, 41 months for two patents.
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`16 Let's assume that could all happen. Then we do three
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`17 months of expert discovery. And a point -- I want to make a
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`18 point on Regeneron's issue on experts, Your Honor. More than
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`19 one of these patents has already been challenged in the patent
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`20 office. One patent. And Regeneron had five expert witnesses
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`21 for one patent. Now we're talking about 24 patents, 11 subject
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`22 matters. So I -- I question the amount of expert witnesses
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`23 that will be necessary here.
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`24 But, again, let's assume we get all that done in
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`25 three months. Even if we go to trial in June 2023 as Regeneron
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`1 says, the parties -- even if in July of next year we did all
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`2 post-trial briefing and then Your Honor drafting an opinion on
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`3 24 or even 12 patents in the month of July, they still wouldn't
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`4 get this Federal Circuit appeal decision anywhere near in time
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`5 before that date in May of 2024. Federal Circuit run rate for
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`6 a simple appeal is 12 months. I'm not aware of any Federal
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`7 Circuit appeal ever getting done on 12 to 24 patents in less
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`8 than 12 months.
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`9 And, in fact, if they want a final decision, we have
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`10 to factor in rehearing proceedings. So they would need a
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`11 Federal Circuit decision in eight months. That's not going to
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`12 happen. It's unrealistic, Your Honor. So even under their
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`13 schedule it's futile and it's not going to work and it's
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`14 certainly not a reason to take away Mylan's due process rights.
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`15 Point four, Your Honor: This whole emergent
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`16 circumstances or expediency they're raising is undermined by
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`17 their conduct in that so-called "patent dance" they just
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`18 mentioned. They sat back for 209 days, 120 days of which they
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`19 control. They solely could have expedited 120 days. They
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`20 never did anything. They let the time go by, and then they
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`21 ambushed Mylan after the complaint was filed, waiting 30 days
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`22 to file the complaint, and then they raised the fact that they
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`23 want this expedient schedule. If they wanted expediency, Your
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`24 Honor, they could have shaved many, many months off of this.
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`25 But, instead, they let the time go by.
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`1 On that same issue, on the patent dance, no court has
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`2 ever held and no statute says that that is a substitute for
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`3 litigation and discovery. Quite the contrary, Your Honor. The
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`4 courts have held that nothing in that binds the defendant like
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`5 Mylan. Mylan is entitled to defend itself in any way, shape,
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`6 and form that is reasonable and proper. It's entitled to seek
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`7 the discovery to do that.
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`8 Point five, your Honor. And I'll try and be brief.
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`9 We've still gotten no answers as to how this schedule could
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`10 even possibly happen from Regeneron. We don't have any
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`11 indications on claim reductions, patent reductions, except for
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`12 what I just heard was we could go through all discovery and
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`13 then maybe we might get a reduction. We have no indications on
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`14 fact witnesses. We have 33 unique inventors, no indication of
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`15 who will come to trial, who they have control over, whether we
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`16 have to go overseas, to The Hague, for foreign inventors.
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`17 We've not gotten anything in that regard from them. We've
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`18 gotten no limits on expert witnesses, no explanation for how we
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`19 do Markman, much less an opinion on Markman in one and a half
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`20 months. And, again, this would be super, super expedited.
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`21 It's unprecedented.
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`22 And by the way, Your Honor, the examples they put in
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`23 their papers -- the Twitter example, the Telecom example, ITC
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`24 examples -- none of those had anything to do with a 24-patent
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`25 biologic case.
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`1 And lastly, Your Honor, kind of the elephant in the
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`2 room, which is we have no explanation on what's going to happen
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`3 with all these other patents. The whole point of this action
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`4 is to try and get some type of patent certainty with 24
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`5 patents. They're suggesting trying 12 patents and then holding
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`6 these other 12 back. What does that mean? Can they assert
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`7 them after the first trial? Can they assert them in serial
`
`8 fashion after that? We have no explanations on that. None
`
`9 whatsoever.
`
`10 So what we've done is made a -- what we believe is a
`
`11 cooperative and accommodating proposal, Your Honor, two part.
`
`12 If Regeneron insists on asserting 24 patents and they will not
`
`13 drop them, give us covenants not to sue or dismiss them with
`
`14 prejudice, we are proposing a standard 24-month schedule, which
`
`15 in and of itself would be ridiculously fast for 24 patents.
`
`16 That's part one of our proposal.
`
`17 If Regeneron doesn't like that, if they won't give us
`
`18 certainty -- meaning they'll drop most of these patents with
`
`19 covenants, dismissals with prejudice, what have you -- and we
`
`20 could get it down to a manageable number, say eight, and they
`
`21 reduce the claims, then Mylan is willing to do a 15-month
`
`22 schedule, which gets us to trial, I believe, by December of
`
`23 2023.
`
`24 So Mylan is willing to be reasonable. We're willing
`
`25 to move quick. But we are not willing to move so quick that,
`
`Samsung Bioepis Exhibit 1052
`Page 16
`
`Biocon Exhibit 1052 - Page 16
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 90 Filed 11/02/22 Page 17 of 46 PageID #: 2265
`
`1 again, it deprives us of the ability to fully and fairly defend
`
`2 ourself, Your Honor.
`
`3 And I should say, lastly, Mylan is not trying to run
`
`4 out the clock. Regeneron tried to run out the clock during the
`
`5 patent dance. If they really wanted to move fast, they could
`
`6 have self-expedited and not wasted those many months.
`
`7 Thank you, Your Honor.
`
`8 THE COURT: All right. Thank you, Counsel.
`
`9 Mr. Berl.
`
`10 MR. BERL: If I could respond to the six points that
`
`11 Mr. Rakoczy just made.
`
`12 First he said that there is other relief in the BPCIA
`
`13 other than the statutory relief. He's right, of course. But
`
`14 the ability to obtain other relief does not moot the statutory
`
`15 relief that Congress provided. And his view of the law is that
`
`16 Congress provided statutory relief for no reason; it's a dead
`
`17 letter and a biosimilar applicant, like Mylan today, can come
`
`18 into the court and run out the clock. That's exactly what's
`
`19 going on here. Make no mistake. A December 2024 trial date --
`
`20 or a December 2023 trial date deprives us of any opportunity
`
`21 for statutory relief. They don't have to face it on the
`
`22 merits. They just run out the clock. That's exactly what's
`
`23 going on here.
`
`24 And to be clear, we didn't run out the clock during
`
`25 the patent dance. We had to review their materials. And we
`
`Samsung Bioepis Exhibit 1052
`Page 17
`
`Biocon Exhibit 1052 - Page 17
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 90 Filed 11/02/22 Page 18 of 46 PageID #: 2266
`
`1 did self-expedite and serve our submissions before they were
`
`2 due.
`
`3 With respect to his due process sort of arguments,
`
`4 number one, I'd note that there's no citation anywhere in
`
`5 Mylan's papers about the proposition that a court setting a
`
`6 trial date nine months after a scheduling conference somehow
`
`7 deprives a party of due process. That's because it's not true.
`
`8 All of his arguments that you just heard from Mr. Rakoczy
`
`9 depend on a fallacy. And that fallacy is that we are proposing
`
`10 to proceed all the way to trial on 24 patents. That's not
`
`11 true. We are proposing to proceed on a subset of those
`
`12 patents, 12 patents now. And if Your Honor thinks that's too
`
`13 much to accommodate Mylan's needs, we're prepared to be
`
`14 flexible on that and we're prepared to move forward with this
`
`15 first phase with fewer than that. We could do even six patents
`
`16 if that's more palatable.
`
`17 But at the end of the day, this notion that we're
`
`18 going forward on 24 patents with 11 different families simply
`
`19 is not true. There are 12 patents that we have identified for
`
`20 the first part of litigation. There are only 4 patent
`
`21 families, not 11. And we'd be prepared right now to go down to
`
`22 3 patent families to make the burden even lower on the parties
`
`23 and on The Court. That's not so much. That's not nearly as
`
`24 many as in the papers. And we're cutting out all of the time
`
`25 for document production by having already reviewed and
`
`Samsung Bioepis Exhibit 1052
`Page 18
`
`Biocon Exhibit 1052 - Page 18
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 90 Filed 11/02/22 Page 19 of 46 PageID #: 2267
`
`1 collected the lion's share of the documents. And we're
`
`2 prepared to produce them with alacrity.
`
`3 With respect to the futility argument, respectfully,
`
`4 it's the same fallacy, Your Honor. There's not fact discovery
`
`5 on 24 patents. There's fact discovery on far fewer than that,
`
`6 three or four patent families. That's it.
`
`7 And the Markman hearing? Courts frequently limit the
`
`8 number of Markman disputes in order to prevent an unwieldy
`
`9 process. It's common in other courts, from Texas to California
`
`10 and elsewhere, for The Court to pronounce that it will
`
`11 adjudicate eight or ten different Markman disputes. We can
`
`12 choose five; they can choose five. If there are fewer than
`
`13 ten, there are fewer than ten. And that ensures that it won't
`
`14 be an unwieldy Markman process.
`
`15 And by the way, Mr. Rakoczy is not correct that we
`
`16 provided some time limit for the Markman decision. We would
`
`17 not suggest that Your Honor has some deadline. That's for Your
`
`18 Honor to decide the Markman issues after they're presented.
`
`19 We've obviously provided a deadline for the parties to submit
`
`20 their papers and to present the Markman issues to The Court,
`
`21 and we would hope that Your Honor would rule on them after
`
`22 that. But it's not true that everything has to be decided in
`
`23 six weeks under our schedule, let alone 24 patents in
`
`24 11 families, let alone some innumerable number of claim terms.
`
`25 We think that that could be done in an expedited fashion by
`
`Samsung Bioepis Exhibit 1052
`Page 19
`
`Biocon Exhibit 1052 - Page 19
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 90 Filed 11/02/22 Page 20 of 46 PageID #: 2268
`
`1 selecting ten claim terms at most and having the parties work
`
`2 out which those are that require adjudication by The Court.
`
`3 Same thing with respect to fact discovery. It's not
`
`4 24 patents. Nor is it for an expert discovery. We're not
`
`5 going to have five experts on one patent, Your Honor. We're
`
`6 not going to do that having requested this schedule. We will
`
`7 be reasonable as to the number of experts that will be present.
`
`8 If we go forward on three patents, it's very unlikely that
`
`9 we'll have more than five experts in total in the case, let
`
`10 alone one patent, smaller than the typical case of this size.
`
`11 With respect to the Federal Circuit and the futility,
`
`12 I would respectfully disagree with Mr. Rakoczy. Upon Your
`
`13 Honor's ruling we will, of course, make the Federal Circuit
`
`14 aware of the timing issue so that this will not be a typical
`
`15 appeal. And we will explain to the Federal Circuit that
`
`16 justice delayed is justice denied, that we would self-expedite
`
`17 our briefing, and that we would submit that the Federal Circuit
`
`18 should issue a decision by May 18th, 2024, so that we have
`
`19 the relief that Congress provided.
`
`20 Now, obviously, I don't control what the Federal
`
`21 Circuit does in that regard. But having practiced before that
`
`22 court a substantial number of times, it's my strong belief that
`
`23 they would treat this case differently given the statutory
`
`24 deadline that Congress has imposed here in order not to moot
`
`25 the relief that Regeneron is entitled to.
`
`Samsung Bioepis Exhibit 1052
`Page 20
`
`Biocon Exhibit 1052 - Page 20
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 90 Filed 11/02/22 Page 21 of 46 PageID #: 2269
`
`1 Now, Mr. Rakoczy suggests that this relief doesn't
`
`2 really matter because in other BPCIA cases innovators have not
`
`3 received that relief. And I want to be very clear about this,
`
`4 Your Honor. Because he's half right, but he's not revealing
`
`5 what matters. The BPCIA, as I've said, was passed as part of
`
`6 Obamacare. So the first wave of BPCIA cases related to old
`
`7 biologic products. These are typically products that you've
`
`8 seen advertisements on TV while you watch football games, like
`
`9 Keymyra and Enbrel. These are old products approved generally
`
`10 in the 1990s. And what happened is

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