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
`·2
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`·3· REGENERON PHARMACEUTICALS, INC.,
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`·4· · · · ·Plaintiff,
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`·5· · vs.· · · · · · · · · · · · · CASE NO.:
`· · · · · · · · · · · · · · · · · ·1:22-CV-61
`·6· MYLAN PHARMACEUTICALS INC.,
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`·7· · · · ·Defendant.
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`·8· · · · · · · · · · · · · · · ·- - -
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`·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
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`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
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`25· · · ·APPEARANCES CONTINUED ON NEXT PAGE
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`Case 1:22-cv-00061-TSK-JPM Document 90 Filed 11/02/22 Page 2 of 46 PageID #: 2250
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`·1· · · ·On behalf of the Defendant via Zoom:
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`·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
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`·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
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`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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`Case 1:22-cv-00061-TSK-JPM Document 90 Filed 11/02/22 Page 4 of 46 PageID #: 2252
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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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`Case 1:22-cv-00061-TSK-JPM Document 90 Filed 11/02/22 Page 5 of 46 PageID #: 2253
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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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`Case 1:22-cv-00061-TSK-JPM Document 90 Filed 11/02/22 Page 6 of 46 PageID #: 2254
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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
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`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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`Case 1:22-cv-00061-TSK-JPM Document 90 Filed 11/02/22 Page 7 of 46 PageID #: 2255
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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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`Case 1:22-cv-00061-TSK-JPM Document 90 Filed 11/02/22 Page 10 of 46 PageID #: 2258
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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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`Case 1:22-cv-00061-TSK-JPM Document 90 Filed 11/02/22 Page 11 of 46 PageID #: 2259
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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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`Case 1:22-cv-00061-TSK-JPM Document 90 Filed 11/02/22 Page 12 of 46 PageID #: 2260
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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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`Case 1:22-cv-00061-TSK-JPM Document 90 Filed 11/02/22 Page 13 of 46 PageID #: 2261
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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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`Case 1:22-cv-00061-TSK-JPM Document 90 Filed 11/02/22 Page 14 of 46 PageID #: 2262
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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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`Case 1:22-cv-00061-TSK-JPM Document 90 Filed 11/02/22 Page 15 of 46 PageID #: 2263
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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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`

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`Case 1:22-cv-00061-TSK-JPM Document 90 Filed 11/02/22 Page 16 of 46 PageID #: 2264
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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
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`·8· fashion after that?· We have no explanations on that.· None
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`·9· whatsoever.
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`10· · · · · · So what we've done is made a -- what we believe is a
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`11· cooperative and accommodating proposal, Your Honor, two part.
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`12· If Regeneron insists on asserting 24 patents and they will not
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`13· drop them, give us covenants not to sue or dismiss them with
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`14· prejudice, we are proposing a standard 24-month schedule, which
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`15· in and of itself would be ridiculously fast for 24 patents.
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`16· That's part one of our proposal.
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`17· · · · · · If Regeneron doesn't like that, if they won't give us
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`18· certainty -- meaning they'll drop most of these patents with
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`19· covenants, dismissals with prejudice, what have you -- and we
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`20· could get it down to a manageable number, say eight, and they
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`21· reduce the claims, then Mylan is willing to do a 15-month
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`22· schedule, which gets us to trial, I believe, by December of
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`23· 2023.
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`24· · · · · · So Mylan is willing to be reasonable.· We're willing
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`25· to move quick.· But we are not willing to move so quick that,
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`

`

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

`

`Case 1:22-cv-00061-TSK-JPM Document 90 Filed 11/02/22 Page 18 of 46 PageID #: 2266
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`·1· did self-expedite and serve our submissions before they were
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`·2· due.
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`·3· · · · · · With respect to his due process sort of arguments,
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`·4· number one, I'd note that there's no citation anywhere in
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`·5· Mylan's papers about the proposition that a court setting a
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`·6· trial date nine months after a scheduling conference somehow
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`·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
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`·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
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`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
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`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
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`19· is not true.· There are 12 patents that we have identified for
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`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
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`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
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`25· for document production by having already reviewed and
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 90 Filed 11/02/22 Page 19 of 46 PageID #: 2267
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`·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,
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`·4· it's the same fallacy, Your Honor.· There's not fact discovery
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`·5· on 24 patents.· There's fact discovery on far fewer than that,
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`·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
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`·9· process.· It's common in other courts, from Texas to California
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`10· and elsewhere, for The Court to pronounce that it will
`
`11· adjudicate eight or ten different Markman disputes.· We can
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`12· choose five; they can choose five.· If there are fewer than
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`13· ten, there are fewer than ten.· And that ensures that it won't
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`14· be an unwieldy Markman process.
`
`15· · · · · · And by the way, Mr. Rakoczy is not correct that we
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`16· provided some time limit for the Markman decision.· We would
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`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
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`20· their papers and to present the Markman issues to The Court,
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`21· and we would hope that Your Honor would rule on them after
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`22· that.· But it's not true that everything has to be decided in
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`23· six weeks under our schedule, let alone 24 patents in
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`24· 11 families, let alone some innumerable number of claim terms.
`
`25· We think that that could be done in an expedited fashion by
`
`

`

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

`

`Case 1:22-cv-00061-TSK-JPM Document 90 Filed 11/02/22 Page 21 of 46 PageID #: 2269
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`·1· · · · · · Now, Mr. Rakoczy suggests that this relief doesn't
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`·2· really matter because in other BPCIA cases innovators have not
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`·3· received that relief.· And I want to be very clear about this,
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`·4· Your Honor.· Because he's half right, but he's not revealing
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`·5· what matters.· The BPCIA, as I've said, was passed as part of
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`·6· Obamacare.· So the first wave of BPCIA cases related to old
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`·7· biologic products.· These are typically products that you've
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`·8· seen advertisements on TV while you watch football games, like
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`·9· Keymyra and Enbrel.· These are old products approved generally
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`10· in the 1990s.· And what happened is that Congress provided in
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`11· the BPCIA 12 years of regulatory exclusivity, plus some
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`12· additional exclusivity in certain cases.· That was all expired
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`13· before Obamacare was even enacted, let alone the BPCIA
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`14· litigation regarding those products or patents.· In a sense,
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`15· those were all grandfathered into the statute.· So this
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`16· regulatory exclusivity and the statutory remedies were, per se,
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`17· unavailable in those old grandfather c

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