UNITED STATES PATENT AND TRADEMARK OFFICE
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` BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`Page 1
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`________________________________
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`MYLAN PHARMACEUTICALS INC.,
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` Petitioner,
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` v. Case No.
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`BAUSCH HEALTH IRELAND LIMITED, IPR2022-00722
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` Patent Owner. Patent 7,041,786
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`________________________________
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` VIDEOCONFERENCE HEARING
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`DATE: Thursday, July 28, 2022
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`TIME: 2:00 p.m.
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`BEFORE: Honorable Judge Scott Valek
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`LOCATION: Remote Proceeding
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` Washington, DC 20005
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`REPORTED BY: Timothy Guevara, Notary Public
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`JOB NO.: 5348387
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`Veritext Legal Solutions
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`MYLAN EXHIBIT - 1056
`Mylan Pharmaceuticals, Inc. v. Bausch Health Ireland, Ltd. - IPR2022-00722
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`
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` BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`Page 1
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`________________________________
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`MYLAN PHARMACEUTICALS INC.,
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` Petitioner,
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` v. Case No.
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`BAUSCH HEALTH IRELAND LIMITED, IPR2022-00722
`
` Patent Owner. Patent 7,041,786
`
`________________________________
`
` VIDEOCONFERENCE HEARING
`
`DATE: Thursday, July 28, 2022
`
`TIME: 2:00 p.m.
`
`BEFORE: Honorable Judge Scott Valek
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`LOCATION: Remote Proceeding
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` Washington, DC 20005
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`REPORTED BY: Timothy Guevara, Notary Public
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`JOB NO.: 5348387
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`MYLAN EXHIBIT - 1056
`Mylan Pharmaceuticals, Inc. v. Bausch Health Ireland, Ltd. - IPR2022-00722
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`Page 2
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` A P P E A R A N C E S
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`ON BEHALF OF PETITIONER MYLAN PHARMACEUTICALS INC.:
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` JAD A. MILLS, ESQUIRE (by videoconference)
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` RICHARD TORCZON, ESQUIRE (by videoconference)
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` GRACE A. WINSCHEL, ESQUIRE (by videoconference)
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` Wilson Sonsini Goodrich & Rossati
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` 1700 K Street Northwest, 5th Floor
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` Washington, DC 20006
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` jmills@wsgr.com
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` rtorczon@wsgr.com
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` gwinschel@wsgr.com
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` 206-883-2500
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` A P P E A R A N C E S (Cont'd)
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`ON BEHALF OF PATENT OWNER BAUSCH HEALTH IRELAND
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`LIMITED:
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` JUSTIN HASFORD, ESQUIRE (by videoconference)
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` JOSHUA L. GOLDBERG, ESQUIRE (by videoconference)
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` KYU YUN KIM, ESQUIRE (by videoconference)
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` Finnegan, Henderson, Farabow, Garrett &
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` Dunner LLP
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` 901 New York Avenue Northwest
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` Washington, DC 20001-4412
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` justin.hasford@finnegan.com
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` joshua.goldberg@finnegan.com
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` kyuyun.kim@finnegan.com
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` 202-408-4000
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`ALSO PRESENT:
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` Judge Hardman [ph] (by videoconference)
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` Judge Hulse (by videoconference)
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` E X H I B I T S
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`NO. DESCRIPTION ID/EVD
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` P R O C E E D I N G S
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` THE COURT: -- -00722.
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` This is Judge Valek, and I have Judges
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`Hulse and Hardman [ph] on the line with me.
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` Let's start off with having counsel for
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`both parties introduce themselves, beginning with the
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`petitioner.
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` MR. MILLS: Hello, Your Honor. This is
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`Jad Mills representing the petitioner. With me, I
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`believe also on the call, I have Richard Torczon and
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`Grace Winschel.
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` THE COURT: Okay. Who do we have for
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`patent owner?
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` MR. HASFORD: Good afternoon, Your
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`Honor. This is Justin Hasford. I'm representing
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`Patent Owner. I also have on the call with me my
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`colleagues Josh Goldberg and Kyu Yun Kim.
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` THE COURT: All right. Is there a
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`court reporter on the line?
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` THE REPORTER: Yes, Your Honor. This
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`is Timothy Guevara, the court reporter.
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` THE COURT: All right. So since we
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`have a court reporter will you please file a
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`transcript -- I don't know who hired the court
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`reporter, but will somebody please file the transcript
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`in due course once we get done?
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` MR. MILLS: Yes, Your Honor.
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` THE COURT: Thank you.
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` So we're here today regarding two
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`issues. First we have Patent Owner's request for
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`authorization to move to strike Paper 9, which is
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`Petitioner's updated mandatory notices. Then we also
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`have Petitioner's request for a five-page reply to the
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`preliminary response.
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` We'll begin with the first issue -- and
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`this is for Patent Owner -- will you please give us a
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`brief explanation why, in your view, the updated
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`notices failed to comply with Rule 42.8.
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` MR. HASFORD: Certainly, Your Honor.
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` So as you're aware, Rule 42.8, in
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`particular Section (a)(3), requires that a mandatory
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`change of information notice be filed within 21 days
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`of any such change in information.
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` So taking a bit of a step back here,
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`Petitioner Mylan specifically sought authorization,
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`sought consent from us to correct what they referred
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`to as ministerial issues with these three exhibits
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`that they filed in connection with their petition.
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`And they stated that these exhibits had image problems
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`with the PDFs. And so we had no issue with that. We
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`consented to their filing of these corrected exhibits.
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` The problem is when they filed those
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`corrected exhibits they, at the same time, filed this
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`updated change of information notice without seeking
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`our agreement or without the Board's authorization.
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` And the information they've included,
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`Your Honor, in this updated change of information
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`notice Mylan has known about for a long time;
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`certainly more than 21 days. And we believe, Your
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`Honor, that they are trying -- that Mylan is trying to
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`add this information for an improper purpose to shore
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`up what we believe is a deficient real party-in-
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`interest position.
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` As Your Honor is aware, we challenged
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`real party-in-interest in our Patent Owner
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`Preliminary Response. It's our position that the
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`Petitioner failed here to disclose all the real
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`parties-in-interest, at least because Mylan didn't
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`disclose two other entities that we believe are real
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`parties-in-interest. Those are Viatris Inc. and
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`Mylan Inc.
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` And now they are trying to add
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`information, although not in a sense of identifying
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`those real parties-in-interest. They're just trying
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`to add additional information in this updated change
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`of information notice, in our view, to try to shore up
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`this deficient real party-in-interest position,
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`despite the fact that -- they filed this on July 11th
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`despite the fact that they've known about this
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`information for years.
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` The petitioner did not identify
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`Viatris Inc. or Mylan Inc. as real parties-in-interest
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`in their petition. In our view they still have not
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`identified them properly as real parties-in-interest
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`in this updated change of information notice. They
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`merely state that Viatris Inc. and Mylan Inc. are
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`parent companies. They did not state they're real
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`parties-in-interest.
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` They have done this -- they have stated
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`those two entities are real parties-in-interest in
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`other IPRs. For example, in IPR 2021-880 [sic], which
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`is Mylan v. Regeneron; they've done it in 2021-881
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`[sic]; they've done it in 2022-517 [sic] against
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`Bayer. They did not do that here. And it's our
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`position, Your Honor, that Mylan is engaging in
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`gamesmanship.
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` They were required to identify all real
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`parties-in-interest in their petition; they failed to
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`do so. And in our view, as we stated in our
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`preliminary patent owner response, this deficiency
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`warrants denial of institution.
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` Now they're trying to, apparently, add
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`this information through this updated change of
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`information notice. We don't believe that they should
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`be able to do so. We don't believe that it requires
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`-- that it complies, rather, with 37 C.F.R. 42.8(a)(3)
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`and, therefore, we believe that it should be stricken.
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` They also put additional information in
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`this updated change of information notice that we also
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`believe is deficient. For example, they identified a
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`co-pending district court case in New Jersey involving
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`the same patent that was filed more than a year ago
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`and in the Western District of Pennsylvania that
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`involved the same petitioner that was administratively
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`closed back in April.
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` That's old information, far more than
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`21 days prior, and we, therefore, for all these
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`reasons, respectfully request authorization to move to
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`strike what we view as an improper paper.
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` THE COURT: All right. Let me ask you
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`a follow-up on that, Counsel. Does Patent Owner
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`contend that Viatris Inc. or Mylan Inc. would be time
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`barred or estopped from seeking in inter partes review
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`here?
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` MR. HASFORD: Absolutely, Your Honor.
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`The one-year date under 35 U.S.C. Section 315(b), in
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`our view, would be July 22, 2022. So last week. And,
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`yes, they would be time barred.
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` THE COURT: Let me ask it a different
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`way. If the amendment were allowed -- and so they've
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`got the date that they were identified as RPIs as of
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`the date the petition was filed, does Patent Owner
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`contend that Viatris Inc. or Mylan Inc. would be time
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`barred?
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` MR. HASFORD: We would contend they're
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`still time barred, Your Honor, because if this paper
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`were allowed to be entered, it actually still does not
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`identify Viatris Inc. or Mylan Inc. as real parties-
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`in-interest. It initially stated Petitioner Mylan
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`Pharmaceuticals Inc. is a co-defendant with Mylan
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`Laboratories Ltd., Agila Specialties Inc., Mylan API
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`US LLC, Mylan Inc., and Viatris Inc. in parallel
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`litigation.
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` We pointed out in our preliminary
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`Patent Owner response pursuant to the relevant case
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`law why that is not sufficient as a real party-in-
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`interest identification. Now they simply add that
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`Viatris Inc. and Mylan Inc. are parent companies of
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`Mylan. They still do not identify them or state that
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`they are real parties-in-interest. They have so
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`stated this in other IPRs.
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` THE COURT: Let me just interrupt you.
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`I think I -- Counsel, just for a moment. Of course,
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`that wouldn't be a time bar. That would just be, in
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`your view, they haven't properly identified them as
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`RPIs. How, if they were entitled to have their
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`amendment as of the date the petition was filed, would
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`Viatris and Mylan Inc. be time barred?
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` The reason I'm asking -- I think more
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`specifically what I'm asking is have these entities
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`previously been sued or in some other way -- something
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`that would give rise to that 315(b) time bar clock
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`starting to tick a little bit earlier than for the
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`other entities named in the original petition?
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` MR. HASFORD: Absolutely, Your Honor.
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`They were all sued as of, I believe, late March or
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`early April of 2021 in the District of New Jersey.
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`Service was waived for all of these entities -- for
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`all six of those entities -- but including for
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`Viatris Inc. and Mylan Inc. service was waived as of
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`July 22, 2021.
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` There has been a great deal of
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`procedural wrangling and so the case ultimately was
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`transferred from the District of New Jersey to the
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`Northern District of West Virginia. But the service
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`was effectuated -- there's no question that the waiver
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`of service was -- on behalf -- was signed by one of
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`the attorneys of record, Nicole Stafford here -- was
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`signed on July 22, 2021. It was filed in U.S.
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`District Court for District of New Jersey that very
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`same day. It's on Pacer, publicly available.
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` And that would be the day as to which
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`their one-year time bar would run. Their one-year
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`time bar would be July 22, 2022. And that date has
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`passed.
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` THE COURT: Okay. But the petition was
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`filed on, looks like, March 17th of this year.
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` MR. HASFORD: I believe that's correct,
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`Your Honor.
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` THE COURT: And so if in fact they were
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`allowed to amend their notices and so -- and all of
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`these parties, including Mylan Inc. and Viatris Inc.,
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`were identified as RPIs as of that date, there
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`wouldn't be a time bar for any of these entities. Is
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`that correct?
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` MR. HASFORD: Well, sure, if Your Honor
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`found and allowed them effectively -- as I understand
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`Your Honor's question, if Your Honor allowed them to
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`retroactively amend their notices such that they would
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`be deemed real parties-in-interest as of the March
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`filing date of this petition, that is correct, they
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`would then be within the law.
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` THE COURT: All right. Let's let
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`Petitioner have a chance to respond.
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` And, Petitioner, I'd like you to tell
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`us, if you can, whether the revision to the real
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`party-in-interest section, the identification of these
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`two entities, I guess as corporate parents, reflects
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`some sort of change that's occurred within 21 days of
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`filing the Paper 9.
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` MR. MILLS: Thank you, Your Honor.
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`This is Jad Mills for the Petitioner.
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` So if I can just back up briefly. The
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`updates to the mandatory notices were filed on
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`July 11, 2022. One of the most important issues that
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`was mentioned in that update is the setting of the
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`trial date by the district court. And that trial date
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`was set on June 30, 2022.
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` So we filed within 21 days of that
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`noting the update to the trial date. And our
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`action -- doing that actually resulted in the Patent
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`Owner withdrawing their Fintiv arguments.
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` The Patent Owner raised in their
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`preliminary response filed the day before the trial
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`date was set on June 29th an allegation that our --
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`the RPI listing in the petition, which indisputably
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`identified every single entity that they now allege
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`should have been identified -- but they said that the
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`disclosure was deficient for needing to state that
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`Viatris Inc. and Mylan Inc. are parent companies of
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`Mylan Pharmaceuticals Inc.
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` So within 21 days of becoming aware of
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`the Patent Owner's concern about that issue, which
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`they admit in their papers that the Board was already
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`aware of -- but within 21 days of becoming aware that
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`they were going to be making this argument -- which in
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`a moment I'll explain why we believe the argument is
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`actually frivolous.
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` But within 21 days of becoming aware
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`that they were making the argument we included that
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`information in our mandatory notices in an effort to
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`avoid needless costs and time and expense from the
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`parties in between the Board.
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` THE COURT: Let me follow up on that,
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`Counsel.
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` So did the ownership -- the corporate
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`ownership change such that at the time you filed the
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`petition Viatris and Mylan Inc. weren't parent
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`companies of -- I think it's Mylan Pharmaceuticals
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`Inc., or has that changed?
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` MR. MILLS: We are not asserting that
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`Viatris and Mylan Inc. were not parent companies of
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`Mylan Pharmaceuticals at the time the petition was
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`filed.
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` THE COURT: Okay. And are Viatris Inc.
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`and Mylan Inc. real parties-in-interest? I mean,
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`they're disclosed in this amended notice and disclosed
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`in the real parties-in-interest section.
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` MR. MILLS: Right. We are not
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`disputing in this proceeding that Viatris Inc. and
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`Mylan Inc. were real parties-in-interest in this
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`proceeding.
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` THE COURT: What is --
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` MR. MILLS: Your Honor --
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` THE COURT: Oh, sorry. Go ahead,
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`Counsel.
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` MR. MILLS: As Your Honor mentioned,
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`there is no allegation that there is a time bar or an
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`estoppel that was in effect at the time that these
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`entities were identified in the real party-in-interest
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`section of the mandatory notices when the petition was
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`filed.
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` In fact, the allegation that there's
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`any time bar violation is new. It's not in the
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`preliminary response, it was not raised through our
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`meet and confer, and it was not raised in the e-mail
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`to the Board. But there indisputably was no time bar.
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` The entities were identified in the
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`mandatory notices section; thereby fulfilling the
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`purposes of the section which is to provide the Board
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`with notice so that they can perform their conflict --
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`and also to provide the Patent Owner with notice so
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`that they can determine whether any party or any real
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`party-in-interest or potential party-in-interest is
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`subject to a time bar, which they indisputably were
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`not subject to a time bar at the time the petition was
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`filed.
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` THE COURT: Let me ask another
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`question. What is Petitioner's explanation for why
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`these entities, Viatris Inc. and Mylan Inc., were not
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`identified as parent companies of Mylan
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`Pharmaceuticals in your original notices once you
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`filed the petition?
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` MR. MILLS: Your Honor, under the
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`precedential Board decision, SharkNinja v. iRobot --
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`it's IPR 2020-00743, April 11 -- the Board made clear
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`that the parties and the Board do not need to engage
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`in lengthy, possibly, exercises regarding the
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`identification of RPIs so long as there is no estoppel
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`or statutory bar in place.
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` THE COURT: Sure. Sure. I understand.
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`I understand SharkNinja and what you're getting at,
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`but I guess my question is a little different. Since
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`you're not contesting that Viatris and Mylan Inc. are
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`parent companies and they are RPIs, why weren't they
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`identified in the notices in the original petition?
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` Was it just a ministerial oversight,
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`someone make a mistake? What's the reason why they
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`weren't in there?
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` MR. MILLS: So Your Honor, to be clear,
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`they are listed in the RPI section. As Your Honor --
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`why there wasn't the lengthy explication of the
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`corporate relationships or a variety of other factors
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`that the Patent Owner, you know, need to cite to raise
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`at some point. For the purposes of the real party-in-
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`interests requirement for the petition we provided the
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`identification.
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` There was no intent, you know, to keep
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`anything from the Board. The intent was to provide a
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`straight-forward identification of the potential RPIs
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`so that the Board could perform its conflicts check
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`and so that the patent owner could satisfy themselves
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`that none of those entities were subject to a time
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`bar.
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` THE COURT: Okay. I think we have --
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`actually, Counsel, you said that you were going to
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`talk a little bit about the RPI issue itself. And I
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`believe that Patent Owner had a chance to address
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`that. Do you have anything else you want to say about
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`that before we move on to the next issue?
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` MR. MILLS: Yes. So if I could just
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`briefly. I mentioned the purposes of the RPI listing.
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`There are several cases where the Board has discussed
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`that. One of the cases is NRG v. Midwest Energy, IPR
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`2020-00832, Paper 17, where the listing of RPIs as
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`well as potential RPIs is not a violation.
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` Even in that case there were dozens of
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`RPIs that were listed, and the key is whether the
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`entities are listed, whether they're identified or
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`should provide notice to the Board so that they can
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`evaluate whether there's any conflicts of interest
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`which was satisfied here as well as to evaluate
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`whether any of those entities are time barred.
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` A second case is PNC Bank v. United
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`Services Automobile Association. It's
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`IPR 2021-01073. It's Paper 20, but it appears in the
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`top of this Paper 25 in the public version where they
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`named themselves as an RPI.
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` The Patent Owner contended that they
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`should have named another entity involved in the
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`lawsuit as an RPI, and the Board declined the
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`SharkNinja case, held that there is no statutory bar
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`and therefore that there was no need to address the
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`RPI issue.
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` Also I suppose I would say that to the
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`extent that the Board thinks that there should be
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`something additional listed in our RPI section, then
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`we would ask the Board to permit us to do so and we
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`would update our notices as appropriate and as
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`requested by the Board.
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` THE COURT: I'll follow up on something
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`since you're quoting so many of our cases. Another
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`one of our precedential decisions like ShankNinja is
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`Adello Biologics. And there when the petitioner
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`needed to identify additional RPIs in their -- from
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`the one in their petition they asked for authorization
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`to file amended notice before they actually filed it.
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` But you didn't do that here. Is there
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`a reason why you didn't do that here?
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` MR. MILLS: So in the Adello case,
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`Your Honor, there was an -- the entity that was simply
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`not listed, which means that the notice function of
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`the rule had not been satisfied. And the parties did
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`request authorization and they were granted
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`authorization.
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` Our understanding is that the entity
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`has been identified and that the rule has been
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`satisfied. And for that reason we, you know, did not
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`see need to use the court resources to request a
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`motion. But if the Board believes that a motion would
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`be desirable, then we're happy to make a motion and we
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`would ask the Board for authorization for any -- that
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`the Board deems necessary.
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` THE COURT: Okay. Let's move on to the
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`second request since that one is yours. My
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`understanding from the e-mail is that Petitioner does
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`not intend to address -- or strike that.
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` What I meant to say is my understanding
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`of the e-mail is that you and him to address 325(d) in
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`the RPI arguments and you won't get into the merits
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`other than to address the material error prong of the
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`325(d) analysis. Is that correct, Petitioner?
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` MR. MILLS: Yes. We would not be
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`addressing the merits except to the extent that
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`they're integrated within the 325(d) arguments
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`themselves.
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` THE COURT: All right. Let me go to
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`the Patent Owner then. Does Patent Owner oppose the
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`reply as its so limited and you get a chance to sur-
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`reply?
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` MR. HASFORD: I think if its so limited
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`to those narrow issues, that's correct. I mean -- so
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`here is our issue, Your Honor. We don't believe that
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`they should get into the substantive merits of, for
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`example, lead compound.
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` As Your Honor is aware, this patent
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`covers the compound plecanatide that is the active
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`pharmaceutical ingredient in Trulance. And because
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`it's a compound patent, under controlling federal
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`circuit case law you got Otsuka v. Sandoz -- that's
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`Federal Circuit 2012; Takeda v. Alphapharm, 2007;
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`Daiichi v. Matrix, 2010.
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` They were required in their petition to
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`identify a lead compound in the prior art and show why
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`there would have been motivation for a person of
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`ordinary skill in the art to choose that particular
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`lead compound over other compounds and also why there
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`would have been a motivation for a person of ordinary
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`skill in the art to modify that particular lead
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`compound in such a way over other modifications to
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`result in the claimed plecanatide compound with a
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`reasonable expectation of success.
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` And as we point out in our preliminary
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`patent owner response they engaged in none of that
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`analysis in their petition. We don't believe that
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`they should be entitled to use this as a backdoor to
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`now try to engage in that analysis in response to
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`325(d).
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` Really, the only issue as to 325(d), as
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`Your Honor of course knows, is were the references
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`before the examiner or were they cumulative. And I
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`think to the extent they're looking to narrowly do
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`what Your Honor suggested, I believe that would be
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`fine. I think we'd have to see what they do and then,
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`you know, reserve the right to move to strike if they
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`try to go further.
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` But that's what we don't want to have
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`happen, Your Honor, is a full-on -- you know,
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`effectively going back in the merits here.
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` THE COURT: May I ask Petitioner, is
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`that what you're intending to do? Are you going to
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`use this as a backdoor to supplement your petition?
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` MR. MILLS: No, that's not what we're
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`doing. And if I can just briefly respond -- and I
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`won't go into depth, but we disagree with the patent
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`owner's characterization and we also disagree with
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`their arguments that this simply requires the
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`identification of a single lead compound. But the
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`purposes of our briefing would be to respond to the
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`325(d) arguments.
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` THE COURT: Okay. And one more
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`question for you, Petitioner. If we were to authorize
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`you to move to amend your mandatory notices, as was
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`the case in Adello, to include that additional
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`information of Viatris and Mylan Inc., would you be
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`able to brief that motion along with your response to
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`Patent Owner's RPI argument in a reply?
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` MR. MILLS: Yes. You're saying within
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`the five-page limit?
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` THE COURT: Yeah. And if you need a
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`little bit more we can give you some more, just we'd
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`like to keep the number of papers in the schedule kind
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`of on track, is what I'm getting at.
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` MR. MILLS: Yes, of course. We
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`certainly can address it in the same time schedule,
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`and a page or two extra would be appreciated.
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` THE COURT: Okay.
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` MR. HASFORD: And Your Honor -- I
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`apologize. Go ahead.
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` THE COURT: No, if you want to say
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`something, go ahead, please.
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` MR. HASFORD: I mean, the parties
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`agreed on five pages. We think that all of this can
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`be addressed in five pages. I mean originally we were
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`talking about seven pages, but that was when we
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`thought we were also going to be addressing the Fintiv
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`arguments, and we did withdraw our Fintiv arguments.
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` As Your Honor is aware, we submitted
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`the amended paper or supplemental paper yesterday on
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`that with those redacted. So we think five pages that
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`the parties agreed upon are certainly sufficient.
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` THE COURT: Okay. I think we
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`understand each side's position. If you would just
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`stay on the line for a moment while I confer with my
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`colleagues.
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` MR. HASFORD: Yes, Your Honor.
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` THE COURT: Okay. Can everyone hear
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`me?
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` MR. HASFORD: Yes, Your Honor.
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` MR. MILLS: Yes.
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` THE COURT: All right. So I've
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`conferred with Judges Hulse and Hardman, and we're
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`going to authorize Petitioner to move to amend its
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`mandatory notices, and we'll leave Paper 9 in place
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`pending the outcome of that motion.
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` Since the updated notices are related
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`to the RPI issue we'd like Petitioner to include that
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`motion in its reply brief which we're also going to
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`authorize. Patent Owner can present any opposition it
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`may have to Petitioner's motion in its sur-reply.
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` And we'll allow five pages for the
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`reply and sur-reply. The reply is going to be due ten
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`days from tomorrow and a sur-reply ten days after
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`that.
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` Does that timeline work for Petitioner?
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` MR. MILLS: Yes. I do ask whether it's
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`ten business days or calendar days.
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` THE COURT: Calendar days.
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` MR. MILLS: Okay. Thank you.
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` THE COURT: And we'll issue an order
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`preserving all this after the hearing so that you have
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`firm deadlines for your papers.
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` Does that timeline also work for Patent
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`Owner?
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` MR. HASFORD: I believe that works for
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`Patent Owner, Your Honor.
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` So you're authorizing them to move to
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`amend -- just so I'm clear -- move to amend their
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`mandatory notices and then we would get to oppose that
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`in our sur-reply and also respond to the positions
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`that they're raising in their reply; is that correct?
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` THE COURT: Yes, that's absolutely
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`right.
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` MR. HASFORD: Okay. That's fine with
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`us.
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` And it looks like, if I'm looking at my
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`calendar correctly, ten calendar days from today would
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`be Sunday, August 7th, to the extent that makes a
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`difference.
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` THE COURT: Yeah. It'll be ten
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`calendar days from tomorrow. So we'll actually make
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`it Monday, the 8th --
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` MR. HASFORD: Got it.
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` THE COURT: -- and then you'll also be
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`due, it looks like, 17th; is that correct? 18th.
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`18th, I'm sorry.
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` But we'll put this in a written order
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`so that you have the deadlines in writing so that
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`everybody is on the same page.
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` MR. MILLS: That sounds good. Thank
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`you very much, Your Honor.
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` THE COU
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