UNITED STATES PATENT AND TRADEMARK OFFICE
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`Page 1
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` MYLAN PHARMACEUTICALS, INC.,
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` Petitioner,
`
` vs. Case IPR2021-00881
`
` Pat. No. 9,254, 338 B2
`
` REGENERON PHARMACEUTICALS, INC.,
`
` Patent Owner.
`
` TELECONFERENCE
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` February 23, 2022
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`Veritext Legal Solutions
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`Mylan Exhibit 1089
`Mylan v. Regeneron, IPR2021-00880
`Page 1
`
`

`

` UNITED STATES PATENT AND TRADEMARK OFFICE
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`Page 2
`
` MYLAN PHARMACEUTICALS, INC.,
`
` Petitioner,
`
` vs. Case IPR2021-00881
`
` Pat. No. 9,254, 338 B2
`
` REGENERON PHARMACEUTICALS, INC.,
`
` Patent Owner.
`
` REPORT OF PROCEEDINGS from the
`
`Teleconference taken by Ms. Suzanne Benoist, RPR,
`
`CCR-MO, CCR-KS, CSR-IL, CSR-IA, pursuant to the
`
`provisions of the Federal Code of Civil Procedure
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`and Rules of the United States Patent and Trademark
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`Office, commencing at 1:59 p.m. on February 23,
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`2022.
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`Veritext Legal Solutions
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`Mylan Exhibit 1089
`Mylan v. Regeneron, IPR2021-00880
`Page 2
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`

`

` APPEARANCES
`
`Page 3
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` FOR THE PETITIONER:
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` RAKOCZY MOLINO MAZZOCHI & SIWIK LLP
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` MR. HEINZ J. SALMEN
`
` MR. NEIL MCLAUGHLIN
`
` 6 West Hubbard Street
`
` Chicago, Illinois 60654
`
` (312) 527-2157
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` hsalmen@rmmslegal.com
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` nmclaughlin@rmmslegal.com
`
` FOR THE PATENT OWNER:
`
` ARNOLD & PORTER
`
` MR. DAVID CAINE
`
` MS. ALICE HO
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` 3000 El Camino Real, #500
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` Palo Alto, California 94304
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` (650) 319-4710
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` david.caine@arnoldporter.com
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` alice.ho@arnoldporter.com
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`Mylan Exhibit 1089
`Mylan v. Regeneron, IPR2021-00880
`Page 3
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`

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`Page 4
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` -oOo-
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` (Whereupon, the conference began at 1:59 p.m.)
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` JUDGE NEW: This is Patent Judge John
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`New, I'm here with members of the panel.
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` Are counsel for both parties present?
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` MR. SALMEN: Yes, Your Honor. This
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`is Heinz Salmen on behalf of Petitioner Mylan.
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` MS. FISHMAN: Yes, Your Honor, this
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`is Deborah Fishman for Patent Owner Regeneron,
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`although I think I may have been admitted last, I'm
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`not sure who else is on the line for Patent Owner.
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` MR. CAINE: You've also got David
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`Caine and Alice Ho, Deborah, for the Patent Owner.
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` MR. COBB: And Jeremy Cobb from
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`Arnold & Porter as well.
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` MR. SALMEN: And Your Honor, just so
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`the record is complete also with me are Neil
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`McLaughlin and Eric Hunt, also on behalf of
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`Petitioner Mylan.
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` JUDGE NEW: Thank you very much Mr.
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`Salmen.
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` I understand Mr. Salmen you've
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`arranged for a court reporter?
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` MR. SALMEN: Yes, I have, and I
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`believe she is on.
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`Mylan Exhibit 1089
`Mylan v. Regeneron, IPR2021-00880
`Page 4
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`

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`Page 5
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` JUDGE NEW: Very good. Thank you
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`very much.
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` Mr. Salmen, could you please once a
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`transcript of this conference has been prepared can
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`you please submit that as an exhibit?
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` MR. SALMEN: Yes, absolutely, Your
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`Honor.
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` JUDGE NEW: Thank you very much.
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` So we're here today to discuss
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`Petitioner's seeking authorization for a motion to
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`strike certain portions of the Patent Owner's
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`response.
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` Mr. Salmen, since you requested this
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`conference why don't you go ahead and explain what
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`it is you're looking for precisely without going
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`into too much detail?
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` MR. SALMEN: Yes, Your Honor.
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` First, thank you for accepting our
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`request for this teleconference, and Petitioner
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`submits that a motion to strike is the appropriate
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`procedure here. We believe that striking the
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`improperly incorporated by reference testimony will
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`best alleviate the prejudice and undue burden on
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`Petitioner the Patent Owner has created here.
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` As you know, Your Honor, we are
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`Mylan Exhibit 1089
`Mylan v. Regeneron, IPR2021-00880
`Page 5
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`

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`Page 6
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`currently in Petitioner's discovery period and we
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`only have less than three months now of which we've
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`already expended nearly two weeks addressing this
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`noncompliance with the rules. As we intend to show
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`in our motion to strike, Your Honor, we submit that
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`large portions of Patent Owner's expert
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`declarations are improperly incorporated by
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`reference into their responsive briefs. We've
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`provided examples in our e-mail requesting this
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`call and I'm happy to go through those now if it
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`will help Your Honor in deciding our request for
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`leave to file this motion.
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` JUDGE NEW: Why don't you go into it
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`right now Mr. Salmen, I'd like to know what you
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`have to say on this matter.
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` MR. SALMEN: Absolutely.
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` So the first example we presented in
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`our e-mail, Your Honor, comes from paper number 40
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`in Patent Owner's response in the 338 patent,
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`that's the 00881 IPR matter, and particularly
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`referring you to Section VIII.B of that brief.
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`This section is entitled quote, Objective Evidence
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`Confirms the Non-Obviousness of the Claimed Dosing
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`Regimen, close quote.
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` Now, this section is only three and a
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`Mylan Exhibit 1089
`Mylan v. Regeneron, IPR2021-00880
`Page 6
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`

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`Page 7
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`half pages long and approximately 900 words. Also
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`in this section there is a table where Patent Owner
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`presents a side-by-side comparison of the
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`challenged claim limitations against what they
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`characterize as quote, evidence of nexus.
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` Now, following those headers are row
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`after row Patent Owner presents what we maintain
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`are conclusory statements that simply repeat the
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`claim element and those are followed by
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`incorporations by reference to multiple Do
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`declaration paragraphs. Nearly 70 paragraphs are
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`incorporated by reference in this table alone.
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`Those 70 paragraphs encompass nearly 25 pages of
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`testimony and over 6,000 words. By comparison,
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`Your Honor, the Board held in the Cisco case that
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`only 17 pages of incorporated reference throughout
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`the entire brief was improper incorporation by
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`references.
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` Now, and this is just one example in
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`this very small section. The Patent Owner also
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`cites to its experts Brown and Dr. Manning, and if
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`we were to address those sections as well the
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`incorporation by reference amounts to nearly an
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`additional 15,000 words.
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` In addition to that, Your Honor,
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`Mylan Exhibit 1089
`Mylan v. Regeneron, IPR2021-00880
`Page 7
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`

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`Page 8
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`there is a section in the 069 brief that is paper
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`number 39 in the 880 matter. Here it appears at
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`section 4 on pages 7 through 9, this section is
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`entitled Claim Construction, and here, Your Honor,
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`Patent Owner on the one hand states that it quote,
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`does not advance claim construction positions in
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`this matter, but then on the other hand via a
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`footnote at the bottom of page 8 Patent Owner
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`states, quote, that if the Board decides to
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`construe the term method of treating or tertiary
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`dose in this IPR, then the Board should be so
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`consistent with Patent Owner's argument set forth
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`in its Patent Owner response for IPR 2021 dash 881,
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`and that's the 338 patent brief.
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` So in other words, Your Honor, Patent
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`Owner directs the Board here to pages 31 and 37 of
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`its 338 patent brief to incorporate by reference
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`its entire claim construction argument and we
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`believe that this is in violation of the Board's
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`rules banning such incorporations by reference
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`under 37 PFR section 42.683.
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` We also note on this point, Your
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`Honor, that it was very clear in the Board's
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`scheduling order, and this is consistent with the
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`Board's decision in I believe the interactive, I'm
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`Mylan Exhibit 1089
`Mylan v. Regeneron, IPR2021-00880
`Page 8
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`

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`Page 9
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`sorry, interactive broker's case, Your Honor, that
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`Patent Owner's were put on notice and cautioned
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`that if any arguments are not raised in their
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`response they may be deemed waived, and we submit,
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`Your Honor, that at the least this claim
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`construction argument that's being incorporated by
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`reference into this 069 patent from the 338 patent
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`brief should be deemed waived.
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` Your Honor --
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` JUDGE NEW: Thank you.
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` MR. SALMEN: I'm sorry, I was going
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`to say I can go into the other examples but they're
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`very consistent with the two that I've presented in
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`the 338 brief.
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` JUDGE NEW: I understand that. I've
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`looked at those portions of the responses that you
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`have sent in your e-mail and I just wanted to
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`understand precisely where you were going with
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`this.
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` Ms. Fishman, I assume you're speaking
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`for the Patent Owner today?
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` MS. FISHMAN: Actually Your Honor,
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`I'd like my partner colleague Mr. David Caine to
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`address Petitioner's arguments.
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` JUDGE NEW: That's just fine.
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`Veritext Legal Solutions
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`Mylan Exhibit 1089
`Mylan v. Regeneron, IPR2021-00880
`Page 9
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`

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`Page 10
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` Mr. Caine, can you please respond to
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`that?
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` MR. CAINE: Yes, I will, Your Honor.
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`Thank you for hearing us today.
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` I think, let me start with sort of
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`the merits discussion, and I can circle back to
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`the, maybe the procedure about how to address the
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`Petitioner's argument, if that's helpful for me to
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`address that.
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` With respect to the overall argument,
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`I think that what the Patent Owner has done in each
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`of these two responses is perfectly aligned with
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`the Board's, the practice guide and the regulations
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`which say that the arguments belong in the Patent
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`Owner response and in the petition, all of the
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`papers, in this case we presented our arguments in
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`the Patent Owner response, we have then cited to
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`the evidence that supports those arguments in the
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`form of declarations and other evidence, and in the
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`case of expert declarations, which is really the
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`focus I think of Petitioner's arguments, those
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`expert declarations provide as they should under
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`the regulations for the facts and data that
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`underlie the expert's opinions. If they hadn't
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`done that then the Board could disregard or give
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`Veritext Legal Solutions
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`Mylan Exhibit 1089
`Mylan v. Regeneron, IPR2021-00880
`Page 10
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`

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`Page 11
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`little weight to those opinions as being
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`unsupported. So in the case of the example of the
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`discussion of nexus which is found on pages 59 and
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`60 of the Patent Owner response in paper 40 in the
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`881 IPR, the chart that's provided includes the
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`claim language on the left, and although the
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`heading says evidence of nexus what is included on
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`the right-hand side of the chart is the Patent
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`Owner's arguments about why the Eylea label and
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`physician's practice of treating patients using
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`Eylea as it's described in the paragraph preceding
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`the table, satisfy each and every limitation of
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`each of the claims that are being challenged, and
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`the claim language is grouped where on the
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`left-hand side of the chart with similar language
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`grouped together, and then as I said the arguments
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`about how that, about how the label and physician
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`practice meet those limitations is contained on the
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`right side of the chart along with the evidence of
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`nexus and citations to Dr. Do's declaration. And
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`Dr. Do's declaration then provides not only Dr.
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`Do's opinions about how those limitations are met,
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`which Patent Owner relies on in making its
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`argument, but also the data and the facts that Dr.
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`Do relied upon in coming to that opinion. So in
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`Veritext Legal Solutions
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`Mylan Exhibit 1089
`Mylan v. Regeneron, IPR2021-00880
`Page 11
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`

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`Page 12
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`that way Patent Owner's argument is not
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`incorporating arguments being made by Dr. Do but is
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`citing properly to her opinions and the facts and
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`data underlying those opinions.
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` The same is the case with respect to
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`the arguments about the objective indicia,
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`including identification and satisfaction of a
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`long-felt need, commercial success, et cetera.
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`Both Dr. Brown and Dr. Manning have, offer opinions
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`that are in support of the arguments that are set
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`out on pages 60, 61 and 62, and also earlier in the
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`Patent Owner response to the 881 IPR, those are
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`found for example in the introduction on pages 2
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`through 6 where there are details about for example
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`failure of others to satisfy the long-felt need
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`that existed in the industry, and again, as with
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`Dr. Do's declaration Dr. Manning and Dr. Brown
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`provide their opinions which we cite as evidence in
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`support of the arguments made in the Patent Owner
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`response and the data and facts that underlie them.
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`So in that sense as I said, with Dr. Do it's, we're
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`similarly situated in that the arguments are set
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`out in the Patent Owner response and they are
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`citing to evidence in the form of expert
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`declarations and other documents that support those
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`Veritext Legal Solutions
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`Mylan Exhibit 1089
`Mylan v. Regeneron, IPR2021-00880
`Page 12
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`Page 13
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`opinions. So we think those are fully in
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`compliance with the Board's ruling.
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` In terms of the 669, the 880 IPR
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`concerning the 669 patent, and what counsel for the
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`Petitioner, counsel for Petitioner characterized
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`that argument, I think that that, the argument
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`that's made in the 669 patent IPR is that no
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`construction of a tertiary dose of the preamble
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`language is required, that's all our argument, and
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`we're not incorporating by reference argument,
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`claim construction arguments made in the 881 IPR,
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`rather what we're doing, particularly in the
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`context of footnote 5, is citing to case law that
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`says that when you have two patents that arise from
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`the same parent application the common terms in
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`those patents should be construed consistently.
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` So that's a citation to case law and
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`an acknowledgement of the fact that we've made
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`claim construction arguments in the other
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`proceeding. We don't think those arguments, the
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`claims need to be construed in the 669 patent but
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`all we're saying there is if they do the
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`construction should be consistent.
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` So again, that's not incorporating
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`arguments for claim construction in another brief,
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`Veritext Legal Solutions
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`Mylan Exhibit 1089
`Mylan v. Regeneron, IPR2021-00880
`Page 13
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`Page 14
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`it's simply citing to applicable laws and saying if
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`the terms are construed they should be construed
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`consistently because of the common parent
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`application.
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` JUDGE NEW: Thank you Mr. Caine.
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` MR. CAINE: I'd be pleased to circle
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`back on the procedure if that's helpful to the
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`Board.
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` JUDGE NEW: That's all right Mr.
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`Caine.
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` Mr. Salmen, do you have a response to
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`that?
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` MR. SALMEN: Yes. A few responses,
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`Your Honor.
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` So first regarding what Counsel
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`clarified as the merits part of his argument. We
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`simply respectfully disagree. We do not see any
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`arguments in this section, and I think the words
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`will speak for themselves here. We only see
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`conclusory statements with supporting citations to
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`the expert declaration, and we defer to the Board's
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`judgment with respect to whether or not those
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`statements rise to the level of argument, or if
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`they are as we submit conclusory statements. And I
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`would point out, Your Honor, that the table that
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`Mylan Exhibit 1089
`Mylan v. Regeneron, IPR2021-00880
`Page 14
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`counsel referred to as evidence of Eylea having
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`support, I'm sorry, that the counsel argued Eylea
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`should be, the claims have a nexus to Eylea, but I
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`would point out, Your Honor, that the table does
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`not provide a single citation to the Eylea label.
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`There are only citations again to the Do
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`declaration with the exception to two other
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`references, and those are to the 758 patent and its
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`file history. Nothing in there tying the claim
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`limitation to Eylea or the Eylea label.
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` Now, another clarification on
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`Counsel's argument regarding failure of others and
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`the Patent Owner's citations to the ground
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`declaration. I think there was a little ambiguity
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`in the argument there respectfully, Your Honor,
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`when Counsel was directing your attention to other
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`portions of the brief, whereas in this particular
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`section under secondary considerations Patent Owner
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`cites to paragraphs 150 to 181 and on page 58 in
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`the immediately preceding section they cite to 109
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`through 113 and 153 through 167, all of that
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`referring to quote unquote, failure of others. No
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`argument is presented there, and the references
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`that -- and one additional point there, those
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`paragraphs, 150 to 181, appear nowhere else in
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`Mylan Exhibit 1089
`Mylan v. Regeneron, IPR2021-00880
`Page 15
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`

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`Page 16
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`Patent Owner's brief. They are strictly limited to
`
`this very small section regarding secondary
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`consideration, specifically failure of others.
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` Then lastly, Your Honor, on the claim
`
`construction point, I just want to point out and
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`clarify it is not simply a citation to standing
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`case law here. The footnote specifically reads
`
`that the Board, quote, should construe consistently
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`with the constructions Regeneron has proposed in
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`its contemporaneously filed response. That is not
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`deference to standing case law, Your Honor. We
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`submit that that is an express incorporation by
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`reference that violates the Board's rules and
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`should be deemed waived.
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` Thank you, Your Honor.
`
` JUDGE NEW: Thank you Mr. Salmen.
`
` I'm going to consult with the panel
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`here now so if I can beg your indulgence just to
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`hang on the line a few minutes.
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` MR. SALMEN: Yes, please.
`
` MR. CAINE: Yes, Your Honor.
`
` JUDGE NEW: Counsel. Thank you for
`
`your patience.
`
` The panel consulted on this matter
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`and it is the sense of the panel that we are not
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`Veritext Legal Solutions
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`Mylan Exhibit 1089
`Mylan v. Regeneron, IPR2021-00880
`Page 16
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`

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`Page 17
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`going to authorize a motion to strike. I'm going
`
`to direct you to page 80 of our trial practice
`
`guide which says that striking is an extraordinary
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`remedy, it's something we grant only very rarely,
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`and in most cases the Board's capable of
`
`identifying new issues or belatedly presented
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`evidence, or other questionable writings when
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`weighing the evidence at the close of trial and
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`disregarding issues that were belatedly put into
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`evidence that exceeds the proper scope of replier's
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`surreply, and I think that's particularly true in
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`this case where what Petitioner seems to be mainly
`
`arguing is that many of the arguments were
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`statements presented by the Patent Owner are
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`conclusory. I think the Board is quite capable of
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`sorting out conclusory statements from legitimate
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`arguments as supported by evidence.
`
` So we are not going to authorize at
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`this time a motion to strike by the Petitioner,
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`however, what we will authorize at this time is
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`Petitioner can file an identification of
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`nonresponsive evidence and arguments, that's not to
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`exceed three pages and it's not to be
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`argumentative, it is just an identification of
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`those issues and locations which the Petitioner is
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`Mylan Exhibit 1089
`Mylan v. Regeneron, IPR2021-00880
`Page 17
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`

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`challenging at this point. We would find that very
`
`helpful I think when we get to the final written
`
`decision phase of the IPR. That would be due in
`
`three business days from today by close of
`
`business, followed by which the Patent Owner can
`
`respond. Also non-argumentatively by listing
`
`portions of the Patent Owner's response to which
`
`the item responds.
`
` So just pure identification of the
`
`issue and its location without any argumentation on
`
`the merits, I think the Board would find that very
`
`helpful as I said in the final written decision
`
`phase, but we are not going to entertain a motion
`
`to strike which is an extraordinary remedy and one
`
`that it's the panel's consensus is not warranted by
`
`the arguments we're hearing today.
`
` Are there any questions on that?
`
` MR. SALMEN: Just one clarification
`
`on the Board's order, Your Honor. Would you like
`
`us to include our argument, not our argument, but
`
`our identification of the claim construction issue
`
`in the 069 patent brief? Because we view that as a
`
`slightly different scenario.
`
` JUDGE NEW: Yes, you can include
`
`that.
`
`www.veritext.com
`
`Veritext Legal Solutions
`
`888-391-3376
`
`Mylan Exhibit 1089
`Mylan v. Regeneron, IPR2021-00880
`Page 18
`
`

`

`Page 19
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` MR. SALMEN: Okay.
`
` JUDGE NEW: And the Patent Owner's
`
`response will be three days after the filing of
`
`Petitioner's paper. Petitioner may want to
`
`consider doing that as a table, that's just a very
`
`clean way for us to look at it but we would leave
`
`that to your discretion.
`
` Any other questions?
`
` MR. CAINE: Not from Patent Owner.
`
` MR. SALMEN: No thank you, Your
`
`Honor.
`
` MS. LUNTZ: Your Honor if I may just
`
`to complete the record, my name is Shannon Luntz
`
`and I have been listening in on behalf of joint
`
`party Apotex, just to make sure that appears in the
`
`record.
`
` JUDGE NEW: Thank you very much.
`
` Anything else?
`
` UNIDENTIFIED: And this is Laura -- I
`
`have been listening in for Joint Petitioner
`
`Celltrion as well as my colleague Robert Jalinski.
`
` JUDGE NEW: Thank you.
`
` MR. CAINE: This is David Caine
`
`again, I apologize, I may have spoken too soon
`
`without looking at my notes. I do want to make
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`Veritext Legal Solutions
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`Mylan Exhibit 1089
`Mylan v. Regeneron, IPR2021-00880
`Page 19
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`

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`Page 20
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`sure I'm clear that the Patent Owner's response
`
`would be three business days or three days after
`
`the Petitioner's submission?
`
` JUDGE NEW: Three business days.
`
` MR. CAINE: Okay. Thank you.
`
` JUDGE NEW: Yes. That's it.
`
` Any other questions?
`
` Very good. If not thank you both for
`
`your time and we stand adjourned.
`
` (Whereupon, the conference adjourned at 2:24 p.m.)
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`Veritext Legal Solutions
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`Mylan Exhibit 1089
`Mylan v. Regeneron, IPR2021-00880
`Page 20
`
`

`

` REPORTER CERTIFICATE
`
`Page 21
`
` I, SUZANNE BENOIST, Certified Shorthand
`
`Reporter, do hereby certify that there came before
`
`me via Zoom, the above-referenced parties, that the
`
`proceeding was translated and proofread using
`
`computer-aided transcription, and the above
`
`transcript of proceedings is a true and accurate
`
`transcript of my notes as taken at the time of said
`
`event.
`
` I further certify that I am neither attorney
`
`nor counsel for nor related nor employed by any of
`
`the parties to the action in which this examination
`
`is taken; further, that I am not a relative or
`
`employee of any attorney or counsel employed by the
`
`parties hereto or financially interested in this
`
`action.
`
` Dated this 23rd day of February, 2022.
`
` <%15322,Signature%>
`
` Ms. Suzanne Benoist, RPR,
`
` CCR-MO, CCR-KS, CSR-IL, CSR-IA
`
`Notary Public No. 07541281
`
`State of Missouri - Jefferson County
`
`My commission expires: 5/10/2024
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`Veritext Legal Solutions
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`Mylan Exhibit 1089
`Mylan v. Regeneron, IPR2021-00880
`Page 21
`
`

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`[& - board's]
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`&
`& 3:4,15 4:15
`0
`00881 6:20
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`1:59 2:20 4:2
`2
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`2 12:13
`2021 8:13
`2022 1:17 2:21
`21:18
`23 1:17 2:20
`23rd 21:18
`25 7:13
`2:24 20:12
`3
`3000 3:18
`31 8:16
`312 3:9
`319-4710 3:20
`338 1:9 2:9 6:19
`8:14,17 9:7,14
`37 8:16,21
`39 8:2
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`4
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`4 8:3
`40 6:18 11:4
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`www.veritext.com
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`5 13:13
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`500 3:18
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`6
`6 3:7 12:14
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`9
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`argumentation
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`888-391-3376
`
`Mylan Exhibit 1089
`Mylan v. Regeneron, IPR2021-00880
`Page 22
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`

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`[bottom - discuss]
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`bottom 8:8
`brief 6:21 7:17 8:1
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`briefs 6:8
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`c
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`888-391-3376
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`Mylan Exhibit 1089
`Mylan v. Regeneron, IPR2021-00880
`Page 23
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`

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`[discussion - ipr]
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`discussion 10:6
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`disregard 10:25
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`give 10:25
`go 5:14 6:10,13
`9:12
`going 5:15 9:11,18
`16:17 17:1,1,18
`18:13
`good 5:1 20:8
`grant 17:4
`ground 15:13
`grouped 11:14,16
`guide 10:13 17:3
`h
`
`half 7:1
`hand 8:5,7 11:8,15
`hang 16:19
`happy 6:10
`headers 7:6
`heading 11:7
`hearing 10:4
`18:16
`heinz 3:5 4:7
`held 7:15
`help 6:11
`helpful 10:8 14:7
`18:2,12
`hereto 21:16
`history 15:9
`ho 3:17 4:13
`honor 4:6,8,16 5:7
`5:17,25 6:5,11,18
`7:15,25 8:4,15,23
`9:1,5,9,22 10:3
`14:14,25 15:4,15
`16:4,11,15,21
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`Page 3
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`18:19 19:11,12
`hsalmen 3:10
`hubbard 3:7
`hunt 4:18
`i
`ia 2:17 21:22
`identification 12:7
`17:21,24 18:9,21
`identifying 17:6
`il 2:17 21:22
`illinois 3:8
`immediately 15:20
`improper 7:17
`improperly 5:22
`6:7
`include 18:20,24
`included 11:7
`includes 11:5
`including 12:7
`incorporate 8:17
`incorporated 5:22
`6:7 7:12,16 9:6
`incorporating
`12:2 13:10,24
`incorporation
`7:17,23 16:12
`incorporations
`7:10 8:20
`indicia