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`UNITED STATES DISTRICT COURT
`
`NORTHERN DISTRICT OF WEST VIRGINIA
`
`Regeneron Pharmaceuticals, Inc.
`
` Plaintiff,
`
` VS. CIVIL ACTION NO.
`
` 1:22-cv-61
`
`Mylan Pharmaceuticals, Inc., and
`
`Biocon Biologics, Volume 7
`
` Defendants.
`
`- - -
`
`Proceedings had in the bench trial of the above-styled
`action on June 21, 2023, before Honorable Thomas S. Kleeh
`District Judge, at Clarksburg, West Virginia.
`
`- - -
`
` APPEARANCES:
`
` On behalf of the Plaintiff:
`
`David I. Berl
`Ellen E. Oberwetter
`Arthur J. Argall, III
`Kathryn S. Kayali
`Andrew V. Trask
`Williams & Connolly, LLP
`680 Maine Avenue, SW
`Washington, D.C. 20024
`202.434.5000
`
`
`
`Andrew E. Goldsmith
`Kellogg, Hansen, Todd, Figel & Frederick, PLLC
`1615 M. Street NW, Suite 400
`Washington, DC 20036
`202.326.7945
`APPEARANCES CONTINUED ON NEXT PAGE
`
`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
`
`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
`
`Samsung Bioepis Exhibit 1073
`Page 1
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`UNITED STATES DISTRICT COURT
`
`NORTHERN DISTRICT OF WEST VIRGINIA
`
`Regeneron Pharmaceuticals, Inc.
`
` Plaintiff,
`
` VS. CIVIL ACTION NO.
`
` 1:22-cv-61
`
`Mylan Pharmaceuticals, Inc., and
`
`Biocon Biologics, Volume 7
`
` Defendants.
`
`- - -
`
`Proceedings had in the bench trial of the above-styled
`action on June 21, 2023, before Honorable Thomas S. Kleeh
`District Judge, at Clarksburg, West Virginia.
`
`- - -
`
` APPEARANCES:
`
` On behalf of the Plaintiff:
`
`David I. Berl
`Ellen E. Oberwetter
`Arthur J. Argall, III
`Kathryn S. Kayali
`Andrew V. Trask
`Williams & Connolly, LLP
`680 Maine Avenue, SW
`Washington, D.C. 20024
`202.434.5000
`
`
`
`Andrew E. Goldsmith
`Kellogg, Hansen, Todd, Figel & Frederick, PLLC
`1615 M. Street NW, Suite 400
`Washington, DC 20036
`202.326.7945
`APPEARANCES CONTINUED ON NEXT PAGE
`
`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
`
`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
`
`Samsung Bioepis Exhibit 1073
`Page 1
`
`
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`Case 1:22-cv-00061-TSK-JPM Document 566 Filed 06/26/23 Page 2 of 277 PageID #:
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`On behalf of the Plaintiff, continued:
`
`
`
`Steven Robert Ruby
`Carey, Douglas, Kessler & Ruby, PLLC
`797 Virginia Street, East, Suite 901
`Charleston, WV 25301
`304.345.1234
`
`
`Petra Scamborova
`Regeneron Pharmaceuticals, Inc.
`777 Old Saw Mill River Road
`Tarrytown, NY 10591-6717
`914.847.7611
`
`On behalf of the Defendant:
`
`Deanne M. Mazzochi
`William A. Rakoczy
`Heinz J. Salmen
`Eric R. Hunt
`Lauren M. Lesko
`Neil B. McLaughlin
`Lawrence Scott Beall
`Katie A. Boda
`Rakoczy, Molino, Mazzochi & Siwik, LLP
`6 W. Hubbard Street, Suite 500
`Chicago, IL 60654
`312.527.2157
`
`Gordon H. Copland
`William J. O'Brien
`Steptoe & Johnson
`400 White Oaks Blvd.
`Bridgeport, WV 26330
`304.933.8162
`
`
`
`
`
`
`
`
`
`
`
` Proceedings recorded utilizing realtime translation.
` Transcript produced by computer-aided transcription.
`
`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
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`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
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`Samsung Bioepis Exhibit 1073
`Page 2
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`Wednesday Afternoon Session,
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`June 21, 2023, 9:00 a.m.
`
`- - -
`
`THE COURT: Day seven, I think, we convene for trial.
`
`Counsel is present. Dr. MacMichael is on the stand. I believe
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`we're ready for redirect.
`
`Is that correct, Counsel?
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`Madam Court Reporter is ready. You may proceed.
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`MR. SALMEN: Yes, Your Honor. For the first portion
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`of my redirect, I'm probably going to have to get into some
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`information that has been designated confidential. So pursuant
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`to your previous order, we ask for a sealed courtroom.
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`THE COURT: Understood.
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`In an effort to get everyone their steps in early
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`this morning, those of you not permitted to be here under the
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`Court's protective order, if I could ask you to step out. We
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`would certainly appreciate it.
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`We'll also ask the court security, once those folks
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`have vacated the premises, to seal our courtroom, please.
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`Thank you so much.
`
`(The following proceedings (1527/23 to 1533/12) were
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`had under seal, and are filed under separate cover.)
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`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
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`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
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`Samsung Bioepis Exhibit 1073
`Page 3
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` (Courtroom unsealed.)
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`THE COURT: Welcome back, everybody.
`
`Counsel, you may proceed.
`
`MR. SALMEN: Thank you, Your Honor.
`
`BY MR. SALMEN:
`
`Q.
`
`Dr. MacMichael, do you recall Mr. Berl asking you the
`
`question "Polysorbate in Claim 1 is being used as a
`
`surface-active agent to prevent aggregation and denaturation?"
`
`A.
`
`Q.
`
`I don't recall the specific question.
`
`That appears at trial transcript page 1455. Why
`
`don't we put that on the screen to refresh your recollection.
`
`I'll give you a moment to read that.
`
`A.
`
`Q.
`
`Yes.
`
`Do you recall this question?
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`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
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`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
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`Samsung Bioepis Exhibit 1073
`Page 4
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`A.
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`Q.
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`Yes.
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`Let's take a look at the '865 patent Claim 1, please.
`
`Claim 1 of the '865 patent does not require
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`polysorbate, does it?
`
`A.
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`Q.
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`It does not call out polysorbate.
`
`Dr. MacMichael, you were asked about Dr. Rabinow's
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`testimony. And to refresh your recollection, let's pull up
`
`page 1482 to 1483.
`
`Do you recall being shown this testimony from
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`Dr. Rabinow?
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`A.
`
`Q.
`
`Yes, I do.
`
`And you see here Dr. Rabinow was being asked about
`
`optimizing the stability of a protein formulation, a single
`
`formulation, right?
`
`A.
`
`Q.
`
`Yes.
`
`Were you asked to provide an opinion regarding
`
`whether the patent enables just a single formulation or whether
`
`the patent enables the full scope of the universe of
`
`formulations covered by the asserted claims?
`
`A.
`
`Q.
`
`Yes, I was asked.
`
`Were you asked whether the patent enables a single
`
`formulation or whether the patent enables the full scope of
`
`formulations covered by the asserted claims?
`
`A.
`
`I apologize. I can't recall the specificity of that
`
`question, but I can answer the question. But I believe it does
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`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
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`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
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`Samsung Bioepis Exhibit 1073
`Page 5
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`Case 1:22-cv-00061-TSK-JPM Document 566 Filed 06/26/23 Page 6 of 277 PageID #:
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`not give a description on how to make multiple formulations.
`
`Q.
`
`Thank you.
`
`Now, Dr. MacMichael, Mr. Berl asked you about undue
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`experimentation and your interpretation of that term. Do you
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`remember those questions?
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`A.
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`Q.
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`Yes.
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`Now, you've formed an opinion regarding the amounts
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`of experimentation required to practice the full scope of the
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`asserted claims; is that correct?
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`A.
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`Q.
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`Correct.
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`What level of experimentation, in your opinion, is
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`required for the person of ordinary skill in the art to
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`practice the full scope of the asserted claims?
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`A.
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`It would take a significant amount of
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`experimentation.
`
`Q.
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`When you previously suggested that -- I'm sorry.
`
`What was the term you used?
`
`A.
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`Q.
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`I used "significant" as opposed to "undue."
`
`Okay. When you previously suggested that significant
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`experimentation would be necessary, do you consider significant
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`experimentation to be undue in view of the full scope -- the
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`full scope of the '865 patent claims?
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`A.
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`Yeah. I remember we had quite some discussion on
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`that.
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`Undue means so much experimentation that you wouldn't
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`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
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`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
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`Samsung Bioepis Exhibit 1073
`Page 6
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`be able to achieve it. What I was testifying yesterday is it
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`would be a significant amount of work, whether it was undue,
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`but it would take a lot of work on the part of the formulation
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`department. So --
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`Q.
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`A.
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`Now, Doctor -- I'm sorry.
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`I was just going to say whether you call that undue
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`or significant is a relative term.
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`Q.
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`Dr. MacMichael, you were also asked by Mr. Berl
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`whether you identified any formulation that you would not be
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`able to make.
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`Do you recall those questions?
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`Yes.
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`And is that the evaluation that you were asked to
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`A.
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`Q.
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`make in determining enablement, whether you could not make a
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`certain formulation, or were you asked to form an opinion
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`regarding whether the skilled person could practice the full
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`scope of the claims?
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`A.
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`I don't know if I can get to the specifics of the
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`question of how -- what was asked yesterday, but the second
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`part of the question was?
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`Q.
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`Were you asked whether the skilled person could
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`practice the full scope of the asserted claims?
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`A.
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`Q.
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`I believe I was.
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`Dr. MacMichael, you were also asked about the
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`Kaisheva reference. Do you remember that one?
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`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
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`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
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`Samsung Bioepis Exhibit 1073
`Page 7
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`Case 1:22-cv-00061-TSK-JPM Document 566 Filed 06/26/23 Page 8 of 277 PageID #:
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`A.
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`Q.
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`Yes.
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`And in this line of questions Mr. Berl suggested that
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`the '865 patent informed the skilled person of an optimum pH
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`for the formulations in the asserted claims.
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`Do you recall that?
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`Yes, I do.
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`And that appears for the record at trial transcript
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`A.
`
`Q.
`
`pages 1488 to 1489.
`
`Now, let's take a look at the '865 patent, Claim 1,
`
`Dr. MacMichael.
`
`Dr. MacMichael, is Claim 1 limited to a formulation
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`with a pH of 6.2 to 6.3?
`
`A.
`
`Q.
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`No.
`
`The full scope of the formulation pH under Claim 1
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`would be much broader, right?
`
`A.
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`Well, it's not -- I don't see a definition for the
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`value of the pH in Claim 1, so one would assume it's broad.
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`Q.
`
`Now, let's take a look at Claim 4.
`
`Is Claim 4 limited to a specific pH?
`
`A.
`
`Q.
`
`No.
`
`Let's take a look at Claim 5. Is Claim 5 limited to
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`a specific pH?
`
`A.
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`Q.
`
`No.
`
`Let's take a look at the Kaisheva reference, Claim 1
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`of Kaisheva. This is DTX 3610, page 20 to 21. There is a copy
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`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
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`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
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`Samsung Bioepis Exhibit 1073
`Page 8
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`of it, Dr. MacMichael, in your cross-examination binder,
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`Volume 1, if that helps.
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`A.
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`That's Volume 2. I'm sorry. Could you give me
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`the --
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`Q.
`
`Yes. DTX 3610. And I think Mr. Gibson has it up on
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`the screen now.
`
`A.
`
`Q.
`
`Okay. Okay.
`
`And you see there in the third line of Claim 1 it
`
`reads "About 5 to 25 millimolar histidine buffer, having a pH
`
`from about 5.5 to 6.5."
`
`Do you see that?
`
`Yes, I do.
`
`So, Dr. MacMichael, does the claim in the Kaisheva
`
`A.
`
`Q.
`
`reference identify the specific pH range?
`
`A.
`
`Yes, it does -- it uses the term "about." Yes, it
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`does. It gives 5.5 to about 6.5.
`
`Q.
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`Right. And we don't see that specificity in the
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`'865 patent Claims 4 or 5, right?
`
`A.
`
`Q.
`
`No.
`
`Okay.
`
`We can take that down.
`
`Dr. MacMichael, you recall when Mr. Berl asked you
`
`about certain internal documents from Regeneron where they used
`
`the term "cosolvent," right?
`
`A.
`
`Yes.
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`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
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`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
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`Samsung Bioepis Exhibit 1073
`Page 9
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`MR. SALMEN: And for the record, Your Honor, this is
`
`at trial transcript pages 1476.
`
`BY MR. SALMEN:
`
`Q.
`
`Dr. MacMichael, you provided your opinion in this
`
`case that polysorbate 20 is not -- sorry.
`
`And you provided your opinion in this case that
`
`polysorbate 20 is not an organic cosolvent in Mylan's product
`
`under the Court's claim construction, right?
`
`A.
`
`Q.
`
`That's correct.
`
`Okay.
`
`Mr. Gibson, you can take that down.
`
`Were Mr. Berl's questions regarding the internal
`
`Regeneron documents specific to the Court's claim construction?
`
`A.
`
`Q.
`
`I don't believe so.
`
`Do you have any idea whether Regeneron was applying
`
`the Court's claim construction when it used the term
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`"cosolvent" in those internal documents?
`
`A.
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`No. I don't know the mind of the Regeneron
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`personnel.
`
`Q.
`
`And would the person of ordinary skill in the art
`
`have access to the Regeneron internal documents?
`
`A.
`
`Well, they're internal documents. They're
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`confidential.
`
`Q.
`
`Thank you.
`
`Now, Dr. MacMichael, I'd like to ask you about when
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`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
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`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
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`Samsung Bioepis Exhibit 1073
`Page 10
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`Mr. Berl asked you several questions about preventing
`
`aggregation using polysorbate. And I want to first ask you to
`
`consider a hypothetical formulation of aflibercept without
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`polysorbate.
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`A.
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`Q.
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`A.
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`Q.
`
`Okay.
`
`Are you with me?
`
`Yes, I am.
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`That solution would have to be in some kind of a
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`container, right?
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`A.
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`Q.
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`Yes.
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`And I believe you testified yesterday that protein
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`interactions with the surface of the container or interactions
`
`with the air can result in protein adsorption which can lead to
`
`aggregation. Was that right?
`
`A.
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`Q.
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`Yes. And denaturation.
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`And denaturation. If I had the same solution in
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`three different containers -- one in a smooth glass, a second
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`in a jagged plastic container, and a third in a completely
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`rubber container -- are you still with me?
`
`A.
`
`Q.
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`Yes, I am.
`
`The propensity for the protein to aggregate in those
`
`various containers is going to be different, right?
`
`A.
`
`Q.
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`Yes, it will be.
`
`Now, if I pick the best container, the one where the
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`protein showed the least amount of aggregation -- let's say the
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`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
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`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
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`Samsung Bioepis Exhibit 1073
`Page 11
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`glass. Okay? And I put my solutions in only glass, I would
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`have reduced the propensity for the protein to aggregate by
`
`eliminating the rubber or the jagged plastic, right?
`
`A.
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`What you're saying -- you're saying -- through
`
`experimentation, we demonstrated that we saw a greater
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`propensity in one container versus another? Is that your
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`question?
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`Q.
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`A.
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`Q.
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`Yes.
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`Yes.
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`And so by putting it in the best container, I would
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`have reduced the propensity for the protein to aggregate now
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`that it's in the glass, right?
`
`MR. BERL: Objection, Your Honor. This is leading.
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`THE COURT: Sustained.
`
`BY MR. SALMEN:
`
`Q.
`
`So, Dr. MacMichael, would you equate removing the
`
`rubber interface which reduced the likelihood of protein to
`
`aggregate the equivalent of using a cosolvent to increase the
`
`protein solubility?
`
`A.
`
`No, because if you start getting aggregation, that
`
`container, once -- you might change the rate -- depending on
`
`the container without polysorbate -- and, again, we're talking
`
`hypothetical experimentation here -- once you initiated
`
`aggregation, if you're going to see aggregation lesser in the
`
`glass and faster in the rubber, ultimately, in the glass you're
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`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
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`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
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`Samsung Bioepis Exhibit 1073
`Page 12
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`still going to get -- hint at the final amount of aggregation.
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`So the rate might be different. So you'd need to add a
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`surfactant whether using glass or rubber to prevent that
`
`aggregation.
`
`Q.
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`And would the fact that the surface is glass versus
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`rubber be the equivalent of adding a cosolvent to increase
`
`solubility of the protein?
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`A.
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`Well, first of all, adding a cosolvent -- we're using
`
`a generic term -- "cosolvent" here -- to increase solubility?
`
`Q.
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`A.
`
`Q.
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`Yes.
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`The answer would be no.
`
`Thank you.
`
`I think you also testified in response to Mr. Berl's
`
`questions that adding hydrochloric acid to protein solutions
`
`might cause aggregation by denaturing the protein; is that
`
`right?
`
`A.
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`Yes. When you're adjusting the pH of a protein
`
`solution, you have to be very careful that there's not -- as
`
`you're adding it, that there's not high concentrations of acid
`
`before it diffuses. In those areas, you can get denaturation.
`
`Q.
`
`But would you then say that not adding hydrochloric
`
`acid to my formulation would be the equivalent of using a
`
`cosolvent to increase solubility?
`
`A.
`
`No. It's two different things. The hydrochloric
`
`acid would be a denaturing agent. And not using the
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`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
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`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
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`Samsung Bioepis Exhibit 1073
`Page 13
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`hydrochloric acid doesn't make it equivalent to using a
`
`surfactant if that is the question.
`
`Q.
`
`Thank you, Dr. MacMichael.
`
`Last questions here, Dr. MacMichael.
`
`You recall the analogy Mr. Berl presented to you
`
`about driving your separate cars through a snowstorm, right?
`
`A.
`
`Q.
`
`Yes.
`
`Let me pose a similar hypothetical. But in mine
`
`let's put the person skilled in the art of driving in snowy
`
`conditions behind the wheel of the car. Okay?
`
`Now, a person skilled in the art of driving through
`
`snow would know that having a good set of snow tires on your
`
`car is going to make that car sufficiently stable in the event
`
`a snowstorm does occur, right?
`
`A.
`
`Q.
`
`Correct.
`
`And the skilled person might even have studded snow
`
`tires which have been road tested and proven to be sufficiently
`
`stable in pretty serious weather conditions, right?
`
`A.
`
`Q.
`
`Correct.
`
`And the skilled person of driving in the snow would
`
`know the snow tires alone would be sufficient to prevent the
`
`car from sliding off the road, right?
`
`A.
`
`Q.
`
`Correct.
`
`So adding chains on top of those snow tires would
`
`merely provide the skilled person some added assurance; isn't
`
`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
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`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
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`Samsung Bioepis Exhibit 1073
`Page 14
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`that right?
`
`A.
`
`Correct.
`
`MR. SALMEN: That's the end of my redirect, Your
`
`Honor.
`
`THE COURT: Thank you, Counsel.
`
`Recross?
`
`MR. BERL: Your Honor, I was going to start where
`
`Mr. Salmen started; but, unfortunately, that's the confidential
`
`document.
`
`THE COURT: No. Understood.
`
`Time for more steps, everyone. I'd like to ask you
`
`to step out of the courtroom and ask court security to seal our
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`courtroom once everyone's had a chance to depart.
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`(The following proceedings (1544/16 to 1550/4) were
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`had under seal, and are filed under separate cover.)
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`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
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`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
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`Samsung Bioepis Exhibit 1073
`Page 15
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`(Courtroom unsealed.)
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`THE COURT: Thank you, Officer.
`
`Mr. Berl, you may proceed.
`
`BY MR. BERL:
`
`Q.
`
`Do you recall a few moments ago you were asked
`
`questions about the pH range and whether the claims in the
`
`'865 patent were limited to a particular pH range?
`
`A.
`
`Q.
`
`I recall the questioning around the pH, yes.
`
`You agree that the specification limits the
`
`formulation pH to within the range of 5.8 to 7, right?
`
`A.
`
`If you could pull up the claims and the
`
`specifications, I'd like to see them so I can confirm.
`
`Q.
`
`Let's just pull up your expert report, your reply
`
`report, PTX 62. This is your reply expert report, sir,
`
`correct?
`
`A.
`
`Q.
`
`I believe so, yes.
`
`And in the second to last bullet point on page 10 it
`
`says, "The pH. The specification only limits the
`
`formulation of pH to within the wide range of 5.8 and 7.0."
`
`Do you see that?
`
`Yes, I do.
`
`And that's a correct statement, right?
`
`A.
`
`Q.
`
`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
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`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
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`Samsung Bioepis Exhibit 1073
`Page 16
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`Case 1:22-cv-00061-TSK-JPM Document 566 Filed 06/26/23 Page 17 of 277 PageID #:
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`A.
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`Q.
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`I made it.
`
`Now, finally, I want to ask you about the testimony
`
`you gave about trying to distinguish between a formulation and
`
`whether that's routine to make and multiple formulations.
`
`Do you recall that in Mr. Salmen's questioning of
`
`you?
`
`A.
`
`Q.
`
`Yes, I do.
`
`Doctor, just so everyone's clear, your opinion is
`
`that protein formulations are routinely optimized to improve
`
`the stability of their active ingredients, correct?
`
`Yes.
`
`Not a protein formulation; protein formulations.
`
`A.
`
`Q.
`
`Right?
`
`A.
`
`When I said protein formulations, I was talking about
`
`the body of biotechnology and multiple companies and multiple
`
`products. That's why I used the term in plural. Formulations
`
`require significant amount of work. That was what I was
`
`referring to.
`
`Q.
`
`Okay. So final question. Protein formulations are
`
`routinely optimized to improve the stability of their active
`
`ingredients.
`
`Do I have that right?
`
`A.
`
`That's a fair statement.
`
`MR. BERL: No more questions, Your Honor.
`
`THE COURT: Rereredirect.
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`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
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`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
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`Samsung Bioepis Exhibit 1073
`Page 17
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`MR. SALMEN: No questions, Your Honor.
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`THE COURT: All right. Do we have any exhibits that
`
`we need to -- one second, Doctor. Sorry.
`
`MR. BERL: I just have two, Your Honor. I imagine
`
`Mr. Salmen has a lot more than that. So maybe I'll just get my
`
`two done, which are PTX 672 and PTX 1948.
`
`THE COURT: Understood.
`
`Any objection to those two documents?
`
`MR. SALMEN: Let me just check, please.
`
`THE COURT: Sure.
`
`MR. SALMEN: Actually, Your Honor, we do object to
`
`admitting those documents into evidence with this expert.
`
`Those are the two Regeneron internal documents that
`
`Dr. MacMichael stated he had not seen before. I don't think
`
`this is the witness to properly authenticate those documents.
`
`THE COURT: Mr. Berl.
`
`MR. BERL: Yes, Your Honor. We can admit them
`
`through someone else, but the point is we've been admitting
`
`throughout the trial cross-examination testimony or -- and the
`
`associated documents.
`
`THE COURT: Is there any suggestion that these
`
`documents are not actually authentic? That is a low
`
`evidentiary hurdle the opponent has to climb over.
`
`MR. SALMEN: We have no objection to their
`
`authenticity, Your Honor. It's just -- and that was not the
`
`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
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`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
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`Samsung Bioepis Exhibit 1073
`Page 18
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`
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`basis of the objection, but these --
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`THE COURT: Then what is the basis?
`
`MR. SALMEN: The lack of foundation with this expert.
`
`THE COURT: With respect to authenticity. What other
`
`foundation? They were used to cross the bases of the doctor's
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`many opinions, correct, Mr. Berl?
`
`MR. SALMEN: I'll withdraw the objection, Your Honor.
`
`THE COURT: With objection withdrawn, both of those
`
`exhibits are hereby deemed admitted.
`
`And, Counsel, if you want to review your list very
`
`slowly, please.
`
`(PTX 672 and PTX 1948 were admitted.)
`
`MR. SALMEN: Yes. I'll go through them slowly, Your
`
`Honor. DTX 0007, DTX 0030, DTX 2687, DTX 3463, DTX 3465,
`
`DTX 3466, DTX 4116, DTX 4229, DTX 4430, DTX 5011, DTX 5012,
`
`DTX 5053, DTX 5172, DTX 5196, DTX 5273, DTX 7087, DTX 8206,
`
`DTX 8207, DTX 8208, and DTX 8209.
`
`THE COURT: Any objection to any of those items on
`
`the list?
`
`MR. BERL: No, Your Honor.
`
`THE COURT: Without objection, each of those shall be
`
`deemed admitted.
`
`(DTX 0007, DTX 0030, DTX 2687, DTX 3463, DTX 3465,
`
`DTX 3466, DTX 4116, DTX 4229, DTX 4430, DTX 5011, DTX 5012,
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`DTX 5053, DTX 5172, DTX 5196, DTX 5273, DTX 7087, DTX 8206,
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`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
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`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
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`Samsung Bioepis Exhibit 1073
`Page 19
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`DTX 8207, DTX 8208, and DTX 8209 were admitted.)
`
`THE COURT: Anything further we need from the good
`
`doctor?
`
`MR. SALMEN: No, Your Honor.
`
`THE COURT: All right. Doctor, thank you so much,
`
`sir. You can step down. I throw you back into the waters.
`
`They're free to talk to you again.
`
`THE WITNESS: Thank you.
`
`THE COURT: Mylan may call its next witness.
`
`MS. MAZZOCHI: Your Honor, Mylan does not have any
`
`further live witnesses for its case in chief. I did, however,
`
`before we closed yesterday we had talked about introducing
`
`exhibits that were raised by Regeneron at Dr. Stewart's cross.
`
`THE COURT: Correct.
`
`MS. MAZZOCHI: We would like to move into evidence
`
`PTX 3348, which is one of his publications that was used on
`
`cross.
`
`THE COURT: Any objection to 3348?
`
`MR. GREGORY: No objection.
`
`THE COURT: Without objection, 3348 deemed admitted.
`
`(PTX 3348 was admitted.)
`
`THE COURT: Were there any other loose ends from
`
`Dr. Stewart's testimony in terms of exhibits?
`
`MS. MAZZOCHI: I don't believe so. I think we got
`
`all the rest of his exhibits into evidence.
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`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
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`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
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`Samsung Bioepis Exhibit 1073
`Page 20
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`THE COURT: Okay. Understood.
`
`Regeneron, any remaining?
`
`MR. GREGORY: Yes, Your Honor. Given that they're
`
`moving 448, I'd like to take an opportunity to go back and take
`
`a look at the other exhibits moved on cross and see if you
`
`wanted to move a couple of those into evidence as well.
`
`THE COURT: Continue to have Dr. Stewart's exhibits
`
`at loose end then. That's fine.
`
`So Mylan is resting its case in chief, correct?
`
`MS. MAZZOCHI: Yes. With that, Your Honor, we would
`
`rest our case in chief. And then as we had indicated
`
`yesterday, however, Mylan does have some objections to the
`
`witnesses and some of the deposition designations that
`
`Regeneron is proposing to offer today.
`
`I believe one of their next witnesses was going to be
`
`Ms. Chu. There were objections that we had to Regeneron
`
`calling her in her individual capacity to talk on particular
`
`topics. I believe we filed a motion on that this morning.
`
`THE COURT: I believe that you did, 6:49 a.m. It's
`
`21 pages in length with attachments.
`
`MS. MAZZOCHI: Yes. And I can certainly summarize
`
`briefly what the issues are. And it's basically this.
`
`THE COURT: Let's pause on that.
`
`Given that Mylan has rested, are there any motions
`
`from Regeneron at this juncture?
`
`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
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`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
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`Samsung Bioepis Exhibit 1073
`Page 21
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`Case 1:22-cv-00061-TSK-JPM Document 566 Filed 06/26/23 Page 22 of 277 PageID #:
`43631
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`We'll come back to that.
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`MR. BERL: Yes, Your Honor. Regeneron moves for
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`judgment under Rule 52(c). I understand, Your Honor, that this
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`is a bench trial; so I'll be brief.
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`But I would note that beginning with the formulation
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`case, as it relates to invalidity, Mylan's combinations are
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`plainly deficient. Even taking their expert's testimony as
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`true, he failed to show multiple limitations of the claim were
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`met by the asserted combinations, including, but not limited
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`to, the requirement of an ophthalmologic formulation, which is
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`present in neither Fraser nor the Liu reference with which it
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`was combined; and the at least 98 percent native conformation
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`limitation, which is not present with respect to aflibercept in
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`any of their combinations and is not even tested for any
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`product or any molecule or any formulation with respect to the
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`combination of Fraser and Lucentis.
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`Absent a showing that all limitations of the claim,
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`the claim as a whole, is obvious, an obviousness case simply
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`cannot succeed.
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`With respect to the Dix reference, Mylan advanced no
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`evidence, zero, that the Dix application and the application at
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`issue here were not commonly owned or were not subject to a
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`common assignment by the same company, Regeneron. It's clear
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`from the face of that; they're all Regeneron's applications.
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`And, accordingly, under 35 U.S.C. 103(c), it cannot be used as
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`C i n d y L . K n e c h t , R M R / C R R / C B C / C C P
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`P O B o x 3 2 6 W h e e l i n g , W V 2 6 0 0 3 3 0 4 . 2 3 4 . 3 9 6 8
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`Samsung Bioepis Exhibit 1073
`Page 22
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`Case 1:22-cv-00061-TSK-JPM Document 566 Filed 06/26/23 Page 23 of 277 PageID #:
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`prior art for purposes of obviousness.
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`With respect to anticipation of Dix, even taking as
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`true everything their expert Dr. Rabinow said, regarding the
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`40 mg/mL limitation of the claim, it's just not there. He
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`relies only on the disclosure of 10 to 50 mg/mL, a range which
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`is not directed to aflibercept.
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`But in any event, the law is clear. Disclosure of a
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`range is not the disclosure of any number within that range,
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`and any anticipation argument that Mylan attempts to advance
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`simply is inconsistent with that controlling precedent, and so
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`it cannot succeed either.
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`Now, with respect to Section 112, Your Honor just
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`heard Dr. MacMichael, and the testimony was clear. He had
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`numerous opportunities, both on cross-examination and again
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`this morning on redirect, to tell Your Honor that the
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`experimentation to practice the claim was undue. He repeatedly
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`declined. And that's the standard from the Wands case all the
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`way down to Alcon v. Barr. It's routine experimentation or
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`undue experimentation.
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`They had two experts testify. We haven't gone yet,
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`of course. Their first expert, Dr. Rabinow, said it's routine.
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`Their second expert didn't disagree with that, and he doesn't
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`say it's undue experimentation either. You can't have an
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`enablement case without undue experimentation, and there's no
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`evidence that there is.
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`C i n d y
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