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` UNITED STATES PATENT AND TRADEMARK OFFICE
` _________________________
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` __________________________
`
`Page 1
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` MYLAN PHARMACEUTICALS, INC.,
` MSN LABORATORIES PRIVATE LTD.,
` and MSN PHARMACEUTICALS, INC.,
` Petitioners,
` v.
` BAUSCH HEALTH IRELAND LIMITED,
` Patent Owner.
`
` ___________________________
` Case No. IPR 2022-00722
` Patent 7,041,786
`
` _____________________________
`
` Telephone Conference held on:
` August 17, 2023
` 3:02 p.m.
`
` Before:
` Judge Michael Valek
` Judge Tina Hulse
` Judge Cynthis Hardman
`
`Veritext Legal Solutions
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`MYLAN EXHIBIT - 1076
`Mylan Pharmaceuticals, Inc. v. Bausch Health Ireland, Ltd.
`IPR2022-00722
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` _________________________
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` __________________________
`
`Page 1
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` MYLAN PHARMACEUTICALS, INC.,
` MSN LABORATORIES PRIVATE LTD.,
` and MSN PHARMACEUTICALS, INC.,
` Petitioners,
` v.
` BAUSCH HEALTH IRELAND LIMITED,
` Patent Owner.
`
` ___________________________
` Case No. IPR 2022-00722
` Patent 7,041,786
`
` _____________________________
`
` Telephone Conference held on:
` August 17, 2023
` 3:02 p.m.
`
` Before:
` Judge Michael Valek
` Judge Tina Hulse
` Judge Cynthis Hardman
`
`Veritext Legal Solutions
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`MYLAN EXHIBIT - 1076
`Mylan Pharmaceuticals, Inc. v. Bausch Health Ireland, Ltd.
`IPR2022-00722
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`
`
`APPEARANCES:
`
`FOR THE PETITIONER: JAD A. MILLS, Esquire
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` Wilson, Sonsini, Goodrich & Rosatio
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`Page 2
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`FOR THE PATENT OWNER: JUSTIN HASFORD, Esquire
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` Finnegan, Henderson, Farabow,
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` Garrett & Dunner
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` P-R-O-C-E-E-D-I-N-G-S
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` JUDGE VALEK: I'd like to have parties introduce
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`themselves beginning with the petitioner.
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` MR. MILLS: This is Jad Mills from Wilson Sonsini on
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`behalf of Petitioner Mylan. On the call we have Rick Torczon
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`and Tasha Thomas.
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` JUDGE VALEK: Okay. Who is on the line for patent
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`owner.
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` MR. HASFORD: Your Honor, for patent owner, this is
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`Justin Hasford of Finnegan here and I'm also joined by my
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`partner, Joshua Goldberg.
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` JUDGE VALEK: Okay. Well, we're here today regarding
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`patent owner's request to submit supplemental information.
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` Mr. Hasford, before you get into the substance of your
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`argument, can you just briefly identify what it is you're
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`seeking to submit as supplemental information in this
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`proceeding.
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` MR. HASFORD: Certainly, Your Honor. We're seeking to
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`submit the expert report of Dr. Sunny Zhou that we contend sets
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`forth position. Looks like the report was served by Mylan in
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`parallel district court with the issue involving the same
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`parties and the same active pharmaceutical ingredient that's at
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`issue here. And it's our position that this expert report of
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`Dr. Zhou sets forth positions that contradict Mylan's arguments
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`in this IPR proceeding.
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` JUDGE VALEK: When was Dr. Zhou's report served on
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`patent owner?
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` MR. HASFORD: It was served July 14th, Your Honor.
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` JUDGE VALEK: And Dr. Zhou is not currently a witness
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`in this IPR proceeding, is that correct?
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` MR. HASFORD: That is correct, Your Honor.
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` JUDGE VALEK: So, it kind of goes without saying, but
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`patent owner's request for supplemental information comes very
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`late in this proceeding. But, Mr. Hasford, you can have a few
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`minutes to explain why patent owner believes it is in the
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`interest of justice to allow this information into the record at
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`this point.
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` MR. HASFORD: Certainly, Your Honor. Specifically, in
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`this IPR proceeding, Mylan is arguing obviousness of the 786
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`patent claims. And Mylan and it's IPR expert, Dr. Blake
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`Peterson have argued that topoisomerism was not a problem that
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`would have persuaded a person of ordinary skill in the art from
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`selecting human uroguanylin, a unique compound, and modifying it
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`to make the claimed Plecanatide compound with a reasonable
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`expectation of success.
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` And point out, Your Honors, that Dr. Peterson presents
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`his opinion throughout Section 3(b) of his second declaration.
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`More specifically, in paragraph 31 of his second declaration,
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`Dr. Peterson opines that with respect to topoisomerism
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`associated with human uroguanylin, quote, a person of ordinary
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`skill in the art would not expect this to have a materially
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`adverse impact of its efficacy, end quote.
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` And Mylan repeatedly cites this opinion from Dr.
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`Peterson in its reply brief, Your Honor, and in the final oral
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`hearing, Mr. Mills on behalf of Mylan stated, quote,
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`topoisomeric interconversion is not a credible concern, end
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`quote.
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` Now, however, Your Honor, in the parallel district
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`court case, Mylan and Dr. Zhou just argued that topoisomerism in
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`fact was a long known property with human uroguanylin, because
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`one topoisomer of human uroguanylin was, quote, practically
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`inactive, end quote.
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` This is exactly the opposite of Mylan's and Dr.
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`Peterson's argument in this IPR proceedings, Your Honors. And
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`it's consistent with patent owner's and Dr. Davies' position
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`that human uroguanylin would not have been a suitable choice and
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`a lead compound for drug development. Dr. Zhou presents this
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`opinion, at least, six times in his expert report in the
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`district court case, Your Honors, and Dr. Zhou relies on some of
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`the same prior art, including the Chino reference that Mylan and
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`Dr. Peterson address at this IPR proceeding.
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` Mylan served the expert report of Dr. Zhou a full
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`month after final oral hearing in this IPR proceeding. Patent
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`owner could not obtain this new concession from Mylan earlier,
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`Your Honors, and respectfully submits the Board's consideration
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`of this information would be in the interest of justice. And we
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`therefore seek authorization to submit this information to the
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`Board in accordance with Section 42.123.
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` Specifically, Your Honors, we respectfully request a
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`five-page submission due no later than one week from today, on
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`August 24th and we would not oppose a five-page responsive
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`submission from Mylan one week later on August 31st.
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` And we note, Your Honors, the Board granted a similar
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`request in SZ DJI Technology v. Autel Robotics in IPR 2019-343
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`where they received inconsistent testimony provided by the
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`petitioner's expert in a parallel ITC proceeding where the
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`patent owner could not attain to it.
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` Thank you very much for entertaining our request, Your
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`Honor.
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` JUDGE VALEK: Sure. I have a couple questions before
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`I allow the petitioner to respond.
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` What is your explanation for why you waited from the
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`time you received the report in middle of July, I believe, until
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`last week to bring this request to the Board? The reason I'm
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`asking is because you know that we have a statutory deadline in
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`this case. And, so, yeah, even if it's just two weeks or three
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`weeks, that's a lot of time at this point in the proceeding,
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`because we're less than a month out from that statutory
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`deadline.
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` MR. HASFORD: We understand and certainly appreciate
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`that, Your Honor.
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` Mylan served hundreds of pages of expert reports on us
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`in the district court case encompassing well over a thousand
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`total paragraphs. It took a long time to go through those
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`reports with our experts.
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` So, within two or so weeks after we received those
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`expert reports, we contacted -- we reached out to Mylan. We
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`asked that they meet and confer. They asked for additional
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`information before meeting and conferring with us. We provided
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`that additional information. Met and conferred approximately a
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`week later. And then shortly after the meet and confer, we
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`submitted the request to Your Honors. That was last week and
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`then, of course, got on the phone today.
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` JUDGE VALEK: Okay. And these five-page submissions
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`that you're referring to, are those -- is that a motion for
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`supplemental information or is that additional briefing
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`regarding the import of Dr. Zhou's expert report in the other
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`proceeding.
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` MR. HASFORD: We, of course, would defer to Your
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`Honors as to what procedurally you would like us to do, but
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`we're happy to provide substantive input in those five pages,
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`unless Your Honor prefers that we submit a preliminary motion to
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`seek the authorization. We're effectively seeking the
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`authorization here.
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` JUDGE VALEK: Okay. And you're seeking authorization
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`to submit the supplemental information on this call. And the
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`submission that you're proposing would be a submission
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`addressing the application of Dr. Zhou's expert report to the
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`issues in this proceeding? Is that it?
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` MR. HASFORD: That's exactly correct, Your Honor.
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` JUDGE VALEK: Okay. Are there any other questions
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`from the panel before we pass this to the petitioners to hear
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`their point of view?
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` Okay.
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` JUDGE HARDMAN: This is Judge Hardman, no.
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` JUDGE VALEK: All right. Thank you, Mr. Hasford.
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`Let's hear from Mr. Mills.
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` MR. MILLS: This is Jad Mills. If I could, I'd like
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`to address first the, that the request is not in the interest of
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`justice; that the patent owner has not demonstrated that --
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` There is no inconsistent sworn testimony by anyone,
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`certainly not by a trial witness. And there has been no basis
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`identified for admission of the document, much less
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`demonstration of an actual contradiction.
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` The patent owner is already asking -- inviting the
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`Board to participate in legal error that's predicated on the
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`idea that there cannot be a motivation to modify unless there is
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`a teaching away.
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` In the IPR proceedings, we argued repeatedly that
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`topoisomerism could be and would be identified. The topoisomers
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`routinely separated as characterized, and Dr. Zhou's report is
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`consistent with that.
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` In addition to the patent owner failing to demonstrate
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`that there's an inconsistency in sworn testimony, there's a real
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`risk of confusion, undue prejudice and this is a large document
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`that the patent owner is attempting to take out of context.
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`It's addressing various patents, including the testimony (sic)
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`at issue in addressing patents with a later priority date and
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`have different claims and different claim scope.
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` And indeed, Dr. Zhou's testimony supports the position
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`in the IPR and, in fact, provides evidence that contradicts
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`Bausch's own unexpected results arguments. And there are
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`references that Dr. Zhou relies upon in there that do that.
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` And so, if this document is submitted, then we believe
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`that opens the door for us to provide briefing explaining how
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`Dr. Zhou's opinion supports the IPR positions, as well as to
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`submit that additional evidence that he relies upon.
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` To the extent that the Board thinks the patent owner
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`has satisfied its burden or potentially even could have
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`satisfied its burden, one option for the Board to consider is to
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`perform an in camera review of the document, rather than fully
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`submitting it.
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` Now, if I could briefly address the untimeliness. The
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`patent owner has mentioned the July 14th submission of the
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`document. They waited two weeks, more than two weeks until
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`August 1st to reach out to us. When they reached out to us, the
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`information they gave us was very terse. We had to repeatedly
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`ask for more information to understand the nature of the
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`request.
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` And then once we investigated the request that they
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`made, we discovered that the things that they're pointing to are
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`almost word for word identical to statements that were made in
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`the invalidity contention that we served on them almost one year
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`ago on August 18th, 2022, and the supplemental invalidity
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`contention on November 17th, 2022. And for that additional
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`reason, we believe that they have not made the requisite showing
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`here. Thank you.
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` JUDGE VALEK: Just a few additional questions for
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`patent owner.
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` How long about is the expert report that you're trying
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`to submit?
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` MR. HASFORD: I believe the expert report itself is
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`several hundred paragraphs. So, I think it's roughly couple
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`hundred pages, several hundred paragraphs.
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` However, we would point to a specific -- certain
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`specific sections of that expert report. I mean, a lot of that
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`expert report will be dealing with other issues that wouldn't
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`directly address this issue, but there are at least six
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`occasions in that expert report in which Dr. Zhou provide the
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`opinion that the one topoisomer of human uroguanylin is
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`practically inactive.
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` And so, we can certainly point the Board very easily
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`to those specific sections such that the Board wouldn't need to
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`necessarily consider other portions of the report that, perhaps,
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`didn't speak to this issue.
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` And I have a couple of other items to respond to, but
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`I'll ask Your Honor, does that satisfactorily answer your
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`question? Do you have further questions that I can address on
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`the other issues Mr. Mills raised?
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` JUDGE VALEK: That answers that question, but I do
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`have another question.
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` Does patent owner contend that this multi-hundred page
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`document you want to submit relates to any issue in the IPR,
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`other than the lead compound analysis.
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` MR. HASFORD: The issue that it predominately relates
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`to is lead compound analysis and we would be submitting it for
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`that purpose. We would not be submitting it for a different
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`purpose within the IPR. So, if that answers your question,
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`Your Honor.
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` JUDGE VALEK: And the particular opinion that you're
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`pointing to from Dr. Zhou is that one of the two topoisomers of,
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`I guess, human uroguanylin is practically inactive is how you
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`characterized it, is that right?
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` MR. HASFORD: That's exactly correct. Those are the
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`words he used, practically inactive.
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` JUDGE VALEK: Let me ask this question for the
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`petitioner. Is that even a disputed fact in this case?
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` MR. MILLS: Thank you for that question, Your Honor.
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`The reference that Dr. Zhou is quoting from in that section of
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`the report is a reference that's already in the record. It's in
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`the Chino reference. And so, the text of the Chino reference is
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`not in dispute in the IPR.
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` JUDGE VALEK: I didn't understand and maybe I missed
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`it somewhere, but I didn't understand petitioner to be arguing
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`that both of the topoisomers of human uroguanylin are active or
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`known to be active.
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` MR. MILLS: Yes. So whether it is completely inactive
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`or whether there some level of activity, I don't know that we
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`specifically addressed that. The statement in Chino, the patent
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`owner is referring to is already in the record in the case and
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`we have not argued that that statement is inaccurate.
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` JUDGE VALEK: So, let me go back to Mr. Hasford for a
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`moment.
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` Mr. Hasford, how is it that Dr. Zhou's opinion in this
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`expert report is not cumulative of the evidence that's already
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`in the record in the IPR proceeding? I'm failing to see why it
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`matters.
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` MR. HASFORD: Because Dr. Peterson, Your Honor,
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`opines, specifically, quote, with respect to the topoisomers
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`associated with human uroguanylin. He stated, quote, a person
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`of ordinary skill in the art would not expect this to have a
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`materially adverse impact on its efficacy.
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` So, Dr. Peterson is opining the topoisomers that are
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`present, that's set forth in the prior art would not be expected
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`to impact the efficacy of human uroguanylin. And Dr. Zhou in
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`contrary fashion says that it was long known that there was this
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`problem of human uroguanylin with respect to its efficacy, the
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`inactive topoisomer or this topoisomer rather was both
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`practically inactive. So, that's the problem here, that's the
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`inconsistency.
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` JUDGE VALEK: But as I understand Mr. Mills' position,
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`you already have the Chino reference which is one of the
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`exhibits of record that says the same thing is what you're
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`saying is important from Dr. Zhou's expert report. And so, I
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`don't understand why you need supplemental information of the
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`same thing so late in the game.
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` MR. HASFORD: Respectfully, Your Honor, I think
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`there's a little bit more to it with Dr. Zhou. He is opining
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`that the topoisomers in the human uroguanylin was a long known
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`problem.
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` So, his opinion, and I can pull it up here,
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`specifically, is over a decade before priority date those of the
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`art knew and scientist understood this. He sets it up as a long
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`known problem that a person of ordinary skill in the art would
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`have had to address. And that is inconsistent, in our view,
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`entirely with Dr. Peterson's opinion. So, it's more than simply
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`seeing the Chino reference that's already in the record.
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` JUDGE VALEK: But what he cites for that statement is
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`Chino, correct?
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` MR. HASFORD: He is citing Chino for that statement.
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`That is correct, Your Honor.
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` JUDGE VALEK: I have another question for you.
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` Is it true that you've known about these positions
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`since the invalidity contentions that were served? So even
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`though the expert report was served in mid-July, you had
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`invalidity contentions that that petitioner says are nearly word
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`for word in your possession for over a year now. Is that true?
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` MR. HASFORD: I'm happy to address that, Your Honor.
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` So, respectfully, Mylan's contentions constituted
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`hundreds and hundreds of pages of attorney prepared arguments.
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`Those are not evidence and no expert or any other witness for
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`that matter provided these opinions on behalf Mylan until the
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`middle of last month, one month after the final oral hearing in
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`the IPR proceeding.
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` So, we respectfully submit that even if Mylan, in
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`fact, included some of these issues in attorney argument
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`contentions to us in the district court case, we of course had
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`no way of knowing what opinions any of their experts were going
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`to provide until they actually provide us with expert reports,
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`and that was last month.
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` JUDGE VALEK: But the expert reports aren't evidence
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`either. They are just a summary of what the expert is intending
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`to testify about at trial. And as I understand it, you want to
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`offer the expert report here to impeach the position that the
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`petitioner's expert has taken. You could have done the same
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`thing with the invalidity contentions, right?
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` MR. HASFORD: Well, what I would say, Your Honor, is
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`that that wasn't Mylan's own expert saying something that's
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`completely contrary to what another of their experts said in the
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`case. I think it's --
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` Your Honor is correct, an expert report itself is not
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`evidence. However, we expect that Mylan's expert would testify
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`at trial in the district court case consistent with what is in
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`his expert report. And, therefore, we think that that's
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`important to provide to the Board consistent with the
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`requirements of Section 42.123.
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` JUDGE VALEK: Okay. Mr. Hasford, do you have anything
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`else that you'd like to respond to in Mr. Mills' argument?
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` MR. HASFORD: Briefly, Your Honor. It appears that
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`Mr. Mills wants to explain away the opinions of Dr. Zhou in the
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`district court case. What we would respectfully submit to
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`Your Honors is that this is not a basis to deny our request to
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`submit supplemental information for Your Honor's consideration.
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`If Mylan wants to address the substance of Dr. Zhou's opinions,
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`Mylan can do so in a five-page response on paper.
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` But in our view, Your Honor, there is not a legitimate
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`dispute that the opinion of Dr. Peterson in the IPR proceeding
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`and the opinions of Dr. Zhou parallel in the district court case
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`are facially inconsistent with each other. And that is exactly
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`why we are requesting authorization to submit the relevant
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`information Your Honors and the Court consistent with 42.123.
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` JUDGE VALEK: I think we understand each side's
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`positions. Why don't you stay on the line for a moment while I
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`confer with my colleagues.
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` MR. HASFORD: Thank you, Your Honor.
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` (Pause in proceedings.)
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` JUDGE VALEK: This is Judges Valek, Hulse and Hardman,
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`and we have decided that we are not going to authorize patent
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`owner's request because we do not believe that it would be in
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`the interest of judgment to allow this proposed supplemental
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`information at this point in the proceeding.
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` It seems like most of the information is already in
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`the record in the form of this Chino reference and that any
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`incremental value of the report is outweighed by the actual
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`prejudice, I suppose, that would be -- that petitioner would
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`face from us allowing it into the record now at this stage in
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`the proceeding given that we're less than a month out from the
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`statutory deadline.
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` The additional brief you proposed doesn't seem like it
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`would add much of import to the current record or to the
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`resolution of these issues.
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` We'll, of course, issue a written order confirming
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`this, but just so the parties can plan, we are not going to
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`authorize this particular request.
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` Does either side have any questions before we adjourn?
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` MR. HASFORD: No questions from patent owner, Your
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`Honor.
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` MR. MILLS: Nothing from petitioner.
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` JUDGE VALEK: Okay. Thank you for your time. And
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`just one thing, make sure that the transcript for the call gets
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`filed in the record, but do not include Dr. Zhou's report.
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`That's not authorized, just the transcript of this call.
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` MR. MILLS: Yes, understood.
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` JUDGE VALEK: Thank you all. Appreciate it. We're
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`adjourned.
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` (The matter concluded at 3:37 p.m.)
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` * * *
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` CERTIFICATE OF COURT REPORTER
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` I, Linda C. Marshall, certify that the foregoing is a
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`correct transcript from the record of proceedings in the
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`above-entitled matter.
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` <%28729,Signature%>
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` _________________________
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` Linda C. Marshall, RPR
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` Official Court Reporter
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`n 3:1
`nature 10:3
`nearly 14:11
`necessarily
`11:4
`need 11:3 13:15
`new 5:24
`note 6:8
`november
`10:10
`
`o
`
`o 3:1
`obtain 5:24
`
`obviousness
`4:14
`occasions 10:24
`offer 15:4
`office 1:1
`official 18:8
`okay 3:7,12
`7:14,25 8:6,9
`15:17 17:9
`once 10:5
`opens 9:15
`opines 4:24
`12:24
`opining 13:3,18
`opinion 4:22
`5:3,18 9:16
`10:25 11:20
`12:19 13:21
`14:1 16:2
`opinions 14:17
`14:23 15:20,24
`16:3
`oppose 6:6
`opposite 5:13
`option 9:20
`oral 5:4,23
`14:18
`order 17:2
`ordinary 4:17
`4:25 13:1,24
`outweighed
`16:19
`own 9:12 15:8
`owner 1:9 2:4
`3:8,9 4:2,10
`
`5:24 6:12 8:15
`8:20 9:3,6,18
`9:24 10:14
`11:12 12:
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