UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`Page 1
`
` MYLAN PHARMACEUTICALS, INC., )
` CELLTRION, INC., AND APOTEX, )
` INC., ) Case IPR2021-00880
` )
` Petitioners, ) Patent 9,669,069 B2
` )
` vs. )
` ) Case IPR2021-00881
` REGENERON PHARMACEUTICALS, )
` INC., ) Patent 9,254,338 B2
` )
` Patent Owner. )
`
` Report of Proceedings had at the
`teleconference hearing of the above-entitled cause,
`before the HONORABLE JUDGES ERICA A. FRANKLIN,
`JOHN G. NEW, and SUSAN L.C. MITCHELL, on
`May 19, 2022, commencing at 1:00 p.m. CST.
`
`Reported remotely by June M. Funkhouser, CSR, RMR
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`www.veritext.com
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`888-391-3376
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`Veritext Legal Solutions
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`Mylan Exhibit 1116
`Mylan v. Regeneron, IPR2021-00880
`Page 1
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`A P P E A R A N C E S V I A T E L E C O N F E R E N C E :
` R A K O C Z Y M O L I N O M A Z Z O C H I S I W I K L L P b y
` M S . D E A N N E M . M A Z Z O C H I
` M R . H E I N Z J . S A L M E N
` M R . N E I L B . M C L A U G H L I N
` M R . J E F F R E Y A . M A R X
` 6 W e s t H u b b a r d S t r e e t , S u i t e 5 0 0
` C h i c a g o , I l l i n o i s 6 0 6 5 4
` 3 1 2 . 5 2 7 . 2 1 5 7 | 3 1 2 . 8 4 3 . 6 2 6 0 ( f a x )
` d m a z z o c h i @ r m m s l e g a l . c o m
` h s a l m e n @ r m m s l e g a l . c o m
` n m c l a u g h l i n @ r m m s l e g a l . c o m
` j m a r x @ r m m s l e g a l . c o m
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` o n b e h a l f o f t h e P e t i t i o n e r s ;
`
` A R N O L D & P O R T E R b y
` M S . D E B O R A H F I S H M A N
` M R . D A V I D A . C A I N E
` 3 0 0 0 E l C a m i n o R e a l F i v e P a l o A l t o S q u a r e ,
` S u i t e 5 0 0
` P a l o A l t o , C a l i f o r n i a 9 4 3 0 6
` 6 5 0 . 3 1 9 . 4 5 0 0 | 6 5 0 . 3 1 9 . 4 7 0 0 ( f a x )
` d e b o r a h . f i s h m a n @ a r n o l d p o r t e r . c o m
` d a v i d . c a i n e @ a r n o l d p o r t e r . c o m
`
` A R N O L D & P O R T E R b y
` M R . M A T T H E W M . W I L K
` 2 5 0 W e s t 5 5 t h S t r e e t
` N e w Y o r k , N e w Y o r k 1 0 0 1 9
` 2 1 2 . 8 3 6 . 8 0 0 0 | 2 1 2 . 8 3 6 . 8 6 8 9 ( f a x )
` m a t t h e w . w i l k @ a r n o l d p o r t e r . c o m
` A R N O L D & P O R T E R b y
` D R . A L I C E H O , P h . D .
` 6 0 1 M a s s a c h u s e t t s A v e , N W
` W a s h i n g t o n , D C 2 0 0 0 1
` 2 0 2 . 9 4 2 . 5 0 0 0 | 2 0 2 . 9 4 2 . 5 9 9 9 ( f a x )
` a l i c e . h o @ a r n o l d p o r t e r . c o m
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` o n b e h a l f o f P a t e n t O w n e r .
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`www.veritext.com
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`Veritext Legal Solutions
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`Mylan Exhibit 1116
`Mylan v. Regeneron, IPR2021-00880
`Page 2
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`

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`Page 3
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` JUDGE FRANKLIN: Good afternoon. This is
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`Judge Franklin. I'm on a line with Judges New and
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`Mitchell.
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` This is a conference call in
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`IPR2021-00880 and 881.
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` Who do we have for Petitioner?
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` MR. SALMEN: Hello, Your Honor. This is
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`Heinz Salmen on behalf of Petitioner of the law
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`firm Rakoczy, Molino --
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` JUDGE FRANKLIN: I'm sorry. One moment.
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`I'm having a little trouble hearing you. One
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`second.
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` Okay. Could you start again?
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` MR. SALMEN: Yes. Is this better now?
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` JUDGE FRANKLIN: Yes.
`
` MR. SALMEN: Okay. This is Heinz Salmen
`
`of the law firm Rakoczy, Molino, Mazzochi, Siwik on
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`behalf of Petitioner Mylan.
`
` On the call with me I have my
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`colleagues Deanne Mazzochi and Jeff Marx, and also
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`on the call Neil McLaughlin.
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` JUDGE FRANKLIN: Okay. Thank you.
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` And who do we have for Patent Owner?
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` MS. FISHMAN: Good afternoon or good
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`Veritext Legal Solutions
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`Mylan Exhibit 1116
`Mylan v. Regeneron, IPR2021-00880
`Page 3
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`morning, Your Honor. This is Deborah Fishman of
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`the firm Arnold & Porter on behalf of Patent Owner
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`Regeneron.
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` I believe with me today I have my
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`partner David Caine, though I didn't hear him
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`announce himself on the call.
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` David, are you here?
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` MR. CAINE: I'm here.
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` MS. FISHMAN: Okay; perfect.
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` And then I believe we also have our
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`colleagues Matthew Wilk and Alice Ho, also of the
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`law firm Arnold & Porter, on behalf of Patent Owner
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`on the call today.
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` I heard Matthew introduce himself.
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`Alice, are you here?
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` DR. HO: Yes, I am.
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` MS. FISHMAN: Okay. That's all that
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`we're expecting on behalf of Patent Owner, Your
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`Honor.
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` JUDGE FRANKLIN: Okay. Thank you.
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` And do we have a court reporter?
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` THE REPORTER: Yes, Your Honor. My name
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`is June Funkhouser with the firm Veritext.
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` JUDGE FRANKLIN: Okay. And who arranged
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`Veritext Legal Solutions
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`Mylan Exhibit 1116
`Mylan v. Regeneron, IPR2021-00880
`Page 4
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`for the court reporter?
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` MR. SALMEN: Your Honor, that would be
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`Petitioner arranged for the court reporter.
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` JUDGE FRANKLIN: Okay; thanks.
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` So I just wanted to instruct you to
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`provide a copy of the transcript as soon as it's
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`available, and also while I'm talking to you I'll
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`let you go ahead and begin and explain a little
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`background in terms of it looks like maybe you were
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`seeking to get an agreement for discovery and that
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`because no agreement was reached you wanted to gain
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`some guidance on seeking authorization for a motion
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`for additional discovery.
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` So please expand on that or correct my
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`impression of that, if appropriate.
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` MR. SALMEN: Yes, Your Honor. Again,
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`this is Heinz Salmen for Petitioner.
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` With your permission, Your Honor, my
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`colleague, Jeff Marx, is going to handle today's
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`call and present our positions for you.
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` JUDGE FRANKLIN: That's fine.
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` MR. SALMEN: I'll hand it over to Jeff.
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` MR. MARX: Your Honor, Jeff Marx.
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` Petitioner took the depositions of
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`Mylan Exhibit 1116
`Mylan v. Regeneron, IPR2021-00880
`Page 5
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`Page 6
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`Patent Owner's expert declarants and during those
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`depositions requested certain documents on the
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`record, and, as Your Honor alluded to, we've
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`attempted to reach an agreement with Patent Owner
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`for the production of information but we were
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`unable to do so and have sought the Board's
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`assistance.
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` JUDGE FRANKLIN: Okay. Can you describe
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`what those documents are?
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` MR. MARX: Certainly. Certainly.
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` I think it would be most efficient if
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`we start with what is the fifth request for
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`information concerning the education and
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`professional background of Dr. Yancopoulos.
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`Dr. Yancopoulos is the sole inventor of the patents
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`that are at issue in each IPR, the '069 patent and
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`'338 patent.
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` Now during the deposition of Patent
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`Owner's expert Dr. Do, Dr. Do asserted that a
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`person of ordinary skill in the art must be a
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`licensed ophthalmologist familiar with treating and
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`diagnosing angiogenic eye disorders. Now such a
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`high level of a person of ordinary skill in the
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`art, that would exclude the only named inventor
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`Veritext Legal Solutions
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`Mylan Exhibit 1116
`Mylan v. Regeneron, IPR2021-00880
`Page 6
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`Page 7
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`here, Dr. Yancopoulos.
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` As the Board is familiar, an inventor,
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`they're a person of extraordinary skill in the art,
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`and the definition of a person of ordinary skill in
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`the art that would exclude the inventor is plainly
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`inconsistent.
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` At the deposition of Dr. Do, Mylan
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`introduced two exhibits attempting to set forth
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`Dr. Yancopoulos's background and professional
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`level, and the Patent Owner objected to each of
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`those exhibits and their use and to date they have
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`refused to withdraw their objection.
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` So following the deposition of Dr. Do,
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`Mylan promptly requested that Patent Owner produce
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`Dr. Yancopoulos's curriculum vitae or some other
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`document, equivalent document, setting forth his
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`education and his professional background and they
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`have refused to do so, which brings us before the
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`Board.
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` We've requested that the education and
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`professional background of Dr. Yancopoulos be
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`produced, at least as it's routine discovery,
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`because it is inconsistent with the Patent Owner's
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`expert's position which excludes Dr. Yancopoulos.
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`Veritext Legal Solutions
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`Mylan Exhibit 1116
`Mylan v. Regeneron, IPR2021-00880
`Page 7
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`Page 8
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`And that, as I'm sure Your Honor is aware, is Rule
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`42.51(b)(1)(iii) that requires a party to produce
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`information inconsistent with a position advanced
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`by the party. Here Dr. Do's extremely high level
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`of a person of ordinary skill in the art is plainly
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`inconsistent with the inventor's own skill level.
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` Now, if the Board determines that
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`production of Dr. Yancopoulos's CV isn't mandated
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`as routine discovery, Petitioner requests that it
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`should be granted as permissible additional
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`discovery set forth in Rule 42.51(b)(2).
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` As I'm sure Your Honor is aware,
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`additional discovery is typically governed by the
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`Garmin factors, the five factors that are important
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`to the Board's analysis. Garmin factor 1, which is
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`perhaps most critical here, states that whether
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`there exists more than a possibility and a mere
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`allegation that something useful will be
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`discovered, and "useful" in this context Garmin
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`states that it means favorable and substantive
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`value to a contention of the moving party for
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`discovery.
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` Here Mylan, we assert that such a high
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`level of skill in the art is certainly inconsistent
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`Veritext Legal Solutions
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`Mylan Exhibit 1116
`Mylan v. Regeneron, IPR2021-00880
`Page 8
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`Page 9
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`with the inventor's own skill level, and so
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`Dr. Yan --
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` JUDGE FRANKLIN: I'm sorry. I'm sorry,
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`Mr. Marx. I apologize for interrupting.
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` I don't really want you to go through
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`each of the Garmin factors while you're just
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`introducing the document that Petitioner seeks, but
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`since you've begun on those factors I'm going to
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`have you jump to factor 3 because it sounds as
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`though you may have had some information on -- on
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`this expert's background.
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` So talk a little bit about Garmin
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`factor 3.
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` MR. MARX: Certainly.
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` So here whether the moving party,
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`Petitioner, has the ability to generate equivalent
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`information by other means. As I noted, at
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`Dr. Do's deposition Mylan, we introduced Deposition
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`Exhibits 2 and 3 seeking to set forth
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`Dr. Yancopoulos's education level and his
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`professional background, and Patent Owner objected
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`to both of those exhibits and in correspondence
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`prior to seeking the Board's assistance they
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`refused to withdraw those objections.
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`Veritext Legal Solutions
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`Mylan Exhibit 1116
`Mylan v. Regeneron, IPR2021-00880
`Page 9
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`Page 10
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` So while Mylan has tried to generate
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`equivalent information, Patent Owner has objected
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`to its use.
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` JUDGE FRANKLIN: What were the objections
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`at the deposition?
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` MR. MARX: Mr. Salmen, can you recall
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`what those were?
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` MR. SALMEN: Sorry. I was on mute.
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` I don't recall the exact objections,
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`but I can look them up very quickly.
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` JUDGE FRANKLIN: All right.
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` MS. FISHMAN: Your Honor, this is counsel
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`for Patent Owner. I have the transcript in front
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`of me, if it would be helpful.
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` JUDGE FRANKLIN: You can answer the
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`question.
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` MS. FISHMAN: And I can -- yeah, and the
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`only objections, because I defended that
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`deposition, the only objections that were lodged to
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`the use of the documents with the witness is that
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`the witness testified she hadn't seen them before
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`and they asked her for -- they asked her to testify
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`as to matters she does not have personal knowledge
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`about, so there were objections, speculation
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`Mylan Exhibit 1116
`Mylan v. Regeneron, IPR2021-00880
`Page 10
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`Page 11
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`objections, but there was no foundational objection
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`or authenticity objections lodged with respect to
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`what were Exhibits 2 and 3 that were marked at her
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`deposition.
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` And the relevant passages at her
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`deposition start I believe around page 56 in that
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`they asked her about what she knows about George
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`Yancopoulos's background and training, and she
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`provided testimony on that but she didn't have
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`personal knowledge about the documents they were
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`putting in front of her to question her about.
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` JUDGE FRANKLIN: Okay. Thank you.
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` I'm going to turn back to Mr. Marx.
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`Did you have any more comments on factor 3? I cut
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`you in between there.
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` MR. MARX: No, no additional comments
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`other than subsequent to the deposition we asked
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`Patent Owner to remove their objections to Do
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`Exhibits 2 and 3 and they refused to do so.
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` JUDGE FRANKLIN: Okay. And I want you to
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`take the order that you want to to discuss the five
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`documents mentioned in your e-mail, but I'm curious
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`if you want some direction for you to talk about
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`the document number 3 in the e-mail, the notes
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`Veritext Legal Solutions
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`Mylan Exhibit 1116
`Mylan v. Regeneron, IPR2021-00880
`Page 11
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`Page 12
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`taken by Dr. Manning.
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` MR. MARX: Certainly.
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` So I think to provide background to
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`the Board, requests number 1 through 4, those all
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`relate to Patent Owner's expert declarant
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`Dr. Manning and his assertions of commercial
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`success. In Dr. Manning's declaration he cites to
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`numerous interviews with unnamed Regeneron
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`employees which informed his opinion and were the
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`basis for information in his declaration.
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` There are over 15 footnotes to these
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`conversations with unnamed employees, and he
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`confirmed at deposition similarly that these
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`conversations formed the basis of his opinion. At
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`deposition, though, he still couldn't recall these
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`individuals' names, couldn't recall the substance
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`of what they discussed, any details of those
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`conversations.
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` And Dr. Manning at his deposition also
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`testified he didn't provide or conduct any
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`independent analysis or assessment information that
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`these unnamed employees provided to him in response
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`to his request, yet he relied on them as the
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`factual predicate for his opinion.
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`Veritext Legal Solutions
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`Mylan Exhibit 1116
`Mylan v. Regeneron, IPR2021-00880
`Page 12
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`Page 13
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` So Regeneron's actions not providing
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`the names of these employees, Dr. Manning's
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`inability to recall the substance of what was
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`discussed, it deprives Mylan of discovery to which
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`we'd be entitled that includes these individuals
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`should have submitted factual affidavits attesting
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`to the veracity of the information, documents or
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`otherwise provided to our expert, which under the
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`rules, Rule 42.51(b)(1)(ii), Mylan would be
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`entitled to cross-examination of that affidavit
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`testimony. Similarly, it deprives Mylan of
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`developing a full record that we would be
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`permitted.
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` Now, if Patent Owner continues to
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`withhold this information the underlying record
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`should be stricken because Mylan -- there's no
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`foundation for this information provided to
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`Dr. Manning and Mylan has been unable to seek such
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`discovery from Patent Owner.
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` Now, importantly, Your Honor may be
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`aware, earlier this week Mylan filed amended
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`mandatory notices, and in that Mylan included two
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`related matters that would affect a decision in
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`these pending IPRs. Those two matters include a
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`Veritext Legal Solutions
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`Mylan Exhibit 1116
`Mylan v. Regeneron, IPR2021-00880
`Page 13
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`Page 14
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`civil complaint by the United States Department of
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`Justice asserting that the Patent Owner engaged in
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`illegal kickback schemes for the drug at issue
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`here, Eylea. They were paying off patients and
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`doctors to generate prescriptions and sales.
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` The complaint from the Department of
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`Justice states "substantial sums" were spent to
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`ensure patients on Eylea didn't have to make
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`co-pays and physicians didn't have to collect
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`Medicare co-pays, and the Department of Justice
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`also states that senior company executives took
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`extensive measures to cover up this scheme.
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` In a second civil matter filed by Blue
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`Cross Blue Shield of New Jersey, an insurer, they
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`similarly state that Regeneron, the Patent Owner,
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`violated federal law using an illegal kickback
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`scheme because prescribers without this kickback
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`they preferred a competing drug.
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` Now these allegations of an illegal
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`kickback scheme, paying off patients and paying off
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`doctors to gin up sales of the drug at issue, those
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`are clearly at odds with any assertion of
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`commercial success, yet Patent Owner to date hasn't
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`produced anything related to these matters.
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`Veritext Legal Solutions
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`Mylan Exhibit 1116
`Mylan v. Regeneron, IPR2021-00880
`Page 14
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`Page 15
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`Petitioner Mylan, we discovered this on our own.
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` Now, at Dr. Manning's deposition he
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`was unable to identify whether or where any costs
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`associated with these kickbacks were accounted for
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`or weren't accounted for in the data that he
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`received from Regeneron. He doesn't know if
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`they're accounted for in promotional advertising,
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`in rebates. He was unaware.
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` Moreover, at his deposition
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`Dr. Manning testified that a critical basis for his
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`commercial success opinion are that Eylea costs
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`more than the competition yet generated sales, but
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`these kickback litigations filed by the U.S.
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`Government and an insurer, they state directly the
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`opposite. They're contradictory. They state that
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`sales wouldn't have happened without these
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`kickbacks.
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` So Mylan has made the limited requests
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`1 through 4 in an attempt to seek this information
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`from Patent Owner both because it's contradictory
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`and inconsistent with their assertion of commercial
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`success and because by failing to include factual
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`affidavits from these individuals, including
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`providing their names and laying foundation for
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`888-391-3376
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`Veritext Legal Solutions
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`Mylan Exhibit 1116
`Mylan v. Regeneron, IPR2021-00880
`Page 15
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`

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`Page 16
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`documents provided, Mylan has improperly been
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`permitted -- improperly been prevented from taking
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`routine discovery to which we'd otherwise be
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`entitled.
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` JUDGE FRANKLIN: Okay. So regarding the
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`documents listed at number 3, all notes taken by
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`Dr. Manning and/or his team, including but not
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`limited to Ryan Marsh, interviews with Regeneron
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`employees.
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` MR. MARX: Yes, Your Honor. Dr. Manning
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`testified that Dr. Marsh is a colleague of his or
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`works on his team and that Dr. -- or Mr. Marsh may
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`have taken notes during these meetings.
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`Dr. Manning himself does not recall taking any
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`notes.
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` So we have sought copies of those
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`notes to determine what actually was the data that
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`was provided to Dr. Manning and what he requested.
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`They may help illuminate where these funds that
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`went to a kickback scheme are accounted for or
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`aren't accounted for in the data he relied on.
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` JUDGE FRANKLIN: All right. And I'll
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`give you this opportunity to address the remaining
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`documents listed at -- if you want to separately,
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`Veritext Legal Solutions
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`Mylan Exhibit 1116
`Mylan v. Regeneron, IPR2021-00880
`Page 16
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`Page 17
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`it's 1 -- what do we have left -- 1, 2, and 4.
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`You've spoken about them collectively, but if you
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`want to say anything about them specifically you
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`may do so now before we turn to Ms. Fishman.
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` MR. MARX: Certainly.
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` With respect to our request number 2,
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`by failing to provide names of the individuals that
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`Dr. Manning spoke to Mylan is deprived of the
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`opportunity to cross-examine those individuals. We
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`believe that is critical in particular because of
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`the U.S. Government's assertions in the kickback
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`litigation that senior executives covered up this
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`scheme. I think it's important that Mylan be able
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`to learn the names of the individuals and depose
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`them, including determining who their superiors are
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`and the information that they generated for
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`Dr. Manning.
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` Similarly, request number 1, native
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`copies of Excel spreadsheets, Mylan has requested
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`those in an effort on our own to try and determine
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`whether the data relied on by Dr. Manning somehow
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`includes accounting for these kickback payments
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`that were made.
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` And then request number 4, Dr. Manning
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`Veritext Legal Solutions
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`Mylan Exhibit 1116
`Mylan v. Regeneron, IPR2021-00880
`Page 17
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`Page 18
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`testified at deposition that Regeneron sent him a
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`collection of marketing materials and he reviewed
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`that collection, but he only cited a small portion
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`of that in his declaration. Because the content of
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`that marketing material is central to his
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`commercial success analysis, Mylan is seeking the
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`Board's authorization to seek discovery of that
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`information to determine if that actual marketing
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`message is consistent with Dr. Manning's position.
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`We're concerned that the small selection that he
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`has cited may be inconsistent, which is why we
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`requested it.
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` JUDGE FRANKLIN: I see. Okay.
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` One moment. I'm going to check with
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`my Panel to see if we have additional questions for
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`you before we turn to Patent Owner's counsel.
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` (Whereupon there was a pause in
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` the proceedings.)
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` JUDGE FRANKLIN: Okay. It does not seem
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`as though we have any additional questions from the
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`Panel for you yet, Mr. Marx, so, Ms. Fishman, if
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`you'd like to --
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` MR. MARX: Your Honor, if I could only
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`add one thing. I pulled up a copy of the
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`Veritext Legal Solutions
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`Mylan Exhibit 1116
`Mylan v. Regeneron, IPR2021-00880
`Page 18
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`Page 19
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`deposition transcript from Dr. Do, and Patent Owner
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`counsel did object as to the foundation of those
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`exhibits.
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` JUDGE FRANKLIN: There was a foundation
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`objection?
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` MR. MARX: Correct.
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` MS. FISHMAN: Can you please identify on
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`the record where that was? I'm looking at the
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`transcript.
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` MR. MARX: That was on page 60 of the
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`transcript. The question: According to the
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`documents, Dr. Yancopoulos was never a licensed
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`ophthalmologist with firsthand experience of
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`diagnosing and treating angiogenic eye disorders;
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`right?
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` Counsel for Patent Owner: Objection;
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`lacks foundation, calls for speculation --
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` MS. FISHMAN: That's not about the doc --
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`okay. So couple things, first of all. Throughout
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`the deposition, again, this is a little beside the
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`point, there's no such thing as a licensed
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`ophthalmologist. Ophthalmologists are board
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`certified, physicians are licensed, but your
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`colleague continued to use the term "licensed
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`Veritext Legal Solutions
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`Mylan Exhibit 1116
`Mylan v. Regeneron, IPR2021-00880
`Page 19
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`Page 20
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`ophthalmologist" throughout the proceeding but that --
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` JUDGE FRANKLIN: Ms. Fishman --
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` MS. FISHMAN: -- term lacks basis.
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` JUDGE FRANKLIN: Ms. Fishman --
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` MS. FISHMAN: Second of all, this isn't a
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`an objection to a document --
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` JUDGE FRANKLIN: Ms. Fishman.
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` MS. FISHMAN: This is -- yes.
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` JUDGE FRANKLIN: Excuse me.
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` MS. FISHMAN: Sorry. I apologize, Your
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`Honor.
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` JUDGE FRANKLIN: And so you know, it was
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`my third attempt to get your attention.
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` I want you to direct your comments
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`toward me.
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` MS. FISHMAN: Sorry. I apologize, Your
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`Honor. I apologize, Your Honor.
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` JUDGE FRANKLIN: So now you may respond
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`to what you've heard.
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` MS. FISHMAN: It's a little heated.
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` JUDGE FRANKLIN: That's okay. You may
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`respond to what you've heard now.
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` MS. FISHMAN: Certainly.
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` I believe that the relevant transcript
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`Veritext Legal Solutions
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`Mylan Exhibit 1116
`Mylan v. Regeneron, IPR2021-00880
`Page 20
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`Page 21
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`citation that he's referring to is an objection to
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`the questioning attorney asking the witness about
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`something she said she had no basis to speak to
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`because she lacked personal knowledge, and it was
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`not a foundational objection to the document.
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` But, you know, the transcript can be
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`provided.
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` JUDGE FRANKLIN: Thank you.
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` And so now let's have you turn to any
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`responses you want to make to the other argument
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`made by Mr. Marx regarding the documents that they
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`seek.
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` MS. FISHMAN: Thank you, Your Honor.
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` JUDGE FRANKLIN: And when you discuss
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`them, it would be helpful if you discussed them in
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`terms of routine discovery or potential additional
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`discovery.
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` MS. FISHMAN: Understood, Your Honor.
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` And for purposes of responding to the
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`five requests that Petitioner is seeking, we have
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`divided them up and I'm planning on covering, and
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`I'll take them out of order because Petitioner did,
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`but I'll plan on covering the George Yancopoulos CV
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`issue and then I'll have my partner and colleague,
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`Veritext Legal Solutions
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`Mylan Exhibit 1116
`Mylan v. Regeneron, IPR2021-00880
`Page 21
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`Page 22
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`Dr. -- not Dr., pardon me -- Mr. Caine cover the
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`Manning-related requests, which are document
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`request numbers 1 through 4.
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` And with respect to all of the
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`requests, and David Caine, Mr. Caine, can speak to
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`this, you know, at more length as it relates to the
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`Manning-related requests, but I will note that the
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`first time Petitioner asked for these requests was
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`during the deposition of our expert declarant.
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` And so, again, without belaboring it,
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`I would say that Petitioner is mischaracterizing
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`the meet and confer process. We asked Petitioner
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`to put in writing their request after meet and
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`confer. They sent us a number of requests, some of
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`which I understand they're no longer seeking based
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`on our responses. We'd asked for additional
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`information regarding why this -- some of what they
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`were seeking was useful in this proceeding and for
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`the most part did not receive responses. We -- you
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`know, again, we nonetheless tried to meet and
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`confer to resolve these issues. We were unable to
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`do so.
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` And I guess one point that is
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`certainly true for number 5 but I think for all of
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`Veritext Legal Solutions
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`Mylan Exhibit 1116
`Mylan v. Regeneron, IPR2021-00880
`Page 22
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`Page 23
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`these is we don't understand why for it to be
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`useful in this proceeding Patent Owner waited until
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`after expert depositions or in the midst of expert
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`depositions to ask for these materials.
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` So turning -- I'll turn to number 5,
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`which is the requested CV for Dr. Yancopoulos, and
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`this is the -- this is the one item where I believe
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`in our meet and confer Petitioner has suggested
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`that it should be routine discovery under
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`42.51(b)(1) and suggested that somehow George
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`Yancopoulos's CV would be inconsistent with the
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`position advanced by Patent Owner. We do not
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`believe that it's routine discovery, and as we
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`conveyed to Petitioner during the meet and confer
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`process Patent Owner has never taken a position on
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`what Dr. Yancopoulos's experience was. We never
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`said that he did or didn't have certain experience.
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`We never took the position that Dr. Yancopoulos is
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`an ophthalmologist. We never took a position that
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`Dr. Yancopoulos is one of ordinary skill in the
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`art.
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` That's not something that we've taken
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`a position on, so we don't believe that whatever
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`Dr. Yancopoulos's level of skill is is inconsistent
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`888-391-3376
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`Veritext Legal Solutions
`
`Mylan Exhibit 1116
`Mylan v. Regeneron, IPR2021-00880
`Page 23
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`Page 24
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`with the position that Patent Owner has taken in
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`this proceeding. So we believe that it's
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`appropriate we consider the request for
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`Dr. Yancopoulos's CV, it's appropriately considered
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`a request for additional discovery under
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`42.51(b)(2).
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` And regarding Mr. Marx's argument
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`that, you know, Dr. Do took the position in
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`deposition that they believe is inconsistent in
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`terms of the definition of the level of skill of
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`the POSA, I would like to point out that in her --
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`in Dr. Do's expert declaration, which was submitted
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`on February 11th as Exhibit 2051, at paragraph 27
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`through 29 she both reiterates Petitioner's
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`definition of the POSA, that's in paragraph 27.
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` Paragraph 28 she goes on to say: In
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`my view, the skilled artisan is an ophthalmologist
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`with experience in treating angiogenic eye
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`disorders, including through the use of VEGF
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`antagonists. In the event that Mylan argues that
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`the skilled artisan need not be a licensed
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`physician (ophthalmologist), whatever other
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`qualifications they must possess I disagree because
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`only an ophthalmologist would have the firsthand
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`888-391-3376
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`Veritext Legal Solutions
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`Mylan Exhibit 1116
`Mylan v. Regeneron, IPR2021-00880
`Page 24
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`

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`Page 25
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`experience of diagnosing and treating angiogenic
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`eye disorders to which the patent is plainly
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`directed.
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` Then in paragraph 29 she goes on to
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`say that her opinions nonetheless remain the same
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`whether you're using Petitioner's definition or
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`Patent Owner's qualification to Petitioner's
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`definition.
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` So in short, Patent Owner's position
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`on the level of skill of the POSA has been known to
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`Mylan since at least February 11, and yet the first
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`time they've asked for Dr. Yancopoulos's CV was in
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`the deposition of Dr. Do.
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` We engaged in meet and confer, but
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`even so and what Mylan's counsel did not convey to
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`the Panel is that we nonetheless went to Regeneron
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`and asked does Dr. Yancopoulos have a current CV,
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`does he hav