Deposition of:
`Jason McConville
`
`January 11, 2022
`
`In the Matter of:
`United Therapeutics Corporation vs.
`Liquidia Technologies (IPR)
`
`Veritext Legal Solutions
`800-734-5292 | calendar-dmv@veritext.com |
`
`Liquidia's Exhibit 1109
`
`
`Jason McConville
`
`January 11, 2022
`
`In the Matter of:
`United Therapeutics Corporation vs.
`Liquidia Technologies (IPR)
`
`Veritext Legal Solutions
`800-734-5292 | calendar-dmv@veritext.com |
`
`Liquidia's Exhibit 1109
`
`
`
`Page 1
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` UNITED STATES PATENT AND TRADEMARK OFFICE
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
` _______________________________
`
` LIQUIDIA TECHNOLOGIES, INC.,
`
` Petitioner
`
` vs.
`
` UNITED THERAPEUTICS CORPORATION,
`
` Patent Owner
`
` ________________________________
`
` IPR2021-00406
`
` U.S. Patent No. 10,716,793
`
` Remote Videotaped Deposition of
`
` JASON McCONVILLE, Ph.D.
`
` January 11, 2022
`
` 9:03 a.m.
`
` Reported by: Bonnie L. Russo
`
` Job No. 5008632
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`Liquidia's Exhibit 1109
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`
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` Remote Videotaped Deposition of Jason
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` McConville, Ph.D. held through:
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` Veritext Legal Solutions
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` 1250 I Street, N.W.
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` Washington, D.C.
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` A P P E A R A N C E S :
`
` O n b e h a l f o f t h e P e t i t i o n e r :
`
` J O N A T H A N D A V I E S , E S Q U I R E
` D O U G L A S W I L L I A M C H E E K , E S Q U I R E
` C O O L E Y L L P
` 1 2 9 9 P e n n s y l v a n i a A v e n u e , N . W .
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` W a s h i n g t o n , D . C . 2 0 0 0 4
` j d a v i e s @ c o o l e y . c o m
` d c h e e k @ c o o l e y . c o m
`
` O n b e h a l f o f t h e P a t e n t O w n e r :
` A R T D Y K H U I S , E S Q U I R E
` M c D E R M O T T W I L L & E M E R Y
` 2 0 4 9 C e n t u r y P a r k E
` S u i t e 3 2 0 0
` L o s A n g e l e s , C a l i f o r n i a 9 0 0 6 7
` a d y k h u i s @ m w e . c o m
` - a n d -
` J O S H R E V I L L A , E S Q U I R E
` M c D E R M O T T W I L L & E M E R Y
` 5 0 0 N . C a p i t o l S t r e e t , N . W .
` W a s h i n g t o n , D . C . 2 0 0 0 1
` j r e v i l l a @ m w e . c o m
` - a n d -
` S T E P H E N M A E B I U S , E S Q U I R E
` F O L E Y & L A R D N E R L L P
` 3 2 1 N o r t h C l a r k S t r e e t
` S u i t e 3 0 0 0
` C h i c a g o , I l l i n o i s 6 0 6 5 4
` s m a e b i u s @ f o l e y . c o m
`
` A l s o P r e s e n t :
` O r s o n B r a i t h w a i t e , V i d e o g r a p h e r
` R o b e r t B e n i m o f f , C o n c i e r g e
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` I N D E X
` EXAMINATION OF JASON McCONVILLE, Ph.D. PAGE
` BY MR. DAVIES 8
` 231
` BY MR. DYKHUIS 228
`
` EXHIBITS
`
` Exhibit 1001 United States 52
` Patent No. 10,716,793 B2
`
` Exhibit 1006 United States 86
` Patent No. 6,521,212 B2
` Exhibit 1007 University of Iowa 87
` Excerpt of European
` Heart Journal
` August/September 2004
`
` Exhibit 1008 Supplement to 90
` Circulation
` of Abstracts from
` Scientific Sessions 2004
` Exhibit 1037 OptiNeb-ir Operating 161
` Instructions
`
` Exhibit 1062 Article titled 112
` "Ultrasonic
` versus jet nebulization or
` iloprost in severe
` pulmonary hypertension"
`
` Exhibit 1066 AccuNeb Inhalation 159
` Solution
` Patient's Instructions
` for Use
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`Liquidia's Exhibit 1109
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` EXHIBITS (CONTINUED):
`
` Exhibit 1083 Ventavis (iloprost) 183
` Inhalation Solution
` Description
` Exhibit 2053 Declaration of 10
` Dr. Jason McConville
`
` Exhibit 2054 Curriculum Vitae of 13
` Jason T. McConville, Ph.D.
` Exhibit 2075 Article titled 136
` "A review
` of the technical aspects
` of drug nebulization"
`
` Exhibit 2077 Article titled 131
` "Performance
` Comparison of Nebulizer
` Designs: Constant-Output,
` Breath-Enhanced, and
` Dosimetric
` Exhibit 2078 Article titled 134
` "The Inhalation of
` Drugs: Advantages and
` Problems"
`
` Exhibit 2082 Article titled 143
` "Aerosol Deposition
` in Neonatal Ventilation"
`
` (Exhibits bound separately.)
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` P R O C E E D I N G S
`
` (9:03 a.m.)
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`Page 6
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` THE VIDEOGRAPHER: Good morning.
`
` We are going on the record at
`
` a.m. on January 11, 2022.
`
` This is Media Unit 1 of the
`
` remote-recorded deposition of Dr. Jason
`
` McConville in the matter of Liquidia
`
` Technologies versus United Therapeutics
`
` Corporation filed in the United States Patent
`
` and Trademark Office, Patent Trial and Appeal
`
` Board, Case No. IPR2021-00406.
`
` My name is Orson Braithwaite from
`
` the firm Veritext Legal Solutions, and I am the
`
` videographer. The court reporter is Bonnie
`
` Russo from the firm Veritext Legal Solutions.
`
` Counsel will now state their
`
` appearances and affiliations for the record.
`
` MR. DAVIES: Jonathan Davies from
`
` Cooley LLP for petitioner, Liquidia
`
` Technologies, and with me today is my
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` colleague, Douglas Cheek also of Cooley LLP.
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` MR. DYKHUIS: Art Dykhuis with
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` McDermott Will & Emery for patent owner, United
`
` Therapeutics Corporation. I also have with me
`
` Josh Reville, also with McDermott.
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` THE VIDEOGRAPHER: Thank you. Will
`
` the court reporter please swear in the witness.
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` THE COURT REPORTER: Yes. First,
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` I'll have a stipulation to put on the record.
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` The attorneys participating in this
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` deposition acknowledge that I am not physically
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` present in the deposition room and that I will
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` be remote -- reporting this deposition
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` remotely.
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` They further acknowledge that, in
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` lieu of an oath administered in person, I will
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` administer the oath remotely.
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` The parties further agree that if
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` the witness is testifying from a state where I
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` am not a notary, that the witness may be sworn
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` in by an out-of-state notary.
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` If any party has an objection to
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` this manner of reporting, please state it now.
`
` (Pause.)
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` THE COURT REPORTER: Hearing none,
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` we can proceed and I will swear in the witness.
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` JASON T. McCONVILLE, Ph.D.,
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` being first duly sworn, to tell the truth, the
`
` whole truth, and nothing but the truth,
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` testified as follows:
`
` EXAMINATION BY COUNSEL FOR PETITIONER.
`
` BY MR. DAVIES:
`
` Q. Good morning, Dr. McConville.
`
` A. Good morning.
`
` Q. Can you state your full name for the
`
` record.
`
` A. Yes. Jason Thomas McConville.
`
` Q. And you understand that you are here
`
` today for a deposition regarding your opinions
`
` that you presented in the declaration you
`
` submitted in IPR2021-00406?
`
` A. Yes.
`
` Q. Have you been -- have you been
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` deposed before?
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` A. Yes.
`
` Q. About how many times?
`
` A. I guess all together, you know,
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` 10 -- 10 to 15 times.
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` Q. So you have some familiarity,
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` obviously, with the -- with the process. You
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` understand that you are under oath today?
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` A. Yes.
`
` Q. And that I'll be asking you
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` questions, your counsel may object throughout
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` the day, but you understand that you need to
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` answer my question unless counsel instructs you
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` not the answer.
`
` Do you understand that?
`
` A. Yes.
`
` Q. Great. And your volume has been
`
` great, but because we are remote and because
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` this is solely on -- on video, I just ask that
`
` you provide verbal responses to my questions as
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` clearly as you can and not just shake your head
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` or -- or nod. Okay?
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` A. Yeah. Yeah. I'll do -- I'll do my
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` best, but you know, please, you know, remind me
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` if I am doing that because these Zoom sessions
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` sometimes that -- that slips away, and you
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` know, I have been in many faculty meetings and
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` sat there for hours just nodding, you know, so.
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` Q. Well, I -- we will all do our best
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` today, and we'll -- we'll work with it.
`
` A. Okay.
`
` Q. I'll ask you questions throughout
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` today. If you answer my question, I will
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` understand that you -- I will understand that
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` you understood my question.
`
` Does that make sense?
`
` A. Okay. Yeah.
`
` Q. Any reason why you can't provide
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` truthful and accurate testimony today?
`
` A. No.
`
` MR. DAVIES: Okay. Let's go ahead
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` and enter IPR Exhibit 2053.
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` (Deposition Exhibit 2053 was marked
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` for identification.)
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` BY MR. DAVIES:
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` Q. And, Dr. McConville, just let me
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` know once you have access to that.
`
` MR. CHEEK: It should be entered.
`
` THE WITNESS: Yeah. It's just
`
` refreshing at the moment.
`
` BY MR. DAVIES:
`
` Q. Okay.
`
` A. Okay. I see -- there's 53 and 54
`
` there actually.
`
` Q. Go ahead and open 53 first, and then
`
` we will get to 2054 in a minute.
`
` A. Okay.
`
` Q. Do you have Exhibit 2053 open?
`
` A. Yeah.
`
` Q. And that's a document identified on
`
` its face as the declaration of Dr. Jason
`
` McConville IPR2021-00406. U.S. Patent
`
` No. 10,716,793.
`
` Do you see that?
`
` A. Yes.
`
` Q. And then if you turn to the very
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` last page of the declaration, Dr. McConville,
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` you will see a date of November 10, 2021.
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` A. That's correct, yes.
`
` Q. Okay. And underneath that, there is
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` a signature and then the name Dr. Jason
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` McConville.
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` Do you see that?
`
` A. Yeah.
`
` Q. And is that your signature?
`
` A. It is, yes.
`
` Q. And do you see above that a
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` declaration that the statements in this
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` declaration are true and believed to be true by
`
` you.
`
` Do you see that?
`
` A. Yes.
`
` Q. Do you still believe the statements
`
` in this declaration are true and accurate?
`
` A. Yes, I do.
`
` Q. Okay. And this is, just for
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` clarity, the declaration that you submitted in
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` the -- I will refer to it as the '793 IPR.
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` A. Yes.
`
` Q. Okay. And if I refer to the '793
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` IPR, will you understand that to be referring
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` to IPR2021-00406?
`
` A. Yeah.
`
` Q. Great.
`
` MR. DAVIES: Can we enter Exhibit
`
` 2054.
`
` (Deposition Exhibit 2054 was marked
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` for identification.)
`
` BY MR. DAVIES:
`
` Q. And just let me know once you have
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` that open, Doctor.
`
` A. Yeah, I got that up.
`
` Q. Great. And review whatever portion
`
` you need to, but my question is: Can you
`
` confirm that this is a copy of your curriculum
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` vitae that was submitted with your declaration
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` in the '793 IPR.
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` A. Yes, that's -- that's what it is.
`
` Q. Okay. Great.
`
` And I understand that you have a
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` clean, paper copy of your declaration with you
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` today; is that correct?
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` A. That's correct, yes.
`
` Q. Okay. There is no highlights or any
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` mark-ups in that declaration?
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` A. No, there isn't.
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` Q. Okay. No tabs or flags in your
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` declaration?
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` A. Nothing at all. It's a absolutely
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` clean copy.
`
` Q. Okay. Other than the declaration, a
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` clean copy of your '793 IPR declaration, do you
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` have any other documents with you today?
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` A. I don't.
`
` Q. Okay. Going back to the Exhibit
`
` 2053, your declaration, generally, how was your
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` declaration prepared?
`
` A. Well, you know -- sorry. Sorry,
`
` Art.
`
` MR. DYKHUIS: Sorry, Dr. McConville.
`
` And I'll just put in the objection
`
` to the extent the question calls for anything
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` privileged, I caution the witness not to
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` disclose any communications with counsel.
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` BY MR. DAVIES:
`
` Q. And just to be -- I am not asking
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` for any specific communications with counsel.
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` I am just asking generally how was your -- your
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` report assembled.
`
` A. Yeah. Okay. We had -- I guess we
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` started off with meetings with counsel. You
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` know, I -- I reviewed materials, some of which
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` I'd obtained and some from counsel, and I
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` formed my opinions. I'd asked counsel to
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` prepare a draft based on my opinions. They
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` sent me some materials back, and so there was
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` quite a bit of back and forth.
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` Actually, I'd prepared sections
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` myself in this declaration. And then, you
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` know, eventually we end up with something I had
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` -- I could sign off on which represents my
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` opinions.
`
` Q. Great. Do you recall when the first
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` meeting was that you had with counsel?
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` A. Yeah. I -- I can't exactly
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` remember. It was probably toward the end of
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` what I -- I call the summer period, you know,
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` not -- not in -- it was out of the semester, so
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` sometime then, I think --
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` Q. What --
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` A. -- or at least I wasn't -- I wasn't
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` teaching at that point.
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` Q. Got it. Got it. I know that that
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` school calendar is -- is the thing we all live
`
` by when we're -- we're in academia.
`
` So in terms of the end of the
`
` summer, what year was that?
`
` A. Oh, that would have been, yeah,
`
` last -- last year.
`
` Q. Okay. 2021?
`
` A. Yeah.
`
` Q. Okay. Great.
`
` Do you recall who you worked with in
`
` preparing your declaration primarily?
`
` A. Yes. Art Dykhuis on this.
`
` Q. Anyone else?
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` A. You know, there -- there were
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` several people. You know, Josh -- Josh has
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` been working on this with me --
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` Q. Okay.
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` A. -- recently, so you know, I can't
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` remember everybody.
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` Q. Okay. Other than counsel, is there
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` anyone else that you spoke to in preparing your
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` declaration, your '793 IPR declaration?
`
` A. No.
`
` Q. You mentioned that you "prepared
`
` sections yourself of the declaration."
`
` Do you recall which sections those
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` were that you prepared of the declaration?
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` MR. DYKHUIS: Objection to form and
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` to the extent it mischaracterizes.
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` THE WITNESS: Yeah. Well, you know,
`
` overall, the declaration was prepared by me,
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` you know, with edits back and forth, as I've
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` said, with, you know, making sure the wording
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` was correct.
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` And you know, I suppose I could say
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` I started off with, you know, my -- my
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` background section in there. I remember that
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` was a good place to start, of course.
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` BY MR. DAVIES:
`
` Q. Okay. Any other sections that you
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` recall you yourself drafted?
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` A. Well, as -- as I say, the entire
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` document is something I have gone through with
`
` counsel, so there was input from me all the way
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` through.
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` Q. Okay. And, again, I am just asking
`
` because you had made the statement that you had
`
` prepared sections yourself, and I am just
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` wondering if there were some sections that you
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` feel you didn't prepare and others you did
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` prepare?
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` MR. DYKHUIS: Objection. Form.
`
` THE WITNESS: Yeah. That's --
`
` that's not really what I meant. I -- you know,
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` as I say, I started with the background and
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` went through with counsel in -- in the bulk of
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` the document, I would say.
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`Liquidia's Exhibit 1109
`Page 18
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`
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` BY MR. DAVIES:
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` Q. You mentioned that you reviewed some
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` materials.
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` Do you recall that?
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` A. Yes.
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` Q. And some of those you mentioned you
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` had obtained and others you received from
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` counsel.
`
` Do you recall that?
`
` A. Yes.
`
` Q. Do you recall the materials that you
`
` yourself obtained?
`
` A. Specifically, I know that -- that
`
` there -- some -- some of which are included in
`
` this declaration, and I can't remember
`
` everything that, you know, I might have put in
`
` there, but scattered throughout, I'd say, there
`
` is supporting documents that I -- you know, in
`
` forming my opinions.
`
` Q. You mentioned, I think, that you had
`
` been deposed about 10 to 15 times; is that
`
` correct?
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` A. Yeah.
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` Q. Within the last four years, do you
`
` know how many times you have been deposed?
`
` A. Yeah. Just -- just twice,
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` essentially, before the pandemic, I -- I guess.
`
` Q. Okay. And is one of those the Amgen
`
` v. Amneal case in Delaware?
`
` A. Yes, that's right.
`
` Q. Okay. Do you recall, generally,
`
` what the subject matter of that case was?
`
` A. Yeah. Roughly. I think that was
`
` the last one I did --
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` Q. Did --
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` A. -- and you know, was -- was deposed
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` on it and it went to trial.
`
` Q. Okay. Did that concern a particular
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` drug product?
`
` A. Yeah. Yes, it did.
`
` Q. Okay. And what was that drug
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` product?
`
` A. As far as I recall, that would be
`
` cinacalcet.
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` Q. Is that an inhaled therapy?
`
` A. No.
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` Q. Is that for the treatment of
`
` pulmonary hypertension?
`
` A. No, not as far as I know.
`
` Q. Okay. There is another one, Cipla
`
` v. Sunovian Pharmaceuticals also in Delaware.
`
` Did you offer testimony by
`
` deposition in that case?
`
` A. I did, yes.
`
` Q. Okay. And what, generally, was the
`
` subject matter of that case?
`
` A. So it was an inhaled therapy.
`
` Q. Okay. What is it indicated for?
`
` A. So this one was related, I -- I
`
` think possibly, to COPD.
`
` Q. Do you recall the name of the drug
`
` product in that case?
`
` A. Levalbuterol tartrate.
`
` Q. So other than those two cases, have
`
` you offered any other expert testimony, whether
`
` by deposition or at trial on inhaled therapies?
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` A. You know, I can't actually recall
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` prior to that. There -- there may have been
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` some but -- or one or two. Yeah. I can't
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` remember unless I have -- unless I look at my
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` entire list going back to when I started doing
`
` any expert consulting, I can't recall the
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` different products.
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` Q. Got it. And that -- that list isn't
`
` in your CV, right, the list that you would
`
` refer to?
`
` A. No, it's not.
`
` Q. Okay. Okay. So sitting here today,
`
` you can't recall whether any of the past
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` testimony by deposition or at trial concerned
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` inhaled therapies, correct?
`
` A. Yeah. I can't remember fully about
`
` that.
`
` Q. Have you ever offered any opinions
`
` related to the treatment of pulmonary
`
` hypertension by deposition or at trial?
`
` A. Right. Well, not -- not as far as I
`
` recall, no.
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`Liquidia's Exhibit 1109
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` Q. Okay. Have you ever offered any
`
` opinions at either deposition or at trial
`
` related to prostacyclins?
`
` A. I don't think so, no.
`
` Q. Have you ever offered testimony at
`
` deposition or trial on powder formulations?
`
` A. How do you mean "powder
`
` formulations"?
`
` Q. Let me -- let me rephrase that.
`
` Have you ever offered any testimony
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` at deposition or trial on inhaled powder
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` formulations?
`
` A. I mean, like I say, I can't -- I
`
` can't recall specifically whether that has come
`
` up or not.
`
` Q. Okay. What did you do generally to
`
` prepare for your deposition today?
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` MR. DYKHUIS: And, again, I would
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` just -- hearing the question, but to the extent
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` it calls for anything privileged, I caution the
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` witness not to disclose communications with
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` counsel.
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`Liquidia's Exhibit 1109
`Page 23
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`
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` THE WITNESS: Yeah. In general I
`
` guess I took time to look at my declaration
`
` again just to refresh myself on that.
`
` BY MR. DAVIES:
`
` Q. Did you do anything else to prepare
`
` for today?
`
` A. Well, counsel and I have had some
`
` discussions prior to meeting today. I -- I
`
` guess, you know, all related to declaration
`
` material.
`
` Q. Who did you meet with?
`
` A. Mr. Dykhuis and Mr. Reville.
`
` Q. Okay. Anyone else?
`
` A. No.
`
` Q. Other than counsel, did you meet
`
` with anyone else in preparation for your
`
` deposition today?
`
` A. No.
`
` Q. Okay. About how long did you meet
`
` with counsel?
`
` A. I mean, we -- we met yesterday for a
`
` period of time, and then prior to that, we --
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`Liquidia's Exhibit 1109
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` we had had some calls. You know, I -- I guess
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` those calls may have been for an hour or -- or
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` two here and there. You know, I can't recall
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` exactly when -- when we'd met before.
`
` Q. How long did you meet yesterday?
`
` A. Yeah. Well, there -- there was a
`
` period of yesterday related to setting up quite
`
` a bit, you know, with the -- this is the first
`
` virtual deposition I have been involved in, and
`
` so we had to, you know, get all that -- those
`
` kinks ironed out, I suppose if you like.
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` And, you know, I am broadcasting
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` from a hotel to try and stay away from the
`
` distractions, mainly for you guys. And so
`
` those are -- a fair bit setting up. So, you
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` know, for -- for the period of yesterday, there
`
` was some talk about declaration and there was
`
` setting up and all that kind of business.
`
` Q. About how long total yesterday?
`
` A. You know, probably, you know, from
`
` about ten-ish, about after ten to end of
`
` business day.
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`Liquidia's Exhibit 1109
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`
`
` Q. Okay. You had mentioned that you
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` had also done some looking at your declaration
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` on your own, I believe, is that correct, to
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`Page 26
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` prepare for today?
`
` A. Yeah.
`
` Q. Okay. About how long did you spend
`
` doing that?
`
` A. You know, I took some time, I
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` guess, last -- last week, looked at it in the
`
` evenings here and there, did little sections,
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` and then I looked at it over the weekend, tried
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` to do a good read-through then, you know, just
`
` to refamiliarize myself because it's -- you
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` know, before the Christmas break this was put
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` in.
`
` Q. In -- in preparing for your -- your
`
` deposition today, do you recall reviewing any
`
` materials that are not cited in your '793 IPR
`
` declaration?
`
` A. No, I don't recall looking at
`
` anything else.
`
` Q. Okay. Let's go to 2054, which is
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`Liquidia's Exhibit 1109
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` your CV, and let me know once you are there,
`
` Doctor.
`
` A. Yeah. I have the exhibit up still.
`
` Q. Okay. What is your current home
`
` address?
`
` A. Is -- is the -- is the work one not
`
` good enough?
`
` Q. If you would rather give work,
`
` that's -- that's fine.
`
` A. Yeah. I mean, it -- it varies.
`
` It's -- it's a bit patchy on, you know, going
`
` in at the moment with the way things are, but
`
` you know, if -- if -- you know, that's my
`
` preferred address really, rather than receiving
`
` materials at home unless absolutely necessary.
`
` Q. Is your work address the mailing
`
` address that is indicated in your CV?
`
` A. Yes, that's correct.
`
` Q. Okay. And do you reside in
`
` Albuquerque?
`
` A. Yes.
`
` Q. Okay. And what is your current
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`Liquidia's Exhibit 1109
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` position?
`
` A. I am an associate professor in the
`
` college of pharmacy at the University of New
`
` Mexico.
`
` Q. Can you go to the education section
`
` of your CV.
`
` A. Yeah.
`
` Q. And let me know once you are there.
`
` A. I'm there. It's the front page.
`
` Q. Okay. You have a Bachelor of
`
` Science with honors in applied chemistry; is
`
` that correct?
`
` A. That's correct, yes.
`
` Q. And then a Doctor of Philosophy in
`
` pharmaceutics?
`
` A. Yes.
`
` Q. With respect to your education, did
`
` you do any research on prostacyclins?
`
` A. No.
`
` Q. During your education from 1991 to
`
` September of '02, did you do any work
`
` developing therapies for pulmonary
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`Liquidia's Exhibit 1109
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`Page 29
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` hypertension?
`
` A. No.
`
` Q. From October 2002 to August 2006,
`
` you were
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