Deposition of:
`Aaron Waxman , M.D., Ph.D.
`
`January 8, 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 1108
`
`
`Aaron Waxman , M.D., Ph.D.
`
`January 8, 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 1108
`
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`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
`
` AARON B. WAXMAN, M.D., Ph.D.
`
` January 8, 2022
`
` 10:34 a.m.
`
` Reported by: Bonnie L. Russo
`
` Job No. 5008601
`
`Veritext Legal Solutions
`215-241-1000 ~ 610-434-8588 ~ 302-571-0510 ~ 202-803-8830
`
`Liquidia's Exhibit 1108
`Page 1
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`
`
` Remote Videotaped Deposition of Aaron B.
`
` Waxman, M.D., Ph.D. held through:
`
`Page 2
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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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` Pursuant to Notice, when were present on behalf
`
` of the respective parties:
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` A P P E A R A N C E S :
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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 :
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` J O N A T H A N D A V I E S , 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 .
` S u i t e 7 0 0
` 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
` - a n d -
` B R I T T A N Y C A Z A K O F F , E S Q U I R E
` 1 1 9 5 1 F r e e d o m D r i v e
` 1 F r e e d o m S q u a r e
` R e s t o n T o w n C e n t e r
` R e s t o n , V i r g i n i a 2 0 1 9 0
` b c a z a k o f f @ 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 :
` M A N D Y K I M , 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
` 1 8 5 6 5 J a m b o r e e R o a d , S u i t e 2 5 0
` I r v i n e , C a l i f o r n i a 9 2 6 1 2
` m h k i m @ 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 2 8 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
` P e t e r C u r r a n , C o n c i e r g e
`
`Veritext Legal Solutions
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`
`Liquidia's Exhibit 1108
`Page 3
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`
`
`Page 4
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` I N D E X
` EXAMINATION OF
` AARON B. WAXMAN, M.D., Ph.D. PAGE
`
` BY MR. DAVIES 8
`
` 168
` BY MS. KIM 165
`
` EXHIBITS
`
` Exhibit 1 Curriculum Vitae of 54
` Aaron B. Waxman,
` M.D., Ph.D.
`
` Exhibit 2 Annual Report 2005 112
` European Society of
` Cardiology
`
` Exhibit 1001 United States Patent 31
` No. 10,716,793 B2
` Exhibit 1006 United States Patent 67
` No. 6,521,212 B1
`
` Exhibit 1007 Excerpt of European 88
` Heart Journal
` August/September 2004
`
` Exhibit 1008 Supplement to 72
` Circulation
` Excerpt of Abstracts
` from Scientific
` Sessions 2004
`
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` EXHIBITS (CONTINUED):
` Exhibit 1018 Product Information 136
` Remodulin (Treprostinil
` sodium) Injection
` Description
`
` Exhibit 1062 Article entitled 122
` "Ultrasonic versus
` jet nebulization or
` iloprost in severe
` pulmonary hypertension"
`
` Exhibit 1065 Article entitled 119
` "Inhaled Iloprost for
` Severe Pulmonary
` Hypertension"
` Exhibit 1083 Ventavis 161
` (iloprost) Inhalation
` Solution
` Description
`
` Exhibit 2001 Declaration of 21
` Dr. Aaron Waxman
` Exhibit 2002 Harvard Medical School 46
` Curriculum Vitae of
` Aaron B. Waxman,
` M.D., Ph.D.
`
` Exhibit 2034 Highlights of Prescribing 97
` Information for Tyvaso
` Exhibit 2036 Article entitled 156
` "Efficacy and Safety
` of Treprostinil: An
` Epoprostenol Analog for
` Primary Pulmonary Hypertension
` Exhibit 2052 Declaration of 24
` Aaron Waxman, M.D., Ph.D.
` (Exhibits bound separately.)
`
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`
`Liquidia's Exhibit 1108
`Page 5
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`Page 6
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` P R O E E D I N G S
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` (10:34 a.m.)
`
` 10:34:44
`
` THE VIDEOGRAPHER: Good morning. 10:34:48
`
` We are going on the record at 10:34 10:34:52
`
` a.m. on January 8, 2022. 10:34:55
`
` This is Media Unit 1 of the 10:34:58
`
` remote-recorded deposition of Dr. Aaron Waxman 10:35:01
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` in the matter of Liquidia Technologies versus 10:35:03
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` United Therapeutics Corporation filed in the 10:35:07
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` United States Patent and Trademark Office, 10:35:11
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` Patent Trial and Appeal Board, Case No. IPR 10:35:16
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` 2021-0046 -- excuse me -00406. 10:35:19
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` My name is Orson Braithwaite from 10:35:24
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` the firm Veritext Legal Solutions. I am the 10:35:27
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` videographer. The court reporter is Bonnie 10:35:29
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` Russo from the firm Veritext Legal Solutions. 10:35:30
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` Counsel will now state their 10:35:32
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` appearances and affiliations for the record. 10:35:34
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` MR. DAVIES: Jonathan Davies from 10:35:37
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` Cooley. With me today is my colleague, 10:35:39
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` Brittany Cazakoff, representing the petitioner, 10:35:44
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` Liquidia Technologies. 10:35:46
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` MS. KIM: Mandy Kim with McDermott 10:35:48
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` Will & Emery on behalf of the patent owner, 10:35:55
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`Page 7
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` United Therapeutics Corporation.
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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. Before I
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` do that I have a quick stipulation to put on
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` 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 reporting this deposition 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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`Veritext Legal Solutions
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`Liquidia's Exhibit 1108
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`Page 8
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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.
`
` AARON B. WAXMAN, M.D., Ph.D.,
`
` being first duly sworn, to tell the truth, the
`
` whole truth, and nothing but the truth,
`
` testified as follows:
`
` EXAMINATION BY COUNSEL FOR PETITIONER 10:36:45
`
` BY MR. DAVIES: 10:36:45
`
` Q. Good morning, Dr. Waxman, and thank 10:36:45
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` you for giving us a little bit of your time on 10:36:50
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` a Saturday. 10:36:50
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` A. Thanks for accommodating me. 10:36:50
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` Q. Can you state your full name for the 10:36:52
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` record. 10:36:54
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` A. Aaron B. Waxman. 10:36:55
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` Q. And can you provide your current 10:36:57
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` address? 10:36:59
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` A. Home or business? 10:36:59
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` Q. Home. 10:37:02
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` A. 673 Centre Street, C-E-N-T-R-E in 10:37:03
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` Newton, Massachusetts 02458. 10:37:10
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` Q. And you understand that you are here 10:37:14
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` today for a deposition regarding your opinions 10:37:15
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` that you offered in two declarations that were 10:37:18
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` submitted in an IPR concerning the '793 patent? 10:37:21
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` A. Yes. 10:37:25
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` Q. Okay. Great. Have you ever been 10:37:26
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` deposed before? 10:37:30
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` A. Yes. 10:37:33
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` Q. Okay. About how many times? 10:37:33
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` A. A lot. I don't remember. 10:37:35
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` Q. Okay. So you are obviously familiar 10:37:38
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` with the basics then. Just because it's over 10:37:40
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` video I just ask that we try and avoid talking 10:37:43
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` over each other and allow more time for the lag 10:37:49
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` that may occur during video. 10:37:51
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` Is that okay? 10:37:53
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` A. Yes. 10:37:54
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` Q. Today I will try and speak clearly 10:37:55
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` and provide clear answers. If you answer my 10:37:57
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` questions I will assume that you understood my 10:38:02
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` question; is that fair? 10:38:04
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` A. Yes. 10:38:05
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` Q. And you understand that today your 10:38:06
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` counsel may be objecting but you still need to 10:38:08
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` respond to my question unless counsel instructs 10:38:11
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` you not to answer? 10:38:14
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` A. Yes. 10:38:15
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` Q. Okay. Great. And your sound sounds 10:38:16
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` great, but I just ask that when you answer that 10:38:19
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` you respond verbally as you have been rather 10:38:22
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` than nodding your head or shaking your head. 10:38:24
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` Okay? 10:38:27
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` A. Yes. 10:38:27
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` Q. Is there any reason why you can't 10:38:28
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` provide full and accurate testimony today? 10:38:30
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` A. No. 10:38:33
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` Q. Okay. With regard to your past 10:38:33
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` deposition experience have you ever provided 10:38:37
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` deposition testimony in an IPR proceeding 10:38:41
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` previously? 10:38:46
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` A. Well, I have given a deposition in 10:38:46
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` the Watson v. UTC. I don't know specifically 10:38:50
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` if that was an IPR. 10:38:55
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` Q. And what was the subject matter of 10:38:59
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` that suit? 10:39:01
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` A. I think again a patent infringement. 10:39:02
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` Q. Other than that proceeding have you 10:39:07
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` provided deposition testimony in any other 10:39:12
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` patent proceeding? 10:39:15
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` MS. KIM: Objection. Vague. 10:39:20
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` THE WITNESS: I don't believe so. 10:39:22
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` I -- I was involved in another patent case but 10:39:23
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` I don't recall being deposed. 10:39:26
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` BY MR. DAVIES: 10:39:28
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` Q. Did the subject matter of the other 10:39:31
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` case concern treprostinil? 10:39:33
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` A. No. 10:39:37
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` Q. Did it concern inhaled therapies? 10:39:37
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` A. No. 10:39:41
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` Q. Did it concern treatments for 10:39:41
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` pulmonary hypertension? 10:39:49
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` A. Yes. 10:39:50
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` Q. It did. Do you recall about how 10:39:50
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` long ago that case was? 10:39:52
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` A. It was probably in 2008, 2009, but 10:39:53
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` I'm not totally sure. 10:39:59
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` Q. Can you recall the names of either 10:40:01
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` of the parties involved in that case? 10:40:03
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` A. One of the parties was Pfizer. The 10:40:05
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` other was a Canadian drug company at which I 10:40:10
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` don't recall the name. 10:40:14
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` Q. Were you consulting with Pfizer as 10:40:15
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` part of that case? 10:40:24
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` A. No. 10:40:25
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` Q. Were you consulting with the 10:40:25
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` Canadian drug company as part of that case? 10:40:28
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` A. Yes. 10:40:31
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` Q. Was there an approved drug product 10:40:37
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` that was the subject of that case? 10:40:42
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` A. Yes. 10:40:43
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` Q. Do you recall what that was? 10:40:44
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` A. Revatio versus sildenafil. 10:40:46
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` Q. Can you spell that for me, the first 10:40:54
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` one. 10:40:54
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` A. R-E-V-A-T-O. I think it's T-I-O 10:40:54
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` actually. 10:41:01
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` Q. And that's a treatment for pulmonary 10:41:02
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` hypertension? 10:41:05
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` A. Yes. 10:41:05
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` Q. I'm sorry if I already asked this, 10:41:15
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` but were you deposed in that case? 10:41:17
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` A. That's what I don't recall. I don't 10:41:19
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` recall being deposed. 10:41:21
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` Q. Do you recall if you testified at 10:41:23
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` trial in that case? 10:41:27
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` A. I did not. 10:41:28
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` Q. Were you retained by the Canadian 10:41:29
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` drug company as an expert witness in that case? 10:41:37
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` A. Yes. 10:41:40
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` Q. So other than the IPR or patent 10:41:54
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` litigation between Watson versus UTC and the 10:42:00
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` Revatio case that we have talked about are 10:42:06
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` there any other cases where you believe you may 10:42:07
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` have testified via deposition? 10:42:16
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` A. When you say "cases," do you mean 10:42:20
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` patent cases or just general cases? 10:42:23
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` Q. Let's stick with patent cases. 10:42:25
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` A. No other patent cases. 10:42:27
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`Page 14
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` Q. Outside of -- have you ever served 10:42:29
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` as an expert in a medical malpractice case? 10:42:41
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` A. Yes. 10:42:44
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` Q. Outside of serving as an expert in a 10:42:45
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` medical malpractice case have you served as an 10:42:47
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` expert consultant in any other case beyond 10:42:50
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` those we have already discussed? 10:42:54
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` A. Yes. 10:42:56
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` Q. When was the most recent? 10:42:59
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` A. It's been a few years. 10:43:01
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` Q. In the last five years? 10:43:08
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` A. Probably. 10:43:12
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` Q. Did you testify as an expert with 10:43:17
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` respect to treatments for pulmonary 10:43:19
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` hypertension? 10:43:21
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` A. No. These were not PH cases. 10:43:21
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` Q. Generally what was the subject 10:43:28
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` matter of those cases? 10:43:30
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` A. They were product liability cases 10:43:31
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` related to complications of prosthetic joints. 10:43:33
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` Q. In your -- are you testifying from 10:43:52
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` home today? 10:43:59
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` A. Yes. 10:43:59
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` Q. Do you have any materials with you 10:44:00
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` there in your office that you plan to rely on 10:44:05
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` during your testimony today? 10:44:08
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` A. Well, I have all the materials 10:44:09
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` related to the case that are all electronic. 10:44:11
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` Q. Okay. And when you say "the 10:44:14
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` materials that are related to the case," what 10:44:16
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` materials are you talking about? 10:44:19
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` A. My reports, the patents, and all of 10:44:20
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` the literature that was cited in the reports as 10:44:26
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` well as the literature pertinent to the case 10:44:29
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` from both Liquidia and UTC. 10:44:34
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` Q. Do you have any documents there that 10:44:37
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` were not cited in your first and second IPR 10:44:40
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` declarations that you submitted in this IPR? 10:44:47
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` A. No. 10:44:50
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` Q. Okay. Are the electronic documents 10:44:50
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` that you have there in any way marked up? 10:44:54
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` A. No. 10:44:56
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` Q. Are there any comments in them? 10:44:57
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` A. No. 10:45:01
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` Q. Any notes? 10:45:01
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` A. No. 10:45:02
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` Q. Highlighting? 10:45:03
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` A. I'm sorry. You said "highlighting"? 10:45:07
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` Q. Highlighting, yeah. Sorry. 10:45:09
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` A. No. 10:45:11
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` Q. Do you have them arranged in any 10:45:11
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` specific subfolders on your desktop? 10:45:19
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` A. They are in subfolders. 10:45:23
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` Q. Can you just tell me generally how 10:45:26
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` you have them organized on your desktop? 10:45:29
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` A. Sure. So I have them based on the 10:45:33
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` specific reports or declarations for '793, and 10:45:41
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` then the files related to that from Liquidia 10:45:46
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` and UTC, and then I have Dr. Hill's rebuttals, 10:45:50
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` and then my specific declaration from October, 10:45:59
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` and then files that pertain to the Delaware 10:46:08
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` prior art from Liquidia and UTC, and then the 10:46:14
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` documents that were cited in Dr. Hill's 10:46:18
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` rebuttal and my reply, and documents referenced 10:46:26
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` in Hill opening, and then files that were 10:46:32
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` provided to me for the first report related to 10:46:40
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` the products, and then a file of Liquidia 10:46:46
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` exhibits, public Liquidia information, and then 10:46:52
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` a separate folder of the reports and 10:46:58
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` declarations, and then the UTC exhibits, and 10:47:00
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` then the deposition transcripts. 10:47:07
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` Q. Okay. It sounds, Doctor, like you 10:47:09
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` may have documents beyond those just recited in 10:47:13
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` your two IPR declarations; is that fair? 10:47:16
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` MS. KIM: Jonathan, can I just step 10:47:20
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` in for a second because I think there was some 10:47:23
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` confusion around the IPR and district court, so 10:47:25
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` can we get off the record for a second -- 10:47:29
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` MR. DAVIES: Sure. That's fine. 10:47:29
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` MS. KIM: And have him get his 10:47:30
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` reports and then we can pop back on. 10:47:32
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` MR. DAVIES: Yeah, we can go off the 10:47:34
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` record. That's fine. 10:47:36
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` MS. KIM: Thank you. 10:47:38
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` THE VIDEOGRAPHER: The time is 10:47 10:47:39
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` a.m. We are off the record. 10:47:42
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` (A short recess was taken.) 10:47:43
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` THE VIDEOGRAPHER: The time is 10:49 10:49:44
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` a.m. We are back on the record. 10:49:49
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` BY MR. DAVIES: 10:49:51
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` Q. Welcome back, Dr. Waxman. 10:49:52
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` So as we discussed at the break, we 10:49:53
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` will be entering exhibits in this deposition 10:49:56
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` through Exhibit Share which I understand you 10:50:00
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` were able to set up this morning. To the 10:50:02
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` extent you rely on any documents other than the 10:50:05
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` exhibits that we have entered through Exhibit 10:50:07
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` Share we just ask that you acknowledge that and 10:50:10
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` indicate what other document you feel you may 10:50:13
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` need to rely on so that we can also enter that. 10:50:16
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` Is that agreeable to you? 10:50:19
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` A. Yes. 10:50:21
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` Q. Okay. Thank you very much. 10:50:22
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` What did you do today -- what did 10:50:24
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` you do to prepare for your deposition today? 10:50:26
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` A. Today? 10:50:28
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` Q. What did you do before today or 10:50:31
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` today to prepare for your deposition that is 10:50:34
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` occurring today? 10:50:37
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` A. I read through my declarations, read 10:50:39
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` through the patents, read through the other 10:50:43
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` declarations pertinent to today, and also just 10:50:47
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` reviewed the literature that was cited in my 10:50:52
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` IPR declaration. 10:50:56
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` Q. You mentioned other declarations 10:50:58
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` that were pertinent today that you reviewed. 10:51:01
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` Do you recall what those were? 10:51:05
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` A. Well, I am referring to Dr. Hill 10:51:07
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` specifically. 10:51:09
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` Q. Did you meet with anyone in 10:51:11
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` preparation for your testimony today? 10:51:14
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` A. Other than the attorneys or just the 10:51:15
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` attorneys? 10:51:20
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` Q. Including the attorneys. 10:51:20
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` A. Just the attorneys from -- 10:51:21
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` representing UTC. 10:51:24
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` Q. Okay. And who were those attorneys? 10:51:25
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` A. Well, Mandy was one, Art and J -- 10:51:27
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` I'm going to try to do justice to her name. 10:51:34
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` Jiaxiao Zhang. 10:51:39
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` Q. Anyone else? 10:51:39
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` A. I don't remember who else was on the 10:51:40
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` call but those were the primary interactions. 10:51:45
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` Q. Do you believe someone else was on 10:51:49
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` the call? 10:51:51
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` A. I think Doug was on the call. 10:51:52
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` Q. Okay. Maybe Doug Carsten? 10:51:54
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` A. Yes. 10:51:59
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` Q. Anyone else you can recall? 10:51:59
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` A. Russell was on the call but he never 10:52:01
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` speaks so... 10:52:05
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` Q. Do you recall Russell's last name? 10:52:06
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` A. I don't. 10:52:12
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` Q. That's fine. Anyone else you can 10:52:13
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` recall? 10:52:14
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` A. I don't think so. 10:52:14
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` Q. Beyond the attorneys that you have 10:52:15
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` identified is there anyone else that you called 10:52:19
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` or met with to prepare for your deposition 10:52:22
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` today? 10:52:24
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` A. No. 10:52:25
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` Q. When did these calls or meetings 10:52:26
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` occur in preparation for your testimony? 10:52:31
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` A. We have had a number of calls over 10:52:34
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`Liquidia's Exhibit 1108
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` the past several weeks. I mean, one was last 10:52:36
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` night, but other than that it's every couple of 10:52:44
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` days over the last couple of weeks. 10:52:47
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` Q. And about how many calls have you 10:52:50
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` had in preparation for your deposition today? 10:52:52
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` A. Probably about four. Well, they 10:52:54
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` were not specific to the deposition. I think 10:52:55
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` we have only had two or three that were 10:52:58
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` specific to the deposition. 10:53:00
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` Q. And what is the total time between 10:53:03
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` those two or three calls or meetings that you 10:53:06
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` had to prepare for the deposition? 10:53:10
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` A. Just the calls; total time is 10:53:12
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` probably around eight, nine hours. 10:53:18
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` Q. Did you spend additional time beyond 10:53:23
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` those calls and meetings preparing on your own? 10:53:26
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` A. Yes. 10:53:29
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` Q. About how much additional time? 10:53:29
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` A. Probably another four to six hours. 10:53:32
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` MR. DAVIES: Let's enter IPR Exhibit 10:53:47
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` 2001. 10:53:51
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` (Deposition Exhibit 2001 was marked 10:53:52
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` for identification.) 10:53:53
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` BY MR. DAVIES: 10:53:53
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` Q. Dr. Waxman, let me know once you are 10:54:03
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` able to access that. 10:54:05
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` A. Do I need to refresh my screen to 10:54:06
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` see that or it should show up? 10:54:09
`
` Q. I don't believe so. I believe it -- 10:54:12
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` MS. KIM: You have to refresh. 10:54:15
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` MR. DAVIES: Oh, you do have to 10:54:15
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` refresh. 10:54
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