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`Alexander Dominic D'Addio - February 21, 2018
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`Page 1
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________________
` )
`ARGENTUM PHARMACEUTICALS LLC,)
` ) Case No.
` Petitioner, ) IPR2017-00807
` )
` )
` ) U.S. Patent No.
` )
` 8,168,620
` )
` )
` )
`_____________________________)
`
`v.
`
`CIPLA LIMITED,
`
` Patent Owner.
`
` DEPOSITION OF DR. ALEXANDER DOMINIC D'ADDIO
`
` Washington, D.C.
`
` Wednesday, February 21, 2018
`
`Reported By: Goldy Gold, RPR
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
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`Exhibit 1141
`IPR2017-00807
`ARGENTUM
`
`000001
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`Alexander Dominic D'Addio - February 21, 2018
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`Page 1
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________________
` )
`ARGENTUM PHARMACEUTICALS LLC,)
` ) Case No.
` Petitioner, ) IPR2017-00807
` )
` )
` ) U.S. Patent No.
` )
` 8,168,620
` )
` )
` )
`_____________________________)
`
`v.
`
`CIPLA LIMITED,
`
` Patent Owner.
`
` DEPOSITION OF DR. ALEXANDER DOMINIC D'ADDIO
`
` Washington, D.C.
`
` Wednesday, February 21, 2018
`
`Reported By: Goldy Gold, RPR
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Exhibit 1141
`IPR2017-00807
`ARGENTUM
`
`000001
`
`
`
`Alexander Dominic D'Addio - February 21, 2018
`
`Page 2
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` 9:00 a.m.
`
` February 21, 2018
`
` Deposition of DR. ALEXANDER DOMINIC
`
` A'DDIO, commencing at 9:02 a.m., Wednesday,
`
` February 21 2018, at Sterne Kessler
`
` Goldstein Fox, 1100 New York Avenue, NW,
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` Washington, D.C., 20005, before Goldy Gold, a
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` Registered Professional Reporter and a Notary
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` Public within and for the District of
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` Columbia.
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`A P P E A R A N C E S:
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`On Behalf of the PLAINTIFF:
`
` ANDREW CHESLOCK, ESQUIRE
`
` Foley & Lardner, LLP
`
` 321 North Clark Street - Suite 2800
`
` Chicago, Illinois 60654
`
` E-mail: acheslock@foley.com
`
` TYLER LIU, ESQUIRE
`
` In-House Counsel,
`
` Argentum Pharmaceuticals
`
`On Behalf of the DEFENDANT:
`
` ADAM C. LaROCK, ESQUIRE
`
` Sterne Kessler Goldstein Fox
`
` 1100 New York Avenue, NW
`
` Washington, D.C. 20005
`
` E-mail: alarock@skgf.com
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` I N D E X
`
` Deposition of Dr. Alexander Dominic D'Addio
`
` February 21, 2018
`
`EXAMINATION BY PAGE
`
` MS. LIU 5
`
` *****
`
` E X H I B I T S
`
`D'ADDIO
`EXHIBITS DESCRIPTION PAGE
`
`Exhibit 1056 U.S. Patent No. 41
` 6,417,206, Antitussive
` Antihistaminic
` Decongestant Compositions,
` July 9, 2002
`
` *****
`
` INFORMATION TO BE FURNISHED
`
`Description: Page:
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` [None.]
`
` *****
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`WHEREUPON,
`
` DR. ALEXANDER DOMINIC D'ADDIO,
`
`called as a witness, having been duly sworn by a
`
`Notary Public, was examined and testified as
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`follows:
`
` EXAMINATION
`
`BY MS. LIU:
`
` Q. Good morning.
`
` A. Good morning.
`
` Q. Could you please state your full name
`
`for the record.
`
` A. Alexander Dominic D'Addio.
`
` Q. Dr. D'Addio, I'm going to be handing
`
`you a deposition notice for today. Have you seen
`
`this document before?
`
` A. I don't believe I have.
`
` Q. Can you just confirm for me that that
`
`is your name on the first page and that you are
`
`being cross-examined today?
`
` A. Yes, that is my name.
`
` Q. Okay. Great.
`
` Dr. D'Addio, have you ever been
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`deposed before?
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` A. I have.
`
` Q. And how many times have you been
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`deposed?
`
` A. I'm not sure. Maybe five or six
`
`times.
`
` Q. Okay, and all of those times were all
`
`patent matters?
`
` A. That's correct.
`
` Q. Did they all relate to pharmaceutical
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`formulation technology?
`
` A. Yes.
`
` Q. So I take it you are familiar with the
`
`general ground rules for a deposition?
`
` A. Yes.
`
` Q. And I just want to go over just a few
`
`things with you before we get started. Is that
`
`okay?
`
` A. Yes.
`
` Q. I'm going to ask you a series of
`
`questions. If there is any question that I ask
`
`that you don't understand, or you don't understand
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`something within my question, please ask me for
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`clarification. Okay?
`
` A. Yes.
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` Q. If you don't understand the question,
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`I will try to restate the question and clarify it
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`for you. Is that okay?
`
` A. Yes.
`
` Q. If you answer a question, I'm going to
`
`assume that you heard the question and you
`
`understood it. Is that okay?
`
` A. Yes.
`
` Q. Now, during the deposition, counsel
`
`for the patent owner will probably at some point
`
`object to my question. When this happens, I want
`
`you to be clear that unless counsel instructs you
`
`not to answer the question, you are still required
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`to answer my question. Do you understand that?
`
` A. Yes.
`
` Q. Of course, the exception is that if
`
`you believe the question I have asked requires you
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`to reveal information you believe is protected by
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`work product or attorney/client privilege.
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`Understood?
`
` A. Yes.
`
` Q. Also, please let me know at any time
`
`if you need to take a break.
`
` A. Thank you.
`
` Q. Dr. D'Addio, are there any medications
`
`you're taking which would prevent you from
`
`answering my questions accurately and truthfully
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`today?
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` A. No.
`
` Q. Are there any other issues that would
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`otherwise prevent you from answering my questions
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`accurately and truthfully today?
`
` A. No.
`
` Q. Great.
`
` Dr. D'Addio, did you do anything to
`
`prepare yourself for this deposition?
`
` A. I reviewed some notes with my
`
`attorney.
`
` Q. Okay, and I'm assuming Mr. LaRock?
`
` A. Correct.
`
` Q. You met with Mr. LaRock?
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` A. Correct.
`
` Q. And when did that meeting occur?
`
` A. Yesterday.
`
` Q. And how long, approximately, did it
`
`last?
`
` A. Five or six, six or seven hours.
`
` Q. Dr. D'Addio, did you review any
`
`documents in preparation for your deposition
`
`today?
`
` A. I did.
`
` Q. And which documents did you review?
`
` A. The documents that were associated
`
`with my declaration.
`
` Q. So I assume all of the exhibits in the
`
`declaration, that are listed in the declaration?
`
` A. Yes.
`
` Q. I will now provide you, Dr. D'Addio,
`
`what's been previously marked Patent Owner's
`
`Exhibit 2148. It's been previously marked.
`
` Do you recognize this document,
`
`Dr. D'Addio?
`
` A. Yes, this is the declaration that I
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`submitted.
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` Q. Dr. D'Addio, I'm sure you're aware
`
`that there as a first D'Addio declaration and a
`
`second D'Addio declaration, correct?
`
` A. That's correct.
`
` Q. And for purposes of clarity today, are
`
`you comfortable if I refer to Patent Owner's
`
`Exhibit 2148 as "your declaration"?
`
` A. Yes.
`
` Q. Are you aware of any material
`
`differences between your first declaration and
`
`second declaration?
`
` A. There are a couple of footnotes added
`
`and some clarification on documentation.
`
` Q. Dr. D'Addio, let's turn to page 5 of
`
`your declaration, right before paragraph 10. Let
`
`me know when you're there.
`
` A. I have it.
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` Q. Here you begin to discuss the product
`
`journey. Do you see that?
`
` A. In paragraph 10?
`
` Q. Yes.
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` A. Yes.
`
` Q. Now let's direct your attention to
`
`paragraph 11.
`
` You state in your declaration that in
`
`2002, under your direction, Meda had considered
`
`three lifecycle options, the first being an
`
`Astelin steroid combination; the second a new
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`Astelin formulation that masked the bitter taste
`
`issues associated with azelastine; and the third,
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`developing a new azelastine formulation with
`
`improved taste and dosing profiles, correct? And
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`that goes onto page 6.
`
` A. Yes, that does. I see it.
`
` MR. LaROCK: I am just going to object
`
` to the extent it mischaracterizes the
`
` document, because I don't think you've read
`
` every word.
`
` Q. So during this time, Meda never
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`considered any other antihistamine besides
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`azelastine hydrochloride, right?
`
` MR. LaROCK: Object to the form of the
`
` question.
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` A. In -- in this report, we're only
`
`talking about products with azelastine.
`
` Q. What I'm referring to is your product
`
`lifestyle strategies that your PPD group had
`
`instituted. You guys never considered any other
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`antihistamine besides azelastine, correct?
`
` MR. LaROCK: Object to the form of the
`
` question. Outside the scope.
`
` A. So in this report, we -- this report
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`reports about management, and the only thing that
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`we discussed are products using azelastine
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`hydrochloride.
`
` Q. So the bitter taste issues that you
`
`referenced were not considered significant enough
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`to prevent a formulation containing azelastine
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`from being accepted into the marketplace, correct?
`
` A. I'm sorry --
`
` MR. LaROCK: I object to the form of
`
` the question. Object to the form of the
`
` question, outside the scope of this
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` declaration.
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` You can answer.
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` A. I'm sorry. Repeat the question.
`
` Q. So the bitter taste issues that you
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`referenced were not considered significant enough
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`to prevent a formulation containing azelastine
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`from being accepted into the marketplace, correct?
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` MR. LaROCK: Same objections.
`
` A. As a matter of fact, there was a fair
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`amount of work that went into developing an
`
`improved formulation for azelastine hydrochloride.
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`Trying to do the taste masking took an awful lot
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`of work, often in the laboratory and in clinical
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`studies.
`
` Q. Aside from the bitter taste issues,
`
`was azelastine considered the best antihistamine
`
`for Meda's purposes at that time?
`
` MR. LaROCK: Object to the form of the
`
` question. Outside the scope of this
`
` declaration.
`
` A. It was a product that -- azelastine
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`hydrochloride, that we had a lot of experience
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`with.
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` Q. I don't think you answered my
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`question.
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` I just said aside from the bitter
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`taste issues, was azelastine considered the best
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`antihistamine for your consideration at this time
`
`period?
`
` MR. LaROCK: Again, object to the form
`
` of the question. Outside the scope of this
`
` declaration.
`
` A. We focused on azelastine because it
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`was the one that we had the most experience with.
`
` Q. So it had nothing to do with
`
`azelastine's efficacy?
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` MR. LaROCK: Object to the form of the
`
` question.
`
` A. We knew the properties of it. We knew
`
`it was an effective antihistamine.
`
` Q. Okay. If you follow me on page 6 of
`
`your declaration, you state that by
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`September 2002, you started analyzing the first
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`out of the three options, which was an Astelin
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`steroid combination product, correct?
`
` A. Yes.
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` Q. Now, after choosing the first option,
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`the PPD group added the task, "New nasal solution
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`product, combination of azelastine hydrochloride
`
`and an approved steroid," in paragraph 11. Do you
`
`see that?
`
` A. We added it to our weekly program and
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`priorities chart, correct.
`
` Q. So at this point you were only looking
`
`at FDA-approved steroids to combine with
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`azelastine, right?
`
` A. We were looking at approved steroids
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`at that time.
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` Q. So FDA-approved steroids, correct?
`
` A. Correct.
`
` Q. Now, at this point, you had also not
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`decided on which steroid you were going to use; am
`
`I correct?
`
` A. We had not picked a steroid at this
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`point, no.
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` Q. Okay. Now, could you please direct
`
`your attention to paragraph 13.
`
` In paragraph 13, you describe one
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`aspect of why Meda's PPD group viewed combining
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`azelastine and a steroid as difficult, right?
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` A. That actually --
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` MR. LaROCK: Hold on. Object to the
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` extent it mischaracterizes the declaration.
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` You can answer.
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` A. It actually flows from the previous
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`paragraph, paragraph 12. And this was one of the
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`items that we recognized that was going to provide
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`a challenge to us in developing a formulation.
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` Q. Now, one aspect of that difficulty was
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`due to azelastine being fully dissolved in a nasal
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`spray vehicle, but that steroids are suspension
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`formulations where the steroid particles are not
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`dissolved in the nasal spray vehicle, but are
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`instead suspended in it, right?
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` A. I'm sorry. What was the question? I
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`mean, you read the sentence --
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` Q. Yes.
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` A. -- but I didn't hear a question in it.
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` Q. I'm just saying if that was true, what
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`I just read.
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` A. That's exactly what I said here in the
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`declaration.
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` Q. Yes. So steroid formulations were
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`always in suspension, correct?
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` MR. LaROCK: Object to the form of the
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` question, and outside of the scope of his
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` declaration.
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` A. So I'm not sure that that's true for
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`every steroid product. But as far as we knew for
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`nasal sprays, nasal suspensions, with steroids, I
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`believe that they are all suspensions.
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` Q. So at that time you were not aware of
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`any nasal -- nasal sprays that were -- strike
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`that.
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` So at that time you were not aware of
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`any steroid formulations that were not suspensions
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`for nasal sprays, correct?
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` MR. LaROCK: Object to the form of the
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` question. Outside the scope of his
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` declaration. Calls for speculation.
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` A. So it -- I just -- I wasn't aware of
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`any other products at that time.
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` Q. If you could now turn to paragraph 16
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`of your declaration, on page 8. Here you state
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`that because of the low probability of success and
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`the anticipated technical obstacles, this project
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`became a low priority, correct?
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` A. That's in the first sentence, based on
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`the low product of success and the challenges, it
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`became a low priority, correct.
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` Q. Then, in the same paragraph, you
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`stated that between the years of 2003 to 2006,
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`Meda began working to identify possible dual
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`chamber devices that would allow azelastine and
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`fluticasone to be stored in separate bottle
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`chambers but could also be coadministered in one
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`spray. Do you see that?
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` MR. LaROCK: Object to the extent it
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` mischaracterizes the document.
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` You can answer.
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` A. So between that -- that period, we did
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`look for possible dual chamber devices. There
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`would be, of course, two different formulations,
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`two different solutions, stored in the dual
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`chambers that would be combined in a single spray.
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` Q. When did Meda identify fluticasone as
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`a steroid of choice in a combination with
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`azelastine?
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` MR. LaROCK: Objection. Outside the
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` scope of his declaration.
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` A. I don't recall when the decision to
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`use fluticasone was made.
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` Q. Did you test -- did Meda test any
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`other steroids, besides fluticasone, in
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`combination with azelastine?
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` MR. LaROCK: Objection. Outside the
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` scope of this declaration.
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` A. When? In what period?
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` Q. In the period from late 2003 to 2006
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`and onwards, did Meda test any other steroid
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`besides fluticasone in combination with
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`azelastine?
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` MR. LaROCK: Objection. Outside of
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` scope of this declaration.
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` A. At this time we weren't looking or
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`using any azelastine or fluticasone. We were
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`looking for different devices.
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` Q. Yes, but the devices were made to
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`allow azelastine and fluticasone to be stored in
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`separate bottle chambers, as it states in
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`paragraph 16.
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` So you were looking at azelastine and
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`fluticasone in particular, correct?
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` A. Right. But your question was, were we
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`working with them. So we did not have any
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`formulations with azelastine or fluticasone. We
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`were looking for devices that could contain those
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`formulations.
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` Q. And Meda never looked at any other
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`steroid to put in that dual chamber device besides
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`fluticasone, correct?
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` MR. LaROCK: Objection. Outside the
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` scope of his declaration. Calls for
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` speculation.
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` A. Again -- again, the focus was on the
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`dual chamber device.
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` Q. Yes, the dual chamber device was
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`azelastine and fluticasone, correct?
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` A. Again, I don't remember when we
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`decided to use fluticasone in this.
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` Q. My question was very clear. It was
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`just, did you use any other steroid -- did Meda
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`look at any other steroid to put in this dual
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`chamber device, besides fluticasone?
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` MR. LaROCK: Objection. Outside the
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` scope of this declaration.
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` A. I don't recall.
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` Q. Isn't it true that fluticasone's
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`efficacy was one factor in Meda's decision to use
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`it in combination with azelastine?
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` MR. LaROCK: Objection. Outside the
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` scope of this declaration.
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` A. It -- that made -- that was a
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`determination that was probably made by our
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`medical group. I'm a formulation scientist.
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` Q. So I'm assuming Meda believed at that
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`time that the combination of azelastine and
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`fluticasone would work better than either of those
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`drugs just by themselves, right?
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` MR. LaROCK: Objection. Form, outside
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` the scope, calls for speculation.
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` A. I don't know what medical thought the
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`result would be of adding those two together, if
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`there would be a superior product or not.
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` Q. And at that time, from late 2003 to
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`2006 -- strike that.
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` So from late 2003 to early 2006, Meda
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`wasn't aware of Cipla's patent application,
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`correct?
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` MR. LaROCK: Objection. Object to the
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` form of the question.
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` A. I don't recall that, no.
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` Q. Okay. Well, let's go to paragraph 26
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`on page 12.
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` A. Yes.
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` Q. Do you see that in the first sentence
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`of paragraph 26, you say, "Shortly thereafter, in
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`May 2006, Meda discovered Cipla's published patent
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`application directed to azelastine steroid
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`formulations, U.S. 2006/0025391. Do you see that?
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` A. I do. We found that and the Duonase
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`product.
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` Q. So before May 2006, Meda was already
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`attempting to combine azelastine and fluticasone,
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`independent of Cipla's patent application,
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`correct?
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` MR. LaROCK: Objection to the form of
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` the question.
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` A. So before May 2006, we had, it stated
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`in the declaration, we had performed some
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`feasibility experience with azelastine and
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`fluticasone, correct.
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` Q. Are you aware of any information that
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`Meda might have relied upon in deciding to pursue
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`a combination formulation using azelastine and
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`fluticasone?
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` MR. LaROCK: Object to the form of the
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` question. Outside the scope.
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` A. Not to my memory. Again, it was a
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`decision that was made by our management and the
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`medical team.
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` Q. Dr. D'Addio, I am going to direct your
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`attention back to paragraph 16 on page 8. Now,
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`for this dual chamber device that Meda was working
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`on, Meda had used the -- was considering using the
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`Astelin formulation for the azelastine component
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`of the dual chamber device, correct?
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` A. I don't know that we had made a
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`decision about what that formulation would be in a
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`dual chamber device.
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` Q. So you were saying at this point in
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`time you were only looking at the devices, not any
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`formulations for either azelastine or fluticasone,
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`correct?
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` A. We were looking at the device that
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`would be able to hold two formulations separate.
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`We hadn't gotten to the point where we made
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`decisions on what formulations to use.
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` Q. So I take it you did not know --
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`strike that.
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` So I take it Meda had not decided on
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`what fluticasone formulation to use for the bottle
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`chamber device as well, correct?
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` MR. LaROCK: Object to the form of the
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` question.
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` A. Not that I recall.
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` Q. Dr. D'Addio, let's move on to the
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`small scale formulation effort that Meda embarked
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`upon, starting, I believe, in paragraph 17 of your
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`declaration.
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` Now I'd like you to look at
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`paragraph 19 of your declaration on page 9.
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` A. Yes.
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` Q. Now, this is where you outline the
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`plans that Dr. Kalidas Kale -- am I pronouncing
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`that correctly?
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` A. It's Kalidas Kale.
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` Q. I will restate the question.
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` Now, in paragraph 19, you outlined the
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`plans that Dr. Kalidas Kale drew up as part of the
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`feasibility assessment plan for an azelastine and
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`Flonase combination, correct?
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` A. Yes.
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` Q. Now, Plan A, drawn up by Dr. Kale,
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`involved an experiment to test whether azelastine
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`could be soluble in the Flonase suspension, right?
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` A. Maybe if we could go to that, I can
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`speak to it specifically.
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` Q. That is on paragraph 19, the first
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`sentence.
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` A. Right. I mean, the plan itself is in
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`my declaration as one of the attachments.
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` Q. I'm just asking a general question as
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`to what Plan A involved.
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` A. Right. And that's why I'm asking. I
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`can go down the specifics of that, if you take out
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`the plan for me.
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` Q. Well, just -- I'm asking just a basic
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`question on what Plan A generally was about. And
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`it was involving an experiment to test whether
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`azelastine could be dissoluble in the Flonase
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`suspension, correct?
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` A. After the removal of the fluticasone.
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` Q. Now, Plan B proposed to identify a
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`water-soluble steroid compatible with a azelastine
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`hydrochloride solution, correct?
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` A. Yes.
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` Q. And Plan C tested various solubility
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`enhancement technologies to increase the
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`solubility of fluticasone, correct?
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` A. That's correct.
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` Q. So only Plan A and Plan C involved
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`testing fluticasone propionate, correct?
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` MR. LaROCK: Objection. Object to the
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` form of the question.
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` You can answer.
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` A. So we know that fluticasone is not
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`water soluble, so Plan B would not have included
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`fluticasone. Plans A and C did focus on
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`fluticasone propionate.
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` Q. Now, Plan B proposed to identify a
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`water-soluble steroid compatible with an
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`azelastine hydrochloride solution, correct?
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` A. Correct.
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` Q. Does that mean that your statement
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`regarding steroids only being suspensions was
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`inaccurate, in paragraph 13 of your declaration?
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` MR. LaROCK: Object to the form of the
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` question. Object to the extent it
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` mischaracterizes the document, his testimony.
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` A. So paragraph 13, again, talked about
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`existing -- 13 -- right. So, again, for nasal
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`spray vehicles, the suspensions that we were aware
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`of are not soluble and are suspended in these
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`nasal spray suspensions. The goal here was to
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`look for other steroids that may be water-soluble.
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` Q. So Plan B proposed to identify
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`water-soluble steroids that were not available at
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`the time for a nasal spray vehicle?
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` A. We were going to do a search to see if
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`there were any available.
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` Q. Okay. Dr. D'Addio, then you moved --
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`Meda moved forward with Plan A, which was
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`determine whether azelastine could dissolve in
`
`Flonase formulation without fluticasone particles,
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`correct?
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` MR. LaROCK: Object to the extent it
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` mischaracterizes his testimony.
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` A. I'm sorry. Can you repeat that?
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` (Whereupon, the referred-to question
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` was read back by the Reporter.)
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` A. That was the outline. That was what
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`Plan A, the feasibility experiment, was intended
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`to do, correct.
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` Q. Now, Mr. D'Aconti was the one
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`performing these experiments, right?
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` A. John D'Aconti in combination with
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`Dr. Kalidas.
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` Q. So if you follow me on paragraph 24,
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`on page 11.
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` A. Yes.
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` Q. Actually it's paragraphs 23 and 24.
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`You state in your declaration that Mr. D'Aconti
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`attempted the first step under Plan A and had to
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`repeat it the following day, because the sample
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`was more than the filter could withstand, and the
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`sample spilled, correct?
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` MR. LaROCK: Object to the extent it
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` mischaracterizes his testimony.
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` A. So this was the initial experiment, in
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`which they were trying to isolate the solid
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`fluticasone particles from the formulation. And
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`in ultimately trying to filter it, the sample was
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`lost, correct.
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` Q. Now, if you turn to page 12, in the
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`same paragraph, you stated that on April 26, 2006,
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`Mr. D'Aconti performed the same experiment from
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`the day before, and found that a major portion of
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`the azelastine hydrochloride had not dissolved,
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`right?
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` A. I'm sorry. You're looking at
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`paragraph 24?
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` Q. Yes, the last part of paragraph 24, on
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`page 12.
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` A. Right. But the beginning of that,
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`that's where you stated that the team prepared
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`another sample. That's correct. That's in the
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`beginning.
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` And then -- I'm sorry, then you jumped
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`down to the fact that the team had found the major
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`portion of the azelastine had not dissolved in
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`that second sample, another sample, correct.
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` Q. Isn't it true that whatever remained
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`undissolved could have been a number of things
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`besides the azelastine hydrochloride?
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` MR. LaROCK: Objection. Outside the
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` scope of his testimony. Calls for
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` speculation.
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`GregoryEdwards.com | 866-4Team GE
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`000030
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`Alexander Dominic D'Addio - February 21, 2018
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`Page 31
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` A. John -- John was an experienced
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`formulator. So he recognized the material that he
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`put into the vial of the azelastine hydrochloride,
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`and would likely have recognized that the shape of
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`the material and crystals would have been the same
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`the following day.
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` Q. Dr. D'Addio, I'm going to be -- I'm
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`handing you what has been previously marked as
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`Patent Owner Exhibit 2061.
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` Dr. D'Addio, do you recognize this
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`exhibit?
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` A. I do.
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` Q. What is this document?
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` A. This is a photocopy of a laboratory
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`notebook that was used by John D'Aconti in
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`recording experiments in our laboratories.
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` Q. So could you now please turn to
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`page 18 of Exhibit 2061.
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` A. I have it.
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` Q. Now, this was cited on page 12 of your
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`declaration for the proposition that a major
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`portion o
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