UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`APOTEX, INC.
`Petitioner,
`
`v.
`
`UCB BIOPHARMA SPRL,
`Patent Owner.
`
`U.S. Patent No. 8,633,194 to Fanara et al.
`Issue Date: January 21, 2014
`Title: Pharmaceutical Composition of Piperazine Derivatives
`
`Inter Partes Review No.: IPR2019-00400
`
`
`
`JOINT STIPULATION REGARDING THE DEPOSITION OF
`DOMENICO FANARA
`
`
`
`
`
`
`
`

`

`
`
`Petitioner Apotex Inc. (“Petitioner”) and Patent Owner UCB Biopharma Sprl
`
`(“Patent Owner”) hereby stipulate to the following pursuant to 37 CFR
`
`§ 42.53(c)(2):
`
`1.
`
`Domenico Fanara is a named inventor on the U.S. Patent No. 8,633,194 (“the
`’194 patent”).
`
`2. Mr. Fanara submitted a declaration pursuant to 37 CFR § 1.132 (EX1027)
`during the prosecution of the application which led to the ’194 patent.
`
`3.
`
`Patent Owner and Patent Owner’s declarant, Dr. Sarfaraz Niazi, refer to Mr.
`Fanara’s declaration in their Patent Owner Response (Paper 22) and
`supporting declaration (EX2034) respectively.
`
`4. Mr. Fanara was deposed on February 21, 2019 in the underlying litigation
`(UCB, Inc. et al. v. Apotex Inc., No. 0-18-cv-60846 (S.D. Fla.)) in his
`individual capacity and as UCB’s 30(b)(6) witness for certain topics. The
`February 21, 2019 deposition of Mr. Fanara addressed subject matter that is
`not part of the record in this proceeding.
`
`5.
`
`In the interest of avoiding a dispute between the parties as to whether Mr.
`Fanara must be made available for deposition in this proceeding upon notice
`from Petitioner, the parties have agreed to designate portions of Mr. Fanara’s
`February 21, 2019 deposition. These designations are reflected in the
`excerpted version of the transcript that is filed herewith as Attachment A.1
`Petitioner will also file the designated portions of Mr. Fanara’s February 21,
`2019 deposition as a new Exhibit in this proceeding when Petitioner files its
`Reply.
`
`6.
`
`Petitioner and Patent Owner agree that in view of this Stipulation:
`
`
`1 Attachment A hereto contains Patent Owner’s confidential information as is subject
`to the concurrently filed Patent Owner’s Motion to Seal Pursuant to 37 C.F.R.
`§ 42.54. Therefore, the parties have only attached a coversheet for Attachment A
`to this Stipulation while a complete unredacted copy of Attachment A has been
`filed “Board and Parties Eyes only”. Attachment B hereto is a redacted, public
`version of Attachment A.
`
`1
`
`

`

`
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`F.
`
`G.
`
`H.
`
`Petitioner does not need to provide a Notice of Deposition for Mr.
`Fanara in connection with this proceeding (see 37 CFR § 42.53(d)).
`
`Neither party will object in this proceeding that by providing only the
`excerpted version of the transcript (Attachment A) that Mr. Fanara’s
`transcript is incomplete under Federal Rule of Evidence 106.
`
`The testimony in Attachment A may be used by either Party in this
`proceeding in any manner permitted by the United States Patent Trial
`and Appeal Board (“Board”) rules and/or applicable Board guidance.
`
`Recognizing that the February 21, 2019 deposition was not taken
`pursuant to the rules of the Board, and with the exception of Paragraph
`6.B of this Stipulation, Petitioner will not oppose any objection that
`Patent Owner may raise on the basis that Patent Owner did not state the
`objection on the record during the deposition. However, Petitioner
`maintains the right to rebut any objection made by Patent Owner in any
`other manner permitted by the Board rules and/or applicable Board
`guidance.
`
`Patent Owner will not contend before the Board, the Southern District
`of Florida, or any other court, that use of the deposition of Mr. Fanara
`as contemplated by this Stipulation constitutes a violation of any
`protective order of any court or that its use in this proceeding is
`prohibited by any other protection Patent Owner enjoys.
`
`Petitioner will not seek relief from the Board seeking a deposition of
`Mr. Fanara. However, Petitioner does not waive any other objection it
`timely raises pursuant to applicable Board rules and/or applicable
`Board guidance.
`
`Patent Owner reserves the right to add additional counter-designations
`related to the specific subject matter of Petitioner’s Reply.
`
`The designation of the exhibit list at page 4 of Attachment A is solely
`for ease of reference, and no exhibit listed therein is being submitted as
`an exhibit in this proceeding solely due to its inclusion in those
`designations.
`
`7.
`
`Except as otherwise noted in this Stipulation, nothing herein waives any
`objection that either party may raise in this proceeding, presently or in the
`future, including objections to the admissibility under Board rules and/or
`
`2
`
`

`

`
`
`applicable Board guidance to any portion of the above-designated testimony
`and/or exhibits referenced therein.
`
`DATED: 11/26/19
`
`Counsel of Record in IPR 2019-00400
`
`
`Katten Muchin Rosenman LLP
`
`/Jitendra Malik/
`Jitendra Malik, Ph.D.
`Reg. No. 55,823
`
`Counsel for Petitioner Apotex Inc.
`
`
`
`
`
`
`
`Fenwick & West LLP
`
`/Robert E. Counihan/
`Robert E. Counihan
`Reg. No. 61,382
`
`for Patent Owner UCB
`Counsel
`Biopharma Sprl
`
`3
`
`

`

`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e), I hereby certify that on November 26, 2019,
`
`the foregoing document is being served by filing this document through the Patent
`
`Trial and Appeal Board End to End System, as well as by delivering a copy via
`
`electronic mail upon the following counsel of record for the Petitioner:
`
`jitty.malik@kattenlaw.com
`alissa.pacchioli@kattenlaw.com
`joe.janusz@kattenlaw.com
`lance.soderstrom@kattenlaw.com
`
`
`Date: November 26, 2019
`
`
`
`
`Respectfully submitted,
`
`
`
`/Robert E. Counihan/ (Electronically signed)
`Robert E. Counihan
`Reg. No. 61,382
`Phone: (212) 430-2600
`
`
`4
`
`

`

`Attachment A
`
`Attachment A
`
`

`

`Filed Under Seal
`
`Filed Under Seal
`
`

`

`Attachment B
`
`Attachment B
`
`

`

`TextMap Annotation Digest Report
`Case Name: UCB, Inc. v. Apotex Inc. (18-cv-60846-MGC/PMH)
`Transcript: [2/21/2019] Fanara, Domenico
`
`Pg: 1 Ln: 1 - Pg: 21 Ln: 14
`
`Annotation:
`1: 1
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE SOUTHERN DISTRICT OF FLORIDA
`
`______________________________________________
`
`)
`UCB, INC., and BIOPHARMA SPRL, )
`)
`Plaintiffs, )
`)
`vs. ) CASE NO.
`) 18-cv-60846-MGC/PMH
`APOTEX, INC., )
`)
`Defendant. )
`)
`______________________________________________)
`
`HIGHLY CONFIDENTIAL
`
`2
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`3
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`4
`
`5
`
`6
`
`7
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`8
`
`9
`10
`11
`12
`13
`
`VIDEOTAPED DEPOSITION OF DOMENICO FANARA
`FEBRUARY 21, 2019
`New York, New York
`
`14
`15
`16
`TRANSCRIPT of the stenographic notes of
`17
`18 the videotaped deposition of DOMENICO FANARA in the
`19 above-entitled matter, as taken by and before
`20 LORRAINE B. ABATE, a Certified Shorthand Reporter and
`21 Notary Public of the State of New York and Registered
`22 Professional Reporter, held at the offices of Fenwick
`23 & West, 902 Broadway, New York, New York, on February
`24 21, 2019, commencing at 9:16 a.m., pursuant to
`25 Notice.
`2: 1 A P P E A R A N C E S:
`
`FENWICK & WEST, LLP
`Attorneys for the Plaintiffs
`902 Broadway, Suite 14
`New York, New York 10010
`BY: ROBERT COUNIHAN, ESQ.
`(212) 430-2748
`rcounihan@fenwick.com
`
`KATTEN MUCHIN ROSENMAN, ESQS.
`Attorneys for the Defendant
`550 S. Tyron Street, Suite 2900
`Charlotte, North Carolina28202-4213
`BY: JITENDRA MALIK, ESQ.
`(704)344-3185
`jitty.malik@kattenlaw.com
`
`2 3
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`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
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`

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`TextMap Annotation Digest Report
`Case Name: UCB, Inc. v. Apotex Inc. (18-cv-60846-MGC/PMH)
`Transcript: [2/21/2019] Fanara, Domenico
`
`Pg: 1 Ln: 1 - Pg: 21 Ln: 14 continued...
`
`Annotation:
`2:18
`19 A L S O P R E S E N T:
`20 Darak Lighty, Videographer
`21
`22
`23
`24
`25
`3: 1
`
`2 3 4 5
`
` * * * * *
`6 IT IS HEREBY STIPULATED AND AGREED, by and
`7 between counsel for the respective parties hereto,
`8 that the filing, sealing and certification of the
`9 within deposition shall be and the same are hereby
`10 waived.
`11 IT IS FURTHER STIPULATED AND AGREED that all
`12 objections, except as to the form of the question,
`13 shall be reserved to the time of the trial.
`14 IT IS FURTHER STIPULATED AND AGREED that the
`15 within deposition may be signed before any Notary
`16 Public with the same force and effect as if signed
`17 and sworn to before the Court.
`18 * * * * *
`19
`20
`21
`22
`23
`24
`25
`4: 1 I N D E X
`2 WITNESS: DOMENICO FANARA
`
`3 4
`
`EXAMINATION BY: PAGE
`5 Mr. Malik ........................................... 7
`
` **********
`
` E X H I B I T S
`
`6 7
`
`8 9
`
`10
`11 FANARA PAGE
`12 EXHIBIT 1 Notice 22
`13 EXHIBIT 2 Responses and Objections of UCB, Inc.
`14 and UCB Biopharma SPRL 25
`15 EXHIBIT 3 US Patent No. USS 8,633,194 B2 47
`16 EXHIBIT 4 Declaration and Power of Attorney
`17 For Patent Application 48
`
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`

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`TextMap Annotation Digest Report
`Case Name: UCB, Inc. v. Apotex Inc. (18-cv-60846-MGC/PMH)
`Transcript: [2/21/2019] Fanara, Domenico
`
`Pg: 1 Ln: 1 - Pg: 21 Ln: 14 continued...
`
`Annotation:
`4:18 EXHIBIT 5 Document titled Antimicrobial Efficacy
`19 Of the Parabens in Levocetirizine 80
`20 EXHIBIT 6 Document titled Antimicrobial Efficacy
`21 Of the Parabens in Cetrizine Solutions 91
`22 EXHIBIT 7 Technological Transfer Dossier 103
`23 EXHIBIT 8 Xyzal Oral Solution Product Detail 113
`24 EXHIBIT 9 NDA 22-157 114
`25
`5: 1 E X H I B I T S
` ( CONTINUED )
`
`2 3
`
`FANARA PAGE
`4 EXHIBIT 10 E-Mail dated February 22, 2001 130
`5 EXHIBIT 11 Memo dated March 27, 2001 132
`6 EXHIBIT 12 Memo dated November 24, 2003 136
`7 EXHIBIT 13 E-Mail Chain 140
`8 EXHIBIT 14 E-Mail Chain 145
`9 EXHIBIT 15 E-Mail Chain 147
`10 EXHIBIT 16 E-Mail Chain 149
`11 EXHIBIT 17 Declaration of Domenico Fanara 155
`12 EXHIBIT 18 Xyzal Product Literature 167
`13 EXHIBIT 19 US Patent No. 5,698,558 170
`14
`15 **********
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`6: 1 DOMENICO FANARA
`2 THE VIDEOGRAPHER: Here begins media
`3 unit No. 1, volume 1 in the video deposition of
`4 Domenico Fanara in the matter of UCB, Inc. and
`5 UCB Biopharma SPRL versus Apotex, Inc. Today's
`6 date is February 21st, 2019, and the time is
`7 9:16 a.m.
`8 This deposition is being held at Fenwick
`9 & West, LLP. My name is Darak Lighty and the
`10 court reporter today is Lorraine Abate, both
`11 associated with Gregory Edwards, LLC.
`12 Counsel will now state their appearances
`13 for the record.
`14 MR. COUNIHAN: Robert Counihan from
`15 Fenwick & West.
`16 MS. BLANCHARD: Amanda Blanchard, UCB.
`
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`

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`TextMap Annotation Digest Report
`Case Name: UCB, Inc. v. Apotex Inc. (18-cv-60846-MGC/PMH)
`Transcript: [2/21/2019] Fanara, Domenico
`
`Pg: 1 Ln: 1 - Pg: 21 Ln: 14 continued...
`
`Annotation:
`6:17 MS. SUTTER: Erica Sutter, Fenwick &
`18 West.
`19 MR. MALIK: Jitendra Malik from the law
`20 firm of Rosenman for Apotex.
`21 THE VIDEOGRAPHER: Will the court
`22 reporter please swear in the witness.
`23 D O M E N I C O F A N A R A,
`24 Having been first duly sworn by a Notary
`25 Public of the State of New York, was
`7: 1 DOMENICO FANARA
`2 examined and testified as follows:
`3 EXAMINATION BY MR. MALIK:
`4 Q. Good morning, Mr. Fanara.
`5 A. Good morning.
`6 Q. Just again, can you state your name.
`7 A. Domenico Fanara.
`8 Q. Your current address?
`9 A. Sorry?
`10 Q. Your current address.
`11 A. Rue Pont de Soleil -- Rue, Street, Pont,
`12 P-O-N-T de Soleil S-O-L-E-I-L, 2-A 5 -- 4520 Wanze,
`13 W-A-N-Z-E. This is the city.
`14 Q. Are you currently employed?
`15 A. Yes.
`16 Q. Who is your current employer?
`17 A. UCB.
`18 Q. Okay. Mr. Fanara, do you understand
`19 today you're under oath? Do you understand you're
`20 under oath?
`21 A. Yeah.
`22 Q. And do you understand today that you're
`23 obligated to answer my questions?
`24 A. Yeah.
`25 Q. Obviously, I'll ask you a series of
`8: 1 DOMENICO FANARA
`2 questions. If today you don't understand it, one of
`3 my questions, let me know and I'll try to rephrase.
`4 Fair enough?
`5 A. Thank you.
`6 Q. If not, I'll assume you understood my
`7 question. Fair enough?
`8 A. Yes.
`9 MR. COUNIHAN: So you'll need to -- you
`10 have to answer verbally for Lorraine's sake.
`11 THE WITNESS: Okay.
`12 Q. From time to time, your counsel may
`13 object for the record. But unless instructed not to
`14 answer, you understand that you're obligated to
`15 answer my question to the best of your ability?
`16 A. Yes.
`
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`TextMap Annotation Digest Report
`Case Name: UCB, Inc. v. Apotex Inc. (18-cv-60846-MGC/PMH)
`Transcript: [2/21/2019] Fanara, Domenico
`
`Pg: 1 Ln: 1 - Pg: 21 Ln: 14 continued...
`
`Annotation:
`8:17 Q. As far as breaks, I try to stop on the
`18 hour every hour. If you want a break, let me know
`19 and I'll do my best to accommodate you. My only rule
`20 is if I'm in the middle of a question, you go ahead
`21 and answer that question and then we'll see what we
`22 can do about getting you a break. Fair enough?
`23 A. Fair.
`24 Q. Is there any reason today that you
`25 cannot tell the truth?
`9: 1 DOMENICO FANARA
`2 A. No.
`3 Q. Okay. In connection with your
`4 deposition today, who did you meet with, the names;
`5 did you meet with the attorneys?
`6 A. Yes.
`7 Q. Okay. Which attorneys?
`8 MR. COUNIHAN: You can identify us by
`9 name for Lorraine's sake.
`10 A. So Bobby and Erica.
`11 Q. Okay. Was anyone else present during
`12 your deposition -- was anyone else present during
`13 your deposition prep?
`14 A. Amanda was partially present.
`15 Q. Okay. In connection with your
`16 deposition, did you talk to anyone else other than
`17 the three individuals here?
`18 A. No.
`19 Q. Have you been deposed before?
`20 A. No.
`21 Q. What is your current position with UCB?
`22 A. I'm head of technology platform
`23 innovation. And I'm working into the technical
`24 operation into the delivery device team.
`25 Q. You understand today that this matter
`10: 1 DOMENICO FANARA
`2 concerns levocetirizine, correct?
`3 A. Yes.
`4 Q. When was the last time you worked with
`5 levocetirizine?
`6 A. Maybe more than 10 years ago.
`7 Q. So is it fair to say that your current
`8 work doesn't involve levocetirizine?
`9 A. Correct.
`10 Q. Starting after high school, where did
`11 you get your college degree from?
`12 A. University of Liege.
`13 Q. Can you spell that, please.
`14 A. L-I-E-G-E.
`15 Q. And what degree did you get?
`16 A. I don't know what we -- we don't use
`
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`TextMap Annotation Digest Report
`Case Name: UCB, Inc. v. Apotex Inc. (18-cv-60846-MGC/PMH)
`Transcript: [2/21/2019] Fanara, Domenico
`
`Pg: 1 Ln: 1 - Pg: 21 Ln: 14 continued...
`
`Annotation:
`10:17 degree like in the U.S.
`18 Q. What did you get from the University of
`19 Liege?
`20 A. I was pharmacist. Is that what you
`21 mean?
`22 Q. Yeah.
`23 A. Okay. Sorry.
`24 Q. After the University of Liege, did you
`25 get any other degrees, any graduate degrees?
`11: 1 DOMENICO FANARA
`2 A. No. I had a lot of trainings, business
`3 trainings and stuff like that, but no other degrees.
`4 Q. Okay. After you finished at the
`5 University of Liege, did you go work for an employer?
`6 A. For an employer, yeah.
`7 Q. Which employer?
`8 A. It was a small generic company called
`9 Galephar in Brussels. G-A-L-E-P-H-A-R.
`10 Q. What year was that?
`11 A. In 1986.
`12 Q. And how long were you at this generic
`13 pharmaceutical company?
`14 A. Until 1992, November.
`15 Q. And while at that generic company, did
`16 you work on cetirizine or levocetirizine?
`17 A. No.
`18 Q. Generally speaking, what kind of
`19 projects was it when you worked at this generic
`20 company, without getting into confidentiality?
`21 A. It was mainly slow release formulation
`22 of off-patent products.
`23 Q. And then in 1992, you left the generic
`24 pharmaceutical company, correct?
`25 A. Yeah, and I joined -- yeah.
`12: 1 DOMENICO FANARA
`2 Q. And who did you join?
`3 A. UCB, January 3rd, 1993.
`4 Q. And what was your first position with
`5 UCB?
`6 A. When I joined UCB, I was doing a Ph.D.
`7 at the University of Brussels while being part of the
`8 formulation team as -- I would say a junior
`9 scientist.
`10 Q. Did you finish your Ph.D. in Brussels?
`11 A. No.
`12 Q. Just for the court reporter's sake, just
`13 let me finish my question, and then answer. It makes
`14 for a much cleaner transcript. Fair enough; yes?
`15 A. Yes.
`16 Q. So when you joined UCB, just to be
`
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`TextMap Annotation Digest Report
`Case Name: UCB, Inc. v. Apotex Inc. (18-cv-60846-MGC/PMH)
`Transcript: [2/21/2019] Fanara, Domenico
`
`Pg: 1 Ln: 1 - Pg: 21 Ln: 14 continued...
`
`Annotation:
`12:17 clear, you were still -- you were also -- strike
`18 that.
`19 Okay. When you first joined UCB in
`20 1993, what project were you assigned to work on?
`21 A. So I was working on my Ph.D., the main
`22 topic. And I had side project related to the taste
`23 masking of oral solid form of cetirizine.
`24 Q. What was the -- let me break that up a
`25 little bit.
`13: 1 DOMENICO FANARA
`2 What was the main topic of your --
`3 A. The oral absorption of peptide.
`4 Q. And just in connection with your Ph.D.,
`5 I assume since it was based on the peptide work, it
`6 had nothing to do with cetirizine or levocetirizine?
`7 A. No.
`8 Q. So let's talk about the side project of
`9 taste masking, working with oral cetirizine.
`10 Was that the first time that you were
`11 aware -- you personally were aware of the compound
`12 cetirizine?
`13 A. What do you mean by being aware?
`14 Q. When did you first hear of the compound
`15 cetirizine?
`16 A. I heard about the compound because when
`17 I joined UCB, it was the biggest project in the
`18 organization. We just -- yeah.
`19 MR. COUNIHAN: I'm not sure where we're
`20 going to go with this point, but can I just
`21 designate the transcript highly confidential.
`22 MR. MALIK: Sure.
`23 MR. COUNIHAN: Thanks.
`24 MR. MALIK: We're going to go there
`25 anyway, so yes.
`14: 1 DOMENICO FANARA
`2 Q. So the biggest project at the time was
`3 cetirizine; is that correct?
`4 A. For UCB, yes.
`5 Q. What were you trying to do with
`6 cetirizine?
`7 A. Well, as I said, my main project was my
`8 Ph.D., but I've been given a side project which was
`9 trying to develop a formulation minimizing the taste
`10 of cetirizine, because the taste is very awful.
`11 Q. And that was the first time you heard of
`12 the compound cetirizine, correct?
`13 A. Not that I heard about, but that I
`14 worked on.
`15 Q. Okay. And you didn't invent the
`16 compound cetirizine, correct?
`
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`TextMap Annotation Digest Report
`Case Name: UCB, Inc. v. Apotex Inc. (18-cv-60846-MGC/PMH)
`Transcript: [2/21/2019] Fanara, Domenico
`
`Pg: 1 Ln: 1 - Pg: 21 Ln: 14 continued...
`
`Annotation:
`14:17 A. No.
`18 Q. How long did you work on cetirizine?
`19 A. On this specific project?
`20 Q. Yes.
`21 A. A couple of years.
`22 Q. So until about 1995?
`23 A. Yeah. In fact, it had different steps.
`24 So you know, I started on a small project and then it
`25 evolved, but it's difficult to say how long it was
`15: 1 DOMENICO FANARA
`2 really, I mean. But initial project was a couple of
`3 years.
`4 Q. Okay. Now, you're aware that cetirizine
`5 has two enantiomers, correct, levocetirizine and
`6 dextro cetirizine?
`7 A. Yes.
`8 Q. Okay. When was the first time you were
`9 aware of levocetirizine?
`10 A. I don't know. In the Nineties, but I
`11 don't recall exactly.
`12 Q. And just to be clear, you don't claim to
`13 be an inventor of levocetirizine, correct?
`14 A. No.
`15 Q. Those compounds were known before you
`16 got to UCB, correct?
`17 MR. COUNIHAN: Objection. Form.
`18 A. I don't know for levocetirizine. I know
`19 for cetirizine.
`20 Q. Okay. So you said you worked on a side
`21 project in 1995. And then obviously, continued.
`22 After 1995, what was your I guess title
`23 at UCB?
`24 A. So I took more responsibility within the
`25 organization. And I was I think a small group of
`16: 1 DOMENICO FANARA
`2 formulation.
`3 Q. In 1995?
`4 A. No. It was '96, '97.
`5 Q. Okay. And what was your title
`6 in '96, '97?
`7 A. I was heading a formulation group. So I
`8 was possibly head of formulation, but I was not the
`9 only formulation group.
`10 Q. Okay. And when you were in the -- the
`11 head of formulation group -- or strike that.
`12 In '96, '97, when you were working in
`13 the formulation group possibly as its head, what
`14 project were you assigned to work on?
`15 A. It was solid form of cetirizine, mainly,
`16 plus some early project coming from research.
`
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`TextMap Annotation Digest Report
`Case Name: UCB, Inc. v. Apotex Inc. (18-cv-60846-MGC/PMH)
`Transcript: [2/21/2019] Fanara, Domenico
`
`Pg: 1 Ln: 1 - Pg: 21 Ln: 14 continued...
`
` interested -- well,
`
`Annotation:
`16:17 Q. Was that early project coming from
`18 research related to cetirizine or levocetirizine?
`19 A. No.
`20 Q. Okay. Focusing only on cetirizine, the
`21 solid form of cetirizine when you were the --
`22 possibly the head of formulation from '96 to '97,
`23 what were you tasked with doing?
`24 A. So it was the time we entered in the
`25 collaboration with U.S. pharma company, and I was
`17: 1 DOMENICO FANARA
`2 part of the development team with the -- development
`3 team with the U.S. pharma company.
`4 Q. Which pharma company?
`5 A.
`6 Q. And what was
`7 strike that.
`8 What was the nature of the collaboration
`9 with
` as it relates to cetirizine?
`10 MR. COUNIHAN: Objection, form.
`11 Just to be clear, and I know you haven't
`12 talked about the 30(b)(6) aspect of this, but
`13 with respect to cetirizine, he's certainly only
`14 testifying to his personal knowledge.
`15 MR. MALIK: Yeah.
`16 A. So we were developing life cycle
`17 management project on cetirizine.
`18 Q. What do you mean by life cycle
`19 management project?
`20 A. New formulation.
`21 Q. Were you also at this time working with
`22 levocetirizine?
`23 A. No.
`24 Q. When did you first start working with
`25 levocetirizine?
`18: 1 DOMENICO FANARA
`2 A. Should have been early 2000.
`3 Q. And why did you start working with
`4 levocetirizine? Was there an impetuous behind it,
`5 was there some drive to work with levocetirizine
`6 internally?
`7 MR. COUNIHAN: Objection, form.
`8 MR. MALIK: Let me rephrase.
`9 Q. So you said in early 2000, you started
`10 working with levocetirizine, correct?
`11 A. Yes.
`12 Q. Why?
`13 A. Because levocetirizine was one of the
`14 UCB product under development, among others.
`15 Q. Who asked you to work with
`16 levocetirizine in early 2000?
`
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`TextMap Annotation Digest Report
`Case Name: UCB, Inc. v. Apotex Inc. (18-cv-60846-MGC/PMH)
`Transcript: [2/21/2019] Fanara, Domenico
`
`Pg: 1 Ln: 1 - Pg: 21 Ln: 14 continued...
`
`Annotation:
`18:17 A. My management.
`18 Q. Did they give you a reason why they
`19 wanted you to work with levocetirizine?
`20 A. No specific reason.
`21 Q. Do you have any understanding as to why
`22 there was interest within UCB to work with
`23 levocetirizine?
`24 A. We were looking at the next generation
`25 antihistamine drug.
`19: 1 DOMENICO FANARA
`2 Q. Antihistamine?
`3 A. Yeah. And we had a series of option,
`4 one being levocetirizine.
`5 Q. What were the other options, if you
`6 recall?
`7 A. Efletirizine was one of the other
`8 options.
`9 Q. Which one?
`10 A. Efletirizine.
`11 Q. Can you spell that, please.
`12 A. E-F-L-E-L-T-I-R-I-Z-I-N-E.
`13 Efletirizine.
`14 Q. In early 2000 when you started working
`15 with levocetirizine, what was your position?
`16 A. Again, I was head of formulation, but
`17 with a broader scope that initial for years before.
`18 I had more and more people reporting to me, to the
`19 formulation team.
`20 Q. And with respect to your work with
`21 levocetirizine early 2000, what were you specifically
`22 tasked with doing?
`23 A. What I was specifically doing on
`24 levocetirizine?
`25 Q. Yeah. What were you asked to do with
`20: 1 DOMENICO FANARA
`2 levocetirizine?
`3 A. To participate in the development of
`4 formulation for the commercialization of the product.
`5 Q. And what specifically were you looking
`6 at in connection with the formulation of a
`7 commercialization of the product? Were you looking
`8 at stability, what were you tasked with specifically
`9 doing?
`10 A. I was developing the oral solution with
`11 my team.
`12 Q. And at the time in early 2000, oral
`13 solutions of cetirizine were known, correct?
`14 A. Correct.
`15 Q. And oral solutions of levocetirizine had
`16 been reported, correct?
`
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`TextMap Annotation Digest Report
`Case Name: UCB, Inc. v. Apotex Inc. (18-cv-60846-MGC/PMH)
`Transcript: [2/21/2019] Fanara, Domenico
`
`Pg: 1 Ln: 1 - Pg: 21 Ln: 14 continued...
`
`Annotation:
`20:17 MR. COUNIHAN: Objection, form.
`18 A. It was the beginning of the -- so it was
`19 the beginning of development of it.
`20 Q. Were you aware of prior reports of using
`21 levocetirizine in oral solutions?
`22 A. In clinical trial, possibly.
`23 Q. Do you have any recollection more
`24 specifically of what the nature of the clinical
`25 trials using oral solutions of levocetirizine were?
`21: 1 DOMENICO FANARA
`2 A. No.
`3 Q. When you use the word oral solution,
`4 what do you mean?
`5 A. A composition containing the active
`6 ingredient in a water-based system with the flavoring
`7 agent and a series of excipients that improve the
`8 palatability of the formulation.
`9 Q. In early 2000, why was UCB interested in
`10 developing a levocetirizine formulation?
`11 MR. COUNIHAN: Objection, form.
`12 A. We were not interested in developing a
`13 specific levocetirizine formulation. We were
`14 interested in developing levocetirizine compound.
`
`Pg: 28 Ln: 2 - Pg: 29 Ln: 20
`
`Annotation:
`28: 2 Q. And then you also have been designated
`3 as UCB's 30(b)(6) deponent for topic 14, correct?
`4 A. I'm not sure I full understand, but when
`5 I see commercial success, I'm not involved in those
`6 element.
`7 Q. You said I'm not sure I understand.
`8 What about topic 14 is -- do you not
`9 understand?
`10 A. Why commercial success is part of it. I
`11 mean...
`12 Q. Okay. So in connection with topic 14,
`13 you don't believe that you have any information as it
`14 relates to commercial success?
`15 A. Correct.
`16 Q. Okay. What about long-felt need, do you
`17 have any --
`18 A. What does it mean, long-felt need?
`19 Q. Well, let me ask you this; do you have
`20 any understanding of what the term long-felt need
`21 means?
`22 A. No.
`23 MR. COUNIHAN: So objection. Calls for
`24 legal conclusion and you know -- well, you can
`
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`TextMap Annotation Digest Report
`Case Name: UCB, Inc. v. Apotex Inc. (18-cv-60846-MGC/PMH)
`Transcript: [2/21/2019] Fanara, Domenico
`
`Pg: 28 Ln: 2 - Pg: 29 Ln: 20 continued...
`
`Annotation:
`28:25 keep asking your questions, or we can just --
`29: 1 DOMENICO FANARA
`2 you know, you offered a broad topic here, and
`3 he's here to talk about aspects of it. If you
`4 just want me to tell you on the record what
`5 aspects, we can do that. Is that -- would that
`6 be the most efficient way forward or do you want
`7 to try and go back and forth with him about the
`8 legal meanings of some of these terms?
`9 MR. MALIK: I guess if topic 14 has
`10 been -- well, I guess if any of the designated
`11 topics have been narrowed, yeah, I think it
`12 would be helpful on the record if you tell me
`13 what specifically he's been designated for.
`14 MR. COUNIHAN: So for topic 14, he's
`15 here to testify about unexpected results.
`16 MR. MALIK: Okay. Just so I'm clear,
`17 nothing in connection with long-felt need,
`18 commercial success, copying, industry praise or
`19 failure of others?
`20 MR. COUNIHAN: As a 30(b)(6), correct.
`
`Pg: 30 Ln: 5 - 8
`
`Annotation:
`30: 5 Q. So Mr. Fanara, just to be clear, in
`6 connection with topic 14, you are only here to talk
`7 about unexpected results?
`8 A. Yes.
`
`Pg: 30 Ln: 9 - Pg: 40 Ln: 22
`
`Annotation:
`30: 9 Q. Okay. Do you have any understanding of
`10 what unexpected results are?
`11 MR. COUNIHAN: Objection. Calls for
`12 legal conclusion.
`13 A. In the context of trial IP, I have some
`14 understanding, yes.
`15 Q. What is that understanding?
`16 A. That you run an experiment and you have
`17 a result that was not expected at all.
`18 Q. Okay. Okay.
`19 A. It is the same meaning as yours?
`20 Q. I just want to understand your meaning.
`21 Let me just go a little back to your
`22 background now.
`23 You understand that cetirizine is used
`24 as an API, correct, active pharmaceutical ingredient?
`25 A. Yes.
`
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`TextMap Annotation Digest Report
`Case Name: UCB, Inc. v. Apotex Inc. (18-cv-60846-MGC/PMH)
`Transcript: [2/21/2019] Fanara, Domenico
`
`Pg: 30 Ln: 9 - Pg: 40 Ln: 22 continued...
`
`Annotation:
`31: 1 DOMENICO FANARA
`2 Q. And you also understand that
`3 levocetirizine is used as an active pharmaceutical
`4 ingredient, correct?
`5 A. Yes.
`6 Q. And when was the fir