Dr. Sarfaraz Niazi - December 6, 2019
`
`Page 1
`
`I N T H E U N I T E D S T A T E S P A T E N T A N D T R A D E M A R K O F F I C E
`
` _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
`
` B E F O R E T H E P A T E N T T R I A L A N D A P P E A L B O A R D
`
` _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
`
`
`
` A P O T E X , I N C . ,
`
` P e t i t i o n e r ,
`
` v .
`
` U C B B I O P H A R M A S P R L ,
`
` P a t e n t O w n e r .
`
` _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
`
` U . S . P a t e n t N o . 8 , 6 3 3 , 1 9 4
`
` I n t e r P a r t e s R e v i e w N o . : I P R 2 0 1 9 - 0 0 4 0 0
`
` _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
`
` D E P O S I T I O N O F D R . S A R F A R A Z N I A Z I
`
` N E W Y O R K , N E W Y O R K
`
` F R I D A Y , D E C E M B E R 6 , 2 0 1 9
`
`R E P O R T E D B Y :
`
`D A N I E L L E G R A N T
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Apotex (IPR2019-00400) Ex. 1043 p. 001
`
`

`

`2 (Pages 2 to 5)
`
`Dr. Sarfaraz Niazi - December 6, 2019
`
`Page 2
`
`Page 4
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
` DR. SARFARAZ NIAZI
`DR. SARFARAZ NIAZI, called as a witness, having
` been first duly sworn by Danielle Grant,
` a Notary Public within and for the State
` of New York, was examined and testified
` as follows:
`DIRECT EXAMINATION BY
`MR. MALIK:
`
` Q Q Good morning, Dr. Niazi.
`
` Q Q
`
` A A Good morning.
`
` A A
`
` Q Q So I've given you four exhibits.
`
` Q Q
`So the record is clear, I've given you your
`declaration, first one, correct?
`
` A A Yes, I have it here.
`
` A A
`
` Q Q And you signed it October 14,
`
` Q Q
`2019, as on Page 89, correct?
`
` A A Yes.
`
` A A
`
` Q Q I've also given you the '194
`
` Q Q
`Patent, Exhibit 1001, correct?
`
` A A Yes.
`
` A A
`
` Q Q I assume you've seen this patent
`
` Q Q
`before?
`
` A A Yes.
`
` A A
`
` Q Q And I have also given you WO 094,
`
` Q Q
`Exhibit 1007, correct? At the very bottom
`
`Page 5
`
` DR. SARFARAZ NIAZI
`you'll see 1007.
`
` A A This one here?
`
` A A
`
` Q Q Yes.
`
` Q Q
`
` A A Yes.
`
` A A
`
` Q Q And then the fourth document, if
`
` Q Q
`you look on the -- and the last document, the
`fourth document that I've handed you right at
`the beginning is, if you look on the bottom
`right, Exhibit 1004, which is EP 203, correct?
`
` A A This one?
`
` A A
`
` Q Q Yes.
`
` Q Q
`
` A A Yeah. Four.
`
` A A
` MS. SUTTER: Yeah, Jitty, I'm
` just going to make that statement on
` the record.
` MR. MALIK: Oh, yes, of course
` sorry. Of course.
` MS. SUTTER: Pursuant to our
` agreement before the last depositions
` going forward, any objections except
` for hearsay, relevance, privilege,
` foundation, all other objections are
` preserved, if I stated that correctly.
` MR. MALIK: Correct. That is my
`
` December 6, 2019
` 9:35 a.m.
`
` Deposition of DR. SARFARAZ NIAZI, held
`at the offices of Fenwick & West LLP, 902
`Broadway, New York, New York pursuant to Notice
`before DANIELLE GRANT, a Shorthand Reporter and
`Notary Public of the State of New York.
`
`Page 3
`
`A P P E A R A N C E S:
`
`KATTEN MUCHIN ROSENMAN, LLP
`Attorneys for the Petitioner Apotex
`550 South Tryon Street
`Suite 2900
`Charlotte, North Carolina 28202-4213
`BY: JITENDRA MALIK, Ph.D., ESQ., of Counsel
` ALISSA M. PACCHIOLI, ESQ., of Counsel
`
`FENWICK & WEST, LLP
`Attorneys for the Patent Owner, UCB Biopharma
`902 Broadway
`Suite 14
`New York, New York 10010
`BY: ERICA R. SUTTER, ESQ., of Counsel
` ROBERT COUNIHAN, ESQ., of Counsel
`
`1 2 3 4
`
`5
`
`6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`1
`
`2 3
`
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Apotex (IPR2019-00400) Ex. 1043 p. 002
`
`

`

`3 (Pages 6 to 9)
`
`Dr. Sarfaraz Niazi - December 6, 2019
`
`Page 6
`
`Page 8
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
` DR. SARFARAZ NIAZI
` understanding too.
`
` Q Q Dr. Niazi, you understand you're
`
` Q Q
`under oath to today?
`
` A A Yes.
`
` A A
`
` Q Q You understand you're obligated
`
` Q Q
`to answer my questions?
`
` A A Yes.
`
` A A
`
` Q Q Any reason today you cannot tell
`
` Q Q
`you truth?
`
` A A No.
`
` A A
`
` Q Q Okay. If you -- if I ask a
`
` Q Q
`question and you don't say it's unclear, I
`assume you understood the question, fair enough?
`
` A A Yes.
`
` A A
`
` Q Q And I ask that all the answers
`
` Q Q
`that you give me today are from the perspective
`of a POSA unless you indicate otherwise, fair
`enough?
` MS. SUTTER: Object to form.
`
` A A Yes.
`
` A A
`
` Q Q And do you understand that this
`
` Q Q
`is an IPR deposition?
`
` A A Yes.
`
` A A
`
` Q Q And PTAB rules prevent you from
`
` Q Q
`
`Page 7
`
` DR. SARFARAZ NIAZI
`discussing the substance of your testimony and
`anticipated testimony for the duration of this
`cross?
` Do you understand that?
`
` A A Yes.
`
` A A
`
` Q Q That includes during the breaks.
`
` Q Q
`
` A A Yes.
`
` A A
` MR. MALIK: And, Counsel, to the
` extent Dr. Niazi says anything today
` that will support a motion to strike,
` I will give you the full basis at the
` end of the cross, and that way you
` have the opportunity to redirect him
` however, but I'll give you a notice of
` it.
`
` Q Q Paragraph 12, in your
`
` Q Q
`declaration, those are the documents you
`considered, correct -- well, turn to Paragraph
`12, I'm sorry, of your declaration.
` MS. SUTTER: Object to form.
`
` Q Q Let me know when you're there.
`
` Q Q
`
` A A Yes.
`
` A A
`
` Q Q It says in Paragraph 12: I
`
` Q Q
`considered the materials as submitted by patent
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
` DR. SARFARAZ NIAZI
`owner in this proceeding.
` Do you see that?
`
` A A Yes.
`
` A A
`
` Q Q In connection with forming your
`
` Q Q
`opinion, did you look at any other documents
`other than what's mentioned in Paragraph 12?
` MS. SUTTER: Object to form.
`
` A A In forming opinion I looked at
`
` A A
`quite a few documents in my own experience.
`
` Q Q Okay. Let me ask you this: Have
`
` Q Q
`you read the deposition of Mr. Fanara?
`
` A A Yes.
`
` A A
`
` Q Q When did you read the deposition
`
` Q Q
`of Mr. Fanara?
`
` A A I believe yesterday.
`
` A A
`
` Q Q Yesterday, okay.
`
` Q Q
` Have you seen UCB's complete
`response to the PTAB?
`
` A A No, I have not seen that complete
`
` A A
`response.
`
` Q Q Is it fair to say that in
`
` Q Q
`connection with forming your opinions in this
`hatter, you relied on all of the documents at
`least referenced in your declaration?
`
`Page 9
`
` DR. SARFARAZ NIAZI
`
` A A That's correct.
`
` A A
` MS. SUTTER: Object to form.
` Just if you can, you know,
` pause so I have time to object.
` THE WITNESS: Okay.
`
` Q Q Sitting here today, are you aware
`
` Q Q
`of any document that's in your declaration that
`you did not rely on in forming your opinions?
`
` A A No.
`
` A A
`
` Q Q I assume you read the deposition
`
` Q Q
`transcript of Dr. Laskar, correct?
` MS. SUTTER: Object to form.
`
` A A Yes.
`
` A A
`
` Q Q Now, do you have an understanding
`
` Q Q
`that the declaration Exhibit 202 -- sorry, 2034
`was exposed to be a complete response to Dr.
`Laskar as of the date you signed the
`declaration?
` MS. SUTTER: Object to form?
` MR. MALIK: The basis of the
` objection, counsel?
` MS. SUTTER: Legal. If he has an
` understanding of how the proceedings
` work and what you're saying a complete
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Apotex (IPR2019-00400) Ex. 1043 p. 003
`
`

`

`4 (Pages 10 to 13)
`
`Dr. Sarfaraz Niazi - December 6, 2019
`
`Page 10
`
`Page 12
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
` DR. SARFARAZ NIAZI
` response is supposed to be.
` MR. MALIK: Fair enough.
`
` Q Q Do you understand that this was
`
` Q Q
`supposed to be a response to Dr. Laskar, the
`declaration?
`
` A A Yes.
`
` A A
`
` Q Q And so as of the signing of this
`
` Q Q
`declaration, which is October 14, 2019, have you
`formed any additional opinions that are not
`reflected in Exhibit 2034?
`
` A A No.
`
` A A
`
` Q Q Have you received any additional
`
` Q Q
`information that would make you change the
`opinions reflected in Exhibit 2034?
`
` A A No.
`
` A A
`
` Q Q Any corrections I should be aware
`
` Q Q
`of in Exhibit 2034 before we get started?
`
` A A Not that I think I can think of
`
` A A
`now.
`
` Q Q Do you stand by the opinions in
`
` Q Q
`Exhibit 2034?
`
` A A I do.
`
` A A
`
` Q Q Okay. Let's start at
`
` Q Q
`Paragraph 16. There in Paragraph 16 you say: I
`
`Page 11
`
` DR. SARFARAZ NIAZI
`understand the earliest priority date to which
`the '194 Patent is entitled is July 4, 2004.
` Do you see that?
`
` A A Yes.
`
` A A
`
` Q Q And in Paragraph 17 you state: I
`
` Q Q
`understand that an obviousness analysis is
`viewed from the perspective of a person of
`ordinary skill in the art, POSA.
` Do you see that?
`
` A A Yes.
`
` A A
`
` Q Q Is it your understanding that a
`
` Q Q
`person of ordinary skill in the art is a
`hypothetical person that is assumed to be aware
`of all pertinent art?
`
` A A Yes.
`
` A A
`
` Q Q Paragraph 21, you provide the
`
` Q Q
`definition of a POSA, correct?
`
` A A Yes.
`
` A A
`
` Q Q And there you say that a POSA has
`
` Q Q
`certain educational requirements and certain
`years of relevant experience in developing and
`formulating aqueous pharmaceutical formulations,
`correct?
`
` A A Yes.
`
` A A
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
` DR. SARFARAZ NIAZI
`
` Q Q And in Paragraph 22 you say: The
`
` Q Q
`POSA would extensive experience formulating
`multiple types of liquid pharmaceutical
`formulations, including oral solutions, nasal
`drops, eye drops, and ear drops.
` Do you see that?
`
` A A Yes.
`
` A A
`
` Q Q Can you expand on what you mean
`
` Q Q
`by "extensive experience"?
` MS. SUTTER: Object to form.
`
` A A I think extensive is a broad
`
` A A
`experience dealing with many types of dosage
`forms.
`
` Q Q Can you expand on what you mean
`
` Q Q
`by "expansive experience formulating multiple
`types of liquid pharmaceutical formulations"?
` MS. SUTTER: Objection to form.
`
` Q Q As stated in Paragraph 22 of your
`
` Q Q
`declaration?
`
` A A What I mean here is that they
`
` A A
`would have formulated product, many different
`active ingredients many active different
`properties of solutions like pH, dielectric
`constant, solubility, presence or need for
`
`Page 13
`
` DR. SARFARAZ NIAZI
`preservatives, the need for delivering a dosage
`form which is suitable for the purpose, meaning
`is it an adult dosage form or children's dosage
`form. All of those very large number
`considerations that go into formulating any
`dosage form.
`
` Q Q So the POSA would also have
`
` Q Q
`experience with preservatives, correct?
`
` A A If the formulation requires a
`
` A A
`preservative, that would be one of the many
`things that he or she would have knowledge of.
`
` Q Q Have you ever worked with
`
` Q Q
`Levocetirizine?
`
` A A No, I've not.
`
` A A
`
` Q Q Have you are worked with
`
` Q Q
`Cetirizine?
`
` A A No, I've not.
`
` A A
`
` Q Q Let's turn to Exhibit
`
` Q Q
`1007 -- strike that.
` Yeah, 1007, which is WO094.
`Let me know when you have that. Turn to Page
`4, Lines 24, start there. Let me know when
`you are a ready to proceed?
`
` A A Okay.
`
` A A
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Apotex (IPR2019-00400) Ex. 1043 p. 004
`
`

`

`5 (Pages 14 to 17)
`
`Dr. Sarfaraz Niazi - December 6, 2019
`
`Page 14
`
`Page 16
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
` DR. SARFARAZ NIAZI
`
` Q Q Okay. You see where it says:
`
` Q Q
`Best results have been obtained with an oral
`dosage form, in particular liquid formulations
`such as syrup for children and film-coated
`tablets for adults.
` Do you see that? Line 24.
`
` A A On which page is that?
`
` A A
`
` Q Q Page 4.
`
` Q Q
`
` A A Oh, yes.
`
` A A
`
` Q Q You see where it says -- just so
`
` Q Q
`the record is clear line, on WO094, Line 24:
`Best results have been obtained with oral dosage
`form, in particular liquid formulations such as
`a syrup for children and film-coated tablets.
` Do you see that?
`
` A A Yes.
`
` A A
`
` Q Q Paragraph 22 you say that: The
`
` Q Q
`POSA would have extensive experience with
`multiple types of liquid pharmaceutical
`formulations including oral solutions, nasal
`drops, eye drops, and ear drops, correct?
`
` A A Yes.
`
` A A
`
` Q Q Show me in that declaration where
`
` Q Q
`the POSA has any experience with tablet
`
`Page 15
`
` DR. SARFARAZ NIAZI
`formulations? Sorry, Paragraph 22.
`
` A A Yeah. Well, if to this form is
`
` A A
`supposed to be a tablet, then that's a delivery
`system, then a POSA would have that experience.
`
` Q Q I'm simply asking in Paragraph
`
` Q Q
`22, show me any -- or Paragraph 21, where you
`state that the POSA has any experience in tablet
`formulations.
`
` A A I'm referring to a POSA who will
`
` A A
`be formulating this product, I'm not generically
`talking about POSA.
`
` Q Q Do you understand that you were
`
` Q Q
`supposed to give your opinions on the definition
`of a POSA?
`
` A A Yes.
`
` A A
`
` Q Q Do you understand the definition
`
` Q Q
`of a personal of ordinary skill in the art that
`you provided is reflected in Section 4 of your
`declaration?
`
` A A Yeah. A POSA would have
`
` A A
`extensive experience in pharmaceutical liquid
`formulations which is where the '194 is all
`about.
`
` Q Q Okay. I'm asking in, Paragraphs
`
` Q Q
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
` DR. SARFARAZ NIAZI
`20, 21, 22, or 23 under the section Person of
`Ordinary Skill in the Art in your declaration,
`show me where it says that the POSA would have
`any experience in tablet formulations?
`
` A A Again, I will provide the same
`
` A A
`answer is that, if a POSA is required to make a
`tablet, then a POSA will know all about tablets.
`In this statement I'm specifically referring to
`designing and making a formulation which is a
`liquid formulation.
`
` Q Q My question, though, now
`
` Q Q
`remember, at the beginning of the declaration --
`I mean deposition -- one of the rules I said was
`you were obligated to answer my questions?
` Do you remember that?
`
` A A Yes.
`
` A A
`
` Q Q And you said under oath that you
`
` Q Q
`would agree to that, correct?
`
` A A Yes.
`
` A A
`
` Q Q In Paragraph 20 through 23, the
`
` Q Q
`word "tablet" do not appear, correct?
`
` A A Yes, for reason.
`
` A A
`
` Q Q The words "solid dosage form" do
`
` Q Q
`not appear in Paragraphs 20 through 23, correct?
`
`Page 17
`
` DR. SARFARAZ NIAZI
`
` A A Yes, for reason.
`
` A A
`
` Q Q What reason?
`
` Q Q
`
` A A Because this opinion is specific
`
` A A
`to a formulation, and it's not a general opinion
`for any POSA.
`
` Q Q Are you giving the opinions in
`
` Q Q
`this declaration from the definition of POSA
`that you have provided in Paragraphs 20 through
`23, or is it some other POSA?
`
` A A No, this is a POSA capable of
`
` A A
`formulating the product in question.
`
` Q Q And that POSA has extensive
`
` Q Q
`experience in liquid formulations, but I can see
`no experience in tablet formulations, correct,
`based on Paragraphs 20 through 23?
`
` A A If he's making a solution, then
`
` A A
`it has to have liquid formulations, all types,
`to do a liquid formulation.
`
` Q Q Let me ask you this: Would you
`
` Q Q
`agree that if the POSA had no experience in
`tablet formulations but extensive experience
`with multiple types of liquid formulations, in
`WO094 what we discussed on paragraph -- on Page
`4, Line 24, they would focus on the liquid
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Apotex (IPR2019-00400) Ex. 1043 p. 005
`
`

`

`6 (Pages 18 to 21)
`
`Dr. Sarfaraz Niazi - December 6, 2019
`
`Page 18
`
`Page 20
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
` DR. SARFARAZ NIAZI
`formulations because they wouldn't know how to
`make tablet formulations, correct?
` MS. SUTTER: Object to form.
`
` A A Yes, but to the extent that it
`
` A A
`doesn't apply to a liquid dosage form it's not
`relevant.
`
` Q Q What does that mean?
`
` Q Q
`
` A A It means that the delivery form,
`
` A A
`a tablet and liquid are miles apart.
`
` Q Q Okay.
`
` Q Q
`
` A A You know, if the purpose is to
`
` A A
`deliver drug in a liquid form, there's a
`different knowledge required than making
`tablets, so that is possible.
`
` Q Q Your POSA has no knowledge how to
`
` Q Q
`make tablets according to Paragraphs 20 through
`23, correct?
` MS. SUTTER: Object to form.
`
` A A In most of the formulation you're
`
` A A
`talking about a POSA who has gone through
`extensive education, okay. And every POSA would
`have substantial knowledge, if not extensive
`knowledge of all the dosage forms, okay. So I'm
`not going to agree he doesn't know anything
`
`Page 19
`
` DR. SARFARAZ NIAZI
`about tablets.
`
` Q Q Just show me in Paragraphs 20 to
`
` Q Q
`23 where it says in any knowledge of tablets?
` MS. SUTTER: Object to form.
`
` A A My argument goes back to, not
`
` A A
`just experience, okay, but also education. When
`you go to school and when you get a Ph.D. in
`pharmacy, you learn about all the forms. What
`you are practicing today may be a different form
`of dosage form, yes, but you already have
`experience in all dosage forms.
`
` Q Q You said from school, correct?
`
` Q Q
`
` A A Correct.
`
` A A
`
` Q Q So they learned about other
`
` Q Q
`dosage forms, correct?
`
` A A Correct.
`
` A A
`
` Q Q But they don't have extensive
`
` Q Q
`experience in formulating those dosage forms?
`
` A A That may or may not be the case.
`
` A A
`A POSA may be involved into multiple dosage
`forms, but in this case I focused only on the
`experience in doing liquids.
`
` Q Q Let me ask you this: In the
`
` Q Q
`statement that we looked at on Page 4, Line 24,
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
` DR. SARFARAZ NIAZI
`hypothetically speaking, let's just say if a
`POSA has no experience in tablet formulations,
`they would not focus on the tablet formulation
`there, would they?
` MS. SUTTER: Object to form.
`
` A A If a POSA is making a liquid
`
` A A
`formulation, there is no need for him or her to
`look at any other dosage form.
`
` Q Q But my question is: If the POSA
`
` Q Q
`had no experience in making tablet formulations,
`in WO 094, they wouldn't even know how to make a
`tablet, correct?
`
` A A Not true.
`
` A A
` MS. SUTTER: Object to form.
`
` A A They would know how to make a
`
` A A
`tablet, but they would know this is totally
`irrelevant. If I'm making a solution -- if the
`POSA is making a solution, he would have no need
`to look at any tablet formulation of any value.
`He or she may know, and they all do, how to make
`a tablet.
` MS. SUTTER: Objection to the
` form.
`
` Q Q You agree that a syrup is a
`
` Q Q
`
`Page 21
`
` DR. SARFARAZ NIAZI
`liquid formulation, correct?
`
` A A Say again?
`
` A A
`
` Q Q You agree that a syrup is a
`
` Q Q
`liquid formulation, correct? Yes?
` MS. SUTTER: You have to answer
` verbally.
` MR. MALIK: And a little bit
` louder.
`
` Q Q And based on Paragraph 22 --
`
` Q Q
`well, Paragraphs 20 through 23, the POSA would
`certainly know how to make a syrup, correct?
` MS. SUTTER: Object to form.
`
` A A Yes. Yes.
`
` A A
`
` Q Q Let's go to the '094 patent.
`
` Q Q
`Let's look at Page 4, Line 33. Let me know when
`you are there.
`
` A A Okay.
`
` A A
`
` Q Q It says: As an example of a
`
` Q Q
`composition in accord with the present
`invention, the following formulation of a syrup
`is preferred: Levocetirizine dihydrochloride,
`methyl and propylparaben, saccharin and purified
`water.
` Do you see that?
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Apotex (IPR2019-00400) Ex. 1043 p. 006
`
`

`

`7 (Pages 22 to 25)
`
`Dr. Sarfaraz Niazi - December 6, 2019
`
`Page 22
`
`Page 24
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
` DR. SARFARAZ NIAZI
`
` A A Yes.
`
` A A
`
` Q Q So the formulation in WO 094 that
`
` Q Q
`I just read has both Methyl and Propylparaben,
`correct?
`
` A A Yes, in a syrup form.
`
` A A
`
` Q Q A syrup form. And saccharinium,
`
` Q Q
`that's sugar, correct?
`
` A A Correct.
`
` A A
`
` Q Q And syrup formulations contain
`
` Q Q
`water, correct?
`
` A A Yes.
`
` A A
`
` Q Q In Paragraph 47 of your
`
` Q Q
`declaration. Paragraph 47. Let me know when
`you've read it.
`
` A A Okay.
`
` A A
`
` Q Q At the very end it says: Thus,
`
` Q Q
`when working with liquid and particularly
`aqueous products, a POSA expects that the
`formulation will be exposed to substantial
`amounts of bacteria.
` Do you see that sentence?
`
` A A Yes.
`
` A A
`
` Q Q What do you mean by that?
`
` Q Q
`
` A A During use by a patient, there is
`
` A A
`
`Page 23
`
` DR. SARFARAZ NIAZI
`inevitable exposure to many microorganisms;
`therefore, I conclude it will be exposed to
`bacteria also.
`
` Q Q And so turn to Paragraph 55 of
`
` Q Q
`your declaration. Let me know when you're
`there.
` I take it you read
`Paragraph 55?
`
` A A Yes.
`
` A A
`
` Q Q Paragraph 55, you say: In
`
` Q Q
`preparing the formulation, a POSA would play it
`safe and include preservatives.
` Do you see that?
`
` A A Yes. But before I answer the
`
` A A
`question, there's also a -- a clarification.
`
` Q Q Sure.
`
` Q Q
`
` A A Within the bounds of what the FDA
`
` A A
`and other agencies consider acceptable.
`
` Q Q Instead of seeking to eliminate
`
` Q Q
`preservatives, correct?
`
` A A That's correct.
`
` A A
`
` Q Q Let's unpack that statement.
`
` Q Q
`What did you mean by within the bounds of what
`the FDA and other regulatory agencies consider
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
` DR. SARFARAZ NIAZI
`acceptable?
`
` A A Regulatory agencies are all,
`
` A A
`number one is to assure safety. Number two,
`safety. Number three is safety. In a product
`such as an aqueous solution, in a product that
`is aqueous the solution and subject to exposure
`during the use, where the risks are higher, the
`agencies require that you make the product safe
`in all conditions of use, and as a result, they
`require certain testing of the product to make
`sure that the product is capable of staying safe
`during the course of manufacture and during the
`course of use.
` And these recommendations are
`available from agencies, and these
`recommendations are followed by every POSA to
`make sure the product is safe. And that's
`what I meant by here looking at regulatory
`agencies consider acceptable.
`
` Q Q And in preparing the formulation,
`
` Q Q
`the POSA would play it safe and include
`preservatives instead of seeking to eliminate
`preservatives; is that fair?
` MS. SUTTER: Objection to form.
`
`Page 25
`
` DR. SARFARAZ NIAZI
`
` A A We cannot make a blanket
`
` A A
`statement. I POSA will consider what -- a
`formulation is an extremely complex exercise.
`You can look at it and say all you have is just
`a water and a drug and a couple other
`ingredients, that's not true. There's no way to
`predict how when you combine so many things,
`okay, there may be situations where if I'm using
`a product which already has -- if it's an
`antibiotic, okay, I may have different need for
`it, maybe no need for a preservative.
`
` Q Q I guess what I'm asking is when
`
` Q Q
`you said: In preparing a formulation, a POSA
`would play it safe and include preservatives,
`what do you mean by that?
`
` A A Very good. A POSA would play it
`
` A A
`safe means if a POSA considers that this product
`is subject to contamination, then it will play
`safe I mean it will provide the means to make
`sure the product does not turn unsafe during the
`course of the use. Play safe means very simply,
`when you know the risks, you mitigate the risks.
`
` Q Q By including preservatives, is
`
` Q Q
`that what you mean?
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Apotex (IPR2019-00400) Ex. 1043 p. 007
`
`

`

`8 (Pages 26 to 29)
`
`Dr. Sarfaraz Niazi - December 6, 2019
`
`Page 26
`
`Page 28
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
` DR. SARFARAZ NIAZI
`
` A A That would be one of the many
`
` A A
`things that a POSA might do. It will, again, I
`will repeat myself. A formulation is an
`extremely complex exercise, even though it m