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`Case 1:15-cv-01159-GMS-SRF Document 146 Filed 10/27/17 Page 1 of 241 PageID #: 2497
`
`IN THE UNITED STATES DISTRICT COURT.
`IN AND FOR THE DISTRICT OF DELAWARE
`- - -
`
`))
`
`))
`
`)
`- - -
`
`)C.A. No. 15-1159 (GMS)(SRF)
`)
`)CONSOLIDATED
`)
`
`ALCON RESEARCH, LTD.,
`Plaintiff,
`
`v.
`WATSON LABORATORIES, INC.,
`Defendant.
`
`ALCON RESEARCH, LTD.,
`Plaintiff,
`
`v.
`LUPIN LTD. and LUPIN
`PHARMACEUTICALS, INC.,
`Defendants.
`
`))
`
`))
`
`))
`
`)
`
`))
`
`)
`- - -
`Wilmington, Delaware
`Tuesday, October 3, 2017
`9:00 a.m.
`Bench Trial - Day 2
`- - -
`BEFORE: HONORABLE GREGORY M. SLEET, Senior Judge, U.S.
`District Court of DE
`
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`Novartis AG Exhibit 2006
`Ayla Pharma LLC v. Novartis AG
`IPR2020-00295
`
`
`Case 1:15-cv-01159-GMS-SRF Document 146 Filed 10/27/17 Page 1 of 241 PageID #: 2497
`
`IN THE UNITED STATES DISTRICT COURT.
`IN AND FOR THE DISTRICT OF DELAWARE
`- - -
`
`))
`
`))
`
`)
`- - -
`
`)C.A. No. 15-1159 (GMS)(SRF)
`)
`)CONSOLIDATED
`)
`
`ALCON RESEARCH, LTD.,
`Plaintiff,
`
`v.
`WATSON LABORATORIES, INC.,
`Defendant.
`
`ALCON RESEARCH, LTD.,
`Plaintiff,
`
`v.
`LUPIN LTD. and LUPIN
`PHARMACEUTICALS, INC.,
`Defendants.
`
`))
`
`))
`
`))
`
`)
`
`))
`
`)
`- - -
`Wilmington, Delaware
`Tuesday, October 3, 2017
`9:00 a.m.
`Bench Trial - Day 2
`- - -
`BEFORE: HONORABLE GREGORY M. SLEET, Senior Judge, U.S.
`District Court of DE
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`Novartis AG Exhibit 2006
`Ayla Pharma LLC v. Novartis AG
`IPR2020-00295
`
`
`
`249
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`APPEARANCES:
`MARYELLEN NOREIKA, ESQ.
`Morris Nichols Arsht & Tunnell LLP
`-and-
`CHRISTOPHER J. MANDERNACH, ESQ., and
`ADAM PERLMAN, ESQ.,
`JOELLE JUSTUS, ESQ., and
`CHRISTOPHER SUAREZ, ESQ.
`Williams & Connolly LLP
`(Washington, DC)
`Counsel for Plaintiff
`Alcon Research, Ltd.
`MELANIE K. SHARP, ESQ., and
`ROBERT VRANA, ESQ.
`Young Conaway Stargatt & Taylor LLP
`-and-
`MARK D. SCHUMAN, ESQ.,
`TODD S. WERNER, ESQ.,
`JENELL C. BILEK, ESQ.,
`SHELLEAHA JONAS, ESQ., and
`CAROLINE R. MARSILI, ESQ.
`Carlson Caspers
`(Minneapolis, MN)
`
`Counsel for Defendant
`Watson Laboratories, Inc.
`DOMINICK GATTUSO, ESQ.
`Heyman Enerio Gattuso & Hirzel LLP
`-and-
`IMRON T. ALY, ESQ.,
`JOHN K. HSU, ESQ., and
`CHRISTINE WILSON FELLER, ESQ.
`Schiff Hardin
`(Chicago, IL and New York, NY)
`Counsel for Lupin Limited and
`Lupin Pharmaceuticals, Inc.
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`Ayla Pharma LLC v. Novartis AG
`IPR2020-00295
`
`
`
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`THE COURT: Good morning. Please, take your
`
`seats.
`
`MR. SCHUMAN: Good morning, Your Honor.
`THE COURT: Mr. Schuman.
`MR. SCHUMAN: We have a short statement to read
`into the record with your indulgence, please.
`THE COURT: Go ahead.
`MR. SCHUMAN: I have some written notes. I am
`going to try to get it right. My esteemed colleague will
`correct me if I get it wrong.
`Alcon sued Watson and Lupin on the '053 patent
`and Alcon has chosen not to assert the '053 patent against
`Watson and Lupin at trial in this case.
`The parties are working on language for a filing
`or stipulation to remove the '053 patent formally from the
`case.
`
`Alcon will not seek a final judgment against
`Watson or Lupin on the '053 patent in the case.
`Likewise, based on this representation by Alcon,
`Watson and Lupin will not seek final judgment on their
`declaratory judgment counterclaims on the '053 patent in
`this case.
`
`Thank you, Your Honor.
`THE COURT: Do we have a witness?
`MR. SCHUMAN: We do. Yesterday we told you
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`09:03:44
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`Novartis AG Exhibit 2006
`Ayla Pharma LLC v. Novartis AG
`IPR2020-00295
`
`
`
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`about the video depositions. We worked over the night. We
`have good news for you.
`We did eliminate the one witness we said we
`would do by video. We have one left. And it turns out that
`what's left of that testimony, as we started winnowing it
`down, is really related to the rebuttal case. We think it
`makes more sense to the put that video in context with the
`rebuttal evidence.
`We are going to jump right into the last live
`witness in our case-in-chief, who will be Dr. Maurin. So
`with your permission we will go right to Dr. Maurin.
`Thank you.
`THE COURT: That's good.
`MS. BILEK: Good morning, Your Honor. My name
`is Jennell Bilek. I represent Watson.
`Your Honor, may it please the Court, defendants
`call Dr. Michael Maurin. Dr. Maurin is an expert formulator
`who will testify about the obviousness of the asserted
`claims from the perspective of a formulator.
`THE COURT: Mr. Buckson will get those from you.
`... MICHAEL B. MAURIN, having been duly sworn as
`a witness, was examined and testified as follows ...
`THE COURT: Good morning, Doctor.
`THE WITNESS: Good morning.
`MS. BILEK: Your Honor, may I approach?
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`09:05:41
`
`Novartis AG Exhibit 2006
`Ayla Pharma LLC v. Novartis AG
`IPR2020-00295
`
`
`
`252
`Case 1:15-cv-01159-GMS-SRF Document 146 Filed 10/27/17 Page 5 of 241 PageID #: 2501
`Maurin - direct
`THE COURT: You may.
`DIRECT EXAMINATION
`
`BY MS. BILEK:
`Good morning, Dr. Maurin.
`Q.
`Good morning.
`A.
`Would you please state your full name for the record?
`Q.
`Michael B. Maurin.
`A.
`Where do you live?
`Q.
`I live in Florida but I spend the summers in Delaware.
`A.
`Did you have slides prepared to assist the Court with
`Q.
`your testimony today?
`Yes, I did.
`A.
`If we could turn to the Slide DDX-202, please.
`Q.
`Briefly, what claims are you here to testify about today?
`That Claims 8, 9, and 21 through 24 of the '154 patent
`A.
`would have been obvious to a person of ordinary skill in the
`art as of October 2011.
`Thank you. Let's talk about your background a little
`Q.
`bit, then we will get back into your opinions in more
`detail.
`
`If you could please turn to the document in your
`binder JTX-49.
`What are we looking at here?
`That's my CV.
`If we could turn to DDX-203, please. Dr. Maurin, what
`
`A.
`Q.
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`09:07:19
`
`Novartis AG Exhibit 2006
`Ayla Pharma LLC v. Novartis AG
`IPR2020-00295
`
`
`
`253
`Case 1:15-cv-01159-GMS-SRF Document 146 Filed 10/27/17 Page 6 of 241 PageID #: 2502
`Maurin - direct
`is your educational background?
`I have a Bachelor of Science degree in pharmacy from
`A.
`the University of Pittsburgh in 1983 and a Ph.D. degree with
`a focus in pharmaceutical sciences from the University of
`Kentucky in 1988.
`You have pharmacy degree. Did you ever work as a
`Q.
`pharmacist?
`Yes, I did.
`A.
`Are you currently a registered pharmacist?
`Q.
`Yes, I am.
`A.
`You said you received a Ph.D. in pharmaceutical
`Q.
`sciences. What is pharmaceutical sciences?
`The focus of my Ph.D. in pharmaceutical sciences
`A.
`related to the characterization of the physical and chemical
`properties of drugs and excipients and polymers and how they
`influence the design of dosage forms.
`Generally describe the work you did while you were
`Q.
`pursuing your Ph.D.?
`The first project that I did while pursuing my Ph.D.
`A.
`degree involved development of a formulation for the
`administration of 5-fluoro-uracil to the eye. The
`5-fluoro-uracil in that application was being used to treat
`a type of glaucoma, it was being applied to the surface of
`the eye.
`Moving to the next area of the slide. I see you spent
`Q.
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`09:08:32
`
`Novartis AG Exhibit 2006
`Ayla Pharma LLC v. Novartis AG
`IPR2020-00295
`
`
`
`254
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`Maurin - direct
`many years at DuPont and QS Pharma. How long were you at
`DuPont and QS Pharma?
`Approximately 20 years.
`A.
`When did you start at DuPont?
`Q.
`I originally started in 1982 as a summer intern. Upon
`A.
`completion of my Ph.D. degree, I joined as a full-time
`employee until 1988.
`What were your responsibilities while working at
`Q.
`DuPont?
`My responsibilities were in relationship to
`A.
`characterizing the physical and chemical properties of the
`drugs that were being discovered at DuPont, and developing
`them into dosage forms.
`Ultimately, the group that I was responsible for
`had responsibilities for all the drugs we were developing,
`it didn't matter what they were for, and all types of dosage
`forms. It didn't matter what the dosage form, either, was.
`We had responsibilities from discovery through the
`completion of the pivotal clinical trials.
`Were you involved in the development of any of
`Q.
`solution formulations?
`Yes.
`A.
`What kind of solution formulations?
`Q.
`Solutions for oral administrations, solutions for
`A.
`injection, solutions for administration to the eye and to
`
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`09:09:35
`
`09:09:38
`
`Novartis AG Exhibit 2006
`Ayla Pharma LLC v. Novartis AG
`IPR2020-00295
`
`
`
`255
`Case 1:15-cv-01159-GMS-SRF Document 146 Filed 10/27/17 Page 8 of 241 PageID #: 2504
`Maurin - direct
`
`the nose.
`In your time at DuPont did you work on any eye
`Q.
`formulations?
`Yes.
`A.
`Approximately how many?
`Q.
`There were several.
`A.
`Looking further down on Slide 203, you moved to QS
`Q.
`Pharma in 2002. What is QS Pharma?
`QS Pharma is a contract research organization that I
`A.
`founded in 2002. QS Pharma characterizes physical and
`chemical properties of drugs, develops formulations up
`through clinical on to commercialization, and all the
`associated analytical testing.
`At QS Pharma I did, for the most part, the same
`sort of things that I did when I was at DuPont. But we were
`working on drugs that belonged to other people.
`Did any of your work at QS Pharma involve solution
`Q.
`formulations?
`Yes.
`A.
`In your time at QS Pharma did you work on any eye
`Q.
`products?
`Yes. There were two.
`A.
`What kind of eye products?
`Q.
`One was a product that involved solubilizing the drug
`A.
`for injection into the eye. So it was injected back in the
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`
`Novartis AG Exhibit 2006
`Ayla Pharma LLC v. Novartis AG
`IPR2020-00295
`
`
`
`256
`Case 1:15-cv-01159-GMS-SRF Document 146 Filed 10/27/17 Page 9 of 241 PageID #: 2505
`Maurin - direct
`vitreous portion of the eye.
`The other one involved an aqueous solution
`dosage form that was applied to the surface of the eye.
`About how many drugs did you work on during your time
`Q.
`at DuPont and QS Pharma?
`Thousands.
`A.
`About what percent of your time was spent with liquid
`Q.
`dosage forms?
`About half.
`A.
`Out of the thousands approximately, what percent of
`Q.
`your time was spent with the development of eye
`formulations?
`About five to ten percent.
`A.
`Are you a named inventor on any patents?
`Q.
`Yes, I am.
`A.
`How many?
`Q.
`Five.
`A.
`Do you have any academic appointments?
`Q.
`Yes. I hold an adjunct faculty position at the
`A.
`University of Maryland in the School of Pharmacy.
`MS. BILEK: Your Honor, defendants offer Dr.
`Maurin as an expert in the design and development of drug
`formulations?
`MR. PERLMAN: No objection.
`THE COURT: The Doctor is accepted as an expert
`
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`09:11:45
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`09:11:47
`
`Novartis AG Exhibit 2006
`Ayla Pharma LLC v. Novartis AG
`IPR2020-00295
`
`
`
`257
`Case 1:15-cv-01159-GMS-SRF Document 146 Filed 10/27/17 Page 10 of 241 PageID #: 2506
`Maurin - direct
`in the design and development of drug formulations.
`MS. BILEK: Thank you, Your Honor.
`BY MS. BILEK:
`Doctor, were you given a legal standard to apply in
`Q.
`interpreting whether the asserted claims were obvious?
`Yes, I was.
`A.
`Please turn to DDX-204. What legal standard did you
`Q.
`apply?
`I applied four factors. The scope and content of the
`A.
`prior art. The level of ordinary skill in the art. The
`difference between the claimed invention and the prior art.
`And any secondary considerations of nonobviousness.
`Now, how did you take into account the perspective of
`Q.
`this ordinarily skilled person when considering the asserted
`claims of the patent in suit were obvious?
`I sort of envisioned myself back in time at or before
`A.
`October 2011, with the education and experience and training
`I had, as well as information that was available in the
`literature.
`Can you please turn to DDX-205. What level of
`Q.
`ordinary skill in the art do you believe qualifies someone
`as a person of ordinary skill in the art?
`That individual would have a Pharm D, or a Ph.D. in
`A.
`pharmaceutics, chemistry, or pharmacology.
`In addition, they would have three years of
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`09:13:06
`
`Novartis AG Exhibit 2006
`Ayla Pharma LLC v. Novartis AG
`IPR2020-00295
`
`
`
`258
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`postdoctoral or practical experience developing drug
`formulations, including ophthalmic formulations.
`Alternatively, the individual could have a B.S.
`or M.S. in those fields with four-plus years of such
`experience.
`Is Alcon's definition the same as what you proposed?
`Q.
`No, it's different.
`A.
`How does it differ?
`Q.
`The definition, the Alcon definition includes a
`A.
`clinician.
`Does this difference affect your opinion that the
`Q.
`asserted claims are obvious?
`No, it does not.
`A.
`Turning back to DDX-202, please. Before discussing
`Q.
`the prior art to the patents in suit, what date did you use
`to determine whether a reference was prior art?
`October 2011.
`A.
`If you could briefly describe for the Court the
`Q.
`subject matter of the patent in suit?
`The patent in suit involves olopatadine, an aqueous
`A.
`solution, to treat allergic conjunctivitis at a
`concentration of .67 to 1 percent. In addition, it contains
`other excipients at specified ranges and some other
`properties and formulations well, like pH and osmolality.
`Are you aware of the Court's claim construction
`Q.
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`opinion or Markman decision?
`Yes, I am.
`A.
`Mr. Haw, can we please put up DDX-256 at Page 2.
`Q.
`Did you take into account the preamble of each
`asserted claim of the patent in suit for purposes of
`rendering your opinion?
`Yes, I did.
`A.
`What is olopatadine?
`Q.
`Olopatadine is an antiallergy drug.
`A.
`Was olopatadine known in the United States prior to
`Q.
`October 2010 or '11?
`Yes.
`A.
`Was olopatadine commercially available as an eye
`Q.
`formulation in the United States prior to October 2011?
`Yes.
`A.
`What were the concentrations of olopatadine of the
`Q.
`commercially available eye formulations?
`0.1 percent and 0.2 percent.
`A.
`What was the dosage form of the commercially available
`Q.
`eye formulations of olopatadine?
`The dosage form was an aqueous solution.
`A.
`Were you here when Dr. Modi testified yesterday?
`Q.
`Yes, I was.
`A.
`Dr. Modi testified about dose selection and
`Q.
`specifically she suggested concentrations of 0.7 to 1
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`percent olopatadine. Do you recall that testimony?
`Yes, I do.
`A.
`What type of dosage forms for the eye were available
`Q.
`by 2011?
`By 2011 there were solutions, suspensions, gels,
`A.
`ointments, some others as well.
`Based on your work in the field, what dosage form
`Q.
`would a person of ordinary skill in the art have selected in
`early 2011 when tasked with developing an olopatadine eye
`formulation at a concentration of around 0.7 to 1 percent?
`A solution.
`A.
`Why?
`Q.
`Well, solutions were the most common ophthalmic
`A.
`formulations for direct topical administration to the eye.
`The marketed products, Patanol and Pataday, were
`aqueous solutions. And in addition, I think it's important
`to keep in mind that the eye the drug was being used to
`treat is irritated, it's inflamed, and there is a chance,
`for example, that the particles, if you chose to use a
`suspension, the particles of the suspension could irritate
`the eye or, alternatively, if you were to use a gel, the gel
`is kind of is a gooey texture and would feel uncomfortable
`in the eye.
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`I think a solution would avoid the pitfalls of
`the other types of those forms.
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`What is the first thing a person of ordinary skill in
`Q.
`the art would investigate about olopatadine before starting
`to formulate a 0.7 to 1 percent eye solution?
`Certainly, a person of ordinary skill in the art would
`A.
`want to look at the structure, evaluate its properties, and
`look to the literature for any available information.
`What pH would a person of ordinary skill in the art
`Q.
`have preferred for an eye solution in 2010?
`I think the preferred pH would be at or around 7.
`A.
`Why is that?
`Q.
`That's the pH of the fluid in and around the eye. If
`A.
`you go far from that, you have a chance of irritating the
`eye.
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`As I have said, that eye is already irritated
`and inflamed. So you would want to do -- you would want to
`take steps to try and mitigate chances for further
`irritation to the eye.
`Were these properties of olopatadine known by 2011?
`Q.
`Yes.
`A.
`And what specific properties are you thinking of?
`Q.
`I am thinking there is a patent by Singh.
`A.
`That discusses properties?
`Q.
`It discusses the structural properties and the
`A.
`solubility behavior in water, yes.
`Why don't we turn to JTX-51. Is this the same Singh
`Q.
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`
`you just mentioned?
`Yes, it is.
`A.
`What is the title?
`Q.
`The title is Olopatadine Formulations For Topical
`A.
`Nasal Administration.
`When was it published?
`Q.
`2007.
`A.
`Who is the assignee?
`Q.
`Alcon.
`A.
`The first inventor there, Singh, who is Onkar Singh?
`Q.
`Onkar Singh is or was Alcon employee and is a named
`A.
`inventor on the patent in suit.
`What does Singh report about the solubility of
`Q.
`olopatadine?
`I think that's described in part on what is Page No. 3
`A.
`in Figure 1B.
`What is described there?
`Q.
`What is depicted here is the solubility of olopatadine
`A.
`on a percentage basis as a function of pH.
`What did the prior art teach about the pH of
`Q.
`olopatadine in solutions?
`The pH of olopatadine at a neutral pH, the solubility
`A.
`is just a little below 0.2 percent.
`Did you create a slide about what the prior art talked
`Q.
`about the pH of olopatadine in solutions?
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`
`Yes.
`A.
`Why don't we turn to DDX-206. There is a number of
`Q.
`references here. Would you please state them for the
`record?
`The references are JTX-64, JTX-65, JTX-70, JTX-54, and
`A.
`JTX-56.
`What is the approximate pH identified in each of these
`Q.
`references?
`The pH is approximately a range, or it's a range,
`A.
`centered around 7.
`Do all of these references involve olopatadine?
`Q.
`Yes, they do.
`A.
`You mentioned what was already reported in the prior
`Q.
`art as the solubility of olopatadine at neutral pH I believe
`as a little below of 0.2?
`Correct. I think about 0.18.
`A.
`What type of molecule is olopatadine at a pH of around
`Q.
`7?
`At a pH of around 7 olopatadine exists as what is
`A.
`called a zwitterion.
`What does that mean?
`Q.
`A zwitterion means that it contains both a positive
`A.
`and a negative charge. So while the olopatadine molecule
`itself at pH 7 technically has an overall charge of neutral,
`it is actually quite highly charged, containing both that
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`Ayla Pharma LLC v. Novartis AG
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`positive and negative charge.
`How does that affect if at all developing a
`Q.
`formulation with olopatadine?
`Well, that's part of the reason why olopatadine's
`A.
`solubility is the lowest at around pH 7 because that's where
`it exists as its zwitterion. And it also instructs one that
`when you are looking at ways to solubilize olopatadine, you
`want to look at uncharged excipients to avoid any
`interactions between -- potential interactions between the
`charge of the excipients and the charges in olopatadine.
`What would a person of ordinary skill in the art's
`Q.
`likelihood of success have been in developing an olopatadine
`eye formulation above its water solubility limit?
`I believe it would be quite high.
`A.
`How would a person of ordinary skill in the art know
`Q.
`what you could make -- that you could make an olopatadine
`eye solution in a concentration above its water solubility
`limit?
`Well, that's what formulators do. I mean, you are
`A.
`really not looking to increase the solubility all that much.
`It is .18. You want to get to .7. That is less than a
`fourfold increase. There is information in the literature
`about solubilizing drugs and increasing the solubility
`hundreds to thousands of times their water solubility.
`So it's what people like I do and did.
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`Ayla Pharma LLC v. Novartis AG
`IPR2020-00295
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`What was the upper limit concentration of olopatadine
`Q.
`in solution disclosed in the prior art?
`The upper limit disclosed was 5 percent.
`A.
`Do you recall any references in particular that taught
`Q.
`olopatadine in concentrations of 5 percent?
`Yes. There is a reference, a patent by Hayakawa.
`A.
`Please return to JTX-55, please.
`Q.
`This is Hayakawa?
`Yes, it is.
`A.
`Is this one of the documents you relied on in forming
`Q.
`your opinions in this matter?
`Yes.
`A.
`How is Hayakawa relevant to your obviousness opinion?
`Q.
`Hayakawa describes olopatadine at concentrations of up
`A.
`to 5 percent and describes them as aqueous solutions.
`How do you know that Hayakawa discloses aqueous
`Q.
`solutions of olopatadine up to 5 percent?
`It's described in the patent, I think around Column 6.
`A.
`Why don't we go to Page 4 of JTX-55, please.
`Q.
`Lines 40 through 49.
`What would a person of ordinary skill in the art
`understand about the dosage form and concentration of
`olopatadine based on what is discussed in this paragraph?
`The dosage form is an aqueous solution, and the
`A.
`concentration of olopatadine can be up to 5 percent.
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`Novartis AG Exhibit 2006
`Ayla Pharma LLC v. Novartis AG
`IPR2020-00295
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`The Compound A, by the way, in this refers to
`
`olopatadine.
`Why does this paragraph, how does that help you
`Q.
`understand that these are aqueous solutions that are taught
`in Hayakawa?
`In the first sentence that starts around Line 40, it
`A.
`describes how Compound A and an isotonic agent are added to
`water and if required other ingredients are added to the
`solution and dissolved therein.
`So they are being placed in a solution and all
`the all the residuals are being dissolved. So it is an
`aqueous solution.
`THE COURT: Counsel, do you have another copy of
`JTX-55? I don't have it in my binder.
`THE WITNESS: I don't have it, either.
`MS. BILEK: It could be in Dr. Modi's binder.
`THE COURT: Okay. He wouldn't have that.
`MS. BILEK: I apologize.
`THE COURT: I don't have Dr. Modi's binder.
`MR. PERLMAN: I don't, either.
`MS. BILEK: Your Honor, may I approach? I have
`one copy here.
`THE COURT: At least your witness should have
`
`it.
`
`MS. BILEK: Okay.
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`Ayla Pharma LLC v. Novartis AG
`IPR2020-00295
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`THE COURT: If you can find another, opposing
`counsel should have it.
`MR. PERLMAN: Your Honor, I may find it in my
`stuff. You take the extra copy.
`THE COURT: Sometimes my law clerks and I like
`to mark things up. Sometimes it is helpful for the Court to
`have them. That's okay.
`THE WITNESS: I can probably do it by screen.
`It might be a little slower.
`THE COURT: That's okay.
`What column and line were we?
`BY MS. BILEK:
`Dr. Maurin, where are we?
`Q.
`Column 6, starting on Line 40 is the part.
`A.
`MS. BILEK: Your Honor, that is Lines 40 through
`
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`49.
`
`THE COURT: I am with you.
`BY MS. BILEK:
`Dr. Maurin, just describe what was happening with the
`Q.
`solution and its being dissolved therein, at the first
`sentence, is there anything else in this paragraph that
`would suggest that Hayakawa is talking about solutions?
`Yes. I guess it's the third sentence that starts on
`A.
`Line 46, slightly left of the center, that says, "After
`dissolution, the pH is adjusted," and it goes on to talk
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`Novartis AG Exhibit 2006
`Ayla Pharma LLC v. Novartis AG
`IPR2020-00295
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`about that some more. But after dissolution means that's
`after everything was dissolved.
`So it's a solution, and olopatadine as well as
`all the other ingredients are all dissolved in that
`solution.
`Just for the record, that paragraph is discussing the
`Q.
`concentration range of what in olopatadine?
`The concentration range goes from as low as 0.001 to 5
`A.
`weight/volume percent.
`What does weight/volume percent mean?
`Q.
`Weight/volume percent is a common way of expressing
`A.
`percentage. It refers to grams of the solute, what is being
`dissolved in a resultant volume of a hundred milliliters.
`For example an approximate 5 percent weight/volume solution
`of olopatadine would mean that there are 5 grams of
`olopatadine dissolved into a final volume of a hundred
`milliliters.
`What would a person of ordinary skill in the art
`Q.
`conclude about the concentration range of olopatadine to use
`for an eye solution?
`That you could make concentrations as high as 5
`A.
`percent in an aqueous solution.
`Were there other olopatadine specific references that
`Q.
`taught up to 5 percent olopatadine solutions?
`Yes.
`A.
`
`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
`
`09:27:03
`
`09:27:06
`
`09:27:07
`
`09:27:10
`
`09:27:13
`
`09:27:15
`
`09:27:21
`
`09:27:24
`
`09:27:31
`
`09:27:31
`
`09:27:34
`
`09:27:39
`
`09:27:46
`
`09:27:49
`
`09:27:52
`
`09:27:54
`
`09:28:00
`
`09:28:00
`
`09:28:03
`
`09:28:05
`
`09:28:07
`
`09:28:11
`
`09:28:13
`
`09:28:17
`
`09:28:20
`
`Novartis AG Exhibit 2006
`Ayla Pharma LLC v. Novartis AG
`IPR2020-00295
`
`
`
`269
`Case 1:15-cv-01159-GMS-SRF Document 146 Filed 10/27/17 Page 22 of 241 PageID #: 2518
`Maurin - direct
`If you could turn to JTX-56, please.
`MS. BILEK: Your Honor, do you have JTX-56?
`THE COURT: I do: Most importantly, I think
`probably the witness has it as well.
`BY MS. BILEK:
`I am hoping if one of you has it, everyone has it.
`Q.
`Do you recognize this?
`Yes, can I do.
`A.
`What is it?
`Q.
`It's U.S. Patent 6,375,973, from 2002, entitled
`A.
`Ophthalmic Antiallergy Compositions Suitable For Use With
`Contact Lenses. The inventor is Yanni. And the assignee is
`Alcon.
`Is it okay if I refer to JTX-56 as Yanni 2002?
`Q.
`Yes.
`A.
`What is the maximum concentration for olopatadine
`Q.
`taught by Yanni 2002?
`Yanni teaches a concentration up to as high as 5
`A.
`percent.
`What would a person of ordinary skill in the art
`Q.
`understand from Yanni 2002 about the dosage form to use with
`concentrations of olopatadine up to 5 percent?
`That Yanni is referring to a solution.
`A.
`Now, could it be other dosage forms?
`Q.
`Sure, it could be.
`A.
`
`10
`11
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`13
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`16
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`18
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`20
`21
`22
`23
`24
`25
`
`Q.
`
`1 2 3 4 5 6 7 8 9
`
`09:28:20
`
`09:28:27
`
`09:28:29
`
`09:28:33
`
`09:28:35
`
`09:28:35
`
`09:28:42
`
`09:28:44
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`09:28:44
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`09:28:46
`
`09:28:54
`
`09:28:58
`
`09:29:02
`
`09:29:02
`
`09:29:07
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`09:29:09
`
`09:29:12
`
`09:29:16
`
`09:29:21
`
`09:29:21
`
`09:29:25
`
`09:29:29
`
`09:29:32
`
`09:29:35
`
`09:29:40
`
`Novartis AG Exhibit 2006
`Ayla Pharma LLC v. Novartis AG
`IPR2020-00295
`
`
`
`270
`Case 1:15-cv-01159-GMS-SRF Document 146 Filed 10/27/17 Page 23 of 241 PageID #: 2519
`Maurin - direct
`Why do you say solution?
`Q.
`Well, because earlier in the patent, on Column 1,
`A.
`line, I guess it's about 27 or 28, he refers back to the
`patent, 5,641,805, that is what we were referring to as the
`Hayakawa patent
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