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`Argentum Pharmaceuticals LLC v. Cipla Ltd.
`
`Robert P. Schleimer
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`Page 1
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` ARGENTUM PHARMACEUTICALS LLC
` Petitioner
` v.
` CIPLA LTD.
` Patent Owner
` Patent No. 8,168,620
` IPR2017-00807
`
` Deposition of ROBERT P. SCHLEIMER, PH.D., at
` the offices of Foley & Lardner, 321 North
` Clark Street, Chicago, Illinois, before
` Donna M. Kazaitis, IL-CSR, RPR, and CRR,
` commencing at the hour of 10:00 a.m. on
` Friday, October 20, 2017
`
`____________________________________________________
` DIGITAL EVIDENCE GROUP
` 1730 M Street, NW, Suite 812
` Washington, D.C. 20036
` (202) 232-0646
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2017
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`202-232-0646
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`CIP2158
`Argentum Pharmaceuticals v. Cipla Ltd.
`IPR2017-00807
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`10/20/2017
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`Argentum Pharmaceuticals LLC v. Cipla Ltd.
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`Robert P. Schleimer
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`Page 2
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`APPEARANCES:
`ON BEHALF OF THE PETITIONER:
` FOLEY & LARDNER LLP
` BY: MICHAEL R. HOUSTON, PH.D., ESQ.
` 321 North Clark Street
` Suite 2800
` Chicago, Illinois 60654-5313
` 312.832.4378
` mhouston@foley.com
`
`ON BEHALF OF THE PATENT OWNER:
` STERNE KESSLER GOLDSTEIN FOX
` BY: DENNIES VARUGHESE, PHARM.D., ESQ.
` DEBORAH STERLING, PH.D., ESQ.
` JOSHUA I. MILLER, ESQ.
` 1100 New York Avenue, NW
` Washington, DC 20005
` 202.371.2600
` dvarughe@skgf.com
` dsterlin@skgf.com
` jmiller@skgf.com
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`Argentum Pharmaceuticals LLC v. Cipla Ltd.
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`Page 3
`
` INDEX
` PAGE
`ROBERT P. SCHLEIMER, PH.D.
` Examination by Mr. Varughese 4, 111
` Examination by Mr. Houston 108
`
` EXHIBITS
` PAGE
`Exhibit CIP2018 12/13/16 trial transcript 5
`Exhibit CIP2019 12/14/16 trial transcript 7
`Exhibit CIP2025 9/29/16 depo transcript 8
`Exhibit CIP2145 U.S. Patent 6,599,914 B2 38
`Exhibit CIP2146 U.S. Utility 9/841,506 40
`Exhibit 1003 Declaration of Robert P. 23
` Schleimer, Ph.D.
` (IPR2007-00807)
`Exhibit 1007 U.S. Patent 5,164,194 52
` (IPR2007-00807)
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`(Witness sworn.)
` ROBERT P. SCHLEIMER, PH.D.,
`having been first duly sworn, was examined and
`testified as follows:
` EXAMINATION
`BY MR. VARUGHESE:
` Q. Good morning, Dr. Schleimer.
` A. Good morning, Mr. Varughese.
` Q. Just for the record, my name is
`Dennies Varughese from the law firm of Sterne
`Kessler on behalf of patent owner here in this
`proceeding Cipla. With me today is backup counsel
`of record Deborah Sterling. And also joining us
`is Joshua Miller, an associate at our firm.
` Dr. Schleimer, we have met before.
` A. We have.
` Q. We've been in another proceeding,
`which we'll get to.
` Given our familiarity, I'm not
`going to go over some of the preliminaries. I
`assume that you're familiar with the deposition
`and what we're here to do today, just the typical
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`rules.
` One of them is I'm going to use
`plain English words. I'm going to presume that
`you understand the meaning of the words that I use
`in my questions unless you tell me otherwise; is
`that fair?
` A. That's fair.
` Q. Okay. Are you on any medication or do
`you suffer from any ailment that would preclude
`you from testifying truthfully and accurately
`today?
` A. No.
` Q. So, Dr. Schleimer, I am going to hand
`you what has been previously marked in this
`proceeding as CIP 2018. (Document tendered to the
`witness.)
` A. Okay.
` Q. Please take a moment to orient
`yourself to that document.
` A. Okay.
` Q. Do you recognize this document?
` A. Well, I recognize the front page. It
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`Page 6
`appears to be from the court case in Wilmington,
`Delaware that was last December.
` Q. And just for identification purposes,
`I think that court case that you're referring to
`is Meda Pharmaceuticals and Cipla Ltd., vs. Apotex
`Inc. and Apotex Corp., Case Number 14-1453-LPS.
` A. Yes.
` Q. And this is a trial between Meda and
`Apotex involving, among other things, the '620
`Patent that is at issue in this IPR proceeding;
`correct?
` A. Correct.
` Q. If you flip through that document, and
`take as much time as you need, would you recognize
`this document as your trial testimony from that
`trial?
` MR. HOUSTON: Objection, form.
` THE WITNESS: Well, it may have my
`testimony in it, but it appears to have many other
`testimonies.
`BY MR. VARUGHESE:
` Q. If I can direct you to Page 141.
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` A. Okay.
` Q. Do you recognize that as beginning
`your testimony?
` A. It appears to be when Mr. Klein said
`"Good afternoon, Dr. Schleimer."
` Q. Yes. And then flipping through this,
`do you have any reason to believe that this is not
`a transcript of your testimony from that trial,
`recognizing that it also contains other material,
`as you've alluded to?
` A. Well, yeah, my brief inspection
`suggests that it is a transcript.
` Q. Okay. And when you testified in that
`trial, you testified under oath; correct?
` A. I did.
` Q. Dr. Schleimer, I'm going to hand you
`what's been previously marked as CIP2019 in this
`IPR proceeding. (Document tendered to the
`witness.)
` A. Okay.
` Q. Take a moment to orient yourself to
`that document, please.
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` A. Okay. I've looked at the front page.
` Q. Do you recognize this document?
` A. It looks very similar to the one you
`just handed me.
` Q. Okay. The one I just handed you being
`the trial transcripts from the December trial mean
`Meda and Apotex; correct?
` A. Yes.
` Q. And then would you agree that this
`document, CIP2019, is the remainder of your
`testimony from that trial proceeding?
` A. That would be a reasonable assumption
`on my part. It starts on Page 157 and this one
`ends at 156, yes.
` Q. And the testimony that you gave that's
`reflected in this second half of the transcript
`was still under oath; correct?
` A. That's correct.
` Q. Dr. Schleimer, I'm going to hand you
`what's been previously marked as CIP2025 in this
`IPR proceeding. (Document tendered to the
`witness.)
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` A. Okay.
` Q. Take a moment to orient yourself to
`the document, please.
` A. These are heavy. I didn't know I was
`going to get exercise.
` Q. Killed a lot of trees.
` A. Yes.
` Q. Can you identify this document?
` A. Well, on the front page it says it's a
`transcript from the videotaped deposition of me at
`Winston & Strawn.
` Q. And who is Winston & Strawn?
` A. Those are the attorneys that were
`representing Apotex.
` Q. And they were representing you for
`purposes of that deposition? Is that fair to say?
` A. I guess technically. You tell me.
`I'm not a lawyer.
` Q. Sure. So let's take a step back.
` Looking at this document, does it
`appear to be the transcript of your testimony from
`a deposition that took place on September 29,
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`2016?
` A. Yes.
` Q. And that deposition was conducted in
`connection with Meda Pharmaceuticals and Cipla
`Ltd., versus Apotex Inc.; correct?
` A. Yes.
` Q. And this deposition would have been
`related to the testimony that you ultimately gave
`at trial in that case; correct?
` A. Yes.
` Q. And that testimony were the two
`previous exhibits that we just discussed.
` A. Yes.
` Q. And Winston & Strawn, they were the
`law firms that attended that deposition?
` A. That's correct.
` Q. And they worked with you to prepare
`for that deposition?
` A. Yes.
` Q. And they were there representing you
`in the sense that they lodged objections or maybe
`other comments during that deposition on your
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`behalf?
` A. If that's an appropriate use of the
`word "represented," I would say yes.
` Q. Okay.
` A. I viewed them as representing Apotex
`and bringing me in as an expert witness.
` Q. Understood. You can set that aside
`for now.
` So, Dr. Schleimer, where are you
`currently employed?
` A. At Northwestern University.
` Q. And your title there?
` A. I'm a professor of medicine, professor
`of microbiology immunology, professor of
`otolaryngology, head and neck surgery, and the
`chief of the allergy and immunology division.
` Q. So can you briefly summarize for us
`your post high school education and training?
` A. Post high school. Well, I went to
`University of California, San Diego, and majored
`in biology. After that I attended the University
`of California, Davis, where I received a Ph.D.
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`And then I was a post-doctoral fellow at Johns
`Hopkins University, joined the faculty, and stayed
`there for a total of 25 years.
` Then in 2004 Northwestern offered
`me the job as the chief of allergy and immunology,
`and I left Johns Hopkins.
` Q. So at no time did you earn a medical
`degree or an M.D. degree, if I can call it that?
` A. That's correct.
` Q. So you're not a medical doctor or a
`physician.
` A. I am not.
` Q. So you cannot prescribe medications
`for patients?
` A. That's correct.
` Q. Have you ever been involved in drug
`formulation work?
` A. I'm certainly familiar with
`formulation. I've done a limited amount of it for
`humans. I've done more in mouse studies,
`formulating vaccines or drugs to treat the
`animals, as well as other species of animals
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`during my training as a Ph.D. student. But I
`would say I'm not an expert in formulation even
`though I understand the principles of it.
` Q. And in the work that you did where you
`say you were involved in formulating, did your
`activities include selecting excipients and
`actually developing prototypes in a laboratory
`setting?
` A. It wasn't terribly involved, but the
`excipients would have included saline and a buffer
`and things like that in which we suspended an
`experimental drug.
` Q. And you mentioned experimental drug.
`Did the drug that you worked on ever make it to
`market?
` A. No.
` Q. Now, focusing on nasal spray products.
`In your opinion was it important for drugs in a
`nasal spray product to be evenly distributed in
`the medium?
` MR. HOUSTON: Objection, form.
` THE WITNESS: I'm not sure what you
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`mean by "evenly distributed."
`BY MR. VARUGHESE:
` Q. So when I use the phrase "evenly
`distributed" in the drug product, you don't know
`what I'm referring to?
` A. I don't. It could have various
`interpretations.
` Q. Give me one interpretation.
` A. Well, in the case of a suspension, the
`drug might be a particulate or it might be in
`droplets of oil and they could settle or they
`could rise to the top. So some formulations have
`to be shaken, for example, in order to distribute
`the drug. And it's still not completely evenly
`distributed. So I'm not sure what you mean by
`that question.
` Q. So you mentioned there could be
`sedimentation -- I'm paraphrasing -- is that fair?
`You said sometimes the suspension could settle at
`the bottom, the drug? Is that what you said
`earlier?
` A. Some intranasal preparations need to
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`be shaken before administered so that it
`distributes the drug throughout the volume of the
`preparation so that when it's sprayed, the small
`amount sprayed, has a representative amount of
`drug of the totality that's in the canister.
` Q. So when you say shaken so that it
`distributes the drug throughout the volume of the
`preparation, how in your view is that different
`than evenly distributed?
` A. Well, it's still unevenly distributed
`if it's a suspension. Wherever there's a
`particle, there's very high amounts of drug, and
`wherever there's not a particle there's very low
`amounts of drug. But the particles can be evenly
`distributed such that in, let's say
`100 microliters, the number of particles will be
`roughly the same from spray to spray.
` Q. That's helpful. Thank you.
` So when you shake a drug product
`that is a suspension, the particles themselves
`will be evenly distributed, whereas the drug would
`be concentrated around the location of the
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`particles themselves?
` A. This is a theoretical discussion, but
`yes, what you said can occur in some situations.
` Q. Okay. So let's focus on the drug
`fluticasone. Are you familiar with fluticasone?
` A. Yes.
` Q. Do you understand that that's one of
`the drugs that are at issue for purposes of this
`patent which we'll get into?
` A. Yes.
` Q. Do you have just a general
`understanding of what fluticasone is in terms of
`its class?
` A. I do. It's an anti-inflammatory
`steroid, sometimes called glucocorticosteriod or
`corticosteroid.
` Q. And you understand that fluticasone is
`practically insoluble in water?
` A. Yes.
` Q. And do you know that this means that
`fluticasone can't be used in a solution?
` A. That question is actually not clear.
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`It can be used in a solution of acetone no
`problem, it'll dissolve in acetone.
` Q. So can fluticasone dissolved in
`acetone be administered to patients?
` A. No.
` Q. Why not?
` A. Well, you wouldn't administer acetone
`to patients. So your question was can it be
`dissolved, and my answer is it depends on the
`solvent.
` But let me say that I have not
`represented myself as a formulator, and I have not
`testified in any detail about formulations. So I
`mean I'm happy to answer your questions, but I'm
`not presenting myself as an expert in the
`formulation components of this litigation.
` Q. I appreciate that. I guess just to
`maybe close the loop here. Setting aside acetone,
`do you know if fluticasone can be formulated in a
`water solution?
` MR. HOUSTON: Objection, beyond the
`scope.
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` THE WITNESS: By "formulated" you mean
`in a pharmaceutically acceptable way?
`BY MR. VARUGHESE:
` Q. Yes.
` A. Yes. It's used in, it's one of the
`most popular drugs in our field and it's used in
`Flonase in a formulation.
` Q. Will fluticasone go into solution in
`water?
` A. A small amount will, but a majority of
`it will stay out of solution.
` Q. So you're here testifying today,
`Dr. Schleimer, on behalf of a company called
`Argentum; is that correct?
` A. Yes.
` Q. When were you first contacted by
`Argentum or its counsel to work on this matter?
` A. The first two weeks in January of this
`year I believe.
` Q. Who contacted you?
` A. I don't recall his name. I never met
`him in person. I'm sorry. I could find out, but
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`I don't recall his name.
` Q. Where would you need to look to find
`out?
` A. I would have to go to my office and
`look at my email.
` Q. Was it Michael R. Houston, Mr. Houston
`who's here present today representing you in this
`deposition?
` A. No.
` Q. Was it Joseph P. Mira?
` A. I don't believe it was either of them.
` Q. Was it someone named James P.
`McFarland?
` A. I don't think so.
` Q. Was it Tyler C. Liu of Argentum
`Pharmaceuticals?
` A. I spoke with him early on. He was one
`of the -- I mean I spoke with more than one of
`them. I was on vacation and they were calling me.
`He was one of the early ones, but I'm not sure he
`was the first one to call. I'm sorry.
` Q. That's okay, that's okay.
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` When you say one of the early ones,
`do you mean in that first two weeks in January
`timeframe?
` A. Yeah. When I said I spoke with more
`than one of them, he was one of the two or three
`people that I spoke with in that timeframe,
`January, February.
` Q. Had you ever spoken with Mr. Tyler Liu
`before that conversation in January of 2017, just
`to be precise?
` A. No, not to my knowledge.
` Q. Do you recall seeing him at the Apotex
`trial, which is the trial that we discussed
`earlier today?
` A. I don't specifically recall that. I
`know that there were some people at that trial
`from other companies that had an interest. I
`don't know which side they were interested in.
` I know it's a little like a
`wedding. There was a couple of them sitting on
`the Apotex side. But I didn't have lengthy
`conversations with them. And I don't recall that
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`Tyler Liu was there.
` Q. That trial certainly made me think of
`a wedding too.
` A. Yeah.
` Q. Were you ever contacted by Mr. Jeffrey
`Gardner?
` A. Can you tell me who he is? Is he with
`Argentum also?
` Q. So I don't want to testify on your
`behalf. My understanding --
` A. I don't recall the name. I may have,
`you know. These brief interactions my brain is
`programmed to forget quickly, unless there's a
`reason to remember.
` Q. Argentum in this proceeding is being
`represented by the law firm Foley & Lardner;
`correct?
` A. Yes.
` Q. And Mr. Houston is an attorney from
`the Foley & Lardner firm.
` A. That's correct.
` Q. Do you recall when you first started
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`working with the Foley law firm in connection with
`this proceeding?
` A. It's fuzzy in my mind. I know that
`the declaration was a collaboration that involved
`a number of people on the attorney side.
` As I said, we didn't have
`face-to-face meetings, so I was dealing with, you
`know, the electronic world, sending me documents
`and we were sending them back and forth.
` So I can't tell you what month. In
`fact, I can't even recall the date of the
`declaration. It's probably on the declaration.
`It was sometime that spring.
` Q. Okay. Do you have a written agreement
`setting forth your engagement with Argentum for
`this proceeding?
` A. I'm not sure. I don't think I do, but
`I may.
` Q. Have you served as a testifying
`witness for other companies in your career?
` A. On a few occasions, yes.
` Q. Is it your practice to have a written
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`engagement with those companies?
` A. I think I have had one on occasion.
`I've not done a lot of this, but I think there may
`have been one once.
` Q. What would we need to do to confirm
`whether you have a written engagement with
`Argentum in this case or not?
` A. Again, I'd need to go to my office and
`look. If I had one, it would be at my work office
`and my secretary would have a copy of it.
` Q. Okay. Do you recall executing a
`written engagement with the Foley & Lardner law
`firm in connection with this proceeding?
` A. I do not. Again, that doesn't mean
`there isn't one, but I do not recall having one.
` Q. Dr. Schleimer, I'm going to hand you
`what's been marked as Exhibit 1003 in this IPR
`proceeding. (Document tendered to the witness.)
` A. Thank you.
` Q. Can you identify this document?
` A. Yeah, on the face of it it's my
`declaration in this litigation.
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` Q. Let's turn to Page 57 of this
`document.
` A. Okay.
` Q. Is that your signature on the bottom?
` A. Yes, it is.
` Q. And it was signed February 2, 2017?
` A. Yes.
` Q. So in flipping through this, does this
`appear to be a fair and accurate copy of the
`declaration that was submitted in this case?
` A. Looks to be.
` Q. Okay. Can we turn to Paragraph 62 of
`your declaration is. Do you mind just reading
`Paragraph 62 into the record?
` A. "Azelastine was the most effective
`antihistamine on the market. As stated earlier,
`intranasal antihistamines were known to be better
`than oral antihistamines, since they were safer
`and had additional anti-inflammatory effects not
`shared by oral antihistamines. Most importantly,
`intranasal antihistamines do not have the systemic
`side effects that often result from utilizing oral
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`antihistamines."
` Q. So in reading that paragraph, and I'm
`going to paraphrase this for simplicity sake but
`please correct me if I'm saying anything
`incorrect, it was your opinion that at the time of
`invention here, the '620 Patent, that a POSA would
`have viewed intranasal antihistamines as preferred
`over oral antihistamines; is that correct?
` A. No, no, I would not say that. I said
`here that it's better, it's more effective. But
`there are issues of patient choice that play a
`huge role in all drugs but in antihistamines as
`well.
` A lot of patients don't like to use
`nasal sprays. They don't like the feel of it.
`They don't want to do it in public. It makes them
`uncomfortable some other way. And even though
`intranasal drugs may be the most effective, they
`may prefer to take an oral antihistamine.
` Also, the oral antihistamines have
`actions that can be beneficial outside of the
`nose. Many of these patients have what's called
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`the allergic diathesis. They can have dermatitis,
`they can have itching in the ears or the eyes, and
`some of those patients will prefer to take an
`oral, nonsedating antihistamine because it not
`only helps them with their nasal symptoms but can
`also help them with the itching in their skin or
`their ears or their eyes.
` So this statement has to do with
`the signs and symptoms of allergic rhinitis.
` Q. What statement are you talking about?
` A. That azelastine was the most
`effective.
` So the flipside of that coin is
`that by using them topically and locally, they
`have many fewer systemic side effects than the
`oral antihistamines.
` So each patient and each physician
`weighs the benefits of the different forms of
`taking these different drugs and decides for
`themselves.
` Q. So depending on the context, some
`physicians and patients would prefer oral
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`antihistamines, whereas in other contexts some
`physicians and patients would prefer nasal
`antihistamines. Is that fair to say?
` A. Yeah, I think it's not uncommon for
`the decision to also be made on the basis of the
`severity of the illness.
` So if somebody comes into a
`doctor's office and they have very mild symptoms,
`a little sneezing and itchiness of the nose, maybe
`a little running of the nose but nothing too
`bothersome, the doctor may give them an oral
`antihistamine that's nonsedating but with
`reasonable expectation that the symptoms would
`improve greatly. And, as I said, many patients
`like to take oral medicines. They can do it
`easily. There's no bother with an intranasal
`preparation.
` Q. So let's go to the 2001, 2002
`timeframe.
` A. Okay.
` Q. You know what a POSA is, P-O-S-A --
` A. Yes.
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` Q. -- in the context of this case?
` A. Person of skill in the art.
` Q. Person of skill in the art.
` And the declaration that you
`submitted, both in this IPR and your expert report
`testimony in the Apotex litigation, you were
`offering opinions from the perspective of a POSA?
` A. Yes.
` Q. So if I were to ask you to go back to
`the 2001, 2002 timeframe, would a POSA have a
`preference as to intranasal antihistamines versus
`oral antihistamine?
` A. You mean as a scientist? As a person
`who either treats patients or develops drugs for
`allergy or both, would they have a preference?
` Q. Let's talk about someone who treats
`patients.
` A. Sure. I mean that's why we pay our
`doctors to help us with our decisions of what
`drugs to take. Different doctors have different
`preferences. But yeah, doctors each have their
`own paradigm, their own regimen for treating
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`patients.
` But then, as is true now,
`antihistamines represented fully two thirds of the
`total market for allergic rhinitis. So they were
`a major weapon in the armamentarium of all
`doctors, be they internists or allergists, who
`were treating allergic rhinitis. Some of those
`would be POSAs by my definition and others would
`not.
` So there are plenty of treating
`physicians that are not persons of skill in the
`art, as I have defined it. And there are plenty
`of treating physicians who are as long as they
`have also a scientific background and have spent a
`few years studying drug development or formulation
`or that sort of thing.
` Q. So -- and I apologize if you answered
`this part of the question there -- but let's talk
`about the POSA, as you've defined it --
` A. Yes.
` Q. -- based on your definition. And if
`it's helpful for you, we can go back to your
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`declaration and see what that is if you'd like to.
` A. Sure. Do you have a paragraph?
` Q. So take a look at your declaration and
`I'll reask that question.
` A. Paragraph 12?
` Q. I think it's Paragraphs 11 and 12 I
`think you've identified them.
` So now that you've had a chance to
`review your definition of a POSA, I'd like to ask
`that same question. A POSA, based on your
`definition in the 2001, 2002 timeframe, did that
`POSA have a preference as to oral versus
`intranasal antihistamines?
` MR. HOUSTON: Objection, form.
` THE WITNESS: I thought I answered
`that.
` Well, "preference" is a very
`subjective word. As a patient, they may, if
`they're a patient. As a physician, they may, if
`they're a physician. As a scienti