465
`
`CIVIL ACTION
`
`NO. 14-1453-LPS
`
`::
`
`::
`
`IN THE UNITED STATES DISTRICT COURT
`IN AND FOR THE DISTRICT OF DELAWARE
`- - -
`:
`:
`:
`
`MEDA PHARMACEUTICALS, INC.,
`and CIPLA LTD.,
`Plaintiffs,
`
`v.
`APOTEX INC. and APOTEX CORP.,
`Defendants.
`
`- - -
`Wilmington, Delaware
`Friday, December 16, 2016
`Bench Trial - Volume D
`- - -
`HONORABLE LEONARD A. STARK, Chief Judge
`- - -
`
`BEFORE:
`APPEARANCES:
`
`RICHARDS LAYTON & FINGER, P.A.
`BY: FREDERICK L. COTTRELL, III, ESQ., and
`SELENA E. MOLINA, ESQ.
`and
`STERNE KESSLER GOLDSTEIN & FOX, LLP
`BY: UMA N. EVERETT, ESQ.,
`DENNIES VARUGHESE, ESQ.,
`RAMI BARDENSTEIN, ESQ.,
`ADAM C. LaROCK, ESQ.,
`JOSHUA I. MILLER, ESQ.,
`JOSEPHINE J. KIM, ESQ.,
`STEPHANIE NGUYEN, ESQ., and
`MARK FOX EVENS, ESQ.
`(Washington, District of Columbia)
`Counsel for Plaintiffs
`
`Kevin Maurer
`Official Court Reporter
`
`Brian P. Gaffigan
`Official Court Reporter
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`1
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`CIP2021
`Argentum Pharmaceuticals LLC v. Cipla Ltd.
`IPR2017-00807
`
`
`
`CIVIL ACTION
`
`NO. 14-1453-LPS
`
`::
`
`::
`
`IN THE UNITED STATES DISTRICT COURT
`IN AND FOR THE DISTRICT OF DELAWARE
`- - -
`:
`:
`:
`
`MEDA PHARMACEUTICALS, INC.,
`and CIPLA LTD.,
`Plaintiffs,
`
`v.
`APOTEX INC. and APOTEX CORP.,
`Defendants.
`
`- - -
`Wilmington, Delaware
`Friday, December 16, 2016
`Bench Trial - Volume D
`- - -
`HONORABLE LEONARD A. STARK, Chief Judge
`- - -
`
`BEFORE:
`APPEARANCES:
`
`RICHARDS LAYTON & FINGER, P.A.
`BY: FREDERICK L. COTTRELL, III, ESQ., and
`SELENA E. MOLINA, ESQ.
`and
`STERNE KESSLER GOLDSTEIN & FOX, LLP
`BY: UMA N. EVERETT, ESQ.,
`DENNIES VARUGHESE, ESQ.,
`RAMI BARDENSTEIN, ESQ.,
`ADAM C. LaROCK, ESQ.,
`JOSHUA I. MILLER, ESQ.,
`JOSEPHINE J. KIM, ESQ.,
`STEPHANIE NGUYEN, ESQ., and
`MARK FOX EVENS, ESQ.
`(Washington, District of Columbia)
`Counsel for Plaintiffs
`
`Kevin Maurer
`Official Court Reporter
`
`Brian P. Gaffigan
`Official Court Reporter
`
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`1
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`CIP2021
`Argentum Pharmaceuticals LLC v. Cipla Ltd.
`IPR2017-00807
`
`
`
`APPEARANCES: (Continued)
`
`466
`
`PROCTOR HEYMAN ENERIO, LLP
`BY: DOMINICK GATTUSO, ESQ.
`and
`WINSTON & STRAWN, LLP
`BY:
`GEORGE C. LOMBARDI, ESQ.,
`SAMUEL S. PARK, ESQ.,
`KEVIN E. WARNER, ESQ., and
`RYAN B. HAUER, ESQ.
`(Chicago, Illinois)
`and
`WINSTON & STRAWN, LLP
`BY: CHARLES B. KLEIN, ESQ., and
`ILAN WURMAN, ESQ.
`(Washington, District of Columbia)
`Counsel on behalf of Defendants
`
`- oOo -
`P R O C E E D I N G S
`(REPORTER'S NOTE: The following bench trial
`hearing was held in open court, beginning at 8:30 a.m.)
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`467
`
`Kaliner - direct
`THE COURT: Good morning.
`(The attorneys respond, "good morning.")
`THE COURT: It's nice to say good morning
`instead of good evening. So is there any issue before we
`get Dr. Kaliner back on the stand, Mr. Varughese?
`MR. VARUGHESE: No, Your Honor.
`THE COURT: Mr. Klein?
`MR. KLEIN: No, Your Honor.
`THE COURT: Okay. All right. Doctor, why don't
`you come forward please.
`... MICHAEL KALINER, having been previously
`sworn as a witness, was examined and testified as follows ...
`THE WITNESS: Good morning, sir.
`THE COURT: Good morning, I hope you are well
`this morning.
`THE WITNESS: Thank you.
`THE COURT: I remind you that you remain under
`
`oath.
`
`THE WITNESS: Thank you.
`THE COURT: You may proceed.
`MR. VARUGHESE: Thank you, Your Honor.
`DIRECT EXAMINATION
`
`BY MR. VARUGHESE:
`Q.
`Good morning, Dr. Kaliner.
`A.
`Good morning.
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`Kaliner - direct
`Do you have your pointer there with you?
`Q.
`I do.
`A.
`When we left off last night, I believe we were
`Q.
`looking at the ARIA guidelines. Do you recall that?
`A.
`I don't recall the slide, though.
`Q.
`I think we have a demonstrative up which is the ARIA
`guidelines?
`A.
`Yes.
`Q.
`Okay. Can we go to the box on the bottom right,
`please?
`Okay. Here.
`A.
`So you are familiar with the ARIA guidelines?
`Q.
`I am.
`A.
`You testified earlier that you followed them?
`Q.
`I do. Well, I followed the Dykewicz guidelines and
`A.
`some the ARIA guidelines.
`Q.
`Thank you for that clarification. Here, the section
`we highlighted, it says the management of allergic rhinitis.
`Do you see that?
`A.
`Yes.
`Q.
`It starts with pharmacological management of
`rhinitis?
`A.
`Yes.
`Q.
`Now, in your experience and practice, are you aware
`of any nonpharmacologic management techniques for rhinitis?
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`Kaliner - direct
`
`469
`
`Yes, I am.
`A.
`And can you describe for the Court some of them?
`Q.
`Well, I think Dr. Wedner does the same thing. I use
`A.
`nasal saline washes. I use it with nearly every patient.
`And so the saline washes can be a large volume wash with
`something like a NeilMed sinus rinse, which is eight ounces,
`or just simply saline sprays. You can buy them all over the
`counter in any drugstore in the country. And the patients
`find that just wash, putting in a couple of sprays in their
`nostrils washes the nose, and remarkably it has a dramatic
`effect on the congestion and secretions, so a lot of
`patients just do saline sprays. We start them on medicine
`and saline sprays and end up using just saline spray. So
`it's an extremely effective, completely benign way to treat
`patients.
`Q.
`Now, does that benefit from the saline substance
`itself or is it the fluid?
`A.
`It's the fluid. It's just the washing. Saline is
`tolerable to patients, it feels good, but you can use any
`liquid that didn't hurt the patient and you get the same
`result, I think.
`Q.
`Okay. Now, looking back at the ARIA guidelines, do
`you recall Dr. Schleimer's testimony from a few days ago
`where he suggested that the ARIA guidelines would have
`motivated a person of ordinary skill in the art to combine
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`470
`
`Kaliner - direct
`azelastine and fluticasone into a fixed dose formulation?
`A.
`I do. Yes.
`Q.
`And do you agree with his position on that?
`A.
`Well, no. Not based on the guidelines.
`Q.
`Can you explain for the Court why you disagree?
`A.
`Well, I think the guidelines are a stepwise, the
`guidelines are recommending a stepwise procedure with adding
`medications until you get relief, and then stepping down
`from medications once relief is achieved, and so the
`guidelines in no way suggest a fixed dose combination.
`Q.
`And do you think Dr. Accetta's records, from what we
`can tell, do you think he follows the guidelines?
`A.
`Well, Dr. Accetta is, and I said this already, and I,
`have been using Astelin and nasal steroids in relationship
`to each other in a very variable way. In no way were they a
`fixed dose combination.
`Q.
`Okay. Thank you. Let's go back to the PDX-2.
`Now, Dr. Kaliner, earlier you testified in your
`summary that you thought that Dymista, Duonase and some of
`these other products in India were related to the patents.
`Do you recall that?
`A.
`I do.
`Q.
`Can you explain to the Court why that is your belief?
`A.
`Well, I showed on this slide, Dymista, which is the
`American patent, expression of the patent; Duonase, which is
`
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`
`Kaliner - direct
`the Indian expression of the patent, and then there is all
`these other medicines; there are six listed here, I
`understand there are as many as 11, are all Indian copycats
`and the Indian system is very different.
`So each of these products is a nasal spray. And
`they contain azelastine and fluticasone and in every
`manifestation they are the same concentration, and they are
`all used for the treatment of seasonal allergic rhinitis and
`I think that is the expression of the patent.
`Q.
`In compiling this information, you relied on PTX-24,
`which is a Dymista package insert?
`A.
`Yes.
`Q.
`PTX-134, Duonase package insert?
`A.
`Yes.
`Q.
`And PTX-26, which are the imitator product labels?
`A.
`Yes.
`Q.
`You also mentioned in your earlier testimony that in
`your view, as of 2002, there was a need for a better
`treatment of allergic rhinitis. Do you recall that?
`A.
`I do.
`Q.
`In your opinion, does Dymista meet that need?
`A.
`Yes.
`Q.
`Can you explain to the Court why you believe that?
`A.
`Well, Dymista, I mentioned yesterday that Ratner was
`a proof of concept study. And it showed that conceivably
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`472
`
`Kaliner - direct
`the combination of the products would work well together.
`Now, Dymista is in a patent, this is where you
`actually formulated the azelastine and fluticasone into the
`same bottle so they got the same spray. So let me take you
`through this slide.
`This is a very busy slide, Your Honor, I am
`sorry, I am going to take you through this step by step. It
`covers a lot of information and it is a very important way
`for all the points about Dymista.
`So first of all, the way this experiment is
`done, sorry about the jargon, they took patients with
`allergic rhinitis and they had to have moderately severe
`disease. The way they had that -- this is a standard FDA
`requirement, this is for every patient, every drug approved
`for allergic rhinitis today goes through the same procedure.
`Patients are asked to grade their symptoms,
`sneezing, itching, runny nose and congestion.
`Four symptoms.
`The severity can be zero, no symptoms, 1, 2, and
`3. 3 is quite incapacitating, so the patients grade
`themselves 0, 1, 2, 3. There are four symptoms and the
`scale is zero to 3, so the maximum number you could have is
`12 in a 12-hour period.
`In order to get in the study, patients had to
`have at least eight. So they had to be two-thirds as severe
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`473
`
`Kaliner - direct
`as they could have been. And they had to have at least 2 on
`a 3-point scale for congestion. So they had to have
`moderate disease to get into the study at all.
`Then the study involved giving either a placebo
`spray, one spray Flonase, one spray Astelin, or one spray
`Dymista, one spray, each of them twice a day. And over a
`two-week period patients were grading their symptom score on
`the same zero, 1, 2, 3 scale.
`What this shows is the onset of effect. So it
`has a 15 to 30 minute -- actually, this is of statistical
`significance, that occurs in that time frame. So I already
`mentioned that the Astelin package insert showed that the
`product worked within three hours.
`I know there has been some discussion about
`rapid onset of effect with Astelin or azelastine depending
`on the models. But this is the first time the company had
`actually confirmed that that data -- that the onset of
`effect was in 30 minutes.
`And the FDA allowed them to put it in the
`package insert. So this is real data, approved by the FDA,
`and kind of irrefutable.
`From the package insert, Flonase has an effect
`within 12 hours to several days.
`So that's the onset.
`Great onset.
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`Kaliner - direct
`The middle data shows the improvement in symptom
`scores. So each of these numbers here is an improvement in
`symptom score. To be in the study patients had to have
`eight or more, and you can see that they had an improvement
`of five points, symptom score points. That's with Dymista.
`That is a huge improvement relative to anything else that's
`ever been shown in the American market.
`So Flonase was minus 3.8. Astelin was minus
`3.25. And the combination was minus 5.31. That number is
`statistically significant compared to Astelin and is
`statistically significant compared to Flonase.
`So it fulfills the FDA's combination rule that
`each component part has to contribute to the efficacy.
`This is really phenomenal data. This is
`phenomenal data. You don't get data like this very often.
`The relative potency of Dymista compared to
`placebo, the increment, comparing Dymista's improvement to
`placebo, is the largest increment of any product that has
`ever been marketed in the United States. This is the
`strongest medicine, the most effective medicine that has
`ever been marketed in the U.S.A. There is nothing that
`competes with this.
`Q.
`Just to clarify, for allergic rhinitis?
`A.
`For allergic rhinitis, I am sorry. Everything I am
`saying is for allergic rhinitis.
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`
`Kaliner - direct
`As you look at this data, there is nothing ever
`done, approved by the FDA, that competes with this product
`for efficacy.
`So then, you know, I have already shown you,
`combining azelastine and fluticasone in the Ratner study led
`to increased side effects. Dymista, amazingly, has
`decreased side effects with the reformulation.
`What they have done is -- I am not a
`formulations expert. I am not going to really get into the
`formulation.
`
`Whatever magic they did, in making this product,
`they reduced the dysgeusia from 19.7 to 4 percent, the
`headache two percent. The somnolence is gone. So they have
`less than one percent somnolence.
`So the holy grail of medication is rapid onset,
`more rapid onset, better efficacy and fewer side effects.
`And lo and behold, Dymista fulfills the holy grail.
`This is really an incredible medication. And,
`yes, you asked me the question of does this fill an unmet
`need in the treatment of allergic rhinitis. This is the
`best we have ever had.
`I think others agree with me that this is the
`standard of care for treatment of allergic rhinitis in the
`United States after 2012.
`Q.
`By others, you mean other clinicians and
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`Kaliner - direct
`practitioners treating allergic rhinitis?
`A.
`Yes. I think the practice -- well, yes, other
`people, including the people who have reviewed the
`literature and the data for this product.
`Q.
`Can we go to DDX-4.23.
`Dr. Kaliner, do you recall Dr. Schleimer during
`his testimony discussing the Berger study from 1999?
`A.
`I do.
`Q.
`What was your understanding of Dr. Schleimer's
`opinions regarding Berger?
`A.
`I think, as I heard -- this is my memory from a few
`days ago. I think that Dr. Schleimer said that this data --
`this article suggested that azelastine should be used in
`combination with an intranasal spray.
`Q.
`Do you agree?
`A.
`No, that's not what the article was. What Berger
`did, it's a funny study, but what Berger did was he looked
`at Astelin, azelastine, and compared to it a nasal steroid
`and an oral antihistamine. And he showed that Astelin was
`not as good as the nasal steroid and the oral antihistamine.
`And his conclusions were, the whole conclusion
`reads, "Azelastine nasal spray can be used either in place
`of the oral antihistamines, in combination with an
`intranasal corticosteroids, or, as demonstrated in these
`studies, as an alternative to the combination therapy of an
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`
`Kaliner - direct
`oral antihistamine and a nasal steroid.
`That is what the article looked at, was the
`azelastine compared to the oral antihistamine and the nasal
`steroid with azelastine was as good and could be
`substituted.
`
`But this article did not look at the conjunctive
`use of azelastine and the nasal steroid.
`So I think that emphasizing parts of that
`sentence is a little misleading.
`Q.
`Can we turn to DDX-4.4, please.
`Again, during Dr. Schleimer's testimony, do you
`recall him referring to the Spector article from 1999?
`A.
`I do.
`Q.
`This is the demonstrative that he used. He said,
`Spector really laid it out when Dr. Schleimer was describing
`the optimal treatment for patients.
`Do you recall that?
`
`I do.
`A.
`Do you agree with him?
`Q.
`No, I don't.
`A.
`What is your position?
`Q.
`So, again, just so you understand what Spector did
`A.
`was he looked at the literature, looked at nasal steroids
`and oral antihistamines and in fact never mentioned nasal
`antihistamines once in the article.
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`Kaliner - direct
`What he did was said the ideal product would
`have antihistamine activity and also anti-inflammatory
`activity, suggesting the ideal molecule would combine the
`best attributes of a nasal steroid and an oral
`antihistamine. In fact, that is what he says here.
`He says the ideal pharmacologic therapy would be
`a drug that possessed not only H1 receptor antagonist
`activity but also anti-inflammatory activity.
`So he was saying, make a better antihistamine
`that has anti-inflammatory activity. He never, ever said
`combining an antihistamine and a nasal steroid was the ideal
`way. He was saying make a better drug that has
`anti-inflammatory and H1 activity.
`That's not a bad idea. That's why it got
`published. But it's not the same thing as combining these
`two products.
`Q.
`Can we go back to the PTX, the last slide.
`Dr. Kaliner, you were discussing the Hampel
`study for the Court here?
`A.
`Yes.
`Q.
`The Hampel study, PTX-230?
`A.
`Yes.
`Q.
`Finally, based on the last hour or so of your
`testimony, and our discussion, is there anything as of 2002
`in your view to suggest that a fixed dose combination of
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`Kaliner - direct
`azelastine and fluticasone is where a POSA would have come?
`A.
`I think it's very clear. This is not just my opinion
`but the opinion of people who have looked at the literature,
`independently, at the time, and even after the time, that
`there was no information at 2002 that suggested in any
`scientifically established way that adding an oral
`antihistamine to a nasal corticosteroid would give you
`additional benefit and that at the time there was not a
`single study looking at nasal antihistamines combined with a
`nasal steroid, not a single published study that showed that
`combination.
`
`So my conclusion is that it is completely
`nonobvious that these products would be combined.
`MR. VARUGHESE: Your Honor, I would like to
`enter a few exhibits. Plaintiffs move to enter PTX-27, the
`Kaliner CV, PTX-1, the '620 patent, PTX-3, the '428 patent,
`PTX-20, the Demoly study, PTX-42, the Storms study, PTX-58,
`the article by Michael Blaiss, PTX-11, the Astelin label,
`PTX-103, the Optivar label, PTX-59, the Flonase label,
`PTX-98, the Data Monitor article from 2004, PTX-337, the
`Howarth article, PTX-36, the Nielsen 2001 article, PTX-53,
`the Akerlund article, PTX-330, the Ratner 2008 study,
`PTX-24, the Dymista label, PTX-134, the Duonase label, and
`PTX-230, which is the Hampel study.
`THE COURT: Any objection?
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`
`Kaliner - direct
`MR. KLEIN: No objection.
`THE COURT: Those are all admitted.
`(Above-referenced exhibits received in
`
`evidence.)
`
`MR. VARUGHESE: Thank you, Your Honor. One more
`item of housekeeping. I talked to the court reporter.
`There are a number of PDX's on Dr. Kaliner's demonstratives
`that overlap with defendants' DTX's. The court reporter
`indicated that it might be helpful if I on the record
`identify which ones they are.
`THE COURT: Sure.
`MR. VARUGHESE: He did caution me to go slow.
`THE COURT: Go slowly, please.
`MR. VARUGHESE: They are PTX-22 is DTX-246,
`Dykewicz. PTX-326 is DTX-81, ARIA. PTX-336 is DTX-40,
`Juniper. PTX-13 is DTX-248, Benincasa. PTX-39 is DTX-49,
`Simpson. PTX-333 is DTX-32, Drouin. PTX-332 is DTX-28,
`Brooks. PTX-331 is DTX-140, Ratner 1998. PTX-85 -- strike
`that one.
`
`PTX-21 is DTX-31, Di Lorenzo. PTX-12 is
`DTX-227, Barnes.
`That should be it.
`Thank you, Your Honor.
`THE COURT: Thank you very much.
`Cross-examine.
`
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`Your Honor.
`
`Kaliner - cross
`THE COURT: Cross-examination.
`MR. KLEIN: We have a binder for the witness,
`
`481
`
`THE COURT: Yes, you may.
`(Binders passed forward.)
`THE COURT: You may proceed when you are ready.
`MR. KLEIN: Thank you.
`CROSS-EXAMINATION
`
`BY MR. KLEIN:
`Q.
`Good morning, Dr. Kaliner.
`A.
`Good morning.
`Q.
`You and I haven't met; right?
`A.
`No, we haven't met.
`Q.
`Just as an introduction, my name is Chuck Klein and
`I'll ask you a few questions on behalf of Apotex.
`Just to be clear, you have a very close
`relationship with Meda, right?
`A.
`I have been a consultant with Meda for a long time.
`Q.
`So back in the early 2000s, you helped Meda improve
`its marketing for Astelin; is that right?
`A.
`I did.
`Q.
`And you also spent a long time helping Meda improve
`its marketing for Dymista; right?
`A.
`Yes, sir.
`Q.
`Okay. And since the early 2000s, Meda has paid you
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`482
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`Kaliner - cross
`to promote its products by serving on its Speakers Bureau;
`right?
`A.
`Q.
`A.
`Q.
`copy --
`A.
`
`That's correct.
`And Meda has paid you a lot of money over the years?
`I get paid for lecturing, yes.
`Let's go to DDX-7.01. Okay. And on the screen is a
`
`I'm sorry. I don't have it. Where is it?
`THE COURT: It is in his binder as well.
`MR. KLEIN: It's on the screen but you can look
`
`at it.
`All right.
`A.
`This is a snapshot from DTX-322. And this is a
`Q.
`propublica website, Dollars For Docs. I think we looked at
`something similar a couple days ago. And according to this
`document, you were paid $104,000 from the period August 2013
`to December 2015; is that right?
`A.
`That is what it says, yes. I haven't seen this
`number.
`Okay. And just to be clear, so this is payments
`Q.
`going from Meda to yourself during that period; right?
`A.
`Yes. And it would have been probably for lecturing
`and consulting, slide preparation, things like that.
`Q.
`In fact, you are the third top doctor receiving
`payments from Meda according to this document; right?
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`483
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`Kaliner - cross
`I'm kind of surprised I'm not the number one doctor.
`A.
`I could be. I can't see parts of it. I see the red box.
`Who is above me? I want to confront them with that.
`Q.
`Meda also paid you more than $80,000 in consulting a
`decade earlier for the period March 2003 to June 2004; does
`that sound right?
`A.
`You said $80? In one-year period?
`Q.
`Well, let's go to DDX-7.02.
`And this is a portion of the NDA for Astelin.
`It's DTX-316.27. So this is something that was submitted
`to the FDA reports. That for the period March 1st, 2003 to
`June 30th, 2004, you received roughly $80,000. Does that
`sound about right?
`A.
`It isn't that -- I have never seen these numbers
`before but it seems to me those are overlapping. And they
`are probably redundant numbers, the same time period and for
`the same services. So they're probably the same number.
`And I have to tell you that, you know --
`Q.
`Sir. Sir. Sir.
`A.
`-- $80 thousand a year is not bad.
`Q.
`Just answer my questions. This is cross-examination.
`A.
`The answer, I see the numbers.
`MR. VARUGHESE: Objection, Your Honor. I think
`Dr. Kaliner should be allowed to complete his answer.
`THE COURT: All right. Well, that objection is
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`484
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`Kaliner - cross
`overruled. We will move on.
`BY MR. KLEIN:
`Q.
`Now, so just to be clear, you think that $30 and the
`$50 are overlapping numbers?
`A.
`No, this number and the previous slide are probably
`the same numbers. I can't imagine I made more than $40,000
`a year from this company.
`Q.
`So you see the date is March 1st, 2003 to June 30th,
`2004?
`Oh, no. I didn't see that. I'm sorry.
`A.
`So clearly these don't overlap?
`Q.
`No, I'm sorry. I thought these were 13 and 15. I
`A.
`misunderstood. I'm looking at the title, August 13 to
`December.
`Q.
`Oh, I'm sorry. The title is the wrong title.
`A.
`Okay. Well, that seems like a lot of money, but if
`it's there, I probably got it.
`Q.
`So we just looked at about a two and-a-half year
`period. Roughly, how much money has Meda paid you over the
`last 15 years in total?
`A.
`I don't know.
`Q.
`More than $200,000?
`A.
`Probably.
`Q.
`More than $300,000?
`A.
`I don't know.
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`485
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`Kaliner - cross
`Well, you developed quite a sense of loyalty for Meda
`Q.
`over the years; right?
`A.
`You know I consult with a number of companies.
`Q.
`Okay. Well, have you developed a sense of loyalty
`for Meda?
`A.
`I have.
`Q.
`All right. And, in fact, it was a clinical director
`at Meda, not Meda's attorneys who first approached you to
`see if you could serve as an expert in this case; right?
`A.
`No, that is not true.
`Q.
`Okay. You remember you were deposed in this case?
`A.
`Not the exact wording but I know what happened.
`Q.
`No, I'm just asking. Do you remember that your
`deposition was taken in this case?
`A.
`So, why don't you show me what I said and then we can
`talk about it.
`Q.
`Let's -- your transcript is there but we will play a
`video. It is page 106, lines 10 through 21.
`"Answer: It was the clinical director at Meda
`with whom I discussed opportunity to possibly deal with this
`case first."
`
`THE COURT: I'm sorry. It started with a
`
`question.
`
`MR. LOMBARDI: It started with a question.
`"Question: How did you first get contact or who
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`486
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`Kaliner - cross
`first contacted you about this case?
`"Answer: It was the clinical director at Meda
`with whom I discussed the opportunity to possibly deal with
`this case first. Actually, Bob Sheridan was probably the
`first person I spoke with. He's a guy at Meda.
`"Question: He's a guy at Meda?
`"Answer: He's a fellow, he's been with Meda 30
`years, 35 years. From that conversation, I dealt with the
`clinical director -- the project manager, not director. He
`may have a different title than that. And then eventually,
`I dealt with these guys."
`"Question: Okay."
`BY MR. KLEIN:
`Q.
`Okay. So that was your testimony?
`A.
`Yes. So what I said --
`Q.
`All I asked, was that your testimony?
`A.
`Yes.
`Q.
`All right. And I think you testified yesterday
`that even before the Meda contacted you, it was Apotex who
`reached out to you; right?
`A.
`Yes.
`Q.
`And you found that Apotex was looking to invalidate
`the Dymista patents; right?
`A.
`I think so, yeah.
`Q.
`And you knew that if you were to find the Dymista
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`487
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`Kaliner - cross
`patents obvious, that would hurt Meda; right?
`A.
`As I said, I didn't -- I felt very uncomfortable and
`even unethical doing anything adverse to Meda.
`Q.
`So you turned down Apotex for that reason; right?
`A.
`Yes.
`Q.
`And you worked too closely with Meda to do anything
`that would hurt them; right?
`A.
`No. What I said is I have had an intimate
`relationship with Meda, as you see. And I did feel
`uncomfortable being adverse to them.
`Q.
`Okay. You told Apotex you couldn't represent them
`because morally you couldn't. You worked with Meda too
`closely to do anything that would hurt them. Right?
`A.
`I could not oppose them. That's right.
`Q.
`So you are not disagreeing with the way I
`characterized?
`A.
`I don't remember the exact words of the phone call a
`year ago, but the context is correct.
`Q.
`Let's go to DDX-7.03, please. And just to be clear,
`this is the same as PDX-2.02.
`Do you remember talking about this slide on
`
`direct?
`Yes.
`A.
`Okay. And so your opinion is that experts in
`Q.
`the field consistently expressed skepticism that an
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`488
`
`Kaliner - cross
`antihistamine would add benefit to a nasal corticosteroid;
`right?
`Yes, sir.
`A.
`And you were certainly an expert in the field of
`Q.
`treating allergic rhinitis as of June 2002; right?
`A.
`I was.
`Q.
`But, sir, in May 2002, one month before the priority
`date in this case, didn't you tell your peers the exact
`opposite of what you told the Court?
`A.
`Could you give more? I'm sure you are going to show
`me an example. Why don't we just go to it.
`Q.
`Let's go to DDX-7.04.
`This is an article from Allergy and Asthma.
`It's called Symposium, Ineffective Diagnosis and Treatment
`of Rhinitis - Can We Afford the Consequences?
`And you see there is a date there. It says May
`to June of 2003. Do you see that?
`A.
`I do.
`Q.
`And this is actually publishing pieces from an
`earlier symposium. Do you understand that?
`A.
`Yes.
`Q.
`Okay. Let's go to DDX-7.05. And this is page 163 of
`the document.
`This is your article; right?
`
`A.
`
`Okay.
`
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`489
`
`Kaliner - cross
`It's called Symposium Continued. Progressive
`Q.
`Management Strategies in the Treatment of Rhinitis.
`Correct?
`A.
`Right.
`Q.
`And in the bottom, you see it says from the George
`Washington University School of Medicine, Washington, D.C.
`and the Institute for Asthma and Allergy, Chevy Chase,
`Wheaton, Maryland.
`That is your institute, right?
`
`Yes.
`A.
`And it says: Presented At the Preconference
`Q.
`Symposium of the Eastern Allergy Conference, Key Biscayne,
`Florida, May 2, 2002. Right?
`A.
`Yes.
`Q.
`And obviously May 2, 2002, that is just a month
`before the priority date at issue in this case; right?
`A.
`Yes.
`Q.
`And this presentation was given to clinicians who
`treat allergic rhinitis; right?
`A.
`Yes.
`Q.
`Okay. And those are people who satisfy your
`definition of a person of ordinary skill in the art?
`A.
`Yes.
`Q.
`Let's look at DDX-7.07.
`And this is page -- this is DTX-312, the same
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`490
`
`Kaliner - cross
`document at page 6 of the document. And here, you told
`those skilled in the art in May 2002 that symptoms typical
`of allergic rhinitis; primarily sneezing, nasal itching and
`rhinorrhea; benefit most from an intranasal corticosteroid
`combined with an oral antihistamine to which a topical
`antihistamine can be added for additional symptomatic
`control. Right?
`A.
`Yes.
`Q.
`And let's turn to DDX-7.08.
`This is DTX-312 at page 8. Here, this is a
`section called Progressive Management Algorithms; right?
`A.
`Yes.
`Q.
`And you are talking about the ARIA guidelines, the
`allergic rhinitis and its impact on asthma?
`A.
`Yes.
`Q.
`Okay. Here, you told those skilled in the art in
`March-May 2002 that the allergic rhinitis and its impact on
`asthma guidelines and other successful management strategies
`for allergic rhinitis suggested the combined use of an oral
`antihistamine with an intranasal corticosteroid; right?
`A.
`Yes.
`Q.
`And then you go on to say, residual symptoms can be
`treated by adding the topical antihistamine azelastine to
`the regimen; right?
`A.
`Yes.
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`491
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`Kaliner - cross
`And you have actually relied heavily on the ARIA
`Q.
`guidelines in support of your opinions; right?
`A.
`No. I mean I said that, I quoted the ARIA guidelines
`mostly in response to your using -- your witnesses using the
`ARIA Guidelines. I have significant problems with the ARIA
`Guidelines, but in the context of what we're talking about
`here, I largely agree with them.
`Q.
`Okay. Let's go to DTX-7.09.
`This is a paragraph 20 from the opening report.
`In your opening report, did you say: I rely heavily on the
`Dykewicz guidelines from 1998 and the allergic rhinitis and
`its impact on asthma guidelines from 2001?
`A.
`I just said within the context. I mean I have
`problems with the ARIA guidelines. I critiqued it very
`heavily for the American Academy of Allergy; but in the
`context of what we're talking about today, I do agree
`largely with what they say, but I like Dykewicz and that is
`what I use more, but that is all right.
`Q.
`Okay. Let's go back to 7.08 again.
`Now, when you talk about intranasal
`corticosteroids, that would obviously include fluticasone;
`right?
`Yes. Okay.
`A.
`So you told your peers in May of 2002 that the ARIA
`Q.
`Guidelines suggest combining intranasal steroids like
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`492
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`Kaliner - cross
`fluticasone with azelastine along with oral antihistamines;
`right?
`A.
`Q.
`A.
`Q.
`
`That would have been an example of the choices, yes.
`Okay. And here you see you refer to Table III.
`Okay.
`Let's look at that. DDX-7.10.
`All right. This is the Table III that you were
`referring to; right?
`A.
`Yes.
`Q.
`And it is called Algorithms For Progressive
`Management Approaches; right?
`A.
`Yes.
`Q.
`And for allergic rhinitis, the first thing you listed
`was oral antihistamine plus nasal corticosteroid; right?
`A.
`That's correct.
`Q.
`And then the second thing you listed was oral
`antihistamines plus nasal corticosteroids plus nasal
`antihistamines for residual symptoms; right?
`A.
`Yes.
`Q.
`And, of course, azelastine is a nasal antihistamine;
`right?
`Right.
`A.
`And then, the third thing you listed is the saline
`Q.
`nasal irrigation; right?
`A.
`Correct.
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`493
`
`Q.
`
`Kaliner - cross
`Let's go back to DDX-7.11.
`Now, on your direct, you actually accused
`Dr. Schleimer of being misleading when he quoted from some
`of the prior art. Do you remember that?
`A.
`Yes.
`Q.
`During your direct you said experts in the field
`consistently expressed skepticism that an antihistamine
`would add benefit to a nasal corticosteroid. Right?
`A.
`Yes.
`Q.
`But at the relevant time, May 2002, you personally
`taught clinicians as part of a treatment algorithm that an
`antihistamine would add benefit to a nasal corticosteroid.
`Right?
`Well, I note, what I say here is the way that we
`A.
`treat patients, and I think we went over this, not you and I
`but your colleague and I, in great detail at deposition,
`about how I treat patients. This is precisely how I treat
`patients.
`
`I was quite frank. This is the way we do it.
`An oral antihistamine, if it didn't work we added a nasal
`steroid. If it didn't work, we added other agents. In this
`case we added a nasal antihistamine. By and large, patients
`improve.
`Q.
`So just so I understand, are you telling the Court
`that a person of ordinary skill in the art in June 2003
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`494
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`Kaliner - cross
`would have ignored what you were telling clinicians in May
`2002?
`No, I am not saying that.
`A.
`Now, on direct, I think you testified
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