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`Meda Pharmaceuticals Inc., et al. v. Apotex Inc., et al.
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`Maureen Donovan
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` IN THE UNITED STATES DISTRICT COURT
` FOR THE DISTRICT OF DELAWARE
`
` MEDA PHARMACEUTICALS, INC., )
` and CIPLA, LTD., )
` )
` Plaintiffs, )
` ) Civil Action No.
` vs. ) 1:15-cv-785
` )
` APOTEX, INC., )
` )
` Defendant. )
` _________________________ )
`
` Videotaped deposition of DR. MAUREEN
` DONOVAN, taken in the above-captioned
` cause, at Winston & Strawn, 35 West Wacker
` Drive, Chicago, Illinois, before Rachel F.
` Gard, CSR, RPR, CLR, CRR, commencing at the
` hour of 9:06 a.m. on Friday, October 7,
` 2016.
`
`____________________________________________________
` DIGITAL EVIDENCE GROUP
` 1730 M Street, NW, Suite 812
` Washington, D.C. 20036
` (202) 232-0646
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2016
`
`202-232-0646
`
`1
`
`CIP2014
`Argentum Pharmaceuticals LLC v. Cipla Ltd.
`IPR2017-00807
`
`
`
`Meda Pharmaceuticals Inc., et al. v. Apotex Inc., et al.
`
`Maureen Donovan
`
`Page 1
`
` IN THE UNITED STATES DISTRICT COURT
` FOR THE DISTRICT OF DELAWARE
`
` MEDA PHARMACEUTICALS, INC., )
` and CIPLA, LTD., )
` )
` Plaintiffs, )
` ) Civil Action No.
` vs. ) 1:15-cv-785
` )
` APOTEX, INC., )
` )
` Defendant. )
` _________________________ )
`
` Videotaped deposition of DR. MAUREEN
` DONOVAN, taken in the above-captioned
` cause, at Winston & Strawn, 35 West Wacker
` Drive, Chicago, Illinois, before Rachel F.
` Gard, CSR, RPR, CLR, CRR, commencing at the
` hour of 9:06 a.m. on Friday, October 7,
` 2016.
`
`____________________________________________________
` DIGITAL EVIDENCE GROUP
` 1730 M Street, NW, Suite 812
` Washington, D.C. 20036
` (202) 232-0646
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2016
`
`202-232-0646
`
`1
`
`CIP2014
`Argentum Pharmaceuticals LLC v. Cipla Ltd.
`IPR2017-00807
`
`
`
`10/7/2016
`
`Meda Pharmaceuticals Inc., et al. v. Apotex Inc., et al.
`
`Maureen Donovan
`
`Page 2
`
`APPEARANCES:
`ON BEHALF OF THE PLAINTIFFS:
` STERNE KESSLER GOLDSTEIN & FOX
` BY: MS. UMA N. EVERETT
` MR. RAMI BARDENSTEIN
` 1100 New York Avenue, NW
` Washington, DC 20005
` 202.371.2600
` ueverett@skgf.com
` rbardenstein@skgf.com
`
`ON BEHALF OF THE DEFENDANT:
` WINSTON & STRAWN, LLP
` BY: MR. KEVIN E. WARNER
` 35 West Wacker Drive
` Chicago, Illinois 60601
` 312.558.5852
` kwarner@winston.com
`
`ALSO PRESENT:
` Kimberly Ortiz (Videographer)
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`Maureen Donovan
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` I N D E X
`WITNESS PAGE
`DR. MAUREEN DONOVAN
` Examination by Ms. Everett 6
` Examination by Mr. Warner 280
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` E X H I B I T S
`
`DEPOSITION EXHIBITS PAGE
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` Exhibit 1 Expert Report of Maureen 38
` Donovan, Ph.D.
` Exhibit 2 Expert Rebuttal Report of 39
` Maureen D. Donovan, Ph.D.
` Exhibit 3 Expert Reply Report of 39
` Maureen D. Donovan, Ph.D.
` Exhibit 4 Imitrex label 96
` Exhibit 5 Loyd Allen article 108
` Exhibit 6 '194 patent 131
` Exhibit 7 Report of Matthew Herpin, 173
` Ph.D.
` Exhibit 8 Cramer reference 176
` Exhibit 9 Exhibit R, Pump Delivery 185
` Shot Weight Raw Data
` Sprayability Check
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`Maureen Donovan
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`Page 4
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` E X H I B I T S (Continued)
`DEPOSITION EXHIBITS PAGE
` Exhibit 10 Expert Report of 203
` Ramprakash Govindarajan
` Ph.D.
` Exhibit 11 Exhibit C, Cramer 209
` Example I
` Exhibit 12 Exhibit D, Dr. 209
` Govindarajan Process
` Exhibit 13 PH reports for 209
` Dr. Herpin's tests
` Exhibit 14 Feasibility assessment 222
` plan
` Exhibit 15 Lab notebook 242
` Exhibit 16 Chapter of Remington's 265
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`Maureen Donovan
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`Page 5
` THE VIDEOGRAPHER: This is videotape No. 1 in
`the videotaped deposition of Dr. Maureen Donovan,
`taken by plaintiffs' counsel in the matter of Meda
`Pharmaceuticals, Inc., and Cipla, Limited, versus
`Apotex, Inc., in the United States District Court
`for the District of Delaware, Case No. 1:15-CV-785.
` This deposition is being held at Winston &
`Strawn, LLP, 35 West Wacker Drive, Chicago,
`Illinois, on Friday, October 7, 2016. The time on
`the video screen is 9:06 a.m.
` My name is Kim Ortiz. I am the legal
`videographer from Digital Evidence Group. The court
`reporter is Rachel Gard, in association with Digital
`Evidence Group.
` Will counsel please introduce themselves
`for the record.
` MS. EVERETT: Uma Everett from Sterne, Kessler,
`Goldstein & Fox on behalf of plaintiffs. With me
`today is my colleague, Rami Bardenstein.
` MR. WARNER: Kevin Warner of Winston & Strawn
`on behalf of Apotex and the witness.
` THE VIDEOGRAPHER: Will the court reporter
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`please swear in the witness.
` (Witness sworn.)
`WHEREUPON:
` DR. MAUREEN DONOVAN,
`called as a witness herein, having been first duly
`sworn, was examined and testified as follows:
` EXAMINATION
`BY MS. EVERETT:
` Q. Good morning, Dr. Donovan.
` A. Good morning.
` Q. Can you please state your name.
` A. Maureen Donovan.
` Q. What is your work address?
` A. 115 South Grand Avenue, University of Iowa
`College of Pharmacy.
` Q. Have you ever provided deposition
`testimony before?
` A. Yes, I have.
` Q. When did you do that?
` A. Most recently about 6 months ago, and quite
`a few years ago previous to that.
` Q. What was the testimony you provided 6
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`months ago?
` A. 6 months ago was in a pharmaceutical patent
`litigation case.
` Q. Who did you -- strike that.
` Who retained you in that case?
` A. I was retained by a number of firms, and
`Winston & Strawn happened to be one of the group.
` Q. What was the nature of your opinion in
`that case?
` A. My nature -- My opinion was -- well, it was
`a solid oral dosage form. And my opinion was
`directed primarily at the formulation development
`aspects of that.
` Q. You stated that you gave deposition
`testimony several years ago as well?
` A. Uh-huh.
` Q. And what was the case for which you gave
`deposition testimony?
` A. I've had other -- well, several other
`depositions. Most of them have been in the areas of
`nasal sprays and some in ophthalmic delivery
`systems.
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`Page 8
` Q. Where you provided deposition for nasal
`sprays, what were the products at issue?
` A. The one that's publicly available for
`everybody to go view is Nasacort.
` Q. And what was the nature of your opinion in
`the Nasacort case?
` A. In the Nasacort case, I was working with a
`firm that was representing a generic company. And I
`was again an expert witness regarding formulation
`and nasal deposition.
` Q. Who retained you in the -- strike that.
` Have you provided opinion testimony in
`other litigations related to nasal sprays?
` A. Yes, I have.
` Q. What products were at issue?
` MR. WARNER: Actually, I'll let her answer.
`But I guess if you've done deposition testimony or
`trial testimony, then it's known. One of your
`responses earlier made me think that there may be
`some engagements that aren't public, ones you
`haven't done testimony for them. We just need to be
`careful about those. But things you testified under
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`
`Maureen Donovan
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`oath, that's okay.
`BY THE WITNESS:
` A. We're kind of in the wayback machine on a
`number of things whether I was deposed in those
`cases or not. And there was a -- this is a long-ago
`case where I was deposed, and that was -- the case
`settled. And it was an intranasal product. And I
`believe it was an antihistamine, if I remember that
`case correctly.
` Q. It was an intranasal antihistamine, you
`said?
` A. Yes.
` Q. Was it any Astelin?
` A. It was related to Astelin, yeah.
` Q. Was it Astepro?
` A. I don't think I've ever been deposed about
`Astepro, no.
` Q. In addition to Nasacort and the Astelin
`cases, are there any other cases where you provided
`opinion testimony related to a nasal spray?
` A. I don't think any -- I've been involved in
`other cases. I don't think I've ever been deposed
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`Page 10
`in any of them. Again, they've all been quite a few
`years ago, and I don't remember necessarily which
`one corresponded to which.
` Q. Understood. In the Astelin case, who
`retained you?
` A. I'm pretty sure at the time it was Husch
`Blackwell. But the lawyers involved have moved to a
`different firm, so again it's way back there.
` Q. Do you remember which company retained
`you?
` A. To be honest, I do not.
` Q. Was it for a generic company?
` A. Yes, I was representing a generic.
` Q. For the -- you -- strike that.
` You said you provided deposition testimony
`for ophthalmic products?
` A. Yes.
` Q. Which ophthalmic products?
` A. Most of them have surrounded olopatadine as
`one of the agents.
` Q. Which companies retained you to provide
`deposition testimony?
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` A. Apotex has been one. I'm trying to
`remember. There were probably several others
`involved, but I -- and I think Sandoz was involved
`with one of the ophthalmic cases with olopatadine.
`Again, I don't remember exactly.
` Q. It was generic manufacturers you
`represented?
` A. It was generic manufacturers that I
`represented, yes.
` Q. Have you ever represented a branded
`pharmaceutical company in a patent litigation case?
`Or strike that. Have you ever been retained --
`strike that again.
` Have you provided testimony on behalf of a
`branded pharmaceutical company in a patent
`litigation?
` A. I have not provided testimony regarding --
`for a branded company.
` Q. Have you been retained to -- strike that.
` Have you ever consulted with a branded
`pharmaceutical company?
` A. Yes, I have.
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` Q. Okay. In what context?
` A. In a variety of contexts. In early
`formulation development activities, in activities
`regarding patent litigation.
` Q. In -- You said in activities related to
`patent litigation?
` A. Uh-huh.
` Q. In a consulting role?
` A. Yes.
` Q. Your deposition testimony has been on
`behalf of generic companies so far?
` A. I believe all of my deposition testimony
`that's of record is on behalf of generic companies.
` Q. Have you provided any trial testimony?
` A. Yes, I have.
` Q. And what was the nature of -- strike that.
` Who -- what was the nature of the case in
`which you --
` A. Again, that was a nasal spray case.
` Q. Which case was it?
` A. That was the Nasacort case.
` Q. Are there any other cases in which you
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`provided trial testimony?
` A. No.
` Q. So I will just go over some -- obviously
`you know some of the basics on depositions. I think
`we're falling into a little bit of this so it's
`worth going over. Obviously we have a court
`reporter here to take down my questions and your
`answers.
` I think we just have to be cognizant of
`not speaking one over other. I'm sure there will be
`plenty of times you anticipate my question. I think
`you have already a few times this morning.
` I will let you finish your answer. Please
`let me finish my question. And that way we'll have
`a clean record.
` If there's any question you don't
`understand, please ask for clarification and I will
`endeavor to make my questions clear. If you answer,
`I will assume you've understood the question.
` Is that fair?
` A. Sure.
` Q. Is there any reason you can't testify
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`truthfully today?
` A. No.
` Q. If you need breaks at any time, please let
`me know and we'll stop for a break. We intend to
`take breaks about every hour or so anyway.
` A. Okay.
` Q. I just ask if you need a break, we just
`finish the question that's pending and we'll get you
`a break.
` A. Sure.
` Q. Dr. Donovan, in your background, have you
`formulated a nasal spray?
` A. Yes, I have.
` Q. When you formulate a nasal spray -- How
`many nasal sprays have you formulated?
` A. I don't keep track because I'm not -- I'm
`not formulating a product. I formulate nasal sprays
`for research endeavors. So it could be in the
`thousands if we count every single solution or
`suspension or gel or film or whatever that I've
`made, so ...
` Q. Are there considerations that are unique
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`to the nasal sprays as opposed to another dosage --
`or another delivery system?
` MR. WARNER: Objection to the form of the
`question. Vague. It's an incomplete hypothetical.
`Go ahead.
`BY THE WITNESS:
` A. Okay. There are a number of factors that a
`nasal spray needs to have as its characteristic and
`its function. And a lot of any dosage form factor
`is dependent on, you know, what the drug is, what
`the intended use is. And we formulate around that
`for hopefully the most convenient use and best
`product, if we're actually trying to formulate for a
`commercial use. I formulate a number of things
`where I have no intention of them being a commercial
`use. They contain materials that I want to include
`as probe molecules to understand basic activities in
`the nasal cavity.
` Q. For a nasal spray that is going to be used
`by a person or as a method of treatment, are there
`unique characteristics to consider in a nasal spray
`different from other dosage forms?
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` MR. WARNER: Same objection. It's vague, and
`it's kind of an incomplete hypothetical.
`BY THE WITNESS:
` A. Okay. And yeah. I think I'm going to ask
`for a clarification. Are you talking about a nasal
`formulation that is intended to be delivered via
`a -- some sort of spray unit? Is that what you're
`trying to have me answer?
` Q. Yes. Is there a different -- a nasal
`spray that can be delivered differently that you're
`thinking of?
` A. Well, there are characteristics about any
`formulation that require them to be compatible if
`you need to essentially couple that with a device
`for delivery. You have to address whether that
`formulation is compatible with the device you intend
`to have it be delivered with.
` But there are a lot of devices available,
`so you've got similarly to you have formulation
`latitude; you've got device latitude. There are
`characteristics, but a lot of them are
`characteristics of a specific device that you're
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`Maureen Donovan
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`trying to couple your formulation to.
` Q. Are there characteristics that are unique
`to the formulation separate from the device that you
`would consider?
` MR. WARNER: Same objections.
`BY THE WITNESS:
` A. The characteristics for a nasal spray or
`for a nasal that's going to be formulated in -- or
`for a nasal formulation, or a nasal formulation
`that's going to be formulated for a spray?
` Q. For a nasal spray formulation.
` A. Well, there are characteristics of nasal
`spray formulations that are well accepted in the
`art, and formulators are aware of those. They're
`not rigid rules. They're not legally enforceable.
`There's latitude for formulation components and
`styles, forms depending on again the drug product
`and the intended use or intended strategy for
`delivery.
` And so yeah. There are general guidances.
`And I'm not speaking to the FDA guidances in any
`strict fashion, but there are generally recognized
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`strategies that people use for nasal spray
`formulations. They look quite similar to strategies
`that formulators use for a number of other delivery
`systems or dosage forms.
` Q. Understood. But I'm trying to focus on
`what is unique about nasal sprays. For example,
`isotonicity. Is that a consideration in a nasal
`spray?
` A. Isotonicity is a consideration in a nasal
`spray, but it's not unique to formulation of nasal
`sprays.
` Q. But it's not something that's considered,
`say, in solid dosage form?
` A. No, because the administration or
`application site differs in those -- between those
`two. So it's not the same, but it's relatively the
`same as an ophthalmic, for example. And it's
`relatively the same as an oral mucosal delivery
`system.
` Q. And a moment ago you referred to general
`guidelines. You said not FDA guidelines but
`guidelines. What were you referring to?
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` A. Well, I'm referring to the number of
`textbooks and book chapters and review articles and
`so forth where authors have put down various
`characteristics of nasal spray formulations that
`guide individuals in approaches for developing nasal
`formulations.
` Q. In addition to isotonicity, are there
`other characteristics that you consider for a nasal
`spray when formulating a nasal spray?
` A. Well, there's a lot of things that get
`considered. There's everything from the dose that's
`intended, the solubility, the volume you're going to
`be able to administer, how you're going to be able
`to administer that. And if you have -- if there's a
`particular goal in mind regarding that formulation,
`where you're actually formulating it potentially to
`be administered to patients or potentially being
`turned into a commercial product. There are some
`additional factors regarding shelf life and drug
`stability and ease of manufacturing, and there can
`be a whole number of things that get considered,
`again depending on what the goal is for the
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`Digital Evidence Group C'rt 2016
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`Maureen Donovan
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`Page 20
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`particular formulation activity.
` Q. For a nasal spray that will be
`administered as a method of treatment to a human,
`what are the characteristics you would consider in a
`nasal spray?
` MR. WARNER: Objection to the form of the
`question. Vague. Incomplete hypothetical.
`BY THE WITNESS:
` A. Essentially many of the things I just
`finished listing. And questions about whether --
`whether the dose is -- as a formulator, you'd need
`to have at least a range of doses that you were
`targeting. You have an idea of how that formulation
`might be administered.
` You have -- You'd likely be keeping in
`mind, you know, is this going to be something that's
`made at the patient's bedside? Is it something
`that's going to be made an hour before? Is it
`something that's going to be made a year before and
`provided? And all of those things have different
`levels of consideration regarding what might be
`included in the formulation and formulation
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`Maureen Donovan
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`Page 21
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`approaches.
` Q. When you said that you would consider the
`doses that you -- that were targeted, what did you
`mean by that?
` A. Well, as a formulator, we need to know how
`much drug it is that we're intended to deliver. And
`typically that's whatever pharmacologic dose is
`going to give the response that's desired.
` Now, doses are a -- are often given as a
`range that you don't -- that a specific number isn't
`the only number that gives the desired response.
`And so there's oftentimes a range of appropriate
`doses, and we oftentimes need to or we'd like to
`know what that range is to, again, give us again the
`latitude on balancing chemical characteristics with
`pharmacologic need and other issues regarding how
`we're going to go about manufacturing or providing
`that particular drug product or dosage form or
`formulation kind of depending on where we are in the
`process of evaluating its use.
` Q. So if you determine that you are targeting
`a particular dose or dose range, it's important that
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`www.DigitalEvidenceGroup.com
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`Digital Evidence Group C'rt 2016
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`Maureen Donovan
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`Page 22
`the drug deliver that dose or dose range, correct?
` A. It's important that the formulation deliver
`that, the dose that you intend.
` Q. Okay. Is that -- and that's an important
`characteristic in all nasal spray products; is that
`correct?
` A. It's an important characteristic in any
`drug product, including nasal sprays.
` Q. Next, you said you would consider how the
`formulation was administered. And I think we were
`talking about nasal sprays. So what did you mean
`specifically on how it's administered?
` A. Well, if we're talking about nasal sprays
`as a subcategory, the need to consider what spray
`device it is that it's going to be administered in.
`Is somebody going to empty out a Dristan bottle and
`you're going to refill that Dristan bottle with your
`formulation? Are you going to obtain other spray
`devices from other vendors?
` There's a number of them to pick from, so
`you need to know which of the many that you might
`use, whether you're going to use all of the above,
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`www.DigitalEvidenceGroup.com
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`Digital Evidence Group C'rt 2016
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`202-232-0646
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`10/7/2016
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`Meda Pharmaceuticals Inc., et al. v. Apotex Inc., et al.
`
`Maureen Donovan
`
`Page 23
`whether there's only a single one that you might
`have access to, a number of factors that go into
`selecting the spray device. And then formulating so
`that it delivers the proper dose is another activity
`that would become part of a plan for formulation
`development if that spray device was required for
`dose administration.
` Q. And you also said it's important that when
`a patient -- when the formulation would be made in
`relation to when it was administered, for example, I
`think you gave whether it's made up at the patient's
`bedside or a year before, there would be various
`considerations on that as well?
` A. Is there a question there?
` Q. Is that a correct summary? Is that
`correct?
` A. Well, I said those are certainly
`considerations that the length of time over which
`that formulation will rest before it's being
`administered is a consideration that a formulator
`addresses.
` Q. Are there -- in addition to the three
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`202-232-0646
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`Meda Pharmaceuticals Inc., et al. v. Apotex Inc., et al.
`
`Maureen Donovan
`
`Page 24
`we've just gone over, can you think of any other
`considerations that you would think about when you
`were formulating a nasal spray that will be
`administered to humans as a method of treatment?
` A. Well, one of the issues, again
`eventually -- well, even if it's not a commercial
`product, if it's going to be administered to humans,
`it doesn't have to be sterile. But you -- your
`strategy is best formulated -- bad word -- best
`planned to attempt to either be able to sterilize
`the product or have it as, quote/unquote, near
`sterile as possible.
` Q. Is that because of nasal sprays are
`multiple use or just sterility is an important
`consideration?
` A. Sterility is an important consideration or
`near sterility. There's a debate about whether it's
`mandatory, necessary, or just important.
` Q. What is your view on that?
` A. My view is that a nasal formulation does
`not need to be sterile to be administered. It does
`need to be as low bioburden as possible.
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`Meda Pharmaceuticals Inc., et al. v. Apotex Inc., et al.
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`Maureen Donovan
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`Page 25
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` Q. What is low bioburden?
` A. Low bioburden is the population of bacteria
`and pyrogens and potentially other fungi, other
`contaminants that are what we're trying to avoid
`when we actually sterilize products. And meeting
`the requirements for sterile dosage form for a nasal
`delivery system, again, I don't believe it's in all
`cases to have it absolutely sterile. But it has to
`be low bioburden. We shouldn't be inoculating
`people with bacteria or fungi laden dosage forms.
` Q. That sounds like a good approach.
` A. Yes, usually is.
` Q. Earlier you stated you may have formulated
`in the thousands of nasal sprays. About how many of
`those nasal sprays were for potential use for humans
`as a method of treatment?
` MR. WARNER: Objection to the form of the
`question. Vague.
`BY THE WITNESS:
` A. Well, and I think I'll back up. I'm not
`sure. I may have been presumptive in my answer.
`I've formulated thousands of formulations, not all
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`Maureen Donovan
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`Page 26
`of them nasal sprays. And so of the materials that
`I've formulated as nasal sprays, some of them had a
`goal of eventually being used in humans if
`preclinical results looked worth -- looked like they
`were worth going forward. But all of my formulation
`activities are very early in the preclinical to
`clinical assessment phases. So I have not
`formulated directly a nasal spray product that was
`absolutely moving forward into use in humans.
` Q. Have you formulated a nasal spray with two
`active ingredients?
` A. I believe I have, yes.
` Q. What were the two --
` A. Actually, it wasn't a nasal spray. It was
`a nasal formulation with more than one active
`ingredient.
` Q. How was it delivered if it was not a
`spray?
` A. It was probably delivered by drops, the
`level we were working at.
` Q. What were the two actives?
` A. I'm trying to remember. There was likely
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`Maureen Donovan
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`Page 27
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`an anti-inflammatory. There was likely an
`antihistamine. I don't remember whether there
`were -- there was an antibacterial in it or not.
`And any variety of a number of other sort of
`combinations of drugs that you'd consider using
`nasally, we may have combined at points in time
`during our research.
` In a lot of the research that I do, we
`combine things that are the actual active and then
`something else that could be considered an active
`agent but we're using it as an inhibitor instead.
`So it's sort of an anti-active.
` Q. So you referenced an anti-inflammatory.
`Which active was that?
` A. I have no recollection on the detail of
`which one specifically that was.
` Q. And then you said there was an
`antihistamine. Do you recall which?
` A. I don't remember. We've used a series of
`antihistamines in my lab. I've worked with private
`sponsors on other antihistamines they were
`interested in. I have no recollection of which ones
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`Maureen Donovan
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`Page 28
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`we've combined and what we've done with them.
` Q. Is this --
` A. Specifically.
` Q. Oh, I apologize.
` A. No, no, it's just I don't specifically
`remember which ones and in what combinations.
` Q. So is this nasal drop product the only one
`you can recall where you combined multiple active
`ingredients for use as active ingredients?
` A. And again, you know, I'm struggling over
`the term "active ingredient" because I just have a
`different view on what the FDA labels as active
`ingredient and what's active, so -- but to try to
`meet the question you've asked, if we're talking
`about two -- what the FDA would require, the
`identification as the active agent, I'm sure we've
`combined plenty of active agents in various
`situations in my research program. I just struggle
`to come up with the exact examples of when we did
`that or what was the motivation to do it at the
`time.
` Q. Do you recall whether these active agents
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`that were combined were all in solution?
` A. They were likely in solution. But I can
`think of cases where we've dealt
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