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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`COALITION FOR AFFORDABLE )
`DRUGS II, LLC, ) Case:
` Petitioner, ) IPR2015-00990
` vs. )
`NPS PHARMACEUTICALS, INC., ) Patent:
` Patent Owner. ) 7,056,886
`-----------------------------)
`
`VIDEO DEPOSITION OF ANTHONY PALMIERI III, PH.D.
` Alexandria, Virginia
` Thursday, December 10, 2015
`
`Reported by:
`CAROL L. NAUGHTON, RPR, CCR
`JOB NO. 101126
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`NPS EX. 2042
`CFAD v. NPS
`IPR2015-01093
`
`
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`COALITION FOR AFFORDABLE )
`DRUGS II, LLC, ) Case:
` Petitioner, ) IPR2015-00990
` vs. )
`NPS PHARMACEUTICALS, INC., ) Patent:
` Patent Owner. ) 7,056,886
`-----------------------------)
`
`VIDEO DEPOSITION OF ANTHONY PALMIERI III, PH.D.
` Alexandria, Virginia
` Thursday, December 10, 2015
`
`Reported by:
`CAROL L. NAUGHTON, RPR, CCR
`JOB NO. 101126
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`NPS EX. 2042
`CFAD v. NPS
`IPR2015-01093
`
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` December 10, 2015
` 9:30 a.m.
`
` The video deposition of
`ANTHONY PALMIERI III, PH.D., held at the
`offices of Merchant & Gould, 1701 Duke
`Street, Suite 310, Alexandria, Virginia,
`before Carol L. Naughton, RPR, CCR, a
`Notary Public of the Commonwealth of
`Virginia.
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`A P P E A R A N C E S:
`
` MERCHANT & GOULD
` Attorneys for Petitioner
` 1701 Duke Street
` Alexandria, Virginia 22314
` BY: MATTHEW FEDOWITZ, ESQUIRE
` MARY BRAM, ESQUIRE
`
` TROUTMAN SANDERS
` Attorneys for Patent Owner
` 875 Third Avenue
` New York, New York 10022
` BY: JOSEPH ROBINSON, ESQUIRE
` HEATHER ETTINGER, ESQUIRE
`
`ALSO PRESENT:
` MARGO FURMAN, Ph.D., JD
` AVERY GIMBLE, Legal Video Specialist
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` A. PALMIERI
` THE VIDEOGRAPHER: The Coalition for
`Affordable Drugs versus NPS
`Pharmaceuticals. This deposition is being
`held at 1701 Duke Street, Alexandria,
`Virginia, on Thursday, December 10, 2015,
`at approximately 9:30 a.m.
` My name is Avery Gimble, and I am
`the legal video specialist from TSG
`Reporting, Inc., headquarters at 747 Third
`Avenue, New York, New York. The court
`reporter is Carol Naughton in association
`with TSG Reporting.
` Will counsel please introduce
`yourself. Will the court reporter please
`swear in the witness. Thank you.
` MR. FEDOWITZ: Matthew Fedowitz and
`Mary Bram of Merchant & Gould on behalf of
`petitioner, Coalition for Affordable Drugs
`II, LLC.
` MR. ROBINSON: Joseph Robinson,
`Heather Ettinger, and Margo Furman -- the
`former two from Troutman Sanders, the
`latter from Shire Pharmaceuticals --
`representing NPS Pharmaceuticals, Inc.,
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` A. PALMIERI
` patent owner.
` ANTHONY PALMIERI III, PH.D.,
` called as a witness, having been duly sworn
` by a Notary Public, was examined and
` testified as follows:
` EXAMINATION
`BY MR. ROBINSON:
` Q. Good morning, Dr. Palmieri.
` A. Good morning.
` Q. How are you?
` A. Good.
` Q. I'm Joseph Robinson. I'm
`representing the patent owner in this inter
`partes proceeding. I will be asking you
`questions, and please answer the questions to
`the best of your ability. If you have any
`questions about my questions, feel free to ask
`them.
` If your counsel objects to any of
`the questions, you will still be required to
`answer the question unless he instructs you not
`to answer.
` Is that clear?
` A. I believe so.
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` A. PALMIERI
` Q. Okay. Could you state your name and
`address, please.
` A. Anthony Palmieri III. My address is
`16313 Northwest County Road 231, Gainesville,
`Florida 32609.
` Q. And what is your occupation?
` A. As of July, I retired from the
`University of Florida.
` Q. What do you currently do?
` A. I'm retired, and I continue my
`expert witness activities.
` MR. ROBINSON: Okay. Let me just
` mark some exhibits now, and we'll get this
` out of the way.
` We'll mark this as Patent Owner's
` Exhibit 100.
` (Palmieri Exhibit 1001 marked for
` identification.)
`BY MR. ROBINSON:
` Q. Dr. Palmieri, do you recognize this
`exhibit?
` MR. FEDOWITZ: Just for clarity,
` Joe, do we want to stick with the exhibit
` number that it already has? Because the
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` A. PALMIERI
` whole series is --
` MR. ROBINSON: I don't know if the
` whole series will have it. Well, most
` will. Yeah, why don't we do that.
` Sorry about that. Change it to CFAD
` Exhibit 1001.
` THE WITNESS: So just to be clear,
` this is now Exhibit 1001?
`BY MR. ROBINSON:
` Q. Yes.
` Do you recognize CFAD Exhibit 1001?
` A. I believe so.
` Q. What is it?
` A. This is my -- a copy of my
`declaration in this case.
` Q. Okay. Is everything in CFAD
`Exhibit 1001 correct?
` A. I realized yesterday that there was
`a typographical error.
` Q. Would you like to point that out,
`please?
` A. Yes, please.
` In paragraph 84, on Page 43, the
`line beginning 1 microgram per kilogram times
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` A. PALMIERI
`70 kilograms per milliliter, that first number
`should be 100 micrograms per kilogram.
` Q. Other than that one error in
`column -- paragraph 84 of CFAD Exhibit 1001, is
`your declaration otherwise correct?
` MR. FEDOWITZ: Objection.
` THE WITNESS: There is one other
` typographical error in paragraph 53. In
` paragraph 53, the line beginning 101
` micrograms per kilogram times 70 kilograms
` per milliliter should be 100 micrograms per
` kilogram.
`BY MR. ROBINSON:
` Q. Other than the two errors that you
`just pointed out in CFAD Exhibit 1001, is CFAD
`Exhibit 1001 correct?
` MR. FEDOWITZ: Objection.
` THE WITNESS: Those were the only
` two typographical errors that I recall
` seeing.
`BY MR. ROBINSON:
` Q. Are there any other errors that you
`know of in your declaration?
` MR. FEDOWITZ: Objection.
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` A. PALMIERI
` THE WITNESS: Not that I recall
` sitting here today.
` MR. ROBINSON: Let me show you what
` was previously marked as CFAD Exhibit 1002.
` (Palmieri Exhibit 1002 marked for
` identification.)
` THE WITNESS: Thank you.
`BY MR. ROBINSON:
` Q. Dr. Palmieri, do you recognize CFAD
`Exhibit 1002?
` A. This appears to be a copy of my
`curriculum vitae.
` Q. Is everything in CFAD Exhibit 1002
`correct?
` MR. FEDOWITZ: Objection.
` THE WITNESS: At the time of the
` filing of the declaration, I was still on
` the faculty, and I have since, as I
` expressed earlier, retired as of July 1,
` 2015.
`BY MR. ROBINSON:
` Q. Is that the only change that -- or
`is that the only addition to CFAD Exhibit 1002
`that you would make?
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` MR. FEDOWITZ: Objection.
` THE WITNESS: As far as I recall,
` yes.
` MR. ROBINSON: Let me show you what
` was previously marked as CFAD Exhibit 1003.
` (Palmieri Exhibit 1003 marked for
` identification.)
`BY MR. ROBINSON:
` Q. Dr. Palmieri, do you recognize CFAD
`Exhibit 1003?
` A. Yes.
` Q. What is it?
` A. This appears to be a copy of U.S.
`Patent 7,056,886.
` Q. Let me show you a copy of what was
`previously marked as CFAD Exhibit 1028.
` (Palmieri Exhibit 1028 marked for
` identification.)
`BY MR. ROBINSON:
` Q. Dr. Palmieri, do you recognize CFAD
`Exhibit 1028?
` A. I believe so, yes.
` Q. What is it?
` A. This appears to be a document from
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` A. PALMIERI
`the PCT patent application of WO 98/52600.
` Q. And did you refer to CFAD
`Exhibit 1028 in your declaration?
` A. I believe so, yes.
` Q. And how did you refer to it?
` MR. FEDOWITZ: Objection.
`BY MR. ROBINSON:
` Q. By what name?
` A. As I recall, I referred to it as
`Drucker '600. But I'm not exactly sure.
` Q. Let me show you what was previously
`marked as CFAD Exhibit 1029.
` (Palmieri Exhibit 1029 marked for
` identification.)
`BY MR. ROBINSON:
` Q. Dr. Palmieri, do you recognize CFAD
`Exhibit 1029?
` A. I believe so, yes.
` Q. What is it?
` A. This is United States Patent
`5,789,379.
` Q. And did you refer to CFAD
`Exhibit 1029 in your declaration, CFAD
`Exhibit 1001?
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` A. PALMIERI
` MR. FEDOWITZ: Objection.
` THE WITNESS: I believe so, yes.
`BY MR. ROBINSON:
` Q. And did you refer to it by any
`shortened name in your declaration?
` MR. FEDOWITZ: Objection.
` THE WITNESS: I believe I referred
` to it as the '379 patent or as '379 or as
` Drucker '379.
` MR. ROBINSON: Let me show you what
` was previously marked as CFAD Exhibit 1027.
` (Palmieri Exhibit 1027 marked for
` identification.)
`BY MR. ROBINSON:
` Q. Do you recognize CFAD Exhibit 1027?
` A. I recognize Exhibit 1027, yes.
` Q. What is it?
` A. This is a U.S. patent, Patent Number
`5,652,216.
` Q. Did you refer to CFAD Exhibit 1027
`in your declaration?
` MR. FEDOWITZ: Objection.
` THE WITNESS: I have cited that in
` my declaration, yes.
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`BY MR. ROBINSON:
` Q. And did you refer to it by any
`shortened name in your declaration?
` MR. FEDOWITZ: Objection.
` THE WITNESS: As I recall, I
` referred to it as the '216 or as Kornfelt,
` as I recall sitting here today.
` MR. ROBINSON: Let me show you what
` was previously marked as CFAD Exhibit 1030.
` (Palmieri Exhibit 1030 marked for
` identification.)
`BY MR. ROBINSON:
` Q. Do you recognize CFAD Exhibit 1030?
` A. I believe so.
` Q. What is it?
` A. This is an article by Osterberg and
`Wadsten titled "Physical state of L-histidine
`after freeze-drying and long-term storage,"
`published in the European Journal of
`Pharmaceutical Sciences.
` Q. Did you refer to CFAD Exhibit 1030
`in your declaration?
` MR. FEDOWITZ: Objection.
` THE WITNESS: I recall referring to
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` A. PALMIERI
` it in my declaration, referencing it, yes,
` citing it.
`BY MR. ROBINSON:
` Q. Did you refer to it in any
`particular shortening?
` MR. FEDOWITZ: Objection.
` THE WITNESS: As I recall, I
` referred to it as Osterberg.
` MR. ROBINSON: Thank you.
` Let me show you what was previously
` marked as CFAD Exhibit 1018.
` (Palmieri Exhibit 1018 marked for
` identification.)
`BY MR. ROBINSON:
` Q. Do you recognize CFAD Exhibit 1018?
` A. I believe so, yes.
` Q. What is it?
` A. This is an article by Kieffer and
`Habener titled "The Glucagon-Like Peptides"
`published by The Endocrine Society.
` Q. And did you refer to CFAD
`Exhibit 1018 in your declaration?
` MR. FEDOWITZ: Objection.
` THE WITNESS: I believe so, yes.
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`BY MR. ROBINSON:
` Q. And did you refer to Kieffer -- CFAD
`Exhibit 1018 in any shortened name in your
`declaration?
` MR. FEDOWITZ: Objection.
` THE WITNESS: I recall referring to
` it as Kieffer.
`BY MR. ROBINSON:
` Q. Thank you. Let's take a look at
`CFAD Exhibit 1002.
` A. That would be my CV, I think.
` Q. Yes.
` A. Yes, I have that.
` Q. What is pharmaceutics?
` MR. FEDOWITZ: Objection.
` MR. ROBINSON: State the basis of
` your objection.
` MR. FEDOWITZ: Form.
` THE WITNESS: I don't -- I don't
` understand the question.
`BY MR. ROBINSON:
` Q. Your declaration refers to you as an
`assistant scholar of pharmaceutics and an
`associate scholar of pharmaceutics. I'd like
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` A. PALMIERI
`to know what pharmaceutics is. I'm sorry.
`Your CV.
` A. In that context, pharmaceutics is
`the science of dosage form, dosage form design,
`and evaluation. It encompasses that area and
`also areas such as pharmacokinetics,
`pharmacodynamics, among others. It's a
`commonly used term in pharmacy schools to
`designate a department.
` Q. And what is --
` A. It may also include -- biochemistry
`depends on it. But pharmaceutics is
`essentially the science of pharmacy.
` Q. What's dosage form design?
` A. Dosage form design, as I use it, is
`taking an active pharmaceutical ingredient,
`which we call an API, and creating a dosage
`form, a physical form that a patient can take
`by a variety of relative administration, be it
`by injection or oral, and then evaluation of
`that dosage form for things such as stability,
`patient compliance, and the like.
` Q. And what goes into creating a dosage
`form?
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` A. PALMIERI
` MR. FEDOWITZ: Objection.
` THE WITNESS: I don't quite
` understand. That's a very broad question.
`BY MR. ROBINSON:
` Q. Well, you said that dosage form
`design involves creating a dosage form.
` A. Correct.
` Q. And I'd like to know what creating a
`dosage form involves.
` MR. FEDOWITZ: Objection.
` THE WITNESS: To create a dosage
` form -- to create a dosage form requires a
` number of intellectual and physical
` exercises ranging from identifying the
` active ingredient, determining the
` stability of the active ingredient,
` determining the route of administration,
` and then preparing a dosage form that's
` acceptable, and evaluation of that dosage
` form.
`BY MR. ROBINSON:
` Q. And how does one prepare a dosage
`form that's acceptable?
` MR. FEDOWITZ: Objection to form.
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` THE WITNESS: Again, you've asked a
` very broad question and -- would you repeat
` the question or restate it, please.
`BY MR. ROBINSON:
` Q. Well, you said that part of the
`intellectual and physical exercises that you
`engage in in dosage form design is preparing a
`dosage form that's acceptable, and I want to
`know what that is.
` MR. FEDOWITZ: Objection.
` THE WITNESS: First of all, we have
` to define what is an acceptable dosage
` form.
`BY MR. ROBINSON:
` Q. How do we do that?
` MR. FEDOWITZ: Objection. Form.
` THE WITNESS: And again, you've
` asked a very general question. So I'm
` answering it to the best of my ability
` sitting here today, and it certainly was
` not in my declaration.
` The first question a formulator
` would ask is what is the purpose of this
` dosage form? Is it for human consumption?
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` Is it for FDA approval? Is it going to be
` taken internally?
` And then one, again, would determine
` what route of administration, if it was
` going to be given orally, what was the
` utility of it? Was it to be simply doing
` in vitro tests, or was it for in vitro
` tests, and go from there.
`BY MR. ROBINSON:
` Q. And after you define an acceptable
`dosage form in preparing a dosage form, is
`there a next step?
` MR. FEDOWITZ: Same objection.
` THE WITNESS: Again, I don't fully
` understand your very broad question, and I
` need it back.
`BY MR. ROBINSON:
` Q. Okay. You said that as part of the
`intellectual and physical exercises that you
`engage in in dosage form design, you prepare a
`dosage form that's acceptable.
` Is there anything else that you
`engage in in dosage form design other than
`preparing a dosage form that's acceptable?
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` A. PALMIERI
` MR. FEDOWITZ: Same objection.
` THE WITNESS: Once a scientist, a
` person of ordinary skill has identified the
` dosage form and physically prepared the
` dosage form, that person, either in their
` laboratory or in the laboratory of others,
` would evaluate that dosage form for
` stability, for patient acceptance, and in
` preparing the dosage form itself, a
` formulator would look at the prior art to
` determine where their best chance of
` success was.
`BY MR. ROBINSON:
` Q. And what would the formulator be
`looking for in the prior art to determine where
`their best chance of success was?
` MR. FEDOWITZ: Objection.
` THE WITNESS: And again, I want to
` say it's a very broad question. The
` formulator would look in scientific
` literature, in textbooks, rely on their
` knowledge and education and experience, and
` also look at all of the patent literature.
`BY MR. ROBINSON:
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` Q. And for what would the formulator be
`looking in the scientific literature and in
`textbooks and his education and experience to
`determine where their best chance of success
`was?
` MR. FEDOWITZ: Objection. Form.
` Foundation.
` THE WITNESS: Again, you've asked a
` very general question, and I need it
` repeated.
`BY MR. ROBINSON:
` Q. Okay. You said -- let's go back.
` The question was originally: You
`said that as part of the intellectual and
`physical exercise that you would engage in
`dosage form design, you'd prepare a dosage form
`that's acceptable.
` And I said: Is there anything else
`that you engage in in dosage form design other
`than preparing a dosage form that's acceptable?
` And you said that once you have
`identified the dosage form -- a personal of
`ordinary skill -- and prepared the dosage form,
`that person in their laboratory or in a
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`laboratory of others would evaluate the dosage
`form for stability, patient acceptance, and
`preparing the dosage form itself, and then the
`formulator would look at the prior art to
`determine where the best chance of success was.
` And I asked you what would the
`formulator be looking for in the prior art to
`determine where their best chance of success
`was, and you said that the formulator would
`look in scientific literature, in textbooks,
`rely on knowledge and education and experience
`and also look at all of the patent literature.
` And I wanted to know what would the
`formulator be looking for in the scientific
`literature, textbooks, education and
`experience, and the patent literature.
` MR. FEDOWITZ: Objection. Form.
` THE WITNESS: I believe I understand
` the question.
` A formulator would look -- once the
` API or even just the general group of
` active pharmaceutical ingredients were
` identified, the formulator would do the
` patent and scientific literature search to
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` determine what had been done with that
` active pharmaceutical ingredient or that
` group of active pharmaceutical ingredients.
`BY MR. ROBINSON:
` Q. What do you mean by what had been
`done with that active pharmaceutical ingredient
`or that group of pharmaceutical ingredients?
` MR. FEDOWITZ: Objection.
` THE WITNESS: Again, one would look
` in the available scientific literature,
` such as textbooks, journals, presentations,
` and also the patent literature.
`BY MR. ROBINSON:
` Q. I understand where you would look,
`but what I want to know is: You said what had
`been done. And what do you mean "what had been
`done"?
` MR. FEDOWITZ: Same objection.
` THE WITNESS: What I mean by what
` had been done was that how other
` formulators had approached that problem of
` formulation or a similar problem.
`BY MR. ROBINSON:
` Q. Okay. And what do you mean by "had
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`approached"?
` MR. FEDOWITZ: Objection.
` THE WITNESS: The formulator, a
` person of ordinary skill, would look at a
` compound or look at -- through the
` literature and say, well, this compound,
` for example, is a peptide. What has been
` reported in the literature, scientific and
` patent literature; what had been reported
` as to the efforts of other people to make
` the formulation?
`BY MR. ROBINSON:
` Q. By "efforts of other people," do you
`mean what components or excipients were used
`with that particular API?
` MR. FEDOWITZ: Objection.
` THE WITNESS: It's not that narrow.
` It would be the entire gamut. What
` excipients did they use? How did they use
` these excipients, in what amounts? What
` equipment did they use? Did they use
` lyophilization, or did they use other
` procedures readily available?
`BY MR. ROBINSON:
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` Q. Is there anything else that would be
`involved in the efforts of others that you
`would look towards?
` MR. FEDOWITZ: Objection. Form.
` THE WITNESS: I'm sorry. I don't --
` again, you're asking a very general
` question.
`BY MR. ROBINSON:
` Q. Right. You said -- I asked: By
`"efforts of others," do you mean the components
`or excipients? And you said that's not that
`narrow. It would be the entire gamut; what
`excipients were used, how they were used, what
`equipment they used. Did they use
`lyophilization? Did they use other procedures
`readily available?
` Would there be anything else within
`the scope of "efforts of other people" that you
`referenced?
` MR. FEDOWITZ: Same objection.
` THE WITNESS: And I still don't
` quite -- I'm having trouble getting my mind
` around the exact question when you ask what
` else would they look for or what else would
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` they do.
`BY MR. ROBINSON:
` Q. Well, you said "efforts of other
`people."
` A. Efforts of other people.
` Q. And the efforts of other people that
`you listed were excipients they used, how they
`used them, the equipment they used; did they
`use lyophilization, or did they use other
`procedures?
` And I want to know is there anything
`else within the efforts of other people to
`which you would be looking?
` MR. FEDOWITZ: Same objection.
` THE WITNESS: Well, certainly. They
` would look, for example -- and this is not
` an all-inclusive list. They would look at
` what -- what sort of stability they had if
` stability was important, what was the pH
` that they used, what other excipients, for
` example, buffers they used or excipients to
` add various characteristics to the dosage
` form to make it an acceptable dosage form.
` And there may be others. You know, the
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` A. PALMIERI
` formulator looks at the entire body of
` literature to see what is out there.
`BY MR. ROBINSON:
` Q. Okay. And you mentioned what sort
`of stability they had if stability were
`important. What do you mean by what sort of
`stability they had if stability were important?
` MR. FEDOWITZ: Objection.
` THE WITNESS: For example, if I
` was -- if I wanted to prepare a formulation
` that was available that was made and I was
` going to use it tomorrow, it would be very
` different than a formulation that I needed
` a shelf life of a year or two years or so.
` And how they evaluated those stability
` questions.
`BY MR. ROBINSON:
` Q. In other words, how they had
`previously stabled the molecule and the results
`they had gotten?
` MR. FEDOWITZ: Objection. Form of
` the question.
` THE WITNESS: Again, it's a very
` broad question. But a formulator would
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` A. PALMIERI
` look at all of the literature. They would
` say -- they would look and see whether or
` not others had prepared stable dosage forms
` and what they did, not only of the specific
` API, but other similar compounds.
`BY MR. ROBINSON:
` Q. By "what they did," you mean what
`they did to stabilize the formulation?
` MR. FEDOWITZ: Objection. Form.
` THE WITNESS: They would read the
` entire document.
`BY MR. ROBINSON:
` Q. Are you on any editorial boards
`currently of any peer review journal?
` A. Yes, I am.
` Q. Which?
` A. I'd need to go back to my CV. I've
`been on a number of editorial boards including
`the Journal of Pharmacy and Pharmaceutical
`Sciences. I'm still a member of that. I have
`previously served on the editorial board of the
`Journal of the American Pharmacists
`Association. I'm presently on the editorial
`advisory board of the Journal of Chemical and
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` A. PALMIERI
`Pharmaceutical Sciences and the advisory board
`of Research Journal of Pharmaceutical,
`Biological and Chemical Sciences.
` Q. What did you do with respect to the
`evaluation of various dosage forms at
`Pharmacia?
` MR. FEDOWITZ: Objection.
` THE WITNESS: I'm sorry. I didn't
` quite hear the end of the question.
`BY MR. ROBINSON:
` Q. What did you do with respect to the
`evaluation of various dosage forms at
`Pharmacia?
` A. At Pharmacia?
` Q. Yes.
` A. I was at Pharmacia from -- or I
`joined Pharmacia at 1985, as I recall, and I
`was there until 2000. At Pharmacia I was in
`the research and development division of Upjohn
`Pharmacia, and I would have daily interactions
`with scientists, including dosage form
`scientists, and would interact and they would
`seek my advice into evaluation of dosage forms
`and how to prepare those dosage forms, how to
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` A. PALMIERI
`interpret the results, and how to improve the
`performance of those dosage forms numerous
`times.
` Q. What is physical pharmacy?
` A. Again, you ask a very broad
`question. Physical pharmacy is the
`application, if you will, of principles of
`physical chemistry to pharmaceutical
`applications such as hydrogen bonding, such as
`solubility and stability.
` Q. Have you done any work with the
`stabilization of peptides or proteins in
`pharmaceutical formulations?
` MR. FEDOWITZ: Objection.
` THE WITNESS: When I was at Upjohn
` Pharmacia, I had very -- numerous
` interactions with formulation scientists
` involved with bovine growth hormone.
`BY MR. ROBINSON:
` Q. Did you do any work on the
`stabilization of peptides or proteins in
`pharmaceutical formulations?
` MR. FEDOWITZ: Objection.
` THE WITNESS: As I recall, I would
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` have discussions with them about dosage
` formulations that may have included
` stabilization or stability.
`BY MR. ROBINSON:
` Q. You're not sure if it did or it
`didn't?
` MR. FEDOWITZ: Objection.
` THE WITNESS: That was a while back.
` I don't recall exactly. We did have an
` active biotechnology formulations group at
` that time.
`BY MR. ROBINSON:
` Q. Were you part of the biotechnology
`formulations group at that time?
` MR. FEDOWITZ: Objection.
` THE WITNESS: I was in the same
` research and development division of
` Pharmacia Upjohn at that time.
`BY MR. ROBINSON:
` Q. But were you part of the
`biotechnology formulations group?
` MR. FEDOWITZ: Objection.
` THE WITNESS: I was not -- my direct
` reporting relationship was not through that
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` group, no.
`BY MR. ROBINSON:
` Q. Have you ever been part of a group
`that formulated proteins or peptides?
` MR. FEDOWITZ: Objection.
` THE WITNESS: As I recall, that was
` the major interactions. I'm a formulator.
` The science of physical pharmacy and
` physical chemistry is the same regardless
` of the API.
`BY MR. ROBINSON:
` Q. So the science and physical
`chemistry of formulation is the same for small
`molecules as it is for proteins; is that
`correct?
` MR. FEDOWITZ: Objection.
` THE WITNESS: The same basic
` principles and applications involved are,
` yes.
`BY MR. ROBINSON:
` Q. Are there any differences in the
`science and physical chemistry of formulation
`of small molecules and proteins or peptides?
` MR. FEDOWITZ: Objection.
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` THE WITNESS: I don't quite
` understand the question.
`BY MR. ROBINSON:
` Q. Well, you said that the same basic
`principles and applications are involved in the
`science of and physical chemistry formulation
`of small molecules and proteins and peptides,
`but what I would like to know is: Are there
`any differences in the science and physical
`chemistry of the formulation of small molecules
`and proteins and peptides?
` MR. FEDOWITZ: Objection.
` THE WITNESS: Each API, each
` molecule is subjected or is -- each
` mole
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