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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`--------------------------------)
`PAR PHARMACEUTICAL, INC., )
`BRECKENRIDGE PHARMACEUTICAL, )
`INC., and ROXANE LABORATORIES, )
`INC., )
` )
` Petitioners, )
` )
` vs. ) Case IPR2016-00084
` ) U.S. Patent No.
`NOVARTIS AG, ) 5,665,772
` )
` Patent Owner. )
`--------------------------------)
`
` *REVISED*
` DEPOSITION OF WILLIAM R. ROUSH, Ph.D.
` New York, New York
` November 21, 2016
`
`Reported by: BONNIE PRUSZYNSKI, RMR, RPR, CLR
`JOB NO. 115234
`
`TSG Reporting - Worldwide - 877-702-9580
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`Ex. 1115-0001
`
`
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`--------------------------------)
`PAR PHARMACEUTICAL, INC., )
`BRECKENRIDGE PHARMACEUTICAL, )
`INC., and ROXANE LABORATORIES, )
`INC., )
` )
` Petitioners, )
` )
` vs. ) Case IPR2016-00084
` ) U.S. Patent No.
`NOVARTIS AG, ) 5,665,772
` )
` Patent Owner. )
`--------------------------------)
`
` *REVISED*
` DEPOSITION OF WILLIAM R. ROUSH, Ph.D.
` New York, New York
` November 21, 2016
`
`Reported by: BONNIE PRUSZYNSKI, RMR, RPR, CLR
`JOB NO. 115234
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`Ex. 1115-0001
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`Page 2
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` November 21, 2016
` 9:05 A.M.
`
` DEPOSITION OF WILLIAM R. ROUSH,
` Ph.D., held at the offices of Fitzpatrick, Cella,
` Harper & Scinto, 1290 Avenue of the Americas, New
` York, New York, before Bonnie Pruszynski, a
` Registered Professional Reporter, Registered Merit
` Reporter, Certified Livenote Reporter, and Notary
` Public of the State of New York.
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`Ex. 1115-0002
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`A P P E A R A N C E S:
`
`FITZPATRICK CELLA HARPER & SCINTO
`Attorneys for Patent Owner
` 1290 Avenue of the Americas
` New York, New York 10104
`BY: JARED STRINGHAM, ESQ.
` CHRISTINA SCHWARZ, ESQ.
`
`LATHAM & WATKINS
`Attorneys for Par Pharmaceuticals
` 555 Eleventh Street
` Washington, DC 20004
`BY: JONATHAN STRANG, ESQ.
` BRENDA DANEK, ESQ.
`
`MERCHANT & GOULD
`Attorneys for Breckenridge Pharmaceutical, Inc.
` 1900 Duke Street
` Alexandria, VA 22314
`BY: MARY BRAM, ESQ. (telephonic appearance)
`
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` W. Roush
` (Witness sworn.)
`WILLIAM R. ROUSH, PH.D.,
` called as a witness, having been first
` duly sworn, was examined and testified 09:05
` as follows:
`EXAMINATION
`BY MR. STRANG:
` Q. Good morning, Mr. Roush.
` A. Good morning. 09:05
` Q. Traveling in okay?
` A. So far, yeah.
` Q. I am handing you expert declaration
` of William R. Roush. It's already been
` marked as Novartis Exhibit 2093. If you want 09:06
` to take the time to take a look at that.
` Do you recognize this document,
` Dr. Roush?
` A. I do.
` Q. And do you agree this is your 09:06
` expert declaration in this proceeding?
` A. I believe that is the case.
` Q. And do you agree with your opinions
` as set forth therein?
` A. I do. 09:06
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`Ex. 1115-0004
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` W. Roush
` Q. Will you turn to -- do you have any
` corrections you would like to make before we
` begin?
` A. Nothing of any substance, no. 09:06
` Q. Okay. If you see some typos, I'm
` sure you will let us know. Correct?
` A. Thank you.
` Q. Could you turn to paragraph 47.
` It's on page 17 of your declaration, please. 09:07
` And do you agree this is in the
` section labeled "Person of Ordinary Skill in
` the Art"?
` A. Paragraph 47 is in the Section C
` for "Person of Ordinary Skill in the Art." 09:07
` Q. In paragraph 47, do you agree that
` you testified that a person of ordinary skill
` in the art would have a Ph.D. in medicinal or
` organic chemistry, or a bachelor's or
` master's with practical experience in the 09:07
` field? Is that correct?
` A. That is what I have written here.
` Q. Do you consider yourself a
` medicinal chemist?
` A. I do. 09:07
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`Ex. 1115-0005
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` Q. Now, in paragraph 48 you further
` state that a person of ordinary skill in the
` art would have access to persons with
` experience in crystallography. 09:07
` A. I do.
` Q. What sort of experience with
` crystallography would be required by this
` person?
` A. Given that in this case, questions 09:08
` of structure-based design were raised, a
` person of skill, if -- if the medicinal
` chemist himself or herself didn't have that
` experience, then I think they would speak
` with somebody who was trained as a 09:08
` crystallographer who could help them use the
` modeling software and so on, to perform
` analysis.
` Q. Could we go to -- back to paragraph
` ten, please. 09:08
` A. To paragraph?
` Q. Ten.
` Pardon me. I have got the fans
` right behind me. If I need to speak louder,
` please let me know. 09:09
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`Ex. 1115-0006
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` W. Roush
` You state that you developed a
` class of or are currently developing a class
` of prodrugs; is that correct?
` A. Specifically antibody drug 09:09
` conjugates, which are a type of prodrug
` construct, yes.
` Q. Can you tell me a little bit about
` this product, about how this prodrug works?
` A. Well, it's not yet a product. It's 09:09
` a research effort, and we are developing --
` myself, I'm in charge of the chemistry side
` of it. I have a collaborator at Scripps, who
` is the individual who actually produces the
` antibodies. 09:09
` We have one student jointly
` mentored by my collaborator and by myself,
` and we are working on developing novel linker
` technologies for coupling drugs to the
` antibody. The antibodies are designed in 09:10
` order to target certain receptors on cancer
` cells.
` The antibodies will be internalized
` by way of these receptors -- the antibody
` drug conjugate, excuse me, will be 09:10
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`Ex. 1115-0007
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` W. Roush
` internalized into the cell by way of the
` receptors that are being targeted. And these
` linkers have enzymatically cleavable -- we
` have some that are non-cleavable, and we have 09:10
` some that are cleavable, such that once
` internalized, the drug is released by one of
` several mechanisms.
` Q. You say that there is a conjugate.
` Can you explain what a conjugate is in the 09:10
` context of a prodrug?
` A. An antibody is a large molecule.
` It's a protein. And we are taking advantage
` of specifically engineered sites on the
` antibody. We have introduced -- my 09:11
` collaborator has introduced certain amino
` acids that can be specifically targeted
` chemically, and so we have a drug, I mean in
` my right hand a drug. We have a big group
` over here in my left hand, an antibody, and 09:11
` somehow you have to connect the two.
` And so, the linker, I think was
` your question, would be then the unit that we
` connect to the drug at one end, and then
` connect to the antibody at the other, and 09:11
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`Ex. 1115-0008
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` within this construct there are -- it's been
` designed to have sites that are enzymatically
` cleavable once inside the cancer cell in
` order to release the drug from the antibody. 09:11
` Q. So, the drug is released once it's
` inside the cancer cell?
` A. In the examples that we are working
` on, that is what we are doing, yes.
` Q. And as far as in vitro testing, how 09:11
` do you test when the antibody and the drug
` are cleaved?
` A. That takes a variety of
` experiments, but in vitro we would test with
` the specific cathepsin that is present at a 09:12
` high level in the cancer cell and show that
` in a biochemical assay, we can accomplish the
` release.
` Once released within the cell, we
` use a series of positive and negative 09:12
` controls to help assess what is going on. We
` do mass spectrometry at a high level to
` assess drug release and where the site of
` conjugation starts.
` There is no one assay. There is a 09:12
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`Ex. 1115-0009
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` multitude of assays that are performed.
` Q. And how do you decide which assays
` need to be performed?
` A. How do you decide which assays need 09:13
` to be performed? This is all part of an
` ongoing research project, and I haven't -- in
` this instance, I have not decided which
` assays to perform. My biological
` collaborator has, and our jointly mentored 09:13
` student are designing those assays, and the
` assays, specific assays are designed to
` address specific questions that come up in
` the course of the work, and that may vary
` from day to day and week to week. 09:13
` Q. You said what -- what two people
` were deciding which assays you need to
` perform in vitro?
` A. I said are developing the assays.
` So, Christoph Rader is my cancer biology 09:14
` collaborator, and we have a graduate student
` who I am -- we are both Ph.D. mentors for the
` student.
` Q. And you said Christoph Rader was
` the biological assay? 09:14
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`Ex. 1115-0010
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` W. Roush
` A. He is the faculty member. He is
` not an assay. Christoph Rader is my
` biological collaborator, the co-principal
` investigator of this program. 09:14
` Q. It's Rader, R-A-D-E-R?
` A. Correct.
` Q. What is Dr. Rader's background?
` A. He is an -- I don't actually know
` what his background is. He has -- I believe 09:14
` he is an M.D./Ph.D. He's trained and worked
` in immunology laboratory. He was employed at
` the National Cancer Institute, making --
` focusing on drug antibody conjugate
` technologies before he was hired to join the 09:15
` faculty of the Scripps Research Institute.
` Q. So, deciding what assays you need
` to develop, you farmed that out to Dr. Rader
` because that's his specialty?
` MR. STRINGHAM: Objection, 09:15
` mischaracterizes the witness' testimony.
` A. Yeah, I never said it was farmed
` out to anyone. I'm a chemist. I'm designing
` the linker technology. I'm designing and
` responsible for other aspects of the program, 09:15
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`Ex. 1115-0011
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` and --
` Q. So, it's a joint effort between you
` and Dr. Rader to decide what assays are
` required to -- 09:15
` A. There certain have been multiple
` occasions where questions have come up and
` where we are having joint meetings, I suggest
` an assay that needs to be done, or I say here
` is a question that needs to be addressed and 09:15
` solved. We need to get data on this point or
` points. And then they will generate the
` assay to do it.
` So, yes, it's a collaborative joint
` effort. 09:16
` Q. You said there are questions that
` need to be solved. What sort of questions
` need to be solved?
` MR. STRINGHAM: Objection,
` mischaracterizes the witness' testimony. 09:16
` A. I said whatever specific questions
` happen to come up at a given time. In a
` recent example, which we have not yet
` published, we've just submitted the first
` paper on this, the question was, did we 09:16
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`Ex. 1115-0012
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` conjugate at specifically the site that we
` had been targeting, and so I suggested an
` enzymatic assay in order to address that
` question, were we actually conjugating where 09:16
` we had designed, what we wanted to, so -- and
` that is just one of a myriad of examples of
` situations where we might need to develop an
` assay to address a given question.
` Q. So, on other given questions, one 09:16
` of the given questions you said is doing
` assays to make sure that the prodrug is
` cleaved at the correct location? Is that
` what you said?
` A. We need to make sure that the 09:17
` prodrugs that can be cleaved off are cleaved
` off. There are -- there are constructs where
` it does not have to be cleaved off, because
` the antibody itself is degraded within the
` cells, so in essence, the natural enzymatic 09:17
` degradation of the protein does release the
` drug, but we haven't designed a specific
` releasable site because the cell takes care
` of the degradation release itself.
` Q. How do you make sure that the 09:17
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`Ex. 1115-0013
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` degradation doesn't happen before you are in
` the cell?
` A. We run all sorts of -- I mean, I
` said there are a multitude of experiments 09:17
` that are performed. Partly that would be a
` question of cytotoxicity.
` You look at the effectiveness of
` these constructs with cell lines that either
` do or do not have the receptor that we are 09:18
` targeting. We look at the toxicity of the
` antibody constructs, in the presence of a
` variety of other cells. And it's a -- there
` is not a one single experiment to address and
` answer that question. 09:18
` Q. Have you begun in vivo testing?
` A. Absolutely.
` Q. And what are the -- what is the
` in vivo testing process that you are going
` through? 09:18
` MR. STRINGHAM: Objection, form.
` A. The in vivo testing at this stage
` are animal studies, and we look at the
` ability, the capability of these antibody
` conjugates to either stop tumor growth, to 09:19
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`Ex. 1115-0014
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` W. Roush
` cause tumor size regression, and we do this
` in comparison with other antibodies that are
` either -- antibody drug conjugates that are
` either commercially available, i.e., are 09:19
` existing drugs, and we are using those as
` benchmark references, or we've, on a number
` of occasions, used other research-level
` antibody conjugates in comparison for
` benchmarking with ours to see how effective 09:19
` are we performing, as well, better, or worse
` than existing technologies.
` Q. Which animals are you testing in?
` A. I believe all of the studies so far
` have been in mice. 09:20
` Q. In mice.
` Are there any plans to test in
` other animals?
` A. We are actively seeking corporate
` sponsorship to move this technology forward, 09:20
` and ultimately for testing in other animals,
` so moving towards an IND. So that's
` something we have talked about. But have we
` done that today, and do we have specific
` plans laid out? No. We don't have the 09:20
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`Ex. 1115-0015
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` funding yet to do this.
` Q. Why do you need to test in other
` animals?
` A. If we wish to move forward to an 09:20
` IND, the FDA, my understanding, always
` requires testing in several animal species,
` including a non-rodent species.
` Q. Why does the FDA require testing in
` several different animals including a 09:21
` non-rodent species?
` A. I don't -- I have never spoken with
` people at the FDA. I don't know why they
` have the requirements that they do. This is
` my understanding, that there is a 09:21
` requirement.
` Q. Do the results in other animals
` that are including non-rodent animals always
` match the initial tests in mice?
` MR. STRINGHAM: Objection, form. 09:21
` A. You are asking a hypothetical,
` moving forward with the case, and since we
` have not done these antibody constructs in
` other animals, I couldn't -- I don't know.
` Q. Have you ever seen data from 09:21
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`Ex. 1115-0016
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` non-rodent testing that did not match the
` rodent testing?
` MR. STRINGHAM: Objection, form.
` A. In all of the projects that I have 09:22
` been intimately involved with, I haven't -- I
` don't think in any of the projects that I
` have been involved with, that we have had
` anything other than rodent testing, so I
` couldn't answer. I don't have personal 09:22
` experience on that.
` Q. Can we go back to paragraph 48 of
` your declaration. And earlier we mentioned
` that a person of ordinary skill in the art
` would have access to a person with experience 09:22
` in crystallography; is that correct?
` A. I recall you asking that, yes.
` Q. And you stated that the person that
` has experience in crystallography would have
` the ability to grow the crystals; is that 09:23
` correct?
` MR. STRINGHAM: Objection, form,
` mischaracterizes the witness' testimony.
` A. Yeah, I made no comments about
` growing the crystals. 09:23
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`Ex. 1115-0017
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` Q. Well, let's -- what sort of
` experience would the person that you
` mentioned here with experience in
` crystallography, what sort of experience 09:23
` would that person need to have?
` A. For the issues in this case, the
` ability to collect the data, to do the x-ray
` diffraction experiments and solve the
` structure. 09:23
` Q. Now, when you say to do the x-ray
` diffraction experiments, can you explain to
` me what you mean by that?
` A. X-ray crystallography requires
` taking a crystal, mounting it on an 09:24
` instrument such that the crystal is then
` bombarded by x-rays. The x-rays are
` diffracted by the -- the sample, and the
` x-rays are then recorded, if you will, in
` protein crystallography. It's called an area 09:24
` detector, and so there is this pattern of
` spots. And the data that appears on the area
` detector then has to be mathematically
` converted ultimately into the refined
` structure. 09:24
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`Ex. 1115-0018
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` Q. Does the crystallographer need to
` grow the crystals?
` A. Not necessarily. Some
` crystallographers may just take crystals 09:24
` provided to them. Some crystallographers do
` generate the crystals. I think it varies on
` who the individual is and what they're doing
` and why.
` Q. Is it your opinion that a person of 09:25
` ordinary skill in the art needs to be a
` crystallographer?
` MR. STRINGHAM: Objection, to the
` form.
` A. No. I haven't defined a person of 09:25
` ordinary skill as a crystallographer. I have
` defined a person of ordinary skill in the art
` as a medicinal Ph.D. -- as you read to me
` back from paragraph 47, that's my definition.
` But there are aspects of the case 09:25
` where the expertise of a crystallographer
` might come to bear, and it's my opinion that
` the person of ordinary skill would have
` access to that type of individual.
` Q. The person -- the crystallographer 09:25
`
`TSG Reporting - Worldwide - 877-702-9580
`
`Ex. 1115-0019
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`Page 20
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` W. Roush
` to which the person of ordinary skill would
` have access to, does that crystallographer
` need the ability to grow the crystal?
` MR. STRINGHAM: Objection, form. 09:26
` A. A crystal has to be generated in
` order to solve the structure, so, I would
` assume that the crystallographer -- and I
` don't know if all crystallographers have that
` skill. For the purposes here, I think the 09:26
` crystallographer would be the one to grow the
` crystal.
` Q. So, you said the crystallographer
` here would be the one to grow the crystal; is
` that correct? 09:26
` A. I think so, because I don't think
` the person of ordinary skill, a medicinal
` chemist, a synthetic chemist -- growing a
` protein crystal is very, very different than
` growing a crystal with an organic molecule. 09:26
` And I don't think a person of ordinary skill
` has the skills to grow such a protein
` crystal.
` Q. Okay. Pardon me. The wind has not
` been kind to my lungs. Hopefully you are 09:27
`
`TSG Reporting - Worldwide - 877-702-9580
`
`Ex. 1115-0020
`
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`Page 21
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` doing better than I am.
` Are you from New York City?
` A. No.
` Q. Where did you fly in from? 09:27
` A. I flew in from Boston.
` Q. So it's gotten cold there, too.
` A. Apparently.
` Q. So you heard.
` Can we go to paragraph 38, please. 09:27
` Pardon me.
` In paragraph 38, you stated that
` the board will consider whether the prior art
` would have motivated a person of skill in the
` art to modify the lead compound with a 09:27
` reasonable expectation of success. Is that
` correct?
` A. That is my understanding as
` presented to me by counsel.
` Q. Pardon me. 09:28
` And in paragraph 39, you state, in
` determining whether there would have been a
` reasonable expectation of success, "the board
` will consider whether there would have been a
` reasonable expectation of achieving the 09:28
`
`TSG Reporting - Worldwide - 877-702-9580
`
`Ex. 1115-0021
`
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`Page 22
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` W. Roush
` unique combination of properties possessed by
` the claimed compound." Is that correct?
` A. Again, that is my understanding.
` This is the standard that counsel had 09:28
` described to me that are applicable in this
` case.
` Q. Is that the standard that you
` applied in your opinion?
` A. It is, yes. 09:28
` MR. STRINGHAM: Objection. Form,
` mischaracterizes the witness' testimony.
` Q. Let's break that down.
` When you said "the unique
` combination of properties possessed by the 09:28
` claimed compound," did you mean all of the
` properties possessed by the claimed compound?
` MR. STRINGHAM: Objection, form.
` A. The unique combination of
` properties are all of the properties of the 09:29
` claimed compound, is my understanding, yes.
` Q. Does that -- when we say "all,"
` that means all known and unknown -- all known
` and unknown properties; correct?
` MR. STRINGHAM: Objection, form. 09:29
`
`TSG Reporting - Worldwide - 877-702-9580
`
`Ex. 1115-0022
`
`
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`Page 23
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` W. Roush
` A. It's my understanding that this
` would be all of the properties that are known
` as of today.
` Q. As of today. 09:29
` A. And I have not considered whether
` this would include additional properties
` unknown today that might be discovered in the
` future. That I don't know. But I had not
` thought of that possibility. 09:29
` Certainly my understanding is that
` this would at minimum include all of the
` properties of the claimed compound known as
` of today.
` Q. Can we go to paragraph 150 of your 09:30
` declaration, please. On paragraph 150, you
` identify three of the properties of the
` claimed -- of the claimed compound, and those
` are a beneficial half-life, the ability to be
` co-administered at the same time as 09:31
` cyclosporine, and multiple antitumor
` indications. Is that correct?
` A. That is what I have written here,
` yes.
` Q. Do you know when the half-life of 09:31
`
`TSG Reporting - Worldwide - 877-702-9580
`
`Ex. 1115-0023
`
`
`
`Page 24
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` W. Roush
` everolimus was discovered?
` A. Precisely, no, I don't.
` Q. You cite -- in paragraph 151, you
` cite two references showing the half-life of 09:31
` everolimus. The Zortress label,
` Exhibit 2055, and the Kahan article,
` Exhibit 2054; is that correct?
` MR. STRINGHAM: Objection to form,
` mischaracterizes the witness' 09:31
` declaration.
` A. I don't see -- could you repeat
` your question, please.
` Q. Do you see in paragraph 151 where
` you cite Exhibit 2055, the Zortress label? 09:32
` A. I do.
` Q. And what do you cite the Zortress
` label for?
` A. For the half-life of everolimus.
` MR. STRANG: I am handing the 09:32
` witness Novartis Exhibit 2055, which is
` the Zortress label.
` Q. Do you recognize this document,
` Dr. Roush?
` A. I do, yes. 09:32
`
`TSG Reporting - Worldwide - 877-702-9580
`
`Ex. 1115-0024
`
`
`
`Page 25
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` W. Roush
` Q. Do you know what date this label
` was prepared?
` A. Well, the approval was 2010, so, my
` apologies, but I don't see the actual date of 09:33
` when it was first prepared.
` Q. Do you see on the first column,
` first page, top left, where it says "Initial
` U.S. Approval: 2010?
` A. That's -- I commented on that 09:33
` already. I said the initial approval was
` 2010, but I don't know if that's the date
` that this was generated.
` Q. So, there is no indication that
` this was generated any earlier than that 09:34
` date; correct?
` A. To my knowledge, no.
` Q. And there is no indication that
` this was made public any earlier than that
` date; is that correct? 09:34
` A. To my knowledge, no.
` MR. STRANG: Let the record show
` I'm handing the witness Exhibit 2054. It
` is the Kahan exhibit.
` I should be giving you these, too. 09:34
`
`TSG Reporting - Worldwide - 877-702-9580
`
`Ex. 1115-0025
`
`
`
`Page 26
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` W. Roush
` Q. Have you reviewed the document,
` Dr. Roush?
` A. Prior to submitting my declaration,
` yes. 09:35
` Q. Is this the document that you cite
` at the end of paragraph 151?
` A. I believe it is.
` Q. Do you see the publication -- the
` publication date, October 27, 1999, on the 09:35
` top right-hand corner there?
` A. I do.
` Q. And in the document itself, on the
` first page of the article, do you see that
` the first sentence after the bolded section 09:36
` starts off saying, "SDZ-RAD (RAD*)"?
` A. I'm sorry, I missed which page you
` are referring to.
` Q. Pardon me. The very first page of
` the article. It's page 1100, page two of 09:36
` eight by the exhibit numbering. At the
` end -- yeah, I need my glasses, too.
` At the end of the bolded section,
` do you see the first page of regular font
` text which starts off "SDZ-RAD (RAD*)"? 09:36
`
`TSG Reporting - Worldwide - 877-702-9580
`
`Ex. 1115-0026
`
`
`
`Page 27
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` W. Roush
` A. I do.
` Q. And reading that sentence, do you
` agree that when Kahan refers to SDZ-RAD or
` just RAD, do you agree that Kahan is 09:37
` referring to everolimus?
` A. Well, it's RAD with the asterisk,
` and I read that to be everolimus, yes.
` Q. And just above that, in the bolded
` section under the results, do you see where 09:37
` Kahan concludes that everolimus displayed a
` half-life shorter than that of rapamycin?
` A. I do. In the conclusion section,
` yes.
` Q. Do you know of any earlier 09:37
` publication with everolimus' half-life?
` A. Sitting here today this morning, I
` can't remember any earlier ones.
` Q. And you didn't cite any in your
` declaration; is that correct? 09:37
` A. This is the -- this and the product
` label are the documents I cited concerning
` half-life. Product insert, excuse me.
` Q. So, had we challenged this patent
` in 1998, which is before October 1999, how 09:38
`
`TSG Reporting - Worldwide - 877-702-9580
`
`Ex. 1115-0027
`
`
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`Page 28
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` would that have changed your reasonable
` expectation of success --
` MR. STRINGHAM: Objection.
` Q. -- opinion? 09:38
` MR. STRINGHAM: I'm sorry, are you
` finished?
` MR. STRANG: Yes. I will just
` reask the question. It's not a problem.
` Q. So, suppose that you rendered your 09:38
` opinion in 1998, which is before
` October 1999. How would that have changed
` your reasonable expectation of success
` analysis?
` MR. STRINGHAM: Objection, form. 09:39
` Lack of foundation.
` A. That's a question I have not
` considered, because the challenge is being
` made today and not in 1998. So, I haven't
` considered that. I don't know. 09:39
` Q. Well, you challenged -- you said
` one of the things the person of ordinary
` skill must reasonably expect to obtain is a
` half-life, a beneficial half-life; is that
` correct? 09:39
`
`TSG Reporting - Worldwide - 877-702-9580
`
`Ex. 1115-0028
`
`
`
`Page 29
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` MR. STRINGHAM: Objection,
` mischaracterizes the witness' testimony.
` A. Yeah, I didn't say that the --
` my -- my testimony was not as you put into 09:39
` your question. My testimony has been that as
` of today, we know about the beneficial
` half-life, and that is an unexpected result.
` So, it's all with the present
` knowledge that that information is put 09:40
` forward.
` Q. But isn't -- isn't it what the --
` isn't what you are saying is that, and I am
` reading the heading here, "one of ordinary
` skill in the art would not have reasonably 09:40
` expected everolimus to have the unique
` combination of properties it has"? Is that
` correct?
` MR. STRINGHAM: Objection,
` mischaracterizes the witness' 09:40
`
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