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` DAVID ROSS, M.D.
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
` _______________________________________
`
` SANDOZ, INC.,
` APOTEX, INC., and APOTEX CORP.,
` EMCURE PHARMACEUTICALS, LTD.,
` HERITAGE PHARMA LABS., INC.,
` HERITAGE PHARMACEUTICALS, INC.,
` GLENMARK PHARMACEUTICALS, INC., USA,
` GLENMARK HOLDINGS, SA,
` GLENMARK PHARMACEUTICALS, LTD., MYLAN
` LABORATORIES LIMITED,
` TEVA PHARMACEUTICALS,
` FRESENIUS KABI USA, LLC and WOCKHARDT BIO AG,
` Petitioners,
` v.
` ELI LILLY & COMPANY,
` Patent Owner.
` ________________________________________
`
` Case No. IPR2016-00318
` Patent No. 7,772,209
`
` VIDEOTAPED DEPOSITION OF DAVID B. ROSS, M.D.
` Friday, January 20, 2017
` Chicago, Illinois
`
`Reported By:
`TRICIA J. FLASKA, CSR, RPR
`JOB NO. 117984
`
`TSG Reporting - Worldwide 877-702-9580
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`Sandoz v. Lilly IPR2016-00318
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`

`

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` DAVID ROSS, M.D.
`A P P E A R A N C E S:
` BRINKS, GILSON & LIONE
` BY: JOSHUA JAMES, ESQ.
` LAURA LYDIGSEN, ESQ.
` 455 North Cityfront Plaza Drive
` Chicago, Illinois 60611
` ATTORNEYS FOR SANDOZ, INC.,
`
` RAKOCZY MOLINO MAZZOCHI SIWIK
` (Via Telephone)
` BY: PATRICK KILGORE, ESQ.
` 6 West Hubbard Street
` Chicago, Illinois 60654
` ATTORNEYS FOR APOTEX, INC. and APOTEX
` CORP.,
`
` ALSTON & BIRD (Via Telephone)
` BY: THOMAS PARKER, ESQ.
` 90 Park Avenue
` New York, New York 10016
` ATTORNEYS FOR MYLAN LABORATORIES LIMITED,
`
`Page 5
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` DAVID ROSS, M.D.
` I N D E X
` WITNESSES
`All Witnesses: Page
`DAVID B. ROSS, M.D. for Defendant
` Examination by Mr. Krinsky 6
` Examination by Mr. James 130
`
` (No exhibits marked.)
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` DAVID ROSS, M.D.
`
` Friday, January 20, 2017
` 8:23 a.m.
`
` VIDEOTAPED DEPOSITION OF DAVID B. ROSS,
`M.D., held at Brinks, Gilson & Lione, 455 North
`Cityfront Plaza Drive, Chicago, Illinois 60611
`before Tricia J. Flaska, CSR, RPR.
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`Page 4
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` DAVID ROSS, M.D.
`A P P E A R A N C E S: (Cont'd):
`
` WILLIAMS & CONNOLLY
` BY: DAVID KRINSKY, ESQ.
` ALEC SWAFFORD, ESQ.
` 725 Twelfth Street, N.W.
` Washington, DC 20005
` ATTORNEYS FOR THE PATENT OWNER;
`
` SKIERMONT DERBY (Via Telephone)
` BY: SARAH SPIRES, ESQ.
` MIEKE MALMBERG, ESQ.
` 2200 Ross Avenue
` Dallas, Texas 75201
` ATTORNEYS FOR NEPTUNE GENERICS, LLC;
`
`ALSO PRESENT: Jeremy Mangan, Videographer
` Jim Leeds
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`Lilly Ex. 2132
`Sandoz v. Lilly IPR2016-00318
`
`

`

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` DAVID ROSS, M.D.
` THE VIDEOGRAPHER: We are now on the record.
`This marks the beginning of media number one in the
`deposition of David B. Ross, M.D., in the matter of
`Sandoz, Inc., et. al. versus Eli Lilly & Company in
`the U.S. Patent and Trademark Office before the
`Patent Trial and Appeal Board, Case Number
`IPR-201600318.
` This deposition is being held at 455 North
`Cityfront Plaza, Chicago, Illinois on January 20th,
`2017, and the time is now 8:23 a.m. All attorneys
`present will be noted on the stenographic record.
` Will the court reporter please swear in the
`witness.
` D A V I D R O S S, M.D.
`called as a witness, having been first duly sworn by
`a Notary Public, was examined and testified as
`follows:
` EXAMINATION
`BY MR. KRINSKY:
` Q Good morning.
` A Good morning.
` Q You're a medical doctor, correct?
` A Yes.
` Q So shall I refer to you as Dr. Ross?
`
`Page 8
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` DAVID ROSS, M.D.
`interfere with the ability to testify truthfully?
` A No.
` Q Nothing that would impair your cognition?
` A No.
` Q Okay. Briefly describe your educational
`background.
` A I received my bachelor of science in
`molecular biophysics and biochemistry at Yale
`University in 1980. I matriculated at New York
`University School of Medicine, as well as the NYU
`Graduate School of Arts and Sciences in 1980, and I
`was awarded a Master's degree in biochemistry in
`1985, an M.D. in 1988, and a Ph.D in biochemistry in
`1988.
` I subsequently completed a categorical
`internal medicine residency, again at NYU. I then
`went on and did fellowship training in infectious
`diseases at Yale University and Yale-New Haven
`Hospital, completed that in 1994.
` And then in terms of other formal
`education, I received a Master's in biomedical
`informatics at Oregon Health & Sciences University
`in, I believe it was 2012.
` Q And when did you start that master of
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` DAVID ROSS, M.D.
` A Please.
` Q Could you briefly describe your -- well,
`first of all, have you ever been deposed before?
` A A few times.
` Q Okay. So you -- you know how this process
`works?
` A In general. If you can just briefly review
`kind of what --
` Q Well, but the -- your -- I'll let your
`counsel, you know, speak to the -- the details, but
`I -- I'm here to ask you questions and you're here
`to answer those questions and your -- your counsel
`has the right to object, but the fact that they
`object doesn't mean that you don't still have to
`answer the questions, is, I think, the nutshell that
`you need to know.
` A Okay.
` Q And you understand that you're under oath?
`You were just sworn in?
` A Yes.
` Q So is there any reason you can't testify
`fully and truthfully today?
` A No.
` Q Are you on any medication that would
`
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` DAVID ROSS, M.D.
`biomedical informatics program?
` A I believe it was around 2004. Although
`initially, I think it was a less extensive program
`that I enrolled in, and I then decided to proceed
`and get a Master's degree after completing that
`program.
` Q So was this something you were doing
`part-time while you were working?
` A Yes.
` Q And where do you currently work?
` A I'm -- my full-time job is at the
`Department of Veterans Affairs in Washington, DC.
` Q And -- and what is that full-time job?
` A I am director of HIV, hepatitis, and
`related conditions programs in the Veterans Health
`Administration.
` Q And -- and what is the Veterans Health
`Administration?
` A Veterans Health Administration is a
`component of the U.S. Department of Veterans
`Affairs, which is a cabinet-level agency. The VHA
`is the component of VA that provides healthcare to
`enrolled beneficiaries who are primarily veterans
`who are eligible for care in VA. And that's
`
`TSG Reporting - Worldwide 877-702-9580
`
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`Sandoz v. Lilly IPR2016-00318
`
`

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` DAVID ROSS, M.D.
`essentially what VHA is.
` Q And you do -- you do consulting in addition
`to your full-time work as a government employee?
` A I do.
` Q Have you served as an expert witness before
`since your -- beginning your position at the VHA?
` A Yes.
` Q In -- in what capacity, to the extent you
`can say without breaching any confidentiality
`obligations?
` A When -- I'm sorry -- when you say "in what
`capacity" can you --
` Q Well, what -- what type of cases?
` A Oh. In general, cases related to my
`expertise. Some of these have been related to my
`clinical background. Some have been related to my
`background and expertise in FDA. So those have
`included tort claims, securities fraud litigation.
`That's sort of, I think, a summary of the sort of
`the cases that I've been involved in.
` Q Is this your first patent case?
` A Yes.
` Q And you say you've done work related to
`your clinical background. What do you mean by that?
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`Page 12
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` DAVID ROSS, M.D.
`program at the VHA and you also see patients?
` A Yes.
` Q And you also do consulting work?
` A Yes.
` Q Does the VHA know you do this consulting
`work?
` A Yes.
` Q Are there rules surrounding the outside
`expert witness engagements of employees such as
`yourself?
` A Yes.
` Q And do you comply with those rules?
` A Yes.
` Q What are those rules?
` A So the most important rule that applies
`here -- and I can't give you the exact statutory
`language -- is that federal a employee cannot serve
`as an expert witness in a federal -- case in federal
`court or something under federal jurisdiction
`without essentially authorization from the agency if
`it's a case in which the United States has a direct
`and substantial interest.
` Q Do you have authorization from the agency
`to testify in this case?
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` A So the cases that I've worked on have been,
`in general, cases related to clinical infectious
`diseases.
` Q And in what capacity have you testified in
`cases related to clinical infectious diseases?
` A As an expert witness.
` Q In -- in what types of cases have you
`testified as a -- in your capacity as an expert in
`infectious disease as opposed to as an expert in
`FDA?
` A Oh. So these have been, in general,
`medical malpractice cases. Some of these have been
`tort claims that are not necessarily medical
`malpractice, but where there's an infectious disease
`component in terms of causation or where it's --
`that expertise is otherwise relevant.
` Q Is it fair to say that your -- your area of
`medical expertise is in infectious diseases?
` A Well, clinically I provide both infectious
`disease care -- this is in my clinical practice --
`but I also practice as a general internist, and so I
`provide primary care as well. And in the VA, that
`covers quite a lot of ground.
` Q So you have a job as a director of a
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` DAVID ROSS, M.D.
` A There's not -- it -- it's not really
`authorization. If a case does not -- if the U.S. --
`United States is not a direct -- does not have a
`direct and substantial interest in the case, then no
`authorization is -- is needed.
` On occasions when there have been
`questions, I've consulted with the Office of General
`Counsel at VHA if I have questions about whether a
`particular matter may represent an issue, which
`never has.
` The other issue, I'm sorry, I should
`mention is that if there is a case in which it --
`there may be a conflict with my official duties,
`that -- I either have to not accept the case or
`recuse myself from any matters -- official matters
`which might be involved in that. And to date, that
`has not happened.
` Q So you don't see this case as bearing on
`your role at the VHA?
` A I do not.
` Q Is the VHA a consumer of generic drugs?
` A Is it a consumer of generic drugs?
` Q Or let me -- let me rephrase. Does the VHA
`purchase generic drugs for administration to its
`
`TSG Reporting - Worldwide 877-702-9580
`
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`Sandoz v. Lilly IPR2016-00318
`
`

`

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` DAVID ROSS, M.D.
`patients?
` A Yes.
` Q Does it purchase generic oncology drugs?
` A I don't know for sure. I'm -- I'm not
`involved in the pharmacy aspect of -- of that, of
`oncology drugs, so I would presume so, but I don't
`have any direct knowledge of what they do.
` Q Do you ever prescribe generic drugs in your
`practice?
` A I -- what I prescribe are drugs that matter
`in which whether they're generic or trade name is
`usually not something I'm aware of except on very
`rare occasions.
` Q What are those rare occasions?
` A There are sometimes patients who have a
`need clinically for a particular formulation, and in
`those instances, I may make a special request to
`make sure that they're prescribed the appropriate
`formulation, which if it is the -- excuse me --
`innovator drug, if it's a trade name drug, in
`essence, I may ask for that, but that -- that's --
`off the top of my head, I can only think of one
`patient where that's actually happened.
` Q Do you have an understanding that generic
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` DAVID ROSS, M.D.
`negotiation and contracting with pharmaceutical
`companies, so I don't know that that's true. It --
`it could be. Or it could be that the VA is -- VHA,
`I should say, is authorized -- has a number of
`statutory advantages, if you will, where there's a
`statutory discount for drugs.
` And in addition, because of the -- its
`purchasing, the VHA is often able to reach
`agreements with pharmaceutical companies over and
`above that. So I actually don't know that that's
`true.
` Q I think you mentioned that your post M.D.
`fellowship, your first fellowship or residency -- I
`apologize if I --
` A No, that's --
` Q -- don't get the terminology correct --
` A Sure.
` Q -- was in categorical internal medicine?
` A Yes.
` Q What is that?
` A So that is a 36-month training program that
`involves -- at the time that I did it, and it's
`still this way today -- hospital-based internal
`medicine training involving care of patients,
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`drugs often are cheaper than brand name
`counterparts?
` A That's my -- not being, you know, involved
`directly in this area, that's my -- that is my
`understanding.
` Q Do you have an understanding that the
`petitioners in this case are seeking to invalidate
`the patent on a drug that's currently sold as a
`branded drug?
` A That's my understanding.
` Q So if the petitioners prevail, oncology
`drugs will get cheaper for the VHA, won't they?
` MR. JAMES: Objection. Form.
` A I think it's a very broad statement. I
`can't say one way or the other. The only drug that
`I've been asked to look at in this case is -- not --
`that's at issue here is this particular agent. So
`when you say "oncology drugs" --
`BY MR. KRINSKY:
` Q That's -- that's fair. Pemetrexed --
` A Okay.
` Q -- will get cheaper for the VHA if
`petitioners prevail; is that fair?
` A I actually -- the VA has its own
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` DAVID ROSS, M.D.
`didactic lectures, mentoring by more senior
`physicians, as well as maintaining outpatient
`continuity clinic generally once a week. And
`typically that will involve being -- providing
`direct patient care to, in the course of three
`years, over a thousand patients.
` It also comprises receiving both training
`not just in general internal medicine, but exposure
`to very specialty areas of internal medicine, as
`well as consultation on patients outside the general
`internal medicine service.
` Q And then you mentioned after that you
`focused more specifically on infectious disease?
` A Yes.
` Q And can you just describe -- well, first of
`all, your -- your current job with the VHA, I think
`you testified earlier, involves both a director role
`and patient care?
` A Just to clarify, I do not receive
`compensation for the patient care aspect. That is
`-- I am on staff at the Washington, D.C. VA as
`what's called a without compensation physician. So
`I do not receive any payment or any other kind of
`compensation for doing that. That is something that
`
`TSG Reporting - Worldwide 877-702-9580
`
`5
`
`Lilly Ex. 2132
`Sandoz v. Lilly IPR2016-00318
`
`

`

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`is voluntary on my part. I -- I wish to see
`patients and it is not a requirement, either in
`terms of my position description or my performance
`plan.
` Q I see. So you -- you have a job -- your --
`your salaried position is as a director at VHA, and
`then in addition to that, you -- you do essentially
`volunteer work as a physician; is that what you're
`saying?
` A Correct.
` Q Approximately how much time do you spend on
`patient care versus the -- the director role at VHA?
` A I would say on average it's probably -- and
`it can vary from week to week obviously -- but I
`would say roughly 75 percent/25 percent. And
`there's some periods during the year where I'm not
`just seeing outpatients, but I'm also making rounds
`in the hospital. And, you know, then the proportion
`of clinical time compared to the time in my director
`role will go up.
` Q Is it -- is it the kind of thing where you
`-- you spend, you know, one day a week or one
`afternoon a week at the hospital or is it -- how do
`you divide your time?
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` DAVID ROSS, M.D.
`the national level, as I am, or at the regional
`level. And there's -- that takes a lot of time, but
`there's always a need for clinicians at the VA. If
`I can just give an example.
` The current Under Secretary for Health for
`the VHA who was just nominated to be the Secretary
`of VA, Dr. David Shulkin, is an active clinician.
`He sees patients, not on a continuity clinic, that
`wouldn't be practical, but he does see patients
`essentially as the walk-in clinic at the Manhattan
`VA.
` So it's something where, if a physician who
`is not primarily charged with clinical -- I mean, if
`you're talking about a staff physician who's --
`who's there, that's their job. They -- they -- you
`know, they're -- they're taking care of patients,
`but if you have someone whose primary responsibility
`is not patient care, they are still able, if they
`wish, to see patients.
` Q And I think you mentioned this, I
`apologize, but at what hospital do you see patients?
` A The Washington, D.C. VA medical center.
` Q I see. So you're seeing -- you're seeing
`VA patients?
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` A It's -- well, formally, there's one -- one
`day a week, although I actually also every other
`half -- every other Wednesday I have a clinic, but
`in addition, there's -- I generally give myself my
`number to my patients, so I may be dealing with --
`if I'm over at VA central office, I may get a call
`from a patient that I deal with. So it's kind of
`inter- -- intermixed.
` Q So it's even though you're not compensated
`specifically for this clinical time, this is sort of
`a recognized part of your job schedule at the VHA?
` A Yes.
` Q Is this a program that VHA has for its
`employees who are physicians? How did -- how did
`this arrangement come to be?
` A Oh. So when I was at the Food and Drug
`Administration, I started on staff -- this is back
`in '98, I believe -- as WOC physician and -- at the
`D.C. VA. And, again, it was the same sort of thing
`where you're not required to do it, but people would
`-- physicians would choose to do it.
` There are physicians at VA who are -- their
`-- their day job, so to speak, what they're -- we're
`responsible for, are managing programs, whether at
`
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` DAVID ROSS, M.D.
` A Mostly. There's been -- there are -- in
`general, the VA -- or VHA is not allowed to take
`care of non- -- this is a -- I'm oversimplifying
`this, but, in general, it's not a -- it's primarily
`for veterans.
` We do have non-veterans who are eligible
`for care. I can't remember the last time I took
`care of somebody at the hospital that wasn't a
`veteran. I -- I mean, it's -- there are legally
`people who are entitled to care even though they're
`not veterans, but, in general, it's -- I would say
`it's, in my case, it's almost -- it's been a hundred
`percent veterans.
` Q And in what clinical areas do you practice?
` A So I provide primary care, what I think you
`could also say general internal medicine, but I
`think primary care is slightly different
`connotations. I do -- I -- I guess I would say
`primary care and general internal medicine, and then
`I do specialty care in infectious diseases.
` Q And let me -- let me focus, first, on the
`primary care. When you say "primary care," you mean
`just people who, you know, are either sick and --
`and call their doctor because they're not feeling
`
`TSG Reporting - Worldwide 877-702-9580
`
`6
`
`Lilly Ex. 2132
`Sandoz v. Lilly IPR2016-00318
`
`

`

`Page 22
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` DAVID ROSS, M.D.
`well, or people who have -- just need regular
`preventative checkups?
` A Yes. Both. Both of those.
` Q Okay. You're sort of -- from a layperson's
`perspective, you know, the -- the -- just a general
`purpose doctor that you have when you go to the
`doctor once a year?
` A Yes. I think that's a fair statement.
` Q Okay. And then you also mentioned
`specialty infectious disease care. Can you describe
`your -- your role in that?
` A Sure. So majority -- not entirely, but the
`majority of the patients who I see are patients who
`have HIV infection. Some have hepatitis C
`infection. And so I'll provide care for those
`individuals on a continuing basis.
` Just to clarify, there's kind of two --
`again, I'm oversimplifying -- but there's two
`general ways to think about this. There's the
`continuity clinic where you see people on a regular
`basis. And the majority of my patients, not
`everybody, but the majority of patients there have
`HIV infection. And so I'm managing both their
`primary care needs and their HIV infection.
`
`Page 24
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` DAVID ROSS, M.D.
` A Well, just to be a little more concrete
`about it, I'm involved in screening for cancer.
`It's particularly important in the area that I'm in
`because both the chronic infectious conditions that
`I have a -- I guess you could say subspecialty in,
`you're likely to see an increased risk of cancer.
` In addition, I'm dealing with a patient
`population, in general, that is at higher risk for
`malignancy. So lung cancer, esophageal cancer, and
`that's related to exposures like tobacco use and
`alcohol use.
` Just beyond screening there's, of course,
`seeing what's going on with the patient. So I have
`a 74-year-old man who has HIV and hep C infection
`and on exam -- it was probably about a
`year-and-a-half ago -- he had a swollen -- what we
`call a supraclavicular -- I can -- what's called a
`St. Mary Joseph's Node, which is a classic finding
`for malignancy.
` And so I found that and he turned out to
`have what's called follicular lymphoma, and the
`treatments for that involve drugs that suppress the
`immune system. So, you know, I don't write for
`those medications themselves, but a lot of the
`
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` DAVID ROSS, M.D.
` And then there are patients where I'm asked
`to see the patient as a consultant, sent to me from
`their primary care physician because there's an
`infectious disease issue that's come up or somebody
`thinks that something that's going on may be an
`infectious disease.
` So just to give a concrete example, on
`Tuesday I saw a patient who has a very esoteric eye
`condition and there was some lab data that suggested
`he might have a parasitic infection, and so that
`individual was scheduled for my clinic with the
`question of do you think this gentleman has a
`parasitic infection? If so, what should we do about
`it? Because it might -- the treatment might
`intersect -- or the presence of this infection might
`intersect with treatment that we're doing for his
`eye condition.
` Q And you're -- you're not an oncologist, are
`you?
` A I am -- do take care of patients who have
`cancer. I'm not an oncologist, however.
` Q When you say you take care of patients who
`have cancer, you see patients who have cancer in
`your role as a primary care physician?
`
`Page 25
`
` DAVID ROSS, M.D.
`patients who I take care of, they're being given
`drugs that can further compromise their immune
`system, so I get involved in that.
` In this particular case, because lymphoma
`-- some lymphomas are related to hepatitis C, I was
`involved in the treatment of the cancer in the sense
`that I treated him for his hepatitis C and that's
`been shown in some instances to either cause
`lymphoma to resolve or cause it to become less of a
`problem.
` The other way that I'm involved is, for
`patients who don't have HIV, they're very, very
`prone to infectious complications. And so -- and
`this is every time I'm on service, we're called to
`see somebody who's got -- just as an example --
`acute myelogenous leukemia and has had chemotherapy
`and understanding kind of what infectious disease
`complications are -- might be associated with
`particular chemotherapy regimen or other factors is
`extremely important because that can make the
`difference between choosing -- some -- some patients
`are relatively low risk for infectious disease
`complications because of the nature of the cancer
`that they have and the nature of the chemotherapy,
`
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`
`TSG Reporting - Worldwide 877-702-9580
`
`7
`
`Lilly Ex. 2132
`Sandoz v. Lilly IPR2016-00318
`
`

`

`Page 26
`
`Page 27
`
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` DAVID ROSS, M.D.
`others are --
` THE REPORTER: I'm sorry, "other are"?
` A I'm sorry. Others are at much higher risk,
`sorry, because of the nature of the chemotherapy.
` Q That was a -- that was a long answer and I
`understand --
` A I'm sorry.
` Q -- this may be a complicated --
` A Sure.
` Q -- relationship, but the -- is it fair to
`say that when you have -- either have a patient who
`has already -- is known to have cancer or you
`diagnose someone as possibly having cancer, that
`patient also sees an oncologist for the treatment of
`the cancer?
` A In general, yes.
` Q And in general, the oncologist rather than
`you is the one who's prescribing, for example,
`chemotherapy for the cancer, although you may
`consult on that if it's going to interact with their
`infectious disease treatment; is that fair?
` A Yes.
` MR. JAMES: Objection, foundation.
`BY MR. KRINSKY:
`
`Page 28
`
` DAVID ROSS, M.D.
` A I have one patient who's on methotrexate
`and I sometimes will renew that, but that's for
`rheumatoid arthritis.
` Q So to answer my question, you've never
`described pemetrexed?
` A No. I'm -- I'm sorry. I'm -- I'm -- yeah.
`That's correct.
` Q You've -- you've prescribed methotrexate in
`one instance where it was --
` A Initiated. Sorry.
` Q Yeah, I'm sorry. And -- and the court
`reporter will have a much easier time --
` A Yes. I --
` Q -- if I ask questions and you answer them.
` A -- heard her. Understood. Apologize.
` Q I'll try not to talk over you, too, so
`it'll -- it'll all work out.
` Just -- just to clarify the record there,
`you have prescribed methotrexate in the context of a
`patient who was receiving methotrexate for
`rheumatoid arthritis, correct?
` A That's correct.
` Q You have not prescribed methotrexate as a
`cancer treatment?
`
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` DAVID ROSS, M.D.
` Q Have you ever, yourself, prescribed cancer
`chemotherapy? Or at least since you were a general
`resident?
` A I'm sorry. Just to clarify, you mean
`including the time that I was a resident or --
` Q Well, I -- I didn't know if you did a, you
`know, an oncology round as part of your training or
`something. But since -- since that time.
` A Ah. I don't believe so.
` Q So you've -- you've -- have you ever
`prescribed an antifolate?
` A Yes.
` Q In what capacity?
` A Trimethoprim-sulfamethoxazole is a
`antifolate and --
` Q For the treatment of bacterial infections?
` A That's -- well, there's other things it's
`used for in terms of infections besides that, but,
`yeah, you -- for as an antimicrobial, I think is
`what you're -- you're asking, yes, that's correct.
` Q Okay. So you've -- you've never described
`an antifolate for the purpose of treating cancer?
` A I'd say that's correct.
` Q You certainly never prescribed pemetrexed?
`
`Page 29
`
` DAVID ROSS, M.D.
` A That's also correct.
` Q And you've not prescribed pemetrexed at
`all?
` A No.
` Q So let's talk a bit about your time at --
`well, actually, before we do that, could you just
`very briefly describe your non-clinical job duties
`at the VHA today?
` A So I'm responsible for, A, setting policy
`on -- for VHA on diagnosis, treatment, care and
`prevention of HIV and viral hepatitis. Or more
`accurately, I'm the primary -- my office is the
`primary advisor to the Under Secretary on those
`areas, as well as related conditions. So that's
`number one.
` Number two, and this is probably the major
`portion of my -- excuse me -- job, is, from a
`practical point of view, to implement policies that
`are meant to diagnose veterans with those
`conditions, get them into care, get them treated and
`find out how they're doing, basically improve access
`and quality.
` So just to take a very concrete example,
`the VHA has the largest single group of patients
`
`TSG Reporting - Worldwide 877-702-9580
`
`8
`
`Lilly Ex. 2132
`Sandoz v. Lilly IPR2016-00318
`
`

`

`Page 30
`
`Page 31
`
` DAVID ROSS, M.D.
`with hepatitis C in the country. We take care of
`about five percent of all patients with hepatitis C
`-- chronic hepatitis C. And my job over the last
`few years has been to increase testing among
`veterans who are at risk. If they're positive, get
`them into treatment, get them treated, and then get
`them -- look for complications and deal with those
`complications.
` And this is not at a policy level. This is
`at a very practical level of how -- how can we treat
`more patients and cure more patients. So in the
`last three years, we've treated about 50 percent of
`the veterans that we know about with hepatitis C in
`the country. So that's -- that's quick summary of
`and an example of what I do.
` Q Does any of your work in that capacity
`involve cancer treatment?
` A Yes.
` Q And how so?
` A Well, just to get -- give an example,
`hepatitis C is the leading cause of hepatocellular
`carcinoma, primary cancer of the liver, in both the
`United States and the VHA. And the number of
`veterans with hepatitis C, who've been diagnosed
`
`Page 32
`
` DAVID ROSS, M.D.
`question?
`BY MR. KRINSKY:
` Q Sure. I mean --
` A Go ahead. I'm --
` Q Let me -- let me rephrase. That was a
`poorly-worded question.
` The -- it sounds to me like your answer,
`that you do have a role in cancer treatment, was a
`way of saying that you -- you have a role in cancer
`treatment, but that that role in cancer treatment is
`-- relates to the overlap between cancer and
`infectious diseases that your group works on.
` Is that fair?
` MR. JAMES: Objection. Form.
` A I -- you know, I actually would say that
`that's not correct. I think that that is a large
`part of it, but just to give an example, one thing
`that I'm extremely interested in is how can the
`tools that we're developing be used in ot

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