`Tanenberg, M.D., FACP, Robert J.
`
`December 6, 2016
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`1
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` -----------------------------
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` -----------------------------
` MYLAN PHARMACEUTICALS INC.,
` WOCKHARDT BIO AG,
` TEVA PHARMACEUTICALS USA, INC.,
` AUROBINDO PHARMA U.S.A., INC.,
` Petitioners,
` v.
` ASTRAZENECA AB,
` Patent Owner.
` -----------------------------
` Case: IPR2015-01340
` U.S. Patent No. RE44,186
` -----------------------------
`
` DEPOSITION OF ROBERT J. TANENBERG, MD, FACP
` Tuesday, December, 6, 2016
` Greenville, North Carolina
` 9:58 a.m.
`
` Reported in Stenotype by
` Sophie Brock, BA, RPR, CRR
`Transcript produced by computer-aided transcription
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`202-220-4158
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`Page 1 of 60
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`AstraZeneca Exhibit 2222
`Mylan v. AstraZeneca
`IPR2015-01340
`
`
`
`Case: IPR2015-01340
`Tanenberg, M.D., FACP, Robert J.
`
`December 6, 2016
`
`2
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` Tuesday, December 6, 2016
` Greenville, North Carolina
` 9:58 a.m.
`
` T R A N S C R I P T of the Deposition of
`ROBERT J. TANENBERG, MD, FACP, held at the home of
`Dr. Tanenberg, 1866 Blue Banks Farm Road, Greenville,
`North Carolina 27834, on Tuesday, December 6, 2016, at
`9:58 a.m., pursuant to Notice, before Sophie Brock,
`Registered Professional Reporter, Certified Realtime
`Reporter, and Notary Public in and for the State of
`North Carolina.
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`Case: IPR2015-01340
`Tanenberg, M.D., FACP, Robert J.
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`December 6, 2016
`
`3
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` A P P E A R A N C E S
`APPEARING ON BEHALF OF THE PETITIONER MYLAN
`PHARMACEUTICALS INC.:
` WILSON SONSINI GOODRICH & ROSATI, PC
` 1700 K Street, N.W.
` Fifth Floor
` Washington, D.C. 20006-3817
` 202-973-8800
`BY: RICHARD TORCZON, ESQ.
` rtorczon@wsgr.com
`
`APPEARING ON BEHALF OF PATENT OWNER ASTRAZENECA AB:
` FINNEGAN, HENDERSON, FARABOW, GARRETT &
` DUNNER, LLP
` Two Freedom Square
` 11955 Freedom Drive
` Reston, Virginia 20190-5675
` 571-203-2700
`BY: NICOLE A. CONLON, PH.D., ESQ.
` nicole.conlon@finnegan.com
` - and -
` ROBERT F. SHAFFER, ESQ.
` robert.shaffer@finnegan.com
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`Case: IPR2015-01340
`Tanenberg, M.D., FACP, Robert J.
`
`December 6, 2016
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`4
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` INDEX OF EXAMINATIONS
` PAGE
`BY MS. CONLON . . . . . . . . . . . . . . . . .5, 47
`BY MR. TORCZON . . . . . . . . . . . . . . . . . . 45
`
`* There were no exhibits marked *
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` PREVIOUSLY-MARKED EXHIBITS REFERENCED
`NUMBER PAGE
`Exhibit 1001 . . . . . . . . . . . . . . . . . 21
`Exhibit 1042 . . . . . . . . . . . . . . . . . 25
`Exhibit 2057 . . . . . . . . . . . . . . . . . 39
`Exhibit 2080 . . . . . . . . . . . . . . . . . 37
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`Case: IPR2015-01340
`Tanenberg, M.D., FACP, Robert J.
`
`December 6, 2016
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` P R O C E E D I N G S
`Whereupon,
` ROBERT J. TANENBERG, MD, FACP,
` having first been duly sworn/affirmed,
` was examined and testified as follows:
` EXAMINATION BY COUNSEL FOR THE PATENT OWNER
`BY MS. CONLON:
` Q. Good morning, Dr. Tanenberg. My name is
`Nicole Conlon, and I represent AstraZeneca. I'll be
`asking some questions today.
` Can you please state your full name and
`residential address for the record, please.
` A. Sure. Robert J. Tanenberg. My address is
`1866 Blue Banks Farm Road, Greenville, North Carolina
`27834.
` Q. Okay. And do you understand that you are
`appearing in this case as an expert for the
`petitioners?
` A. Yes, I do.
` Q. Okay. And have you been retained by Mylan?
` A. I guess so.
` Q. Were you retained by Wockhardt?
` A. Well, I was contacted by the firm --
` Q. Okay.
` A. -- who represent Mylan.
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`Case: IPR2015-01340
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`December 6, 2016
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` Q. And do you understand whether or not you are
`also retained by Wockhardt, Teva, Aurobindo, Amneal,
`or Sun?
` A. I don't have the name of the firm in front of
`me right now, but this gentleman represents that firm.
` Q. Okay. How did you come to be an expert in
`the case?
` A. I was contacted by Jad Mills, who found me
`and asked if I could do a case like this. And
`I agreed. How he had -- got my name, I do not know.
`It might have been through an expert witness
`organization is possible.
` Q. And do you know what firm Jad Mills is
`associated with?
` A. Wilson Samba, something like that. I don't
`have it in front of me.
` Q. Wilson Sonsini? Does that sound right?
` A. Something like that. He's out of Seattle,
`I guess.
` Q. Okay. And when were you first contacted
`about the possibility of serving as an expert in this
`case?
` A. I believe it was September, October possibly.
`I don't remember exactly.
` Q. September or October --
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`December 6, 2016
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` A. This year.
` Q. -- of this year?
` A. Yeah, this year. 2016. Right.
` Q. And you don't remember whether it was later
`in September or earlier October?
` A. I'd have to look it up. I have records.
`I didn't bring any records.
` Q. And how were you first contacted? Was it by
`email or phone?
` A. It was a phone call, yeah.
` Q. And what was your understanding that your
`assignment was at that time?
` A. My assignment was to review a statement made
`by another endocrinologist regarding class of drugs
`and a particular drug, saxagliptin, and to see if
`I agreed with that statement.
` Q. Okay. And did you understand that you'd be
`submitting an Expert Declaration in this case at that
`time?
` A. Yes.
` Q. Okay. And how many -- about how many
`conversations did you have before you determined
`whether or not you would submit an Expert Declaration
`in this case?
` A. Maybe two or three.
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`Case: IPR2015-01340
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`December 6, 2016
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` Q. Okay. I just want to go back for one minute.
` Have you been deposed before?
` A. Yes.
` Q. Okay. And so you're probably already
`familiar with the ground rules, but I just wanted to
`just go over them again.
` A. Sure.
` Q. It's important for the court reporter that we
`not talk at the same time. So I'll let you finish
`your answer and you'll let me finish my question.
` A. I understand.
` Q. And that the court reporter needs you to use
`words and not gestures. Understand?
` A. Yes.
` Q. Also, if you don't understand a question that
`I ask today, just please ask for a clarification.
` A. Sure.
` Q. I'm happy to do so.
` And we'll take regular breaks; but if you
`need more frequent breaks, just let me know and we'll
`accommodate that.
` A. Okay. That's great.
` Q. All right. What was your understanding of --
`as to the scope of your work in this case?
` MR. TORCZON: Objection. Form.
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`Case: IPR2015-01340
`Tanenberg, M.D., FACP, Robert J.
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`December 6, 2016
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` THE WITNESS: My understanding was that this
`was a patent case involving saxagliptin, and to
`determine whether or not saxagliptin was a unique drug
`and its efficacy in type 2 diabetes vis-à-vis other
`drugs in its class.
`BY MS. CONLON:
` Q. Okay. So you understand that this case
`concerns AstraZeneca's patent, the RE44,186 patent?
` A. Yes.
` Q. And out of convenience, I'll refer to that as
`the '186 patent today.
` A. Yes.
` Q. And you were asked to review the August 2,
`2016, Declaration of Dr. Lenhard --
` A. Yes.
` Q. -- to provide opinions with respect to what
`Dr. Lenhard wrote in that Declaration?
` A. Yes.
` Q. Do you know -- well, you know that a trial
`took place between these parties in this proceeding
`concerning the '186 patent?
` A. I wasn't 100 percent sure of what had taken
`place so far.
` Q. Do you know that there was a trial that was
`held on September 19th to the 21st of this year
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`Case: IPR2015-01340
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`December 6, 2016
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`between the parties in this case?
` A. I don't think I was aware of that.
` Q. Do you recall whether you were contacted
`after September 19th to 21st, 2016, in this case?
` A. I have to look that up because I'm not sure
`exactly what date.
` Q. Okay. And you were aware that Dr. Lenhard
`served as AstraZeneca's expert clinician in that
`litigation?
` A. Correct. Yes. I read his -- I read his CV,
`and I read his -- his manuscript, if you will, his
`Declaration.
` Q. You read Dr. Lenhard's CV and Declaration in
`this proceeding; correct?
` A. Right. I thought it was a deposition.
`I didn't realize it was a court case; I thought it was
`just a deposition and his -- and his -- actually,
`I didn't think I read a deposition of him. I just
`read his Declaration that he wrote. That's all.
` Q. Okay. So you did not read the Declaration
`that Dr. Lenhard submitted in the parallel litigation;
`correct?
` A. I read one Declaration. And I can't tell you
`which one it was. I didn't know there was more than
`one.
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`December 6, 2016
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` Q. Okay. So you haven't considered the
`deposition transcript of Dr. Lenhard from the
`litigation?
` A. I didn't read any depositions of his, no.
` Q. And you haven't considered the trial
`testimony of Dr. Lenhard that was submitted in the
`parallel litigation?
` A. Unh-unh. I only reviewed his Declaration and
`all the supporting documents of that Declaration.
` Q. Okay. So you didn't ask to see a transcript
`from the trial?
` A. I'll be honest with you. I'm not sure I knew
`there was a trial. I'm just trying to do my little
`thing here. That was it. I didn't really get the
`gestalt of the entire case. It was kind of little
`pieces I was given. "Please review this, and what do
`you think?" And that's sort of the way it went.
` Q. Are you aware that Mylan had retained another
`clinician, Dr. Gary Tobin, to respond to Dr. Lenhard's
`Declaration and testimony in the parallel litigation?
` MR. TORCZON: Objection. Form.
` THE WITNESS: No.
`BY MS. CONLON:
` Q. So you were not given an opportunity to
`review Dr. Tobin's Declaration or trial testimony or
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`December 6, 2016
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`deposition testimony --
` A. No.
` Q. -- from the parallel litigation?
` A. No. No.
` Q. And so you didn't ask to see a transcript
`from Dr. Tobin's testimony at trial?
` A. Didn't even know he was testifying. Right.
` Q. Do you think, sitting here today, that would
`have been important or relevant to your analysis in
`connection with the opinions that you've rendered in
`this case, to review those materials of Dr. Lenhard
`and Dr. Tobin from the trial?
` A. I can't say. Not knowing what's in them, I
`can't say.
` Q. So going back to the time when you were
`initially contacted about the case, you understood
`from Mylan's attorneys that you'd be rendering an
`opinion that saxagliptin did not satisfy a long-felt
`need for an alternative therapy to treat type 2
`diabetes?
` A. Yes.
` Q. Okay. And you also understood that you'd be
`rendering an opinion that saxagliptin did not show any
`unexpected results?
` A. Yes.
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` Q. You also understood that you'd be rendering
`an opinion that there were no failures of others to
`come up with a DPP-4 inhibitor like saxagliptin?
` A. Well, I'm not sure how the question's
`phrased, but I assumed that I'd be talking about other
`drugs in this class.
` I was a little confused by the question.
` Q. Can you list which drugs in the class you
`considered?
` A. Yes. I considered vildagliptin, which is not
`in the US. I considered sitagliptin. I considered
`alogliptin. I considered linagliptin. And, of
`course, saxagliptin. So four of them are approved in
`the US. Linagliptin is not. The tradename is
`Tradjenta. The sitagliptin tradename is Januvia;
`Saxagliptin is Onglyza; and alogliptin is Nesina.
`Those are the four that are available in the US today.
` Q. So other than vildagliptin, sitagliptin,
`alogliptin, linagliptin, and saxagliptin, did you
`consider any other DPP-4 inhibitors in your analysis
`for this case?
` A. No.
` Q. Did you consider any other classes of drugs
`in your analysis for this case, other than DPP-4
`inhibitors?
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` A. Yes, because Dr. Lenhard referred to other
`classes, like sulfonylureas and metformin. So, yes, I
`did consider all of the classes of drugs that he had
`referred to.
` Q. Did you consider any other classes other than
`the ones that Dr. Lenhard referred to in his
`Declaration?
` A. No.
` Q. Okay. From your initial meetings with your
`attorneys, did you understand that you would be
`rendering an opinion that was adverse to the patent
`covering saxagliptin?
` A. Yes.
` Q. And at the time when you were first contacted
`about this case, you received information about the
`issues; correct?
` A. Yes.
` Q. Okay. What information did you receive?
` A. I received Dr. Lenhard's paper, his CV, and
`several supporting documents, publications that he had
`used in his research.
` Q. Do you recall which supporting documents you
`received?
` A. I got quite a few. There may have been even
`50 or more. Yes.
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` Q. Okay. And what did you do next after you'd
`received those documents?
` A. I read them.
` Q. And did you read them prior to forming your
`opinions in the case?
` A. Yes.
` Q. And did you do any additional literature or
`patent searching on your own for additional
`information?
` A. I didn't do patent searching. I did -- did
`check to see the dates when the drugs came on the
`market and were approved, but I didn't do any patent
`searching. That's not anything I know about.
` But I just looked at the different drugs,
`when they were released, and some other basic
`information, most of which is familiar to me in my
`work. I know the drugs fairly well.
` Q. Did you identify any other literature other
`than information about when the drugs were approved --
` A. Yeah.
` Q. -- on your own?
` A. I actually -- we had references to the
`literature. I gave them some literature, yes. And
`that's in my Declaration. There are some references
`in there.
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`December 6, 2016
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` Q. Okay. We'll take a look at that in a minute.
` Other than the August 2nd, 2016, Declaration
`of Dr. Lenhard, have you reviewed any other
`Declarations that were submitted in this case?
` A. No.
` Q. So you didn't review the Declaration of
`Dr. Ann Weber?
` A. Never heard of her.
` Q. Okay. Dr. Christine Meyer?
` A. No.
` Q. Dr. David Rotella?
` A. No.
` Q. Ivan Hofmann?
` A. No.
` Q. Or Dr. DeForest McDuff?
` A. No.
` Q. Okay. I'm going to hand you a copy of your
`Declaration --
` A. All right.
` Q. -- which is Exhibit 1041.
` (Document was handed to the witness.)
` THE WITNESS: Okay.
`BY MS. CONLON:
` Q. Do you recognize this as a copy of your
`Declaration that was submitted in this case concerning
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`the '186 patent?
` A. Yes, I do.
` Q. Okay. Please take a look at the last page,
`if you will. Can you confirm that you've signed this
`Declaration?
` A. Yes, that's my signature.
` Q. On page 25?
` A. Right. Yes.
` Q. And have you had an opportunity to review the
`Declaration since you've submitted it?
` A. Yes.
` Q. Are you aware of any errors or inaccuracies?
`Anything you wish to correct?
` A. No.
` Q. Okay. Can you tell me the process of how
`your Declaration in this case was prepared?
` A. I submitted what I thought was the important
`information. And Mr. Mills took the information and
`elaborated on it to come up with this document.
` Obviously, I'm not a lawyer, and I couldn't
`come up with all the legal terms necessary for it.
`But the gist of what I gave him was in here. The
`references that I gave him are in here.
` Q. And I think you said that you'd submitted
`what you believed to be important information. What
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`Case: IPR2015-01340
`Tanenberg, M.D., FACP, Robert J.
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`December 6, 2016
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`was the information that you believed to be important?
` A. Right. I think we talked about it. I'm not
`sure if I actually submitted a sheet with all that,
`other than we just talked about the different
`information. I'm a little hazy on that right now.
`I've had surgery, and I'm not quite 100 percent sure
`exactly how that came about.
` But I do know that in our discussions, with
`the information I had, with the references that I gave
`him, this came to be. And I reviewed it, and
`I approved it.
` Q. Okay. Did anyone else work with you in
`preparing this Declaration other than Mr. Mills?
` A. No.
` Q. Okay. And do you recall when you began
`actually working on the Declaration?
` A. Probably October, November is my guess. I'm
`not 100 percent sure. The signature date is -- let's
`see here. The signature date's November 7, so it was
`probably during October or in the very first week of
`November. That's the best I can recollect.
` Q. Okay. After the September trial dates;
`correct? It would be after September 19th to 21st
`that you began working on this Declaration?
` A. Yes.
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`Case: IPR2015-01340
`Tanenberg, M.D., FACP, Robert J.
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`December 6, 2016
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` Q. Approximately how much time did you spend
`preparing your Declaration?
` A. About 15 hours. That doesn't include review
`times and other things as well. So I probably put
`about -- maybe 24 hours in the case so far.
` Q. Okay. In your Declaration, you focused on
`Claims 25 and 26 of the '186 patent; correct?
` A. Yes.
` Q. And you focused on those claims because those
`were the ones that were also asserted at the trial; is
`that right?
` A. I can't say anything about the trial.
`I don't know anything about the trial.
` Q. Okay. Be fair to say that you did not focus
`on other claims in this patent, though; is that right?
` A. I only focused on the -- what was it? -- the
`'186, I think.
` Q. And you only focused on Claims 25 and 26 of
`the '186 patent?
` A. To be honest with you, I'm not sure what the
`25 and 26 represent. So I would hate to make a
`statement without knowing what they represented. If
`you had it in front of me, I could look at it and
`I could recollect it. But if you give me a number,
`I can't put the number together with what you're
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`Case: IPR2015-01340
`Tanenberg, M.D., FACP, Robert J.
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`December 6, 2016
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`saying.
` I did write (as read):
` "I understand the claims depict a
` chemical structure."
` If that's what you mean.
` "25 and 32 depict a chemical
` structure representing
` saxagliptin."
` And then:
` "Claim 32 recites a method for
` treating diabetes in a mammal by
` administering a pharmaceutical
` composition containing
` saxagliptin, and I am familiar
` with it."
` So that, I reviewed, yes. I wasn't just
`clear about the claim numbers.
` Q. Okay. So I'm looking at paragraph 13 of your
`report. And it's fair to say that you reviewed the
`claims -- all the claims contained in the '186 patent?
` A. Yes. I believe that's true.
` Q. And is your understanding that you focused on
`Claims 25 for the purpose of your analysis?
` A. I think I focused more on Claim 32. 25 was
`just the structure of the compound. I didn't really
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`Case: IPR2015-01340
`Tanenberg, M.D., FACP, Robert J.
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`December 6, 2016
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` have much to say about that. But it was the use of
` the drug in -- I mean, I'm a clinician primarily.
` I teach. I'm a professor at the university, and
` I teach, but I'm not a pharmacologist or pharmacist.
` So I was reviewing how this drug is used and
` their claims this is a drug for type 2 diabetes. That
` was -- I reviewed it from a clinical point of view.
` Q. Understood. So I imagine you focused on
` Claim 32 is -- your analysis was based on Claim 32 of
` the '186 patent?
` A. Yeah. Which is basically how the drug is
` used to treat type 2 diabetes, yes.
` Q. And so you did not focus on Claims 25 and 26
` of the '186 patent with respect to whether evidence of
` secondary considerations of nonobviousness was
` relevant to those claims?
` A. I really don't recall what Claim 26 is. If
` you could inform me, I could tell you if I looked at
` it. But I can't recall -- it's not in my head what
` Claim 26 was.
` Q. Just one second.
` I'm going to hand you a copy of the '186
` patent, which is marked Exhibit 1001.
`(Previously-marked Exhibit No. 1001 was referred to.)
` THE WITNESS: Okay.
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`Case: IPR2015-01340
`Tanenberg, M.D., FACP, Robert J.
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`December 6, 2016
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` BY MS. CONLON:
` Q. If you turn to page 4 -- sorry -- to
` Column 91.
` A. Column 91. I see 51, 63.
` MR. TORCZON: There (indicating).
` THE WITNESS: Okay. Yes, I can see it now.
` BY MS. CONLON:
` Q. Okay. And if you want to just take a minute
` and review Claims 25 and 26.
` A. Sure. Absolutely.
` So 25 and 26 just define the chemical
` structure of the compound.
` Q. Okay. So you did not focus on Claims 25 and
` 26, then, for the purpose of your analysis of
` secondary considerations of nonobviousness; correct?
` A. Yeah. I mean, I'm not a chemist, so I can't
` tell you what that structure -- anything specific
` about the structure by looking at it. I was more
` interested in -- in, you know, Number 32, for example,
` how it worked.
` And 25 and 26 just shows the compound, and
` it's a -- it's a salt of a hydrochloride. I mean,
` it's just -- it's chemistry. Again, I'm not a chemist
` or a pharmacist.
` But, on the other hand, under Number 23, I
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`Case: IPR2015-01340
`Tanenberg, M.D., FACP, Robert J.
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`December 6, 2016
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` did review that, understood that. That's clinical
` information.
` Q. Okay. So then the answer to my question that
` you did not focus on Claims 25 and 26 of the '186
` patent for the purpose of your analysis of secondary
` considerations, the answer to that question is that
` you did not focus on those claims?
` A. That's correct.
` MR. TORCZON: Objection. Asked and answered.
` THE WITNESS: No, I did not.
` BY MS. CONLON:
` Q. Okay. And you understand that the '186
` patent claims to saxagliptin -- Claims 25 and 26 --
` that those include the chemical and biological
` properties that are associated with saxagliptin?
` A. Yes, I understand that.
` Q. Okay. But you -- okay.
` In paragraph -- if we could go back to your
` Declaration.
` A. Sure.
` Q. Paragraph 16.
` A. All right.
` Q. You have listed some secondary
` considerations. And you're only opining on long-felt
` need, unexpected results, and failure of others;
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`Case: IPR2015-01340
`Tanenberg, M.D., FACP, Robert J.
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`December 6, 2016
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` correct?
` A. Could you repeat your question.
` Q. Sure. In paragraph 16, you've listed a
` number of secondary considerations?
` A. Right.
` Q. And for the opinions that you're providing in
` this case, you are only opining on long-felt need,
` unexpected results, and failure of others; correct?
` A. Yeah. I'm not talking about copying of
` invention or anything like that, no. Or praise of
` invention, no, I'm not opining on that at all. Those
` are obviously business- or patent-type issues I don't
` have any expertise on.
` Q. Okay. So, then, for the purpose of this
` case, you are only opining on the three secondary
` considerations that are listed here of long-felt need,
` failure of others, and unexpected results; correct?
` MR. TORCZON: Objection. Asked and answered.
` THE WITNESS: Yes.
` BY MS. CONLON:
` Q. Would you turn the page. The last sentence
` of that paragraph.
` A. Which page? 7?
` Q. Onto page 7.
` A. Yes.
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`Case: IPR2015-01340
`Tanenberg, M.D., FACP, Robert J.
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`December 6, 2016
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` Q. You stated (as read):
` "I am informed that secondary
` considerations are relevant where
` there is a nexus between the
` evidence and the claimed
` invention."
` A. What number are we on?
` Q. It's at the top of page 7. And it's --
` A. Oh, okay. I see.
` Q. -- the end of the paragraph 16.
` A. (Reading.)
` Yes, I read that.
` Q. Okay. And you don't dispute in this
` Declaration that a nexus exists with respect to
` Claims 25 and 26 of the '186 patent; correct?
` A. I don't dispute that, no.
` Q. Are you doing okay? Do you need a break?
` A. Another 15 minutes, maybe, I'll get up and
` walk around. Thank you.
` Q. Just let me know.
` I am going to hand you a copy of your CV.
` A. Do you want this back?
` Q. I'm handing you a copy of your CV, marked as
` Exhibit 1042.
`(Previously-marked Exhibit No. 1042 was referred to.)
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`Case: IPR2015-01340
`Tanenberg, M.D., FACP, Robert J.
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`December 6, 2016
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` THE WITNESS: Okay.
` BY MS. CONLON:
` Q. Is this an accurate copy of your CV?
` A. Yes.
` Q. If you would turn to page 6, you have listed
` a number of research grants.
` A. Yes.
` Q. And these include clinical trials that you've
` been an investigator on?
` A. Correct.
` Q. And some of these were for trials of
` investigational drugs?
` A. Right.
` Q. On page 10 of your CV, at the very bottom,
` you were involved in a clinical trial with a compound
` CP-945,598 for the treatment of type 2 diabetes;
` correct?
` A. Yes.
` Q. And that's also called -- is that compound
` also called otenabant?
` A. I can't remember. This was in 2007. I'd
` have to look it up.
` Q. Okay. And this compound was ultimately
` discontinued; correct?
` A. Yeah, it must be, because I don't recall the
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`Case: IPR2015-01340
`Tanenberg, M.D., FACP, Robert J.
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`December 6, 2016
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` name of it at all, no.
` Q. Okay. So this compound CP-945,598 that was
` tested for the treatment of type 2 diabetes did not
` obtain FDA approval for that indication; is that
` right?
` MR. TORCZON: Objection. Scope.
` THE WITNESS: Apparently not.
` BY MS. CONLON:
` Q. Okay. And on page 11, you were involved in a
` clinical trial for a compound QR-333 for the treatment
` of symptomatic diabetic peripheral neuropathy?
` A. Yes.
` Q. Okay. And that compound was also
` discontinued; is that right?
` A. That's correct.
` MR. TORCZON: Objection. Scope.
` THE WITNESS: That's correct.
` BY MS. CONLON:
` Q. Okay. So it -- and it did not obtain FDA
` approval?
` A. No.
` Q. Back on page 10 -- I guess, before we go
` there, from your own experience, then, you would agree
` that not any drug that goes into chemical testing will
` succeed in becoming an FDA-approved drug; correct?
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`Case: IPR2015-01340
`Tanenberg, M.D., FACP, Robert J.
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`December 6, 2016
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` A. That's correct. In fact, many -- the
` majority of them don't.
` Q. And, at least in some cases, if not many, a
` drug that enters clinical testing will fail for safety
` or efficacy reasons?
` A. Yes, that's correct.
` Q. On page 10 of your CV, you were involved in a
` clinical trial for saxagliptin; is that correct?
` A. Yes, I was.
` Q. Okay. And that was a Phase III clinical
` trial demonstrating the safety and efficacy of
` saxagliptin as a monotherapy --
` A. Yes.
` Q. -- in patients for type 2 diabetes?