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`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`__________________________________
`SANOFI-AVENTIS U.S. LLC,
`AVENTIS PHARMA S.A. and
`SANOFI,
` Plaintiffs,
`-vs-
`FRESENIUS KABI USA, LLC,
`Defendant.
`
`CIVIL ACTION NUMBER:
`3:14-cv-07869-MAS-LHG
`3:14-cv-08082-MAS-LHG
`3:15-cv-02631-MAS-LHG
`
`3:15-cv-02522-MAS-LHG
`3:16-cv-02259-MAS-LHG
`
` TRIAL
` VOLUME 7
`
`3:15-cv-02523-MAS-LHG
`
`SANOFI-AVENTIS U.S. LLC,
`AVENTIS PHARMA S.A. and
`SANOFI,
` Plaintiffs,
` -vs-
`DR. REDDY'S LABORATORIES,
`INC., et al.,
` Defendants.
`
`SANOFI-AVENTIS U.S. LLC,
`AVENTIS PHARMA S.A. and
`SANOFI,
` Plaintiffs,
`
` -vs-
`
`GLENMARK GENERICS INC. et
`al.,
` Defendants.
`_____________________________
`
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`United States District Court
`Trenton, NJ
`
`NEPTUNE GENERICS EX. 1015 00001
`
`
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`1216
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`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`__________________________________
`SANOFI-AVENTIS U.S. LLC,
`AVENTIS PHARMA S.A. and
`SANOFI,
` Plaintiffs,
`-vs-
`FRESENIUS KABI USA, LLC,
`Defendant.
`
`CIVIL ACTION NUMBER:
`3:14-cv-07869-MAS-LHG
`3:14-cv-08082-MAS-LHG
`3:15-cv-02631-MAS-LHG
`
`3:15-cv-02522-MAS-LHG
`3:16-cv-02259-MAS-LHG
`
` TRIAL
` VOLUME 7
`
`3:15-cv-02523-MAS-LHG
`
`SANOFI-AVENTIS U.S. LLC,
`AVENTIS PHARMA S.A. and
`SANOFI,
` Plaintiffs,
` -vs-
`DR. REDDY'S LABORATORIES,
`INC., et al.,
` Defendants.
`
`SANOFI-AVENTIS U.S. LLC,
`AVENTIS PHARMA S.A. and
`SANOFI,
` Plaintiffs,
`
` -vs-
`
`GLENMARK GENERICS INC. et
`al.,
` Defendants.
`_____________________________
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`United States District Court
`Trenton, NJ
`
`NEPTUNE GENERICS EX. 1015 00001
`
`
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`3:14-cv-08079-MAS-LHG
`3:15-cv-02520-MAS-LHG
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`3:14-cv-08081-MAS-LHG
`3:15-cv-02521-MAS-LHG
`
`3:15-cv-00287-MAS-LHG
`3:15-cv-01835-MAS-LHG
`
`_____________________________
`SANOFI-AVENTIS U.S. LLC,
`AVENTIS PHARMA S.A. and
`SANOFI,
`
`Plaintiffs,
`
` -vs-
`ACCORD HEALTHCARE, INC.
` Defendant.
`
`SANOFI-AVENTIS U.S. LLC,
`AVENTIS PHARMA S.A. and
`SANOFI
`
` Plaintiffs,
` -vs-
`BPI LABS, LLC and BELCHER
`PHARMACEUTICALS, LLC
` Defendants.
`
`SANOFI-AVENTIS U.S. LLC,
`AVENTIS PHARMA S.A. and
`SANOFI
` Plaintiffs,
` -vs-
`APOTEX CORP. and APOTEX, INC.
` Defendants.
`_____________________________
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`Trenton, NJ
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`NEPTUNE GENERICS EX. 1015 00002
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`
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`3:15-cv-00776-MAS-LHG
`3:15-cv-03107-MAS-LHG
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`3:15-cv-01863-MAS-LHG
`3:15-cv-00289-MAS-LHG
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`3:15-cv-00290-MAS-LHG
`3:15-cv-03392-MAS-LHG
`
`_____________________________
`SANOFI-AVENTIS U.S. LLC,
`AVENTIS PHARMA S.A. and
`SANOFI
` Plaintiffs,
` -vs-
`
`ACTAVIS LLC and ACTAVIS
`ELIZABETH LLC,
`
`SANOFI-AVENTIS U.S. LLC,
`AVENTIS PHARMA S.A. and
`SANOFI
`
` Plaintiffs,
`
` -vs-
`BRECKENRIDGE PHARMACEUTICAL,
`INC.
`
` Defendant.
`
`SANOFI-AVENTIS U.S. LLC,
`AVENTIS PHARMA S.A. and
`SANOFI,
`
` Plaintiffs,
`
` -vs-
`
`MYLAN LABORATORIES LTD.
`
` Defendant.
`__________________________________
`
`United States District Court
`Trenton, NJ
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`NEPTUNE GENERICS EX. 1015 00003
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`
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`Clarkson S. Fisher United States Courthouse
` 402 East State Street
`Trenton, New Jersey 08608
` September 28, 2017
`
`B E F O R E: HONORABLE MICHAEL A. SHIPP
` UNITED STATES DISTRICT JUDGE
`A P P E A R A N C E S:
`WALSH, PIZZI, O'REILLY, FALANGA LLP, ESQS.
`BY: LIZA M. WALSH, ESQUIRE
` and
` KATELYN O'REILLY, ESQUIRE
`Attorneys for the Plaintiffs Sanofi-Aventis, U.S., LLC
`and Aventis Pharma, S.A.
`(Walsh, Pizzi, et al., does not represent Plaintiff
`(Actavis) in the 15-0776 and 15-3107 matters.)
`
`FITZPATRICK, CELLA, HARPER & SCINTO, ESQUIRES
`BY: WILLIAM SOLANDER, ESQUIRE
` JASON A. LEONARD, ESQUIRE
` UNA FAN, ESQUIRE
` and
` MELINDA E. ROBERTS, ESQUIRE
`Attorneys for the Plaintiffs Sanofi-Aventis U.S. LLC,
`et al.
`TIMOTHY CREAGAN, ESQUIRE
`JIANG LIN, ESQUIRE
`Attorney for the Plaintiffs Sanofi-Aventis U.S. LLC,
`et al.
`GOODWIN PROCTER LLP
`BY: DARYL L. WIESEN, ESQUIRE
` BRIAN J. PREW, ESQUIRE
` EMILY L. RAPALINO, ESQUIRE
` AVIV A. ZALCENSTEIN, ESQUIRE
` and
` ERIC T. ROMEO, ESQUIRE
`Attorneys for the Defendant Fresenius Kabi USA, LLC.
`NATHAN NEWBOLD, ESQUIRE
`ALI I. AHMED, ESQUIRE
`Attorneys for the Defendant Fresenius Kabi USA, LLC.
`JAMES MAHANNA, ESQUIRE
`Attorney for the Defendant Actavis, LLC.
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`Trenton, NJ
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`NEPTUNE GENERICS EX. 1015 00004
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`A P P E A R A N C E S cont'd
`WILSON, SONSINI, GOODRICH & ROSATI, ESQUIRES
`BY: MATTHEW R. REED, ESQUIRE
` WENDY L. DEVINE, ESQUIRE
` and
` KRISTINA HANSON, ESQUIRE
`Attorneys for Defendant Mylan Laboratories Ltd.
`VINNY LEE, ESQUIRE
`Attorney for the Defendant Mylan Laboratories Ltd.
`SAIBER LLC
`JEFFREY SOOS, ESQUIRE
`Attorneys for the Defendant Mylan Laboratories Ltd.
`SCHIFF HARDIN, LLP
`BY: HELEN H. JI, ESQUIRE
`Attorneys for the Defendant Accord Healthcare, Inc.
`
`TAFT, STETTINIUS & HOLLISTER LLP
`BY: ANDREW M. ALUL, ESQUIRE
` ROSHAN P. SHRESTHA, Ph.D
` and
` RICHARD T. RUZICH, ESQUIRE
`Attorneys for the Defendant Apotex Corp. and Apotex
`Inc.
`HILL WALLACK, LLP
`BY: CHRISTINA L. SAVERIANO, ESQUIRE
`Attorneys for the Defendant Apotex Corp. and Apotex
`Inc.
`
`Certified as True and Correct as required by Title 28,
`U.S.C., Section 753
`/S/ Cathy J. Ford, CCR, CRR, RPR
`/S/ Megan McKay-Soule, RMR, CRR
`
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`
`
`WITNESS
`
` I N D E X
`
`DR. WILLIAM ROUSH
`DIRECT EXAMINATION BY MR. LEONARD
`CROSS EXAMINATION BY MR. ALUL
`REDIRECT EXAMINATION BY MR. LEONARD
`RECROSS EXAMINATION BY MR. ALUL
`
`PAGE
`
`1234
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`1386
`1453
`1457
`
`NUMBER
`
`E X H I B I T S
`
`Defendants' JTX-7, JTX-030, JTX-100,
`JTX-103, JTX-105, JTX-116, JTX-162,
`DTX-2116, DTX-2176, DTX-2203, DTX-2256,
`DTX-2320, DTX-2345, DTX-2370, DTX-2558,
`DTX-2560, DTX-2617, DTX-2627, DTX-2630,
`DTX-2635, DTX-2639, DTX-2641, DTX-2648,
`DTX-2650, DTX-2679-A, DTX-2679, DTX-2721,
`DTX-2722, DTX-2723, DTX-2724, DRX-2725,
`JTX-16, DTX-2707 were moved in evidence.
`Plaintiffs' Exhibit JTX-004, JTX-015,
`JTX-033, JTX-095, JTX-107, JTX-118,
`JTX-122, JTX-123, JTX-126, JTX-131,
`PTX-1350, PTX-1351, PTX-1410, PTX-1418,
`PTX-1404, DTX-2241, DTX-2370, DTX-2196C,
`and DTX-2203.
`Defendants' Exhibit DTX-2176
`
` EVID.
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`Trenton, NJ
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`NEPTUNE GENERICS EX. 1015 00006
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`THE DEPUTY COURT CLERK: All rise.
`(Open court begins at 9:30 a.m.)
`THE COURT: Please be seated.
`Good morning. We're back on the record in the
`matter Sanofi-Aventis versus Fresenius, et al., Docket
`No. 14-7869.
`Before we call the next witness, we need to
`handle a few housekeeping items and a few logistical
`issues. So at this point, I understand -- Ms. Ji, are
`you coming forward?
`MS. JI: Good morning, Your Honor.
`THE COURT: Good morning.
`MS. JI: In connection with the testimony of
`Richard Ludueña, Sunil Gupta and Iwao Ojima,
`defendants would like to enter into evidence at this
`time the following exhibits: JTX-7, JTX-030, JTX-100,
`JTX-103, JTX-105, JTX-116, JTX-162, DTX-2116,
`DTX-2176, DTX-2203, DTX-2256, DTX-2320, DTX-2345,
`DTX-2370, DTX-2558, DTX-2560, DTX-2617, DTX-2627,
`DTX-2630, DTX-2635, DTX-2639, DTX-2641, DTX-2648,
`DTX-2650, and DTX-2679-A, which is Pages 78 through
`150 of the exhibit DTX-2679.
`In addition, we would like to mark the
`following clip reports with the --
`THE COURT: Before you do that, let me make
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`sure there are no objections to the evidence itself.
`Mr. Solander.
`MR. SOLANDER: No objections, Your Honor.
`MS. JI: We would also like to mark the
`following clip reports and enter them into evidence.
`DTX-2721 will be the Hansard clip report. DTX-2722
`will be the Gupta video clip report. DTX-2723 will be
`the Gupta paper clip report. DTX-2724 will be the
`Ludueña clip report. And DTX-2725 will be the Ojima
`clip report.
`THE COURT: Okay. Mr. Solander.
`MR. SOLANDER: No objections to any of that,
`Your Honor.
`MS. JI: We'd just like to clarify two
`documents from Monday. We'd like to enter into
`evidence JTX-16 in connection with Dr. Schiff's
`testimony.
`THE COURT: JTX-16?
`MS. JI: JTX-16.
`MR. SOLANDER: That's the label.
`THE COURT: Okay.
`MS. JI: Which is the Jevtana label from 2016.
`MR. SOLANDER: No objection to that, Your
`
`Honor.
`
`THE COURT: Okay.
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`MS. JI: Additionally, DTX-2701 was
`inadvertently moved into evidence instead of DTX-2707.
`THE COURT: Okay.
`MS. JI: So we'd like to enter 2707.
`MR. SOLANDER: No objection to changing that,
`Your Honor.
`THE COURT: Okay. Is that it?
`MS. JI: That's it.
`THE COURT: Thank you.
`MS. JI: Thank you.
`(Defendant's JTX-7, JTX-030, JTX-100, JTX-103,
`JTX-105, JTX-116, JTX-162, DTX-2116, DTX-2176,
`DTX-2203, DTX-2256, DTX-2320, DTX-2345, DTX-2370,
`DTX-2558, DTX-2560, DTX-2617, DTX-2627, DTX-2630,
`DTX-2635, DTX-2639, DTX-2641, DTX-2648, DTX-2650,
`DTX-2679-A, DTX-2679, DTX-2721, DTX-2722, DTX-2723,
`DTX-2724, DRX-2725, JTX-16, DTX-2707 were moved in
`evidence.)
`MR. SOLANDER: Do you guys rest?
`MR. ALUL: Your Honor, we have a dispute with
`Sanofi --
`MR. WIESEN: Before --
`MR. ALUL: I'm sorry. Lack of coordination on
`our part. I apologize, Your Honor.
`MR. WIESEN: Your Honor, with that, that ends
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`the defendants' evidence on the affirmative defenses.
`So just for the formality of it, we'll rest on
`that and the give-and-take that goes on with our
`witnesses out of order, but that was the end of --
`yesterday was the end of our witnesses, so we'll rest
`on the affirmative defenses that we have the burden of
`proof on.
`THE COURT: Okay.
`MR. SOLANDER: Your Honor, we make a motion
`under Rule 52(c) under affirmative defense of
`invalidity of the '592 and the '170 patents.
`THE COURT: At this time the Court is going to
`reserve on that, but thank you for the motion.
`Mr. Alul, there is an issue?
`MR. ALUL: Yes, Your Honor. We have a dispute
`regarding exhibits that we understand that Sanofi
`intends on using with their expert today, Dr. Roush.
`These exhibits essentially fall into two categories.
`The first category of documents involve documents that
`we disclosed to them over two years ago in our
`invalidity contentions. They're documents that our
`experts opined on their opening reports on invalidity.
`They are documents that Dr. Roush did not
`substantively opine on in his rebuttal report on
`invalidity.
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`NEPTUNE GENERICS EX. 1015 00010
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`We approached them on this last night and
`we're told that they felt that Dr. Roush should be
`able to opine on these documents because at some
`point, either in his report or in his deposition, he
`spoke on a topic that somehow relates to the document.
`We think that is unfair. And as it stands right now
`regarding these documents, and in the first category
`I'm talking about JTX-99; JTX-104. JTX-99 is the
`Kartner reference, JTX-104 is the Ojima '94 reference.
`JTX-109 is the Commerçon reference from the ACS
`Symposium. PTX-148 is the Straubinger,
`S-T-R-A-U-B-I-N-G-E-R, from the ACS Symposium. And
`DTX-2241 is the Lampidis reference.
`We -- Your Honor, as it stands right now, I
`have no idea what Dr. Roush is going to say about
`these exhibits, and to me that is the essence of what
`Rule 26 is about. And I feel like I'm getting
`sandbagged on this. And we respectfully request an
`order from this Court precluding Dr. Roush from
`testifying substantively on these exhibits.
`The second category, Your Honor, involved
`documents that were first raised during the
`cross-examination of our expert for the '170 patent,
`our invalidity expert, Dr. Heathcock. They are
`PTX-1514, DTX-2203, and DTX-370. These documents,
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`Your Honor, one of them first came up during Dr.
`Heathcock's cross. The other two came up on redirect.
`At the end of the day on Tuesday, the parties
`tried to move them into evidence. Your Honor the next
`day, which was yesterday, denied entry of those
`documents into evidence.
`Our point with respect to those documents is
`simply that they were nowhere discussed in Dr. Roush's
`expert report. They are discussed during the --
`during the deposition of one of their experts, Dr.
`Ludueña. We're going to be moving at least a couple
`of those in through Dr. Ludueña. But Dr. Roush has
`not opined on those before. We haven't vetted his
`opinions on those documents at all.
`THE COURT: Okay.
`MR. LEONARD: Your Honor, so let me address
`his first issue, which was the subject of the meet and
`confer last night.
`The first category of documents was -- he
`mentioned Kartner, several chapters from the ACS book.
`I think you probably recall this. Dr. Heathcock
`called it the bible.
`He said that these were cited in Dr.
`Heathcock's opening report. Dr. Roush, who is ready
`to testify right here, he considered everything he put
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`in his expert report. He considered everything that
`Dr. Heathcock had cited. He provided his opinions.
`These references discuss the substance of those
`opinions, and they had an opportunity at a deposition
`to ask him any questions on the references. So he's
`prepared to go forward today to address them in
`rebuttal to Dr. Heathcock's opinions on those
`references.
`For the second category of documents, as you
`know, you let two of those documents in yesterday, and
`Mr. Alul just admitted they were first raised on cross
`of Dr. Heathcock. They weren't his affirmative
`opinions; and they certainly admit that the first time
`they showed up in the case was in Dr. Ludeña's
`deposition, which their attorneys brought to the
`deposition. Dr. Ludueña did not opine on those. They
`showed it for the first time, and that was after Dr.
`Roush had put in all of his reports and was deposed.
`So he had no opportunity to respond to those in this
`case. And I would ask the Court if he could have the
`opportunity today to do that.
`THE COURT: Okay.
`MR. ALUL: Your Honor, I'm going to focus on
`category one at the outset.
`I asked them last night where JTX-99, the
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`Kartner reference, was in Roush's rebuttal report.
`They couldn't give me an answer and I can't find it in
`there.
`
`JTX-104, the Ojima '94 reference, JTX-109, the
`Commerçon reference, and PTX-141-A, these are all
`chapters in the ACS book. I can't find them in here.
`Now, admittedly, Dr. Roush does testify about
`other chapters in the ACS book but not these specific
`chapters. And so I don't know what he's going to say
`about these specific chapters. They're chapters
`authored by different individuals. We asked if we
`could move JTX-162, the entirety of the book, in
`yesterday; and they actually opposed on the grounds
`that, look, these are a bunch of different separate
`chapters. We don't know what you guys are going to
`rely on these -- of this stuff for. And so the point
`is with respect to JTX-104, 109 and PTX-1418, I have
`no idea what his opinions are.
`Those were references discussed in Dr.
`Heathcock's reports as well as JTX-99, as well as the
`Lampidis article, Your Honor, DTX-2241. That was
`expressly discussed in Heathcock's report. I can't
`find it anywhere in Dr. Roush's rebuttal report on
`invalidity.
`So, again, I have no idea what he's going to
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`say, and this is the essence of Rule 26 and a
`violation of Rule 26.
`MR. LEONARD: Your Honor, could I address
`
`that?
`
`So Dr. Roush, in his materials, considered --
`cited the entire book. He cited -- as Andy admits, he
`cited various chapters. I think the Court is well
`aware that there's many, many references in this case.
`So all this quibbling over are pincites to particular
`things which they could have clarified in the
`deposition.
`The other thing which just occurred is this
`entire book was admitted into evidence as JTX-162,
`which they just asked for; so I think it's definitely
`unfair if Dr. Roush can't rely on the entirety of the
`reference which they are now relying on.
`MR. ALUL: Your Honor, it wasn't admitted into
`evidence yet. We didn't move it into evidence.
`MR. LEONARD: He just did. It's JTX-162.
`Your Honor, to make this easier --
`MR. ALUL: The real issue, as far as I'm
`concerned, isn't whether it's listed in his materials
`considered. Does he have any substantive opinions
`about these chapters in his expert report that I could
`have read back during discovery and crossed him on
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`during his deposition?
`So, you know, that he may have listed it, you
`know, listed the book in its entirety in his materials
`considered doesn't remedy the problem that I have,
`which is that I don't know what he's going to say
`about these particular individual chapters within the
`book. I know what he's going to say about other
`chapters in the book that he expressly opines on in
`his expert report, but I don't know what he's
`specifically going to say about Ojima, Commerçon and
`Straubinger. And that's the dilemma that I have. I
`have no idea what he's going to say. I wasn't able to
`vet those opinions at his deposition, and I'm not sure
`what he's going to say right now.
`MR. LEONARD: Your Honor, just in response to
`that, if he knew Dr. Heathcock cited them, he could've
`asked Dr. Roush if he had any opinions, if it was
`unclear to him.
`The Roush report, if you've seen it, is over
`300 paragraphs or so, and the book is clearly listed
`as something he considered. So he could have asked
`him if he had any other opinions. That's usually the
`point of the deposition is to make sure you
`understand. This isn't the forum now for him to do
`that. Dr. Roush's opinions he has provided in his
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`report go directly to the heart of these chapters.
`And I think if there's any dispute, he could raise it
`at that time when Dr. Roush addresses it, particularly
`on cross-examination.
`MR. ALUL: One last point, Your Honor.
`Dr. Heathcock rendered substantive opinions on
`these chapters. Okay. He actually discussed these
`chapters, discussed these documents. There is no
`discussion about these individual chapters or these
`exhibits in Dr. Roush's report.
`So, again, I have no idea what he's going to
`say. They know what Dr. Heathcock said about these
`references. I don't know what Dr. Roush is going to
`say about these references. And that is the
`sandbagging that I'm trying to highlight for the
`Court.
`
`THE COURT: Counsel, having heard from both
`sides about this particular issue, I am particularly
`sensitive; as you folks know, I served five years as a
`magistrate judge where I handled these kinds of
`issues. I particularly despise sandbagging. I
`particularly despise surprises at trial. But having
`said that, I'm not sure of the back and forth that
`needs to go on here.
`The way I anticipate moving forward is with
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`regard to Dr. Vrignaud from yesterday and apparently
`now with regard to the testimony here, I'm going to
`let this stuff come in; but I'm going to let you folks
`make some motions prior to any posttrial briefing
`where the Court can render opinions in the full
`awareness of the subject matter being put before the
`Court. And then I'll issue you a decision and then
`you folks can do your posttrial briefing in the full
`awareness of whether or not certain items come in or
`not.
`
`I certainly think that this will preserve for
`you even the argument, Mr. Alul, that you didn't know
`some of this information because you can refer back to
`the deposition transcripts and the like to illustrate
`if this matter certainly was an issue of surprise and
`should be precluded under Rule 26.
`With that being said, I think we need to go
`forward today. And we will get the transcripts to
`you. I understand that we've had a little bit of
`delay in getting the transcripts turned around. We're
`going to get the transcripts turned around and we will
`let the -- I'm not going to call it the posttrial
`date. The objections, the briefing as it relates to
`the objections take place -- I promise I'll hear a
`decision very, very quickly. I will turn it around
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`very, very quickly, and then you folks can move into
`the posttrial briefing. Okay?
`MR. ALUL: Thank you, Your Honor.
`MR. SOLANDER: Thank you, Your Honor.
`THE COURT: With that being said, let's call
`Dr. Roush.
`(DR. WILLIAM ROUSH, HAVING BEEN DULY SWORN/AFFIRMED,
`TESTIFIED AS FOLLOWS:)
`THE DEPUTY COURT CLERK: Please state your
`full name for the record and spell your last name.
`THE WITNESS: William Richard Roush,
`R-O-U-S-H.
`THE COURT: Dr. Roush, you can be seated.
`Please pull yourself as far close to the microphone as
`you can.
`Just for the record, we have a court reporter
`seated directly in front of you. She's taking down a
`record of everything being said here. And to that
`end, I need you to speak clearly and keep your voice
`up. She can't take down nonverbal gestures such as a
`nod of the head or a shrug of the shoulders. So
`please make sure you give a verbal response to the
`questions.
`Also, she can't take two people speaking at
`the same time, so please wait until the question is
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`1235
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`fully posed before you begin to answer. And if
`there's an objection at any time, please just stop
`speaking, let the Court resolve the objection, and
`we'll instruct you on how to proceed from there.
`THE WITNESS: Thank you, sir.
`MR. LEONARD: May I proceed?
`DIRECT EXAMINATION BY MR. LEONARD:
`Q.
`So, good morning, Dr. Roush.
`A.
`Good morning.
`Q.
`Would you please introduce yourself to the
`Court?
`William Richard Roush.
`A.
`I just put up PDTX-802, a summary of your
`Q.
`education and prior appointments. Could you describe
`the academic degrees that you hold?
`A.
`Yes. I received a bachelor's degree in science
`from -- in chemistry at UCLA in 1974. And then I
`moved to the East Coast and took my Ph.D. in chemistry
`from Harvard in 1977. And then I spent an additional
`year as a postdoctoral research associate at Harvard
`until the summer of 1978.
`Q.
`What research did you complete for your Ph.D.?
`A.
`My thesis is in the area of organic synthesis,
`natural products chemistry. And I did a synthesis of
`the natural product, an alkaloid by the name
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`NEPTUNE GENERICS EX. 1015 00020
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`ROUSH - DIRECT - LEONARD
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`1236
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`dendrobium.
`Q.
`Can you please describe your previous academic
`positions?
`A.
`Yes. Thank you.
`So after completing my postdoctoral work, I
`moved to the Massachusetts Institute of Technology as
`an Assistant Professor, and then I was an Associate
`Professor there.
`Early 1987, I moved to Indiana University in
`Bloomington, Indiana, where I -- I think I was on the
`Indiana faculty for ten years. I rose up through the
`ranks ultimately becoming Distinguished Professor of
`Chemistry.
`Then in the summer of 1996, I moved to the
`University of Michigan in Ann Arbor, Michigan, where I
`was appointed the Warner-Lambert/Parke Davis Professor
`of Chemistry. And during the period that I was at
`Michigan, I also served as the Chairman of the
`Department of Chemistry.
`Q.
`Turning now, could you explain to us your
`current academic position?
`A.
`Certainly. Thank you.
`I moved to the Scripps Research Institute, the
`Florida campus of the Scripps Research Institute in
`January of 2005, where I'm Professor of Chemistry.
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`ROUSH - DIRECT - LEONARD
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`1237
`And I've -- I indicated at the bottom of this slide,
`I've held several other positions at Scripps. I still
`hold the position as Executive Director of Medicinal
`Chemistry. I also was the Associate Dean of the
`graduate program, Scripps's graduate program. I was
`responsible for setup, establish the graduate program;
`and ran the graduate program for more than ten years
`in Florida. I stepped down from that position one
`year ago.
`Q.
`Can you tell us about the Scripps's?
`A.
`Certainly. It's a -- Scripps Research Institute
`is a private biomedical research institute that
`focuses on really the interactions of chemistry with
`biology and biology with chemistry. And it's widely
`regarded as one of the leading institutions, certainly
`in the U.S. if not the world, in this particular area
`of research.
`Q.
`What research do you specialize in at Scripps?
`A.
`Over the past decade my program is increasingly
`focused on medicinal chemistry and chemical biology
`and drug discovery. And at this stage I would say 95
`percent or so of my research effort is focused
`entirely on the medicinal chemistry drug discovery,
`chemical biology aspects.
`Q.
`How long have you been active in medicinal
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`chemistry?
`A.
`I think my first medicinal chemistry papers were
`published as early as 1984, so I've had an involvement
`in medicinal chemistry my entire career. But the
`emphasis or the fraction or percentage of my effort
`devoted to medicinal chemistry has increased over the
`years. Such as I mentioned, I'm now essentially
`exclusively focused in that area.
`Q.
`And what drug therapeutic areas have you
`researched?
`A.
`Many. But there would be -- a preponderance of
`the effort has been in the area of cancer, developing
`-- attempts to develop drugs for cancer chemotherapy,
`but I also worked on antibiotics, anti-infectives.
`I've worked on metabolic disease targets. I have a
`promising compound for osteoarthritis at this point.
`So there's really a range of different areas, but
`probably the majority of it has been in the cancer
`area.
`Now, have you reserved any research grants for
`Q.
`your medicinal chemistry research?
`A.
`Yes, I have. My research program is funded from
`-- essentially I think my first NIH grant was received
`-- one after I started at MIT. That would have been
`the summer of 1979, the first grant. I've had
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`continuous funding, multiple grants continuously from
`the NIH ever since.
`Q.
`Do you perform any consulting for medicinal
`chemistry?
`A.
`I do, yes. Over the years I've consulted for a
`number of companies. Some are listed on the slide,
`but over the years Eli Lilly, Pfizer, Genzyme
`Corporation. There's a number here. Currently I'm
`consulting exclusively with the second one on this
`list, which is IMF therapeutics, who are located in
`Boston.
`Q.
`Have you published in the area of organic and
`medicinal chemistry?
`A.
`Yes, I have.
`Q.
`And about how many publications concerned
`medicinal chemistry?
`A.
`At this point in time it's over 350 total
`papers, of which I would say 50 to 60, at least, are
`exclusively devoted to medicinal chemistry aspects.
`Q.
`I know a lot of the prior testimony in this case
`has been about SAR, or structure activity
`relationship. About how many of those publications
`concern SAR studies?
`A.
`Well, I would say that 50 to 60 that I just
`mentioned are either SAR directly or are papers that
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`are looking at the biological characterization of
`molecules that have come out of an SAR effort, so.
`Q.
`Have you ever supervised graduate students doing
`medicinal chemistry?
`A.
`Yes, I have.
`Q.
`About how many of those students have you
`supervised?
`A.
`I've had 80 students as of today who've
`completed Ph.D. degrees that are under my supervision,
`and it's on the order of 10 to 15 of those 80 have at
`least one chapter, if not their entire chapter --
`their entire thesis devoted to medicinal chemistry
`aspects.
`Q.
`Now, about how many of those graduate students
`now work in the pharmaceutical industry?
`A.
`Of the 80 students, probably 90 percent. The
`vast preponderance of those students have worked in
`the pharmaceutical industry. I'm showing my years,
`but it is sort of daunting to know that several of
`those individuals have now already retired. So
`anyway.
`Q.
`Have any of those former students discovered an
`FDA marketed drug?
`A.
`Yes. One of my former students who went to
`Pfizer is the inventor of the smoking cessation drug
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`Chant
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