1
`
`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
`
`MARKMAN HEARING
`
`3:14-cv-1502522
`
`3:14-cv-15-02523
`
`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.
`
`______________________________
`
`United States District Court
`Trenton, New Jersey
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`AVENTIS EXHIBIT 2072
`Mylan v. Aventis, IPR2016-00712
`
`

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`A P P E A R A N C E S cont'd
`
`4
`
`FITZPATRICK, CELLA, HARPER & SCINTO, ESQUIRES
`BY: WILLIAM SOLANDER, ESQUIRE
` JASON A. LEONARD, ESQUIRE
` WHITNEY L. MEIER, ESQUIRE
` JAYITA GUHANIYOGI, ESQUIRE
`Attorneys for the Plaintiffs Sanofi-Aventis U.S. LLC, et al.
`
`PATUNAS & TARANTINO LLC
`BY: MICHAEL E. PATUNAS, ESQUIRE
`Attorneys for the Defendant Fresenius Kabi USA, LLC.
`
`GOODWIN PROCTER LLP
`BY: DARYL L. WIESEN, ESQUIRE
` AVIV ZALCENSTEIN, ESQUIRE
` JOHN P. HANISH, Ph.D
` BRIAN J. PREW, ESQUIRE
`Attorneys for the Defendant Fresenius Kabi USA, LLC.
`
`WILSON, SONSINI, GOODRICH & ROSATI, ESQUIRES
`BY: MATTHEW R. REED, ESQUIRE
` S. BREI GUSSACK, ESQUIRE
`Attorneys for Defendant Mylan Laboratories Ltd.
`
`SAIBER LLC
`BY: ARNOLD B. CALMANN, ESQUIRE
`Attorneys for the Defendant Mylan Laboratories Ltd.
`
`HAYNES AND BOONE, LLP
`BY: C. KYLE MUSGROVE, ESQUIRE
` ROBERT F. VROOM, ESQUIRE
`Attorneys for the Defendant Breckenridge Pharmaceutical, Inc.
`
`TAFT, STETTINIUS & HOLLISTER LLP
`BY: ANDREW M. ALUL, ESQUIRE
` ROGER KILEY, ESQUIRE
`Attorneys for the Defendant Apotex Corp. and Apotex Inc.
`
`HILL WALLACK, LLP
`BY: CHRISTINA L. SAVERIANO
`Attorneys for the Defendant Apotex Corp. and Apotex Inc.
`
`MCNEELY HARE & WAR, LLP
`BY: GABRIELA MATERASSI, ESQUIRE
` WILLIAM HARE, ESQUIRE
` CHRISTOPHER CASIERI, ESQUIRE
`Attorneys for the Defendant BPI Labs, LLC and Belcher
`Pharmaceuticals, LLC.
`
`United States District Court
`Trenton, New Jersey
`
`A P P E A R A N C E S cont'd
`
`5
`
`SCHIFF HARDIN, LLP
`BY: HELEN H. JI, ESQUIRE
`Attorneys for the Defendant Accord Healthcare, Inc.
`
`TRESSLER LLP
`BY: ROBERT FETTWEIS, ESQUIRE
`Attorneys for the Defendant Breckenridge Pharmaceutical, Inc.
`
`CARLSON, CASPERS, VANDENBURGH, LINDQUIST & SCHULMAN, ESQS.
`BY: GARY J. SPEIER, ESQUIRE
`Attorneys for the Defendant Glenmark Pharmaceuticals, Inc.
`
`RIVKIN RADLER, ESQUIRES
`BY: JORDAN MAMORSKY, ESQUIRE
`Attorneys for the Defendant Glenmark Pharmaceuticals, Inc.
`
`LAW OFFICE OF GREGORY J. BEVELOCK, LLC
`BY: GREGORY J. BEVELOCK, ESQUIRE
`Attorneys for the Defendant Actavis LLC.
`
`WILKIE, FARR & GALLAGHER, LLP
`BY: MICHAEL W. JOHNSON, ESQUIRE
`Attorneys for the Defendant Actavis LLC.
`
`BUDD LARNER, P.C.
`BY: FRANK D. RODRIGUEZ, ESQUIRE
`Attorneys for the Defendant Dr. Reddy's Laboratories, Inc.
`and Dr. Reddy's Laboratories Ltd.
`
`Certified as True and Correct as required by Title 28, U.S.C.,
`Section 753
` /S/ Cathy J. Ford, CCR, CRR, RPR
` /S/ Regina A. Tell, CCR, CRR, RMR
`
`United States District Court
`Trenton, New Jersey
`
`2
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`3
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`_________________________________
`
`SANOFI-AVENTIS U.S. LLC, AVENTIS
`PHARMA S.A. and SANOFI,
`
` Plaintiffs,
`
` -vs-
`
`ACCORD HEALTHCARE, INC.
`
` Defendant.
`
`3:15-cv-02520-MAS-LHG
`
`SANOFI-AVENTIS U.S. LLC, AVENTIS
`PHARMA S.A. and SANOFI
`
`3:14-cv-08081-MAS-LHG
`
` 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.
`
`_________________________________
`
`3:15-cv-00287-MAS-LHG
`3:15-cv-01835-MAS-LHG
`
`United States District Court
`Trenton, New Jersey
`
`SANOFI-AVENTIS U.S. LLC, AVENTIS
`PHARMA S.A. and SANOFI
`
`3:15-cv-01863-MAS-LHG
`
` Plaintiffs,
`
` -vs-
`
`BRECKENRIDGE PHARMACEUTICAL, INC.
`
` Defendant.
`
`SANOFI-AVENTIS U.S. LLC, AVENTIS
`PHARMA S.A. and SANOFI,
`
`3:15-cv-00290-MAS-LHG
`3:15-cv-03392-MAS-LHG
`
` Plaintiffs,
`
` -vs-
`
`MYLAN LABORATORIES LTD.
`
` Defendant.
`__________________________________
`
` Clarkson S. Fisher United States Courthouse
` 402 East State Street
` Trenton, New Jersey 08608
` January 23, 2016
`
`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:
`
`CONNELL FOLEY, 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.
`(Connell Foley does not represent Plaintiff (Actavis)
`in the 15-776 and 15-3107 matters.)
`
`
`United States District Court
`Trenton, New Jersey
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` THE DEPUTY COURT CLERK: All rise.
`
`(Open court begins at 9:07 a.m.)
`
`THE COURT: Please be seated. Good morning.
`
`COUNSELS: Good morning, your Honor.
`
`THE COURT: We are here today in the matter of
`
`Sanofi-Aventis vs. Fresenius, et al, Docket Number 14-7869.
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`We're here today during the first part of the morning
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`for the tutorial, after which we will have a break, and then
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`we'll commence with the Markman hearing.
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`I'd like to do appearances. I've asked that only
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`those attorneys in the well enter their appearances. Everyone
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`else has signed in on the sign-in sheet. Your appearances
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`will be on the transcript and noted for the record.
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`So, with that being said, let me have counsel enter
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`their appearances.
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`MS. WALSH: Good morning, your Honor. Appearing on
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`behalf of Sanofi-Aventis, Liza Walsh and Katelyn O'Reilly from
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`Connell Foley. And I'm going to allow my co-counsel, William
`
`Solander, and his associates, partners, I should say,
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`introduce themselves.
`
`THE COURT: Good morning.
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`MR. SOLANDER: Good morning, your Honor. William
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`Solander, Fitzpatrick, Cella, Harper, and Scinto for Sanofi.
`
`MR. LEONARD: Good morning, your Honor. Jason
`
`Leonard from Fitzpatrick, Cella, Harper, and Scinto on behalf
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`THE COURT: Good morning.
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`MR. JOHNSON: Good morning, your Honor. Michael
`
`Johnson from Wilkie, Farr, and Gallagher LLP on behalf of the
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`defendant Actavis LLC.
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`THE COURT: Good morning. Is that everybody?
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`With that being said, we're going to go ahead --
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`let's talk about just a few logistics here.
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`The way I'd like to do this morning, and hopefully we
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`can stick to the time schedule, what I'd like to do -- I'm
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`under the information that the tutorial is, roughly, one hour
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`and 15 minutes; is that correct?
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`MR. SOLANDER: It might be a little bit less than
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`that, your Honor, yes.
`
`THE COURT: Less is always more in this context so...
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`9:15 until 10:30, I'd like to be done with the
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`tutorial by 10:30. After that, we'll take a 15 minute-break,
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`and I'd like to commence with the Markman hearing at 10:45.
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`We'll go from 10:45 until 12:45. We'll take a one-hour lunch,
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`from 12:45 to 1:45, and then we'll conclude with the back end
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`at 1:45 to 2:45, okay. And if we need to be a little fluid
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`with some of these times, if things move faster and quicker,
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`we can certainly do that, but going into this, that's kind of
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`the rough time sketch that I'm working with, okay.
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`Counsel.
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`MR. SOLANDER: Your Honor, I'm happy to start by
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`United States District Court
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`Trenton, New Jersey
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`United States District Court
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`Trenton, New Jersey
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`of Sanofi.
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`MS. MEIER: Good morning, your Honor. Witney Meier
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`Fitzpatrick, Cella, Harper, and Scinto also on behalf of
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`Sanofi.
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`MS. GUHANIYOGI: Good morning, your Honor. Jayita
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`Guhaniyogi on behalf of Sanofi from Fitzpatrick, Cella.
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`THE COURT: Okay. Let me hear from defense.
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`MR. REED: Good morning, your Honor. Matthew Reed
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`from Wilson, Sonsini, Goodrich, and Rosati on behalf of the
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`defendant Mylan Laboratories Limited. And with me today are
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`my associate, Brei Gussack, and, of course, local counsel
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`Arnie Calmann of the Saiber law firm.
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`MR. CALMANN: Good morning, your Honor.
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`MR. WIESEN: Good morning, your Honor. Daryl Wiesen
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`from Goodwin Procter on behalf of Fresenius Kabi defendants.
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`With me is Mike Patunas from Patunas Law.
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`MR. PATUNAS: Good morning, your Honor.
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`MR. MUSGROVE: Good morning, your Honor. Kyle
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`Musgrove from Haynes and Boone for defendant Breckenridge
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`Pharmaceutical. My local Bob Fettweis is back in the well.
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`MR. ALUL: Good morning, your Honor. Andrew Alul
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`from Taft, Stettinius, and Hollister on behalf of defendants
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`Apotex Inc. and Apotex Corp. And with me is my colleague
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`Roger Kiley from Taft, Stettinius, and Hollister and my local
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`counsel Christina Saveriano from Hill Wallack.
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`saying that we've agreed on how we're going to proceed in
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`terms of the order of things. We're going to do the tutorial
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`from the plaintiffs' perspective first, in its entirety, on
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`both of the subject matters of the patent. They will be split
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`between myself and Mr. Leonard on our side, and then the
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`defendants will give their tutorial in its entirety.
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`And then in terms of the argument, we plan to proceed
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`patent by patent. There's only really one term in one of the
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`patents so that will go first, and then we'll proceed to the
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`second patent and we'll go term by term through it.
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`So I'll speak on behalf of the plaintiffs for one
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`term, and then the defendants will go on the same term and
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`proceed that way. And I suspect the arguments will get
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`shorter and shorter as we go because the terms are simpler.
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`So, your Honor, for our tutorial this morning, I plan
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`first to talk a little bit about the product that's at issue
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`and then the technology, in general, that this product is a
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`member of, the taxane class of drug products, and then I'll
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`talk a little bit about the patents-in suit, and then we'll
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`talk about the specific technologies in each of the patents,
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`the acetone solvate patent, which is the first of the
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`technology which will covered by Mr. Leonard, and then the
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`treatment of prostrate cancer, which I'll come back and talk
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`about at the end.
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`So to begin, your Honor, let me talk a little bit
`
`United States District Court
`
`Trenton, New Jersey
`
`United States District Court
`
`Trenton, New Jersey
`
`

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`the inventors, just as the inventors in this case, repeatedly
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`emphasized that aspect of the invention, and, therefore, the
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`Court found that the preamble was limiting because it was a
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`necessary and defining aspect of the invention.
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`Now, your Honor, turning to the second reason why the
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`preamble is limiting in this case is the reliance on preambles
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`to distinguish an invention from the prior art. So, the
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`question is: Did the inventors during the prosecution of this
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`patent say our invention is different than the prior art
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`because our invention is a method for treating these patients?
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`It provides a therapeutic benefit to these patients, whereas,
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`the prior art does not. And, your Honor, that's precisely
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`what they did over and over again. I'm not going to go
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`through each one of these, but just taking the second bullet
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`point, for example, it shows that a prior art reference that
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`was being discussed, the Mita reference, provides insufficient
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`evidence to show that cabazitaxel is effective, is effective.
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`Not might be effective or attempts to be effective, but that
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`cabazitaxel is effective. So the prior art doesn't show it is
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`effective. We did in our patent. So, that is clear reliance
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`on efficacy to overcome the prior art.
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`Again, another prior reference, the Tannock
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`reference, which, again, the applicants argued that docetaxel,
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`which was the drug in that reference, would not have any
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`similar effectiveness, again, relying on effectiveness to
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`examiner's own statements. So, after this long prosecution,
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`after the submission of the Sartor declaration, the examiner
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`finally said, You're right, and allowed the claims. And what
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`did the examiner -- he made these comments why he was allowing
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`the claims. He said, "The examiner is persuaded by
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`Applicants' argument and factual evidence that it is
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`surprising and unexpected that the claimed combination of
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`cabazitaxel and a corticoid are clinically effective in the
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`treatment of prostate cancer that has progressed during or
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`after treatment with docetaxel. Specifically, the [Sartor
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`Declaration] provides convincing evidence that while the art
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`was full of promising early clinical results" -- in other
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`words, methods that do not work -- "these failed to predict
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`whether therapies would ultimately provide a clinically
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`meaningful benefit to the desired patient populations ...."
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`Thus, the inventors and the examiner and any POSA reading this
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`prosecution history in the specification understood that the
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`claims required a method for actually treating patients.
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`Your Honor, there's a couple of cases on this point.
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`I won't belabor them. They're discussed at length in our
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`brief. Just note the Helsinn case. There in that case the
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`defendants argued that it was a mere statement of purpose, and
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`just as the defendants are arguing here that the language that
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`we're trying to say is a limitation is a mere statement of
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`purpose, but the Helsinn case rejected that, and this is from
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`United States District Court
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`Trenton, New Jersey
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`United States District Court
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`Trenton, New Jersey
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`overcome a rejection in the prior art.
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`The applicant submitted the Sartor declaration, which
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`was by an expert, in order to further advance the case. I'm
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`sorry. They submitted a declaration by an expert to explain
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`the prior art and to make arguments during prosecution. The
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`expert, again, relied totally on the clinically meaningful
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`benefit that was provided by the method to say that it was
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`different than what was being taught in the prior art and the
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`prior art that was being cited by the examiner.
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`For example, "a person of ordinary skill in the art
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`would not have found" -- this is the second bullet point --
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`"this result in a single patient [Mita] sufficient to predict
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`whether cabazitaxel would have provided a clinical benefit in
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`palliation or survival for the population ..." that was being
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`studied "... or whether cabazitaxel would have had the
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`risk-benefit ratio such that it would have been considered a
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`treatment for the disease." Again, relying on a clinically
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`meaningful benefit, and that it is a treatment for the disease
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`that it provides therapeutic benefit.
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`Again, the Sartor declaration, none of these
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`treatments succeeded in meeting the clinical need. The
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`clinical need was providing an effective treatment for these
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`patients.
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`And, your Honor, I think this is one of the most
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`important pieces of evidence on this point. And that is the
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`this district only last year. The examiner relied on the
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`applicants' arguments about the preamble language and their
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`arguments distinguishing the prior art reference in allowing
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`the patent to be approved. It is exactly that type of
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`argument and that type of reliance that I have just explained
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`exists in this case.
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`Now, just to respond to a couple of the points raised
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`by the defendants on this issue, they first say, "Sanofi does
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`not point to a single statement where either applicants or the
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`Examiner stated that the claims require 'a method for
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`treating' or 'a method of increasing survival.'" A couple of
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`points.
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`First of all, the examiner made an argument during
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`the prosecution, says, "The Examiner's position that ... Mita,
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`et al. teach that cabazitaxel is effective in treating
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`prostate cancer ...." And we said, no, that's not true. We
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`said, no, "Mita simply provides insufficient evidence to show
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`that cabazitaxel is effective for treating hormone-refractory
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`prostate cancer." And what I showed you earlier in the slide
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`was we said our method is effective. That's how we're
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`different than Mita. In Mita the method, that shows no
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`effectiveness; in our patent we show that effectiveness.
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`Again, in the Sartor declaration, "The claims are
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`directed towards the use of cabazitaxel to treat ..." this
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`disease, and the examiner, again, "The amended claims are
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`United States District Court
`
`Trenton, New Jersey
`
`United States District Court
`
`Trenton, New Jersey
`
`

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`drawn to treating prostate cancer in a patient ...." So,
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`again, I think there are a number of references where the
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`applicant stated that "a method for treating" or "a method of
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`increasing survival" was required by the claims.
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`The second argument they raise is that the -- what
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`we're really talking about here is not a claim limitation, but
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`an unexpected property. And I think just if I can just go
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`30 seconds on obviousness and what that means as an argument.
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`So, if an examiner or a defendant claims that the claims are
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`obvious, what they first must have to show is that there's a
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`prima facie case of obviousness. In other words, what they
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`teach is, what they say is if you look at the prior art as a
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`whole it teaches the claimed invention such that a person of
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`ordinary skill in the art would reasonably expect that
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`invention to work. And if they prove that, they have got a
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`prima facie case. And you can attack that several different
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`ways, one of which is to say that's wrong, you don't have a
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`reasonable expectation of success that it is going to work.
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`The other way you can attack it is to say that may be true,
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`but look at all of these unexpected properties that the
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`invention provides.
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`What we're talking about here is the method of
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`treatment -- that the method for treating that is specifically
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`identified in the claims, which is the treatment of these
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`patents' cancers. It is not some unexpected property that
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`Now, what does that mean in terms of this preamble
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`question? There's no -- I don't think there's any dispute
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`between the two sides that because this term up here provides
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`antecedent basis for this term down here that it has to be a
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`limitation of the claim. The only dispute is whether you can
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`divorce "a method for treating," so what is being done to that
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`patient or "a method for increasing the survival" what is
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`being done to that patient, from the term that everybody
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`agrees is a limitation. Can you do that?
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`Your Honor, there's only one case that they cite
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`where that was actually done. And that is this TomTom case,
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`which TomTom being the navigational aid that you get in a car.
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`It is not "a method for treating" case. And what the Court
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`said there is that the two terms were unrelated. The thing
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`what was being called a limitation and which was providing
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`antecedent basis was totally unrelated to the term that was
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`not providing antecedent basis and which the Court found not
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`to be a limitation.
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`I think a more instructive case is the Blue Calypso
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`case, which we have cited down here, which is Judge Gilstrap
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`in the Eastern District of Texas says, "[T]he language relied
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`upon for antecedent basis is intertwined with the entireties
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`of the preambles such that the preambles cannot be parsed into
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`limiting and non-limiting portions." So, your Honor, that's
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`our case here. It makes no sense to start the claim with "a
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`United States District Court
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`Trenton, New Jersey
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`103
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`105
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`nobody thought might come up and that, therefore, proves the
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`validity of the claims. No, the question that was argued at
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`length in the Sartor declaration, during the prosecution
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`history, and, frankly, in the specification itself was that
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`there was no reasonable expectation that this method would
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`work until the method was actually conducted in the TROPIC
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`study, the results were analyzed, and those are the results
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`you find in the patent. So, we're not talking about an
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`unexpected benefit here. What we're talking about is the
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`examiner's prima facie case and whether or not a person of
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`ordinary skill in the art would have a reasonable expectation
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`of success. And there's some quotes here that talk about just
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`that, but I'll look at the examiner itself. The Sartor
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`declaration "provides convincing evidence that ... the art ...
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`failed to predict whether therapies would ultimately provide a
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`clinically meaningful benefit to the desired patient
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`populations" because this particular type of cancer was
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`"particularly challenging and unpredictable indication."
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`Last point, your Honor, and there's two related
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`slides here. The question of antecedent basis, what does
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`"antecedent basis" mean? What it means is if you use the term
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`later in the claim where it says "said patient" or "the
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`patient" you have to say what patient somewhere earlier in the
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`claim, okay? So if you say "said patient" the question is
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`what patient? It is this patient. All right?
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`patient" when you don't say what's being done to that patient.
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`We all agree some of the preamble is limiting, so we're not
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`even in the case of whether the preamble can be limiting or
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`not. Some of it is. The question is all of it or not? And
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`there's no basis to divorce a method for treating a patient
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`from the patient itself. That's our point.
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`And that also leads to a very strange result if you
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`do that because if you take out that language, if you just cut
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`it out, these two claims are the same. Exactly the same. I
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`won't take you through it. I don't think there's any dispute
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`on that. There's a dispute as to what it means, what that
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`means, but there's no dispute. These are the same claims.
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`All of the limitations that are here are the same.
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`There's a presumption that claims mean different
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`things and cover different aspects of an invention. If you
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`take this out, you don't have that anymore. Those claims now
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`cover the same thing. It is a rebuttable presumption, I'll
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`admit that, and in some cases the presumption was this also
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`happened, and the Court said, Well, that's too bad, the
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`presumption is only a rebuttable presumption, and in some
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`instances it doesn't follow. But, your Honor, I think that's
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`just an additional reason here why those two phrases must be
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`included with the claims to give them different scope, which
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`is what they're supposed to have.
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`Just on the cases that the defendant cited I think
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`United States District Court
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