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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`MYLAN - EXHIBIT 1035
`
`

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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.
`
`WILLKIE, 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
`
`3
`
`_________________________________
`
`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.
`
`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
`
`Connell Foley. And I'm going to allow my co-counsel, William
`
`Solander, and his associates, partners, I should say,
`
`introduce themselves.
`
`THE COURT: Good morning.
`
`MR. SOLANDER: Good morning, your Honor. William
`
`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.
`
`MR. JOHNSON: Good morning, your Honor. Michael
`
`Johnson from Willkie, Farr, and Gallagher LLP on behalf of the
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`defendant Actavis LLC.
`
`THE COURT: Good morning. Is that everybody?
`
`With that being said, we're going to go ahead --
`
`let's talk about just a few logistics here.
`
`The way I'd like to do this morning, and hopefully we
`
`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...
`
`9:15 until 10:30, I'd like to be done with the
`
`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.
`
`MS. MEIER: Good morning, your Honor. Witney Meier
`
`Fitzpatrick, Cella, Harper, and Scinto also on behalf of
`
`Sanofi.
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`MS. GUHANIYOGI: Good morning, your Honor. Jayita
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`Guhaniyogi on behalf of Sanofi from Fitzpatrick, Cella.
`
`THE COURT: Okay. Let me hear from defense.
`
`MR. REED: Good morning, your Honor. Matthew Reed
`
`from Wilson, Sonsini, Goodrich, and Rosati on behalf of the
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`defendant Mylan Laboratories Limited. And with me today are
`
`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.
`
`MR. WIESEN: Good morning, your Honor. Daryl Wiesen
`
`from Goodwin Procter on behalf of Fresenius Kabi defendants.
`
`With me is Mike Patunas from Patunas Law.
`
`MR. PATUNAS: Good morning, your Honor.
`
`MR. MUSGROVE: Good morning, your Honor. Kyle
`
`Musgrove from Haynes and Boone for defendant Breckenridge
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`Pharmaceutical. My local Bob Fettweis is back in the well.
`
`MR. ALUL: Good morning, your Honor. Andrew Alul
`
`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
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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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`in fact. Okay. Your Honor, so this is the last of the series
`
`of patents in time that Sanofi obtained regarding the
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`cabazitaxel development project, and there are a number of
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`disputed terms. The parties have agreed how these are going
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`to be broken up. There's a preliminary question. The first
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`question is whether or not the preambles should be
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`limitations. And then there are two subsidiary questions that
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`are if they are limitations, what do they mean? The next term
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`is the term "administering," what does that mean? And then
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`two related terms down at the bottom "where the cabazitaxel is
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`in the form of an acetone solvate" and "wherein the
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`cabazitaxel is in base form." We're going to go sort of back
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`and forth on each one of these, and I'll start with what I
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`consider to be a preliminary question of whether or not the
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`preambles of the claims are limiting.
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`So, just to set the stage, let me discuss what a
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`preamble is. So, a preamble -- your Honor, do you have these
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`slides? I have color versions. And we're presently on Slide
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`302, which I think is the third slide in the deck.
`
`THE COURT: Okay.
`
`MR. SOLANDER: So, as I was saying, what is a
`
`preamble? Well, a preamble is the words of a claim that come
`
`before the term "comprising." Right there. And that term
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`"comprising" is a claim term that's commonly used in patent
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`drafting. There can be other terms, "consisting of,"
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`particular limitation. If it is not a limitation we don't
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`have to worry about proving infringement of it.
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`And the same is true for invalidity. If it is a
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`limitation of a claim they have the burden under clear and
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`convincing evidence to show that that limitation is taught by
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`the prior art. And if it is not a limitation of the claim
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`they do not have to show that that limitation is taught by the
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`prior art. So, whether something is a limitation or not can
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`be quite important in terms of how the trial is conducted and
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`what things people have to be proving. So, the dispute here
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`is whether "a method for treating" that's part of the preamble
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`is a limitation, is part of the limitation of the entire
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`preamble or is not. That's the dispute. We say, of course,
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`that it is. They say that it is not.
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`So, let me just go the law. This is section 305.
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`The case law says there's no litmus test that defines when a
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`preamble is a limitation, when it limits the claim scope.
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`That's black letter Federal Circuit law. But the Federal
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`Circuit hasn't completely left us at sea. It has articulated
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`in a number of decisions over the years that have been applied
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`by many district courts a number of tests that one can look at
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`to determine whether or not a preamble is limiting, and we
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`have listed some of the pertinent ones that we'll be
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`discussing here.
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`First, do the patentees repeatedly use the preambles
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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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`"consisting essentially of." But, basically, most claims use
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`the term "comprising." And what comes before that term is
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`ordinarily considered the preamble, and that is shown in red
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`up here on the board.
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`So, what is the dispute here? The dispute is
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`highlighted on the next page. The parties agree that the
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`portion in red starting with "a patient" and going down to
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`"docetaxel" in both claims should be limitations of the claim.
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`The parties disagree on whether "a method for treating" or "a
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`method for increasing the survival of a patient" should be a
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`limitation.
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`And let me explain what is a limitation of the claim.
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`Let me use one that nobody disputes is a limitation. The word
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`"cabazitaxel" that's found in the claim. What does that mean
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`to be a limitation? It means in order to prove infringement
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`we have to prove by a preponderance of the evidence that the
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`defendants are using or selling cabazitaxel or telling doctors
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`to administer cabazitaxel. We have to prove that. If they're
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`selling some different drug -- and this isn't in dispute here,
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`but if they were selling some different drug like Taxol or
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`docetaxel they would not meet that limitation, and, therefore,
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`they would not infringe the claims.
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`So, if it is a limitation, we have to prove that they
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`infringed the claims by meeting that limitation, that whatever
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`they're doing, whatever activity they're doing, meets that
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`to describe the invention in the specification or in the
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`prosecution history? And I'll explain what that means, and
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`I'll explain how it applies here in just a moment.
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`The second is did the patentees clearly rely on the
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`preambles during prosecution to distinguish the claimed
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`inventions from the prior art?
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`And the third one is do the limitations in the body
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`of the claims rely upon and derive their antecedent basis from
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`the preambles?
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`In our view, your Honor, all three of these tests are
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`met by the disputed term "a method for treatment" or "a method
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`for increasing the survival thereof," and, therefore, they
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`should be considered limitations on the claim scope of these
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`patents.
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`So, let me, if I could go through each one of those
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`tests and show you the evidence, the intrinsic evidence that
`
`shows that we're right.
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`The first test is whether or not the applicants
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`repeatedly used the preamble language to describe the
`
`fundamental characteristics of their invention. Your Honor, I
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`have highlighted portions of the specification. This is the
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`abstract. The invention relates to a "treatment of prostate
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`cancer" here. Highlights that it is a method of treating
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`prostate cancer, not a method of doing something else. That's
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`describing the invention. When they say "the invention
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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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`

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`relates to" we'll see that in the case law; "invention
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`relates" is the same as the "invention is." It is the same
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`thing.
`
`Next part of the specification now we're actually in
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`the specification itself on Columns 1 and 2. "The present
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`invention relates to a treatment of prostate cancer." "The
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`present invention," again, "relates to a treatment of prostate
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`cancer in patients who have previously treated with a
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`docetaxel-based regimen, an unmet need." So, here the
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`specification is relating the method of treating to an unmet
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`medical need. You don't solve an unmet medical need, unless
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`you provide a method that treats, a method for treating a
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`patient. That's the point. The whole point of this patent is
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`they have identified the unmet medical need, as I discussed
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`during the tutorial. These patients had nothing left after
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`they were done with docetaxel, except to make them feel as
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`comfortable as possible before they died. This gave them
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`additional life. That was the unmet need. That is the
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`treating -- that is what is being done to the patient. It is
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`prolonging their life. It is treating them. That is what the
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`claims mean. That is what they're talking about here in the
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`specification.
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`And, again, meeting an unmet need requires an
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`effective method for treating. Not an ineffective method, not
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`an attempt to treat, it requires an effective method of
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`exactly what is going on here.
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`So, let's look at the case law. This is the In Re:
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`Cruciferous case. It is a very strange name for a case, but,
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`nevertheless, it is a Federal Circuit case, and in that case
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`they held that the term "rich in glucosinates" helps define
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`the invention, and, therefore, the preamble was limiting. And
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`what kind of language did they use in the specification in
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`that case? Well, very similar language to what you just found
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`on the slides that I just showed you. The invention relates
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`to the production and consumption of foods which are "rich in
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`cancer chemoprotective compounds." Those are the glucosinates
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`at the bottom. An object of the invention is to provide foods
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`and additives that are rich in cancer ...
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`And, so, the Federal Circuit says, the specification,
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`therefore, indicates that the inventors believed their
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`invention to be making food products which were rich in
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`glucosinates, thus, the limitation was found -- the preamble
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`language was found to be limiting.
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`Next case is the Galderma case, Your Honor. In this
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`one the issue was the term "useful for the treatment of."
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`Very similar to "method for treating." The Court found that
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`it was a fundamental purpose of the invention to carry out --
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`to carry out this treatment. And it further served to specify
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`the therapeutic application of the method. And that's what we
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`argue is happening here, Your Honor. The "method for
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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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`95
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`97
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`treating.
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`Another part of the specification. "An aspect of the
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`invention." So what does "an aspect of the invention" mean to
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`a person reading a patent? What it means is I have an
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`invention, I'm claiming different aspects of the invention.
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`It is one invention, but I'm claiming different aspects of it.
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`So I can claim a method for treatment, I can say a method for
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`increasing the overall survival of it. One is a subset, if
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`you will, of the former. But it is considered -- the language
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`that people use is it is an aspect of the invention. So, the
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`specification is talking about one aspect of the invention
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`"comprises increasing the survival of a patient." Of course
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`other aspects may lower the PSA, other aspects may improve the
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`patients with respect to their tumor size. But this aspect of
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`the invention "comprises increasing the survival of a patient"
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`who "has previously been treated with a docetaxel-containing
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`regimen" and the patent gives data regarding a "significant
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`longer overall survival" and a 30 percent risk in the
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`reduction of death.
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`So, again, the invention is being described by the
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`applicants in the specification as actually reducing the risk
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`of death and increasing overall survival, which in Claim 27 is
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`the preamble language that we were asking to be a limitation.
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`So, it meets the test. Repeated use of the preamble is to
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`describe fundamental characteristics of the invention. That's
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`treating" language in the claim is specifying that the claim
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`must affect a therapeutic result. That's the point of the
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`invention. That was the unmet medical need. So here the
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`therapeutic application is the use of "the method for treating
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`metastatic castration-resistant prostate cancer."
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`Last case on this subject, your Honor, the Wyeth
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`case. The abstract says, Well, here the language was in the
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`preamble necessary -- I'm sorry. The recited property was "a
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`... formulation that 'provides better control of blood plasma
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`levels than conventional tablet formulations ....'" That was
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`the invention at issue in this case. And the term that was
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`being construed in the preamble was a method for eliminating
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`troughs and peaks of drug concentration in a patient's blood
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`plasma. So, in other words, the invention that they made
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`eliminated wide swings in the blood level of this drug. And
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`that was contained in the preamble. So, that was the use or
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`function of the invention that they created. And that was the
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`method of treating in that case. That was what they were
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`trying to achieve.
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`And the specification repeatedly emphasized that
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`aspect of the invention, and that's what's shown up here. The
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`invention states that "the invention is for a formulation that
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`provides better control of blood plasma." The brief
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`description of the invention explains "this invention provides
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`a method for eliminating the sharp peaks and troughs." So,
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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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`

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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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`99
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`101
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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
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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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`

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`102
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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,