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`C.A. No. 14-1171-GMS
`(CONSOLIDATED)
`
`IN RE COPAXONE 40 MG
`CONSOLIDATED CASES
`
`IN THE UNITED STATES DISTRICT COURT
`IN AND FOR THE DISTRICT OF DELAWARE
`- - -
`)
`)
`- - -
`Wilmington, Delaware.
`Wednesday, September 28, 2016
`9:00 a.m.
`Day 3 of Bench Trial
`- - -
`BEFORE: HONORABLE GREGORY M. SLEET, U.S.D.C.J.
`APPEARANCES:
`JOHN W. SHAW, ESQ., and
`KAREN E. KELLER, ESQ.
`Shaw Keller LLP
`-and-
`PAUL W. WARE, ESQ.,
`DARYL WIESEN, ESQ.,
`JOHN T. BENNETT, ESQ.,
`ELIZABETH J. HOLLAND, ESQ.,
`NICHOLAS K. MITROKOSTAS, ESQ., and
`WILLIAM JAMES, ESQ.,
`Goodwin Procter LLP
`(Washington, D.C.)
`-and-
`STEPHEN B. BRAUERMAN, ESQ., and
`SARA BRUSSIERE, ESQ.
`Bayard P.A.
`
`Counsel for Plaintiffs
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`Case 1:14-cv-01171-GMS Document 284 Filed 12/08/16 Page 1 of 287 PageID #: 7958
`
`C.A. No. 14-1171-GMS
`(CONSOLIDATED)
`
`IN RE COPAXONE 40 MG
`CONSOLIDATED CASES
`
`IN THE UNITED STATES DISTRICT COURT
`IN AND FOR THE DISTRICT OF DELAWARE
`- - -
`)
`)
`- - -
`Wilmington, Delaware.
`Wednesday, September 28, 2016
`9:00 a.m.
`Day 3 of Bench Trial
`- - -
`BEFORE: HONORABLE GREGORY M. SLEET, U.S.D.C.J.
`APPEARANCES:
`JOHN W. SHAW, ESQ., and
`KAREN E. KELLER, ESQ.
`Shaw Keller LLP
`-and-
`PAUL W. WARE, ESQ.,
`DARYL WIESEN, ESQ.,
`JOHN T. BENNETT, ESQ.,
`ELIZABETH J. HOLLAND, ESQ.,
`NICHOLAS K. MITROKOSTAS, ESQ., and
`WILLIAM JAMES, ESQ.,
`Goodwin Procter LLP
`(Washington, D.C.)
`-and-
`STEPHEN B. BRAUERMAN, ESQ., and
`SARA BRUSSIERE, ESQ.
`Bayard P.A.
`
`Counsel for Plaintiffs
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`APPEARANCES CONTINUED:
`FREDERICK L. COTTRELL, III, ESQ.
`Richards, Layton & Finger, P.A.
`-and-
`DAVID L. ANSTAETT, ESQ.
`Perkins Coie LLP
`(Madison, WI)
`-and-
`SHANNON M. BLOODWORTH, ESQ.,
`BRANDON M. WHITE, ESQ.
`EMILY J. GREB, ESQ., and
`ROBERT D. SWANSON, ESQ.
`Perkins Coie, LLP
`(Washington, D.C.)
`
`Counsel for Defendants
`Mylan, Inc. and
`Mylan Pharmaceuticals, Inc.
`DOMINICK T. GATTUSO, ESQ.
`Procter Heyman & Enerio LLP
`-and-
`WILLIAM A. RAKOCZY, ESQ.,
`DEANNE M. MAZZOCHI, ESQ.,
`RACHEL PERNIC WALDRON, ESQ.,
`MATTHEW V. ANDERSON, ESQ.,
`THOMAS H. ERLICH, ESQ.
`ERIN FORBES, ESQ., and
`CHRIS GALLIGAN, ESQ.
`Rakoczy Molino Mazzochi & Siwik LLP
`(Chicago, IL)
`
`Counsel for Defendants
`Sandoz Inc. and Momenta
`Pharmaceuticals, Inc.
`RICHARD W. RILEY, ESQ.
`Duane Morris LLP
`-and-
`CHRISTOPHER S. KROON, ESQ., and
`ANTHONY J. FITZPATRICK, ESQ.
`Duane Morris LLP
`(Boston, MA)
`
`Counsel for Defendants
`Amneal Pharmaceuticals LLC
`and Amneal Pharmaceuticals
`Company GmbH
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`APPEARANCES CONTINUED:
`DAVID BILSON, ESQ.
`Phillips, Goldman, McLaughlin & Hall, P.A.
`-and-
`HANK HECKEL, ESQ.
`Budd Larner
`(Short Hills, NJ)
`Counsel for Defendant DRL
`NEAL C. BELGAM, ESQ.
`Smith Katzenstein & Jenkins LLP
`-and-
`E. ANTHONY FIGG, ESQ.,
`ELIZABETH R. BRENNER-LEIFER, ESQ., and
`BRETT A. POSTAL, ESQ.
`Rothwell, Figg, Ernst & Manbeck, P.C.
`(Washington, D.C.)
`Counsel for Defendants
`Synthon Pharmaceuticals, Inc.,
`Synthon B.V., and Synthon s.r.o.,
`and Pfizer
`- - -
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`THE COURT: Good morning.
`(Counsel respond "Good morning.")
`THE COURT: Please, take your seats.
`I understand that we have an issue or two. Who
`wants to go first?
`MR. WARE: Yes, Your Honor. I would appreciate
`if the Court would entertain us at sidebar.
`(The following took place at sidebar.)
`MR. WARE: Your Honor, yesterday, we had some
`colloquy about Mr. Hassler and the extent to which I would
`be precluded from asking questions on irreparable harm.
`THE COURT: Yes.
`MR. WARE: I believe representations were
`made -- I am not going to characterize those -- I asked for
`the Bench conference in part because I don't want to
`embarrass anybody -- but the representations were made to
`you, including these: that he was never identified in
`response to discovery requests; he was never identified as
`someone who was going to have knowledge on irreparable harm
`issues.
`
`That is not true. Among other things, we gave
`in discovery his declaration filed in the U.S. Supreme
`Court, the subject of which is irreparable harm.
`In fairness, it has to do more with 20 milligram
`than 40 milligram because that was the nature of the case.
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`But the entire content is on the issue of irreparable harm.
`Defendants have marked that as a defense exhibit
`in this case.
`He was deposed six months, ago and he was asked
`time and time again about this issue in the deposition in
`this case.
`
`My feeling was that yesterday, knowing the
`premium the Court puts on fairness, that the Court felt that
`defendants had not been given appropriate notice or an
`opportunity. And that is absolutely not the case. He was
`deposed endlessly on this.
`That is my issue, Your Honor. We should be free
`to inquire on this. I have a suggestion if we get to it.
`MS. BLOODWORTH: Your Honor, if I may.
`First of all, this is the first we are hearing
`about this. We met and conferred with plaintiffs many times
`last night on a variety of issues and this was never brought
`to our attention, that they were going to make this motion
`this morning. So I have no information in front of me about
`what testimony Mr. Ware is actually referencing.
`I can tell you that I was counsel for Mylan in
`the 20 milligram case which went to the Supreme Court. Mr.
`Hassler submitted that harm declaration on whether or not
`generic competition entry of the 20 milligram product
`against Teva's 20 milligram product would cause irreparable
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`Case 1:14-cv-01171-GMS Document 284 Filed 12/08/16 Page 6 of 287 PageID #: 7963
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`harm. That injunction was denied. The Chief Justice of the
`Supreme Court said that that showing did not meet
`irreparable harm.
`Mr. Hassler's deposition, again, Your Honor, I
`have not been able to verify this -- with accusations and
`speaking to Your Honor, I want to be very careful and ask
`for an additional read -- but I want to make the point that
`I do want to say the declaration was used as background in
`Mr. Hassler's deposition because it was all laid out very
`nicely and clearly, his titles and his roles. I believe it
`came up later on. But it was not whether or not a launch of
`a generic product, 40 milligram product, would cause
`plaintiffs harm.
`It was about the market, what plaintiffs were
`saying about the 20 milligram market vis-à-vis the 40
`milligram market. As you know, commercial success is a very
`important issue in this case.
`Again, Your Honor, I am a little sandbagged here
`because I haven't had notice and I don't want to
`misrepresent anything. But I don't see where those two
`issues are related. A harm declaration on a different
`product in a different case and irreparable harm about the
`generic entry of our product vis-à-vis the 40 milligram
`product, that is an issue that is very distinct and
`discrete.
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`486
`Case 1:14-cv-01171-GMS Document 284 Filed 12/08/16 Page 7 of 287 PageID #: 7964
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`And I don't want to misrepresent Ms. Mazzochi's
`comments. I think that is the irreparable harm she was
`talking about.
`Mr. Hassler wasn't able to say, what is the harm
`to Teva if a 40 milligram generic enters the market.
`I do not believe that Mr. Hassler was asked
`about that at his deposition.
`MS. MAZZOCHI: Your Honor, I very much object
`that I was making a misrepresentation, because I personally
`went through the initial disclosure, the supplemental
`disclosures. Mr. Hassler was not identified as having
`knowledge on this issue.
`If Teva is saying we put forth his declaration
`for the on the 20 milligram product, defendants should have
`known, they had knowledge on this issue and deposed him.
`Second, we went through documents, they produced
`documents related to harm. They said they are not producing
`them. When they are not going to produce any documents on
`this issue, okay, let them live with that choice.
`Your Honor, what they are avoiding is the
`fundamental issue, which is that they put nothing on harm in
`the final pretrial order proposed findings of fact and
`conclusions of law.
`That is the universe for the operative facts we
`are talking about here. They didn't do anything on it,
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`Case 1:14-cv-01171-GMS Document 284 Filed 12/08/16 Page 8 of 287 PageID #: 7965
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`despite it being their burden.
`I think, frankly, this issue, it's on them.
`They knew about it. If they thought -- if they were
`anticipating they were going to call Mr. Hassler to talk
`about harm, they could have put that in the proposed
`findings of fact. And they didn't.
`MS. BLOODWORTH: Your Honor, we did raise the
`waiver of the irreparable harm issue in our exchanges
`leading up to the final, submission of the final pretrial
`order. It is H in the schedule. I may have the letter
`wrong. They still didn't put it in any proposed findings of
`fact and conclusions of law.
`Our pretrial disclosures are a very condensed
`time, it is understood. But they had notice, even a little
`bit, which should have been enough to put in the prima facie
`elements.
`
`MR. WIESEN: On last point, Your Honor, we had
`flagged that and we had objected because of the late notice
`that it was an issue. Right before the final pretrial
`conference we engaged in a meet-and-confer and we thought we
`were working towards a resolution.
`Rather than raise it with you, we tried to
`resolve it. And it wasn't until basically the day before
`trial that the discussions fell apart about whether we could
`resolve that issue, maybe a week before.
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`MS. BLOODWORTH: I disagree with that timeline.
`MS. MAZZOCHI: I disagree as well.
`MS. MAZZOCHI: It doesn't change the fact that
`it was your burden to put it forward anyway.
`THE COURT: So let me ask a fundamental question
`from both parties' perspectives. The net effect of my
`ruling as it stands today is what?
`MR. WARE: The net effect is that we are
`precluded from putting in evidence regarding irreparable
`harm.
`
`THE COURT: What is your view, Ms. Bloodworth?
`MS. BLOODWORTH: My view is the same.
`THE COURT: At the end of the day, where does
`that leave the parties? I don't let you put in evidence of
`irreparable harm, you don't get an injunction. Right?
`MR. WARE: Yes.
`THE COURT: That is what we are here about.
`
`Right?
`
`MR. WIESEN: Your Honor, if I could, we may not
`be able to get an injunction under Section 283, although
`that is certainly an eBay balancing question. I will
`confess, it is a difficult question.
`We are also entitled to an injunction under
`271(e)(2)(4) and --
`THE COURT: Do you want to tell me what those
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`sections say?
`MR. WIESEN: When an action is brought under the
`Hatch-Waxman Act, 271(e)(4)(1) --
`THE COURT: Whatever section.
`MR. WIESEN: The (e)(4)(A) section is that you
`order the FDA not approve material with regard to patent
`expiration. The E(4)(B) order is that they not engage in
`commercial manufacture.
`THE COURT: So they got a statutory injunction
`MR. WIESEN: Yes. To be clear, we will talk
`about what is only in the proposed findings and conclusions,
`specifically they only contest the injunction, not the 271
`injunction on the injunctive relief. They have a standing
`argument apparently about the 271(e) injunction. What the
`are trying to do is put us in a position that even if we
`win, you would not enter an injunction.
`THE COURT: If what you say is true and there is
`a statutory prescription that requires, if you are the
`liability winner, that you get your injunction, why do you
`care about eBay? What does it matter? Why do you care
`about Mr. Hassler? Is this much ado about nothing? If I am
`required to impose an injunction by statute, which I sort of
`wonder about. But go ahead.
`MR. WIESEN: We think that is the correct
`interpretation of the law. I am not aware of their
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`authority on that.
`THE COURT: Has this issue been litigated
`MS. BLOODWORTH: Yes, Your Honor, in the Apotex
`case. 271(e)(4)(B) injunctions are subject to the eBay
`factors.
`
`THE COURT: That is my understanding of the law.
`MR. WIESEN: But the 271(e)(4)(A) objections are
`
`not.
`
`MS. BLOODWORTH: That is not an injunction. It
`is a prohibition against FDA approving our ANDA products
`until the expiration of the patents. There are no
`restrictions on commercial manufacture, use, et cetera,
`under the traditional statute.
`THE COURT: I have not had to encounter this
`yet. Maybe I will. But it gets back to the fundamental
`issue that Mr. Ware raised earlier, my concern in any trial
`is being fair to both sides. It seems in this case that Mr.
`Ware and company -- that the defendants have raised a
`legitimate complaint that could have easily been dealt with
`in the lead-up to where we are today.
`MR. WARE: Your Honor, with all deference, I
`think there was an effort to deal with the issue. And
`discussions broke apart. It all happened at the 11th hour.
`The problem couldn't be solved.
`But as important --
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`491
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`THE COURT: Are you talking about during the
`negotiation of the pretrial order?
`MR. WARE: Yes.
`THE COURT: Why not dial the Court up? I am
`
`available.
`
`MR. WARE: Your Honor, there is a limit to how
`often we can dial the Court up.
`THE COURT: That is true. But we were coming on
`a trial. All these cases are important, but obviously this
`case is very important to the parties. I would have made
`myself available.
`MR. WARE: I think the other issue is, this
`declaration dealing with irreparable harm was produced. Mr.
`Hassler was obviously identified as the person with
`knowledge about it, because he was deposed on it.
`Maybe it had to do with 20 milligrams for the
`most part. But the deposition didn't. The deposition was
`in this case with respect to irreparable harm in this case
`and what would happen in the event of a generic launch.
`THE COURT: I was reminded by my law clerk that
`I had said something during the discussion when we first
`addressed this that indicated that I was willing to take
`evidence subject to potentially further briefing. I know I
`ruled the following day, and Ms. Felice said, "Well,
`Judge..."
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`492
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`And I said, you know, that's what I said. But
`they are advocates and they didn't remind me that I said it.
`You, Mr. Bennett, didn't remind me. I think you were
`standing up for plaintiff on this issue. Right? And I
`said -- you know, people have to advocate. Judges don't
`remember everything. My ruling may in fact have been
`inconsistent with what I said the day before. So in the
`interests of fairness -- do you recall that, Ms. Bloodworth,
`that I said that?
`MS. BLOODWORTH: I don't recall that. I thought
`I recalled that about the testimony of Dr. Klinger on the
`scope of her exhibits going in under Rule 26 that had not
`been disclosed in response to the interrogatories.
`MS. BRENNER-LEIFER: That was the issue.
`THE COURT: Counsel.
`MS. BLOOODWORTH: I attended the deposition.
`Mr. Swanson took the deposition. It is my recollection that
`that was a Mylan exhibit that he used on Mr. Hassler that
`was not produced by plaintiffs. And I am asking him to
`confirm that.
`MR. BENNETT: I have a copy.
`THE COURT: Do you folks want to write something
`on this that I and my law clerk can look at during the
`course of the proceedings?
`Mr. Hassler may just have to come back, Mr.
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`493
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`Ware, if I end up agreeing with you.
`MR. WARE: I understand, Your Honor. I held him
`in the area. He lives in Kansas City. He works in Kansas
`City. He is here through tomorrow.
`MS. BLOODWORTH: Your Honor, may I ask a couple
`logistic questions?
`THE COURT: Sure.
`MS. BLOODWORTH: We would strongly disagree with
`revisiting the issue. We believe that the 20 milligram
`questions which this is supposedly based on, all the
`questions at his deposition dealt with the 20 milligram
`product.
`
`Probably my more pertinent point is that it
`still doesn't change the fundamental flaw in the fact that
`the plaintiffs still have not put in any evidence in the
`proposed pretrial findings. We still don't know what Mr.
`Hassler will say.
`Additionally, Mr. Hassler hasn't been
`sequestered. He has been talking to his attorneys about
`this issue. There are problems with calling him
`logistically, Your Honor.
`MR. WARE: No, he has not had any substantive
`conversation with us.
`THE COURT: Why don't you address the point
`before that, concerning the order, the failure, just the
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`494
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`failure to put them on notice.
`MR. WARE: Well, I guess it is a question of
`what is putting them on notice. I think substantively they
`were on notice.
`THE COURT: The affidavit?
`MR. WARE: The affidavit. They are right, there
`is a failure on proof with respect to the conclusions of law
`or the findings of fact. I can't dispute that. I am not
`going to make a representation to the contrary.
`I think, ultimately, it was up to us to figure
`that out. We didn't do it. But all of this information has
`been available. It was discovered. They have this
`affidavit on their exhibit list.
`The substance of all of the irreparable harm
`questions that were asked at the deposition are applicable
`to the 40 milligram. And that was the purpose of asking him
`the questions at the deposition.
`THE COURT: You know I have enormous respect for
`you, Mr. Ware. But these lawyers disagree with you. It's
`clear.
`
`MR. WARE: I have it.
`THE COURT: I know. I will look at it. I will
`at least look at it.
`I know you object, Ms. Bloodworth. And you have
`a right to do so.
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`495
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`I typically, as I think most people here in this
`conference know, I don't like to revisit rulings, and judges
`shouldn't. This is a never-ending polemic, if we do that,
`it continues, because lawyers are smart, you all are clever,
`a lot more than me and Ms. Felice.
`At some point it just has to stop. This is the
`last I am going to look at this. I will look at the
`affidavits. If I have some additional questions, I will ask
`them of you in a sidebar conference or in some way to see if
`I can resolve to my satisfaction whether Teva has been fair
`to the various defendants in this case and whether they are
`put to a disadvantage as a result of certain failings. You
`can give me whatever you want to give me.
`MS. BLOODWORTH: That is what I was going to
`ask. Should we submit the deposition transcript, the
`relevant portions?
`THE COURT: Just the relevant portions.
`MS. BLOODWORTH: And the Supreme Court
`
`affidavit?
`
`THE COURT: Yes.
`MS. MAZZOCHI: Your Honor, I want to have the
`opportunity -- I think it would be easiest for me to know
`exactly the target I am trying to respond to. If Mr. Ware
`could put together whatever he is going to put together, you
`know --
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`THE COURT: And then you respond. That's fair.
`I think that's fair. That will be the logistics.
`MS. BLOODWORTH: Should we do that in one
`submission, plaintiffs send it to us and we will respond?
`THE COURT: You have your teams work it out,
`your poor associates work it out. Let's see where we go
`from here.
`
`It may come to pass that we will have to
`re-convene if I agree. I may not resolve it. I am not
`going to promise that I am going to resolve it.
`I will leave it there. We will see where we go.
`
`Okay?
`
`Please, no depositions at the end of the day,
`Mr. Ware, today. That was excruciating yesterday.
`Who was that?
`MR. WARE: I don't want to identify him.
`THE COURT: We will start in a few minutes.
`(End of sidebar conference.)
`(Recess taken.)
`MR. WARE: Your Honor, could I ask that the
`transcript at sidebar only be sealed?
`THE COURT: Any objection?
`MS. BLOODWORTH: May I ask why it's
`confidential, Your Honor?
`THE COURT: You may. You may respond.
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`Case 1:14-cv-01171-GMS Document 284 Filed 12/08/16 Page 18 of 287 PageID #: 7975
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`MR. WARE: I won't ask for a sidebar.
`THE COURT: Do you need to go to sidebar?
`MR. WARE: If you don't mind.
`THE COURT: Just the two of you.
`(There followed a short conference at sidebar,
`ordered sealed by the Court.)
`(End of sidebar conference.)
`MR. ANSTAETT: Your Honor, I will address this
`issue for all the defendants.
`Dr. Green, Dr. Ari Green is one of the experts
`you will be hearing from in the invalidity portion of the
`case.
`
`THE COURT: For who?
`MR. ANSTAETT: For the defendants. One of the
`defendants' witnesses on invalidity. An issue has arisen.
`We exchanged exhibits that parties are going use
`with the experts. A couple of objections have been raised
`to exhibits we plan to use with Dr. Green.
`Dr. Green we expect will go on tomorrow. But we
`wanted to raise the issue today because the parties exchange
`slides at night and we want to know, is this in or out. The
`issue is with a particular prior art reference, Khan 2009.
`I just misspoke. It is not prior art. It is a publication
`that appeared three weeks after the priority date.
`It describes a two-year study that Dr. Khan had
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`Case 1:14-cv-01171-GMS Document 284 Filed 12/08/16 Page 19 of 287 PageID #: 7976
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`conducted of dosing 20 milligrams of glatiramer acetate
`twice a week and compared that to daily dosage. I know you
`heard in a lot of studies every other day versus daily.
`This was two times a week, even less frequently, versus
`daily.
`
`THE COURT: This was 20 milligrams.
`MR. ANSTAETT: Exactly, yes. The issue is that
`the study, as I say, was begun in 2007, so well, well,
`before the priority date. The publication announcing the
`results of the study came out three weeks after the priority
`date.
`
`The issue is, I think they are moving to exclude
`it because they contend it's not prior art so it can't be
`relevant. There is no issue about whether Mr. Green had
`this in his report, he did. It is not a Rule 26 issue. The
`law on this is abundantly clear that -- I have some case
`citations that may be helpful from the Federal Circuit. But
`the upshot is that you may use later publications as
`evidence of the state of the art before the priority date.
`THE COURT: I have ruled in cases in that way.
`MR. ANSTAETT: Here, we have had -- this is the
`second time we are having this argument with plaintiffs.
`THE COURT: I am better authority than the CAFC.
`MR. ANSTAETT: I absolutely believe that. I
`couldn't agree with you more.
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`Case 1:14-cv-01171-GMS Document 284 Filed 12/08/16 Page 20 of 287 PageID #: 7977
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`THE COURT: I am being facetious, colleagues.
`MR. ANSTAETT: You would also be, in your
`rulings in the past, you would be on the same page with the
`Patent Trial and Appeal Board, because Dr. Green relied on
`this in a reference in his declarations before the Patent
`Trial and Appeal Board on the IPRs in the first three
`patents in this case. They moved to exclude it before the
`PTAB. And the PTAB considered the issue and they said, no,
`this is admissible evidence, it shows motivation, that there
`was no motivation in the art before 2009, before the
`priority date, that skilled artisans were interested in
`dosing glatiramer acetate less frequently.
`Yes, the publications didn't come out until a
`few weeks after. But the study started two years before the
`priority date. So we are not asserting it as an obviousness
`combination.
`
`We are not going to ask Your Honor to invalidate
`the patents based on the disclosure in that prior art. But
`we are going to ask Your Honor to look at it and potentially
`infer that, yes, skilled artisans were interested in less
`frequent dosing because Dr. Khan had started this study two
`years prior to the priority date.
`Again, you are better authority than the Federal
`Circuit, but if you do want case citations --
`THE COURT: Do you want to go ahead?
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`Case 1:14-cv-01171-GMS Document 284 Filed 12/08/16 Page 21 of 287 PageID #: 7978
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`MR. ANSTAETT: Sure. There is the Syntex v.
`Apotex case, 407 F.3d 1371, Federal Circuit 2005. In that
`case a reference was published five days after the priority
`date. I am reminded to be slow with the cites.
`That is 407 F.3d 1371, Syntex v. Apotex.
`A reference published five days after the
`priority date established that a drug was a well-known
`ingredient in pharmaceutical products. And although the
`patent owner in that case contended that because the
`reference was published five days after the priority date,
`it disclosed no prior uses of that --
`THE COURT: Just give me the cite.
`MR. ANSTAETT: All right. But the upshot was
`that the Federal Circuit said it is a little bit incredulous
`that, you know, this motivation would have arisen in the
`five days between the priority date and whether it was
`published. So they said it was relevant.
`The other case, one that was cited by the Patent
`Trial and Appeal Board in its decision is Plant Genetic
`Systems v. DeKalb Genetics Corp., that is 315 F.3d 1335.
`And again, that was a finding -- that was a case that
`approved the use of later publications as evidence of the
`state of the art existing on the filing dates of a patent
`application.
`
`On that basis, the PTAB said we think this is
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`Case 1:14-cv-01171-GMS Document 284 Filed 12/08/16 Page 22 of 287 PageID #: 7979
`
`relevant and we have considered it for motivation purposes.
`THE COURT: Ms. Holland.
`MS. HOLLAND: Thank you, Your Honor.
`First of all, I want to remind you, this is an
`issue that came up during the cross-examination of Dr.
`Klinger. There was a nonpublic document that Ms. Bloodworth
`tried to use during that cross-examination, which included a
`citation to this post art. And we discussed it at that
`time. And Ms. Bloodworth wasn't permitted to question Dr.
`Klinger about that document, other than on issues of
`credibility. Your Honor may remember.
`The issue here, Your Honor, is that when you
`look at the pretrial order, what defendants say they are
`using this post art publication for is evidence of prior
`public use. But there is very, very clear case law and the
`showing you have to make if you want to use something as --
`THE COURT: Again, Ms. Holland, what do you
`understand the purpose is?
`MS. HOLLAND: When you look at their pretrial
`order, they say that they want to prove that there was a
`prior public use, and that that is what this 2009 reference
`established.
`
`THE COURT: That is not what counsel said.
`MS. HOLLAND: That is why I am confused, Your
`
`Honor.
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`Case 1:14-cv-01171-GMS Document 284 Filed 12/08/16 Page 23 of 287 PageID #: 7980
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`MR. ANSTAETT: I can clear up any confusion,
`Your Honor. It is a fair point that Ms. Holland is making.
`We put that in as an abundance of caution. We do not intend
`to offer it as evidence of prior public use. We intend to
`offer it as simply there was motivation in the art before
`the prior art to explore these.
`MS. HOLLAND: I don't think that quite does it,
`Your Honor, because if it is not prior art, and we don't
`have any testimony from Dr. Khan or anybody else about what
`he was thinking at the time, it can't be used as prior art
`in this case.
`The inquiry is what would a person of ordinary
`skill in the art have been able to know based on prior art
`references.
`
`There is no question that Khan 2009 is not a
`prior art reference. There is no evidence in the record and
`defendants are not prepared to offer that what Dr. Khan was
`using was a public use, what he was doing was in any way
`public. There is no evidence of that. So consideration of
`this is just improper under Section 102 and Section 103,
`which require that the expert does his analysis about the
`state of the art as of the time.
`If Dr. Green wants to get on the stand and say
`that he had some knowledge what was going on at the time,
`that's different. But Dr. Green is not going to say he knew
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`Case 1:14-cv-01171-GMS Document 284 Filed 12/08/16 Page 24 of 287 PageID #: 7981
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`Dr. Khan was doing this at the time. He is using it in
`effect as prior art to try to prove motivation of a person
`of ordinary skill in the art before the filing date.
`I would also add, if you look at the Syntex case
`that was cited by Mr. Anstaett, you see that what the Court
`there said was that there was an admission by the inventors
`in that case that an element of the invention was in the
`prior art. The admission came after the filing date. But
`it's clear in the context of that case that the reason this
`was let in was because the inventors themselves admitted
`that there was something in the prior art that was relevant
`to their invention. We don't have anything like that here.
`This is kind of an end run around the prior art
`requirements. We believe that is improper.
`If I could bring up a related issue, Your Honor.
`Maybe Mr. Anstaett can clear this up as well.
`So the document that Ms. Bloodworth tried to use
`with Dr. Klinger on cross that references this post art
`publication, I don't know if that is something that they are
`planning on having Dr. Green testify about as well, but if
`so, I can address that now.
`THE COURT: Mr. Anstaett.
`MR. ANSTAETT: Yes, Your Honor. There seems to
`be some confusion. We are not contending that the
`publication itself is prior art. What we are contending,
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`504
`Case 1:14-cv-01171-GMS Document 284 Filed 12/08/16 Page 25 of 287 PageID #: 7982
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`consistent with, I think, crystal-clear cases from the
`Federal Circuit, is that you can rely on a reference after
`the priority date as evidence of what was happening in the
`art before the priority date.
`Like I said, we are not asserting it as a prior
`art combination that Dr. Green is going use. But he is
`going to simply make the observation, as the PTAB did,
`saying here, at Exhibit 1154, which is the Khan 2009
`abstract, was published three weeks after the priority date
`of the '250 patent, the study reported therein had commenced
`two years before. In other words, Exhibit 1154 reflects
`that before the '250 patent invention, those skilled in the
`art were motivated to investigate dosing regimens with less
`frequent than daily injections.
`That is all we intend to use it for here. Not
`as a piece of invalidating prior art.
`With respect to the second document that Ms.
`Holland talked about, that's the GALA protocol that there
`has been testimony on already, including with Dr. Klinger,
`and we were allowed to use that document with Dr. Klinger
`because it cites the Khan 2008 publication of every other
`day dosing, and the Flechter 2002 publication of every other
`day dosing, there is no dispute that those are prior art.
`And Teva told the FDA the rationale for the reason we
`selected this dosing regimen of 40 milligrams three times a
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`505
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`week was based in part on these studies.
`So we are going to talk to Dr. Green,
`absolutely, about that GALA trial protocol because it
`corroborates his opinions.
`When he came to his opinions, he didn't have the
`benefit of that GALA trial protocol. But he analyzed the
`prior art and offered opinions in this case. Then we got
`the GALA trial protocol, and lo and behold, Teva had a quite
`similar rationale that Dr. Green offers.
`So we are fully intending to use that document
`with Dr. Green, and it was in his expert report.
`MS. HOLLAND: It certainly was in the expert
`report. That doesn't mean, of course, that it is
`admissible.
`
`I will address the points Mr. Anstaett made.
`He is correct that the Patent Trial and Appeal
`Board did have that view of the Khan 2009 reference. We
`believe that that is clear legal error. Tha
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