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`IN THE UNITED STATES DISTRICT COURT
`IN AND FOR THE DISTRICT OF DELAWARE
`- - -
`
`
`
`CIVIL ACTION
`
`NO. 18-00924 (CFC)
`CIVIL ACTION
`
`NO. 18-1363 (CFC)
`
`:::::::::::::::::::::::::::
`
`GENENTECH, INC., and CITY
`OF HOPE,
`Plaintiffs and
`Counterclaim
`Defendants,
`vs.
`AMGEN INC.,
`Defendant and
`Counterclaim Plaintiff
`---------------------------
`GENENTECH, INC.,
`Plaintiff and
`Counterclaim
`Defendant,
`
`VS.
`SAMSUNG BIOEPSIS CO., LTD.,
`Defendant and
`Counterclaim Plaintiff
`
`
`
`
` - - -
`Wilmington, Delaware
`Wednesday, April 24, 2019
`11:00 o'clock, a.m.
` - - -
`
`BEFORE: HONORABLE COLM F. CONNOLLY, U.S.D.C.J.
`- - -
`
`Valerie J. Gunning
`Official Court Reporter
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`APPEARANCES:
`
`McCARTER & ENGLISH, LLP
`BY: DANIEL SILVER, ESQ.
`
`-and-
`
`RICHARDS, LAYTON & FINGER
`BY: FREDERICK L. COTTRELL, III, ESQ. and
`JASON RAWNSLEY, ESQ.
`
`-and-
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`WILMER CUTLER PICKERING HALE AND DORR LLP
`BY: ROBERT J. GUNTHER, JR., ESQ. and
`ANDREW DANFORD, ESQ.
`(New York, New York)
`
` -and-
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`DURIE TANGRI LLP
`BY: DURALYN J. DURIE, ESQ.
`(San Francisco, California)
`
`-and-
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`GENENTECH
`BY: REBECCA GRANT, ESQ.
`
`Counsel for Genentech, Inc. and City
`of Hope
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`APPEARANCES (Continued):
`
`SMITH, KATZENSTEIN & JENKINS
`BY: NEAL BELGAM, ESQ. and
`EVE ORMEROD, ESQ.
`
`-and-
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`COOLEY LLP
`BY: MICHELLE RHYU, ESQ.
`(Palo Alto, California)
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`-and-
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`COOLEY LLP
`BY: EAMONN GARDNER, ESQ.
`(San Francisco, California)
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`-and-
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`COOLEY LLP
`BY: ORION ARMON, ESQ.
`(Broomfield, Colorado)
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`-and-
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`COOLEY LLP
`BY: XIAOXIAO XUE, ESQ.
`(Washington, D.C.)
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`-and-
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`APPEARANCES (Continued):
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`AMGEN, INC.
`BY: NANCY GETTEL, ESQ. and
`THOMAS LAVERY, IV, ESQ.
`
`Counsel for Defendant
`Amgen
`
`POTTER, ANDERSON & CORROON
`BY: DAVID E. MOORE, ESQ.
`
`-and-
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`WHITE & CASE
`BY: DIMITRIOS DRIVAS, ESQ.,
`SCOTT WEINGAERTNER, ESQ. and
`AMIT THAKORE, ESQ.
`(New York, New York)
`
`Counsel for Defendant
`Samsung Bioepsis Co., Ltd.
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`P R O C E E D I N G S
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`
`(Proceedings commenced in the courtroom,
`beginning at 11:02 a.m.)
`
`THE COURT: Good morning. Please be seated.
`Mr. Silver?
`MR. SILVER: Good morning, Your Honor.
`THE COURT: Good morning.
`MR. SILVER: Dan Silver on behalf of the
`plaintiffs in the Amgen case, which is Civil Action No.
`18-924. And with me at counsel table, Your Honor, are
`Daralyn Durie from Durie Tangri.
`MS. DURIE: Good morning.
`MR. SILVER: Andrew Danford from Wilmer Hale and
`William Gunther from Wilmer Hale. We also have with us
`Rebecca Grant from Genentech as well.
`MR. DANFORD: Good morning, Your Honor.
`MR. GUNTHER: Good morning, Your Honor.
`THE COURT: All right.
`MR. SILVER: Thank you.
`THE COURT: Good morning, Mr. Cottrell.
`MR. COTTRELL: Yes. Good morning, Your Honor.
`Fred Cottrell along with my colleague Jason Rawnsley from
`Richards, Layton & Finger. We're Delaware counsel for
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`Genentech in the Samsung case.
`THE COURT: All right.
`MR. COTTRELL: Thank you.
`THE COURT: Thank you. Mr. Belgam?
`MR. BELGAM: Hello, Your Honor. Neal Belgam,
`Smith Katzenstein, for the defendant, Amgen.
`From my firm I have with me Eve Ormerod, and
`from Cooley today, Michelle Rhyu.
`MS. RHYU: Good morning, Your Honor.
`MR. BELGAM: Orion Armon, Eamonn Gardner,
`Xiaoxiao Xue, and from Amgen pro hac vice is Nancy Gettel
`and Thomas Lavery.
`THE COURT: All right. Mr. Moore, how are you?
`MR. MOORE: David Moore from Potter Anderson on
`behalf of Samsung Bioepsis.
`With me at counsel table are Scott Weingaertner,
`Amit Thakore. Also from us from White & Case are Dimitrios
`Drivas and Holly Tao.
`THE COURT: All right. Does that take care of
`everyone, I think?
`All right.
`MS. RHYU: Your Honor, before we start the
`argument today, we ask for your guidance on one of the terms
`on the gene detection patents, the '834 and '066 patent. We
`sat here and intently listened to the argument yesterday and
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`fully appreciate that Your Honor is not interested in
`hearing indefiniteness arguments at this stage, and we
`struggled with this because distinct from the Kao patents
`that you listened to yesterday, for the '834 patent, while
`we looked through that specification for a more definite
`interpretation that we could have, we couldn't come up with
`one, and our position is that the construction that was
`offered by Genentech is likewise indefinite. And so if we
`argue that term, then we're likely to have to raise
`indefiniteness issues.
`Now, last night we reached out to Genentech and
`offered to forego argument on the '834 preamble so that we
`could defer those arguments until a later date when Your
`Honor is ready to hear the indefiniteness issues and
`Genentech rejected that, so we're in a position today where
`if Genentech presents its arguments, we really have the
`unavoidable choice of arguing indefiniteness.
`So we ask that the Court decline to adopt any
`claim construction for the preamble of the '834 term, and we
`have conferred with Samsung's counsel and they are in
`agreement with this approach as well.
`THE COURT: All right. So, and this is only
`whether the preamble is limiting. Is that right?
`MS. RHYU: No. There's agreements that the
`preamble is limiting.
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`THE COURT: Sorry. Oh, wait.
`MS. RHYU: But it is whether Your Honor should
`adopt Genentech's construction since none of the other
`parties have offered that construction.
`THE COURT: On the increasing likelihood?
`MS. RHYU: Exactly. So it's the increasing
`likelihood of therapeutic effectiveness term, and Genentech
`has offered a construction that involves a greater
`likelihood.
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`THE COURT: So you stipulate. You both agree
`it's limiting?
`MS. RHYU: We both agree it's limiting.
`THE COURT: All right. So what I will do is, I
`didn't think we would have argument. If Genentech wants to
`argue, I will listen at least to some extent.
`I think my comments about indefiniteness
`yesterday went to the fact that Amgen took an hour to argue,
`and I was just trying to say, look, I've never completely
`precluded, I don't think I have, any words on indefiniteness
`at a claim construction.
`I will listen briefly, but it's not the time to
`have a lengthy argument on indefiniteness. And my comments,
`I was trying to be subtle and to encourage the advocate to
`move on. It ended up taking an hour. And I don't find that
`compelling and I'm not going to do that today from either
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`side. All right?
`I guess I can hear from Genentech and then we
`can decide how to treat it. I came in here with the
`expectation there wasn't going to be argument on it and,
`frankly, I didn't prepare for that term, but I will listen
`and we can decide then.
`MS. RHYU: Thank you, Your Honor.
`MS. DURIE: Thank you, Your Honor. Daralyn
`Durie for Genentech.
`I think there are two distinct issues here,
`one of which merits the Court's attention at this juncture
`and the other of which probably can be deferred to a later
`date.
`
`THE COURT: And you're now talking about this
`specific term?
`MS. DURIE: I am, Your Honor. I'm talking about
`the '834 patent and specifically, the preamble to it.
`And before I get into the substance of the
`argument -- if we could hand up the slides, Your Honor?
`THE COURT: Sure.
`MS. DURIE: Thank you.
`(Slides handed to the Court.)
`THE COURT: And, again, I mean, you want me to
`rule this morning, just to adopt your, formally to adopt
`your construction?
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`MS. DURIE: That is correct, Your Honor.
`THE COURT: Okay.
`MS. DURIE: We would like the Court to construe
`the term, which is to say, to define what it means.
`THE COURT: Right. Okay.
`MS. DURIE: And it's not clear to me, and we'll
`talk about this, that there's actually even a dispute
`between the parties as to whether the construction that
`Genentech has proposed is a correct definition of the
`preamble.
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`Defendants have taken the position that even as
`so construed --
`THE COURT: Wait. I'm sorry. Did you say the
`definition they proposed?
`MS. DURIE: Correct.
`THE COURT: Okay. And, again, this is the
`problem with, I will say on this particular term, I'm
`somewhat kind of relying on frankly what my clerk has
`presented to me. My understanding is there is no
`alternative definition proposed. They have only said it's
`limiting and it can't be construed.
`So --
`MS. DURIE: The defendants' position has been
`that the term is indefinite.
`THE COURT: Right.
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`MS. DURIE: And the Court is correct, they have
`not proposed any alternative construction.
`THE COURT: Okay.
`MS. DURIE: Their expert agrees with our
`construction in the sense that he agrees that is what the
`preamble means. And it's not clear to me from the briefing
`whether we actually have a substantive dispute about what
`the preamble means, and I will talk about that in more
`detail.
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`THE COURT: So maybe this is a way to cut into
`this again. Again, the disadvantage of not being prepared
`on a particular thing.
`I had a situation involving very, very reputable
`patent counsel a couple weeks back and one of the sides
`wanted a construction, the other side -- kind of almost the
`same situation we have right here, and the only issue was
`whether I would construct the term or construe the term or
`not.
`
`And the plaintiff who wanted construction, or
`the side, yes. The side that wanted construction -- sorry.
`The side that opposed construction, they just wanted the
`ability that if I ultimately ruled it's not indefinite,
`to not be prejudiced. And, sorry. I'm thinking out loud,
`too.
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`I guess what I'm getting at -- let me just start
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`from scratch. Disregard everything I just said. Here's
`where I am. I just hate to waste time on something that I
`don't have to. All right. And so I could adopt your
`construction, but I'm not going to let that influence in any
`way indefiniteness arguments in the future.
`Now, if that's the case, do the defendants care?
`MS. DURIE: And this was the question that we
`had posed when this issue was raised last night, which is to
`the extent that the defendants are willing to stipulate to
`our construction of what the term means, then they can
`reserve their indefiniteness arguments and we have no
`issue with that. But if, in fact, we have a disagreement as
`to what the term means, then we think it makes sense to
`resolve that, and then --
`THE COURT: But they are not proposing an
`alternative. In my view, if you have not proposed an
`alternative claim construction, then either I adopt yours or
`I stay silent, reserve judgment, but yours is the only
`argument that is ever going to be on the table and they've
`waived their right to come forward, which in which case I'm
`going to adopt yours.
`So what I did in this last case that I was
`referring to is, I just adopted the one proposed
`construction and then left indefiniteness for another day.
`MS. DURIE: And I would like to take a shot at
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`having that be the result today.
`THE COURT: You like that. Ms. Rhyu, you
`don't like that. You don't have an alternative
`construction.
`MS. RHYU: It's true. We don't like that. We
`think that the construction that Genentech proposes
`completely rewrites the claim.
`THE COURT: But you didn't propose an
`alternative construction.
`MS. RHYU: As I said, we tried, and we tried
`based on the intrinsic record.
`THE COURT: But that's because --
`MS. RHYU: There was no comparator. It's asking
`for a comparison, an improvement or a greater likelihood of
`effectiveness of treatment, but there's no baseline in the
`patent.
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`THE COURT: Right.
`MS. RHYU: So it's hard to propose any
`construction that we can live by where you don't have that
`baseline.
`
`THE COURT: Well, the way I view it is this, I
`guess. I'm just going to for right now adopt plaintiffs'
`construction. All right.
`My understanding of claim construction, and in
`particular some of the things that Judge Bryson has written,
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`makes it clear that the Court may be obliged to alter claim
`construction depending on how facts and discovery -- how
`facts are developed and discovery unfolds. And, in fact, I
`don't think Judge Bryson is the only Federal Circuit Judge
`that has offered that.
`So I only have one claim construction before me.
`I don't have an alternative. I'm going to adopt the claim
`construction of the plaintiffs for now and I guess if good
`cause could be shown by the defense at a later date for an
`alternative construction, I could entertain it at that
`point. But I do think it would have to be some kind of
`showing. I'm not even sure good cause would be the right
`showing, but it would have to be something because the
`defendants chose not to offer an alternative.
`MS. RHYU: But we do reserve our right to
`challenge the indefiniteness.
`THE COURT: Absolutely. I think we would have
`indefiniteness, yes.
`MR. BELGAM: If I might, Your Honor?
`THE COURT: Yes.
`MR. BELGAM: You started out by saying that we
`might be permitted to spend just a few minutes talking about
`indefiniteness here.
`THE COURT: Well, now we're not even going to
`have any argument. I came out here thinking we weren't even
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`going to have argument on it.
`MR. BELGAM: And the distinction I would make
`would be indefiniteness of the construction and not
`necessarily the claim. If Your Honor doesn't want to hear
`that, then we get the message, but that was our advocate's
`intent, spending a few minutes to talk about the proposed
`construction that Your Honor would be adopting.
`THE COURT: I just -- yes, I'm not going to
`entertain that. I mean, it seems to me just in terms of the
`case management principle, this is a claim construction
`hearing. You had a chance to offer a proposed construction.
`You didn't. So you sat on your indefiniteness position and
`you have to take the consequences that flow from that.
`MR. BELGAM: Understood. Thank you.
`MS. DURIE: Thank you. With that, Your Honor, I
`will move onto the next term at issue. Actually, you're
`right. Before we do, Your Honor, on this family of patents,
`and thank you for that reminder. In addition to the dispute
`with respect to the preamble, there was also a claim
`construction dispute with respect to a substantive
`limitation in the second patent, and I think it does make
`sense to address that. And as a predicate to doing so, it
`might be helpful to provide a little bit of background to
`the Court with respect to what these two patents are
`generally about.
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`THE COURT: Okay. So, and now you're referring
`to what I have -- wait, as the -- sorry. What are you
`referring to?
`MS. DURIE: So, Your Honor, with respect to -- I
`got ahead of myself. With respect to the '066 patent, claim
`1, the final limitation is where in the patient's cancer
`cells express HER2.
`THE COURT: Is that what we're going to turn to
`
`now?
`
`MS. DURIE: Correct.
`THE COURT: Oh, I thought the last thing you
`were dealing with was the '834 patent.
`MS. DURIE: We were.
`THE COURT: Okay.
`MS. DURIE: So there are two patents that are in
`the same patent family.
`THE COURT: I got you.
`MS. DURIE: The '834. The '834 and the '066.
`THE COURT: Okay.
`MS. DURIE: And both of them have the same
`inventor. They're in the same family. There we go. They
`have the same inventor, they are in the same family.
`The substance of the written description is the
`same. The claims are a little bit different. The preamble
`issue arose in the context of the '834 patent. This second
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`issue arises in the context of the '066.
`THE COURT: Right. Okay.
`MS. DURIE: Now, by way of brief technical
`background for the Court, both of these patents pertain to
`Herceptin, which is a drug prescribed for the treatment of
`certain forms of breast cancer. And like Avastin, which we
`were discussing yesterday, Herceptin is a monoclonal
`antibody, so it is a protein that is given to people in an
`infusion to treat their breast cancer. And that protein
`targets another protein that is found on the surface of
`certain breast cancer cells.
`Now, what we have depicted here is a normal
`cell, and by this we mean a cell in the body, not a cell
`that's making the drug in question, but a cell that's in the
`human body. And a normal breast cell has on its surface a
`protein that is a HER2 receptor, and that's a protein
`sitting on the surface of the cell.
`There is a gene that is made up of DNA that
`encodes for that protein, and that is the HER2 gene. So a
`normal breast cell will have DNA that is the HER2 gene.
`That DNA will essentially serve as a template, as was
`discussed yesterday. There will be messenger RNA that is
`made corresponding to that DNA, and that messenger RNA will
`then be used again as a template for the production of the
`protein in question, and here, that protein is this HER2
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`receptor.
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`Now, in certain types of breast cancer, there
`can be duplications of that HER2 gene. So a given cell will
`have more copies of that HER2 gene than it should, and there
`can be extra duplicate copies of that HER2 protein on the
`surface of the cell. We refer to the presence of extra
`copies of the gene of the of the DNA as amplification of the
`DNA. We refer to extra copies of the protein on the surface
`of the cell as over expression of that protein.
`Now, the way that Herceptin works is it targets
`that HER2 protein on the surface of the cell. The reason
`this matters is that what HER2 does in a normal situation is
`it sends a signal to the cell to grow and divide. So you
`can imagine if you have extra copies of this protein on the
`surface of the cell, there's extra signalling going on and
`the cell is growing and dividing more rapidly than it
`should. Thus, being cancerous, that's being malignant.
`The way that Herceptin works is that the
`Herceptin antibody binds to that HER2 protein on the surface
`of the cell and stops that signalling mechanism from
`happening, and so rather than growing and multiplying out of
`control, that cell will either stop or die, and that's the
`way that Herceptin works, by binding specifically to that
`HER2 receptor.
`Now, there are two different ways to test a
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`particular sample to see whether there's too much HER2
`present or too many copies of that HER2 gene. One way is
`something that the patent calls IHC, immunohistochemistry,
`and this is looking at whether the amount of protein that is
`present on the surface of the cell and whether there is an
`excessive amount of that HER2 protein there. So
`immunohistochemistry is looking at protein on the surface.
`FISH, in contrast, is looking at the DNA level
`to see whether there are too many copies of the gene, of the
`DNA present inside the cells.
`So the distinction between IHC and FISH, one of
`them is looking at protein, IHC. The other one, FISH, is
`looking at the gene itself.
`The way that IHC works, the first protein test,
`is that you stain the surface of the cell, and it's a visual
`test after you stained it to see how much protein you
`present on its surface, and this is a staining that is
`specifically staining that HER2 protein.
`So what you see on the left is a negative score.
`There's not an abundance of that protein. What you see on
`the right is a strongly positive score. Everything that you
`see there in that rust color is stained because there's a
`lot of that protein present.
`You also see that there can be intermediate
`results, and one of the characteristics of this type of test
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`is that a pathologist actually looks at the slide and makes
`a judgment about how strongly stained it is and therefore
`what score, zero, one, two or three, to assign to it.
`The way that FISH works, and this is now the
`test that's looking at the DNA level, is that there's a
`chromosome. There is a probe that is put in that is also
`DNA, and that has a fluorescent label attached to it, so
`you'll be able to actually see it.
`The DNA is essentially unwound, and that probe
`attaches to the HER2 gene. It is specific for the HER2
`gene, so it goes in and sticks to the HER2 gene. And you
`can then count how many places that particular probe is
`stuck and that tells you how many copies of the HER2 gene
`you have.
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`And so the way FISH works, if you have a
`negative result, and that's what we see over on the right,
`you have some control, you have the same number of copies of
`the HER2 gene as you do of the control. That's what you
`would normally expect to see.
`On the left you see a positive result. There
`are more copies of the HER2 gene that you would expect.
`That means this particular patient has duplication at the
`gene level of this gene.
`Now, I'm going to skip the '834 patent since we
`have -- I'm going to skip the claim construction issue, but
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`I wanted to just very briefly touch on what these patents
`describe collectively as the invention before we get to the
`deal tales of the second argument.
`The invention that is described in the common
`specification is that it permits treatment of patients who
`have a better likelihood of responding to the treatment by
`treating patients who have been found to have an amplified
`gene. So the gist of the invention here is using FISH, that
`test that is looking for amplification of the gene rather
`than IHC, the test that is looking for overexpression of the
`protein. And in the specification, the inventor explains
`that the invention was based on this discovery, that gene
`amplification is a better test for identifying patients who
`will benefit from Herceptin than IHC.
`If we can now turn --
`THE COURT: Incidentally, the two spots you've
`just shown, they cite the '834 patent.
`MS. DURIE: They do.
`THE COURT: Is this language the identical
`language in the '066 patent?
`MS. DURIE: Yes.
`Now, if we can turn to slide 28, please. The
`claim construction dispute with respect to the '066 patent
`pertains to this requirement that the patient's cancer cells
`express HER2 at a zero or one-plus level by
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`immunohistochemistry. So immunohistochemistry is a
`reference to the overexpression of protein on the surface of
`the cell, and so what we have here is a patient's cancer
`cells express HER2 at what is essentially a negative level.
`In other words, there is not overexpression of HER2 on the
`surface of the cells.
`Genentech's claim construction proposal is that
`what this language means is that the patient's cancer cells
`have an antigen level, and I will get to that word in a
`moment, corresponding to a zero or one-plus score for HER2
`by any immunohistochemistry test. Antigen is just a word
`for a protein that an antibody can bind to. So in this
`context, that just means HER2. That is the antigen.
`Amgen's proposal is where in the patient's
`cancer cells have been found to express HER2 at a zero or
`one-plus level by any immunohistochemistry test.
`So the good news is there are some things about
`which we agree. We agree that the claim relates to any
`immunohistochemistry test. The disagreement between the
`parties is whether when the claim indicates that the cancer
`cells express HER2, whether that means, as we say, that they
`have an antigen level corresponding to the zero or one-plus
`level in the claim, or whether, as Amgen contends, it means
`they have been found to express HER2. In other words, a
`test has already been run and a determination has been made
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`already that that is the HER2 level present.
`Now, when we turn to the intrinsic evidence
`relating to the claim construction dispute, the
`specification in describing the present invention explains
`that it can be used in one of two ways. It can be used
`in the specification it says here as a powerful adjunct to
`IHC.
`
`Now, again, the present invention is using this
`FISH method that is looking at DNA. It's saying you can do
`that as an adjunct to using a test that is looking at the
`protein, so you can run both tests.
`It says, it can also be employed on its own,
`i.e., without IHC, to provide initial screening and
`selection of patients. So the patent is explaining that
`FISH can be used either with or without IHC in the context
`of the present invention, and goes on --
`THE COURT: So I think this is your best
`argument. All right. It's in the written description.
`MS. DURIE: It is.
`THE COURT: But I don't think the claims, which
`I need to look at first, are strong for you. But let's turn
`to what's your best argument.
`MS. DURIE: So the --
`THE COURT: Didn't you during the prosecution of
`the patent, in order to pass scrutiny and get this patented,
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`amend the claims to add the where in clause?
`MS. DURIE: So --
`THE COURT: To address prior art that did
`precisely what that written description that you just quoted
`from says?
`
`MS. DURIE: Yes and no in response to the
`Court's first and second questions. Yes, this limitation
`was added during prosecution. And the limitation that was
`added during prosecution was what we see here on the right
`for the '066 patent, wherein the patient's cancer cells
`express HER2 at a zero or one-plus level. There was prior
`art that related to the use of FISH testing. It did not
`specify whether that was being used with respect to patients
`who had this characteristic in order to select Herceptin
`treatment for them.
`So, yes, I agree that this is a substantive
`claim requirement. In other words, it must be true that the
`patient's cancer cells express HER2 at a zero or one-plus
`level.
`
`THE COURT: And how do you determine that?
`MS. DURIE: So this is precisely the evidentiary
`issue. There are multiple ways that one might determine
`that. One might do a test and one might go back and look at
`patient samples as patients who were screened using FISH and
`who were then treated with Herceptin and determine what the
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`IHC result for those patients would be. One might also
`perform a statistical analysis, which is common in patent
`cases in evaluating the scope of infringement. If we have a
`claim that relates to --
`THE COURT: But actually put aside infringement
`for a second which is evidentiary. Let's just talk about
`practicing the patent. You've got language that talks about
`selecting patients. Right? And so, and we're talking about
`the advantages of this invention are that its unexpected
`finding that folks that score in the zero to one-plus range
`actually still benefit from the administration of the drug.
`Historically, you wouldn't give those patients the drug.
`MS. DURIE: That's right.
`THE COURT: So the whole point of the invention
`is that you can treat these patients, or patients where
`there's a false negative. Right? So help me out with
`that.
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`MS. DURIE: Yes.
`THE COURT: Give me the whole intent of the
`invention. You would have to determine to practice the
`patent who is this group of patients, and, in fact, again, I
`think you used the language, select in the prosecution
`history.
`
`So what do you do to practice the patent?
`MS. DURIE: Yes.
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`THE COURT: Not to prove infringement.
`MS. DURIE: I understand. In order to practice
`the patent, you use FISH as the selection mechanism, and you
`use that as the mechanism for determining eligibility for
`Herceptin treatment.
`THE COURT: So within the folks that, what -- I
`don't know, score, you would find in FISH to narrow the
`range what?
`MS. DURIE: Can we go to slide 16?
`So this is from Amgen's expert, Dr. Press, and I
`asked him at his deposition that question, that if you were
`to select a patient population based on that patient
`population being FISH-positive and then you were to run IHC
`tests on that patient population, would you expect that some
`percentage of them would come back at a zero or a one? And
`his answer was, yes, that it's about nine to ten percent in
`the studies that he has done.
`THE COURT: So do you randomly pick nine to
`ten percent of the people that are FISH positive to get the
`benefit of this drug?
`MS. DURIE: So the benefit of the invention is
`using a patient selection mechanism that is better, and you
`get that benefit by employing FISH
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