`
`Case 1:18-cv-00924-CFC-SRF Document 528 Filed 03/03/20 Page 1 of 309 PageID
`1
`#: 34545
`
`IN THE UNITED STATES DISTRICT COURT
`IN AND FOR THE DISTRICT OF DELAWARE
`- - -
`
`
`
`GENENTECH, INC. and CITY OF
`HOPE,
`
`Plaintiffs,
`
`vs.
`AMGEN INC.,
`
`Defendant.
`---------------------------
`GENENTECH, INC.,
`Plaintiff,
`
`CIVIL ACTION
`
`NO. 17-1407 (CFC)
`CIVIL ACTION
`
`::::::::::::::::::::
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`NO. 18-924 (CFC)
`
`vs.
`AMGEN, INC.,
`Defendant.
`
`
`
`
` - - -
`Wilmington, Delaware
`Wednesday, October 16, 2019
`9:00 o'clock, a.m.
` - - -
`
`BEFORE: HONORABLE COLM F. CONNOLLY, U.S.D.C.J.
` - - -
`
`Valerie J. Gunning
`Official Court Reporter
`
`
`
`
`
`Case 1:18-cv-00924-CFC-SRF Document 528 Filed 03/03/20 Page 2 of 309 PageID
`2
`#: 34546
`
`
`
`
`APPEARANCES:
`
`McCARTER & ENGLISH, LLP
`BY: DANIEL M. SILVER, ESQ.
`
`-and-
`
`WILLIAMS & CONNOLLY LLP
`BY: PAUL B. GAFFNEY, ESQ.,
`DAVID J. BERL, ESQ.,
`THOMAS S. FLTECHER, ESQ.,
`TEAGAN J. GREGORY, ESQ.
`CHARLES McCLOUD, ESQ.
`ANDREW DANFORD, ESQ.
`(Washington, D.C.)
`
`-and-
`
`DURIE TANGRI
`BY: DARALYN DURIE, ESQ.
`
`Counsel for Plaintiffs
`
`YOUNG CONAWAY STARGATT & TAYLOR, LLP
`BY: MELANIE K. SHARP, ESQ. and
`JAMES L. HIGGINS, ESQ.
`
`-and-
`
`PROSKAUER ROSE LLP
`BY: SIEGMUND Y. GUTMAN, ESQ.,
`AMIR NAINI, ESQ. and
`DAVID HANNAH, ESQ.
`(Los Angeles, California)
`
`-and-
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
`Case 1:18-cv-00924-CFC-SRF Document 528 Filed 03/03/20 Page 3 of 309 PageID
`3
`#: 34547
`
`
`
`
`APPEARANCES (Continued):
`
`
`
`AMGEN INC.
`BY: DREW DIAMOND, ESQ.
`
`Counsel for Defendant
`Amgen Inc.
`(CA No. 17-1407-CFC)
`
`SMITH KATZENSTEIN & JENKINS LLP
`BY: NEAL C. BELGAM, ESQ. and
`EVE H. ORMEROD, ESQ.
`
`-and-
`
`COOLEY LLP.
`BY: MICHELLE RHYU, ESQ.,
`PHILIP S. MAO, ESQ. and
`DANIEL KNAUSS, ESQ.
`Counsel for Defendant Amgen
`(CA 18-924-CFC)
`
`- - -
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
`Case 1:18-cv-00924-CFC-SRF Document 528 Filed 03/03/20 Page 4 of 309 PageID
`4
`#: 34548
`
`
`
`
`P R O C E E D I N G S
`
`(Proceedings commenced in the courtroom,
`beginning at 9:00 a.m.)
`
`THE COURT: Good morning. Please be seated.
`(Counsel respond, "Good morning, Your Honor.")
`THE COURT: Mr. Silver?
`MR. SILVER: Good morning, Your Honor.
`THE COURT: How are you?
`MR. SILVER: I'm good. Thanks. How are you?
`THE COURT: Good.
`MR. SILVER: Your Honor, with me on behalf of
`Genentech today are Thomas Fletcher from Williams &
`Connolly, Paul Gaffney from Williams & Connolly, David Berl
`from Williams & Connolly, Luke McCloud from Williams &
`Connolly, Andrew Danford from Wilmer Hale, Daralyn Durie
`from Durie Tangri, and we've got Rebecca Grant from
`Genentech.
`
`THE COURT: All right. Thank you very much.
`Ms. Ormerod, how are you?
`MS. ORMEROD: Eve Ormerod on behalf of Amgen in
`the 18-924 case.
`With me today from Cooley are Michele Rhyu,
`Eamonn Gardner and Phillip Mao, and from Amgen we Lois
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
`Case 1:18-cv-00924-CFC-SRF Document 528 Filed 03/03/20 Page 5 of 309 PageID
`5
`#: 34549
`
`Cosigrove and Nancy Goettel. We also have Neal Belgam from
`my office.
`
`
`
`THE COURT: All right. Thank you.
`Ms. Sharp?
`MS. SHARP: Good morning, Your Honor. Melanie
`Sharp from Young Conaway Stargatt & Taylor for Amgen in the
`17-14-07-case. Also Jim Higgins from Young Conaway. With
`me are my colleagues Your Honor has met, Siegmund Gutman,
`Amir Naini, David Hanna, and Drew Diamond from Amgen.
`THE COURT: All right. Thank you.
`All right. I guess let's begin. You know, the
`declarations were largely about the intrinsic evidence and
`the briefing. As far as I'm concerned, that is already
`dealt with. You can address it real quickly if you want,
`but I thought the purpose of this hearing was to adduce
`extrinsic evidence so I can make a decision. I think I've
`already ruled that I'm unable based on the intrinsic
`evidence to construe the terms.
`MR. FLETCHER: Yes, Your Honor.
`THE COURT: All right.
`MR. FLETCHER: And I think we will go through
`the extrinsic evidence today.
`THE COURT: I mean, did you have a different
`understanding, because I mean the declaration basically just
`went through the Kao patent. I thought that we did that.
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
`Case 1:18-cv-00924-CFC-SRF Document 528 Filed 03/03/20 Page 6 of 309 PageID
`6
`#: 34550
`
`
`
`
`Both sides did it.
`Am I missing something that --
`MR. FLETCHER: I think we have a little bit of
`background regarding the Kao patent, but the vast majority
`of the declaration is the extrinsic evidence, Your Honor.
`Lots of articles and references from literature. So the
`intrinsic evidence there is there for context.
`THE COURT: Okay. All right. Let's go.
`
`Thanks.
`
`And you're calling a witness? You're going to
`be calling a witness?
`MR. FLETCHER: Yes. One witness.
`THE COURT: All right.
`MR. FLETCHER: Dr. Hauser and our opening. May
`I approach with some slides?
`THE COURT: Sure.
`(Mr. Fletcher handed slides to the Court.)
`THE COURT: Okay.
`MR. FLETCHER: Good morning, Your Honor. The
`question of claim construction as well as the question of
`indefiniteness must always be a evaluated in the context of
`the entire claim as a whole, so we're starting with the
`entire claim to an inventive method. And the method
`achieves the result. The method prevents the reduction of a
`disulfide bond in an antibody. That's the goal of the
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
`1 2 3 4 5 6 7 8 9
`
`
`
`Case 1:18-cv-00924-CFC-SRF Document 528 Filed 03/03/20 Page 7 of 309 PageID
`7
`#: 34551
`
`method and that is what the method accomplishes.
`And just a brief refresher from the prior claim
`construction hearing. This is a slide we presented last
`spring. The antibody is depicted on the left of the
`cartoon. The two blue portions are the heavy chains of the
`antibody. The two gold portions are the light chains of the
`antibody. These four chains are held together by the red
`bonds that are shown here. These are the disulfide bonds
`that are protected by the patented method. If those bonds
`are reduced or broken, the antibody can fall apart.
`What's shown here on the screen on slide 4 is
`the bond between the two heavy chains being broken and you
`get two fragments. If instead the bond between one of the
`gold chains and blue chains is broken, you get two different
`fragments. But no matter which bonds are broken, the
`resulting product is not the desired antibody. It is a set
`of contaminants, impurities and fragments that are very
`difficult to remove. And stopping this from happening is
`what this invention is about.
`How does it achieve this goal? How does it
`prevent this reduction? It does so by sparging the culture
`fluid, either the pre-harvest or harvested culture fluid
`with air. Sparging means to bubble the air up into the
`culture, and this act of bubbling the air is what is
`protecting the antibody.
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
`1 2 3 4 5 6 7 8 9
`
`
`
`Case 1:18-cv-00924-CFC-SRF Document 528 Filed 03/03/20 Page 8 of 309 PageID
`8
`#: 34552
`
`The question that is the focus of this hearing
`is this limitation following fermentation and what its role
`is in the context of this claimed method. And what
`following fermentation is doing here is telling you when
`this method should be performed. It shouldn't be performed
`before fermentation. It shouldn't be performed during
`fermentation. It should be performed after fermentation,
`following fermentation. And that makes sense because it is
`during fermentation the antibodies get made, and after
`they've been made, they need to be protected. So that is
`the claim term that we're here talking about in the context
`of this sparger method.
`The importance of this invention I think cannot
`be understated. As soon as Genentech discovered it, they
`solved the problem. They applied for a patent and published
`multiple peer-reviewed articles discussing their discovery
`in disseminating it to the industry.
`They talked about how they identified the
`problem that occurred. They talked about why the problem
`occurs at a cellular level, what are the enzymes that are
`breaking the antibody apart and they talked about how to
`prevent it using air sparging. All of these papers come out
`in quick succession showing how important this research is.
`And you don't have to take my word for it and you don't have
`to take Genentech's word for it. We know the importance of
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
`Case 1:18-cv-00924-CFC-SRF Document 528 Filed 03/03/20 Page 9 of 309 PageID
`9
`#: 34553
`
`this research because Amgen relied upon this research.
`After Genentech explained what a problem
`antibody reduction could be, Amgen published its own paper
`concerning the situation. And Amgen acknowledged that
`reduction of antibody interchain disulfide bond during
`manufacturing has recently been the subject of much
`interest. And the citations that it provides for that
`statement were all of Genentech's papers from the various
`named inventors, Dr. Kao, Dr. Laird, Dr. Trexler-Schmidt.
`Amgen recognized the significance of the
`phenomenon when it occurs. They explained, wow, this
`phenomenon is observed when you extend the amount of time
`that the antibody remains in the culture. When the antibody
`is left sitting in the culture fluid, it is exposed to the
`enzymes that can break it. And Amgen recognized that
`there's a solution to the problem. That if you sparge by,
`you maintain dissolved oxygen levels during the operation,
`the reduction will be virtually eliminated, citing
`Genentech's papers.
`This is a very important breakthrough in
`antibody manufacturing. And it's clear from these papers
`that the industry and Amgen all know when to perform this
`method. There's no mystery about when this method is
`useful.
`
`1 2 3 4 5 6 7 8 9
`
`
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`So turning to the Court's questions that the
`
`
`
`
`
`
`
`Case 1:18-cv-00924-CFC-SRF Document 528 Filed 03/03/20 Page 10 of 309 PageID
`10
`#: 34554
`
`Court posed in its claim construction opinion, we understood
`there to be two: What is fermentation and when does
`fermentation end?
`As to the first question --
`THE COURT: You agree they're the right
`
`questions?
`
`questions.
`
`MR. FLETCHER: I think they're the right
`
`THE COURT: All right.
`MR. FLETCHER: We'll address both of these. Our
`expert, Dr. Hauser, will address both of them.
`The first one, fermentation is a technical term.
`In the context of the Kao patent, it refers to growing cells
`and producing antibodies. That is its meaning in the
`context of antibody manufacturing in the field of antibody
`manufacturing.
`Dr. Hauser has decades of experience in this
`field. He has been doing biotechnology since the early
`1980s. He is a professor from a research institute in
`Germany and he has been deeply involved in running the
`European Society For Animal Cell Technology, which is one of
`the research societies that is publishing several of the
`papers that we cite and it's organizing a lot of the
`research efforts of the industry in this area.
`This is just a brief overview of the
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
`1 2 3 4 5 6 7 8 9
`
`
`
`Case 1:18-cv-00924-CFC-SRF Document 528 Filed 03/03/20 Page 11 of 309 PageID
`11
`#: 34555
`
`manufacturing process that this is all occurring in. It
`relies a little bit on the intrinsic evidence, but that is
`the context in which we are looking at this question.
`But the patent shows in Figure 23 a typical
`antibody manufacturing process, about how you take a small
`number of cells. You take them from the frozen vial and you
`start allowing them to replicate and grow and grow and move
`to bigger and bigger containers until you reach the final
`stage where the cell, once the cells have replicated many
`times, you transfer them to the larger container where they
`undergo fermentation.
`During this process, during fermentation, the
`parameters are very tightly controlled. The growth
`parameters are controlled. Reproduction parameters are
`controlled. Dr. Hauser will explain what these parameters
`are, why it's important to control them to ensure that you
`consistently produce a high quality product.
`Now, this term fermentation in terms of the
`extrinsic evidence is used widely in the industry. We will
`go through without hopefully belaboring the point too long
`reference after reference after reference after reference
`after reference after reference after reference,
`illustrating the use of fermentation in the field of
`antibody manufacturing in Dr. Hauser's field. And when all
`of this extrinsic evidence is taken as a whole, it is clear
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
`1 2 3 4 5 6 7 8 9
`
`
`
`Case 1:18-cv-00924-CFC-SRF Document 528 Filed 03/03/20 Page 12 of 309 PageID
`12
`#: 34556
`
`that it establishes an important meaning for the term
`fermentation.
`We don't think this should be controversial.
`Amgen also uses fermentation in the same way as our proposed
`construction. In Amgen's securities filing, Amgen's
`explained that fermentation is the by processed by which its
`proteins are produced. In Amgen's patent, it says we
`ferment mammalian cells to make our proteins.
`The industry uses this technical term to explain
`a process of growing cells and making antibodies. And
`that's our proposed construction, that following
`fermentation means after the end of the cell growth in
`antibody production faces.
`Now, in the Court's opinion, the Court expressed
`some concern about this word production and how it gets used
`in different ways in different parts of the patent. And we
`think it's clear, but if the word production is giving the
`Court pause, we can strike it from Genentech's proposed
`construction. We can replace it with other words like
`expression, which is the technical term for how antibodies
`are made. So the construction could have said after the end
`of the cell growth and antibody express phases. That would
`be perfectly acceptable to us.
`THE COURT: Yes. My concern, I'm not sure
`that's the right word. I think I'm just observing how the
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
`1 2 3 4 5 6 7 8 9
`
`
`
`Case 1:18-cv-00924-CFC-SRF Document 528 Filed 03/03/20 Page 13 of 309 PageID
`13
`#: 34557
`
`patent uses the term and it uses it inconsistently, and I
`frankly think at times it equates fermentation with
`production. At times it makes it clear they're different.
`And I don't think that's debatable, to you?
`MR. FLETCHER: I think that in different
`contexts, production of different things --
`THE COURT: No. I just want to know, do you
`agree with me that the patent does not consistently use
`production?
`MR. FLETCHER: I think it is debatable,
`respectfully, Your Honor. There are contexts in which
`production is being used as an adjective to describe things
`like a production run. It's just a generic term for
`manufacturing. There's context in which it's referring to a
`production phase, which is a very specific concept in making
`proteins, and that's what's reflected here in our
`construction.
`And then it's also used as a noun, the
`production. And when it's used as a noun, Dr. Hauser will
`explain, fermentation encompasses production. Fermentation
`includes both the growing of the cells and the producing of
`the protein, and so in context, the end of production and
`the end of fermentation are coterminous, at the same time.
`And so I think the patent is using the same word
`in the same way that there are many words in the English
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
`Case 1:18-cv-00924-CFC-SRF Document 528 Filed 03/03/20 Page 14 of 309 PageID
`14
`#: 34558
`
`language that have multiple definitions. Sometimes it's
`using it as an adjective to modify a particular noun. In
`other contexts it's using the word context as a noun. But I
`think critically, production is not part of the claims. It
`only gets introduced here because we added it to our
`construction because we thought it had a clear meaning, and
`if it is not sufficiently clear, we think there's an
`adequate substitute there, antibody expression, and that
`that would be a perfectly reasonable way to construe the
`phrase, following fermentation.
`THE COURT: So now you're proposing to
`substitute production phases with expression. Is that
`right?
`
`1 2 3 4 5 6 7 8 9
`
`
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`MR. FLETCHER: Just the word production for
`expression, antibody expression phases. We view them as
`synonymous in this context.
`I think production is a simpler word for the
`jury to understand, but if we want to use a technical term,
`very precise meaning, expression will do just as well. It's
`the word that's used in the claims when the claims refer to
`expressing an antibody.
`So the next issue is when does fermentation end.
`Dr. Hauser will explain how this is typically done in the
`context of antibody manufacturing, and he will explain that
`processes are designed to end fermentation deliberately.
`
`
`
`
`
`1 2 3 4 5 6 7 8 9
`
`
`
`Case 1:18-cv-00924-CFC-SRF Document 528 Filed 03/03/20 Page 15 of 309 PageID
`15
`#: 34559
`
`People don't want fermentation to continue
`indefinitely because can affect products quality. So when
`processes are designed, they are designed to end
`fermentation. And this happens by changing the condition
`that the cells experience. If you don't change the
`condition that the cells experience, they will keep on
`fermenting. If you change the conditions they experience,
`fermentation can end.
`These steps are critical to ensuring product
`quality, and so this end of fermentation is not mysterious
`and it's not ambiguous. It is something that engineers
`trigger deliberately by changing the cellular conditions
`drastically.
`So, for example, in some processes, the cells
`are killed. Once are killed, fermentation is over. In
`other processes, the cells are chilled. They are cooled
`down to the point that biology stops. They stop growing,
`they stop making antibodies, and that ends fermentation.
`These are all recognized techniques for ending fermentation.
`Dr. Hauser will explain a few more.
`And it's fundamentally unnecessary for the
`person of ordinary skill to do anything more to know that
`fermentation is over after they have changed the conditions
`that they know end fermentation. But to the extent there is
`any doubt about whether fermentation is over, the patent
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
`
`
`Case 1:18-cv-00924-CFC-SRF Document 528 Filed 03/03/20 Page 16 of 309 PageID
`16
`#: 34560
`
`gives us two tests, one for measuring growth rates and one
`for measuring how much antibody is being produced. These
`are standard tests used by everybody. I think both Dr.
`Hauser and Dr. Glacken will explain, these are standard
`tests that the person of ordinary skill knows how to
`perform.
`
`These techniques, I think, lay to rest any
`question as to whether the person of ordinary skill in the
`art can determine whether fermentation has ended. And I
`believe you will not hear any evidence today from Amgen of
`any actual competitors being confused about whether
`fermentation has ended in their processes. You will not
`hear from any actual antibody manufacturers that they lack
`reasonable certainty about when fermentation ends in their
`processes. Because of that, the claim is definite. The
`person of ordinary skill reading it can, with reasonable
`certainty, know when they're allowed to sparge, and when,
`if they sparge, they are potentially infringing the Kao
`patent.
`
`This absence of evidence aligns with the fact
`that when Amgen served its contentions pursuant to the
`patent exam in the Avastin case, among the hundreds of pages
`of contentions, not a word about the indefiniteness of the
`Kao patent. Plenty of pages about noninfringement,
`plenty of pages about obviousness. The fact that Amgen
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
`Case 1:18-cv-00924-CFC-SRF Document 528 Filed 03/03/20 Page 17 of 309 PageID
`17
`#: 34561
`
`could conduct the analysis to figure out why it thinks
`it didn't infringe or why it thinks the patent is obvious
`shows that it was able to understand the metes and bounds of
`its claim.
`
`
`
`THE COURT: Spell that out for me.
`MR. FLETCHER: Sure.
`THE COURT: So they, in the patent exam, is it
`the same paragraph 3 and 4 or different letters?
`MR. FLETCHER: Different letters.
`THE COURT: Okay. So in the biosimilar patent
`exam as an ANDA, they're required to submit a letter. Is it
`two letters, one for infringement, one for validity.
`MR. FLETCHER: I've described it as a large
`stack of papers.
`THE COURT: Okay.
`MR. FLETCHER: The way the patent dance works is
`we, the innovator, review whatever materials they've given
`us and identify a list of patents. Kao is one of them.
`It's incumbent on Amgen to then return what's called a
`detailed statement explaining whatever defenses it has --
`noninfringement, invalidity, unenforceability, whatever they
`may be. And so, you know, it comes in the form of claim
`charts and narratives typically, but it's a single detailed
`statement.
`
`THE COURT: Do they confine their ability to
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
`1 2 3 4 5 6 7 8 9
`
`
`
`Case 1:18-cv-00924-CFC-SRF Document 528 Filed 03/03/20 Page 18 of 309 PageID
`18
`#: 34562
`
`raise invalidity defenses in litigation?
`MR. FLETCHER: This is an issue that we've
`briefed previously in this case, Your Honor. In connection
`with our pending motion to dismiss, it is Genentech's
`position that, yes, these contentions are limiting.
`THE COURT: This is a pending motion I have not
`decided yet. Right?
`MR. FLETCHER: Correct.
`THE COURT: Okay. Is that the only instance in
`which this issue has been raised?
`MR. FLETCHER: I believe that's the context in
`which this has been briefed.
`THE COURT: Okay. Just so you'll know, when you
`ask me to hear 19 discovery disputes in addition to an
`indefiniteness hearing, I just can't get to all the motions
`you all put before me, so I will get to it when I can.
`MR. FLETCHER: Understood, Your Honor.
`THE COURT: Okay.
`MR. FLETCHER: So, finally --
`THE COURT: Well, I just want to just continue.
`So that's an argument, is whether it's confined.
`MR. FLETCHER: Yes.
`THE COURT: Right. So, in other words, you're
`going to take the position it is raised, indefiniteness, in
`their patent dance, but they're precluded from raising it in
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
`Case 1:18-cv-00924-CFC-SRF Document 528 Filed 03/03/20 Page 19 of 309 PageID
`19
`#: 34563
`
`
`
`
`the litigation?
`MR. FLETCHER: That's one argument that arises
`from that, yes.
`THE COURT: Okay.
`MR. FLETCHER: Finally, Amgen has alleged in its
`briefing that the end of fermentation is somehow subjective,
`and I think we need to be very careful with this phrase, end
`of fermentation, and divide out whether fermentation has
`ended from when or how fermentation has ended.
`Dr. Hauser will explain that there's nothing
`subjective about whether fermentation has ended. The
`process engineer can choose how to end fermentation.
`There's lots of options.
`We talked about a few -- killing the cells,
`chilling the cells, others. They can also choose when.
`Different people run their processes for different amounts
`of time, 11 days, 13 days, 15 days. It varies. That is not
`the question raised by the claims. The claims are focused
`on whether fermentation has ended, and that is an objective
`biological fact focusing again on the claims.
`The claims are about a method. The method is
`for preventing the destruction of the antibody. The method
`is achieved by sparging the culture fluid in a particular
`window of time, and it's the window of time after
`fermentation, after fermentation has ended. And that time
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
`
`
`Case 1:18-cv-00924-CFC-SRF Document 528 Filed 03/03/20 Page 20 of 309 PageID
`20
`#: 34564
`
`point is an objective biological fact. Whether the cells
`are growing, whether they're producing antibodies, is an
`objective biological fact that can be discerned from how the
`process is designed and from various standard techniques for
`measuring how the cells are doing and whether they're making
`anything.
`
`THE COURT: What are the names of the two
`standard tests that are disclosed in the patent?
`MR. FLETCHER: Sure.
`THE COURT: What do you call them?
`MR. FLETCHER: Yes. I can go back.
`THE COURT: Just give me two names so I can
`refer to them throughout the hearing.
`MR. FLETCHER: Sure. So this phrase here
`ViCell, you see that.
`THE COURT: Yes.
`MR. FLETCHER: That's an instrument that is able
`to count cells.
`THE COURT: All right.
`MR. FLETCHER: And by counting the cells and
`looking at how many cells there are over time during
`sampling, you can tell, are the cells growing or is it
`flat.
`
`THE COURT: Do you want to call it the ViCell,
`do you want to call it the counting cell?
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
`Case 1:18-cv-00924-CFC-SRF Document 528 Filed 03/03/20 Page 21 of 309 PageID
`21
`#: 34565
`
`MR. FLETCHER: I think we can call it the
`
`
`
`ViCell.
`
`call it.
`
`THE COURT: All right.
`MR. FLETCHER: I think that's a good thing to
`
`At the sample, they were talking about how the
`samples were analyzed by HPLC method. You can call it the
`HPLC method, and that allows you to quantify the amount of
`antibody that is in solution. They're called the titer.
`Titer is the technical term here for the concentration of
`the antibody.
`THE COURT: Right.
`MR. FLETCHER: And so those I think are the two
`tests the patent says to use to figure out are the cells
`growing and is antibody still being made.
`THE COURT: All right. Before you sit down, is
`there any other, and maybe you all have, but we just talked
`about the pending motion to dismiss. It sounds like if I
`agreed with you on your statutory interpretation that they
`can't raise indefiniteness, I would not have to have this
`hearing.
`
`MR. FLETCHER: You would at least not to have it
`in the Avastin case, and in the Herceptin case, I believe
`this indefiniteness argument is not clearly presented in
`their contentions, but I suspect they might dispute that,
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
`1 2 3 4 5 6 7 8 9
`
`
`
`Case 1:18-cv-00924-CFC-SRF Document 528 Filed 03/03/20 Page 22 of 309 PageID
`22
`#: 34566
`
`but I think you would have to resolve that question. But it
`is I think a threshold issue to whether you can hold this
`claim indefinite, you have to first figure out whether
`they're allowed to raise it having not raised it in their
`contentions.
`THE COURT: Okay. And then are there any other
`issues? The only pending motion besides the 19 discovery
`disputes is the motion to dismiss. Is that right?
`MR. FLETCHER: There's also Genentech's motion
`to amend that's out there, and Amgen filed a motion to amend
`a few weeks ago that is, I believe, now fully briefed. So I
`think we've got two motions to amend the pleadings. I'm
`speaking for the Avastin case.
`I believe in the Herceptin case, there's also a
`motion to strike or dismiss that was just filed.
`Any other motion? I apologize, Your Honor.
`THE COURT: Don't apologize. What I'm trying to
`figure out is, in terms of trying to manage this mess is,
`what's the most efficient way to do it. And, frankly, given
`our caseload and the amount of time you already -- I don't
`mean this personally to you, but that you all have taken up
`of the Court's resources and given the pending appeals, I
`made a conscious decision not to address your motion to
`dismiss in the scheme of things. I can only do so much.
`Then I hear this conversation and I'm just thinking to
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
`1 2 3 4 5 6 7 8 9
`
`
`
`Case 1:18-cv-00924-CFC-SRF Document 528 Filed 03/03/20 Page 23 of 309 PageID
`23
`#: 34567
`
`myself, well, maybe it would have been more efficient for me
`to have addressed the motion to dismiss as opposed to this
`first. And I'm just trying -- I just want to hear from you
`now if there's a more efficient way to handle the case.
`Now, it sounds like when I really press you,
`even if I agreed with you on the statutory interpretation
`issue, that might really limit the Avastin case and I'm no
`better off.
`So can you think of any other issues that are in
`that motion, for instance, that would make the handling of
`both of these cases more efficient in some way?
`MR. FLETCHER: I think it would be productive to
`resolve those types of motions to dismiss, but whether the
`BPIC contentions are limiting, because that limits in our
`view the scope of evidence that can come in at trial in
`support of all of these opinions. You know --
`THE COURT: The Avastin trial.
`MR. FLETCHER: And I think in the Herceptin
`trial as well. For example, you know, I submit you're going
`to find at the end of this hearing this claim is reasonably
`definite and able to be understood by a person of ordinary
`skill so we're heading toward a trial patent on the Kao
`patent in a month-and-a-half. And in that scenario, they
`have all of these prior art arguments. I think the vast
`majority, if not maybe all, are not in their contentions,
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
`Case 1:18-cv-00924-CFC-SRF Document 528 Filed 03/03/20 Page 24 of 309 PageID
`24
`#: 34568
`
`and so guidance on the extent to which the contentions are
`limiting will I think shape the evidence that is adduced at
`trial.
`
`
`
`THE COURT: In what form is that issue now
`presented to me?
`MR. FLETCHER: So in the Avastin case, it's
`presented in the context of a motion to dismiss, and I
`believe in the Herceptin case, it is as well, but I don't
`know the document number off the top of my head.
`THE COURT: Okay.
`MR. FLETCHER: And there's one other motion to
`dismiss. In our companion Avastin case, there's also a
`pending motion there.
`THE COURT: When is trial in the companion?
`MR. FLETCHER: We have not had a Rule 16
`conference -- sorry. So there are two Avastin cases.
`There's the 17-1407 case. Trial on that is in July.
`THE COURT: Right.
`MR. FLETCHER: There's a companion case, 19 -- I
`forget the last few digits. It's Genentech versus Immunex.
`That's the one in which we moved for an injunction. That
`case hasn't had a Rule 16 conference yet, so it doesn't have
`a trial date.
`THE COURT: All right.
`MR. FLETCHER: Unless Your Honor has any further
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
`Case 1:18-cv-00924-CFC-SRF Document 528 Filed 03/03/20 Page 25 of 309 PageID
`25
`#: 34569
`
`
`
`
`questions?
`
`THE COURT: No. Thank you.
`All right. Does the defense want an opening
`statement as well or do you want to go right into the
`evidence?
`
`MR. GUTMAN: Your Honor, we have an opening as
`
`well.
`
`THE COURT: All right.
`MR. GUTMAN: Your Honor, may I approach?
`THE COURT: Please.
`(Mr. Gutman handed slides to the Court.)
`MR. GUTMAN: Your Honor, I apologize. I handed
`up the wrong set of slides. Apologies Your Honor.
`THE COURT: That's all right.
`MR. GUTMAN: Thank you (handing slides to the
`Court). Good morning, Your Honor.
`THE COURT: Good morning.
`MR. GUTMAN: Before I get started with my
`opening argument, I wanted to just make a few comments in
`response to a few items that Mr. Fletcher raised.
`First of all, I'm happy to report that I think
`we have some agreements that it's the intrinsic evidence
`that really needs to control and provide context for the
`claim construction and that if terms like production and
`fermentation are confused in the intrinsic evidence, then
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
