UNITED STATES PATENT AND TRADEMARK OFFICE
`__________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________
`
`PFIZER, INC. and
`SAMSUNG BIOEPIS CO., LTD.,
`Petitioners,
`
`v.
`
`GENENTECH, INC.,
`Patent Owner.
`__________
`
`Case IPR2017-01488 (Patent 6,407,213 B1)
`Case IPR2017-01489 (Patent 6,407,213 B1)1
`
`__________
`
`Record of Oral Hearing
`Held: July 16, 2018
`__________
`
`
`
`
`Before SHERIDAN K. SNEDDEN, ZHENYU YANG, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`
`
`
`
`1 IPR2017-01239 and IPR2017-01240, respectively, have been joined to
`these cases. See IPR2017-01488, Paper No. 81.
`
`
`__________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________
`
`PFIZER, INC. and
`SAMSUNG BIOEPIS CO., LTD.,
`Petitioners,
`
`v.
`
`GENENTECH, INC.,
`Patent Owner.
`__________
`
`Case IPR2017-01488 (Patent 6,407,213 B1)
`Case IPR2017-01489 (Patent 6,407,213 B1)1
`
`__________
`
`Record of Oral Hearing
`Held: July 16, 2018
`__________
`
`
`
`
`Before SHERIDAN K. SNEDDEN, ZHENYU YANG, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`
`
`
`
`1 IPR2017-01239 and IPR2017-01240, respectively, have been joined to
`these cases. See IPR2017-01488, Paper No. 81.
`
`
`
`Case IPR2017-01488 (Patent 6,407,213 B1)
`Case IPR2017-01489 (Patent 6,407,213 B1)
`
`
`
`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`BENJAMIN LASKY, ESQ.
`Kirkland & Ellis, LLP
`601 Lexington Avenue
`New York, NY 10022
`212-446-6415
`blasky@kirkland.com
`
`
`
`ON BEHALF OF THE PATENT OWNER:
`
`
`DARALYN J. DURIE, ESQ.
`Durie Tangri, LLP
`217 Leidesdorff Street
`San Francisco, CA 94111
`415-362-6666
`ddurie@durietangri.com
`
`
`
`
`The above-entitled matter came on for hearing on Monday, July 16,
`
`2018, commencing at 1 p.m. at the U.S. Patent and Trademark Office, 600
`Dulany Street, Alexandria, Virginia.
`
`
`
`
`2
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`Case IPR2017-01488 (Patent 6,407,213 B1)
`Case IPR2017-01489 (Patent 6,407,213 B1)
`
`P R O C E E D I N G S
`- - - - -
`JUDGE POLLOCK: This is the final hearing in IPR2017-01488
`and IPR2017-01489, involving U.S. Patent Number 6,407,213 B1.
`IPR2017-02139 and IPR2017-02140 have been joined to these cases.
`I am Judge Pollock. With me are Judges Yang and Snedden.
`Before we begin with the substance of the hearing, I'd like to ask the parties
`to introduce themselves.
`Counsel for Petitioner Pfizer, would you please introduce yourself
`and your colleagues?
`MR. LASKY: Good afternoon, Your Honors. My name is
`Benjamin Lasky from Kirkland & Ellis. I'm here with my colleagues,
`Amanda Hollis, and Mark McLennan, and Sharick Naqi.
`Also here with us is a Pfizer client representative, Wendy Hsu.
`And also here today is Amit Thakore from White & Case, who represents
`the joined Petitioner, Samsung Bioepis.
`JUDGE POLLOCK: Good afternoon. Counsel for Patent Owner
`Genentech, would you introduce yourselves and your colleagues?
`MS. DURIE: Yes. Good afternoon, Your Honor. Daralyn Durie
`from Durie Tangri for Genentech. Here with me at counsel table, is
`Andrew Danford from WilmerHale with the same division requested earlier.
`MR. LASKY: Your Honor, I omitted to introduce Mike
`Dobzowicz. He'll be my travel tech today. He's also from Kirkland &
`Ellis.
`
`3
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`
`Case IPR2017-01488 (Patent 6,407,213 B1)
`Case IPR2017-01489 (Patent 6,407,213 B1)
`
`JUDGE POLLOCK: As set forth in the Hearing Order, each side
`will have 50 minutes. Petitioner will go first followed by Patent Owner.
`Petitioner may reserve time for rebuttal.
`The parties may, but need not use any portion of their time to address
`pending motions. However, when introducing information subject to
`Motion to Strike or Exclude, Counsel shall briefly inform the Court of the
`controversy.
`We will attempt to keep track of time. But each party is ultimately
`responsible for monitoring their remaining time for argument.
`In response to Patent Owner's concerns regarding confidentiality of
`evidence related to its intent to antedate certain references, the parties may
`request that we clear the hearing room of persons deemed not authorized to
`access this information.
`And we ask that the parties narrowly tailor any such requests. And
`subject to our July 11 Order, the transcript will be temporarily sealed in its
`entirety in the event that we need to clear the hearing room.
`When discussing any particular demonstrative, please refer to it by
`slide and page number to help maintain a clear transcript. Counsel may not
`interrupt opposing party during the proceeding.
`To the extent that the party feels that they must lodge an objection
`for the record, they may do so during their next allotted time for it. If no
`time remains, at the end of the presentations. Any objections will be taken
`under advisement.
`
`4
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`
`Case IPR2017-01488 (Patent 6,407,213 B1)
`Case IPR2017-01489 (Patent 6,407,213 B1)
`
`Petitioner, you have the burden of showing unpatentability of the
`challenged claims. How much time would you like to allot to this portion
`of your presentation?
`MR. LASKY: Forty minutes, Your Honor.
`JUDGE POLLOCK: Forty?
`MR. LASKY: Forty of the 50.
`JUDGE POLLOCK: All right. You may begin.
`MR. LASKY: Your Honor, I'm going to begin by discussing
`antedation. I've conferred with the Patent Owner's counsel that there's no
`need to seal the hearing.
`I have -- may I approach?
`JUDGE POLLOCK: Yes, please.
`MR. LASKY: Your Honors, I'd like to start today by discussing
`antedation as I mentioned. It's been discussed in some general terms in the
`prior hearing.
`But I think we need to orient what's being discussed here. We can,
`slide five, please. What is that Genentech actually contends here, it
`contends that the inventors convened and actually reduced to practice the
`invention in certain claims listed on slide five here, before the July 26, 1990
`publication date of the Queen 1990 reference.
`There are a couple of important things though to make clear off the
`bat. First, the antedation arguments cannot save the vast majority of the 29
`challenged claims at issue here.
`
`5
`
`
`
`Case IPR2017-01488 (Patent 6,407,213 B1)
`Case IPR2017-01489 (Patent 6,407,213 B1)
`
`It only applies to these eight claims. And Genentech concedes that
`all the prior art in the instituted grounds applies to the remaining 21
`challenged claims.
`Including the six that it is not defending at all. Slide six, please.
`The other point that's important to make off the bat is that as the
`Federal Circuit has repeatedly stated, including in the Apator case just this
`year, Genentech bears the burden on antedation.
`We have come forward with prior art that we show discloses the
`claimed invention. And the burden has shifted to Genentech to show that it
`is entitled to an earlier priority date.
`And Genentech has failed to meet that burden here. Slide seven,
`
`please.
`
`Again, it's important to understand what specifically is being alleged.
`Genentech alleges in the Patent Owner response that it -- the inventors made
`and tested two specific variants. That's the HuMAb4D5-5 and -8 variants
`before July 26, 1990.
`And these are the two variants that they say actually demonstrate
`reduction to practice of the eight claims subject to their antedation argument.
`Slide eight, please.
`So, what is it that Genentech needs to establish here to meet this
`burden? So first, they must show that the inventors constructed an -- an
`embodiment that met every limitation of each allegedly antedated claim.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`6
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`
`Case IPR2017-01488 (Patent 6,407,213 B1)
`Case IPR2017-01489 (Patent 6,407,213 B1)
`
`That alone is not even enough. Second, they need to show that
`these variants were shown to work for their intended purposes. Slide 12,
`please.
`
`It's not enough here to present testimony from the inventors to show
`actual reduction to practice. Or even inventor notebooks and other
`documents.
`The requirement is for independent corroboration through testimony
`or other evidence. And there are several consequences of this
`corroboration requirement that apply in this case.
`First, the inventors' testimony itself is not sufficient. Second, the
`inventors can't corroborate each other. Here we have two inventors, but
`those, the two inventors cannot corroborate each other's story here.
`And the third, and we'll get to this in a minute, is unwitnessed
`inventor notebooks cannot be relied upon for corroboration. And there's a
`good reason why this standard is so high here.
`Here, Genentech is trying to reach over the public notice function of
`their patent and prove a prior invention. And Your Honor asked, is fraud
`required? Do we need to show fraud?
`The absence of fraud or a showing of fraud does not alleviate or
`lighten the corroboration requirement. The corroboration requirement is
`important for the very reason that we, as the patent challenger, cannot be
`expected to uncover evidence of fraud where the Patent Owner is controlling
`the narrative.
`
`7
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`Case IPR2017-01488 (Patent 6,407,213 B1)
`Case IPR2017-01489 (Patent 6,407,213 B1)
`
`And particularly in this IPR where the Patent Owner is deciding
`what documents should be produced, and how that evidence is presented.
`That's why corroboration is particularly critical here. Slide nine, please.
`So what does Genentech provide in the face of its high burden?
`Well, as an initial matter, Genentech has not provided any evidence from the
`perspective of one skilled in the art, as to what its antedation evidence
`means.
`
`It doesn't provide any expert testimony interpreting or explaining
`that evidence. And this is curious, because Genentech has an expert in this
`case who they say meets the definition of one skilled in the art.
`And he read the declarations of the inventors. And he read the
`other evidence that Genentech relies upon. But he admitted here, and this
`is his deposition testimony, he provided no opinions regarding conception
`and reduction to practice.
`And why? That's never been explained. There are several
`inferences that could be drawn from that. Either they asked him to do it
`and he wouldn't do it.
`Or they didn't think it was worthwhile to even ask him. But
`whether or not the Board draws those inferences, the bottom line is that
`Genentech has no expert evidence or other explanation for the technical
`evidence in the notebooks. Slide ten, please.
`And this means that Genentech is left with its attorneys as the only
`non-inventors to explain this technical evidence. And as courts have stated
`in almost identical circumstances, such unsubstantiated attorney argument
`
`8
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`Case IPR2017-01488 (Patent 6,407,213 B1)
`Case IPR2017-01489 (Patent 6,407,213 B1)
`
`regarding the meaning of technical evidence is no substitute for competent
`substantiated expert testimony.
`And that's the Zimmer case cited in our reply. Slide 11, please.
`So what does -- what does Genentech provide? Well, see in their
`Patent Owner response they note they rely on the inventors having
`documented their progress, developing these variants.
`As we know, the inventor testimony is not enough. It's not
`independent. But what about the documentation? Slide 13, please.
`If you look at all the inventor notebooks that have been submitted in
`this case, two from Dr. Carter and two from Dr. Presta, not a single page is
`witnessed. And some of the pages are even unsigned.
`We couldn't obviously fit all the pages on this slide. But we
`checked. And all the pages, this is Dr. Presta's notebook, all the pages are
`unsigned. Slide 14, please.
`The same is true with Dr. Carter. Every single page unsigned.
`Slide 15, please.
`Both inventors admitted at their depositions, all their notebook pages
`are unwitnessed. So, this is not a case like the Hybritech case that Ms.
`Durie mentioned where some pages were witnessed and some were not.
`These notebooks are completely unwitnessed. Slide 15, please --
`uh, 16, please.
`And the failure to have these notebooks witnessed has never been
`explained. It's certainly not due to ignorance. Here on slide 16 we have a
`call out that's from the policies. They're at the front of every notebook.
`
`9
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`
`Case IPR2017-01488 (Patent 6,407,213 B1)
`Case IPR2017-01489 (Patent 6,407,213 B1)
`
`And they state clearly that the requirement of having a witness sign
`the work not later than a month after it's done. And why? The notebook
`addresses that too.
`Because the notebooks may need to be used in a patent challenge
`like this one. So, this is not a case where they were somehow ignorant of
`this requirement. It was right there in the notebook. Slide 17, please.
`Regardless of why the notebooks don't comply with Genentech's
`witnessing policy, the consequences are clear under the law. This has been
`established for decades. Unwitnessed notebooks cannot be used to
`corroborate the inventor's prior invention.
`Here it is being stated in 1981 by the CCPA in the Reese case.
`Inventors' notebooks are accorded no more weight than inventors' testimony
`in this instance where they are not witnessed, or not signed, or were unseen
`by any witness.
`And then just this year in the Apator case, the Federal Circuit again
`stated that an unwitnessed laboratory notebook alone cannot corroborate an
`inventor's testimony. This also was stated in the Medichem case that Ms.
`Durie referred to.
`Where the unwitnessed notebooks were not permitted to be relied
`upon for corroboration. If we go to slide 18, please.
`Now, the other thing that's clear from the rule of corroboration is that
`the inventors themselves cannot somehow bolster these unwitnessed
`notebooks. That would lead to the trap of falling into the circular logic of
`
`10
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`
`Case IPR2017-01488 (Patent 6,407,213 B1)
`Case IPR2017-01489 (Patent 6,407,213 B1)
`
`using the files to corroborate the testimony, and the testimony to corroborate
`the files.
`So, the inventor testimony and the unwitnessed notebooks here
`provide no weight for corroboration. Slide 19, please.
`So what else is provided? So here they point to several notebooks
`from non-inventors, Brady, Rowland, Hotaling, and Carver. And while it's
`true that these are non-inventors, their notebooks did not corroborate the
`reduction to practice as is required.
`Now they say here in their Patent Owner response that these
`contemporaneous records confirm all aspects of the invention before July 26,
`1990. But where have they shown you that?
`Those notebooks and other records do not do that. And that's what
`I'll show you now. Slide 20, please.
`Here's what Genentech says about these non-inventors. These are
`folks who were given samples by Dr. Carter, and they performed
`experiments on those samples. Either to express them, or to characterize
`the binding affinity.
`But there's not even any argument, much less showing that these
`notebooks provide the necessary detail about the sequences and substitutions
`required to show the tested variance met the claims. Slide 22, please.
`Here is Mr. Brady. Mr. Brady testified that he was just given
`vectors by Dr. Carter, labeled A, B, C, and D. And he just expressed them
`and tested them.
`
`11
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`Case IPR2017-01488 (Patent 6,407,213 B1)
`Case IPR2017-01489 (Patent 6,407,213 B1)
`
`He wasn't knowledgeable about how Dr. Carter and Dr. Presta had
`humanized the 4D5 antibody. And he knew nothing about framework
`residue substitutions. That was outside of his knowledge.
`Now if we can pull up please, Patent Owner's slide 47. So this is
`the one example that you were shown in the prior hearing where Ms. Durie
`alleged that this shows somehow the claimed invention through the
`corroboration materials.
`But, it's clear from this document that it does not. The substitutions
`that are allegedly referred to there, are not mentioned -- or did not match up
`with the variance that are alleged to have been made at the time.
`And on top of that, there is no expert evidence or anything other than
`attorney argument in this very hearing, comparing this notebook page to the
`claims of the invention.
`So, in circumstances where Mr. Brady's notebook does not show that
`the claims were met by these antibodies, and he had no personal knowledge
`himself, Mr. Brady's work could not corroborate the invention.
`And the same is true with Ms. Carver, Mr. Hotaling, Ms. Rowland.
`In fact Genentech didn't present any testimony from them at all.
`And so we don't even know what they knew about the invention.
`Certainly there is no allegation that they knew that it met the claims. And
`that that corroborated this invention. Slide 24, please.
`All that's left is certain non-notebook documents. And we saw a
`couple of those in Ms. Durie's presentation earlier. Not only do these not
`show the claimed invention, but they're not even authenticated.
`
`12
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`
`Case IPR2017-01488 (Patent 6,407,213 B1)
`Case IPR2017-01489 (Patent 6,407,213 B1)
`
`Ms. Loeffler, they presented a declaration from Ms. Loeffler, their
`record's custodian, about, you know, certain notebooks and how they were
`allegedly stored. She admitted she did not know anything about these non-
`notebook documents.
`And she did not mention them in her declaration. So here we have
`some unauthenticated documents that don't corroborate the claimed
`invention. So they can't fill in the gap. Okay. Slide 26, please.
`Even if you were to credit this evidence as corroboration evidence,
`proper corroboration evidence, which we submit would not be correct,
`Genentech still hasn't met the requirements of the standard here.
`As I mentioned earlier, they need to show, and they have the burden
`here that these variants met all the limitations of the claims. And they have
`to have been shown and appreciated to work for their intended purpose.
`Slide 27, please.
`There is no -- not even a scintilla of evidence in the record
`comparing the variance that -- and the notebook records with the claims.
`All we have is this claim chart that's set forth in the Patent Owner response
`that lists the -- that lists the claim language.
`And asks the Board to sift through the evidence to try to find support
`for the statements that are made there. No citations to expert evidence.
`We know that Dr. Wilson didn't address conception reduction to
`practice. This is the very unsubstantiated attorney argument that cases like
`the Zimmer case said is insufficient.
`
`13
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`Case IPR2017-01488 (Patent 6,407,213 B1)
`Case IPR2017-01489 (Patent 6,407,213 B1)
`
`And you know, even more recent cases in the Board, Apple v.
`Personalized Media, IPR2016-755, paper 42 at 73. The Board rejected
`similar evidence, noting that Patent Owner essentially invites the Panel to
`sort through all of its string citations that involve general statements.
`And determine for itself how to apply them separately to find
`support for the claims. Or to apply some or all of the string cites to one or
`more of the embodiments in order to find the requisite support. And that's
`what Genentech is inviting you to do now. And that is not sufficient.
`Slide 29, please.
`So, just as an example, what evidence do they have that these
`variants meet the Markush Groups of the claims? Here we have an
`example. Claim 12 is one that they are -- that their antedation argument
`applies to.
`And we see that it requires substitution of a site selected from the
`group consisting of, and then it has a set of substitutions. Sure enough,
`66L is one of them.
`Now Patent Owner knew -- knows this is a Markush Group. It
`acknowledged it right there in the preliminary response.
`The Federal Circuit has held, and it's well established that these
`Markush Groups create a strong presumption that the claim element is
`closed. And therefore exclude any elements, steps or ingredients not
`specified in the claim.
`So here the strong presumption is that these claims are limited to the
`substitutions in the claim. And Patent Owner has never tried to rebut that
`
`14
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`
`Case IPR2017-01488 (Patent 6,407,213 B1)
`Case IPR2017-01489 (Patent 6,407,213 B1)
`
`presumption in the preliminary response, in the Patent Owner response.
`Slide 30, please.
`So, what is the consequence of that? If we look at the variants that
`they are seeking to rely on, which are listed in Table Three, we see sure
`enough they have substitutions at 66L.
`And there's a mistake in the patent here. It says 56, but it means
`66L. But those variants also have substitutions at four heavy chain
`positions, in 71, 73, 78, and 93.
`And according to the strong presumption that they haven't even
`attempted to rebut, that takes these variants out of the claims. So, this is of
`course, the danger of relying on unsubstantiated claim charts about variants
`that meet the claims.
`There's no evidence actually tying the antedation evidence to the
`requirements of the claims.
`JUDGE POLLOCK: Slide 1 that you have here on slide 30 is
`directed to humanize antibody variable domain.
`MR. LASKY: Yes, Your Honor.
`JUDGE POLLOCK: The heavy chain substitutions are something
`else. It's not excluding that is it?
`MR. LASKY: Your Honor, the variable domain, and I don't think
`there's a dispute about this, this is talking about the variable region that's
`made up by the heavy chain and the light chain regions.
`JUDGE POLLOCK: Okay.
`
`15
`
`
`
`Case IPR2017-01488 (Patent 6,407,213 B1)
`Case IPR2017-01489 (Patent 6,407,213 B1)
`
`MR. LASKY: And so the domain is really what is added to the
`constant region to make up the full antibody. So, and I don't think there's
`any dispute about that.
`JUDGE POLLOCK: Fair enough.
`MR. LASKY: So, slide -- and Judge Yang, you asked about the
`CDR requirement in the previous hearing. And you asked whether there
`was support for the idea that you can have not all CDR residues in the final
`antibody.
`And I didn't hear any answer pointing to a specific portion of the
`patent. But we do have some testimony from the inventor on this very
`point.
`
`If we can pull up Exhibit 1199 at pages -- page 86, line 20 to 87, line
`7. And we'll try to bring that up in a minute.
`But, the inventor, Dr. Presta testified. We asked him, in your view,
`in the claims of the ’213 patent, when it says comprising non-human
`complementarity-determining region amino acid residues which bind an
`antigen, you understand that to mean that all the CDR residues must be
`brought over. Is that right?
`He said, that's the first step. And I clarified, do you mean all the
`CDRs? He said yes, all CDRs. And that makes sense. Because if you
`could just bring over one residue, two residues, there's no standard in the
`patent for anything less than all the residues.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`16
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`Case IPR2017-01488 (Patent 6,407,213 B1)
`Case IPR2017-01489 (Patent 6,407,213 B1)
`
`Now there was also a suggestion that this doesn't preclude later on
`making substitutions. But this is a product claim. This isn't a method
`claim that allows steps after what is in the claim.
`So the claim says that the complementarity-determining region
`amino acid residues must be incorporated into the framework. And that's
`what the product is.
`So here we would submit that this does require all of the residues to
`be mouse residues in the CDR. And as we've shown in the reply, and
`Dr. Foote explained, all the variants here do have substitutions to human
`residues in the CDR.
`And that would further take them out of these claims. But, the
`bottom line here is, there's no evidence addressing these issues. There's
`only this unsubstantiated attorney argument in the Patent Owner response.
`Slide 31, please.
`The other requirement of course is that these be shown to be fit for
`purpose. And the courts have said that there must be appreciation of the
`invention at issue by the inventor.
`And when testing is necessary, there must be recognition and
`appreciation the tests were successful. Slide 32, please.
`And so we asked the inventors about this. There's no dispute. Mr.
`Presta said, testified the purpose of these variants was for human therapeutic
`use.
`
`Which would require a showing not only that these bind in some
`unknown amount. But that they also are less immunogenic than the parent.
`
`17
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`
`Case IPR2017-01488 (Patent 6,407,213 B1)
`Case IPR2017-01489 (Patent 6,407,213 B1)
`
`And that's -- otherwise, one would just use mass. And Dr. Carter
`said, you can only generate those sorts of results by treating humans with the
`antibodies.
`And he admitted that that wasn't done until 1992 at the earliest.
`Well after the July 1990 date.
`So here not only is there no corroboration evidence, not only is there
`no showing that these variants fall within the claims, but there's not even any
`real argument that these were known and appreciated to be fit for their
`intended purpose. Slide 33, please.
`Even if Genentech can jump over all of those hurdles, there's the
`additional hurdle that Your Honors noted in the Institution decision.
`Which is that they need to show that the invention is properly disclosed in --
`well, has written description support and enablement from the ’272
`application.
`Which is the priority application. Because the later application is a
`continuation in part. Slide 34, please.
`So what do they have to meet their burden here? They have
`another conclusory claim chart. In this case it's in -- at least in the
`declaration of their expert.
`That is, the Board noted in the Apple v Personalized Media case that
`I discussed earlier, having a conclusory claim chart with string cites in an
`expert declaration, is no more -- is entitled to no more weight than similar
`claim charts and conclusory argument in the briefing itself.
`
`18
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`Case IPR2017-01488 (Patent 6,407,213 B1)
`Case IPR2017-01489 (Patent 6,407,213 B1)
`
`And again, Dr. Wilson doesn't explain here how the Markush claims
`are met, or how the CDR claim -- elements are met. Slide 36, please.
`So here there's nothing shown to be in the specification that meets
`the claims. Slide 37, please.
`Not only that, but the -- for priority, the Patent Owner has the burden
`of showing that there is sufficient written support for the full scope of the
`claims.
`And that is not addressed anywhere in the evidence. It's not in
`Dr. Wilson's declaration. It's not in the Patent Owner response. And so,
`here where there's a distinct failure of proof, Genentech can't meet its
`burden. Slide 50, please.
`So, I'd like to change topics now and move to the consensus
`sequence issue that we -- that was discussed in the prior hearing. Slide 51.
`So, just to reorient ourselves here, consensus sequence requirement
`is only in a few of the challenged claims, 4, 33, 62, 64, and 69. And none
`of these claims is implicated by Genentech's antedation argument.
`So all of the prior art in the instituted grounds is available. And I
`heard some suggestion that the consensus sequence requirement was
`somehow inherent in the other claims, there's no support for that.
`The other claims do not require a consensus sequence at all. And
`the substitutions that are made, and the rules applied to identify their
`substitutions, are independent of whether a consensus sequence is required.
`So, what does the prior art say about consensus sequence? Slide
`52, please.
`
`19
`
`
`
`Case IPR2017-01488 (Patent 6,407,213 B1)
`Case IPR2017-01489 (Patent 6,407,213 B1)
`
`JUDGE POLLOCK: Mr. Lasky, I believe you reserved 40 minutes.
`But I think the timer was set for 40 minutes.
`MR. LASKY: No. You had said how much do you want to allot?
`And I set it 40 minutes.
`JUDGE POLLOCK: All right. We’re set then. Please continue.
`MR. LASKY: Apologies. The -- as was mentioned in the prior
`hearing, the consensus sequence requirement is explicitly disclosed in Queen
`1990. Here Queen 1990 is providing two options.
`Either use a framework from a particular human immunoglobulin
`that is unusually homologous to the donor immunoglobulin to be
`humanized. Or use a consensus framework from many human antibodies.
`And we heard from Ms. Durie that this -- it might be plausible that
`this could mean some other smaller subset of sequences to make the
`consensus from.
`But what we haven't seen is any evidence that anyone actually ever
`made a consensus sequence using such a subset. In fact, the evidence here
`is all aligned.
`If we look at Slide 53, the argument here is that the consensus from
`many framework -- many human antibodies in Queen is different somehow
`from the patent's definition. Slide 54.
`What we do know from the patent though is at the very least,
`creating a consensus from the sequences in Kabat 1987, is sufficient. And
`in fact, that's the way the inventors did it.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`
`20
`
`
`
`Case IPR2017-01488 (Patent 6,407,213 B1)
`Case IPR2017-01489 (Patent 6,407,213 B1)
`
`And that's the only way that's discussed as being disclosed in the
`prior art. Fifty-five, please.
`Here Dr. Presta confirmed that he used Kabat and that was the only
`way that he could think of to generate a consensus sequence at the time of
`the invention. And Genentech's expert, Dr. Wilson, did not identify any
`other ways either. Slide 56, please.
`In fact, Dr. Wilson agreed that Kabat doesn't claim to list all human
`immunoglobulin sequences of a particular subgroup. Rather, Kabat has
`many sequences in each human subgroup.
`Correct. And that's exactly what Queen 1990 teaches to use. The
`use of Kabat to identify residues to substitute to make the framework more
`generically human, is disclosed throughout the prior art. Slide 57, please.
`Queen 1989 sure enough discloses starting with a best fit framework.
`But then teaches that one should look for unusual residues and substitute
`them to mouse.
`And here what do they say to use to identify common and
`uncommon residues? Kabat once again. Slide 59, please.
`Here in Dr. Foote's opening declaration, he explained that there was
`additional prior art that used the Kabat reference to identify a consensus
`sequence. In fact the CAMPATH antibody that was made and disclosed in
`the Riechmann reference, was in fact made using a consensus sequence
`where judgment of whether a particular residue was the consensus or not,
`was done using Kabat.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`
`21
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`Case IPR2017-01488 (Patent 6,407,213 B1)
`Case IPR2017-01489 (Patent 6,407,213 B1)
`
`And in that case it was Kabat 1983, because the Kabat 1987 had not
`yet even been published. But I don't think there's any suggestion that that
`makes a difference to the disclosure, which edition of Kabat is used. Slide
`60, please.
`Now, I believe this may be subject to the Motion to Strike. But,
`here on Slide 60 what we show is that the Genentech has known for a long
`time that the CAMPATH residue was made using consensus human kappa
`frameworks.
`And indeed this is an excerpt from the prosecution history which
`acknowledged that. So, use of a consensus framework was known and
`disclosed.
`And the -- that requirement cannot bestow patentability on the five
`claims that include the concept. Now, there was some argument that well,
`Foote only describes using consensus for the light chain and not also the
`heavy chain.
`I mean, that's pure attorney argument. We haven't seen any
`argument that porting over consensus to the heavy chain was somehow
`patentable.
`And you know, this is not a situation where they were not aware of
`this position. In fact Dr. Foote testified as to his use of the consensus for
`the light chain in his anti-lysozyme at his deposition, which was held before
`Patent Owner submitted it
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
