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`UNITED STATES PATENT AND TRADEMARK OFFICE
`___________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________
`
`CELLTRION, INC.,
`Petitioner,
`
`v.
`
`BIOGEN, INC.,
`Patent Owner.
`_________
`
`Case IPR2017-01095
`Patent 9,296,821 B2
`___________
`
`Record of Oral Hearing
`Held: August 21, 2018
`___________
`
`
`
`
`Before ERICA A. FRANKLIN, SHERIDAN K. SNEDDEN, and
`JACQUELINE T. HARLOW, Administrative Patent Judges.
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`Case IPR2017-01095
`Patent 9,296,821 B2
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`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`MICHELLE S. RHYU, PhD, ESQUIRE
`DANIEL J. KNAUSS, PhD, ESQUIRE
`Cooley LLP
`3715 Hanover Street
`Palto Alto, CA 94304-1130
`
`
`
`ON BEHALF OF THE PATENT OWNER:
`
`
`J. STEVEN BAUGHMAN, ESQUIRE
`MEGAN RAYMOND, ESQUIRE
`Paul, Weiss, Rifkind, Wharton & Garrison
`2001 K Street, N.W.
`Washington, D.C. 20006
`
`and
`
`Roy Campos (Celltrion)
`
`
`
`
`The above-entitled matter came on for hearing Tuesday, August 21,
`
`2018, commencing at 1 p.m., at the U.S. Patent and Trademark Office, 600
`Dulany Street, Alexandria, Virginia.
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`Case IPR2017-01095
`Patent 9,296,821 B2
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`P R O C E E D I N G S
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`JUDGE FRANKLIN: You may be seated. And, Judge Harlow,
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`are you on the line?
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`JUDGE HARLOW: I am.
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`JUDGE FRANKLIN: Thank you.
`
`
`Good afternoon. Today is August 21st, 2018, and this is a final
`hearing in IPR2017-01095 involving Claims 1 to 6 of U.S. Patent No.
`9,296,821.
`I'm Judge Franklin and to my right is Judge Snedden, and on
`
`
`the monitor is Judge Harlow, who's in Colorado. We welcome everyone and
`thank you for attending.
`
`
`At this time I'd like counsel for the parties to introduce
`themselves and their colleagues, beginning with Petitioner.
`
`
`MS. RHYU: Michelle Rhyu from Cooley, representing
`Petitioner Celltrion. With me is backup counsel, Dan Knauss, and at the
`counsel table is Roy Campos. Thank you.
`
`
`JUDGE FRANKLIN: Thank you.
`
`
`MR. BAUGHMAN: Your Honor, Steve Baughman and Megan
`Raymond from Paul, Weiss for Biogen.
`
`
`JUDGE FRANKLIN: Thank you. Consistent with the hearing
`order, each party has 45 minutes to present arguments. Petitioner may
`reserve time for rebuttal.
`
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`And please be mindful that we do have a court reporter who's
`transcribing this hearing and that Judge Harlow is appearing remotely.
`When referring to a specific exhibit, we ask that you refer to it by number,
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`so that she may follow along.
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`And now, Petitioner, you may proceed after indicating any time
`you would like to reserve for rebuttal.
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`MS. RHYU: Thank you, Your Honor. Would you like hard
`copies of the exhibits?
`
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`JUDGE FRANKLIN: Sure. And how much time would you
`like to reserve?
`
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`MS. RHYU: Fifteen minutes, please.
`
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`JUDGE FRANKLIN: Thank you.
`
`
`(Pause.)
`
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`MS. RHYU: May I proceed?
`
`
`JUDGE FRANKLIN: Yes, you may begin.
`
`
`MS. RHYU: The six claims of the '821 patent are invalid based
`on two independent theories. First, the patent is not entitled to rely on the
`'202 patent application and its August 11th priority date. A person of skill in
`the art reading that '202 application would not have concluded that the
`inventor was in possession of a therapy for low grade lymphoma involving
`administering rituximab during CVP chemotherapy to achieve a beneficial
`synergistic result. Because that disclosure is not in the '202 application, the
`'821 patent claims are only entitled to the priority date of that application,
`which is June 15th, 2012, and with this correct priority date, Marcus, the
`2005 reference, anticipates and invalidates every claim.
`
`
`But the second theory is that even if this panel decides to apply
`the 1999 -- the August 1999 priority date, all of the claims are invalid
`because they were obvious based on the art that was available at the time.
`
`
`Now, these two theories put the Patent Owner in an untenable
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`and irreconcilable position. Because the '202 application never mentions
`administering rituximab during CVP therapy to achieve a beneficial
`synergistic effect, the Patent Owner has had to rely on what a person of
`ordinary skill would know to fill the gaps. Patent Owner's problem is that
`the application makes no contribution over the prior art to support the
`claims, so the very disclosures that they rely on to support the 1999 priority
`date render the claims obvious as of 1999.
`
`
`So, two examples of the irreconcilable positions that the Patent
`Owner has taken. The patent discloses administering rituximab during
`chemotherapy, this was known in the art, but the '202 application never
`discloses administering rituximab during the CVP chemotherapy. So the
`Patent Owner has argued that CVP was a standard chemotherapy as of 1999
`that a person of skill in the art would have taken the general disclosure to
`support their written description of CVP. But if that's true, the facts that the
`prior art talked to administering rituximab and standard chemotherapy
`means that administering rituximab with CVP was obvious.
`
`
`The second example. The patent describes the prior art
`disclosure that administering rituximab with CHOP leads to a beneficial
`synergistic effect, but the '202 application never states that rituximab during
`CVP chemotherapy leads to a beneficial synergistic effect. So the Patent
`Owner relies on the rituximab-plus-CHOP disclosure to support rituximab
`plus CVP plus beneficial synergistic effect and, if the Patent Owner can do
`that, then all of those -- all of the evidence that -- the disclosures that they
`rely on were in the prior art and therefore that combination was obvious.
`
`
`Because the Patent Owner didn't contribute anything to the
`prior art as to these claims, the patent is invalid based on either the first or
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`the second theory.
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`
`Let's turn to slide 2. This slide summarizes all of the arguments
`that are in our demonstratives. Today I'll focus on number 1, the priority
`date; number 3, the fact that Marcus anticipates; and, number 4, that even
`with a priority date with August 11th, 1999, claims 1 to 3 are obvious in
`view of Czuczman, Foon, Dana, with or without IDEC's 10-K. And at the
`very end I'd like to touch on claim construction.
`
`
`The next slide, slide 3. So for today's purposes we'll focus on
`grounds 1 and 3, Marcus and the Czuczman, Foon, Dana, and IDEC 10-K.
`
`
`So let's turn to slide 4 and the reasons why the '821 patent is not
`entitled to the priority date that's earlier than June 12th, 2012.
`
`
`As this panel is well aware, in order to claim the earlier priority
`date, the earlier application had to have demonstrated to a person of ordinary
`skill in the art that the inventor had possession of the claimed invention, and
`it is not sufficient to have disclosed that which was obvious, but that the
`inventor had to demonstrate that it was in possession of all of the invention
`with all of its claimed limitations. That was not the case here, because the
`'202 application simply did not show that the inventor was in possession of
`rituximab administered during CVP treatment to achieve a beneficial
`synergistic effect.
`
`
`On slide 7, we have a portion of the file history of the '821
`patent where the Patent Owner has cited to different places in the
`specification in support of its claims, and in slide 8 we have dissected those
`portions of the specification to show what those portions do not disclose. In
`each of these individual disclosures there is no place where all claim
`limitations are recited together.
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`JUDGE FRANKLIN: Is that necessary?
`
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`MS. RHYU: Pardon me?
`
`
`JUDGE FRANKLIN: Are you suggesting that's necessary?
`
`
`MS. RHYU: It's necessary that the disclosures as a whole
`
`
`demonstrate to a person of ordinary skill in the art that the inventor was in
`possession, but I'll go into --
`
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`JUDGE FRANKLIN: But wait, that wasn't my question.
`
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`MS. RHYU: -- more detail as to why.
`
`
`JUDGE FRANKLIN: You're making a point that the
`limitations of the claim are not disclosed together in one particular location
`and I asked is that necessary. I think your answer is no.
`
`
`MS. RHYU: It's not absolutely necessary. But let's go to claim
`-- slide 10, which shows that in claims 17 and 29 -- and this is also true of
`claim 20 -- the method that's disclosed is just administering rituximab, the
`anti-CD20 antibody, before, during or subsequent to a chemotherapeutic
`regimen, and the same generality applies to claim 29. This information was
`in the prior art.
`
`
`Slide 12 refers to the only place where CVP and rituximab are
`mentioned as being applied to the same patients, but in this case rituximab is
`used as a maintenance therapy, which is a therapy after the CVP and not
`during the CVP therapy.
`
`
`And slide 11 is a critical disclosure that's in the specification,
`one that person of ordinary skill would read to understand what the
`invention -- inventor was in possession of. And in this case the disclosure
`discloses a method of treating B-cell lymphoma comprising administering to
`a patient the antibody before, during or subsequent to a chemotherapeutic
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`regimen -- again, general -- and then lists that the chemotherapy regimen
`may be selected from the group consisting of at the very least, and then lists
`19 different regimens, none of which is CVP.
`
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`So the absence of CVP in this list is telling and one of ordinary
`skill in the art would read this to mean that the CVP chemotherapy in
`particular was not in the mind of the inventor. And this is supported by the
`Lossos declaration, as we indicate in the next slide, slide 9.
`
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`So as for the priority date arguments, we presented an expert
`declaration with specific details and testimony as to why these different
`portions of the specification do not demonstrate that a person of ordinary
`skill would view the inventor as having invented the claims of the '821
`patent. The Patent Owner has provided no expert testimony to priority
`argument. The '202 application simply does not support the '821 claims.
`
`
`And this is a nice time to step back and look at the
`contradictions in the Patent Owner's arguments. On the one hand, to support
`their priority argument, they're saying that the patent -- that CVP is a
`standard chemotherapy and this is something that their expert, Dr.
`McLaughlin, agreed to, and then on the other hand, in replying to the
`obviousness argument, the Patent Owner argues that a person of skill in the
`art would not be motivated to discard CHOP in favor of another
`chemotherapy agent like CVP. They can't have it both ways.
`
`
`The next slide 13 shows another contradiction and this is with
`respect to maintenance therapy. On the one hand, for the priority argument,
`they argue that the disclosure in reference to the ECOG study discloses
`administering rituximab before, during or subsequent to the CVP. Here it
`was the latter of those options, but they're much more clear in their argument
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`against obviousness where they say that that same ECOG study shows
`rituximab not during the chemotherapeutic regimen, but as a maintenance
`therapy after the CVP therapy.
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`Because all of the claims are not entitled to claim priority to the
`'202 application, all of the claims are invalid based on Marcus. And I'm at
`slide 29.
`Slide 31 summarizes the fact that the Patent Owner does not
`
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`dispute that Marcus discloses every claim of the claim -- every element of
`claims 2, 3, 5, and 6, and the Patent Owner's only dispute is that they claim
`that we have not established that Marcos discloses a beneficial synergistic
`effect.
`Slides 32 and 33 highlight the very disclosures of all of the
`
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`elements of claims 1 through 6, which we've gone through -- which are laid
`out in those slides, but the key point here is that the Patent Owner itself has
`argued that Marcus discloses beneficial synergistic effect both here in this
`proceeding and to the Patent Office; it's an admissible by the Patent Owner.
`
`
`And if you turn to Exhibit 2006 from the file history, you can
`see where they've done this. The reference in the top highlighted section on
`page 14 of Exhibit 2006 shows that they're referring to the Marcus blood
`publication from 2005, they present a chart where they show the median
`time to progression and the complete response for rituximab, and then the
`CVP treatment and rituximab plus CVP. And in the sentence that goes
`between pages 14 and 15, they say that a complete response and extended
`medium TTP achieved with a presently claimed combination were more
`than additive, i.e. they were synergistic results. This is the Patent Owner
`itself arguing that Marcus discloses a beneficial synergistic result -- effect
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`and, therefore, Marcus anticipates a rate element of all six claims.
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`Let's turn to ground 3 and why claims 1 to 3 are obvious in
`view of Czuczman, Foon and Dana with or without IDEC's 10-K. So this is
`based on the August 1999 priority date.
`
`
`Slide 43, in slide 43 we've highlighted the relevant disclosures
`from Czuczman and, as this panel knows well, Czuczman discloses treating
`low-grade NHL with rituximab during CHOP chemotherapy, and CHOP is
`CVP plus doxorubicin.
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`Czuczman further explains the rationale for combining C2BA,
`which is rituximab, with CHOP, which includes synergy with
`chemotherapeutic agents, plural.
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`So Czuczman has disclosed that rituximab has synergy with
`chemotherapeutic agents and actually it does so in reference to the Demidem
`reference. And it demonstrates that with the CHOP combination there's an
`overall response rate of 100 percent, and that rituximab plus CHOP in the
`bottom highlighted section has better anti-tumor activity than CHOP alone.
`So Czuczman has already provided the suggestion that rituximab has
`synergy with chemotherapeutic agents, and Foon and Dana describe that
`CVP was a chemotherapeutic combination that was used to treat low-grade
`lymphoma.
`
`
`Slide 44 shows the disclosure in Foon shows that CVP is one of
`only three combination therapies disclosed for low-grade lymphoma and
`CHOP was one of the other therapies disclosed here. And then in slides 45
`and 46, both Foon and Dana recognize that patients treated with CVP have
`an overall survival rate that's not much different from that with patients who
`were treated with doxorubicin added.
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`JUDGE FRANKLIN: Going back to Czuczman where the
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`disclosure is of synergy with chemotherapeutic agents, do you read that as
`having any difference between synergy, which is quoted there in the
`reference, and the claim requirement of a beneficial synergistic effect?
`
`
`MS. RHYU: I see no difference, Your Honor. So under both
`the panel's construction and under the construction that we advanced in our
`original petition, synergy is met by Czuczman.
`
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`JUDGE FRANKLIN: Well, this is probably a good point for
`you then to discuss how Petitioner's proposed construction of that claim
`phrase includes or recognizes the term synergy.
`
`
`MS. RHYU: Sure. So the term synergy is addressed -- let me
`turn to the claim construction slides -- starting at page 15. And slide 17 then
`provides the three definitions that -- the Petitioner's definition, the Patent
`Owner's definition and the Board's construction. It's Petitioner's
`construction that the synergy involves an approved clinical outcome above
`one of the component parts. So the synergy doesn't need to be additive, but
`better than one of the component parts, it's an improved outcome. And that's
`supported by -- that is the broadest definition that's reasonable.
`
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`And if we go to slide 19 --
`
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`JUDGE FRANKLIN: Well, before you do that, is there any
`instance where combining A plus B gives you some improvement over
`either A or B is -- does not show synergy?
`
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`MS. RHYU: Where -- I'm not sure I understand your question.
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`JUDGE FRANKLIN: What's the difference between synergy
`and some additive effect?
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`MS. RHYU: So synergy could also be viewed as sensitization
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`or potentiation of the effect of one compound, and that is the use of synergy
`that was applied by Demidem and by Czuczman in reference to the
`Demidem article --
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`JUDGE FRANKLIN: Is that --
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`MS. RHYU: -- and that was also --
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`JUDGE FRANKLIN: Go ahead.
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`MS. RHYU: And that was also acknowledged by the Patent
`Owner's expert, Dr. McLaughlin, and --
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`JUDGE FRANKLIN: So is -- I'm sorry --
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`MS. RHYU: That's all right. If you go --
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`JUDGE FRANKLIN: -- I keep thinking you're taking
`(indiscernible) --
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`MS. RHYU: -- to the testimony and maybe that would clarify,
`and then we could answer questions from there, shall we -- what
`sensitization involves?
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`JUDGE FRANKLIN: Is there -- may I --
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`MR. BAUGHMAN: I'm sorry to interrupt, Your Honor. I don't
`know what the Board's preference is if we have an objection about a new
`matter. I don't think that there's been an argument before that sensitization --
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`JUDGE FRANKLIN: I'm going to stop you there --
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`MR. BAUGHMAN: Yes, Your Honor.
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`JUDGE FRANKLIN: -- and you're going to get your time --
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`MR. BAUGHMAN: Understood.
`
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`JUDGE FRANKLIN: -- to address that.
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`MR. BAUGHMAN: Thank you.
`
`
`JUDGE FRANKLIN: So, Petitioner, in your construction of a
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`beneficial synergistic effect, the improvement, does that mean a
`sensitization, is that requiring --
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`MS. RHYU: It means a sensitization or a potentiation of the
`effect of one of the compounds.
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`JUDGE FRANKLIN: Okay, that's helpful.
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`MS. RHYU: And just to finish out this section, if you go to
`slide 19, we asked Dr. McLaughlin, "What do you mean by synergy in the
`context of sensitization?"
`
`And he says -- he's trying to stick with
`the panel's definition of synergy, but he says, "You could say ill-advisedly,
`but I just I think there wasn't rigidity about the use of that word synergy."
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`And in slide -- let's see -- slide 22, here's some intrinsic
`evidence of the use of the word synergistic in the context of rituximab
`combined with cytotoxic drugs. And in this context that's where synergy
`comes up, it's in describing this Demidem reference.
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`If you go to slide 23, we asked Dr. McLaughlin, who had
`commented on the Demidem reference back in the 1990s, we asked,
`"Haven't you yourself referred to the Demidem reference as demonstrating
`synergy between rituximab and chemotherapy?"
`And again, he
`wants to adhere to the Board's preliminary definition of synergy. He says,
`"If I at one point or some other author at some point uses the word synergy
`more loosely constructed than the Board's definition, so be it, but that
`finding of the word synergy in publications doesn't necessarily mean the
`stringent definition the Board has stated."
`
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`So here's testimony from a person of ordinary skill in the art,
`the Patent Owner's expert, consistent with the testimony of our own expert,
`that a more generous description of synergy is what they had in mind in
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`talking about the relationship between rituximab and other chemotherapeutic
`agents.
`JUDGE FRANKLIN: I'm looking back now at your -- just to
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`
`round this out, I'm looking back now at your petition to see how extensively
`this was argued there and I am seeing -- or I should say I am not seeing
`much of this argument in your petition.
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`MS. RHYU: Honestly, in the petition we didn't anticipate that
`the definition would be so narrowly construed in light of the fact that
`synergy is closely linked to a potentiation and the Demidem reference --
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`JUDGE FRANKLIN: I understand --
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`MS. RHYU: -- but this was --
`
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`JUDGE FRANKLIN: -- but here you are --
`
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`MS. RHYU: -- provided in rebuttal.
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`JUDGE FRANKLIN: I understand, but here you are giving me
`a further construction of a term used in your proposed interpretation an
`improvement, meaning something slightly different than just an
`improvement, it's a certain type of improvement, right? Some type of
`sensitization or potentiation. I don't see that in the petition; if it's there,
`please direct me to it.
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`MS. RHYU: I acknowledge that, Your Honor. And what I
`would say is that all of the arguments that I'm presenting today don't depend
`on our definition of beneficial synergistic effect, they depend on the Patent
`Owner's definition.
`
`
`JUDGE FRANKLIN: Okay.
`
`
`MS. RHYU: All right? And just to refer to slide 25, that's
`where McLaughlin has noted that sensitization means potentiation and the
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`Case IPR2017-01095
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`activity of the compound. So in the most relevant context with rituximab
`interacting with other chemotherapies, we believe that the broadest
`reasonable definition which is consistent with -- the broadest reasonable
`definition is consistent with what their expert testified to and I'll just leave it
`at that.
`So let's go to ground 3. So we were talking about the
`
`
`disclosures of Czuczman, Foon and Dana, and let's go to slide 48 to look at
`testimony from Dr. McLaughlin again. And here Dr. McLaughlin is
`acknowledging that CVP was a standard chemotherapy and in slide 51 he
`also acknowledges that even after flirting about the impressive results from
`Czuczman he himself pursued a combination of rituximab with other
`chemotherapies. So he didn't just stop at Czuczman and say this is a great
`result, we don't need to look at other chemotherapies, instead he continued to
`look at other combinations himself, in this case with FMD, a chemotherapy
`regimen.
`And in slide 50, this is citing from Dr. McLaughlin's own
`
`
`publication from 1998 where he suggests further investigation in conjunction
`with standard chemotherapy. So between all of those references there's a
`clear motivation to combine rituximab with CVP. And in addition to that,
`slide 64 provides that disclosure from the IDEC 10-K, which explicitly says
`that they are pursuing combination therapies with widely used chemotherapy
`regimens, and again the Foon reference told us that CVP was a widely used
`chemotherapy regimen for low-grade lymphoma.
`
`
`So many of the reasons for motivation to combine also apply to
`a reasonable expectation of success and the panel recognized that on page 29
`of its institution decision.
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`Slide 59 refers specifically to the bcl-2 conversion and why that
`
`
`was an independent reason that there was a reasonable expectation of
`success. So bcl-2 conversion from positivity to negativity is a hallmark of
`successful treatment of low-grade lymphoma and what this Czuczman
`disclosure says is that R-CHOP, in the R-CHOP patients, all four that were
`bcl-2 positive have converted to negativity, and recognizes that CHOP alone
`had previously been shown unable, to be unable to clear bcl-2 positivity.
`
`
`So to see that in diagrammatic form on slide 58, there was no
`conversion from CHOP. There was conversion from Czuczman alone that
`was known in the art, as we have shown in our briefing, and then with R-
`CHOP there was conversion. So because rituximab provided the component
`that appears to be critical here for conversion, one would have a reasonable
`expectation of success that rituximab combined with other chemotherapies
`would also provide bcl-2 conversion.
`
`
`Slide 68 emphasizes that portion of the Czuczman reference
`that discusses the rationale for combining rituximab with CHOP, which
`equally applies to other chemotherapy regimens, and expressly says that
`there is synergy with chemotherapeutic agents. The Patent Owner is now
`disclaiming that this shows synergy for rituximab plus CVP, but as quoted
`from the panel on slide 67, the Patent Owner's synergy argument is not well
`taken as it cuts against the argument that they're making in order to achieve
`the '202 priority date.
`
`
`So when you look at the claimed invention of rituximab plus
`standard chemotherapy leading to a beneficial synergistic result and you see
`that rituximab plus chemotherapy was in the art, the fact that CVP was --
`standard chemotherapy was in the art, this is a textbook example of what
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`KSR describes as obvious. There was a known problem for which there was
`an obvious solution and that solution is encompassed by the claims.
`
`
`And I'll stop there and reserve the rest of my time.
`
`
`JUDGE FRANKLIN: Thank you.
`
`
`MR. BAUGHMAN: Your Honor, may we give you a hard
`copy of the slides?
`
`
`JUDGE FRANKLIN: Yes.
`
`
`MR. BAUGHMAN: Thank you.
`
`
`(Pause.)
`
`
`JUDGE FRANKLIN: When you're ready, you may begin.
`
`
`MR. BAUGHMAN: Thank you, Your Honor. May it please
`the Board. I'm Steve Baughman, along with my colleague Megan Raymond,
`we thank you for your time this afternoon on behalf of Biogen. We'll try to
`address as much as we can in our 45 minutes, but we need to rely on and
`stand by our arguments, evidence and objections that we've submitted along
`the way in this proceeding.
`
`
`After some brief introductory remarks, I plan to touch on the
`Board's proper construction in its institution of beneficial synergistic effect,
`then my colleague Ms. Raymond is going to address some issues relating to
`Petitioner's obviousness arguments, and in particular toxicity and efficacy.
`And I'll touch on some topics relating to priority and, as time permits, at a
`high level I'll address the IDEC 10-K, its originally pivotal role in this matter
`and the hole it has left behind, and certainly of course address any questions
`the Board may have about our papers.
`
`
`But before we dig in, there are three points I'd like to ask the
`Board to bear in mind in assessing the evidence and arguments in this trial,
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`and the first involves burden.
`
`
`If we turn to Petitioner's reply papers, 47 at page 3, page 3 of
`the reply, you'll see in the middle of the page the statement, "Patent Owner
`has failed to demonstrate unpredictability associated with combining
`rituximab and CVP." Respectfully, that turns this whole proceeding on its
`head and it embodies what Petitioner is trying to do here, and that is to shift
`the burden to the Patent Owner here; it's an invitation to error. And just as
`we pointed out in our Patent Owner response, it's also Petitioner's burden to
`show printed publications to satisfy a preponderance, page 18 of our Patent
`Owner response, and on page 57 that it's Petitioner's burden to persuade this
`Board that Biogen is not entitled to the benefit of its earlier filing date of
`August 11th, 1999.
`
`
`The second thing I'd ask the Board to bear in mind in terms of
`trying to meet the burdens in this case is that the reply needs to be ready
`with special care because there are a lot of new arguments, we've identified
`them for Your Honors in a separate paper, but there's no expert declaration
`in support of them. This reflects the general disappearance of Dr. Lossos
`from this proceeding. We've seen in the slides here lots of photos of Dr.
`McLaughlin, but you have to ask yourself what's happened to Dr. Lossos.
`Petitioner's entire obviousness argument for the Czuczman combination
`based on Dr. Lossos hinged on his opinions about the IDEC 10-K as the
`only bridge to Foon and Dana, and Petitioner's only argued reason to swap
`CVP for CHOP and the remarkably successful Czuczman combination was
`an assessment of both efficacy and toxicity argued by Dr. Lossos. Having
`admitted much of what Patent Owner is arguing during his deposition, Dr.
`Lossos has now disappeared and we see new attorney arguments and
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`documents, but no expert testimony to connect them to this case.
`
`
`And then finally the third high-level point we'd ask the Board to
`bear in mind is the Petitioner's assertions need to be read with caution,
`frankly with a skeptical eye, especially a reply without any expert support.
`There is repeated mischaracterization of evidence and arguments, including
`in particular Dr. McLaughlin's testimony. We'll try to call out as much of
`that as we can in our time today, but we'd urge Your Honors to read a little
`before and a little after what you're seeing in citations from the Petitioner.
`
`
`As an example, if we could pull up the reply paper 47 at page 7.
`At the top of the page here we have the statement from Petitioner, "Dr.
`McLaughlin testified that a person of skill the art would have found the
`Board's construction too stringent." Well, Dr. McLaughlin said no such
`thing.
`First, Dr. McLaughlin didn't testify about the proper
`
`
`construction about that official synergistic effect in this matter, he didn't
`analyze that, didn't undertake that, and the testimony that Petitioner is
`pointing to has to do with Demidem's characterization and use of the word
`synergistic. And as Dr. McLaughlin testified, that was somewhat sloppy, it
`was loose, unfortunate, ill-advised, and when other people adopted it, it was
`similarly not following the Board's stringent, correct definition of what the
`patent requires.
`
`
`If you look at their slide 23, for example, you heard about this,
`Dr. McLaughlin testifying about how Demidem used synergy, he talks about
`it being unfortunate and loosely used, not matching the Board's definition
`that was correctly stated.
`
`
`So far from saying that he was criticizing the Board's
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`Case IPR2017-01095
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`construction as too stringent or that a person of skill would, as it says on
`page 7 of their reply, he's talking about the use of synergistic in Demidem.
`
`
`Now, turning to the definition of beneficial synergistic effect
`more generally, I think I'm hearing -- if we turn to their slide -- excuse me --
`pardon me one second -- if we turn to our slide 7, we'll come back to their
`slide, I think we're hearing more words added to their original definition of
`just an improvement in clinical outcome, we're hearing about potentiation
`and so forth. Respectfully, I don't see that in their papers. It is what they
`drew out of Dr. McLaughlin talking about Demidem, but not anybody
`talking about what's in the patent itself, including Dr. Lossos.
`
`
`Now, if we take a look at our slide 8, as Your Honors correctly
`found before at institution, the specification itse
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