`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________
`
`MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED,
`Petitioner
`
`v.
`
`BIOVIE, INC.,
`Patent Owner.
`
`__________
`
`Case IPR2018-00974
`Patent 9,655,945 B2
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`
`
`
`
`__________
`
`Record of Oral Hearing
`Held: August 12, 2019
`__________
`
`
`Before MICHELLE N. ANKENBRAND, Acting Vice Chief Administrative
`Patent Judge, ERICA A. FRANKLIN, and KRISTI L. R. SAWERT,
`Administrative Patent Judges.
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`
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`Case IPR2018-00974
`Patent 9,655,945 B2
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`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`JAMES P. MURPHY, ESQ.
`KEVIN J. DAVIS, ESQ.
`of: POLSINELLI
`1000 Louisiana Street, Suite 6400,
`Houston, Texas 77002
`(713) 374-1631 (Murphy)
`(713) 374-1613 (Davis)
`jpmurphy@polsinelli.com
`kdavis@polsinelli.com
`
`
`
`ON BEHALF OF THE PATENT OWNER:
`
`
`NICOLE E. GRIMM, ESQ.
`PATRICK G. GATTARI, ESQ.
`McDonnell Boehnen Hulbert & Berghoff LLP
`300 South Wacker Drive
`Chicago, Illinois 60606
`(312) 913-3366 (Grimm)
`(312) 913-2375 (Gattari)
`grimm@mbhb.com
`gattari@mbhb.com
`
`
`
`
`The above-entitled matter came on for hearing on Monday, August
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`12, 2019, commencing at 1:00 p.m. at the U.S. Patent and Trademark Office,
`600 Dulany Street, Alexandria, Virginia.
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`P-R-O-C-E-E-D-I-N-G-S
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`1:03 p.m.
`JUDGE SAWERT: Good afternoon, everyone. We have our final
`hearing in IPR2018-00974 between Petitioner Mallinckrodt Pharmaceuticals
`Ireland Limited and Patent Owner BioVie, Inc.
`I'm Judge Sawert. I'm joined today by Acting Vice-Chief Judge
`Ankenbrand and by Judge Franklin who is attending remotely.
`So let's start with introductions. We will start with Petitioner.
`Counsel, will you please introduce yourselves and let us know who will be
`presenting today.
`MR. MURPHY: Good morning, Your Honor. James Murphy on
`behalf of Petitioner. And with me today is Kevin Davis, both of Polsinelli
`Law Firm and also with us is Kenneth Goetz, the representative of Petitioner
`and I'll be presenting the argument today.
`JUDGE SAWERT: Okay. Thank you. Welcome. And for Patent
`Owner?
`MS. GRIMM: Your Honor, I'm Nicole Grimm of McDonnell
`Boehnen Hulbert & Berghoff.
`JUDGE SAWERT: Sorry about that. Continue. I can hear. Thank
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`you.
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`MS. GRIMM: With me today is Patrick Gattari also of McDonnell
`Boehnen Hulbert & Berghoff, and we're here on behalf of Patent Owner
`BioVie, Inc. And also with us is Dr. Penelope Markham. She is the Chief
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`Case IPR2018-00974
`Patent 9,655,945 B2
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`Scientific Officer of BioVie, Inc. and also one of the inventors on the patent
`involved in this proceeding.
`JUDGE SAWERT: Okay. Thank you. Welcome, everyone. I know
`there was some questions about the procedure for today's hearing, so I'll take
`a moment to clarify.
`Each side will have 60 minutes to present arguments. Petitioner
`bears the ultimate burden of proof that the claims at issue in this review are
`unpatentable.
`Petitioner, you will go first to present your case with regard to claims
`and grounds on which trial was instituted and you may also address Patent
`Owner's motion to amend in the first instance.
`Petitioner, you may reserve no more than half of your time for
`rebuttal.
`Patent Owner will then respond to Petitioner's argument. Patent
`Owner may also address its motion to amend and may reserve time for
`surrebuttal.
`Petitioner, you may then use any of your remaining time for reply
`regarding the challenged claims and opposition to Patent Owner's motion to
`amend.
`And finally, to the extent that Patent Owner reserves time, Patent
`Owner may respond to any of Petitioner's arguments made during
`Petitioner's reply.
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`A couple of housekeeping items. Please remember that when you are
`going through your presentation, please state the number of the slide that
`you are on. This will make it much easier when we go back and read the
`transcript.
`And also please remember that you are not allowed to interrupt the
`other party. Please save any objections you have for your own argument
`time or before we adjourn.
`Do you have any questions, Petitioner?
`MR. MURPHY: No, Your Honor.
`JUDGE SAWERT: Thank you. And Patent Owner?
`MS. GRIMM: No, Your Honor.
`JUDGE SAWERT: Okay. Thank you. So with that, we are ready to
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`begin.
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`Petitioner, how much time do you wish to reserve?
`MR. MURPHY: Reserve 20 minutes for rebuttal.
`JUDGE SAWERT: So I will set your time for 40 minutes. And you
`may begin when you're ready.
`MR. MURPHY: Good morning, Your Honors. So today we want to
`talk to you about the petition, but we don't want to spend any time on the
`issues that aren't disputed so we will be relying principally on our briefs for
`those issues. But we want to focus on the disputed issues here with you
`today.
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`If we turn to Slide 2, Petitioner's demonstratives, briefly these are the
`topics we want to discuss and I don't know if we're going to get through all
`of them. We'll see. It depends on the questions. But quickly, I just want to
`highlight the key points of the '945 patent that we think are relevant to the
`disputed issues and then address the prior art rejections, primarily the
`Fimiani rejections which cover all the claims, and lastly, get to the motion to
`amend issues which are primarily 112 related.
`So with that, let's continue on and we're going to start with the '945
`patent. If we go to Slide 4, we have on here two excerpts from the '945
`patent to show you what was known in the art at the time this patent was
`filed. Now terlipressin was known. The inventors here didn't discover
`terlipressin. They weren't the first user of terlipressin. It had been previously
`used to treat hepatorenal syndrome which we refer to as HRS in this
`proceeding, as well as other conditions including esophageal bleeding.
`On top of those conditions, the inventor of the '945 patent also
`acknowledge that investigational studies have been done to show that IV
`injections of terlipressin may resolve refractory ascites. So there's also
`acknowledgment that they were not the first to come up with the idea that
`terlipressin would be used to treat ascites.
`Now if we go to the next slide, Slide 5, it was also known at the time
`of the invention that continuous infusion of terlipressin had been used to
`improve the treatment for conditions such as HRS and particularly the
`continuous infusion achieved similar efficacy but improved the safety of
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`Case IPR2018-00974
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`those treatments. And the one thing that the '945 patent inventors state
`wasn't in the prior art was a study actually showing a continuous infusion
`had been used to treat ascites. That's really what this patent is about. It's not
`about discovering terlipressin use for ascites or even discovering what
`continuous infusion could do to treatments. It's just that there was no
`published study showing those two together. And that is textbook
`obviousness. We're taking a known treatment and known method to improve
`that treatment. And even if it wasn't expressly published anywhere, it would
`have been obvious to one of skill in the art to put those together, and that's
`what we're going to show with our prior art when we get to the arguments.
`Now just briefly go to the next slide, Slide 6. I just want to touch on
`this now and I'm going to come back to where it's relevant in the arguments.
`But example one, the '945 patent gives us two examples. And example one
`is completely prophetic. You can see from the very first sentence that the
`subjects are still to be confirmed. This is not a study that was actually done.
`This is just the inventors' expectations of what's going to occur when this
`study happens. And I'm not going to get into the details now. I'll come back
`to it where it becomes relevant.
`If we go to the next slide, Slide 7. This is the example two. And this
`is the only portion of the '945 specification that actually gives study data for
`the treatment of ascites. And again, this is mostly relevant to the 112 issues,
`and we'll see it does not support their claims and we'll address it there in
`more detail.
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`So with that, I'd like to move on to the prior art grounds here and the
`rejections that were raised in the petition. So the grounds we want to focus
`on first are the Fimiani in view of Robertson and Angeli. And this rejection
`would render obvious all of the issued claims as well as --
`JUDGE SAWERT: Counsel, I'm sorry. We need to pause the hearing
`because we've lost communication with Judge Franklin. I will stop your
`time.
`
`And I'm waiting to hear from our communications person when we
`receive an update. You may sit down and relax if you wish to.
`MR. MURPHY: How much time has elapsed so far, Your Honor?
`JUDGE SAWERT: We're at 35 minutes, 15 seconds -- 35 minutes
`have not elapsed.
`MR. MURPHY: So 35 minutes are left?
`JUDGE SAWERT: Yes. We can go off the record.
`(Whereupon, the above-entitled matter went off the record at 1:12
`p.m. and resumed at 1:15 p.m.)
`JUDGE SAWERT: Let's go back on the record. Sorry for the pause,
`Petitioner. As, I said, you have a little over 35 minutes remaining.
`MR. MURPHY: Thank you, Your Honor. And I believe we're on --
`let's go to Slide 9 of Petitioner's demonstrative. And here's we've got just a
`brief overview of the obviousness rejection and Fimiani discloses every
`limitation of these claims except for one which is the continuous infusion.
`Fimiani gives you the dosage, the duration, and the fact that terlipressin
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`treats ascites. But he administers this as a bolus dose instead of continuous
`infusion.
`So the obviousness argument here is that Robertson or Angeli teach
`continuous infusion by the number of benefits including improved safety,
`reduced cost, and it has at least the same efficacy as the bolus dose.
`If we go to the next slide, the institution decision, the Board
`understood this the same way. You're familiar with your decision. I don't
`need to go into it. This is just to highlight that the actual combination here is
`based on the modification of Fimiani from a bolus dose to continuous
`infusion. And that's going to come into play during Patent Owner's rebuttal
`arguments.
`Let's go to the next slide.
`JUDGE SAWERT: It sounds like to me you agree that Fimiani and
`Robertson or Angeli is your strongest ground. Are you dropping your
`obviousness over Robertson and obviousness over Angeli grounds?
`MR. MURPHY: No, we're not, Your Honor. We address those in the
`slide deck. We're addressing the Fimiani grounds first because they cover all
`the claims.
`JUDGE SAWERT: Okay.
`MR. MURPHY: So in that sense, they're the most important not to
`get all the claims, the other ones are just a subset of the claims.
`So looking at Slide 11, we have up there the -- a summary of the
`Patent Owner's response. And they raise four points in response to the
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`Fimiani grounds. First, they argue that Fimiani doesn't teach treating ascites
`with terlipressin, that there's no motivation to combine Fimiani with either
`Robertson or Angeli, no expectation of success, and lastly they have
`additional considerations.
`Now I want to go through each one of these for point by point. So on
`Slide 12, let's just start with what does Fimiani expressly state? So Fimiani
`did a study to evaluate whether terlipressin in addition to standard therapy,
`diuretics plus albumin, might improve the outcome in ascites.
`At the very outset, we know that Fimiani's goal here was to evaluate
`the addition to terlipressin to the treatment of albumin and diuretics.
`JUDGE ANKENBRAND: I have a question about the claims.
`MR. MURPHY: Yes, Your Honor.
`JUDGE ANKENBRAND: I think -- is it your position that Claim 1
`requires treating ascites, or do you have a different position?
`MR. MURPHY: We have a different position, Your Honor. I think
`that's the Patent Owner's position. And if we go to the next slide, Slide 13,
`I've got Claim 1 and we can take a look at it.
`So Claim 1 requires a patient diagnosed with ascites, but it never
`says that that patient is treated for the ascites. So you have a patient
`diagnosed with ascites, and you have to administer them terlipressin. Now
`the claim on its face never says treating for ascites. That should be the end of
`the claim construction analysis, but even if you go look at the specification,
`and you'll see this on the next slide, Slide 14 -- sorry, it's not Slide 14.
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`The specification, there's another part of the demonstrative as I get
`into it and you'll probably see it later, but the specification gives you a
`number of examples of treatments other than ascites. The specification talks
`about treating HRS in a patient diagnosed with ascites. It talks about treating
`hyponatremia in a patient diagnosed with ascites. Talks about treating
`hepatitis C in patients diagnosed with ascites. And so we have a number of
`examples in the specification of treatments that are not treating ascites, but
`they are treating patients that have been diagnosed with ascites.
`And
`so the specification cannot be used to limit these claims to the treatment of
`ascites, Your Honor.
`JUDGE SAWERT: Does your argument still apply if the claims are
`amended to treating ascites?
`MR. MURPHY: I think the amendment cures that problem, Your
`Honor. They amended the claim specifically treating ascites and on that
`point, you do have to treat the ascites, but there's still another issue involved
`of whether terlipressin alone has to treat it. We don't agree with that. I don't
`think even as amended the claim requires terlipressin alone to treat the
`ascites. It could be terlipressin combined with diuretics and albumin.
`JUDGE SAWERT: So of that combination, Fimiani and Robertson
`or Fimiani and Angeli, which reference teaches treating ascites?
`MR. MURPHY: Fimiani teaches treating ascites, Your Honor, very
`clearly. If we go back a slide, Slide 12, this is what we show in Fimiani. He
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`is unequivocal that the addition of terlipressin shows a synergistic effect
`when added to the diuretics and the albumin.
`JUDGE SAWERT: So is it fair to say that the dispute then becomes
`whether or not the claim requires terlipressin alone versus -- or if the claim
`may encompass terlipressin, diuretics, plus albumin?
`MR. MURPHY: I think that's one dispute that the Patent Owner
`raises. They make argument that the claims are limited to the terlipressin
`alone. I don't think the claims can properly be construed that way. I don't
`think there's anything in the unamended or the amended claims that would
`limit the claims to terlipressin alone, because they're written in comprising
`and a method comprising the administration of terlipressin.
`JUDGE ANKENBRAND: Doesn't Patent Owner also dispute that
`Fimiani actually teaches that terlipressin treats ascites? Don't they say
`something along the lines that it's prophetic or postulated that it will happen,
`and they point to some discussion in Fimiani that essentially says that?
`MR. MURPHY: So the postulated part of Fimiani, Your Honor, is
`not whether there's a synergistic effect. We point to this in our briefs. First, I
`would just like to just mention that argument actually isn't in their brief. It
`was from their expert's declaration and we have a footnote in our brief, we're
`responding to it. But the postulated part, and if we look at the Fimiani itself,
`which is Exhibit 1006.
`If you go to page 589 in the bottom break towards the last paragraph
`where it's got the conclusion that we have on the board, it's actually up on
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`the demonstrative, Your Honor, what I wanted to read to you so we can look
`at the demonstrative. So he says one could speculate that albumin might
`enhance the vasoconstrictive response to terlipressin, thus contributing to the
`counterbalance of negative effects. So what is being speculated here is
`not that the synergistic effect is there, but the mechanism that it works on.
`And so there's no dispute that the synergistic effect of terlipressin is an
`improvement in the treatment.
`JUDGE ANKENBRAND: It looks like though, I'm looking at one of
`Patent Owner's demonstratives and I think they're pointing to -- I can't tell,
`maybe it's page 593 of the exhibit or --
`MR. MURPHY: The point is at page 590, I think, Your Honor.
`JUDGE ANKENBRAND: 590, yes.
`MR. MURPHY: Which are the bullet points at the end which
`summarize the points that have been raised in the Fimiani paper. And there it
`says the synergistic effect of terlipressin for standard therapy patients, it's
`actually cited, have been postulated. And then it goes on to say albumin
`might enhance the vasoconstrictive response. So this is a summary of what
`we are looking at in the conclusion of Fimiani.
`JUDGE ANKENBRAND: Okay, but you're saying that the sentence,
`a synergistic effect of terlipressin versus standard therapy in cases that
`refractory ascites has been postulated, doesn't mean that it's only prophetic,
`but it means that it actually -- that's actually the effect that they saw?
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`MR. MURPHY: Yes, Your Honor. I think Fimiani is very clear on
`that on a number of points. In addition to this conclusion on page 589,
`Fimiani also states, our data clearly shows that the combined treatment with
`terlipressin plus diuretics and albumin might improve the outcome of
`refractory ascites in patients without HRS. And he's got statements like that
`throughout. He's clear that there is an improvement from terlipressin based
`on the synergistic effect. That is not postulated.
`We turn to Slide 14. I wanted to point out that I asked their expert
`during the deposition about that synergistic effect language in Fimiani, and
`their expert agreed that the language on its face would be understood that
`you have a greater effect with a combination of therapies than any single
`therapy. And then we also have the Hsu reference which evaluates the
`Fimiani reference. So here you see in Hsu they're talking about 2011
`multicenter study. That is Fimiani. You can see the cite there at 30 to back
`up Fimiani.
`And Hsu understood Fimiani's conclusion to be that a combination
`of terlipressin and albumin was better. So Fimiani is clear on it. The experts
`agree on it. There's other references that agree on it. There's no doubt that a
`conclusion of Fimiani paper was that terlipressin improves the outcome here.
`Now if we go to the next slide, Slide 15. Patent Owner's primary
`rebuttal to this is that Fimiani can't be believed. And they call Fimiani a
`paper made by a creative group of authors. What they're really just calling
`them are liars and that they shouldn't be trusted here. But I think it's
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`important to note that Fimiani is not a single individual. There are eight
`authors on the Fimiani paper, so to think that all these authors are incorrect
`were just coming up with made-up conclusions is somewhat absurd, and
`they have no evidence to back up that anyone doubted Fimiani's credibility
`here or any of the authors' credibility.
`JUDGE ANKENBRAND: Isn't it also helpful that at least the Hsu
`reference cites to Fimiani as a study that was done with terlipressin and
`doesn't question the veracity of the results?
`MR. MURPHY: Yes, Your Honor. We point to the Hsu reference a
`number of times. I think it's extremely helpful. The Hsu reference
`approvingly cites that Fimiani, along with many of the other studies that you
`see in the record and their analysis is the exact same as ours on what Fimiani
`is actually teaching and even give these references grades of evidence levels.
`Fimiani got a B out of an A, B, C. So the authors of the Hsu paper certainly
`didn't find any significant errors in the Fimiani paper.
`And just following up on this point on demonstrative 15 where
`Patent Owner is arguing that it's completely made up, the problem with this
`whole line of argument, really, Your Honors, is it's legally irrelevant. The
`methodology that Fimiani used, even if there were flaws, can't defeat the fact
`that Fimiani is teaching you terlipressin treats ascites, and terlipressin
`improves the treatment for ascites.
`And let's move on to the motivation arguments, Slide 18, please.
`And so the motivation here is very simple. We actually have the motivation
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`within the references themselves. They tell us the benefits of continuous
`infusion. You see it in Robertson and Angeli, continuous infusion has been
`shown to be safer, reduce costs, as well as having the same or even -- I think
`Angeli says better efficacy. So it's a very straight decision to go from bolus
`to continuous infusion in light of the teachings of these references.
`JUDGE SAWERT: Is there anything in the record about why
`Fimiani was using a bolus injection? Was it earlier in time, before the
`teachings of continuous injections or infusions?
`MR. MURPHY: No, Your Honor. There's nothing in the record that
`explains Fimiani's decision making.
`If we go to the next slide, Slide 19. Patent Owner's main rebuttal to
`the motivation is that terlipressin would essentially have been too dangerous
`to give to non-HRS ascites patients. The problem with this is that Fimiani
`himself is giving terlipressin to non-HRS patients. This isn't even part of the
`combination. We're not modifying Fimiani to give it to non-HRS patients.
`We're modifying Fimiani to go from bolus dose to continuous infusion,
`which everyone agrees would improve the safety profiles. So to the extent
`there are safety concerns, the proposed combination actually addresses those
`safety concerns.
`And as you can see in Fimiani, he had no significant events, which
`sort of underscores that you could administer terlipressin safely to non-HRS
`patients if you know what you're doing, which all these papers are written by
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`POSITAs who understand the risk. They understand what patient groups to
`exclude. And so you can mitigate the potential side effects of terlipressin.
`JUDGE SAWERT: In the literature that the Patent Owner cites to, is
`that literature post-dating or after Fimiani, or before Fimiani?
`MR. MURPHY: That literature is before Fimiani. It's from 2008.
`But if we go to the next slide, Slide 20, I've got a point on that paper. That
`paper was written by Kalambokis in 2008. And he had some hesitancy about
`administering terlipressin in non-HRS patients, but Kalambokis, 2010, two
`years later, he's overcome any of that hesitancy and is actually administering
`terlipressin to cirrhotic and ascites patients without HRS. So even the single
`paper that they have, the author there seems to have changed his mind on the
`dangers and the hesitancy involved.
`So we see in the demonstrative we got the Kalambokis 2010, and he
`administers terlipressin in patients with cirrhosis and ascites without
`hyponatremia or HRS. He's doing exactly what the Patent Owner says would
`never be done.
`JUDGE ANKENBRAND: And this is all before the critical date?
`MR. MURPHY: This is all before the critical date of the patent,
`Your Honor. We also have the Krag reference which is Exhibit 1010. And
`Krag also administered terlipressin in patients with cirrhosis and ascites
`without HRS. So again, we have another example of a paper doing exactly
`what the Patent Owner says would never be done.
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`Now I want to move to Slide 22, Your Honor. I think another
`important point on this issue of the safety is that in the '945 patent in the
`prophetic example that was never actually done, the inventors are able to
`claim that you could administer terlipressin safely to non-HRS and to
`ambulatory patients. Now the only way that they can actually say this is
`those ordinarily skilled in the art would have known this and we agree with
`that.
`
`And the Board can look at this admission in the specification as
`evidence of knowledge of one of skill in the art -- that you could administer
`terlipressin safely to non-HRS ascites patients.
`JUDGE ANKENBRAND: Is it necessarily true that the inventors
`were persons of ordinary skill in the art?
`MR. MURPHY: The inventors might be beyond the level of a person
`of ordinary skill in the art, Your Honor, but to make this statement, there's
`nothing in the '945 patent that is alleged to improve the safety of
`administering terlipressin. They acknowledge that for just using known
`techniques, the known -- the ambulatory pump to continuous infusion and
`that would be completely safe. So there's nothing that the inventors of the
`'945 patent added over the -- what's known in the art that would have
`improved the safety.
`Now if we go to Slide 24, Your Honors. I want to briefly touch upon
`the reasonable expectation of success argument that the Patent Owner raises.
`In reality, this is just a rehash of sort of the original argument. You can see
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`that they argue that Fimiani does not establish that terlipressin was the cause
`of the improvement in ascites, and under that assumption they argue there's
`no reasonable chance of success here. As we looked at, that's not the case.
`Fimiani does teach treating ascites with terlipressin.
`And it's also important to note that the dosages in the prior arts are
`all overlapping. Fimiani is a range of 2 to 4 milligrams of terlipressin per
`day. Robertson is giving a dosage of 3 milligrams per day. So they're all
`consistent with each other in terms of dosage and durations as well. And one
`of skill in the art here would have no problem taking the bolus dose of
`Fimiani and administering that as a continuous dose instead.
`Let's look at Slide 28, Your Honors. So this is the Patent Owner's
`final point which they call additional considerations. I think what they mean
`here is secondary considerations. And they make a couple of arguments, but
`they have zero evidence to back up any of these arguments. So they just
`throw them out there without sort of the evidence to support them.
`The first one that they allege is the shortcomings of the existing
`pharmaceutical drugs with long-felt and unmet needs. But the reality is
`there's a lot of pharmaceutical drugs out there for the treatment of ascites,
`and we see this in the Hsu paper. She gives an entire list of these drugs. And
`so she notes that the main cause of ascites formation, one being salt
`retention, and she gives a list of drugs to treat that cause. And the list
`includes terlipressin in there along with a number of other drugs, albumin,
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`satavaptan. And so there is certainly no lack of pharmaceutical options here,
`and indeed terlipressin was also known as an option.
`Patent Owner also argues failure by skilled artisans who attempted to
`achieve the claimed invention. There's absolutely no evidence that anyone
`tried to achieve the invention and failed. We see in Fimiani they succeeded
`in treating ascites.
`And lastly, the Patent Owner throws out this confirmed trial, and
`even they acknowledge that this evidence post-dates the invention. They
`haven't explained the relevance of evidence after the time of invention to the
`issues here, or what the subjective intent of that trial would have on the
`issues here. So none of these additional considerations play in at all to the
`obviousness analysis, Your Honors.
`If there's no further questions on the Fimiani grounds, I'll briefly hit
`upon the other grounds.
`The first is Robertson anticipation. If we go to Slide 30, the only
`issue here is one of claim construction. If the Board agrees that the claim is
`not limited to treating of the patient for ascites, Patent Owner doesn't dispute
`that Robertson would anticipate these claims.
`And we sort of talked about this earlier on why the '945 patent
`shouldn't be limited that way. If we go to the next slide, Slide 31. This was
`the slide I was looking for. Sort of highlights the portions of the '945
`specification, where you can see specification talks about treating renal
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`function in an ascites patients, correcting hyponatremia in an ascites
`patients. So this is exactly what the claim says.
`JUDGE SAWERT: What about --
`MR. MURPHY: Sorry, Your Honor, go ahead.
`JUDGE SAWERT: Sorry, what about the proposed amended claims?
`If we agree to -- that the claims can be amended to specifically treating
`ascites, does Robertson go away as an anticipation ground?
`MR. MURPHY: It does, Your Honor. We don't allege Robertson
`anticipation for the substitute claims. We do allege Robertson obviousness,
`which we'll get to in a minute.
`JUDGE SAWERT: Likewise, if we -- let's say we decided to change
`our claim construction upon consideration of the entire record, and found
`that the claim was limited to treating ascites. Does your Robertson
`anticipation grounds go away then?
`MR. MURPHY: I believe it would. I mean my only hesitation is
`depending on what the claim construction is, but yes. If the claim is limited
`to treating patients for the ascites, Robertson does not disclose that.
`JUDGE SAWERT: Okay.
`MR. MURPHY: If we go to the next slide, Slide 32, there's even
`more evidence of why the claim should not be construed that way. The
`issued claim. One of the claims they submitted was the original application.
`Claim 9 actually claims the treatment for the renal function of an ascites
`patient rather than the treatment of the ascites itself. So very clearly, they
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`had claims directed to some of these other embodiments that they disclose in
`their specification. And even their expert acknowledged that the treatment of
`these other conditions, such as the treatment of hyponatremia is not the
`treatment of ascites.
`Now I want to move to Robertson obviousness grounds. If we go to
`Slide 34, our basis for the obviousness in Robertson is based on what one of
`ordinary in the art would understand is going on in Robertson, and what
`effect that would have on a patient with ascites. So Dr. Gow, part of his
`testimony was that the improved renal function in Robertson would be
`expected to result in improved removal of excess salt and fluid out of the
`body.
`
`JUDGE ANKENBRAND: Is this in your initial expert report?
`MR. MURPHY: This is. This is in Dr. Gow's initial report and also
`referred to in our petition, Your Honor.
`JUDGE ANKENBRAND: Where in the petition? Because it struck
`me as I was looking at these next coup
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