Trials@uspto.gov
`571-272-7822
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` Paper 77
`Entered: June 22, 2022
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`LIQUIDIA TECHNOLOGIES, INC.,
`Petitioner,
`
`v.
`
`UNITED THERAPEUTICS CORPORATION,
`Patent Owner.
`____________
`
`IPR2021-00406
`Patent 10,716,793 B2
`____________
`
`Record of Oral Hearing
`Held: May 13, 2022
`____________
`
`Before ERICA A. FRANKLIN, CHRISTOPHER M. KAISER, and
`DAVID COTTA, Administrative Patent Judges.
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`571-272-7822
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` Paper 77
`Entered: June 22, 2022
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`LIQUIDIA TECHNOLOGIES, INC.,
`Petitioner,
`
`v.
`
`UNITED THERAPEUTICS CORPORATION,
`Patent Owner.
`____________
`
`IPR2021-00406
`Patent 10,716,793 B2
`____________
`
`Record of Oral Hearing
`Held: May 13, 2022
`____________
`
`Before ERICA A. FRANKLIN, CHRISTOPHER M. KAISER, and
`DAVID COTTA, Administrative Patent Judges.
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`IPR2021-00406
`Patent 10,716,793 B2
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`APPEARANCES
`
`ON BEHALF OF THE PETITIONER:
`
`
`SANYA SUKDUANG, ESQ.
`IVOR R. ELRIFI, ESQ.
`ERIK B. MILCH, ESQ.
`DEEPA KANNAPPAN, ESQ.
`COOLEY LLP
`1299 Pennsylvania Avenue, NW
`Suite 700
`Washington, D.C. 20004
`(202) 842-7800
`
`
`ON BEHALF OF THE PATENT OWNER:
`
`
`DOUGLAS H. CARSTEN, ESQ.
`McDERMOTT WILL & EMERY
`18565 Jamboree Road
`Suite 250
`Irvine, California 92612
`(949) 851-0633
` - and -
`STEPHEN B. MAEBIUS, ESQ.
`MICHAEL R. HOUSTON, ESQ.
`FOLEY & LARDNER LLP
`11988 El Camino Real
`Suite 400
`San Diego, California 92130
`(858) 847-6700
`
`
`
`The above-entitled matter came on for hearing on May 13, 2022,
`commencing at 1:00 p.m. EST, by video/by telephone.
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`IPR2021-00406
`Patent 10,716,793 B2
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` PROCEEDINGS
` JUDGE KAISER: All right. Good afternoon. Thank
`you to everyone for being here.
` This is a hearing in IPR2021-00406, captioned
`Liquidia Technologies Incorporated v. United Therapeutics
`Corporation.
` I am Judge Kaiser, and the other members of the
`Panel are Judges Franklin and Cotta.
` Before we get started, I'd like to do a rollcall
`of anyone else who's here. Let's start with anyone
`representing Petitioner.
` MR. SUKDUANG: Good afternoon, Your Honors.
`Sanya Sukduang. I will be arguing on behalf of
`Petitioner, Liquidia. On the Webex link with us is Erik
`Milch and Deepa Kannappan, and I believe lead counsel,
`Ivor Elrifi, is on the public line.
` JUDGE KAISER: Okay. Thank you.
` Anyone here on behalf of Patent Owner?
` MR. CARSTEN: Yes, Your Honor, good afternoon.
`This is Doug Carsten at McDermott Will & Emery. And along
`with me on the Webex link is Michael Houston of Foley &
`Lardner. Lead counsel is -- since he's not presenting, is
`participating via the public link, and that is Stephen
`Maebius.
` JUDGE KAISER: Okay. Thank you.
` All right. According to the order setting up
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`this hearing, each side will have a total of 60 minutes to
`present its arguments. We'll start with Petitioner's
`presentation, then continue with Patent Owner's response.
`And then, each party will have however much time it
`reserves for its rebuttal. Again, starting with
`Petitioner and concluding with Patent Owner
` Just a few last-minute reminders. First, I
`believe neither party has let us know that they plan to
`discuss any confidential information today. There is, as
`you've both indicated, a public access feed for this
`hearing. And other than the counsel that you both
`mentioned, I haven't been told that anyone is listening to
`the hearing via that feed, but please keep in mind before
`you discuss anything nonpublic that this hearing isn't
`closed.
` The Panel has access to the demonstrative
`exhibits that each side filed, as well as the entire
`record in the proceeding. So please free to direct us to
`any portion of the record if you think it's helpful. If
`you're going to do so, please give us an exhibit number or
`a paper number, as well as page, column, or line numbers
`that's appropriate.
` For demonstrative exhibits, please state which
`slide you're discussing, because it helps us make a clear
`record which is useful for our deliberations and
`decision-making.
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` Finally, we're all appearing remotely by video
`which presents different challenges than being in the same
`room together. And although some amount of talking over
`one another is probably inevitable, it will make the
`reporter's job much easier and help us make a clearer
`record if we all do whatever we can to minimize that as
`much as possible.
` Also, when you're not speaking, please mute your
`microphone, and try to identify yourself when you begin
`speaking in case the reporter has trouble seeing who's
`talking.
` So with those admonitions, we're nearly ready to
`begin, but before we get to the hearing itself, we have a
`preliminary matter to address. So Patent Owner emailed
`the Board on Wednesday night, and Petitioner responded
`yesterday, regarding authorization to file as supplemental
`information several filings from the parallel
`District Court proceeding relating to the parties'
`arguments on the asserted obviousness of Claims 4, 6 and 7
`of the challenged patent. We don't intend to count any
`time that we spend discussing this issue against either
`party's 60-minute time limit, but we also don't intend to
`get bogged down discussing what's really a pretty minor
`piece of why we're here today.
` So with that in mind, I'll ask each party,
`starting with Patent Owner, to explain very briefly your
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`IPR2021-00406
`Patent 10,716,793 B2
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`position on the case. And I guess, Mr. Carsten, I'll give
`you a -- a question to get you started on your
`presentation, which is it sounds from your email as though
`the information you want to present is in response to
`something that appears on Petitioner's demonstrative Ex.
`12. And I -- you know, I would remind you that as we're
`all aware, demonstrative exhibits aren't evidence, and so
`while there are lots of ways to go wrong in putting
`together a demonstrative exhibit, I'm not sure that I've
`ever seen a case where substantive evidence was necessary
`to respond to something that appeared on a demonstrative.
`So I wonder if you might address at least that issue of,
`well, why -- that is why the evidence you'd like to submit
`is necessary to respond to what's on that slide, and why
`in particular it's necessary in light of the substantial
`amount of evidence that already exists in the case.
` MR. CARSTEN: Thank you, Judge Kaiser.
` This is Doug Carsten on behalf of Patent Owner,
`United Therapeutics.
` I recognize that there already is voluminous
`materials that have been submitted, and we're in receipt
`of your email yesterday.
` The reason that I think it's important to
`identify slide 12 is that Liquidia, Petitioner here,
`indicated that there is no dispute pertaining to certain
`dependent claims, 4, 6 and 7. And in fact, that is very
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`much in dispute. It was disputed in the Patent Owner
`Response, and in the reply, they added no further
`evidence. All they said was, We said enough, and the fact
`that there are contrary positions in District Court is of
`no moment. Essentially. I'm paraphrasing very much, but
`it wasn't a large response.
` As you all know, we had the trial back in March.
`And just last Wednesday, so nine days ago, there was a
`filing made of the post-trial briefing pertaining from
`Liquidia's part to the invalidity. In that invalidity
`filing, they, for the first time, took a position that
`solutions and powder formulations are completely
`different. And they went on to say that, A person of
`skill in the art would understand that development of a
`treprostinil solution does not inform the development of a
`treprostinil powder formulation.
` Those are new arguments which have been
`essentially doubling down on the what we see as the lack
`of evidence that was -- that was provided with respect to
`why a person of skill in the art would understand that
`there'd be a reasonable expectation to success with
`respect to Claims 4, 6 and 7.
` We received that nine days ago. We received
`their slides seeing this on Monday afternoon. And then,
`on Tuesday morning -- I'm sorry, on Monday afternoon. On
`Wednesday morning, we reached out to them. We tried to do
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`this as timely as -- as timely as we could. And with
`respect to in the email, the interest of justice, you
`know, Your Honor, I think it's within the interest of
`justice for us to be able to point out we're for the very
`first time, not a witness, this is Liquidia themselves,
`actually taking a position pertaining to reasonable
`expectation of success in the context of enablement. That
`is absolutely contradictory to the cursory evidence that
`they presented in their -- in their opening petition and
`never added to. And so we believe that it is one document
`that we're seeking to add, and in fact, we could excerpt
`that document if that makes the Panel's job easier.
`Obviously, we want to make sure that you have as much
`completeness as you need. But it's not a very lengthy
`document, it's less than 40 pages, I believe. And I think
`the pages that we're looking at total out to be roughly 15
`pages or so, if we were to do some kind of cropping for --
`for the Panel's submission.
` But I think that it is important that you see
`that Liquidia has been talking out of both sides of its
`mouth. We have identified some record of evidence, but
`this is not cumulative, because for the very first time,
`they really do double down and say that everything to do
`with solutions, which is the sum total of what they rely
`upon for their obviousness position, don't inform dry
`powders whatsoever. And that's the gravamen of 4, 6, and
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`IPR2021-00406
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`7, which in our Patent Owner response, we pointed out the
`lack of evidence.
` JUDGE KAISER: Okay. I will be the first to
`admit that the Board's juris prudence on the issue of
`whether parties can take contrary positions in multiple
`parallel related proceedings is not a model of clarity.
`But I guess I wonder whether it's more important that
`Petitioner is taking, let's call them for the sake of
`argument, at least contrary positions here, and in the
`District Court proceeding, or whether it's more important
`that there is some evidence of a, you know, failure of
`enablement or a lack of reasonable expectation to success,
`or however you want to term Dr. Gonda's District Court
`testimony that seems to perhaps contradict what he says
`here.
` In light of the fact that that testimony is
`already in the record, along with your argument stemming
`from it, is what Petitioner argues in the District Court
`of all that importance to our decision-making here?
` MR. CARSTEN: I -- with respect, Your Honor, I do
`believe it is. You're proper to raise -- there are two
`issues here. One is the talking out of both sides of the
`mouth issue. The second has to do with specific
`positions, and what we see as admissions by Liquidia, the
`very party here, about the ability of a person of skill in
`the art to adapt information pertaining to solutions over
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`to dry powders. And that's front and center for these
`dependent Claims 4, 6 and 7, which are very much in
`dispute. So we're not talking necessarily about what Dr.
`Gonda said. In fact, we didn't even move after the
`trial -- the trial happened back in March -- we didn't
`move after the trial to admit Dr. Gonda's trial testimony.
`That is what it is. I think that may be cumulative.
`What's not cumulative here is the fact that Liquidia, the
`very party at issue, has now taken this position in a
`stronger way than ever. And I think that is an admission
`and -- and gets into that second bucket that Your Honor
`identified in terms of its pertinence to the Panel's
`decision-making.
` JUDGE KAISER: Okay. All right. Thank you very
`much.
` Petitioner, I will turn to you, and let me also
`give you a question to start with, which is assuming we
`find that Patent Owner hasn't shown enough -- well, let me
`-- let me narrow the issue here for a second.
` So the issue that we're discussing really is
`whether we should have a, you know, a motion and a
`response to that motion and perhaps a reply, and on
`Petitioner's side, I guess perhaps also a motion and a
`response to a motion and a reply, as opposed to whether
`those motions themselves have enough merit to grant. And
`so let me -- with that background, let me ask Petitioner,
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`you've suggested that you'd like to submit some -- some
`papers as well. I think perhaps just as things that
`respond to what Patent Owner is looking to submit, and you
`know, perhaps just for completeness, and you know, that's
`understandable, I think. If we weren't to admit the
`evidence that Patent Owner seeks to submit at this point,
`would you want to submit that information?
` MR. SUKDUANG: Sure, so I'll address that
`question first.
` If -- if you were not to admit Patent Owner's
`request, then we would similarly withdraw our request,
`because it does address directly the issue Mr. Carsten has
`raised. And Mr. Carsten actually highlighted the problem
`with the argument. He said, expressly, that with respect
`to enablement, there is a reasonable expectation of
`success. That is, of course, wrong. Enablement is
`whether there is undue experimentation. Obviousness is
`reasonable expectation of success.
` So what we're dealing with here in the District
`Court is an argument based on what does the '793 Patent
`teach for a person of ordinary skill in the art. And that
`is enablement with respect to undue experimentation.
` The question before the Panel, before the Board,
`is obviousness. What does the prior art teach to a person
`of ordinary skill in the art. Those two inquiries are
`vastly different. And in fact, there is no dispute, as
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`Mr. Carsten says with respect to the dependent claims.
`Mr. Carsten says, incorrectly, that our argument with
`respect to dependent claims rest solely -- and that was
`his word -- solely on solutions. That is entirely
`incorrect. When you look at our petition, the '212 Patent
`expressly, expressly teaches dry powder formulations from
`treprostinil, dry powders and inhalers, and also the
`different nebulizers in the dependent claims, as well as
`the size of the particle. That was not, as doc -- as Mr.
`Carsten said, disputed in their response. It was not
`disputed in their preliminary response. Dr. Waxman and
`Dr. McConville do not have testimony responding to that.
` So with respect to the issue of dispute -- and
`we'll cover this in the primary argument, but with respect
`to the issue of dispute, this is -- this is a new argument
`backfilling by Petitioner, because when you look at the
`prior art, the '212, ,it expressly teaches that.
` With respect to the issues of Mr. Gond -- Dr.
`Gonda in the District Court versus here, he was talking
`about whether based on the '793 Patent, whether there
`would be undue experimentation to make a powder
`formulation. Here, he's talking about with respect to
`obviousness what is literally disclosed by UTC's own
`patent, the '212 Patent. It's their own patent. They
`can't dispute that. Those are literal terms. And our
`argument here is obviousness, but those dependent claim
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`limitations are anticipated by the '212 Patent. Right?
`We can argue obviousness because all of those dependent
`claim -- excuse me, anticipation, because all of those
`dependent claims are from one, but those are literally
`disclosed. Mr. Carsten cannot dispute that. None of
`their experts can dispute that. 202847
` With respect to our evidence that we seek to
`admit, UTC's experts at the District Court, Dr. Clarke and
`Dr. Smith (phonetic), took the '793 Patent, and just
`discloses it with no dispute, the word, powder. That's
`all it has. A powder and a dry powder inhaler. And they
`said, “Looking at those two words alone, it would be easy
`within three weeks with the knowledge of person already
`skilled in the art to make a dry powder formulation.”
` Well, that evidence - if they want to bring in
`their evidence - that evidence supports the obviousness of
`the claims, because the '212 Patent has the same
`disclosure as '793. And if Dr. Clarke and Dr. Smithe says,
`“All I need to do is see the word, treprostinil powder, and
`that's enough to make a dry powder formulation”, then the
`'212 Patent and our arguments here support the obviousness
`of the dependent claims.
` So again , it's Dr. Clarke and Dr. Smithe
`testified on the issue of enablement. Patent Owner wants
`to submit Dr. -- our brief on the issue of enablement, and
`so if you permit that, then a complete record on the issue
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`of enablement, which is, of course, not before the Board,
`but if that's what Patent Owner wants, then, the Board
`should have the complete record with respect to the issue
`of enablement of the '793 Patent.
` JUDGE KAISER: Okay. Thank you.
` I think I will open the floor to the rest of the
`Panel here in case they have any questions to ask of
`either of you. But from my part, I think I've heard
`enough, and unless the rest of the Panel has questions,
`we'll take the issue of whether to allow some sort of
`briefing on a motion to submit supplemental information
`under advisement and will in due course let the parties
`know whether we've -- whether we'll authorize the motion
`or not.
` And I only take that course because I -- I'm just
`not prepared without some discussion with the Panel to
`make a decision on the fly here. In part because that's
`how the Board does things, and in part because I want to
`give it some thought. But -- but I don't think I have any
`questions for the parties, and it sounds like neither does
`the rest of the Panel.
` So thank you both for your argument on that. So
`now, having dealt with all of I believe -- I believe all
`of the under-cart fights, we'll move on to the main event.
` Petitioner, we'll start with you on the merits of
`your petition. You've got 60 minutes in total. How much
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`of that would you like to reserve for rebuttal?
` MR. SUKDUANG: Thank you, Your Honor. I'd like
`to reserve 25 minutes.
` JUDGE KAISER: Okay. So you have 35 minutes, and
`you can begin whenever you would like. And I'll let you
`know when you start to run into your rebuttal time.
` MR. SUKDUANG: Thank you, Your Honors. Sanya
`Sukduang on behalf of Petitioner, Liquidia Technologies.
` I know that you have the slides in front of you,
`so I will refer to slide numbers. And I'd like to start
`with slide 5. The grounds that we are going to present
`today are Grounds 1 and 2. Both of which cover all of the
`claims in the '793 Patent. Claim 1 and dependent Claims 2
`through 8. Ground 1 rests on the combination of the '212
`Patent, the Voswinckel JESC reference, and the Voswinckel
`JAHA. I'll be referring to those as JESC and JAHA for
`brevity.
` It's important to note that all three references
`are UTC references. They are representations that they've
`made, they've disclosed to the public all before the
`priority date of the '793 Patent.
` The '212 Patent discusses and claims treatment of
`pulmonary hypertension, the subject matter of Claim 1,
`with an inhaled treprostinil product, again, the subject
`of Claim 1, with inhalation devices. Both a nebulizer,
`dry powder inhalers, soft mist inhalers, all of which were
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`IPR2021-00406
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`the dependent claims.
` The '212 Patent further discloses explicitly at
`column 5 dry powdered formulations, dry powder
`formulations where the particle size is 5 microns or less.
`Again, covering the dependent claims. And those solutions
`used in the '212 Patent do not use metacresol, which is
`claim 8 of the '793 Patent.
` The '212 Patent, admittedly, does not disclose
`expressly the 15 to 90 to microgram dose or 1 to 3
`breaths, but that -- that's of no moment because the JESC
`and the JAHA references discloses those elements.
`Remember, this is a combination, and Petitioner -- excuse
`me, Patent Owner argues in their response these references
`individually. And you'll likely hear that from Mr.
`Carsten today discussing these things individually, not in
`combination.
` With respect to JESC, JESC is a study in humans
`that have pulmonary arterial hypertension, which is a form
`of pulmonary hypertension. They receive inhaled
`treprostinil, and they receive that inhaled treprostinil
`by a nebulizer solution. Again, Claim 1 and the dependent
`claims with respect to the devices.
` The concentrations range from 16 micrograms per
`mL all the way to 64 micrograms per mL. And they were
`given that over a six-minute period using a -- using a
`nebulizer. Based on persons of ordinary skill in the art
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`IPR2021-00406
`Patent 10,716,793 B2
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`experience, including Dr. Hill, and reinforced by Dr.
`Gonda, and further reinforced by Dr. Waxman in his
`deposition, all of them understand that at least 1 mL is
`delivered in a nebulizer. And when you look at that, you
`get concentration -- excuse me, doses of 16, 32, 48, and
`64 micrograms, all within the range of the claim.
` Now --
` JUDGE KAISER: Can we for --
` MR. SUKDUANG: Go ahead.
` JUDGE KAISER: I'm sorry, I want to interrupt you
`just for a second.
` Can we talk about -- and I'm sure you're going to
`get to this, and I don't want to rush you ahead out of
`order necessarily, but I think it is important to get to
`Patent Owner's argument on what “delivered dose” means, or
`you know, what it means. I take your point that if
`you've got a concentration of say 32 micrograms per
`milliliter, and you do something with a milliliter of
`that solution, then you're going to do that thing with 32
`micrograms of treprostinil. I guess the question is: ”Is
`the thing that you're doing with that 1 milliliter of
`solution the right thing for these claims?” And so the
`claims require something like a therapeutically effective
`dose, me going back and looking at the precise language of
`the claim, and it isn't necessarily absolutely clear to me
`why -- you know, whether that means what makes into the
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`IPR2021-00406
`Patent 10,716,793 B2
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`bloodstream, what makes it into the lungs, what makes it
`into the patient, what makes it out of the nebulizing
`device, what --
` MR. SUKDUANG: Sure.
` JUDGE KAISER: -- what fed into the nebulizing
`device to begin with. And the imminent -- there isn't a
`lot of argument on this, and no one has, I don't think,
`asked us to construe what therapeutically the effective
`dose or delivery or any similar term means, but it may be
`important to interpreting whether this argument is
`sufficient.
` MR. SUKDUANG: Yeah -- yes, Your Honor. And
`again, you've -- you've recognized no one asked
`construction of this. The -- the issue with
`therapeutically effective single event dose, and those
`contem -- those doses of 15 to 90, the experts agree it's
`what's delivered to the mouthpiece. The reason for
`that -- the reason for that is because there's no real
`good way to measure what is actually delivered into the
`lungs of -- of live patients with pulmonary hypertension.
`And when you look at the specification of the '793 Patent,
`which if you were to try to construe delivered, it is --
`it is absent, right. There is no information regarding
`what is actually deposited into the lungs, right. So
`there's nothing in the '793 Patent specification directed
`to that. There's no discussion with respect to delivered
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`IPR2021-00406
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`in the '793 Patent. All they say is that these particular
`doses were given, were inhaled, right. And that's
`understood to be what happens at the mouthpiece.
` Informative of this -- informative of this, and
`this is of record, it's another prostacyclin, admittedly
`not treprostinil, it's iloprost. And again, when you look
`at those labels, it's what's delivered, it's what goes to
`the mouthpiece, not what's deposited in the lungs. So
`when you look at JESC or you look at JAHA, and in -- in
`light of the claims, the issue is what is delivered to the
`mouthpiece, and does JESC and JAHA, particular JESC,
`deliver between 15 and 90 micrograms to the mouthpiece,
`because there is no evidence anywhere if the '793 Patent
`or otherwise what is actually deposited into the lungs.
` So our argument that we put in our petition with
`respect to how you look at this, how you look at this, is
`1 mL is delivered, right -- and we put that in our
`petition, 1 mL is delivered to the patient through the
`mouthpiece. When that 1 mL is delivered, when you look at
`the concentrations given, it's 16 to 64 micrograms per mL.
`And that is how we view, and I believe the experts view,
`because again, when you -- when you look at the '793, the
`inventors, and there's no evidence measuring what happens
`actually into the lung. Not even actually what's in the
`mouth, because you just can't do that appreciably.
` Does that answer your question, and can I move on
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`IPR2021-00406
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`or is there something else you'd like to ask?
` JUDGE KAISER: Yes, I think that answers what I
`asked. I guess -- so Patent Owner presents a lot of
`evidence about something that it refers to as efficiency,
`right, and so -- and that that make sense to me. You
`know, this is, to be fair, not -- not exactly my field.
`I'm a chemical engineer, right. So efficiencies make
`perfect sense to me, right. If there is some factor
`that's less than 1 by which you multiply something to get
`one half, it's in the real word. And I -- I -- can I can
`believe that there is some loss between when you fill up
`the nebulizer and when some end state occurs, right, that
`there is some amount of treprostinil that is present in
`the machine that doesn't do something. And I'm being
`intentionally vague there, again, because I'm trying to
`avoid answering my own question, which is you know, what
`happens to the stuff that doesn't make it into the lung,
`isn't deposited into the lung, or it doesn't make it into
`the bloodstream, or whatever it is that this drug is
`eventually going to do. Does it still reach the
`mouthpiece, in which case, it's enough to satisfy what
`you've just said, or does it go somewhere else; escape
`into the room or get deposited on the walls of the
`machine, or you know, some -- some other -- you know, some
`other thing and transport sort of a thing. And what's the
`evidence to support that, I guess?
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` MR. SUKDUANG: Sure. So the issue of efficacy --
`excuse me, not efficacy -- efficiency of the nebulizer.
`The nebulizers, the way nebulizers work, and there's no
`dispute here, you put a certain amount of solution into
`the reservoir of the nebulizer, and then, you inhale a
`certain amount. The efficiency that Patent Owner speaks
`of, and this is their -- if you look at their sur-reply,
`which is paper number 55, starting at pages 15 and 16, the
`efficiency is how much gets to the mouthpiece versus
`what's in the reservoir. Okay. When we talk about
`delivered, that's 1 mL. That accounts for that
`efficiency. And importantly, the JESC the JAHA
`references, and this is in the record, and I think I note
`it in slide -- slide 18, 19 and 20.
` The JESC and JAHA authors are from a group called
`“the Giessen group.” Those individuals are at the time the
`preeminent experts in the area of inhaled prostacyclins.
`They developed the very first inhaled prostacyclin,
`iloprost, became the product, Ventavis, and that was
`publicly available and on sale as of 2000 for well before
`the priority date.
` So when you look at the issue of efficacy --
`excuse me, efficiency of the nebulizer, you need to look
`at who the group was, you need look at do they know how to
`use a nebulizer properly to get the amount delivered,
`accounting for the efficiency of the nebulizer, and what
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`IPR2021-00406
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`would a POSITA understand reading this reference from this
`group as opposed to you or I who are biologists and
`chemists who might have never used a nebulizer before.
`Indeed, Dr. McConville testified, and this is his -- this
`is his deposition testimony. I believe it's Ex. 1109 at
`pages 31, 36 and 281. He testified he never developed a
`drug for pulmonary hypertension, never developed -- never
`saw a patient actually use a nebulizer. That's page 281.
`And never worked in a clinical study before on an inhaled
`product. But Dr. Gonda has, Dr. Hill has, and Dr. Waxman
`has. And with respect to the effi -- I keep saying
`efficacy. It's efficiency. With respect to the
`efficiency of these nebulizers, that is -- that is
`understood by a POSA and taken into account. JESC is also
`a dose ranging study. They're trying to figure out
`between 60 and 64, what would be an appropriate dose to
`move forward. Right. If the nebulizer was not efficient,
`then, what would be the point of the study? If 16, 32,
`48, and 64 micrograms were not delivered, then the study
`would be of -- of no value. So a person of ordinary skill
`in the art, looking at JESC, knowing about efficiency of
`nebulizers, would understand that that group knew exactly
`what they were doing, knew how to use these nebulizers.
` Now, going to specifics in terms of efficiency of
`nebulizers, again, I pointed to the Patent Owner's reply
`-- sur-reply, paper 55, pages 15 and 16, they acknowledged
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`IPR2021-00406
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`efficiencies in nebulizers. Page 16, they acknowledged
`nebulizers of 69, 52 and 60 percent efficiency.
` Another bullet point, Mr. -- Dr. McConville, the
`only ultrasonic nebulizer he disclosed and discussed in
`his expert or his declaration have an efficiency of 86
`percent. Right. Page 15, even if you look at it
`conservatively, even assuming that it's 50 percent
`efficient nebulizer, when you look at 16 to 64, you are
`still within the 15 to 90 to microgram range. Even if 1
`mL, even if you want to consider 1 mL, half of that, 64
`micrograms, concent
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