Trials@uspto.gov
`571-272-7822
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`Paper No. 76
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`NEURODERM LTD.
`Petitioner,
`v.
`ABBVIE INC.,
`Patent Owner.
`____________
`
`PGR2022-00040
`Patent 11,091,507 B2
`____________
`
`Record of Oral Hearing
`Held: August 29, 2023
`____________
`
`
`
`Before TINA E. HULSE, DEVON ZASTROW NEWMAN, and
`CYNTHIA M. HARDMAN, Administrative Patent Judges.
`
`
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`571-272-7822
`
`
`Paper No. 76
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`NEURODERM LTD.
`Petitioner,
`v.
`ABBVIE INC.,
`Patent Owner.
`____________
`
`PGR2022-00040
`Patent 11,091,507 B2
`____________
`
`Record of Oral Hearing
`Held: August 29, 2023
`____________
`
`
`
`Before TINA E. HULSE, DEVON ZASTROW NEWMAN, and
`CYNTHIA M. HARDMAN, Administrative Patent Judges.
`
`
`
`
`
`
`
`
`
`
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`PGR2022-00040
`Patent 11,091,507 B2
`
`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`W. CHAD SHEAR, ESQUIRE
`GEOFFREY D. BIEGLER, ESQUIRE
`Cooley LLP
`10265 Science Center Drive
`San Diego, California 92121-1117
`
`ON BEHALF OF PATENT OWNER:
`
`ANTHONY INSOGNA, ESQUIRE
`MATTHEW JOHNSON, ESQUIRE
`SARAH GEERS, ESQUIRE
`KUNYONG YANG, ESQUIRE
`LAURA KANOUSE, ESQUIRE
`Jones Day
`4655 Executive Drive
`San Diego, California 92121
`
`The above-entitled matter came on for hearing on Tuesday, August 29,
`2023, commencing at 1:00 p.m. EDT, by video.
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`PGR2022-00040
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`P R O C E E D I N G S
`- - - - -
`JUDGE HARDMAN: Counsel, this is Judge Hardman, and with me
`are Judges Hulse and Newman. I’m hearing a little feedback, so if you are
`not muted, would you kindly mute, hopefully that will address the feedback
`situation.
`This is the final oral hearing from the PGR2022-00040, NeuroDerm
`Ltd. versus AbbVie. This is a video hearing. We have a court reporter on
`the line, that is Mr. Becker. The Board will issue a transcript for this case
`which will be made part of the record in due course.
`Let’s start with appearances, starting with counsel for Petitioner. Who
`do we have on the line for Petitioner?
`MR. BIEGLER: Good morning, Your Honors, Jeff Biegler of Cooley
`for Petitioner. With me I have Chad Shear, lead counsel, Cooley, and also
`Mark Weinstein and Bonnie Fletcher Price, Cooley. I also have client
`representatives Teris Laumas (phonetic) from NeuroDerm and Nao Takada
`who represents Mitsubishi Tanabe, NeuroDerm’s parent Company.
`JUDGE HARDMAN: Thank you, Mr. Biegler. And will you be
`doing the presentation today?
`MR. BIEGLER: Correct, Your Honor.
`JUDGE HARDMAN: Thank you. Counsel for Patent Owner, would
`you please identify yourself and your team.
`MR. INSOGNA: Good afternoon, Your Honors, Anthony Insogna
`from Jones Day for AbbVie. And with me here in San Diego is Sara Geers
`and Laura Kanouse, both from Jones Day. And I believe our client
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`representatives are listening in but I’d like to announce them. We have
`Laura Johannes and Aamer Ahmed on the line from AbbVie.
`JUDGE HARDMAN: Thank you, sir. And Mr. Insogna, you’ll be
`doing the presentation today?
`MR. INSOGNA: Yes, I will, Your Honor, and I’m assuming you’re
`hearing me okay and the feedback is not from my line I hope?
`JUDGE HARDMAN: I can hear you fine and I’m not hearing any
`feedback, so whatever is causing it is abated.
`MR. INSOGNA: Okay. Right.
`JUDGE HARDMAN: Thank you.
`MR. INSOGNA: One small request, Your Honor, I guess I do have a
`lot of papers in front of me so if you hear papers shuffling and that’s
`disturbing the audio, please let me know and I’ll try to move the mic.
`JUDGE HARDMAN: Thank you. And that might be important for
`Mr. Becker too, so if that is interfering with your work, Mr. Becker, you can
`let us know.
`Okay. So for everybody on the line, if at any time you are having
`technical difficulties with the audio connection, please let us know or
`contact the team member that provided you the connection information so
`we can try to rectify that situation.
`We understand that Petitioner has a pending Motion to Strike, and
`Patent Owner has a pending Motion to Exclude. We do not expect to rule on
`those motions today. We will address them in our final written decision as
`necessary. And counsel is welcome but not required to argue those motions
`during your presentation today.
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`As set forth in our Court Order or Hearing Order, each side has 60
`minutes to present today. The panel will do our best to keep track of time
`but we also suggest that the parties do so also. Petitioner will present its
`arguments first and may reserve up to 20 minutes for rebuttal. Mr. Biegler,
`would you like to reserve any rebuttal time?
`MR. BIEGLER: I’d like to reserve 20 minutes if that’s okay, Your
`Honor.
`JUDGE HARDMAN: Yes. We will note that. Thank you. And, Mr.
`Insogna, you will be presenting second. You may also reserve time to have
`the last word. And would you like to reserve any time?
`MR. INSOGNA: Yes, I would, Your Honor. I would like to reserve
`10 minutes, please.
`JUDGE HARDMAN: Okay. And again, please mute your
`microphone when you’re not speaking. And please be mindful that there can
`be a lag in the audio video so pause before speaking to avoid us speaking
`over one another.
`As you know, the panel has access to the entire hearing record,
`including your demonstratives. When you’re referring to a paper or exhibit
`or demonstrative, please identify it for us by slide number, page number,
`paper number, what have you, so that we’re able to call up what you’re
`referring to on our end.
`All right. Our expectation is that, oh, and I’ll mention, if you wish to
`share your screen, you’re welcome to do that. Our expectation is that unless
`absolutely necessary, counsel for the opposing party will not interrupt the
`other side during their presentation. And with that we are ready to begin
`unless counsel has any questions.
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`MR. INSOGNA: When we’re not speaking, Your Honor, it’s Mr.
`Insogna.
`JUDGE HARDMAN: Yes.
`MR. INSOGNA: So we will mute when we’re not speaking. Do you
`also want us to shut our camera, or is there any guidance in that respect?
`JUDGE HARDMAN: I think leaving your camera on is fine unless
`we encounter some bandwidth issues, but it looks to be fine now. So leaving
`your camera on is fine.
`MR. BIEGLER: Okay. Thank you, Your Honor.
`JUDGE HARDMAN: Any other housekeeping before we begin?
`MR. BIEGLER: None here, Your Honor.
`JUDGE HARDMAN: Okay. All right, with that, Mr. Biegler, we’ll
`put 40 minutes on the clock, and you can begin when you are ready.
`MR. BIEGLER: Okay. And I am going to try to share my slides
`here. Hopefully you all can see that?
`JUDGE HARDMAN: Yes.
`MR. BIEGLER: Okay. Perfect. So these are our Petitioner’s
`demonstratives, Exhibit 1095, and I will do my best to remember to call the
`slide numbers as I go through.
`This case quite simply, Your Honors, is about AbbVie claiming
`something that it did not invent. And I’m going to start on Slide 4 where we
`see the proposed substitute claims. And what AbbVie seeks to claim is
`virtually all effective methods of continuous subcutaneous administration of
`formulations that include both levodopa and carbidopa. And it seeks to do
`that by defining the scope of the claim primarily by the results—through
`effective plasma levels.
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`The problem here, there’s a number of problems, but the main
`problem is that AbbVie’s application says nothing about such methods of
`using levodopa or carbidopa themselves. It doesn’t disclose them, and
`certainly does not enable them.
`And I’m going to jump to Slide 6. Before this proceeding, and before
`AbbVie tried to write claims to cover my client’s product, everyone agreed
`that subcutaneous treatment with levodopa and carbidopa themselves is
`difficult, if not impossible. Prior art publication said it, the inventor said it,
`and AbbVie’s own experts published it.
`And just for a little bit of background here, levodopa and carbidopa
`themselves have been FDA approved for almost half a century now, since
`the 1970s. And they’ve been given primarily in oral form. And it didn’t
`take long for scientists to figure out after they started treating with these
`drugs, that oral administration, while very effective initially, led to
`inconsistent plasma levels and that could drastically effect drugs’ efficacy
`with what I refer to as on and off periods when the drug would be working
`or not working, adding to the fluctuation of plasma levels.
`And so all the way back in 1984 we see here in Exhibit 1012 scientists
`recognized that a continuous subcutaneous method like that used for insulin,
`for example, would be desirable. The problem, as also reflected here, is that
`levodopa and carbidopa have very low solubility and have to be diluted with
`large volumes of fluid to make it feasible for subcutaneous administration.
`I turn to Slide 7. That belief held through the multiple decades that
`followed. Scientists believed that it would be difficult or perhaps
`impossible, to administrate levodopa and carbidopa themselves to get
`continuous subcutaneous infusion. We cited two papers from peer review
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`journals to that effect, Exhibits 1013 and 1014. And for instance at the top
`of Slide 7 here, Exhibit 14, that’s a paper that was published in 2007. It
`looked back on the studies that had been done with levodopa and carbidopa
`and concluded that the low aqueous solubility of levodopa made it
`impossible to consider subcutaneous administration since considerable
`volumes would have been required.
`And moving to Slide 5, AbbVie’s application repeatedly explains the
`exact same thing, that carbidopa and levodopa have inherently low aqueous
`solubility at physiologically acceptable PHs used for infusion. And it refers
`to that low solubility as a significant technical challenge to the development
`of approved pharmaceutical compositions and methods of treatment.
`And moving to Slide 12, even AbbVie’s expert, six years after the
`priority date, this is in 2020, but before getting involved in this proceeding,
`published a paper detailing what he called the major challenges in utilizing
`the subcutaneous route. The very first challenge he listed under the bullet, in
`the middle box, this is from Exhibit 1086, was the lack of solubility of
`levodopa in reference to the large infusion of fluid that would be required for
`levodopa.
`The final thing that he mentioned, the third bullet in that same box,
`was potential co-administration with carbidopa when, in his words, all of the
`above issues become relevant to both drugs.
`So the Board needs to decide if in the face of all of this skepticism and
`evidence that people thought this was impossible, if AbbVie’s application
`itself is enough to describe and enable the claims it seeks to essentially all
`effective formulations of carbidopa and levodopa themselves used
`subcutaneously. The clear-cut answer to that question is no.
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`And turning to Slide 8, AbbVie came up with a very specific solution
`to this problem, the use of a small number of phosphate prodrugs of each of
`levodopa and carbidopa. You can read the entire specification from start to
`finish. It makes clear that AbbVie’s invention here is these particular
`phosphate prodrugs and methods of administration using each one of them.
`And we’ve been through all of this in the briefing, so I won’t belabor
`it, but every relevant portion of the application focuses exclusively on these
`prodrugs. It’s in the abstract, it’s in the field of the invention, it’s in all the
`relevant parts of the detailed description. I didn’t have room to put the
`summary of the invention here, but that talks consistently about prodrugs.
`And all of the examples that either disclose steady-state plasma
`concentrations, or try to predict them, are all based on combinations of two
`prodrugs.
`And the patent also explains the reason why the inventor’s prodrugs
`work. It’s because they are much more soluble than levodopa and carbidopa
`themselves, inherent drugs. That allows for much more concentrated
`solutions of drugs at lower volumes.
`We see here, this is Figure 1 of the patent on Slide 9. And what this
`shows is that levodopa four prime monophosphate will end up in the
`phosphate prodrugs as the top triangle in the figure is on the order of 100
`times more soluble than levodopa itself. This was the inventor’s solution to
`the solubility challenges posed by carbidopa and levodopa.
`Turning to Slide 10, AbbVie’s inventors have said the exact same
`thing in their publications. This is one example of a publication authored by
`inventors Eric Voight and Phillip Kym, this is from 2021, it’s Exhibit 1052.
`They acknowledge the poor solubility of levodopa and carbidopa in the
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`resulting large dose volumes, and they said that their discovery to solve that
`problem, to come up with a better treatment is Foslevodopa/Foscarbidopa.
`That’s two prodrugs, one levodopa prodrug, one carbidopa prodrug. They
`make no mention, they never have in any publication, of having discovered a
`way to overcome the solubility issues with levodopa and carbidopa
`themselves.
`JUDGE HARDMAN: Counsel, it’s Judge Hardman. Let me stop you
`there. I think one of Patent Owner’s arguments is that the large volume is
`not a problem for subcutaneous administration because you can use multiple
`administration sites. What is Petitioner’s response to that argument?
`MR. BIEGLER: Petitioner’s response is that there is no real-world
`proof of that. The Patent Owner hasn’t pointed to one example in the real
`world, besides NeuroDerm where the formulation of levodopa and carbidopa
`was successfully administered to patients in large volumes. NeuroDerm’s
`solution works because it was able to significantly increase the concentration
`of those drugs, levodopa and carbidopa, and provide lower volumes of those.
`And so the prior art we cited, for instance Exhibit 1012 which we
`already looked at, back in the 80s they infused solutions of levodopa
`intravenously. And from that they concluded that the volumes would be
`much too large for subcutaneous administration. And they knew exactly
`what the volumes were. And that’s because if you administer intravenously,
`that’s sort of the most direct way to get drug into blood. If you want to do it
`subcutaneously you’re going to need at least that much volume if not more
`because there’s sort of additional barriers to get through that. So I think both
`the prior art shows that those volumes are not feasible and there’s not a
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`single real-world example of these, you know, supposed really large
`volumes being administered.
`And so that actually leads up to my next point, which is the only
`success with levodopa and carbidopa themselves is NeuroDerm.
`NeuroDerm itself, after years of effort, developed an aqueous solution of
`levodopa and carbidopa, has improved solubility, and it can achieve
`effective levodopa plasma levels via subcutaneous administration.
`NeuroDerm published several papers and posters on this before the
`priority date, the date of the Yacoby-Zeevi poster at issue here. And since
`then the therapy has moved to clinical trials. On the screen we see in
`Exhibit 1068, Phase 2, and ultimately in Phase 3 trials.
`So skipping to Slide 13, this is a mismatch between the specification
`of the claims and NeuroDerm’s own earlier work that proposed substitute
`claims were unpatentable for multiple reasons that we have explained in our
`briefing. I want to start with just a few points on written description, and
`then I’ll move to the other grounds.
`Moving to Slide 15, there is multiple reasons here why the application
`does not adequately describe both substitute claims. First, there are multiple
`claim limitations that just are not described at all, sort of a classic written
`description problem. And second, the application fails to describe the full
`scope of the claims under Ariad and its progeny.
`And moving ahead to Slide 16, I want to start with the missing
`limitations, and particularly the formulation limitations. So the claims
`require a formulation, one formulation, that includes five milligrams per
`milliliter of either levodopa, or oneof three claimed levodopa prodrugs, or a
`pharmaceutically acceptable salt of any of those. The same formulation has
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`to include carbidopa, or a pharmaceutically acceptable salt of carbidopa and
`the formulation has to include an aqueous carrier.
`And I think it’s notable that earlier patients in this family did not
`claim levodopa and carbidopa. There were three patents at issue prior to the
`507 patent’s family. Each is directed to the disclosed phosphate prodrugs.
`That’s Exhibits 1018 through 1020. It wasn’t until six years after the
`provisional filing that AbbVie first sought claims covering levodopa and
`carbidopa themselves. So as a result this is a classic written description
`case, by the old school written description case.
`Well the original purpose, one of the purposes of the requirement is to
`prevent an applicant from later asserting they invented something, for
`instance in a continuation, that they didn’t disclose in their original filing.
`And that’s why the law requires the inventor to recount their invention in
`enough detail so that we can later assess if they actually invented what they
`add to claims in a continuation. It's clear here that the invention that AbbVie
`is now claiming in a continuation years after its original filing is just not
`encompassed in its original disclosure.
`Moving to Slide 17, that’s apparent just by reading the patent. You
`can read it cover to cover, all 83 pages, 116 columns. You won’t find one
`sentence that says the invention includes formulations of levodopa,
`carbidopa. I think to be fair, the closest that the patent comes in the
`background of the invention section where it says that stable, more highly
`concentrated and/or far less viscous formulations comprising levodopa
`and/or carbidopa or prodrugs of them are desirable. That’s at Column 2, 40
`to 61.
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`After that, the patent never again, not once, mentions a formulation of
`levodopa and carbidopa together or suggests that formulations with either or
`part of the invention. Not once. Everything is about prodrugs.
`I think it’s fair to say that AbbVie’s primary support in the
`specification which it relied on is Example 16 and 18. Everyone agrees,
`AbbVie’s experts, example 16 and 19 disclose administration of carbidopa
`and levodopa separately, not together. It’s not formulated or tested,
`carbidopa that is, levodopa, or any of the recited prodrugs. Also in those
`examples the drugs are only used as controls to assess the inventor’s
`prodrugs. And we’re not saying that means the disclosure doesn’t count.
`But it does nothing to indicate to a person of skill that levodopa and
`carbidopa are actually part of the invention. And it’s telling that after
`Example 16 and 19, which Patent Owner says had this revelatory PK data,
`levodopa and carbidopa are never mentioned again.
`There is no discussion of administration of them, there’s no discussion
`of how revelatory this data is, there’s nothing. And in addition, these two
`examples give no information about the subcutaneous formulation of
`levodopa and carbidopa, we don’t know if there’s water, if there’s more than
`just water in there. And we have no idea what the concentration is or if it
`meets the 5 mg per mL requirement for levodopa.
`So in the context of the entire spec, which is all about prodrugs,
`there’s nothing in these examples to signal to a person of skill that
`levodopa/carbidopa themselves are actually part of the invention.
`Moving to Slide 20, I won’t belabor this, but each of the additional
`examples after 16 and 19 disclose administration of two prodrugs, one of
`levodopa and one of carbidopa. And that’s really it, there’s no other
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`disclosure in the specification that AbbVie points to. AbbVie argued in its
`Reply that a person of skill in the art would be able to “both mix and match
`to compounds.” I think I saw that in their demonstratives. We think that’s
`scientifically wrong, but perhaps more importantly, it's legally irrelevant. At
`best we would render these claims or these formulation elements, I guess,
`obvious, and the Fed. Circuit has made it clear that is not enough. We cited
`multiple cases where the Federal Circuit has held that disclosing individual
`elements is not sufficient to describe a combination of those elements.
`Flash-Control, Purdue Pharma, Novozymes, Lockwood, all stand for that
`proposition.
`And moving ahead to Slide 21, the rest of AbbVie’s evidence,
`everything received in their Reply, all of the, what we think is late expert
`evidence, and other exhibits, is all outside the specification, all of it. The
`Federal Circuit has been very clear, the focus of the written description
`requirement is an objective inquiry into the four corners of the specification.
`It is from the perspective of a person of ordinary skill in the art and prior art
`can be considered in some situations, but the law is very clear that it can’t
`be, the prior art can inform what is actually in the specification. You can’t
`teach limitations that aren’t in the specification. Lipocine says that,
`Lockwood says that too, it’s very clear.
`So moving on to the PK elements, the story is very similar. You can,
`I’m sorry, one more thing before I get to the PK elements. I want to just
`quickly mention the other support that AbbVie points to for the formulation
`elements, which is supposed off the shelf prior art formulations of these
`drugs. Again, you go through the patent, there is nothing that points to any
`prior art formulations for any off the shelf solutions.
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`And in fact, I’m going to just jump quickly to AbbVie’s
`demonstrative at Exhibit 2112, demonstratives 120. This has a blowout of
`Column 2 of the patent. And it actually says that if there is any reference to
`existing formulations, that they’re not sufficient. This column lays out the
`major challenges of solubility for levodopa and carbidopa, and then it says
`that stable, more highly concentrated and/or less viscous formulations
`comprising levodopa are desirable. What does that say? That’s saying that
`whatever came before this wasn’t good enough, we need something better.
`So the law is also clear, this is Boston Scientific, that a patentee can’t rely on
`information that is supposedly well known in the art when the four corners
`of the specification directly contradict that information. And that’s exactly
`the case here.
`So I’m going to jump to Slide 27 and address the PK elements briefly.
`As I started to say before, this is much the same story. Moving to Slide 28,
`you can go through the entire application, you’re not going to find a single
`sentence that says a formulation of levodopa or one of the three levodopa
`prodrugs with carbidopa and achieve the same plasma levels. It’s not there.
`We already discussed example 16 and 19, those disclose separate
`administration of levodopa and carbidopa, and in any event don’t have
`steady-state data. There’s no other example where levodopa and carbidopa
`are administered together.
`JUDGE HARDMAN: Counsel, this is Judge Hardman. What is your
`response that a working example is not required to satisfy written
`description?
`MR. BIEGLER: We agree. The law is clear, a working example is
`not required but it certainly is one thing you consider in the written
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`description analysis, the Boston Scientific case that says that the lack of a
`working example is definitely a relevant factor to consider. And coupled
`with the lack of any other disclosure in this application, I think it’s
`extremely relevant here.
`So what AbbVie points to with no example, is they try to say that a
`person of skill could read this and could do simulations to try to predict the
`steady-state L-dopa plasma levels or what’s been claimed but not disclosed.
`To be clear, there’s only one simulation in the application, and that’s
`example 24. And that’s for two prodrugs, the levodopa 4 prime
`monophosphate and carbidopa 4 prime monophosphate.
`You can look at the entire text in Example 24 and anywhere else in
`the patent, there is no suggestion to perform simulations or modeling on any
`other combination outcomes. The application just does not say it. So the
`modeling that Dr. Rosenbaum did, again we think it’s belated, is truly
`irrelevant. At very best the application, the PK modeling, would render the
`proposed claims obvious. That’s not enough. The application doesn’t even
`suggest doing what Dr. Rosenbaum did.
`And even if we consider Dr. Rosenbaum’s modeling, there’s a number
`of other problems. I’m not going to have time to go through them a lot
`today, we outlined them in our Sur-Reply. I think the biggest problem is
`that fundamentally none of it’s in the application. The equation that Dr.
`Rosenbaum uses is not in the application, the bioavailability that she uses in
`her calculations, that’s not in the application, she has to calculate it using
`formula that is again not in the application. The prodrug compound factor
`she uses, those aren’t in the application. She makes a number of
`assumptions that are not stated in the application.
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`And we didn’t have the opportunity to respond to her opinions with
`expert testimony, but had we been, we would have provided expert support
`showing a bunch of additional flaws with her modeling. But I think the
`main point is this modeling is not relevant, it’s not suggested, and it’s
`completely outside the specification, it’s just not sufficient from her
`description.
`JUDGE HARDMAN: Mr. Biegler, it’s Judge Hardman. Just a quick
`question on I guess it goes to your Motion to Strike and the idea that Dr.
`Rosenbaum and the other declarations are belated. What about the fact that
`there is the issue of Patent Owner having to carry the burden of new matter
`in a Motion to Amend, but on the flip side it does have the opportunity to
`respond with declarations to Petitioner’s unpatentability arguments, which
`here include written description, enablement, and printed publication
`challenges. Can we at least take into account the declarations on issues for
`which Petitioner bears the burden of proof that Patent Owner responds to?
`MR. BIEGLER: I think they’re all problematic because all of the
`arguments that they support were made in the Motion to Amend. But I do
`think the declarations that support written description are the most
`problematic because while Petitioner has the ultimate burden of persuasion
`in the non-written description of formidable claims, the Patent Owner does
`have to make a threshold showing of the description in its Motion to Amend.
`And to do that, if AbbVie thought that its support was based on a person of
`skill doing modeling and off the shelf of prior art formulations, it should
`have provided that support with the Motion to Amend to make that threshold
`showing.
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`Instead what it did was withheld its expert evidence, made kind of
`those arguments but didn’t support it at all. Those easily could have been
`provided with the Motion to Amend. And one thing that’s developed since
`we talked about the Motion to Strike several months ago, is we had the
`opportunity to take the Patent Owner’s experts’ depositions. One of them
`started working on their declaration over a year ago. So these things were in
`the works and AbbVie just decided not to submit them until required.
`So just moving on to the last written description problem, which is the
`scope issue. As the Board has recognized, sufficient written description of a
`genus requires (audio skip) to represent a number of species or structural
`features common to members and POSAs. In AbbVie’s Answer we have
`neither here, and I would suggest hasn’t made a meaningful effort to satisfy
`the standard.
`I’m going to go through this pretty quickly because I think we’ve
`covered it, but unpredictability is one thing that’s considered in this analysis.
`The patent itself says this is an unpredictable area and that it’s very
`challenging. Moving to Slide 41, our experts have explained why this area
`is so unpredictable and why it’s so difficult to develop formulations that can
`achieve what’s claimed here.
`And again, AbbVie’s own expert, before this proceeding started,
`published a paper in 2020 explaining the major problems and trying to
`utilize the subcutaneous route of levodopa and carbidopa. There’s really just
`no question that this area was highly unpredictable.
`Turning to Slide 43, these claims also have all the hallmarks of the
`types of claims that Federal Circuit has found problematic. First of all,
`they’re broad respect to their structural, if you will, limitations here, the
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`formulation. There’s no limits on the formulation besides the two active, if
`you will, drugs and the aqueous carrier pertaining to anything else. They
`also place no limit on the upper concentration of either drug. That’s really
`important because the patent itself tells you how challenging it is to
`solubilize these drugs, getting high concentrations, that was the whole
`problem. So these claims reach literally any concentration of these drugs.
`AbbVie’s expert admitted at least 100 mgs per ml of levodopa. I don’t even
`know if that’s been achieved. And it couples that, and defines the claim
`scope, with specific functional PK limitations. So really the scope of the
`claim is defined by the PK limitations.
`I think you’re going to see, the Patent Owner even says that these are
`PK claims. But that’s the problem. The Federal Circuit has said that the
`written description problem is especially acute when you claim a genus that
`uses functional language like this to find the boundaries of the genus, and
`that’s exactly what’s happening here. The definition, the scope of these
`claims is effective therapy as such.
`Just 44, I’m going to just go past this. AbbVie’s expert admitted that,
`you know, there was no limit on the concentrations here. And turning to 45,
`AbbVie’s argued that well, the formulation limitation’s lack of limits on
`excipients, that’s not all because we only got our excipients. First of all they
`haven’t shown one successful real-world attempt with just levodopa and
`carbidopa and water, that doesn’t exist. And even their prior art off the shelf
`formulations, they get minimally over the 5 mgs per ml limit for levodopa,
`those include other ingredients. Even new improvements data that achieve a
`modest proven
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