Trials@uspto.gov
`571-272-7822
`
`
`
`
`Paper # 56
`Entered: 04/26/21
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`COLLEGIUM PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`
`PURDUE PHARMA L.P., PURDUE PHARMACEUTICALS L.P.,
`Patent Owner.
`____________
`
`PGR2018-00048
`Patent 9,693,961 B2
`____________
`
`Record of Oral Hearing
`Held: July 10, 2019
`____________
`
`
`
`Before CHRISTOPHER G. PAULRAJ, JACQUELINE T. HARLOW, and
`KRISTI L. R. SAWERT, Administrative Patent Judges.∗
`
`
`
`
`
`
`
`
`
`
`
`
`∗ Judge Jacqueline T. Harlow is no longer with the Board. The Panel Change Order dated March 2, 2021
`(Paper 55) remains in effect.
`
`
`571-272-7822
`
`
`
`
`Paper # 56
`Entered: 04/26/21
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`COLLEGIUM PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`
`PURDUE PHARMA L.P., PURDUE PHARMACEUTICALS L.P.,
`Patent Owner.
`____________
`
`PGR2018-00048
`Patent 9,693,961 B2
`____________
`
`Record of Oral Hearing
`Held: July 10, 2019
`____________
`
`
`
`Before CHRISTOPHER G. PAULRAJ, JACQUELINE T. HARLOW, and
`KRISTI L. R. SAWERT, Administrative Patent Judges.∗
`
`
`
`
`
`
`
`
`
`
`
`
`∗ Judge Jacqueline T. Harlow is no longer with the Board. The Panel Change Order dated March 2, 2021
`(Paper 55) remains in effect.
`
`
`
`PGR2018-00048
`Patent 9,693,961 B2
`
`
`
`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`JAKE M. HOLDREITH, ESQUIRE
`CHRISTOPHER A. PINAHS, ESQUIRE
`Robins Kaplan, LLP
`800 LaSalle Avenue, Suite 2800
`Minneapolis, Minnesota 55402
`612-349-0162
`jholdreith@robinsonkaplan.com
`cpinahs@robinsonkaplan.com
`
`
`
`ON BEHALF OF THE PATENT OWNER:
`
`
`GASPER J. LaROSA, ESQUIRE
`ADAM M. NICOLAIS, ESQUIRE
`Jones Day
`250 Vesey Street
`New York, New York 10281-1052
`212-326-3939
`gjlarosa@jonesday.com
`anicolais@jonesday.com
`
`
`
`
`
`
`The above-entitled matter came on for hearing on Wednesday, July 10,
`2019, commencing at 1:18 p.m., by video/by telephone.
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`2
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`PGR2018-00048
`Patent 9,693,961 B2
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`P R O C E E D I N G S
`- - - - -
`JUDGE PAULRAJ: Good afternoon, Counsel. Thanks for bearing
`
`with us. This is our hearing in PGR2018-00048. So, let's start with
`appearances, Petitioner's Counsel first and then Patent Owner's Counsel.
`MR. PINAHS: Good afternoon, Your Honor. Chris Pinahs, from
`Robins Kaplan Law Firm on behalf of Collegium Pharmaceutical; also here
`today is Jake Holdreith. We have Cy Martin from our office as well here
`this morning, as well as the client's, Shirley Kohlmann and Alison Fleming.
`JUDGE PAULRAJ: Thank you, Mr. Pinahs.
`MR. PINAHS: Thank you, Your Honor.
`MR. LaROSA: Good morning, Your Honor. Gasper LaRosa from
`Jones Day for the Patent Owner; I'm joined here by Adam Nicolais from my
`office, and also John Normile, my Partner. We have from the client Richard
`Inz and Bruce Koch, also from Purdue Pharma.
`JUDGE PAULRAJ: All right, thank you, Mr. LaRosa. As we said in
`our Trial Hearing Order, each side will have 60 minutes to present their
`arguments, and Petitioner will open their -- open by presenting their case
`regarding the patentability challenges at issue in this proceeding.
`Patent Owner will respond to Petitioner's arguments. We do not have
`a motion to amend in this proceeding, so we don't have to worry to about
`that. Petitioner may reserve some of its time for rebuttal, and Patent Owner
`may use some of their time for surrebuttal to respond to Petitioner's
`arguments.
`So, whenever Petitioner's Counsel goes up, I'll ask you how much
`time you want to reserve. Unless there are any other preliminary matters, we
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`Patent 9,693,961 B2
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`can proceed. And I will remind Counsel on both sides that we have Judge
`Harlow on the screen there, so please make sure to refer to specific
`demonstratives, because she may not be able to see what's being shown on
`the screen here. Whenever you're ready, Mr. Pinahs?
`MR. PINAHS: Thank you, Your Honor. Your Honor, I'm going to
`back out just a second so that it resets our timer here, so that I know where I
`am in my comments.
`Your Honor, again Chris Pinahs from Robins Kaplan Law Firm on
`behalf of Collegium Pharmaceutical. Collegium was the Petitioner is the
`Petitioner in this Post-Grant Review, and has asked that this Board cancel
`claims 1 through 17 of the ’961 Patent. Now, I've put a brief overview on
`the screen at slide 2 of the comments that Collegium will raise today. I will
`handle the first two bullet points, and my colleague, Mr. Holdreith, will
`handle the second three.
`JUDGE PAULRAJ: Mr. Pinahs, could you speak into the microphone
`a little bit clearer? I'm not sure if it's on or not, as long as -- make sure
`there's a green light and a microphone.
`(Off-the-record discussion)
`MR. PINAHS: Is that better, Your Honor?
`JUDGE PAULRAJ: It is. Let me confirm with Judge Harlow to
`make sure she can hear it. All right. Thank you. That's better.
`MR. PINAHS: You're welcome. Thank you. So, Your Honor, just a
`brief overview on the ’961 Patent, now I'd like to note that the ’961 Patent
`was filed on February 4, 2016. It issued roughly a year later in July of 2017,
`some 15 years after the original provisional was filed, and a short time after
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`Patent 9,693,961 B2
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`the ’943 publication, which Collegium argues is the anticipatory piece of
`prior art was published.
`So, when it's often the case, as it's here, that an old provisional
`application is used to try to cover later developed technology, and you need
`to scratch that specification as Purdue did here, and you run into written
`description and enablement problems, as the ’961 Patent has and as
`Collegium has highlighted in its Post-Grant Review.
`Now, the patent specification describes the purported invention as a
`dosage form with less parenteral, intranasal, or oral abuse, and it
`accomplishes that stated goal -- I'm on slide 5 now -- as using an aversive
`agent in the claimed pharmaceutical dosage form, or the described
`pharmaceutical dosage form -- excuse me -- in the specification. And there's
`no dispute amongst the parties as to what an aversive agent is. An aversive
`agent is a bittering agent, an irritant and a gelling agent. There's also no
`dispute amongst the parties as to what the specification describes: which is
`the use of an aversive agent to deter abuse.
`JUDGE PAULRAJ: Let me pause you right there. I realized that, I
`mentioned in the beginning, but I didn’t ask how much time you wanted for
`rebuttal?
`MR. PINAHS: Ten minutes, please, Your Honor.
`JUDGE PAULRAJ: Thank you. Let me actually start that now. I'll
`start the clock at 49 minutes. All right, proceed Mr. Pinahs.
`MR. PINAHS: Thank you, Your Honor. Now I'm on slide 6, and
`there is no dispute amongst either of the parties' expert, there is testimony
`here from Collegium's expert, Dr. Chambliss, on the top of the screen; and
`Purdue's expert at the bottom of the screen, Dr. Constantinides.
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`Patent 9,693,961 B2
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`Now, both agree that the specification of the ’961 Patent solely
`describes abuse deterrents through the use of an aversive agent, again, a
`bittering agent, an irritant or a gelling agent. The claims of the ’961 Patent
`though are not so similarly constrained.
`Now I've put representative claim 1 on the screen. There are 17
`claims in the ’961 Patent, but they all break down roughly in the same way,
`there are structural limitations and functional limitations. So the structural
`limitations of claim 1 are an oxycodone API, a polyglycolyzed glyceride, or
`as the parties refer to, a PGG, a C12 to C40 fatty acid, carnauba wax and
`beeswax. Now, these five structural elements have to be combined in a hot
`homogenous mixture, encapsulated and that capsule dosage form has to
`satisfy two functional characteristics.
`It must both provide 12 hours of therapeutic effect, and it must be
`abuse deterrent when subjected to tampering comprising heating at a
`temperature greater than 45C.
`Now, I'd like to begin with a discussion of Collegium's written
`description defense. Now, this written description defense breaks into two
`different arguments, their independent bases for the invalidity of the ’961
`Patent, and if this Board finds that either one applies, all 17 claims of the
`’961 Patent are invalid.
`Now, I'd like to begin with Collegium's picking and choosing
`argument on written description. And that argument breaks down under the
`case law that one cannot disclose a forest in the original application, as
`Purdue has done here, and then later pick out a tree in that forest and say,
`aha, here's my invention.
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`Now, as Dr. Chambliss testified, there's no description of any
`embodiment of the claimed invention. There's no indication in the
`specification that the inventors were in possession of a capsule dosage form
`that used the structural limitations, that being an oxycodone API, a
`polyglycolyzed glyceride, the waxes and the C12 to C40 fatty acid, that had
`12 hours of therapeutic effect and was abuse deterrent.
`I'll now move forward to slide 13. Not only is there no description of
`the claimed invention in the ’961 Patent, but the examples also don't
`describe or use the claimed invention. Other than one oxycodone API, an
`oxycodone hydrochloride which my colleague will address later --the
`concerns about oxycodone hydrochloride API, but other than that there are
`no examples that use a PGG, there's no examples that use a carnauba wax,
`there's no examples that use a beeswax, and there's no example with a fatty
`acid, a C12 to C40 fatty acid, with an oxycodone API.
`I've moved to slide 14 now. Further, as agreed by the experts in this
`case, PGGs are mentioned just once in the entire patent, and that is as an
`optional surfactant.
`Now I've come to (inaudible) so far on the structural limitations of the
`claimed invention. The experts are also in agreement though, that there is no
`teaching of a dosage form, let alone one with the claimed pharmaceutical
`ingredients that is subjected to tampering at a temperature greater than 45C.
`Moreover, as Dr. Chambliss testified, there's silence in the patent about how
`the claimed pharmaceutical ingredients are to be combined, the process used
`to prepare the homogenous mixture of those ingredients, the order of
`addition of those ingredients or the temperature at which they will be added.
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`Patent 9,693,961 B2
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`And this is important as both Dr. Chambliss testified and this Board
`explained in its institution decision, one of skill in the art would expect the
`inventors to have described how to do that with the claimed pharmaceutical
`ingredients, if they're actually in possession of that invention, especially
`given the various physical chemical properties that the ingredients that are
`claimed encompassed. There are categories of ingredients, and they have
`various physical chemical properties, as Dr. Chambliss testified to, there at
`paragraph 112, and that's on slide 16.
`So moving to slide 17. This is an example where one skilled in the
`art, if they read the original application, would not immediately discern the
`limitations at the issue -- at issue in the claims, and this Board should find
`that the patent lacks adequate written description.
`Now, I'd like to briefly address -- I'm on slide 18 now -- Purdue's
`arguments as to why they think there is written description support for the
`claimed invention -- that this isn't the result impermissible picking and
`choosing.
`And the first is the description of optional binders at column 16 of the
`’961 Patent. Now, I've put on the screen, and it's at slide 19, Purdue's
`argument as to why they believe or what they cite for the disclosure of the
`claimed invention.
`Now, I'll note here that there's no discussion of any of the functional
`limitations of the claim, and importantly as the parties have thoroughly
`briefed, there is no disclosure of a PGG. Now, Purdue's argument is that
`that second highlighted language, fatty acid ester, and fatty acid glyceride,
`despite not using the word PGG is somehow a disclosure of a PGG. Now
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`Patent 9,693,961 B2
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`there's three independent reasons that that's not the case as -- came out and
`was developed during trial here.
`First, and this is just a simple grammatical argument, the inventors
`knew how to describe a PGG when they wanted to, they do so at column 28,
`as Dr. Constantinides agreed. He also agreed that there is no description at
`column 16 of a PGG. It's a tenet of patent law, contract interpretation --
`contract interpretation of patent law that different words are to be given
`different meanings.
`Here, they use the word "PGG" in column 28, the inventors clearly
`knew how to use the word "PGG" when they wanted to refer to one. They
`did not at column 16, and that should not be construed as a PGG.
`Now, I'm on to slide 22. The second reason, and this came out during
`the course of trial, there's two additional reasons, scientifically, that this
`cannot be a disclosure of PGG as at column 16. The first is that this section
`references the genus fatty acid ester, not the species PEG fatty acid ester
`that's required for a PGG. So let me set some context for that.
`JUDGE PAULRAJ: Just going back to that, Counsel.
`MR. PINAHS: Yeah.
`JUDGE PAULRAJ: PGG is not just PEG fatty acid esters, it requires
`fatty acid glycerides on top of that. Is that right?
`MR. PINAHS: Correct. And I'm going to show that in the next slide.
`JUDGE PAULRAJ: And the other question, maybe you'll answer this
`in the next slide as well is: how big is the genus of fatty acid esters? When it
`refers to fatty acid esters, it also refers to fatty acid glycerides in that same
`sentence, so should we read those two together, in our consideration of
`whether the genus itself is sufficient disclosure of PGG?
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`MR. PINAHS: I'll answer both of those in the next couple of slides
`for Your Honor.
`JUDGE PAULRAJ: Okay.
`MR. PINAHS: But to directly answer, the first question, I'll take that
`you asked that isn't a PGG more than just a PEG fatty acid ester, and it is.
`So, the experts are in agreement that a PGG is a mixture of five constituent
`components. And I'm on slide 23 here. It's a monoester, a diester and
`triester of a glycerol, which is the glyceride, and it is a monoester and diester
`of polyethylene glycol or a PEG, a PEG ester. So those are the five
`constituent parts. I think that answers Your Honor's first question.
`There is no disagreement amongst the experts as to the constituent
`parts of a PGG. For the benefit of trial, they are in agreement. The problem
`-- and I think this is going to answer now Your Honor's second question was
`how many -- how big is the genus of fatty acid esters? I think that's what I
`heard the question ask.
`JUDGE PAULRAJ: It is. And to follow up, how big is the genus of
`fatty acid glycerides as well in the next portion of that's now highlighted in
`that slide there?
`MR. PINAHS: So the fatty acid ester genus, other than -- the only
`testimony on this, Dr. Constantinides has entered none, Dr. Chambliss'
`testimony was there's numbers of classes of fatty acid esters. There's not an
`explicit number to be frank with Your Honor, but the only -- as far as I'm
`aware -- description at all of how big that class is, is Dr. Chambliss'
`supplemental declaration, where he testified there's numerous classes of fatty
`acid esters, and there's no reason to believe that the applicant's disclosure of
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`PGR2018-00048
`Patent 9,693,961 B2
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`the genus fatty acid ester is somehow a disclosure of the species PEG fatty
`acid ester.
`Now, the third reason this is not a disclosure of a PGG, the constituent
`part or the species, even if this was found to somehow be the species of a
`PGG, that would be again being the PEG fatty acid esters, somehow this was
`found to be a PEG fatty acid ester. A PGG must be -- the PEG fatty acid
`ester of the PGG must be hydrophilic, the experts are in agreement to this,
`the problem is this section at column 16 only discloses or references
`hydrophobic binder material.
`So I'm trying that now on slide 27. Slide 27 shows both the expert's
`testimony and their agreement. At the bottom the question to Dr.
`Constantinides was, "In that PEG fatty acid ester will always be the
`hydrophilic constituent of the PGG. Correct?" And his testimony, in
`agreement: "Yes."
`So there's no dispute that the PEG fatty acid ester must be hydrophilic,
`the problem, and again, I'm looking at the bottom box in slide 28, is Dr.
`Constantinides when asked, "In the fatty acid esters though, that's described
`here in column 16, is not a hydrophilic fatty acid ester, but a hydrophobic
`fatty acid ester. Correct?" "Yes, it appears so, because it refers to
`hydrophobic binder material."
`So, the experts are in agreement as to what constitutes a PGG, the five
`constituent parts, they're in agreement as to the physicochemical properties
`of those five constituent parts, and that the disclosure at column 16, does not
`in fact, describe those five constituent parts. So, column 16 in the binder
`section is not a disclosure of PGGs.
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`Before I move on though, I think I've overlooked Your Honor's
`question which was: how big is the class of glycerides?
`JUDGE PAULRAJ: Mm-hmm.
`MR. PINAHS: That as far as I know, is not in the record anymore
`from either of the experts. I want to answer Your Honor's question.
`JUDGE PAULRAJ: Okay. Thank you, Counsel.
`MR. PINAHS: This second argument that Purdue raises for why there
`is a disclosure of PGGs is that the aversive agent description in column 17 is
`somehow a description of the claimed invention. Now, I would note, this is
`the description that Purdue points to for the disclosure of the claimed
`invention, slide 30. Now, again, there's no discussion of any other
`functional characteristics in this language, and to even -- there's no
`discussion of any of the claimed pharmaceutical ingredients by name.
`And importantly, what Purdue cites to for the disclosure of PGG is the
`language: at least one aversive agent. Their argument essentially breaks
`down to, well, we think a PGG is an aversive agent, that's their argument
`here, and by aversive agent they say a PGG is a gelling agent, one of the
`classes of aversive agents.
`The problem with that argument -- and I'm at slide 31 -- is that PGGs
`are not gelling agents, and they're not described as such anywhere in the
`priority applications. And again, the experts are in agreement with this. Dr.
`Constantinides' testimony in the bottom square of this: they're not described
`anywhere by name as a gelling agent in the ’961 Patent.
`JUDGE PAULRAJ: But the ’961 Patent does, and (inaudible)
`requires several leaps here of inference, but it does refer to PGGs as
`surfactants. You don't dispute that PGGs can be surfactants?
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`MR. PINAHS: No. No dispute whatsoever, Your Honor.
`JUDGE PAULRAJ: Is there a dispute as to whether any surfactant
`can be a gelling agent?
`MR. PINAHS: The testimony from the expert is that certain PGGs --
`excuse me -- certain surfactants could be gelling agents. That's as close as
`the patent describes it, and that's the expert testimony as well, that's certain
`surfactants could be gelling agents.
`JUDGE PAULRAJ: So when --
`MR. PINAHS: The disagreement between the parties is Dr.
`Constantinides, Purdue's expert, says the PGGs are gelling agents.
`Collegium's expert, Dr. Chambliss, says PGGs are not gelling agents.
`JUDGE PAULRAJ: Okay.
`MR. PINAHS: So the priority applications don't describe PGGs as
`gelling agents -- I'm on slide 32 now -- and Dr. Constantinides further
`testified that he doesn’t cite anything for the fact, no literature, nothing, for
`the fact that PGGs are gelling agents. His declaration is silent on that fact.
`I'll move forward now to slide 33. Dr. Constantinides --
`JUDGE SAWERT: Excuse me. What does your expert cite to for a
`PGG is not a gelling agent?
`MR. PINAHS: So, he cited the priority applications that they don't
`describe PGGs as gelling agents. He cited the Handbook of Pharmaceutical
`Excipients that was in effect as of the priority date of the ’961 Patent which
`didn’t list PGGs, he then cited the -- after the fact, or after the priority dates,
`Handbook of Pharmaceutical Excipients which includes PGGs and lists them
`not as having any function of being a gelling agent.
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`Patent 9,693,961 B2
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`He also cited the trademark application for Gelucire, which is the
`PGG that the parties spent the most time on. Showing that name, even
`though (inaudible) gel is actually a translation from French that it doesn’t
`involve PGGs, or it doesn’t describe it as being a gelling agent either.
`So, I'm on slide 33. Dr. Constantinides also testifies that he's never
`included a PGG in a formulation of the goal deterrent abuse, and as of
`August 2001, the purported priority date, he's never heard of anyone in the
`art using it for abuse deterrent reasons either.
`And now I think this will answer Your Honor's question also about
`what was cited. So Dr. Constantinides testified that something is not a
`gelling agent, unless there's some supporting literature for that fact. Even if
`an excipient was listed in the patent as being "a gelling agent" it's not a
`gelling agent unless there's supporting literature.
`And he cites here, he asked about the Handbook of Pharmaceutical
`Excipients. So, he's saying, yes, the handbook is authoritative. So we went
`to the Handbook of Pharmaceutical Excipients at his deposition.
`Now, this says polyoxylglycerides that is the disclosure of PGGs
`though, both experts agree, this is how the handbook describes PGGs. I
`have no -- Dr. Chambliss, Collegium's expert, was on the Steering
`Committee of the Handbook of Pharmaceutical Excipients as well, he knows
`this publication quite well.
`Now, there's six functional categories listed for PGGs, none of which
`is a gelling agent. That's not because the handbook doesn’t list gelling
`agents, there's over 20 agents as you can see here at slide 36 listed in the
`Handbook of Pharmaceutical Excipients, PGGs are not on that list.
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`So, this Board should find that PGGs aren't gelling agents, and if it
`does, that ends Purdue's written description argument about column 17
`somehow being a disclosure of the claimed invention.
`But I'd like to just walk through how Purdue still argues that PGGs are
`somehow a disclosure of an aversive agent, such that there's written
`description support, because even if this Board were to find that PGGs are
`gelling agents, the patent still lacks written description support.
`So I'm at slide 37 right now. And Purdue's argument breaks down
`like this. The aversive agents are disclosed at column 17 of the patent, then
`you have to go to column 4 of the patent where it defines aversive agents,
`and I've showed you that slide before. The aversive agents were a bittering
`agent, an irritant, a gelling agent.
`Then you have to jump forward to column 6 through 7, where there's a
`laundry list of gelling agents, over 35 disclosed, and there is a disclosure of a
`surfactant there. Then you have to jump 22 columns forward into the patent
`specification, and you find a list of over 45 surfactants of which one is a
`gelling agent.
`So Purdue is using the patent specification like a hopscotch square, or
`grid, back and forth to come up with and arrive at their claimed invention.
`The problem with this is this Board, or this Panel, and the Federal Circuit
`already rejected that argument, so this is a Federal Circuit decision that's
`issued after Collegium filed their reply brief, was submitted into this record
`in Collegium's updated mandatory notice of related cases, that's at Paper 31.
`And Purdue had argued as to the ’376 Patent, it is a sibling patent in
`this family, that there was written description support for two known gelling
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`agents, that being PEO and HPMC, and the Board rejected that argument
`and said such laundry list disclosures do not provide adequate specificity.
`Now, that patent shares the specification with the ’961 Patent, those
`gelling agents were four lines apart, and the Federal Circuit affirmed this
`Board's decision that that was not adequate written description support.
`Here, Purdue is asking this Board to start at column 17, jump to 4,
`jump to 7, and the jump 22 columns forward to 28 to find written description
`support. And I would argue that that is not even prima facie possible under
`the Federal Circuit's decision in the sister IPR and then Federal Circuit
`decision.
`JUDGE PAULRAJ: And wasn’t the issue in that prior case, and
`obviously we were familiar with that since we were on the Panel, whether
`there was written description support for that particular combination of HP
`MCMP --
`MR. PINAHS: Correct. It was --
`JUDGE PAULRAJ: All right, so we have one gelling agent here, or
`related to one ingredient that were primarily focusing on PGG.
`MR. PINAHS: Without a doubt it is different, as Your Honor noted,
`and that case it was -- you were combining two gelling agents that were on
`the list of gelling agents. But I would note there, those gelling agents were
`noted by name in that list four lines apart. In here there's no disclosure at all
`that's anywhere similar, and that you have to make those leaps of logic to get
`to the ultimate conclusion that PGGs are somehow gelling agents.
`Now, I'd just like to conclude with -- on this topic -- on the analysis
`that Dr. Constantinides, Purdue's expert, does to get there, because it is a
`hindsight analysis, and under Novozymes, you cannot find written
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`description support jumping around a patent like this, especially when you're
`using only hindsight analysis to get there .
`So Dr. Constantinides' argument is that a POSA, when they read the
`word "aversive agent" would immediately go: ah-ah, a PGG. That's what
`he's saying, and he gives reasons for that. And I'm going to look at those
`reasons. So, he says that a POSA would have known Gelucire, these are two
`grades of PGGs, that there's no dispute in the record are PGGs, can improve
`drug solubility and dissolution for solid dispersion prepared with melt
`granulation and melt extrusion.
`The problem is that Dr. Chambliss, Collegium's expert, testified that
`everything on that list of surfactants will have that improved drug solubility
`and dissolution. That's the definition of a surfactant, and he cites that at
`Exhibit 1086, and he goes through and he picks out certain ones on that list.
`Here is supporting literature for the fact that, yes, surfactants would have
`that effect, that's to be expected, and it wouldn't make one -- even if a gelling
`agent -- PGG was a gelling to go, ah-ah, of course, a gelling agent.
`Now, Dr. Constantinides also says, yes, well, PGGs were used in melt
`extrusion and melt granulation -- and I'm on slide 45 right now -- a problem
`with that is it contradicts Purdue's argument that it made to the Federal
`Circuit in its appeal to the ’376 Patent.
`In that appeal brief Purdue argued: the physical and thermal forces
`involved in hot melt extrusion presented in our (inaudible) with a range of
`serious problems for designing drug formulations, these incompatibilities
`among the ingredients and instability of the gelling agents which can lead to
`catastrophic effects on the final dosage form. In other words, Dr.
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`Constantinides is just saying, you pick a PGG because you use it with hot
`melt extrusion. The patent describes hot melt extrusion.
`Purdue is telling the Federal Circuit exactly the opposite: you
`wouldn't use a gelling agent with hot melt extrusion because it would lead to
`catastrophic effects on the final dosage form.
`For all these reasons, Your Honor, Collegium argues that there is no
`written description support for the ’961 Patent because of impermissible
`picking and choosing.
`Now, I want to be careful of my time here, so I'm largely going to
`give just a highlighted version of our second written description argument,
`which is the inventors were not in possession of the full scope of abuse
`deterrent dosage forms.
`JUDGE SAWERT: I want to ask you a question about slide 46.
`MR. PINAHS: Please.
`JUDGE SAWERT: Are you saying that we can take, and our prior
`statements into account, as to their credibility, or is it some sort of estoppel
`or?
`
`MR. PINAHS: It adds to the credibility, Your Honor.
`JUDGE SAWERT: Okay.
`MR. PINAHS: They’ve got their experts saying one thing, and they're
`telling the Federal Circuit something completely different. It's the same
`parties. It's the same concept.
`So, as to the full scope of the abuse deterrent dosage forms: I'm
`jumping forward now to slide 51. So, the second written description
`argument breaks down very simply as the claim language encompasses more
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`subject matter than is described in the specification. Purdue has over-
`claimed.
`Now, Dr. Chambliss explained in the blue highlighting there, there is
`description in the specification of a bittering agent, an irritant, a gelling
`agent. There is no description of any other ways to make an abuse deterrent
`dosage form, and that's not in dispute, the experts are in agreement.
`The problem with this though, is that Dr. Constantinides was asked
`about his opinion of the claim term "abuse deterrent dosage form": "It's not
`your opinion that abuse deterrent dosage form is limited to just the use of
`aversive agents to deter abuse. Correct?" "Correct."
`So he's not saying the claims are limited to an aversive agent, he's
`saying they encompass much more. He has also then admitted that the
`specification only describes a bittering agent, an irritant or a gelling agent.
`In other words, this is an example where a broad claim should be found
`invalid, because the entirety of the specification clearly indicates the
`invention was of a much narrower scope.
`JUDGE PAULRAJ: How would you achieve abuse deterrence other
`than the use of an aversive agent as defined in the spec?
`MR. PINAHS: Sorry, I didn’t catch that last part, Your Honor?
`JUDGE PAULRAJ: So, my understanding of the term "aversive
`agent" as it's used in the specification, encompasses the gelling agent, and
`encompasses irritants and other potential ways to more or less make the drug
`less appealable for abuse?
`MR. PINAHS: A bittering agent as well so (crosstalk) --
`JUDGE PAULRAJ: Right, right. So, if that's a pretty broad
`definition of aversive agent.
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`MR. PINAHS: Yep.
`JUDGE PAULRAJ: My understanding -- so how would you achieve
`abuse deterrence other than the use of an aversive agent?
`MR. PINAHS: So there are four different categories that Dr.
`Chambliss testified about. They're in red on the screen.
`JUDGE PAULRAJ: Okay.
`MR. PINAHS: There is a dye, and one of the examples is it makes
`your mouth a certain color, or
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