UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`GRÜNENTHAL GMBH,
`Petitioner,
`
`v.
`
`ANTECIP BIOVENTURES II LLC,
`Patent Owner.
`____________
`
`Case PGR2017-00022
`Patent 9,408,862 B2
`____________
`
`Record of Oral Hearing
`Held: July 24, 2018
`____________
`
`
`
`
`
`
`
`
`
`
`Before GRACE KARAFFA OBERMANN, TONI R. SCHEINER, and
`FRANCISCO C. PRATS, Administrative Patent Judges.
`
`
`
`
`
`
`
`
`
`
`
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`GRÜNENTHAL GMBH,
`Petitioner,
`
`v.
`
`ANTECIP BIOVENTURES II LLC,
`Patent Owner.
`____________
`
`Case PGR2017-00022
`Patent 9,408,862 B2
`____________
`
`Record of Oral Hearing
`Held: July 24, 2018
`____________
`
`
`
`
`
`
`
`
`
`
`Before GRACE KARAFFA OBERMANN, TONI R. SCHEINER, and
`FRANCISCO C. PRATS, Administrative Patent Judges.
`
`
`
`
`
`
`
`
`
`
`
`
`
`Case PGR2017-00022
`Patent 9,408,862 B2
`
`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`DANIEL J. MINION, ESQUIRE
`BRUCE C. HAAS, ESQUIRE
`KATHERINE ADAMS, ESQUIRE
`JAMES R. TYMINSKI, ESQUIRE
`Fitzpatrick, Cella, Harper & Scinto
`1290 Avenue of the Americas
`New York, New York 10104-3800
`
`ON BEHALF OF PATENT OWNER:
`
`MICHAEL I. KATZ, ESQUIRE
`BRENT A. JOHNSON, Ph.D., ESQUIRE
`Maschoff Brennan
`20 Pacifica
`Suite 1130
`Irvine, California 92618
`
`
`
`
`The above-entitled matter came on for hearing on Tuesday, July 24, 2018,
`commencing at 1:00 p.m., at the U.S. Patent and Trademark Office, 600
`Dulany Street, Alexandria, Virginia.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` 2
`
`
`
`Case PGR2017-00022
`Patent 9,408,862 B2
`
`
`
`P R O C E E D I N G S
`- - - - -
`JUDGE OBERMANN: Good afternoon and welcome to the
`PTAB. On the record, please, this is a final hearing in PGR2017-00022,
`Grünenthal GMBH versus Antecip Bioventures. It's a post-grant review in
`which the petition states challenges against claims 1 through 30 of U.S.
`patent number 9,408,862 B2. Patent owner has disclaimed claim 1 and has
`filed a motion to amend.
`I'm Judge Obermann, and to my right is Judge Scheiner. Judge
`Prats is appearing remotely today. He is located in Hershey, Pennsylvania.
`He will be on the screen there on my left. Please be aware that because
`Judge Prats is appearing remotely, I want to remind both sides to please
`identify exhibits by number so that he can pull them up on his screen. You'll
`see us looking at our screens a lot. I assure you that we are following your
`case. We have electronic copies of your demonstratives. We have all the
`briefs on our computer. We are not shopping. We are not checking our
`e-mails. We are paying attention to what you are doing. But if you see us
`scrolling around, it's because we are looking for either an exhibit or a page
`in one of your briefs.
`In that regard, it's really not enough for you to describe the exhibit
`as the Wilson deposition or the Wargin declaration. It's really helpful for us
`if you can tell us the number of the exhibit, especially for Judge Prats to pull
`it up on his computer screen.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`
`
`
`
`
` 3
`
`
`
`Case PGR2017-00022
`Patent 9,408,862 B2
`
`
`So let's start with introductions. Who is presenting for -- I'll start
`with petitioner since you'll be going first.
`MR. MINION: Petitioner is on this side, Your Honor.
`JUDGE OBERMANN: You have got petitioner on your table and
`you have got patent owner on your side. I will get confused without that.
`I'm so sorry. Who do we have for petitioner today?
`MR. MINION: Good afternoon, Your Honor. Daniel Minion
`from Fitzpatrick, Cella, Harper & Scinto on behalf of petitioner, Grünenthal.
`With me is lead counsel, Bruce Haas. Also with me are Jim Tyminski and
`Katherine Adams.
`JUDGE OBERMANN: And you are Mr. Minion?
`MR. MINION: Yes.
`JUDGE OBERMANN: I didn't see your name on the -- have you
`noticed an appearance?
`MR. MINION: I have, Your Honor, yes.
`JUDGE OBERMANN: All right. I must have just been looking at
`an earlier paper.
`MR. MINION: It was not in the beginning. It was later in time.
`JUDGE OBERMANN: Are you appearing pro hoc vice?
`MR. MINION: No, I'm admitted.
`JUDGE OBERMANN: Thank you very much, Mr. Minion. Who
`do we have for patent owner today?
`MR. KATZ: Michael Katz, Your Honor.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`
`
`
`
`
` 4
`
`
`
`Case PGR2017-00022
`Patent 9,408,862 B2
`
`
`JUDGE OBERMANN: Thank you, Mr. Katz. And Mr. Minion,
`will anyone else be presenting argument for petitioner today or will you be
`doing the whole argument?
`MR. MINION: No, Your Honor, just me.
`JUDGE OBERMANN: And Mr. Katz?
`MR. KATZ: I anticipate doing the full argument.
`JUDGE OBERMANN: Thank you. Each party has 60 minutes of
`total time to present argument. We have put out a hearing order that I'm sure
`you are both familiar with. Petitioner will go first and may reserve time for
`rebuttal. That's the first thing I'll be asking you before I start the time. Then
`patent owner will present argument, including any argument that you may
`want to present on your motion to amend and secondary considerations of
`nonobviousness. And patent owner, you may reserve time to present
`rebuttal that's specifically limited to just those two issues if you like. So
`that's the first thing I'll be asking you, Mr. Katz, when you stand is whether
`you want to reserve any time in view of what you hear from petitioner.
`MR. KATZ: Understood.
`JUDGE OBERMANN: I remind everyone that this hearing is
`open to the public. I looked last night and I didn't see any protective order.
`I didn't see any confidential information that's been introduced into the
`record. So I don't foresee any problems with this being open. Neither party
`has filed objections to demonstratives, and I appreciate that. I'll just remind
`counsel that the demonstratives are merely argument aids and they have
`been served but they are not filed in the record. We prefer it that way. And
`as I mentioned previously, each judge has access to those demonstratives on
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
` 5
`
`
`
`Case PGR2017-00022
`Patent 9,408,862 B2
`
`our computer screen, but it's also very helpful for us to have it right here, but
`I don't think that Judge Prats will be able to see the demonstratives that you
`are using. So that becomes very important that you give the slide number
`when you are presenting from the slides so that Judge Prats can pull it up.
`Yes, Mr. Katz?
`MR. KATZ: Just to give fair warning that because our computer
`that we have the slides on doesn't connect, that I may be asking you if you
`have electronic versions to follow along that way. We could try and use the
`ELMO, but it's very awkward.
`JUDGE OBERMANN: That's all right. Let me just check with
`my co-judges, but I have them right on my screen. So if you want to just tell
`us what number you are referring to, if you have a hard copy for yourself
`and you can just tell us what number, I think that's going to work just fine.
`MR. KATZ: Okay, great. That's what I prefer.
`JUDGE SCHEINER: That's fine for me.
`JUDGE OBERMANN: And Judge Prats, do you have your
`exhibits or demonstratives available?
`JUDGE PRATS: Yeah, they are up and running.
`JUDGE OBERMANN: No problem, Mr. Katz. Thank you. With
`that, I will ask petitioner to please step forward. I am going to ask first
`would you like to reserve any rebuttal time?
`MR. MINION: I would, Your Honor. I would like to reserve
`25 minutes for rebuttal.
`JUDGE OBERMANN: Okay. So I am going to put 35 minutes on
`the clock for you. Let me just get it up. Usually we have something behind
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
` 6
`
`
`
`Case PGR2017-00022
`Patent 9,408,862 B2
`
`us where you can see the time. Would you like me to give you a warning
`when you are getting close to the end?
`MR. MINION: Yeah, at 30 minutes would be helpful.
`JUDGE OBERMANN: I'll give you a five-minute warning. And
`I'm going to start the clock when you start speaking.
`MR. MINION: Thank you, Your Honor. May it please the Board,
`for the next 30 minutes or so I'm going to begin by going through the
`grounds on which the Board instituted review on the current claims and
`address petitioner's positions why those claims are unpatentable. In rebuttal
`I will then address the proposed amended claims and why those claims are
`also unpatentable for both the same reasons as the current claims and also
`some additional grounds.
`So turning to the slides, slide 2, I have claim 17 of the '862 patent.
`And there are two sets of claims, just to orient Your Honors. We have
`claims 17 through 30 are directed to -- I have used some sort of shorthand to
`make the claims more readable, but basically claim 17 through 30 are
`directed to pharmaceutical dosage forms comprising zoledronic acid wherein
`the dosage form is free of therapeutically active agents that are not
`zoledronic acid or these other two compounds and wherein the
`bioavailability of zoledronic acid in that dosage form is from about 1.1 to
`about 4 percent. The remaining claims, 2 through 16, are directed to
`methods of using those dosage forms for the treatment of knee pain.
`On slide 4 I list the grounds on which the Board instituted. We
`have enablement as to all of the claims, lack of enablement as all the claims,
`anticipation by Leonard of claims 17 through 30, and then obviousness of
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
` 7
`
`
`
`Case PGR2017-00022
`Patent 9,408,862 B2
`
`the claims over the prior art. I will address each of these grounds in turn.
`I'm going to start with enablement.
`And turning to slide 5, where I would like to start with enablement
`is to address what patent owner alleges to be the invention of the '862 patent.
`So this is from the patent owner's response on page 5. And patent owner
`asserts that the '862 specification teaches at least two things that a POSA
`would not know from the prior art. The first is that a dosage form of
`zoledronic acid with the bioavailability range of about 1.1 to about 4 percent
`is effective in treating a whole host of diseases, here specifically treating
`knee pain.
`Second, the patent owners assert that the '867 [sic] specification
`teaches that one can achieve a dosage form having that claimed
`bioavailability range without the use of permeation enhancers, without the
`use of additional compounds that increase the permeability of zoledronic
`acid in the intestinal tract.
`Now, as I will show, the '862 patent specification teaches neither
`of those things. As to the first point on slide 6 here that I have highlighted,
`as to the efficacy requirement, I'm going to present some testimony from
`patent owner's expert, Dr. Wargin. He was the only expert presented by
`patent owners in the institution phase of this PGR. There were, as I'm sure
`the Board is aware, there are some motions to exclude this testimony and
`other testimony from Dr. Wargin by patent owner on the grounds of --
`several grounds, including relevance, competency of the witness and that the
`testimony is outside the scope of the witness' expert report.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`
`
`
`
` 8
`
`
`
`Case PGR2017-00022
`Patent 9,408,862 B2
`
`
`I would like to first address the competency issue. Dr. Wargin is
`an expert in formulation. He has over 35 years of experience in developing
`oral dosage forms and particularly bioavailability studies. He's clearly
`competent to have given this testimony at his deposition.
`As to the scope, I would like to point out that the quote that I have
`from patent owner's response is coming directly from Dr. Wargin's
`declaration. This is his opinion. That's what patent owners cite for these
`two assertions of what the '862 specification teaches. So I have from
`Exhibit 1083 the deposition transcript of Dr. Wargin here. I asked
`Dr. Wargin: What specifically did the inventor of the '862 patent discover
`that would allow a POSA to determine that a bioavailability range of
`1.1 percent to about 4 percent is effective? What is the basis for that first
`point that he makes.
`And his answer is: Yes, I don't think I can actually answer that.
`Well, there's no additional information in the '862 patent as to the
`efficacy of oral zoledronic acid forms over what was already known in the
`art?
`
`Answer: Not that I can recall.
`As to the second assertion here on slide 7, again, Dr. Wargin,
`Question: You are not aware as of the filing of this '862 patent of the
`inventor actually determining the bioavailability of any oral zoledronic acid
`dosage form in human beings?
`Answer: I'm not aware of any.
`There's certainly no data in the '862 patent itself demonstrating the
`bioavailability of any zoledronic acid dosage form in a human being?
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
` 9
`
`
`
`Case PGR2017-00022
`Patent 9,408,862 B2
`
`
`Answer: That's true. There's no bioavailability data in the patent.
`These are important concessions. And as you can see now on the
`top of page 8, these concessions by Dr. Wargin run directly counter to what I
`expect you are going to hear today from patent owners. And we have, for
`example, in patent owner's reply to the opposition to the motion to amend,
`here is the statement that I have excerpted from there: The first form the
`inventor examined was the disodium salt form. The inventor discovered it
`capable of delivering a higher than expected bioavailability without the need
`for bioavailability-enhancing agents.
`And the first thing I would like to point out, Your Honors, for this
`is there's no citation after that. There's no expert citation. In fact, there was
`no supporting declaration submitted in connection with patent owner's reply
`to the opposition to the motion to amend. It's all attorney argument. Nor is
`there any citation to anywhere in the record for these two points. That's
`because this is not in the record. There is nothing in the record that shows
`that the inventors actually discovered anything in terms of the oral
`bioavailability of any dosage form of zoledronic acid. Certainly nothing in
`the patent from which a person of ordinary skill in the art would come to this
`conclusion that they assert that the POSA would have.
`Notwithstanding the fact that there is no bioavailability data in the
`patent, throughout this proceeding patent owner has cited to three different
`pieces of evidence that they suggest that a POSA would make that
`conclusion, that a POSA would learn from the '862 patent that the inventors
`had actually discovered a dosage form with bioavailability-enhanced
`properties.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
` 10
`
`
`
`Case PGR2017-00022
`Patent 9,408,862 B2
`
`
`The first place patent owner cites to, this is on slide 9, they cite to
`column 7 through 8 of the '862 patent. And what we are looking at here is
`this paragraph is just describing the embodiment in a different way in terms
`of this Nd where we have this equation in the middle here. And in particular,
`what patent owners have cited to is this what I have highlighted here. It
`says, For example, if the diacid form has a bioavailability of .01 and the
`disodium salt form has a bioavailability of .015 and as dosage form would
`contain 1 millimole of the diacid, well, you take the ratio of 1 and 1.5 and
`you get two-thirds of a millimole.
`What this is, is Dr. Wilson, petitioner's expert explained and what
`should be apparent from this, these are hypothetical figures. These are
`hypothetical numbers used to explain to the reader of the '862 patent, the
`POSA, how to go about calculating this value of Nd. It's certainly not
`something from which the POSA would take and say, okay, they have
`actually done this experiment; they have determined the bioavailability of
`the diacid form to be 1 percent and the bioavailability of disodium salt to be
`1.5 percent.
`JUDGE OBERMANN: Did Dr. Wargin -- you cited his deposition
`transcript. Did Dr. Wargin, in his declaration, have any opinion about how a
`person of ordinary skill in the art would read this particular disclosure?
`MR. MINION: This particular disclosure --
`JUDGE OBERMANN: Or any disclosure that would support the
`idea that the inventors had discovered this feature of a bioavailability?
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`
`
`
`
`
` 11
`
`
`
`Case PGR2017-00022
`Patent 9,408,862 B2
`
`
`MR. MINION: I'm unaware of any opinion from Dr. Wargin that
`supports that premise, Your Honor, in his expert report or in his -- sorry, in
`either his declaration or during his deposition.
`JUDGE OBERMANN: So you are saying it's pure attorney
`argument on the other side?
`MR. MINION: That's correct. Same is true with respect to what I
`have here, Your Honor, on slide 10. This also comes just from the patent
`owner's response. And what they did is we had that 1.5 percent number that
`was used in that hypothetical calculation on the last slide, on slide 9, and
`what patent owners have done is they have looked in this broad description,
`and I have underlined in red here where they say the embodiment of the
`invention is an oral bioavailability that can be between .01 percent to about
`5 percent. And within that broad disclosure, there's all sorts of different
`ranges that are disclosed here. And within that disclosure they said, a-ha, I
`see 1.5 percent, about 1.4 to about 1.5 percent, about 1.5 percent to about
`1.6 percent, and they implied that a person of ordinary skill in the art would
`conclude from that that the mere citation to these specific claims, that the
`inventor actually had possession of a dosage form with a bioavailability
`within those narrow ranges. And as Dr. Wilson explained, that is not the
`conclusion that the POSA would make.
`The third argument or the third assertion by patent owners, this is
`on slide 12 here, is looking not to the specification of the '862 patent, but
`they actually go to patent owner's co-pending '669 application. And in the
`'669 application, there is an example 7. And example 7 is a dog study where
`they looked at the relative bioavailabilities of the diacid zoledronic acid and
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
` 12
`
`
`
`Case PGR2017-00022
`Patent 9,408,862 B2
`
`the disodium salt, and they calculated the relative bioavailabilities of those
`two in the dog model. And we are going to hear some later on about this
`assumption that the zoledronic acid has an oral bioavailability of 1 percent.
`They are going to call that a fiction. But they rely on that figure and they
`come up with a 1.46 percent and 1.84 percent in the dog for an absolute
`bioavailability.
`And they make the statement here, and I think it's important, they
`say in two other related proceedings, petitioner has questioned the
`applicability of the dog study to humans. That criticism is not well founded.
`We have, in fact, questioned the applicability of the dog study, that you
`cannot rely on the dog study to extrapolate to human's absolute
`bioavailabilities. And the conclusion that I have in bold here on slide 12 is
`that a POSA would know that the patent owner has demonstrated test results
`confirming bioavailabilities over 1.1 percent using a disodium salt form
`zoledronic acid.
`Now, Dr. Wargin says you can't do that very clearly. A person of
`ordinary skill in the art cannot look at example 7 and say the absolute
`bioavailability of the disodium salt of zoledronic acid is between 1.1 and
`4 percent in humans. What they are relying on for enablement, their own
`expert says you cannot do that. You cannot look at that study and determine
`that the inventors had actually demonstrated a zoledronic acid dosage form
`that had a bioavailability within the claimed ranges.
`JUDGE PRATS: Actually, counsel, if I could interject, isn't
`Dr. Wargin's testimony there based on the interpatient variability? So he
`wasn't really saying you couldn't get to it. He's saying if you pick a narrow
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
` 13
`
`
`
`Case PGR2017-00022
`Patent 9,408,862 B2
`
`range because you have a certain level of patient, patient variability, it's hard
`to say, well, you'll never necessarily get a particular value. And I think later
`on in his testimony in the deposition he says, well, if you pick a broader
`range, you are much more likely to be able to get to that.
`MR. MINION: Actually, Judge Prats, Dr. Wargin's testimony is
`there's a lot of testimony on example 7, and he was much stronger than that.
`There's two issues that Dr. Wargin took with the dog data in the '669
`publication, and he said first of all, all you are looking at is relative
`bioavailabilities. So in order to really calculate the absolute bioavailability
`in the dog, you have to do what's called a crossover study. So you have to
`determine what is the bioavailability of -- sorry, what is the -- assuming
`100 percent bioavailability of the IV form of zoledronic acid, that's your
`baseline from which you can calculate the absolute bioavailability. So that
`was his first problem.
`And what Dr. Wargin noted, which is true, is if you look to the
`'862 patent, they say the oral bioavailability of zoledronic acid could be as
`low as 0.01 percent. So if you have the diacid form of having a
`bioavailability of 0.01 percent and you have increased that bioavailability by
`even 100 percent by going to disodium salt form, you are still not going to
`have evidence that you have a dosage form within the claimed range.
`The second issue, I think, is more important and maybe gets more
`the to your point, Judge Prats, is Dr. Wargin testified, I think he said, I have
`been doing this for 30 years; I have lots of experience doing experiments in
`dog, and it's just not reliable; it's just not reliable to take a data point in dogs,
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`
`
`
`
` 14
`
`
`
`Case PGR2017-00022
`Patent 9,408,862 B2
`
`assuming you actually had a bioavailability within the claimed range, and
`extrapolate that to humans.
`And he said that was based on his extensive experience. Does that
`answer your question, Judge Prats?
`JUDGE PRATS: Yeah, kind of. Since we are -- I hate to jump
`ahead in your presentation, but I might as well do it since I'm thinking about
`it. One thing I didn't see you answer in your reply is I would say patent
`owner made what we could call a burden, a burden argument, that you hadn't
`met your burden of making your case. That is, patent owner and I believe,
`bear with me, cites a couple of cases. I want to say one of them is -- bear
`with me for a second, I have many windows open here, Cephalon versus
`Watson and Moba v. Diamond saying that there's a requirement for if you
`are going to -- for the proponent of a case of nonenabling has to explain how
`much the quantity of experimentation you would have to undertake based on
`the specification at issue. Your response wasn't, I don't want to say wasn't
`direct, but you seem to rely on saying, well, there's nothing in there. But is
`there that requirement to show some kind of quantity of experimentation
`based on what is described in the patent at issue?
`MR. MINION: Yeah. Judge Prats, I think when you are in a
`typical situation and you are talking about what level of experimentation is
`undue, usually you have experts competing and saying, okay, well, here is
`the guidance that's provided by the patent at issue and it sends the person of
`ordinary skill in the art in a certain direction. And we know where the finish
`line is. So we know how to POSA starts and we know where they end. And
`there's usually a dispute of saying, well, that would take a person of ordinary
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
` 15
`
`
`
`Case PGR2017-00022
`Patent 9,408,862 B2
`
`skill in the art six months and cost $2 million, and then the other side said,
`oh, I think the POSA can do it in three months.
`The difference here and why you can't do this quantitative analysis
`of how much experimentation was done to get to the point of considering
`whether that level of experimentation is undue is because you don't have the
`starting point. There is no guidance, as we'll see from -- in a few slides,
`there is no guidance in the '862 patent as to where to go to come up with a
`form zoledronic acid.
`JUDGE PRATS: Actually, if I could interject there, counsel, I
`believe, not to steal patent owner's thunder here, but patent owner would
`say, well, I have told you the disodium salt, and it's of record, I forget the
`reference, Aronhime maybe, that the disodium forms were all known.
`There's seven of them, right? Or eleven. I can't remember the number, but
`there's not more than 12, let's say. So let's address that. Why is that -- why
`haven't they given you a starting point based on what was known in the art
`and what was in the spec based on what I just said?
`MR. MINION: Well, if we go to slide 17, I address this issue here.
`And what happens here and what's happened at the end of the day is sort of
`an inherent argument -- or not inherent, an inherent admission or an
`acknowledgment on patent owner's part that, yes, there is no data in the
`specification. There are no working examples in the specification. There
`are no specific guidance as to how to achieve this unenhanced form. So then
`they looked to the prior art and this Aronhime reference which does, in fact,
`teach different salt forms and the 11 different disodium salt forms of
`zoledronic acid. But that's not sufficient to enable the claims.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
` 16
`
`
`
`Case PGR2017-00022
`Patent 9,408,862 B2
`
`
`This idea of looking to the prior art and what -- sorry. Let me
`finish that thought. So here on slide 17, this is from their patent owner's
`response that Aronhime teaches how to make all these salt forms and diacid
`forms, and they are saying all you need to do is go back and test the
`bioavailability of those to figure out which ones fall within the claims and
`which ones don't. Well, it is not inventive to discover a new property of a
`known substance through routine testing.
`And here we are talking about enablement and we are talking
`about inventiveness, but they really collapse into themselves. And the idea
`is and what leads to this noninventiveness being lack of enablement is you
`cannot rely on the prior art to fill in the entire gap of your missing
`disclosure. You cannot look to the prior art to enable your claims. You can
`look to what was known by the POSA to support the claims, but that's not
`sufficient. So it's not a question of whether it was within the skill of the art
`for a person of ordinary skill -- within the skill of the art of the POSA to
`actually calculate bioavailability of known dosage forms. The question is,
`have they provided guidance from which a person of ordinary skill in the art
`can actually achieve a dosage form within the claimed range.
`And as to the --
`JUDGE PRATS: So why doesn't the -- it's undisputed that the '862
`patent discloses that the disodium salt increases bioavailability up to a great
`percentage. So why isn't that enough?
`MR. MINION: I'm not aware of anywhere in the '862 patent that it
`affirmatively states that the disodium salt increases bioavailability. There is
`a lot of statements in there that says it has increased solubility. It may allow
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
` 17
`
`
`
`Case PGR2017-00022
`Patent 9,408,862 B2
`
`for increased bioavailability. There's a lot of "mays" in the patent. But it
`never comes with data or never a statement that says the disodium salt
`enhances bioavailability. And that's not --
`JUDGE PRATS: What about I'm looking at column 7, lines 35
`and et seq, column 7, lines 35 and following, oral bioavailability zoledronic
`acid may be enhanced by orally administering in disodium salt form?
`MR. MINION: May be enhanced.
`JUDGE PRATS: But the reason I'm hammering on this, I
`understand there's no experimental data or working examples, and I don't
`think patent owner disputes that in this respect. But there is this disclosure
`here at column 7. And the question is why isn't that enough combined with
`what an ordinary -- a skilled artisan would know?
`MR. MINION: First of all, Your Honor, it doesn't say what it
`enhances it to. Remember I mentioned earlier, Your Honor, that --
`JUDGE PRATS: It says up to about 200 percent at line 40 there.
`MR. MINION: But it says the -- the 200 percent, right. So the
`enhancement is a 200 percent enhancement. But a 200 percent enhancement
`of what? It says that the unenhanced form in column 13, column 13 in the
`patent, line 11, an oral dosage form may have an oral bioavailability of
`zoledronic acid of about 0.01 percent to about 10 percent. It doesn't give
`that baseline 1 percent. So saying out of -- in sort of naked form I'm
`increasing bioavailability by a certain percent, it's the same issue that
`Dr. Wargin had with the dog bioavailability.
`JUDGE PRATS: So if I can interject, sorry to interrupt here, so
`looking at column 15, so what you are saying is when it says it could have a
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`
`
` 18
`
`
`
`Case PGR2017-00022
`Patent 9,408,862 B2
`
`bioavailability of 0.01 percent, raising it 200 percent might get you to 0.03?
`Is that what you're saying, basically?
`MR. MINION: That's right. That's, as Dr. Wilson would -- said
`what the POSA would understand from that. And that's consistent --
`JUDGE PRATS: That's in his declaration Dr. Wilson says that?
`MR. MINION: In his declaration, yes. And that's also the
`testimony of Dr. Wargin at -- in his deposition. I could find you that cite as
`well.
`
`JUDGE PRATS: Thank you.
`MR. MINION: I might add, too, this issue of the disodium salt,
`something else that Dr. Wilson made the point and you mentioned, Judge
`Prats, is Aronhime has 11 different disodium salt forms. Nowhere in the
`'862 patent does it describe how to make the particular disodium salt form.
`It doesn't say what disodium salt form. And on this issue of looking to the
`Aronhime reference and looking to the Leonard reference, I have -- you
`know, basically what they are saying is Aronhime -- and maybe take a step
`back.
`
`So Exhibit 1005, which is the original Wilson declaration, that's at
`paragraph 72, and that gets the point exactly that you said, assuming this
`range applies to the diacid form, the maximum improvement and
`bioavailability of the low end of the range would be only 0.03 percent
`bioavailability.
`JUDGE OBERMANN: Is that disputed by your friend?
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`
`
`
`
`
` 19
`
`
`
`Case PGR2017-00022
`Patent 9,408,862 B2
`
`
`MR. MINION: It's an interesting question. It's not clear. And
`there's going to be -- and it's an issue, something I intend to address in
`rebuttal, but I'll address it now.
`JUDGE OBERMANN: My corollary is I'm looking at
`paragraph 72 and it's not supported by anything objective. How do we credit
`that statement? And I guess incident to that, I guess my question is, has
`patent owner?
`MR. MINION: Has patent owner gone back on that?
`JUDGE OBERMANN: Have they cast any doubt on that bare
`opinion?
`MR. MINION: I don't believe there is a response to this particular
`point. In fact, you are going to hear a lot of discussion from Mr. Katz that
`the teaching in the prior art that the bioavailability of oral zoledronic acid
`was 1 percent, which our experts admit was well established, they are going
`to call that a fiction and they are going to say I'll show you -- if you could go
`to 38 -- here is an example. So in the Hanna reference, which I'm getting
`ahead of myself for rebuttal, there's a statement that according to the U.S.
`Food and Drug Administration summary basis of approval, the poor oral
`bioavailability, approximately 1 percent, is partially due to its poor
`permeability. In their slides they refer to this as a fiction, and they say there
`is no data in Hanna or these four other
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
