UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`KOIOS PHARMACEUTICALS LLC,
`Petitioner
`
`v.
`
`MEDAC GESELLSCHAFT FÜR KLINISCHE
`SPEZIALPRÄPARATE MBH,
`Patent Owner
`____________
`
`Case IPR2016-01370
`Patent 8,664,231
`____________
`
`Record of Oral Hearing
`Held: November 7, 2017
`____________
`
`
`
`Before JACQUELINE WRIGHT BONILLA, Vice Chief Administrative
`Patent Judge, TONI R. SCHEINER, and ERICA A. FRANKLIN,
`Administrative Patent Judges.
`
`
`
`
`
`
`
`
`
`
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`KOIOS PHARMACEUTICALS LLC,
`Petitioner
`
`v.
`
`MEDAC GESELLSCHAFT FÜR KLINISCHE
`SPEZIALPRÄPARATE MBH,
`Patent Owner
`____________
`
`Case IPR2016-01370
`Patent 8,664,231
`____________
`
`Record of Oral Hearing
`Held: November 7, 2017
`____________
`
`
`
`Before JACQUELINE WRIGHT BONILLA, Vice Chief Administrative
`Patent Judge, TONI R. SCHEINER, and ERICA A. FRANKLIN,
`Administrative Patent Judges.
`
`
`
`
`
`
`
`
`
`
`
`
`Case IPR2016-01370
`Patent 8,664,231
`
`
`APPEARANCES:
`
`ON BEHALF OF PETITIONER:
`
`
`KAYVAN B. NOROOZI, ESQUIRE
`Noroozi PC
`1299 Ocean Avenue
`Suite 450
`Santa Monica, California 90401
`310-975-7074
`kayvan@noroozipc.com
`
`
`
`ON BEHALF OF PATENT OWNER:
`
`
`JAMES F. HALEY, JR., ESQUIRE
`BRIAN M. GUMMOW, ESQUIRE
`Haley Guiliano LLP
`75 Broad Street
`Suite 1000
`New York, New York 10004
`646-973-2500
`james.haley@hglaw.com
`brian.gummow@hglaw.com
`
`and
`
`HENRY Y. HUANG, ESQUIRE
`Ropes & Gray LLP
`1900 University Avenue
`6th Floor
`East Palo Alto, California 94303-2284
`650-617-4000
`henry.huang@ropesgray.com
`
`
`
`
`
`
`
`The above-entitled matter came on for hearing Tuesday, November 7,
`2017, commencing at 10:00 a.m., at the U.S. Patent and Trademark Office,
`600 Dulany Street, Alexandria, Virginia
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`Case IPR2016-01370
`Patent 8,664,231
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`P R O C E E D I N G S
`JUDGE BONILLA: Good morning. Please be seated. Just give us a
`
`moment to get acclimated.
`
`This is a hearing this morning for IPR2016-01370, between petitioner
`Koios -- how do you pronounce that?
`
`MR. NOROOZI: Koios.
`
`JUDGE BONILLA: Koios, thank you. Pharmaceuticals LLC, and
`also the owner of U.S. Patent No. 8,664,231, Medac, I'm just going to say
`GmbH, rather than pronounce the entire German name. I apologize for that.
`
`Just a few administrator matters before we begin. Just as a reminder,
`if you are going to talk about any demonstratives today, please describe any
`slide that you present by slide number. That will make it easier to read along
`with the transcript and also for us to follow.
`
`I understand that, petitioner, you're the only one that provided slides
`today; is that correct?
`
`MR. NOROOZI: Actually, patent owner.
`
`JUDGE BONILLA: The patent owner. I'm sorry, my apologies.
`
`So there was only you all that brought slides today?
`
`MR. HALEY: That's right, your Honor. Would you like a book of
`the slides or do you have them with your copies?
`
`JUDGE BONILLA: And the court reporter would like a copy as well.
`
`MR. HALEY: May I approach?
`
`JUDGE BONILLA: Sure. Do you have enough copies for the court
`reporter?
`
`MR. HALEY: Yes. We've already given her one.
`
`JUDGE BONILLA: As you know, per our hearing order, each party
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`has 45 minutes to present their arguments. Because the petitioner has the
`burden to show unpatentability of the challenged claims, petitioner will
`proceed first, followed by patent owner.
`
`Petitioner, you may reserve rebuttal time. However, you may only
`use that time to respond, to rebut patent owner's arguments that are made
`here.
`At this time we'd like counsel to introduce themselves, who you have
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`with you, if anybody, beginning with petitioner.
`
`MR. NOROOZI: Kayvan Noroozi, on behalf of Koios
`Pharmaceuticals.
`
`MR. HALEY: Jim Haley, on behalf of Medac, and with me arguing
`today will be Brian Gummow from Haley Guiliano, Henry Huang from
`Ropes & Gray, and I also have Terry Shoemaker, who is CEO of Medac
`Pharma, who's the licensee of the patent in dispute, and two of our
`paralegals from Ropes & Gray.
`
`JUDGE BONILLA: Thank you. Petitioner, would you like to reserve
`any rebuttal time?
`
`MR. NOROOZI: Yes, I would, your Honor. I'd like to reserve 15
`minutes, please.
`
`JUDGE BONILLA: All right. You may proceed.
`
`MR. NOROOZI: Your Honors, we're here today to talk about the
`'231 patent, which has 22 claims and only one independent claim. The '231
`patent is directed to concentrated methotrexate solutions.
`
`And based on the institution order and the extensive briefing that you
`received, it's clear that the board has a firm understanding of the patent and
`the technology at issue, as well as the prior art. So my goal here is to focus
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`today in this hearing on the core issues that remain in dispute.
`
`And the dispute really here only remains with respect to patent owner
`and its lawyers. Patent owner's expert, Dr. Zizic, gave a deposition in which
`he ended up in fact agreeing with many of Koios' key positions as articulated
`by Koios' experts, Dr. Schiff and Dr. Miller.
`
`And, in fact, in some instances he even, Dr. Zizic, realized that he had
`been operating under certain misunderstandings and -- and corrected those
`during his testimony.
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`And so we began this proceeding with a very powerful evidentiary
`showing, we believe, in our petition, and now we've come to the conclusion
`of this proceeding with an even stronger showing.
`
`Notably, Medac did not take the deposition of our experts, and we
`took the deposition of Dr. Zizic, who was the only expert that we needed to
`depose, in light of the cumulativeness of the declarations that patent owner
`has put forth, as well as the specific testimony that Dr. Zizic offered.
`
`Staying true to my promise about focusing this argument, there are 22
`claims but only four of them are really in any dispute at this point. Those
`are claims 1 through 3 and claim 22. And you'll see that when you look at
`patent owner's slides and you open them up, you see in the first or second
`page they only reference those four claims.
`
`Claims 4 through 21 are not materially disputed by patent owner, but
`we've, of course, made an extensive showing as to each limitation of those
`claims, and I'm not by any means suggesting that if patent owner doesn't
`dispute something then you have to assume that it's been sufficiently proven
`in the record. We have made that showing and that's why patent owner
`doesn't dispute it.
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`Focusing on claims 1 through 3 and 22, there's a very important point
`
`I'd like to highlight here about the status of the institution and the grounds
`and the prior art and the coverage of the claims.
`
`The board instituted, with respect to both Grint and Wyeth as
`anticipatory references. However, Grint has only been asserted against
`claims 1 and 2 and 22 out of this set of 1 through 3 to 22. It has not been
`asserted against claim 3. Wyeth has been asserted against 1 through 3 and
`22.
`And Wyeth, by contrast, has not been instituted with respect to certain
`
`dependent claims. Those being 7 through 10, 14 through 16, and 19 to 21,
`whereas Grint has been.
`
`And the reason I bring this up is because we're not -- Koios is not here
`to have an abstract argument about the validity of certain claims and to hope
`to walk away winning a few of them and invalidating a few. We're trying to
`bring a product to market. And for us to do that we need to invalidate all 22
`claims. And in order to do that we need to prevail on both Grint and Wyeth,
`in order to get the coverage as to all of the claims.
`
`So it's important for us that we address any questions that the board
`may have with respect to both Grint and Wyeth and with respect to any
`particular claim so that we have addressed your concerns as to any of the 22
`claims.
`
`Focusing first on claims 1 and Grint, claim 1 has only four elements,
`essentially. And those are, one, a method of treating inflammatory
`autoimmune diseases. Two, by administering methotrexate subcutaneously.
`Three, in a pharmaceutically acceptable solvent. And four, in a
`concentration of 30 milligrams per milliliter.
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`Grint clearly teaches the first three elements, treating inflammatory
`
`autoimmune diseases by administering methotrexate subcutaneously. Grint
`teaches administering methotrexate in a pharmaceutically acceptable
`compound via subcutaneous administration for treating autoimmune
`diseases, and we've put forth evidence of that in our petition at page 13 and
`16.
`JUDGE BONILLA: So your position is that it treats -- it discloses
`
`each of those elements individually; is that correct?
`
`MR. NOROOZI: It also discloses all of them together, your Honor.
`
`JUDGE BONILLA: I think that's where we need to go. Is to explain
`why it discloses all of those in combination.
`
`MR. NOROOZI: Yes, your Honor. So let's talk about what Grint is.
`
`Grint is a patent and it has us teaching about treating inflammatory
`autoimmune diseases including arthritis and psoriasis using a combination of
`interleuken 10 and methotrexate.
`
`And in the context of the patent specification, Grint has certain
`teachings about methotrexate.
`
`Your specific question, your Honor, was about addressing the issue of
`putting everything together sort of in combination. And on that issue we
`have testimony from Dr. Schiff, right.
`
`And so Dr. Schiff's testimony is he points to the specific places in
`Grint that a person of skill in the art would look to. And he explains what in
`total a person of skill in the art would derive from those teachings. So Grint
`clearly states administering methotrexate, and it's got a parenthetical where
`it says oral I believe intramuscular and subcutaneous.
`
`And so subcutaneous methotrexate is absolutely disclosed by Grint.
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`Using subcutaneous methotrexate for the treatment of inflammatory
`autoimmune diseases is absolutely disclosed by Grint.
`
`I think the dispute, if any, is as to -- is as to the teaching of the 40-
`milligram-per-milliliter concentration in Grint. And rather than sort of try to
`guess at the specific issue you have in mind, if -- if it would be helpful to
`you, I'd be happy to address a specific question you have on that teaching.
`
`JUDGE BONILLA: Well, basically, this is column 7 of Grint. It
`talks about -- it does mention the subcutaneous, but it talks about the dose of
`methotrexate was 12.5 to 25 milligrams per week. So I'm trying to figure
`out how that gets you to the concentration of more than 30 milligrams per
`ml. in relation to subcutaneous in particular.
`
`MR. NOROOZI: Okay. And one point that we have emphasized, and
`I believe from your question that it's clear, but I just want to make doubly
`sure, is the distinction between dosage and concentration.
`
`And so dosage is just the absolute amount of the drug that you're
`giving, and the concentration is the amount of that drug in a solution of
`water or saline or something else.
`
`And the claims here, the Medac '231 patent claims, are all about --
`well, at least the independent claims, are all about the concentration, not the
`dosage.
`
`Now, Grint teaches that 12 1/2 to 25-milligram concen -- excuse me,
`dosage as being within the most preferred range, but it also teaches a
`preferred range of I believe one milligram to 35 milligrams. And Dr. Schiff
`talks about that example in his declaration. He says Grint teaches 1 to 35.
`So 35 at the top end is within the preferred range.
`
`And, by the way, that's totally consistent with the state of the art,
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`right. If you look at Dr. Zizic's testimony, he explains at length that prior to
`July 2006 --
`
`JUDGE BONILLA: Could you show us real quick in the record
`where it says 1 to 30?
`
`MR. NOROOZI: 1 to 35.
`
`JUDGE BONILLA: 1 to 35, where is that?
`
`MR. NOROOZI: Yes, your Honor. It is, for instance --
`
`JUDGE BONILLA: Are you talking about in column 6 where it talks
`about the unit dosage form? This is units in milligrams?
`
`MR. NOROOZI: I am talking about -- why don't I just bring up Dr.
`Schiff's declaration for you, and we can look at it right there.
`
`Right here. Column 6, the quote is "methotrexate in amounts ranging
`from," and there's an ellipses here.
`
`JUDGE BONILLA: Right. And that's just the amount, milligrams.
`That doesn't translate to milligrams per week or milliliters per ml., for that
`matter.
`
`MR. NOROOZI: Correct. And the 12 1/2 to 25 milligram that you
`pointed is also dosage. It's just milligrams. It's not concentration.
`
`JUDGE BONILLA: I see it has .1 per 40 milligrams per ml. of
`carrier.
`
`MR. NOROOZI: Yes.
`
`JUDGE BONILLA: The question is, how do we know that that
`translates to subcutaneous?
`
`MR. NOROOZI: So two -- there are actually a lot of pieces of
`evidence that go to that point.
`
`First of all, when it talks about milligrams per milliliter, because it's a
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`concentration, we know that it is only talking about a solution. It's not
`talking about oral.
`
`And Grint has only three options for the administration format that it
`talks about. One is oral. The other is subcutaneous. And let me just pull it
`up right here. The third is intramuscular, right.
`
`Now, the question is what would one of ordinary skill in the art have
`derived from the teachings of Grint. Grint does not expressly ever have to
`say in one sentence, take subcutaneous methotrexate in this concentration
`and administer it for the treatment of rheumatoid arthritis. Those teachings
`are in Grint. And when a person of skill in the art with the relevant
`knowledge at the critical date reads Grint, the question is what do they
`derive from it.
`
`And clearly the evidence demonstrates that a person of skill would
`have known to use methotrexate subcutaneously in these dosages. There's
`lots of evidence of that. Dr. Schiff talks about it, for example. Dr. Zizic --
`
`JUDGE BONILLA: Is Dr. Schiff's testimony the only evidence that
`you have?
`
`MR. NOROOZI: No, your Honor. Dr. Zizic talks repeatedly about
`the fact that prior to July 2006 he was regularly prescribing methotrexate
`subcutaneously to patients in these same dosages that are discussed in Grint.
`And he was doing that over intramuscular. It was the preferred route.
`
`Now we have, in terms of teachings that show what the --
`
`JUDGE BONILLA: Sorry. So you're pointing us to evidence by Dr.
`Zizic that says that he used methotrexate per subcutaneous at the 30
`milligrams per ml. or higher concentration?
`
`MR. NOROOZI: To clarify, your Honor, not quite. Dr. Zizic
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`testified that prior to July 2006 he was regularly prescribing methotrexate
`subcutaneously rather than intramuscularly.
`
`As for concentration, though, his testimony was that the only
`concentration that was available to him in his clinic in a commercially
`available product was a 25-milligram-per-milliliter commercially available
`product. So he said he wanted to. He said he thought of using
`concentrations above 25 milligrams per milliliter before July 2006.
`
`So he had the invention, the purported invention of the '231 patent in
`his own mind prior to July 2006, but he didn't have access to a commercial
`product in his clinic with which to implement the invention.
`
`JUDGE BONILLA: Now, one thing the patent owner points us to is
`language in column 5. Methotrexate may be administered in an amount that
`is conventional practice.
`
`Based on the testimony you just talked about from Dr. Zizic, it implies
`that if you're going to do it subcutaneous that it would have been
`conventional to do 25 milligrams per ml. or less. Can you respond to that?
`
`MR. NOROOZI: Yes, your Honor.
`
`So Grint talks about administering methotrexate in a conventional
`manner and I have that section of Grint pulled up right here on the screen.
`It's at column 5, starting at line 22.
`
`And there are a few things to note here. First of all, the sentence says
`methotrexate may be administered in a manner as is conventionally
`practiced. It does not say only administer it in whatever conventional
`practice means. It says it may be done that way.
`
`And, more importantly, immediately after that we see that what it's
`talking about are different dosage formats, not concentrations, right. And
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`not even dosages. But dosage format.
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`So right after it says, for example, methotrexate may be orally
`administered. It also talks about hard or soft shell gelatin capsules. It talks
`about tablets. It talks about food.
`
`Now, here's the thing: When it talks about conventional practice, it
`certainly does not expressly negate concentrations above 30 milligrams
`milliliter. It does not say conventional practice is 25 milligrams per
`milliliter. It does not say do not do above 30 milligrams per milliliter.
`
`But later on, in the section that we rely on, Grint says, at the bottom of
`column 6, top of column 7, beginning at line 16, column 6, "methotrexate is
`compounded for convenient and effective administration in effective
`amounts," right. And so that's a general teaching. And everybody on both
`sides that has given -- well, let me back up a second.
`
`Dr. Schiff, Dr. Miller, Dr. Zizic all agree, and it's clear from the
`evidence, that a person of skill in the art knows how to balance dosage and
`concentration to get appropriate volumes.
`
`So a person of skill in the art isn't going to take a very low dosage
`amount and pair that with a very high concentration to end up with such a
`tiny volume that they can't administer it. They know not to do that. That's
`just simple, right. We're dealing with actual tangible things. It's liquid. You
`know how much you need to administer. You know what's an appropriate
`amount. And the art shows in the record that when you go above one
`milliliter the injections, especially subcutaneously, become painful.
`
`So there was a motivation in the art, and everyone knew about it, to
`stay within one milliliter. It has advantages in terms of pain tolerance and
`things like that, and that has ongoing advantages in terms of people staying
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`So when Grint talks about
`with their medication and so forth.
`compounded for convenient and effective administration, it later, just a few
`sentences after that, says specifically that methotrexate is generally present
`in from about 0.1 to about 40 milligrams per milliliter of carrier. That's a
`concentration, right. Milligrams per milliliter.
`
`Certainly, certainly, Grint's statement about conventional practice
`can't be read to negate its specific teaching of a range up to 40 milligrams
`per milliliter.
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`JUDGE BONILLA: But the question is whether one would have read
`this to say that when you're doing it subcutaneous, as opposed to a different
`form of administration, that you actually would use doses that are higher
`than 30 milligrams per ml. or higher. That's what we're looking for,
`evidence of that.
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`Other than Mr. -- Dr. Schiff's opinion, is there anything else to suggest
`that, for example, if you go to doses that high, that you would use it for
`subcutaneous, as opposed to orally or intramuscularly?
`
`MR. NOROOZI: And, your Honor, let me reiterate a very important
`point here. It is not possible to use 40 milligrams per milliliter orally
`because it's a conservation, and it can only be for a solution. So it can't be in
`a tablet. So the only options are subcutaneous or intramuscular.
`
`And you have abundant evidence in the record from Arthur, from
`Moitra, from Alsufyani, from numerous references, even Wyeth, that teach
`that subcutaneous and intramuscular are interchangeable. There is no reason
`you would ever use intramuscular but not subcutaneous. This was known in
`the art prior to 2006. And, in fact, quite the opposite. Subcutaneous is
`established to be far more advantageous than intramuscular prior to July
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`2006.
`And the teachings of references like Arthur and Moitra and Alsufyani
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`and others is to move patients over from intramuscular to subcutaneous. By
`contrast, there is not a single piece of evidence in this record, from patent
`owner or otherwise, that says, here's why anyone would use a particular
`concentration of methotrexate only intramuscularly but not subcutaneously.
`
`So they've never made the argument that -- that someone would have
`taken, for example, a 40-milligram-per-milliliter concentration of
`methotrexate as taught in Grint and only understand that to be apply it
`intramuscularly but not subcutaneously. They don't have that argument, and
`they can't make that argument on the face of this evidence, in light of Arthur
`and Moitra and other teachings that are in this record.
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`Does that address the question, your Honor?
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`JUDGE BONILLA: Yes. Let me ask you another question. And this
`is something that the patent owner raises.
`
`They say that this discloses a range, and the patent -- the claims are
`directed to a particular range. And the case law indicates that when the prior
`art discloses a range rather than specific points at issue in the claims, the
`prior art is only -- anticipates that it describes with sufficient specificity it
`says that a reasonable fact finder can conclude there are no reasonable
`differences in how the invention operates over those ranges.
`
`What can you say about evidence in that regard?
`
`MR. NOROOZI: Yes, your Honor. Thank you.
`
`So, first of all, they make an error, patent owner does, in the way that
`they try to argue this point, and I want to clear that up.
`
`The case law, including the Ineos v. Berry case, makes it very clear
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`that the -- when there is a range that is claimed by the patent owner, and
`there is an overlapping range that is taught in the prior art, that the
`overlapping range anticipates, unless there is evidence that the claimed range
`is critical to the operability of the claimed invention.
`So here, applying
`that law, would mean that they would need -- patent owner would need to
`put forth evidence that the ranges recited in their own claims are critical to
`the operability of the invention that they have claimed.
`
`Instead, they try to argue about whether the ranges recited in Grint
`would operate differently across the different points in the ranges. That's not
`the inquiry, right. The inquiry is whether the claimed range is critical to the
`operability of the invention.
`
`And that's relevant to your question about specificity, because the
`patent itself teaches that the invention, as set in the specification, is any
`concentration of methotrexate beginning just above 25 milligrams per
`milliliter and going up to 150, right. And they've only claimed 30 and
`above, 30 to 100, 50 specifically, and 40 to 80.
`
`So their own teaching is that just above 25, to 30, to 50, to 80, to 125,
`to 133, to 149, it's all the same thing. It makes no difference. And they have
`no evidence whatsoever that shows that when you move across different
`points in their claimed range that you end up with a different operability or
`lack of operability in the invention.
`
`Grint --
`
`JUDGE BONILLA: So if I'm understanding you correctly, you're
`saying that it's patent owner's burden of production to show that their
`claimed range is critical over what's there in the prior art, or what's there -- is
`that what you're saying?
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`MR. NOROOZI: So, your Honor, I will point you to a direct quote
`
`from Ineos v. Berry. However, I want to preface this issue of the burden by
`saying the following: The burden issue here does not matter ultimately,
`because we, even though we don't have the burden as the petitioner, we have
`put forth the evidence that their claimed range is not critical to the operation
`of the invention.
`
`We've done that through the testimony of Dr. Schiff, who talks about
`the teachings of the patent, the '231 patent, which say that from 25 -- just
`above 25 to 150 milligrams per milliliter, that's their -- that's their idea of the
`invention and it all works the same. There's no difference. So Ineos --
`
`JUDGE BONILLA: So it sounds to me like you don't think it's
`relevant. If the prior art discloses something much lower than 25, that it
`doesn't matter. That the criticality of that one way or the other doesn't
`matter. It's just the greater than 25 to 100 is what you're referring to?
`
`MR. NOROOZI: Well, and that's partially correct. And here's why
`that's true under the law Judge Wright-Bonilla: The entire doctrine of law
`we're talking about is a doctrine of overlapping ranges.
`
`So it necessarily means that you have some part -- it's like --
`withdrawn. I'm sorry. It's like a Venn diagram, right. There's going to be
`some part that's not fully within the claimed range, and yet the doctrine of
`law says that when the prior art teaches a range that overlaps with the
`claimed range, the prior art anticipates, unless there is evidence that the
`claimed range is critical to the operation such that the -- of the invention
`such that the invention would operate differently or not at all.
`
`And very importantly on this point, we explained in our petition, it's
`not enough to show that the -- that different points in the claimed range lead
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`to greater convenience or they have some kind of a practical benefit. It has
`to be evidence that the invention would not operate or would -- or would
`operate entirely differently, right.
`
`So it has to be critical to the invention. There's no evidence like that.
`They haven't even tried to show it.
`
`JUDGE FRANKLIN: Criticality here is a bit unique because what
`we're looking at are method claims, right. And, at least with respect to claim
`1, we are not looking at any dosage.
`
`So when you're talking about the criticality here, you're really talking
`about the method of treating a certain disease condition, right. Inflammatory
`autoimmune disease. You're not talking about a product in particular, but
`the use of that product. Where we don't have, forgive me for saying, the
`critical step of administering a certain dose to determine a criticality with
`respect to the claim.
`
`You said you endeavored to take on the burden of showing that there
`is no criticality for claimed range or concentration. Did you acknowledge
`these points in that argument?
`
`MR. NOROOZI: About the dosage not being in the claim?
`
`JUDGE FRANKLIN: Right.
`
`MR. NOROOZI: Well, we didn't exact talk about that issue. But it is
`an issue that is important to recognize. Of course, throughout our briefing
`we talk about the important distinction between dosage and concentration
`and the number of ways in which dosage really does matter a lot to what you
`do with methotrexate.
`
`It can have toxicity implications. It can have important implications
`on what kind of patient you're treating for what kind of disease. Children
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`often get different dosages. The way that you --
`
`JUDGE FRANKLIN: And I think we understand that, so I don't want
`you to spend your time on that. But in terms of a claim that's reciting a
`concentration, I'm struggling to understand what criticality -- and maybe I'll
`save this question so, you know, here's a heads up for patent owner -- but
`what is -- what criticality are we looking at? What aspect, what quality of
`this claim are we looking at in terms of criticality? Because we're not
`talking about stability of a product.
`
`MR. NOROOZI: Well, you talk about stability of the product. It
`could in theory be in some product that maybe the difference in
`concentration makes a difference in the stability.
`
`It could have -- in some other products there could be all kinds of
`things that could happen. In this product, concentration has just one
`implication. When we're talking about subcutaneous format, right. Because
`intrathecal is something else. There are different formats that have different
`concentration implications. But subcutaneous and intramuscular.
`
`The only thing that concentration increases do within the ranges that
`they've claimed is they make the volume of the solution smaller. That's it.
`That's all they do.
`
`And it's a convenience benefit that allows you to administer higher
`dosages in the same volume of solution or lower, which lets you give people
`one shot, which lets them have less painful shots and things like that. But
`there is no criticality, in terms of the law of criticality, to moving from 30
`milligrams per milliliter to 50 to 80 or anything like that.
`
`And their own patent makes that clear, right, because it talks about 25
`-- just above 25 to 150 as all being the invention.
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`And let's just zoom out for one second here and think about what
`
`they've done, right. They're sitting there in July 2006, they're looking at the
`field of art. And the field of art is that it is standard to give people 25
`milligrams per milliliter subcutaneously.
`
`And they sit and they write a patent that says, well, why don't we
`claim -- why don't we say that it's an invention to come up with 25.1, 25.01.
`How about we go own that, right. And they say, well, maybe that's too bold.
`So in our claims let's go to 30.
`
`But the problem is that there's nothing special about that move.
`There's nothing special about that move, and it's not taught in the patent that
`there is.
`
`The patent doesn't have a single teaching that says, here's why it's a
`gigantic or even a minor breakthrough of human intellectual thought to go
`from 25 to 30 or even to 50.
`
`And the bigger problem is that we have Wyeth and Grint that teach
`doing that already. Wyeth is an FDA-approved product. It's approved for
`50 milligrams per milliliter.
`
`In his deposition, Dr. Zizic admitted he would take the 50-milligram-
`per-milliliter solution of Wyeth, and he would administer it to a patient for
`the treatment of rheumatoid arthritis and other inflammatory diseases
`subcutaneously, right. If that were the product that were available to him,
`and he had no other option, he would use it.
`
`And the local toxicity concerns he talks about are addressed at the
`very end of his deposition. And there you will see that he says, well, when a
`person of skill has experience administering a certain dosage and knows that
`that's safe, such as 25 milligrams or 40 milligrams, then they would have
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`been comfortable moving to a higher concentration, such as from 25
`milligrams per milliliter to 50 milligrams per milliliter for the dosage that
`they'd already been working with.
`
`And I see --
`
`JUDGE BONILLA: The patent owner says that nobody ever did it,
`though. Nobody ever moved it up. And your response to that is
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