trials@uspto.gov
`571-272-7822
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`IPR2016-00712, Paper No. 98
`July 20, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
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`MYLAN LABORATORIES LIMITED,
`Petitioner,
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`v.
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`AVENTIS PHARMA S.A.,
`Patent Owner.
`____________
`
`Case IPR2016-00712
`Patent 8,927,592 B2
`____________
`
`Held: June 13, 2017
`____________
`
`
`
`
`BEFORE: BRIAN P. MURPHY, TINA E. HULSE, and
`CHRISTOPHER M. KAISER, Administrative Patent Judges.
`
`
`The above-entitled matter came on for hearing on Tuesday, June
`13, 2017, commencing at 2:00 p.m., at the U.S. Patent and
`Trademark Office, 600 Dulany Street, Alexandria, Virginia.
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`571-272-7822
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`IPR2016-00712, Paper No. 98
`July 20, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MYLAN LABORATORIES LIMITED,
`Petitioner,
`
`v.
`
`AVENTIS PHARMA S.A.,
`Patent Owner.
`____________
`
`Case IPR2016-00712
`Patent 8,927,592 B2
`____________
`
`Held: June 13, 2017
`____________
`
`
`
`
`BEFORE: BRIAN P. MURPHY, TINA E. HULSE, and
`CHRISTOPHER M. KAISER, Administrative Patent Judges.
`
`
`The above-entitled matter came on for hearing on Tuesday, June
`13, 2017, commencing at 2:00 p.m., at the U.S. Patent and
`Trademark Office, 600 Dulany Street, Alexandria, Virginia.
`
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`MATTHEW R. REED, ESQUIRE
`JAD A. MILLS, ESQUIRE
`STEVEN PARMELEE, ESQUIRE
`Wilson, Sonsini, Goodrich & Rosati, P.C.
`650 Page Mill Road
`Palo Alto, California 94304
`
`
`ON BEHALF OF PATENT OWNER:
`
`
`
`
`
`WILLIAM E. SOLANDER, ESQUIRE
`DANIEL J. MINION, ESQUIRE
`Fitzpatrick, Cella, Harper & Scinto
`1290 Avenue of the Americas
`New York, New York 10104-3800
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`Case IPR2016-00712
`Patent 8,927,592 B2
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`APPEARANCES:
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`ON BEHALF OF THE PETITIONER:
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`Case IPR2016-00712
`Patent 8,927,592 B2
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`
`P R O C E E D I N G S
`- - - - -
`JUDGE MURPHY: Good afternoon. We will now
`hear arguments in IPR2016-00712, Mylan Laboratories versus
`Aventis Pharma. The case concerns patentability of the claim in
`U.S. patent number 8,927,592. I'm Judge Murphy. We also have
`Judge Hulse and Judge Kaiser appearing remotely.
`Would counsel for the parties please introduce
`yourselves.
`MR. REED: Thank you and good afternoon. Matthew
`Reed on behalf of petitioner, Mylan Laboratories Limited. With
`me today are lead counsel, Steven Parmelee and my colleague Jad
`Mills.
`
`JUDGE MURPHY: Welcome, counsel. Thank you.
`MR. REED: Also present is Ms. Vinny Lee, in-house
`counsel at Mylan.
`JUDGE MURPHY: Welcome to the Board. Thank
`you, Mr. Reed.
`MR. SOLANDER: Good afternoon, Your Honor. My
`name is William Solander on behalf of the patent owner, Aventis.
`With me is Daniel Minion and our lead counsel, Dominick
`Conde, and we are assisted today by Ms. Whitney Meier and
`Ms. Katherine Adams.
`JUDGE MURPHY: Thank you, Mr. Solander.
`Welcome, counsel. Per our oral hearing order, each side will
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`have 60 minutes in total. Petitioner has the burden of proving
`patentability by a preponderance. So Mr. Reed, you will begin.
`You may reserve rebuttal time both to address the opposition as
`well as the contingent motion to amend. Mr. Solander, you also
`may reserve rebuttal time if you wish, but only for addressing the
`contingent motion to amend. Understood?
`MR. SOLANDER: Yes.
`JUDGE MURPHY: The hearing is open to the public.
`We'll have a full transcript prepared in due course. Do be
`mindful of that. A couple of reminders and one kind of question
`or advice for counsel for petitioner, but when you start, because
`Judge Hulse and Judge Kaiser are remote, they do have your
`demonstratives, but they cannot see them when you put them up
`on the screen in this hearing room. They don't have a camera that
`accesses the screen. So it's particularly important for you to take
`your time and identify the demonstratives as you go through so
`that everyone can follow with you, our court reporter can get a
`good transcript, et cetera.
`Now, counsel for petitioner, Mr. Reed, we identified
`two slides, 33 and 34, that have the confidentiality legend on
`them. This is a public hearing. So what I would urge you to do is
`not rely on them if you can help it and try and talk around them
`and don't put them up on the screen because it is a public hearing.
`Is that acceptable?
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`Patent 8,927,592 B2
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`MR. REED: Yes, Your Honor. And I would just note
`that we were informed that the audio-visual equipment is actually
`not working today. So we weren't planning to publish any of our
`demonstratives. And we were hoping that all three members of
`the panel would have hard copies or at least soft copies that they
`can access during the argument.
`JUDGE MURPHY: We do have electronic copies. I
`printed out hard copies, but if you have a hand-up copy, I'm
`happy to take it.
`MR. REED: Yeah, we do have hand-up copies. It
`would be a little hard to hand to Judge Hulse and Judge Kaiser.
`JUDGE MURPHY: Right.
`MR. REED: We've also provided a copy to the court
`reporter.
`JUDGE MURPHY: Thank you. Okay. So counsel, we
`have, I don't know if you have appeared in this hearing room, but
`we have a countdown clock behind us. So when you select how
`much time you wish, I'll set it to that time and it will count down.
`You'll get a two-minute yellow light followed by the red light for
`your warning. Mr. Reed, do you wish to reserve some rebuttal?
`MR. REED: Yes, Your Honor, I would like to reserve
`20 minutes for rebuttal. And that just so happens to be the
`amount of time that's already displayed on the clock.
`JUDGE MURPHY: Funny how that works.
`MR. REED: I guess I got it right at least so far.
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`JUDGE MURPHY: Whenever you are ready, please
`
`begin.
`
`MR. REED: Thank you. And I will try to refer to the
`slides. I appreciate the opportunity to address the Board today,
`and I'll first explain why the current claims of the '592 patent are
`unpatentable including the six grounds on which the Board
`instituted review. And in rebuttal, in the remaining time, I will
`explain why patent owner's proposed substitute claims are
`unpatentable.
`Going through the slides somewhat briefly, slide 3 sets
`forth the six grounds on which the Board instituted review. The
`'592 patent includes only two independent claims, claims 1 and
`27, both of which are included in ground 1. The primary
`references for ground 1 with Winquist and the TROPIC listing.
`And in its institution decision, the Board exercised its discretion
`to include Winquist and the TROPIC listing in view of Attard and
`Beardsley.
`Ground 1 covers the majority of the claims at issue.
`Each of grounds 2 through 5 covers dependent claims and
`includes the Winquist and TROPIC listing references plus one
`additional reference each, and of course ground 6 covers one last
`dependent claim and is basically a combination of grounds 4 and
`5.
`
`Before we get into the grounds and looking quickly at
`slide 4, the prior art is a serious problem for patent owner here.
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`There are several aspects of this problem, but in simple terms,
`patent owner starts at the wrong place and ends at the wrong
`place. I say that patent owner starts at the wrong place because it
`often refers to cabazitaxel as the invention. The compound
`cabazitaxel is not the invention. That was, in fact, covered by a
`completely different patent.
`JUDGE MURPHY: Well, we have method of treatment
`claims, right? Not compound claims.
`MR. REED: That's exactly right. And in fact,
`treatment of prostate cancer with cabazitaxel is not the invention.
`Treatment of post docetaxel metastatic castration-resistant
`prostate cancer with cabazitaxel plus prednisone is not even the
`invention. It's a method of treating. These other aspects are
`unquestionably found in the prior art. So they start at the wrong
`place.
`
`And I say that they end at the wrong place because they
`run afoul of the legal standard for obviousness. Patent owner
`does that in the context most specifically of a reasonable
`expectation of success by trying to focus on the results of a prior
`art method confusing the appropriate standard of patentability
`with such things as successful phase III clinical trial results or
`regulatory approval by FDA. They overlook the fact that this
`claim does not contain any novel elements of the claims or
`objective indicia. That incorrect approach is at the heart of the
`parties' dispute.
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`JUDGE MURPHY: Well, I think I agree that's the heart
`of the dispute. So why don't you take me through your view of
`the claim. In particular, we had the decision to institute ruling
`where the preamble was determined to be nonlimiting. Patent
`owner has not contested that in the response. So what are we to
`make of the preamble at this point when assessing the reasonable
`expectation of success?
`MR. REED: For purposes of the current claims, and if
`we could turn to slide 8, we see the language of the two
`independent claims, claims 1 and 27, set forth. And as you note,
`the Board instituted and decided that the two preambles were not
`limitations. They were nonlimiting. And the differences between
`the rest of the language of these two claims could be
`characterized as somewhat slight. There are differences between
`the types of prostate cancer here and differences in the corticoid,
`the final element of the claims.
`JUDGE MURPHY: Well, the preambles are different,
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`right?
`
`MR. REED: The preambles are certainly different but
`they are nonlimiting. So to the extent that they are directed to
`different patient populations, claim 1 is a patient who has been
`diagnosed with prostate cancer and who has progressed during or
`after treatment with docetaxel. And then claim 27, likewise,
`includes a patient who is diagnosed with castration-resistant or
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`Patent 8,927,592 B2
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`hormone refractory metastatic prostate cancer that has progressed
`during or after treatment with docetaxel.
`So in terms of the patient population here, there is a
`slight difference. But in terms of the limitations that could have
`been found in the preamble, they do not get imported into the
`claims. They are not part of the elements that must be met in
`order to prove obviousness.
`JUDGE MURPHY: So how does that impact the test
`for reasonable expectation? The patent owner has put in a huge
`amount of evidence directed to therapeutic efficacy, successful
`treatment results particularly in phase III. The phase III protocol
`is prior art. The results aren't. So they are emphasizing the
`results.
`
`So my question for you is, based on the case law, what
`is the appropriate standard for assessing and weighing that
`evidence against these claims?
`MR. REED: Quite frankly, we respectfully submit that
`that evidence is irrelevant. There is no therapeutic efficacy
`requirement as a part of the current claims. For purposes of this
`initial discussion, I'm going to limit myself to the current claims.
`We may have further discussion on the same topic when we get
`to the rebuttal and we address the proposed substitute claims. But
`for purposes of the current claims, our position is that therapeutic
`efficacy is absolutely not a claim element, and the evidence that
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`petitioner -- or that patent owner has submitted to try and rebut
`the showing of what is present in the prior art is simply irrelevant.
`JUDGE MURPHY: So in your view, let's take claim 1,
`right, I have claim 1 at least up on my screen, your slide 9 --
`excuse me, claims 1 and claims 27.
`MR. REED: I think it's slide 8, just so the record is
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`clear.
`
`JUDGE MURPHY: Yeah, that's what we want. So just
`take claim 1. In terms of the appropriate test in obviousness,
`what is the successful result of the claimed method that a person
`of ordinary skill needs to have a reasonable expectation of?
`MR. REED: So they have to have a reasonable
`expectation of combining these references to achieve the claimed
`invention. And the claimed invention here are the four elements
`that remain if you take out the preamble. So it's a patient with
`prostate cancer that's progressed during or after treatment with
`docetaxel. It is administering 20 to 25 milligrams per meter
`squared of cabazitaxel or a hydrate or solvate thereof, and doing
`so in combination with a corticoid. Every one of those elements
`is disclosed in the prior art.
`JUDGE MURPHY: Is there any dispute about that in
`terms of what the Winquist and TROPIC listing discloses versus
`claim 1?
`MR. REED: I think the extent of the dispute might
`reference the language that says progressed during or after
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`Patent 8,927,592 B2
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`treatment with docetaxel, where the Winquist reference teaches
`treating patients who are post docetaxel patients. It doesn't
`explicitly say in Winquist that those patients have progressed
`during or after treatment with docetaxel, simply that they are now
`being treated after having previously been treated with docetaxel.
`And slide 10 illustrates this. It includes the excerpt there of the
`Winquist reference and it explicitly talks about how that is
`directed to patients that were previously treated with docetaxel.
`So it doesn't explicitly say that has progressed, but it's implied.
`The only reason a patient would be treated with cabazitaxel after
`having previously been treated with docetaxel is if that patient
`has progressed.
`JUDGE MURPHY: Was there expert testimony on that
`
`point?
`
`MR. REED: There is. In fact, turning to slide 11, both
`experts, both sides' experts addressed this issue. Petitioner's
`expert, Dr. Seth, explicitly points out that if docetaxel had been
`effective at stopping progression, second-line treatment would be
`unnecessary. We wouldn't be treating with cabazitaxel if the
`docetaxel had been effective. Similarly, the patent owner's
`expert, Dr. Sartor, testified at deposition that if a patient had not
`progressed, he would not be treating that patient.
`JUDGE MURPHY: So the notion that is a disclosure
`that a patient had previously been treated with docetaxel and was
`now being treated with cabazitaxel in terms of the prior art
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`disclosures, your argument is that it, by definition, must mean
`that there was progression either during or after the docetaxel
`treatment?
`MR. REED: Absolutely. And lest there be any doubt
`about that, the TROPIC listing is even more explicit. It removes
`any doubt at all. Turning to slide 12, the TROPIC listing set forth
`the inclusion criteria for those who could participate in this
`clinical trial. And it explicitly states that a patient must have
`documented progression of disease. This is in addition to
`everything else in the TROPIC listing. It lists the type of prostate
`cancer and it lists the fact that cabazitaxel is being administered
`in combination with prednisone.
`So that's why we are looking at an obviousness
`combination here between Winquist and the TROPIC listing.
`You put those two together and as the Board, we think, correctly
`found in the institution decision, combining those is, to put it in
`layman terms, a no-brainer because they both describe the same
`listing. They both refer to the same --
`JUDGE MURPHY: Let me ask you about that. Is
`example 1 in the patent, is there a dispute that example 1 in the
`patent discloses essentially -- not essentially. It does disclose the
`TROPIC study including the data and results?
`MR. REED: I don't think there is a dispute about that. I
`think example 1 is setting forth both the protocol which had
`previously been disclosed and then the results. So the big
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`question here is were those results necessary in order to get the
`patent in the first place.
`JUDGE MURPHY: Well, didn't the examiner cite them
`in his reasons for allowance, the data?
`MR. REED: Patent owner cited to this idea of efficacy
`being necessary. There was another thing that was cited here, and
`it had to do with the dose, 20 to 25 milligrams that had to be
`added in by amendment. But the appreciation of what the method
`that was a hundred percent disclosed would achieve is something
`that is not necessary to patentability.
`In fact, in the petition at page 52 we quoted the In re:
`Montgomery case which says, quote, it is well established that a
`patent may be secured and typically is secured before the
`conclusion of clinical trials. And this is entirely consistent with
`petitioner's position that we didn't need to wait until the results of
`that phase III trial in order to get the patent. In that same case,
`the Federal Circuit cites with approval the Patent Office's
`procedure that, quote, if an applicant has initiated human clinical
`trials for a therapeutic product or process, office personnel should
`presume that the applicant has established that the subject matter
`of that trial is reasonably predictive of having the asserted
`therapeutic utility.
`So it's not proving the therapeutic efficacy. It's having a
`reasonable expectation. That is the appropriate standard for
`patentability. That's what should be focused on here, both by the
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`Board and by the parties in their arguments today. Not whether it
`was successful in its phase III trial. Not whether or not it
`received approval from FDA.
`JUDGE MURPHY: With regard to In re: Montgomery
`in particular, I read that case. What is your response to my two
`questions, which are, one, it's distinguishable because it was
`inherent anticipation? You are arguing obviousness. Not
`inherent anticipation. And two, when I read the case there were
`statements that the patent involved in In re: Montgomery did not
`disclose any clinical trial data. It didn't have the results.
`Whereas, the patent here does have results.
`MR. REED: The first question about whether that was
`an anticipatory reference or in here obviousness combination is,
`quite frankly, a red herring. Patent owner pointed that out in the
`papers that were submitted to the Board, but the fact that it was in
`the context of anticipation does not change the fact that patents
`are issued before clinical trial results are in.
`And the second point, the fact that human clinical trials
`had been initiated is reasonably predictive of having that
`therapeutic utility.
`JUDGE MURPHY: Are we bound by such a finding?
`Is that what you are saying? Are we legally bound in this case by
`that statement?
`MR. REED: I do believe that that Federal Circuit
`authority stands for the proposition that in this case, in the context
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`of obviousness, a reasonable expectation of success has been
`established.
`JUDGE MURPHY: But it wasn't an obviousness case.
`MR. REED: It certainly wasn't. It was anticipation for
`sure. Here we are talking about obviousness of two references
`combined having every element. And the question really boils
`down to not so much was there a motivation to combine, because
`I think the patent owner conceded that. It's whether there is a
`reasonable expectation of achieving the claimed invention. And
`here the reasonable expectation comes from the fact that human
`clinical trials had been initiated.
`In fact, they were reported in the Attard reference which
`the Board added as part of this ground 1. There were results
`showing that cabazitaxel had anticancer activity in prostate
`cancer patients who were post docetaxel. There was evidence of
`anticancer activity. In other words, this reasonable expectation is
`based on the fact that there were human clinical trial results. That
`goes beyond what was disclosed in Montgomery.
`Further, the later phase II trial that occurred, it's
`reported in the Pivot reference and it's discussed in Beardsley.
`Beardsley is the reference that the Board explicitly added to the
`ground 1 references. In Beardsley there's a discussion of the fact
`that this cabazitaxel compound was administered to breast cancer
`patients and that it had efficacy and that based on that efficacy in
`breast cancer, a phase III trial had begun in prostate cancer. Now,
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`it's all fine and well for us years later to be looking backwards
`and imagining what would we have thought based on the Attard
`reference, based on Beardsley. But Beardsley herself explicitly
`states that at least in part the phase III clinical trial was begun
`based on the results of what was done in phase II in breast cancer.
`So we do have evidence of activity in prostate cancer
`and in fact, docetaxel refractory prostate cancer. And we do have
`evidence of activity in breast cancer in a phase II trial, so much so
`that it was part of the reason to move forward to a phase III. That
`is a reasonable expectation of success.
`Now, that's not yet successful phase III clinical trial
`data, and it is not yet FDA approval, but those are the wrong end
`points. That's why I said at the beginning they start at the wrong
`place and they end at the wrong place. They start with
`cabazitaxel as a compound many times over. They end at the
`wrong place by trying to hold us to you've got to get to proving to
`a level satisfactory to FDA with successful phase III clinical trials
`that this will be efficacious in patients. So they have it wrong
`both coming and going, so to speak.
`JUDGE HULSE: Counsel, can I ask a quick question.
`Are you saying that any time that there is a phase III clinical trial
`that there must be a reasonable expectation of success?
`MR. REED: I am not saying that quite as boldly as you
`just characterized it. What I am saying is that in this case where
`not only were there phase I and phase II trials and results, but also
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`phase III initiated with this activity that was noted in both of the
`phase I and II trials, and given what the Manual of Patent
`Examining Procedure tells us about reasonably predictive of
`therapeutic utility, that there was certainly a reasonable
`expectation of success given the combination of Winquist and the
`TROPIC listing.
`JUDGE HULSE: And what is your response to patent
`owner's argument that the phase I, that the Mita phase I study
`really only showed just a single patient, that that's not really --
`MR. REED: Well, it's a number of patients. There
`were 25 patients total, eight of whom had prostate cancer. Of
`those eight, two showed that there was anticancer activity. One
`of those two happened to be post docetaxel. So it is a small
`number, but it is evidence showing that a person of ordinary skill
`in the art would consider to be a sufficient basis to find a
`reasonable expectation of achieving this claimed invention.
`JUDGE HULSE: So any time you get to a phase III
`study, though, isn't it true that you would always have positive
`results in your phase I and phase II trials?
`MR. REED: Honestly, I'm not sure. I don't know that it
`is necessary to have positive results in phase I and phase II. And
`I take small issue with the word "successful." That's something
`that I think patent owner has been introducing repeatedly here.
`What do you call a successful phase I? What do you call a
`successful phase II? And as you'll hear from patent owner, what
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`do you call a successful phase III trial? That is, I think, a
`different question than whether you have a reasonable
`expectation of success.
`I think that successful trial is something that might be
`subjective. Patent owner's expert, Dr. Sartor, was involved in a
`trial. It was a trial that took cabazitaxel and tried to show that it
`would be appropriate for first-line use. It did not end up getting
`FDA approval, but he considers that to be a successful trial. He
`did not consider that to be a failure. So what you consider to be a
`successful trial or not, I think, is maybe a question that is better
`left to the regulatory people.
`What we are focused on here is in patentability
`questions, whether there was a reasonable expectation of success
`in achieving the claimed invention. And since there is no
`efficacy requirement, this goes back to your perhaps first or
`second question, Judge Murphy, the reasonable expectation of
`achieving the claimed invention does not even have a therapeutic
`efficacy requirement.
`So when the Board instituted and made the decision that
`those preambles were not limiting, they got it just right. And
`there were at least a few reasons why. Looking at slide 9, two
`aspects of the Board's initial decision to institute are worth
`keeping in mind. First not every patient necessarily demonstrates
`a therapeutic effect from the method of treatment. I think both
`sides' experts are in agreement on the fact that not every patient
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`benefits from this claimed method. And second, the method steps
`are performed the same way regardless of whether a patient
`benefits.
`Curiously, during his deposition, Dr. Sartor, patent
`owner's expert, brought up the situation where halfway through a
`participant in this TROPIC study, the phase III clinical trial for
`cabazitaxel, if halfway through that one particular patient's course
`of treatment the data came in, the results came in, he insisted that
`up until then you could have no intention of treating that patient
`successfully because you just didn't know, and without the
`knowledge that came later, you were unable to be practicing these
`claims.
`
`He said then if the data came in mid-course, you get this
`treatment every three weeks and it lasts five or eight courses, if
`the data came in, the next treatment the doctor would have the
`knowledge and thus could have the intention of treating. So now
`all of a sudden this exact same patient receiving the exact same
`treatment, the method being identical in Dr. Sartor's mind would
`be practicing the invention. And he answered the question as to
`whether this only depended on what was in the physician's mind.
`His answer was absolutely.
`That cannot be the test for patentability. That, I think,
`underscores how the patent owner has approached this entire '592
`reasonable expectation of success analysis. They have held us to
`a bar which is not the bar for patentability.
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`So if I could, I would like to move briefly to the
`question of the other grounds. Ground 1 is based on Winquist
`and the TROPIC listing. But each of the other grounds includes
`an additional reference. For instance, on slide 19, this addresses
`ground 2 that relates to claims 3 and 4. And the difference in
`these two claims is that these two claims deal with acetone
`solvate, an acetone solvate of cabazitaxel, a particular form.
`The additional reference here, Didier, is a patent that
`happens to be owned by patent owner here that explicitly teaches
`an acetone solvate of cabazitaxel with between 5 to about
`7 percent by weight of acetone. This falls squarely within claims
`3 and 4. And the elements of claim 3 and 4, then, are taught by
`Didier. And the question becomes whether there's a motivation.
`And patent owner's sole argument here is that there is no
`motivation to combine Didier with Winquist and the TROPIC
`listing.
`
`As we set out in the petition, however, it's well known
`in the art that nonaqueous solvates such as acetone could be used
`to improve water solubilityof otherwise water-insoluble drugs.
`And patent owner argues that the background art would not
`motivate selecting acetone for a solvate of cabazitaxel, but this
`argument ignores the fact that the existence of other options, the
`availability of other options does not teach away. Rather,
`because Didier itself explicitly teaches making an acetone
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`solvate, we think there is both motivation to combine and
`reasonable expectation of success.
`JUDGE MURPHY: What was the dosage of the drug in
`Didier, if you recall?
`MR. REED: The dosage?
`JUDGE MURPHY: In other words, did they have a
`particular concentration or it was just about solvating --
`MR. REED: It's closer to the compound patent than the
`method of treatment patent. This is kind of an intervening patent.
`In terms of time, there was initially the compound and then there
`was the acetone solvate which was a form of the cabazitaxel.
`And then the third kind of in time is this method of treatment
`patent.
`
`And that's a good point. In terms of timing, recall that
`that compound, the first patent in this chain, the '170 patent issued
`in 1998. And the method of treatment patent could have been
`applied for as early as 1998 or presumably earlier than that. The
`fact that they didn't even apply for their patent until 2009, it's too
`little too late. Effectively what they are trying to do is come in
`here and salvage a patent that if they were going to apply for it,
`they should have applied for it years before they ever did.
`So the ground 3 covers claims 7, 8 and 9. This is on
`slide 21. These claims 7, 8 and 9 each deal with a different
`pharmacokinetic parameter. They include the maximum
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`concentration of the drug or Cmax, the total area under the curve
`or AUC and plasma clearance or CL.
`Now, the values that correspond to the claimed values
`are disclosed in the Mita reference. Dr. Seth did some unit
`conversion for one of these, and he set forth in the table the
`values disclosed in Mita. That is his table towards the bottom of
`slide 21. And those parameters, each of those pharmacokinetic
`parameters falls squarely within the claimed range of values in
`claims 7, 8 and 9. In short, Mita in combination with Winquist
`and the TROPIC listing, renders claims 7 to 9 obvious.
`So then there's ground 4. I'm turning to slide 23. Two
`claims of the '592 patent are directed to a 10-milligram per day
`dose of prednisone. In other words, a particular dose. Prednisone
`in combination with cabazitaxel was taught by both Winquist and
`the TROPIC listing. Here we have the specified 10 milligrams
`per day dose. And then in addition, there are two claims directed
`to monitoring blood during the course of treatment, the neutrophil
`levels, to be precise, and then discontinuing treatment when those
`levels drop to a dangerous point.
`And the Tannock reference, which is the additional
`prior art reference for ground 4, teaches each of these steps in the
`context of docetaxel treatment of metastatic castration-resistant
`prostate cancer. So Tannock was, in the context of docetaxel,
`doing exactly what is now claimed in claims 10, 11, 14 and 16 in
`the realm
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