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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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`APOTEX INC., APOTEX CORP., APOTEX
`PHARMACEUTICALS HOLDINGS INC., AND APOTEX
`HOLDINGS, INC.,
`Petitioner,
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`v.
`
`OSI PHARMACEUTICALS, INC.,
`Patent Owner.
`____________
`
`Case IPR2016-01284
`Patent 6,900,221 B1
`____________
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`Held: October 3, 2017
`____________
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`
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`Before LORA M. GREEN, RAMA G. ELLURU, and ZHENYU
`YANG, Administrative Patent Judges.
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`Case IPR2016-01284
`Patent 6,900,221 B1
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`APPEARANCES:
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`ON BEHALF OF THE PETITIONER:
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`
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`W. BLAKE COBLENTZ, ESQUIRE
`ERIC J. CHOI, ESQUIRE
`Cozen O'Connor
`1200 Nineteenth Street, N.W.
`Washington, D.C. 20036
`
`ON BEHALF OF PATENT OWNER:
`
`
`
`AMY WIGMORE, ESQUIRE
`EMILY R. WHELAN, ESQUIRE
`KEVIN M. YURKERWICH, Ph.D.
`Wilmer Cutler Pickering Hale & Dorr, LLP
`1875 Pennsylvania Avenue, N.W.
`Washington, D.C. 20006
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`
`
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`The above-entitled matter came on for hearing on Tuesday,
`October 3, 2017, commencing at 1:00 p.m., at the U.S. Patent and
`Trademark Office, 600 Dulany Street, Alexandria, Virginia.
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`Case IPR2016-01284
`Patent 6,900,221 B1
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`P R O C E E D I N G S
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`JUDGE GREEN: Good afternoon. Welcome everyone.
`Please make sure all cell phones are turned off as it can interfere
`with the microphones. We are on the record. This is the final
`oral hearing in IPR2016-01284. This proceeding involves U.S.
`patent number 6,990,221. At this time we would like counsel to
`introduce yourselves and your colleagues, beginning with
`petitioner.
`MR. COBLENTZ: Good afternoon. This is Blake
`Coblentz, counsel for petitioner, Apotex. With me is Eric Choi,
`who is also with Cozen.
`JUDGE GREEN: Thank you. Patent owner?
`MS. WIGMORE: Good afternoon, Your Honors. My
`name is Amy Wigmore. I'm here on behalf of patent owner, OSI
`Pharmaceuticals, Inc. With me here today is lead counsel, Emily
`Whelan as well as Kevin Yurkerwich.
`JUDGE GREEN: Thank you. Welcome to the Board.
`I am joined by Judge Yang and Judge Elluru. Consistent with our
`previous order, petitioner and patent owner have 45 minutes to
`present their arguments. Petitioner will proceed first to present its
`case in chief as to the challenged claims and may reserve rebuttal
`time to respond to the arguments made by patent owner.
`Thereafter, patent owner will respond to petitioner's case.
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`Before we start, I would like to start with a few
`housekeeping notes. First, we note that the demonstratives are
`only as an aid to trial and are not evidence of record. That being
`said, we note that patent owner has objected to a number of
`petitioner's demonstratives and we will rule on those objections in
`the final written decision.
`Counsel for petitioner, you may proceed. Would you
`like to reserve time for rebuttal?
`MR. COBLENTZ: Yes. I would like to reserve ten
`minutes. And we have hard copies of the slides. Would that be
`helpful?
`JUDGE GREEN: Yes, please. And you may begin
`when you are ready.
`MR. COBLENTZ: Good afternoon. May it please the
`Board, my name is Blake Coblentz and I'm here on behalf of
`petitioner, Apotex, along with my colleague, Eric Choi.
`Now, if we go to slide 2, I think the first place I want to
`start is kind of give you an overview of where I plan to go today.
`And the first thing that I would like to handle in this argument is
`the petitioner's case that claims 44 through 46 and 53 of the '221
`patent are prima facie obvious. In doing so, I want to go through
`the references and really show that the primary reference, Schnur,
`really has everything in it, and everything in it from the
`compound Erlotinib to therapeutically effective amount treating a
`mammal to treating lung cancer. The one thing that it doesn't
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`necessarily have is differentiating that lung cancer is NSCLC.
`And that's where Gibbs and the OSI 10-K come in because Gibbs
`and the OSI 10-K both have Erlotinib. They single out Erlotinib
`specifically, and they also single out the treatment of NSCLC
`specifically as well.
`JUDGE ELLURU: Counsel, what is the disclosure,
`what is the teaching in OSI that's not available in Gibbs relevant
`to the challenged claims?
`MR. COBLENTZ: I think that the teaching in OSI
`10-K is very duplicative of Gibbs. It teaches a very similar thing.
`It's an OSI publication that actually has the fact that NSCLC was
`targeted, actually that it had completed -- OSI had completed
`Phase I trials and was moving into Phase II trials, and it had the
`fact that it was an EGFR inhibitor. So I think they are very
`duplicative. I think Gibbs maybe gives even a little bit more than
`that by calling out that Erlotinib had a good anticancer activity as
`well.
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`But I think that the original -- we originally put in the
`OSI 10-K for the situation where they would try to swear behind
`the priority date, which they did not do, which would have
`rendered Gibbs maybe not prior art. But since that was not done
`and it was undisputed that the priority date was March 30th of
`2000, I think the OSI 10-K and Gibbs disclosed very similar type
`of things.
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`JUDGE ELLURU: So your only distinction is that
`Gibbs teaches that it is active towards anticancer?
`MR. COBLENTZ: Well, Gibbs provides more
`information in the fact that it actually teaches that there was good
`anticancer activity in patients with non-small cell lung cancer.
`Whereas, the OSI 10-K mentions the words that it targets
`non-small cell lung cancer with several other conditions.
`JUDGE ELLURU: Thank you.
`JUDGE GREEN: Before we go on, one thing I would
`like to clear at the beginning is I think one of patent owner's
`arguments is that neither Gibbs nor the 10-K make the connection
`that CP-358,774 is Erlotinib or Tarceva. And I know in the
`institution decision we relied on paragraph 29, and patent owner
`says we should not have done that because you did not
`specifically cite that paragraph in that paragraph of your expert in
`your petition. What is your evidence that the ordinary artisan
`would have understood that this compound was Erlotinib?
`MR. COBLENTZ: So if we look at slide 16, what we
`see here is that patent owner, in their response, also admit that a
`person of ordinary skill in the art would have reviewed the full
`scope of the references that Gibbs cites. And one of those
`specific references that Gibbs cites is the Moyer reference. It's
`our view that this would have been background knowledge to a
`person of ordinary skill in the art. Moyer was published in 1997
`before these references were published, and so it's our view that a
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`person of ordinary skill in the art would have had the background
`knowledge of knowing that the project name was associated with
`the compound name in references like Moyer.
`So if we look at specifically slide 17, what we see here
`is that Moyer associates the CP-358,774 compound name -- I
`mean, project name with the Erlotinib compound. And if we look
`at slide 18, when we deposed Dr. Bunn on this very thing,
`Dr. Bunn actually admitted that Moyer does teach that. And as
`we said before, the patent owner response acknowledges, and I
`think both experts agree, that they would have been aware of not
`only what Gibbs taught but the references that were mentioned in
`Gibbs and taught there. So that would have been part of the
`background knowledge that would have come with Gibbs. So we
`didn't believe it was necessary to include it as part of that grounds
`because it was part of that background knowledge.
`JUDGE GREEN: Thank you.
`MR. COBLENTZ: Now, I want to touch on the
`motivation to combine after I go through the references that were
`cited by petitioner. Then I would like to hit the reasonable
`expectation of success. I also want to look at some of the patent
`owner's arguments against the prima facie case and explain why
`we think those are unavailing. And the last thing I want to touch
`on is secondary considerations.
`Now, if we go to slide 3, what we see here is we have
`the challenged claims of the '221 patent, and we have specifically
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`44, 45, 46, and claim 53. Now, I'll note that for claims 45 and 46,
`they won't have a lot of discussion today because there was no
`independent grounds set forth by patent owner that those were
`independently not obvious over claim 44. So we think that the
`patent owner has conceded that if claim 44 is obvious, then claim
`45 and 46 would also be obvious as well.
`But what we also see here is we see several terms that
`are highlighted, and those are important terms that we'll kind of
`go through and go through the patent -- go through the prior art
`and also go through patent owner's arguments as to those. The
`first one we see in claim 44 is a method of treating non-small cell
`lung cancer.
`Now, the parties have really focused their analysis on
`the non-small cell lung cancer. And in fact, patent owner's own
`expert admitted that that was the specific cancer in claim 44 that
`he chose to deal with in his declaration. What we also see is that
`we see this in a mammal and we see that it's administering to said
`mammal a therapeutically effective amount. And what we'll see
`in the prior art that was cited by petitioner is that this mammal
`language is important because it doesn't have to be a human. It
`can be just a mammal. And this therapeutically effective amount,
`we see this same language in the Schnur patent.
`JUDGE GREEN: Have you brought in any art that's
`specific to a mammal as opposed to a human?
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`MR. COBLENTZ: We believe Gibbs teaches that. We
`believe Schnur teaches that, first of all, because we think a lot of
`the language -- and if we look specifically at slide 6, we see at
`slide 6 in the very first callout it says that this is a method of
`treating a hyperproliferative disorder in a mammal which
`comprises administering to said mammal a therapeutically
`effective amount of compound claim 1.
`JUDGE GREEN: But we don't have any administration
`of Erlotinib to a mammal in the Schnur reference, correct?
`MR. COBLENTZ: We don't have administration, but
`they were still allowed to get use claims for treating lung cancer
`with compounds like Erlotinib. And I don't think efficacy data is
`needed here because I think, as the case law tells us, these
`specific references are enabled for what they teach. And they
`teach a method of treating hyperproliferative disorders with
`compounds, one of which being Erlotinib.
`And what we see in Gibbs specifically is Gibbs
`mentions that the Erlotinib compound has good anticancer
`activity in patients with non-small cell lung cancer. And that is --
`a person of ordinary skill in the art reading that would understand
`that there has to be data that would support that point because
`how can the author, a very reputable author in a very reputable
`journal making a statement about Erlotinib specifically, one of
`two compounds that it makes a statement about, and calls out that
`it has good anticancer activity in patients with non-small cell lung
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`cancer. We think that's important and a person of ordinary skill
`in the art would read it for that, as Dr. Giaccone said in his
`deposition.
`Now, looking at slide 5 -- let me go back. Let me go
`back to slide 4. And I think it's interesting to put this in a little bit
`of perspective. What we see is that the date that is undisputed for
`the priority date of the '221 patent is March 30th of 2000. And
`the prior art references that the petitioner is relying on, Schnur,
`OSI's 10-K and Gibbs, are contemporaneous references that were
`published within two years of that date. Schnur is in May of '98;
`the OSI 10-K, December '98, and Gibbs as of January 2000.
`And if we move to slide 5, when looking at an
`obviousness case, it's important to look at who the person of
`ordinary skill in the art would be. Petitioner puts forth that a
`person of ordinary skill in the art not only has a background in
`medical oncology, but also has a specialized training in thoracic
`oncology. And the reason we say that is because claim 53 is
`specifically directed to non-small cell lung cancer. Now, claim
`44, yes, it has a bunch of other cancers, but claim 53 is specific to
`non-small cell cancer. So with Dr. Giaccone, we believe it's
`important that a person of ordinary skill in the art has some
`training in the thoracic oncology but also has the background of a
`general oncologist as well.
`Now, if we go to slide 6, we touched on this a few
`minutes ago, but we look at exactly what the primary reference,
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`Schnur, teaches. And the primary reference, Schnur, teaches, you
`see at this very top callout we see very similar language to what
`we see in claim 44 of the '221 patent. We see a method of
`treating a specific condition. We see it in a mammal
`administered to said mammal a therapeutically effective amount
`of the compound of claim 1.
`We also see that Schnur teaches the Erlotinib compound
`specifically and also brings out the fact that those
`hyperproliferative disorders that it's talking about, one of which is
`lung cancer.
`If we go to slide 7 --
`JUDGE GREEN: As to lung, would the ordinary
`artisan read lung as encompassing non-small cell lung cancer or
`would they see those as two separate disorders?
`MR. COBLENTZ: I think that the person of ordinary
`skill in the art and the way we have this framed in our petition
`would see lung cancer as being one of two cancers. And as
`Dr. Giaccone said in his declaration that EGFR inhibitors like
`Erlotinib were oftentimes by persons of ordinary skill in the art,
`they were associated with non-small cell lung cancer because of
`the EGFR expression. So I think when they looked at lung
`cancer, they would be thinking of non-small cell lung cancer
`especially because of the EGFR inhibition and what is noted in
`the Schnur patent for the Erlotinib compound.
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`Now, if we look at slide 7, the '221 patent itself admits
`that Schnur teaches Erlotinib. And in fact, it says in the
`background of the '221 patent that the '498 patent, which is
`Schnur, teaches the Erlotinib compound.
`Now, if we go to slide 8, what we see here is that -- and
`it's important to note that the therapeutically effective amount in
`the '221 patent is defined by a specific range. And it's important
`to note that that specific range that is given for the therapeutically
`effective amount in the '221 patent is the same range that is given
`for effective dosage in Schnur. So it's petitioner's position that
`the person of ordinary skill in the art would understand that a
`therapeutically effective amount is taught by Schnur.
`If we go to slide 9 quickly, I don't think this is much in
`dispute, that Schnur --
`JUDGE ELLURU: Counsel, do you think we need to
`construe therapeutically effective amount --
`MR. COBLENTZ: I don't think so, because I think it's
`defined by the specification of the '221 patent. And as both
`parties originally agreed, therapeutically effective amount has a
`specific definition, has a specific range that is set out in the
`specification of the '221 patent. A person of ordinary skill in the
`art would see that range and understand what that means as it
`pertains to the '221 patent.
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`Now, I was mentioning slide 9. I don't think this is
`much in dispute, but Schnur also teaches that there is
`pharmaceutical compositions and that there's carriers.
`Now, we look at slide 10, and in slide 10 we see that
`Schnur teaches that the Erlotinib functions by EGFR inhibition.
`And this is important because this was a prevailing theory at the
`time, this EGFR inhibition, and it was actually disclosed here in
`Schnur that that was associated with anticancer activity in treating
`hyperproliferative disorders such as cancer and more specifically
`such as lung cancer.
`And why I say most of the elements are -- of the
`challenged claims are disclosed in the '221 patent, I think that is
`supported heavily by the prosecution history that happened in the
`'221 patent. And if we look specifically to slide 12, what we see
`here is that the examiner originally rejected an anticipation
`rejection of the challenged claims over the Schnur patent saying
`that it did treat lung cancer and that it did disclose treating lung
`cancer and that Erlotinib was specifically disclosed.
`And when the applicant chose to try to overcome this
`rejection, we see on slide 13 that the applicant didn't point out any
`other differences of Schnur and the challenged claims except for
`the fact that the applicant pointed out that Schnur did not
`specifically treat NSCLC. I think that's an important point
`because the applicants conceded there -- it's our position that the
`applicants conceded there that this was the only difference. This
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`is the difference. The difference is that NSCLC was not pointed
`out specifically. And patent owner, in their response, don't refute
`this point.
`Now, if we look at the reasons for allowance which is
`on slide 14, what we see is this is the very reason why the Patent
`Office allowed this to begin with. And the Patent Office says it's
`the treatment of these specific cancers that was the reason for
`allowance. And we know from reading the applicant's response
`that that specific cancer that they were referring to was NSCLC.
`I would like to move on to the Gibbs reference which is
`at, if we go to slide 15, and I would like to set up Gibbs a little bit
`in the fact that it is a review article. And as a review article,
`teaching about anticancer drug targets and specifically to growth
`factors and growth factor signaling. It was in a very reputable
`journal, and the journal was the Journal of Clinical Investigation
`by a very reputable author, the director of cancer research at
`Merck at that particular point in time.
`And so if we look at what Gibbs discloses and we go to
`slide 15, what we see here is that it points out two specific
`compounds and it associates those with EGFR inhibition. And
`those specific compounds are the ZD-1839 compound and the
`compound that we talked about just a little while ago, this
`CP-358,774. And Gibbs specifically, in looking at these two
`compounds, uses the plural, and I have underlined that here, the
`plural saying these compounds appear to have good anticancer
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`activity in preclinical models, particularly in patients with
`non-small cell lung cancer. There's no other cancers listed here.
`There's non-small cell lung cancer. And there's only two
`compounds listed. And so there's not a plethora of compounds
`listed here, so we think the author was very deliberate in putting
`that these two compounds had good anticancer activity in patients
`with non-small cell lung cancer.
`JUDGE ELLURU: And what are the references to 12
`and 13?
`MR. COBLENTZ: The references to 12 and 13 is
`Woodburn and Moyer. Woodburn is a reference about ZD-1839
`and the Moyer reference is the one that we discussed earlier. We
`note that the paragraph that is kind of the summation of this
`doesn't have any references to it but that it has just the conclusion
`about this.
`Now, what we see here in Gibbs and a person of
`ordinary skill in the art -- what I forgot to note about Gibbs is that
`Gibbs also mentions that the Erlotinib compound had passed
`through Phase I trials and was initiating Phase II trials, which
`goes with the fact, as we see here, that it had good anticancer
`activity in patients. Those patients, a person of ordinary skill in
`the art would know by knowing that it passed through Phase I
`trials that it had even been used to treat humans and that it had
`shown this good anticancer activity in non-small cell lung cancer.
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`JUDGE YANG: So I recall patent owner actually
`points out reference number 13 here actually has nothing to do
`with non-small cell lung cancer. Instead it was something like a
`head and neck cancer. Can you just explain?
`MR. COBLENTZ: Sure. Moyer does mention head
`and neck cancers as well. But what we also know is that Gibbs
`references that all the data wasn't or all the references were not
`cited in this that support his conclusions. And he specifically
`references, for example, these ASCO proceedings that went on
`which was actually a conference that went on.
`And what we know from the Hidalgo reference which
`petitioners cite not as prior art, but as a fact to corroborate the fact
`that the Phase I data that was done prior to the filing date and that
`was presented in part at this particular conference was -- indeed
`had NSCLC patients that were treated in it. And so we think that
`some of that information that Gibbs has comes from that ACO
`conference. But we also note that a person of ordinary skill in the
`art reading this would read it for what it states here, would read it
`in a very reputable journal by a reputable author, that he knew
`what he was talking about and would have a reasonable
`expectation that CP-358,774, the Erlotinib compound had good
`anticancer activity in non-small cell lung cancer.
`JUDGE GREEN: Before you go on, where is your
`evidence as to what the ordinary artisan would have understood
`what was required to enter into a Phase I trial and to enter into a
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`Phase II trial? Because that's something that you are saying that
`there is a certain amount of evidence that you would have to have
`when you get into a case where an ordinary artisan would have
`understood that you would had to have activity or
`pharmacokinetics or something else.
`MR. COBLENTZ: I think the evidence that we have
`that a person of ordinary skill in the art understood that they
`would have passed through preclinical and Phase I trials is the
`fact that both the OSI 10-K and Gibbs both mention that they
`have initiated Phase II trials. And we believe that a person of
`ordinary skill in the art looking at that would have known that
`they would have successfully passed through preclinical trials,
`would have successfully gone through Phase I trials. But not
`only that, that you have this conclusion from Gibbs that if you put
`two and two together, the person of ordinary skill in the art would
`have known that it showed good anticancer activity in these
`preclinical models.
`JUDGE GREEN: I guess my question is more what
`would were required by these preclinical trials? What would the
`artisan have to show to even get into Phase I trials as to the
`activity of the compound?
`MR. COBLENTZ: I think that if we go to slide 60, we
`think Dr. Bunn answers this question in his deposition. He says
`that when you are looking at preclinical models such as looking at
`a human tumor in a mouse, that is enough to have promising
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`activities or promising activity in these preclinical models in
`order to make way to the Phase I trials after that. So we think
`that a person of ordinary skill in the art that would have been
`looking at preclinical models would have looked at a statement
`like Gibbs and said, okay, there's good anticancer activity in
`treating non-small cell lung cancer especially in preclinical
`models. That's enough to pass into Phase I. And then after you
`move into Phase I, you move into Phase II trials.
`Now, we've looked at Schnur and we've looked at
`Gibbs, and a little while ago I quickly touched on the fact that a
`person of ordinary skill in the art, when looking at Gibbs, would
`have read or looked at the references that were also cited within
`Gibbs, and we mentioned the reference Moyer. I'll quickly tie
`this together that Moyer, if we look at it, Moyer actually teaches a
`person of ordinary skill in the art that this CP-358,774 project
`name is associated with the Erlotinib compound. A person of
`ordinary skill in the art would have known that at the time of
`reading Gibbs and reading the Schnur reference.
`Now, the last thing I want to touch on is the OSI 10-K.
`If we go to slide 20, what we quickly see here in slide 20 is that
`the Erlotinib compound, which is the CP-358,774, is discussed in
`this OSI 10-K. And it also says here that it is being used to target
`a couple of cancers, one being non-small cell lung cancer and that
`it had passed through Phase I and it was initiating Phase II trials
`and that it was an EGFR inhibitor.
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`And we think that is important because, as we stated
`earlier, the missing piece out of Schnur was the fact that it didn't
`specify that the lung cancer was non-small cell lung cancer. The
`OSI 10-K is a reference that not only calls out Erlotinib but it also
`calls out the fact that it is targeting non-small cell lung cancer.
`JUDGE GREEN: How would the ordinary artisan go
`about finding this 10-K?
`MR. COBLENTZ: I think that a part of -- a person of
`ordinary skill in the art, and I think Dr. Giaccone said this in his
`deposition, that there are medical oncologists that work for
`pharmaceutical companies and worked for pharmaceutical
`companies at that specific point in time and that both experts
`acknowledged that a medical oncologist that worked for a
`pharmaceutical company is a person of ordinary skill in the art in
`this particular field, and it was a part of their regular business that
`they would look at competitive information. Some of that
`competitive information is our 10-Ks.
`And we also looked at the testimony from Dr. Gibbs,
`which I think is on -- let me look at the slide here. If we look at
`the testimony from Dr. Gibbs which is on slide 51, what we see
`here is that Dr. Gibbs himself said that, you know, as the clinical
`director of cancer research at Merck, part of his duties was
`looking at competitor information. So this kind of goes along
`with the medical oncologists that would be a part of a
`pharmaceutical company. They would look at this competitive
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`information. And a part of that competitive information they
`would look at is the OSI 10-K.
`JUDGE GREEN: I understand that, but these 10-Ks
`aren't word searchable, correct?
`MR. COBLENTZ: I don't think they were at the time,
`
`no.
`
`JUDGE GREEN: So would you just understand that
`who your competitors are and who are working on similar
`projects? How would you know that OSI was working on this
`particular inhibitor?
`MR. COBLENTZ: I think that, as Dr. Giaccone said,
`that the people like -- he mentioned a name, Dr. Blackledge,
`specifically in his testimony, and he said that he was well aware
`of the companies that were working on specific targets like this
`one and that were competing with them. And they would be
`looking for and be handed competitive information which would
`include this OSI 10-K, especially when it mentions the fact that
`it's looking at a compound like Erlotinib for the treatment of this,
`and this was a part of regular duties as the medical oncologist at
`those companies.
`JUDGE YANG: So early on Judge Elluru asked you to
`explain the difference between Gibbs and 10-K. I just want to
`find out is there any information in OSI's 10-K that's not in
`Gibbs?
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`MR. COBLENTZ: I don't think that there's any
`information in the OSI 10-K that's not disclosed in Gibbs. I think
`they are very similar disclosures. I think Gibbs has even more
`than that. Whereas you had the OSI 10-K mentioning that it
`targets non-small cell lung cancer, which we believe is enough
`because Schnur teaches everything but that the lung cancer is
`specifically non-small cell lung cancer. We think even Gibbs
`goes a step further than that by teaching that it has good
`anticancer activity in patients with non-small cell lung cancer.
`Now, I know I only have seven minutes left, so I want
`to touch on a couple of the arguments that patent owner makes
`and why we think that those are unavailing. And specifically
`looking at the person of ordinary skill in the art, when we look at
`the person of ordinary skill in the art, we see that if we look at
`slide 34, we see that the definitions presented by the experts,
`Dr. Bunn generally relates to a generalist. Whereas,
`Dr. Giaccone has a generalist but also adds the fact that there is
`specialized training in thoracic oncology. And we believe that
`Dr. Giaccone's definition is more correct, and this is slide 33, for
`the record, because both parties really focused the analysis on
`non-small cell lung cancer.
`We see in slide 34 Dr. Bunn mentions that he really
`only dealt with the non-small cell lung cancer. Claim 53 is
`directed to non-small cell lung cancer specifically. And if you
`look at slide 35, Dr. Bunn admits in his deposition that it was
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`thoracic oncologists that specifically treat lung cancer and that
`write scripts for medications for treating lung cancer.
`JUDGE GREEN: Do you think this definition of the
`person of ordinary skill in the art is determinative of this case or
`should the results be the same under whoever party's definition is
`adopted?
`MR. COBLENTZ: I think the results would be the
`
`same.
`
`Now, if we quickly go to slide 39 and looking at the
`therapeutically effective amount, what we see here is that there
`seems to be a dispute over therapeutically effective amount. The
`patent owner would like to divorce the term "therapeutically
`effective" from the term "amount" and instead combine
`therapeutically effective with the word "treatment" that appears
`somewhere else in claim 44. The result of that is they are
`requiring a heightened standard of reasonable expectation of
`success that can't even be met by the disclosure of the 221 patent.
`Now, mind you, the '221 patent only has Phase I data
`and preliminary data from Phase II. They don't have Phase III
`trials. They don't have FDA approval. So we don't think it's a
`reasonable ex
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