throbber
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`571-272-7822
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`IPR2015-01092, Paper No. 72
`IPR2015-01096, Paper No. 72
`IPR2015-01102, Paper No. 74
`IPR2015-01103, Paper No. 75
`September 12, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`COALITION FOR AFFORDABLE DRUGS VI, LLC,
`Petitioner,
`
`v.
`
`CELGENE CORPORATION,
`Patent Owner.
`____________
`
`Case IPR2015-01092, Patent 6,045,501
`Case IPR2015-01096, Patent 6,315,720
`Case IPR2015-01102, Patent 6,315,720
` Case IPR2015-01103, Patent 6,315,720
`____________
`
`Held: July 21, 2016
`____________
`
`
`
`BEFORE: MICHAEL P. TIERNEY, GRACE KARAFFA
`OBERMANN, and TINA E. HULSE, Administrative Patent
`Judges.
`
`
`
`
`
` The above-entitled matter came on for hearing on Thursday, July
`21, 2016, commencing at 1:30 p.m., at the U.S. Patent and
`Trademark Office, 600 Dulany Street, Alexandria, Virginia.
`
`

`
`Case IPR2015-01092, Patent 6,045,501; Case IPR2015-01096,
`Patent 6,315,720
`Case IPR2015-01102, Patent 6,315,720; Case IPR2015-01103,
`Patent 6,315,720
`
`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`
`
`
`
`
`
`
`SADAF R. ABDULLAH, ESQ.
`SARAH E. SPIRES, ESQ.
`Skiermont Derby, LLP
`2200 Ross Avenue, Suite 4800W
`Dallas, Texas 75201
`
`
`
`
`
`
`
`
`F. DOMINIC CERRITO, ESQ.
`ANDREW S. CHALSON, ESQ.
`FRANK C. CALVOSA, ESQ.
`Quinn Emanuel Urquhart & Sullivan
`51 Madison Avenue, 22nd Floor
`New York, New York 10010
`
`
`
`
`
`
`
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`
`
`
`ON BEHALF OF PATENT OWNER:
`
` 2
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`
`
`
`
`

`
`Case IPR2015-01092, Patent 6,045,501; Case IPR2015-01096,
`Patent 6,315,720
`Case IPR2015-01102, Patent 6,315,720; Case IPR2015-01103,
`Patent 6,315,720
`
`
`
`
`P R O C E E D I N G S
`- - - - -
`JUDGE TIERNEY: Welcome, everyone, for the
`hearing today, for inter partes reviews 2015-01092, 01096, 01102
`and 01103. Welcome, everyone. Before I begin today, I was just
`wondering if there are any procedural issues we need to address
`before we start the hearing today. I will start with Patent Owner.
`MR. CERRITO: No, Your Honor.
`THE COURT: Petitioner, any procedural issues?
`MS. SPIRES: No, Your Honor.
`THE COURT: With that, my understanding is we are
`going to have one hour each side, with the Petitioner beginning
`the hearing today. So, Petitioner, when you're ready, please
`begin.
`
`MS. ABDULLAH: Good afternoon, Your Honors. I'm
`Sadaf Abdullah from the law firm Skiermont Derby, and with me
`is our lead counsel, Sarah Spires. We are here on behalf of the
`Petitioner, CFAD.
`In these four proceedings, Petitioner has shown that the
`inventions of the '501 patent and the '720 patent were obvious to a
`person of ordinary skill in the art before their respective priority
`dates. I would like to address each patent separately because the
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`Case IPR2015-01092, Patent 6,045,501; Case IPR2015-01096,
`Patent 6,315,720
`Case IPR2015-01102, Patent 6,315,720; Case IPR2015-01103,
`Patent 6,315,720
`
`main issues of contention are somewhat distinct, and I'd like to
`begin with the '501 patent.
`If we could go to slide 3, that patent is the subject of the
`'1092 proceeding, and the Board instituted this proceeding on the
`ground of whether claims 1 through 10 of that patent are obvious
`over Powell, Mitchell, and Dishman.
`If we could go to slide 7, this is independent claim 1 of
`the '501 patent. It's the only independent claim. And the dispute
`between the parties as to what is disclosed in the prior art
`references with respect to this claim and the other claims of the
`patent center on three issues.
`The first is the claim term of "computer readable
`storage medium," which first appears in element (a) and then is
`referred back to throughout the claim. The second issue is the
`inclusion of male patients that appears in claim element (d). And
`then the third issue is whether there was a motivation to combine
`the three references that I referenced.
`Unless the Board has questions about the other aspects
`of the proceeding, I'd like to focus my presentation on these three.
`Beginning first with the "computer readable storage medium"
`claim term, if we could go to slide 19, Patent Owner wants to
`read into this claim term a limitation that the computer readable
`storage medium must be one centralized database. That
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`Case IPR2015-01092, Patent 6,045,501; Case IPR2015-01096,
`Patent 6,315,720
`Case IPR2015-01102, Patent 6,315,720; Case IPR2015-01103,
`Patent 6,315,720
`
`construction has no support in the record, and it specifically has
`no support in the specification.
`The specification is obviously very relevant, especially
`under a BRI standard, where the claim has to be given its
`broadest reasonable construction in light of the specification of
`the patent in which it appears. And Patent Owner essentially
`disregards the specification in making its arguments.
`If we can go to slide 20, this is the relevant portion of
`the specification, which on the left-hand side of this slide refers to
`pharmacies being registered in a computer readable storage
`medium and then goes on to say that that may be the same as or
`different from the computer readable storage medium in which
`the prescribers are registered.
`And going on to the right side of the screen, it's even
`more explicit. The registration into one or more computer
`readable storage medium appear in the specification.
`In looking at Patent Owner's proposed construction, if
`we go to slide 21, we have the testimony from its expert,
`Dr. Frau, that actually indicates that the BRI standard was not
`applied, and the primary piece of evidence that Patent Owner
`relies on is a portion of the prosecution history, which if we take
`a look on slide 23 actually doesn't really even support that
`construction.
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`Case IPR2015-01092, Patent 6,045,501; Case IPR2015-01096,
`Patent 6,315,720
`Case IPR2015-01102, Patent 6,315,720; Case IPR2015-01103,
`Patent 6,315,720
`
`
`In the context of this portion of the prosecution history,
`applicant is distinguishing the Sloane reference, which refers
`solely to the internet, as Patent Owner or as applicant itself said,
`and it's distinguishing that on the basis that the invention, the
`claimed invention, defines methods for centralizing certain
`information. So, we're talking about the centralization of
`information. Nowhere does it say that it has to be one, single
`structure, a database, that contains all of the information.
`So, with that proper understanding of the claim term in
`mind, we look to references such as the Dishman reference,
`which disclosed registration of the components that are claimed,
`and it does so in a manner that renders obvious other claimed
`methods.
`Going on to the second major issue, if we can go to
`slide 36, Patent Owner argues that the inclusion of males in the
`subpopulation for individuals for special counseling would not
`have been obvious. Now, when we're talking about these
`references in the context of testing for pregnancy, obviously,
`males are not going to be included in the group that's tested for
`pregnancy. So, what we're really talking about here is counseling
`and, more specifically, contraception counseling.
`And with regard to that issue, the disclosures in the art
`are such that the Board recognized in its institution decision that
`it would have been apparent that sperm of male patients could be
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`
`Case IPR2015-01092, Patent 6,045,501; Case IPR2015-01096,
`Patent 6,315,720
`Case IPR2015-01102, Patent 6,315,720; Case IPR2015-01103,
`Patent 6,315,720
`
`damaged by teratogenic drugs and consequently result in birth
`defects if the male was to impregnate a female. In that context,
`the Board's relied on Dr. Fudin's testimony as well as the Mann
`reference.
`If we can go to the Mann reference on slide 35, that
`reference talks about thalidomide specifically, and it says that
`thalidomide is known to be strongly absorbed by sperm, and it
`goes on to refer to an experiment where thalidomide administered
`to male rabbits adversely affects the pregnancy of females mated
`to these males. This very same piece of evidence was actually
`referenced in the context of Celgene's development of its
`S.T.E.P.S. program.
`If we can go to slide 40, this is the Vanchieri reference.
`This reference discusses the process by which the thalidomide
`program, the S.T.E.P.S. program, was created. It involves
`discussions with the FDA and other commentators in the field,
`and in this specifically, Vanchieri calls out that because of a
`recent study showing thalidomide in rabbits semen and
`uncertainty about its presence in human semen, both women and
`men receiving the drug will be required to use contraception.
`If we go on to slide 38, this is the FDA meeting
`workshop where a number of commentators, including many
`Celgene employees, discussed the thalidomide program, and here,
`too, they make it explicit that it's better to be actually very safe
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`
`Case IPR2015-01092, Patent 6,045,501; Case IPR2015-01096,
`Patent 6,315,720
`Case IPR2015-01102, Patent 6,315,720; Case IPR2015-01103,
`Patent 6,315,720
`
`than sorry. They have -- even though there's no opportunity to
`absolutely discount the chance that there may be even small
`levels of the drug in semen, it is entirely appropriate that they
`engineer a program that avoids that problem.
`So, even Celgene itself recognized that there was reason
`to include males within the subpopulation, even in the face of
`uncertainty. Celgene's primary arguments against this is, first of
`all, that the Powell reference, which says something along the
`lines of no effects on sperm are recognized, actually teaches
`away, and in light of these disclosures, where it's clear that there
`is some evidence there, in those rabbit experiments, combined
`with somewhat of an uncertainty, that a POSA would still have
`been motivated to include males within that subpopulation. And
`we have Dr. Fudin's testimony on that, supported by Mann.
`The only other argument that Celgene makes in this
`setting is that -- is the idea that the Mann reference wouldn't have
`been consulted because it was authored by a teratologist, and that,
`too, is contradicted in the next slide, 39, which again is an excerpt
`from the FDA meeting where a person from the Genetic Society
`actually makes it explicit and says that many clinical geneticists
`around the country are expected to provide counseling to
`pregnant women about exposures in pregnancy, so the geneticists,
`in fact, are often the clinical teratologists. And the genetics
`aspect of this also becomes relevant later to the '720 patent.
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`Case IPR2015-01092, Patent 6,045,501; Case IPR2015-01096,
`Patent 6,315,720
`Case IPR2015-01102, Patent 6,315,720; Case IPR2015-01103,
`Patent 6,315,720
`
`
`And then the final major point of contention between
`the parties is the motivation to combine, and if we can go to slide
`52, we have Dr. Fudin's testimony on the record that the Accutane
`program, the isotretinoin program described in Mitchell, was well
`known in the art by August 1998.
`If we go to the next slide, 53, we also have his
`testimony about the Clozaril program, which is also referred to as
`clozapine, and is referenced in the Dishman publication. So, both
`of these programs being known in the art, Dr. Fudin has testified
`further, going to slide 54, that there was a recognition in the art
`for a need for stringent controls. And so, naturally, a person of
`ordinary skill in the art would look to past programs where drug
`distribution has been restricted and programs that would have
`been successful.
`Celgene's arguments in this regard are essentially that --
`either that Dr. Fudin's testimony is contradicted by the record,
`and second, with respect to Dishman specifically, that it's
`irrelevant because it relates to Clozaril, which is not a teratogenic
`drug. But neither of these are credible, especially when you look
`at the record.
`So, starting with the Mitchell reference itself, slide 64,
`Mitchell is the one that describes the Accutane/isotretinoin
`program, and then in the end it specifically mentions thalidomide
`as a potential application for its methods. So, it says, "The
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`
`Case IPR2015-01092, Patent 6,045,501; Case IPR2015-01096,
`Patent 6,315,720
`Case IPR2015-01102, Patent 6,315,720; Case IPR2015-01103,
`Patent 6,315,720
`
`experience gained with isotretinoin can serve as basis for
`determining how such drugs" -- referring back to thalidomide --
`"should be used and monitored."
`Going on to slide 65, here we go back to the Vanchieri
`reference we saw earlier. We see that the FDA moved ahead on
`the Celgene program due to the isotretinoin experience.
`Vanchieri writes that based on the isotretinoin experience, 20
`years of testing in ENL, and limited use of thalidomide by 72
`women with AIDS wasting syndrome or aphthous ulcers, the
`FDA is prepared to move ahead.
`If we could go to the next slide, 66, this is also in the
`Vanchieri reference. It refers to the isotretinoin program. It
`refers to it as being considered as a model for thalidomide, and it
`calls that program, the isotretinoin program, unprecedented and
`novel.
`
`If we can go to the Marwick reference on slide 67, that
`also acknowledges that the plan for thalidomide is built on
`experiences with restrictions on such other drugs with severe
`adverse effects as Accutane, and then it also refers to Clozaril.
`So, that's both what's disclosed in Mitchell and Dishman.
`And then we also can look at Zeldis on slide 68, and
`Zeldis is dated 1999, so it's not a prior art publication, but it's
`looking back and it's talking about the development of the
`S.T.E.P.S. program, and it acknowledges that Celgene itself and
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`
`Case IPR2015-01092, Patent 6,045,501; Case IPR2015-01096,
`Patent 6,315,720
`Case IPR2015-01102, Patent 6,315,720; Case IPR2015-01103,
`Patent 6,315,720
`
`the inventors looked to isotretinoin and clozapine in using them
`as guides in order to develop their program. So, Celgene's
`arguments that these programs were not relevant are just not
`credible in terms of what's in the record. Going to slide 73,
`Celgene's expert, Dr. DiPiro, also admitted that those two
`programs were relevant as guides.
`Celgene also argues that the results of the program, the
`S.T.E.P.S. program, was not predictable. If we go to slide 65, we
`saw this a few minutes ago, the FDA actually approved
`thalidomide based on the experience with isotretinoin. So, clearly
`the FDA believed that it was predictable that something based on
`that model would work.
`If we go to slide 80, which is another excerpt from
`Marwick, it refers to a workshop where the thalidomide program
`was discussed, and no one at the workshop suggested banning the
`drug outright. So, again, it shows that commentators in the field,
`persons of ordinary skill in the art, were looking at this program,
`basing it on isotretinoin and Clozaril, and recognizing that those
`two programs were successful and taking that, predicting that the
`S.T.E.P.S. program would work, and it did. So, it was, in fact,
`very predictable.
`JUDGE OBERMANN: Do you agree that the
`S.T.E.P.S. program has had a zero pregnancy rate?
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`

`
`Case IPR2015-01092, Patent 6,045,501; Case IPR2015-01096,
`Patent 6,315,720
`Case IPR2015-01102, Patent 6,315,720; Case IPR2015-01103,
`Patent 6,315,720
`
`
`MS. ABDULLAH: No, Your Honor, and we can talk
`about that. If we go to slide 82, the claim that Celgene makes is
`that it's been 100 percent successful at preventing birth defects.
`There's a couple of issues.
`First, if you actually look at the patent, the method is for
`avoiding the delivery of the drug to a fetus, that's the goal. If we
`go to the next slide, 83, there's publications out there that show
`that there have been patients exposed to Celgene's thalidomide
`with four confirmed fetal exposures. So, just simply by the
`numbers, the patent has not been 100 percent successful.
`And in addition to that, we have -- if we can go to the
`next slide, 84 -- the evidence that Celgene relies on is essentially
`a self-serving declaration from a Celgene employee, and if you
`talk to the experts that Celgene has put forward, they rely for their
`opinions completely on that one declaration and admit that they,
`themselves, have never searched for any studies, never seen any
`studies on the particular issue of whether there was fetal exposure
`or birth defects. It seems that their entire argument is that if there
`were birth defects, we would know about them, and as Dr. Fudin
`put it, the absence of evidence is not evidence of absence.
`JUDGE HULSE: Counsel, didn't Patent Owner argue
`that that number is worldwide and isn't necessarily in the United
`States?
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`

`
`Case IPR2015-01092, Patent 6,045,501; Case IPR2015-01096,
`Patent 6,315,720
`Case IPR2015-01102, Patent 6,315,720; Case IPR2015-01103,
`Patent 6,315,720
`
`
`MS. ABDULLAH: Well, they did acknowledge that at
`least one of them was in the United States, and so, you know --
`and even though that might not be a big deal, one is not that
`many, it just goes to show you that 100 percent is not quite true,
`and when you're comparing it to other programs that they claim
`are not successful, like, for example, the Mitchell PPP, those are
`actually similar in numbers in terms of preventing, you know,
`exposure to pregnant patients. I mean, we're talking about --
`JUDGE OBERMANN: I thought I saw something
`relating to Mitchell where there were 76 birth defects or some --
`MS. ABDULLAH: Right. So, if we actually can go
`back to -- I believe it is 66, slide 66. There's a little bit of an
`analysis of the number of patients that became pregnant, but
`where -- but what this actually shows that you're talking about,
`210,000 women that were surveyed, out of them 623 were
`pregnant. So, it's a very small percentage. So, and Celgene itself
`and other commentators in the field acknowledge that that rises to
`the level of successful.
`So, the question is not, you know, not whether it's 100
`percent successful, whether it's -- it would have been successful at
`all in terms of the standards applied by the persons of ordinary
`skill in the art at the time. And the answer is that, yes, but it
`would have also been predicted to be that way based on these
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`
`Case IPR2015-01092, Patent 6,045,501; Case IPR2015-01096,
`Patent 6,315,720
`Case IPR2015-01102, Patent 6,315,720; Case IPR2015-01103,
`Patent 6,315,720
`
`other programs. So, in other words, there were no -- there was no
`unexpected aspect of success.
`If I may, I'd like to turn briefly to the '720 patent, and if
`we can go to slide 90. The '720 patent is the subject of the '1096
`proceeding, the '1102 proceeding, and the '1103 proceeding.
`'1096 was instituted on the basis of claims 1 through 32, obvious
`over Thalomid PI in view of Cunningham and in further view of
`Keravich, Zeldis, and Mundt.
`If we can go to slide 91, here we have -- '1102 is
`proceeding on the basis of Powell and Dishman and Cunningham,
`and in further view of a number of references that are listed on
`that slide. And then the final one, '1103, on slide 92, is
`essentially the same as '1102, except that it is the Mitchell
`reference in place of Powell.
`If we can go to slide 96, this is independent claim 1,
`written in Jepson format, as an improvement over the '501 patent,
`which we just discussed. And here, there are two major issues
`that are a focus of the parties' arguments, and I will begin with
`those, and there are two smaller issues that we might come to if
`we have time. The two major disputed issues are, once again, an
`issue of claim construction and an issue of motivation to combine
`references.
`If we can go to slide 103, here what's happening is that
`there's a term, "prescription approval code," and actually, let's go
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`Case IPR2015-01092, Patent 6,045,501; Case IPR2015-01096,
`Patent 6,315,720
`Case IPR2015-01102, Patent 6,315,720; Case IPR2015-01103,
`Patent 6,315,720
`
`back to 96 for a second to ground ourselves. The prescription
`approval code is mentioned in step (e) of this method and says,
`"upon a determination that said risk is acceptable, generating a
`prescription approval code to be retrieved by said pharmacy
`before said prescription is filled."
`So, going back to 103, what Patent Owner would like to
`do is define that term itself, "prescription approval code," as a
`code representing that an affirmative risk assessment has been
`made, and it goes on to talk about side effects. This is an overly
`restrictive definition. It has no support in the specification and is
`essentially unnecessary for understanding what the invention is.
`If we look at the specification, and especially under the
`BRI standard -- 105, slide 105 -- I'm sorry, 104. This is a portion
`of the specification that discusses approval code, and if you see
`right above the highlighting, it says, "This approval code is
`preferably not provided unless the prescriber, the pharmacy, the
`patient, the patient's risk group, and the patient's informed
`consent have been properly registered." And then it goes on to
`say that it "may further require the registration in the storage
`medium of an additional set of information."
`So, the "approval code" itself doesn't necessarily require
`it. Could it require that additional information? Yes, but to try to
`import that into the definition of the claim term itself is not
`supported by the specification.
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`
`Case IPR2015-01092, Patent 6,045,501; Case IPR2015-01096,
`Patent 6,315,720
`Case IPR2015-01102, Patent 6,315,720; Case IPR2015-01103,
`Patent 6,315,720
`
`
`If we go to slide 108, again, here, Celgene ignores the
`specification and looks to a portion of the prosecution history
`that's taken out of context. Here, applicant is attempting to
`distinguish the Boyer reference, and the Boyer reference talks
`about -- the highlighted portion -- a prescription number or code
`that's simply an identifier for the prescription. So, there is no step
`of authorization, validation, approval of some sort with that. It's
`simply a number associated with a prescription.
`And so when the applicant was distinguishing that
`particular number, it said -- it says clearly that it's not an approval
`code. So, there is some sort of approval, validation, authorization
`step involved; however, what it doesn't say is anything about
`having to do with side effects or having to import some sort of
`affirmative side effect determination, and that's what Patent
`Owner is asking the Board to put into the definition.
`JUDGE TIERNEY: Counsel, if we could just stop right
`
`here.
`
`MS. ABDULLAH: Yes.
`JUDGE TIERNEY: Would you like to reserve some
`time for rebuttal today?
`MS. ABDULLAH: Yes. I should have said that at the
`beginning.
`JUDGE TIERNEY: How much? Not a problem.
`MS. ABDULLAH: Twenty minutes, if that's okay.
`
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`
`Case IPR2015-01092, Patent 6,045,501; Case IPR2015-01096,
`Patent 6,315,720
`Case IPR2015-01102, Patent 6,315,720; Case IPR2015-01103,
`Patent 6,315,720
`
`
`JUDGE TIERNEY: Twenty, that would be great.
`On the approval code, so what is the broadest
`reasonable interpretation of the term "approval code"?
`MS. ABDULLAH: Your Honor, we would say it's
`exactly what's in the patent. So, if we go back to 103 --
`JUDGE TIERNEY: 104?
`MS. ABDULLAH: -- or 104, thank you. If we look at
`the specification, it says the approval code is not provided unless
`the registration occurs. So, that's clearly a requirement. And then
`there might be an additional requirement.
`JUDGE TIERNEY: Actually, Counsel, if you read it
`again, the point you've directed us to says, "This approval code is
`preferably not provided..."
`MS. ABDULLAH: Yes.
`JUDGE TIERNEY: So, is that a preferred
`embodiment?
`MS. ABDULLAH: Well, yes, it is, and, yes, there
`might be other embodiments that don't necessarily have
`registration, but -- but even -- but if we look at the claim term in
`the context of the claim, if we could go back to 96, what's
`important here is that step (e) actually begins with this element,
`"upon a determination that said risk is acceptable," right? So,
`there is -- in the claim itself, there is that determination being
`made. But the approval code, when you're looking at that
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`

`
`Case IPR2015-01092, Patent 6,045,501; Case IPR2015-01096,
`Patent 6,315,720
`Case IPR2015-01102, Patent 6,315,720; Case IPR2015-01103,
`Patent 6,315,720
`
`precisely, that -- that's not -- that doesn't necessarily incorporate
`that in every single embodiment.
`JUDGE TIERNEY: So, what would be the broadest
`reasonable interpretation of the term "approval code"?
`MS. ABDULLAH: Your Honor, it would be a code
`that represents some sort of authorization, approval, or validation.
`I mean, this is not -- we have not offered a definition because we
`think that that's the plain and ordinary meaning to a person of
`ordinary skill in the art, but that is -- that is what we would say.
`And so with that proper meaning in mind, if we look to
`Cunningham, the Cunningham reference -- slide 158, please --
`JUDGE TIERNEY: And Cunningham teaches that
`they're approved to receive the medica -- the sample.
`MS. ABDULLAH: Exactly, yes. So, there is
`authenticity that must be established, there's a full validation, and
`then once validation is established, the pharmacy then dispenses
`the pharmaceutical trial product.
`And here we know that Celgene has made arguments
`about it being a sample and that, you know, there are no free
`samples of Thalomid or thalidomide floating around, but that's all
`irrelevant, because if we go to 192, we know that Cunningham
`discloses a method for managing and tracking the distribution of
`a pharmaceutical trial or sample products, but there's no reason
`that it could just be pharmaceutical products, and that's exactly
`
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`

`
`Case IPR2015-01092, Patent 6,045,501; Case IPR2015-01096,
`Patent 6,315,720
`Case IPR2015-01102, Patent 6,315,720; Case IPR2015-01103,
`Patent 6,315,720
`
`what Dr. Fudin has testified, that looking at this reference, a
`POSA of the proper background would see this as a way to track
`pharmaceutical products for any purpose.
`And if you look towards the right, it makes the --
`Cunningham makes it even more explicit that the process
`inherently includes checks and balances, and checks is balances is
`precisely what Celgene says its program was all about.
`Turning to the other major area of dispute, Petitioner
`has established that a person of ordinary skill in the art would be
`motivated to improve upon the S.T.E.P.S. program. The essential
`rationale is that there were improvements to be made based on
`what was in the prior art in Mitchell, in Dishman, and as well as
`the S.T.E.P.S. program itself, that would improve compliance by
`all participants.
`So, if we look to slide 175, we have Dr. Fudin's
`testimony on that topic, including one of his suggestions, which is
`to enhance the computerized tracking system, and that would
`include by introducing a code.
`Celgene contends that there is some confidential
`information that Celgene had, that nobody else knew, that was the
`basis for their improvement on S.T.E.P.S., but no one has been
`able to tell us what that confidential information is.
`First of all, one thing that we discussed briefly is that
`the S.T.E.P.S. program wasn't 100 percent successful, it wasn't
`
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`

`
`Case IPR2015-01092, Patent 6,045,501; Case IPR2015-01096,
`Patent 6,315,720
`Case IPR2015-01102, Patent 6,315,720; Case IPR2015-01103,
`Patent 6,315,720
`
`that, you know, there was no improvement whatsoever, because
`there was at least one, possibly more, fetal exposures. But
`second, more importantly, Celgene relies on Exhibit 2007 in I
`believe it's the '1102 proceeding, that some confidential FDA
`letter where it describes what enhanced S.T.E.P.S. is all about.
`JUDGE TIERNEY: I do have a question here. This is
`a Jepson claim. Could you give an idea of what the invention's
`"improvement" is? I mean, if they admitted the prior art in the
`Jepson format, what is an improvement here that we're discussing
`today?
`
`MS. ABDULLAH: Your Honor, I think it centers on
`the approval code, introduction of the approval -- of approval
`code as a more sort of computerized technique for controlling
`things, and really that's all that Celgene has put forward, aside
`from the dependent claim.
`JUDGE TIERNEY: Has an approval code prevented
`any birth defects? Has it prevented additional exposures? Is
`there anything on the record that would --
`MS. ABDULLAH: There is nothing on the record that
`demonstrates what additional steps -- I mean, what additional
`birth defects it might have prevented; however, there really is no
`evidence on the record at all about studies, whether there are birth
`defects, whether it happens. Celgene has no motivation to
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`

`
`Case IPR2015-01092, Patent 6,045,501; Case IPR2015-01096,
`Patent 6,315,720
`Case IPR2015-01102, Patent 6,315,720; Case IPR2015-01103,
`Patent 6,315,720
`
`conduct those studies, because if anything comes out, it weighs
`negatively on its program.
`JUDGE TIERNEY: So, is it your position that the
`approval code is an improvement or is it your position that the
`addition of an approval code is not a real improvement?
`MS. ABDULLAH: Well, do you mean in terms of if
`we assume the patent is valid or --
`JUDGE TIERNEY: I am assuming that if it's prior art,
`that it's part of the Jepson format, part of the Jepson claim is prior
`art, is the addition of an approval code to the prior art an
`improvement over the prior art?
`MS. ABDULLAH: If it hadn't been obvious, it would
`have been. Does that answer your question? I mean, our
`argument is that the approval code was already obvious based on
`what's disclosed in the prior art, but in terms of what's claimed --
`sorry.
`
`JUDGE TIERNEY: So, then, it would have actually
`prevented additional exposures by having an approval code?
`MS. ABDULLAH: Well, it would have improved
`compliance, and, again, that was the motivation.
`JUDGE TIERNEY: So, you're saying that people in the
`art would not have already done that already, like a pharmacist
`wouldn't have picked up the phone and checked to see if the
`person was capable of receiving the prescription?
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`

`
`Case IPR2015-01092, Patent 6,045,501; Case IPR2015-01096,
`Patent 6,315,720
`Case IPR2015-01102, Patent 6,315,720; Case IPR2015-01103,
`Patent 6,315,720
`
`
`MS. ABDULLAH: They would have because that was
`part of the --
`JUDGE TIERNEY: Then how is the approval code an
`improvement?
`MS. A

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