throbber
Trials@uspto.gov
`571-272-7822
`
`
`
`
`Paper No. 28
`Entered: September 24, 2020
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`SANDOZ INC.,
`Petitioner,
`
`v.
`
`PHARMACYCLICS LLC,
`Patent Owner.
`____________
`
`IPR2019-00865
`Patent 9,795,604 B2
`____________
`
`Record of Oral Hearing
`Held: June 19, 2020
`____________
`
`
`
`Before SHERIDAN K. SNEDDEN, SUSAN L. C. MITCHELL, and
`DAVID COTTA, Administrative Patent Judges.
`
`
`
`
`
`
`
`
`
`
`
`

`

`IPR2019-00865
`Patent 9,795,604 B2
`
`
`
`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`KIRK BRADLEY, ESQ.
`Alston & Bird
`One Atlantic Center
`1201 West Peachtree Street
`Suite 4900
`Atlanta, GA 30309-3424
`
`
`
`ON BEHALF OF THE PATENT OWNER:
`
`
`WILLIAM B. RAICH, ESQ.
`Finnegan, Henderson, Farabow,
`Garrett & Dunner, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
`
`
`
`
`The above-entitled matter came on for hearing on Friday, June 19,
`2020, commencing at 9:00 a.m. EDT, by video/by telephone.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`2
`
`

`

`IPR2019-00865
`Patent 9,795,604 B2
`
`
`P R O C E E D I N G S
`- - - - -
`JUDGE COTTA: Good morning. This is the Final Hearing in
`IPR2019-00865 regarding Claims 1, 4, 6 through 10, 13, 15, 24, 28 through
`31, 35, 39, 43 through 46, 50 through 53 and 55. This is patent number
`9,795,604. The Petitioner is Sandoz, Inc., the Patent Owner is
`Pharmacyclics LLC. The hearing is open to the public and a full transcript
`of the hearing will be made part of the record.
`I'm Judge Cotta, with me are Judges Snedden and Mitchell. Counsel
`for Petitioner, could you please identify yourself for the record?
`MR. BRADLEY: Good morning, Your Honors, this is Kirk Bradley
`of Alston & Bird on behalf of the Petitioner, Sandoz, Inc.
`JUDGE COTTA: Okay and counsel for Patent Owner, would you
`kindly identify yourself for the record?
`MR. RAICH: Good morning, Your Honors, this is Bill Raich from
`Finnegan on behalf of Patent Owner, Pharmacyclics.
`JUDGE COTTA: Okay, so as set forth in our Hearing Order of May
`15th, each side has one hour to present its case. My colleagues and I will do
`our best to keep track of time, but we suggest that the parties do the same.
`Counsel for the Petitioner, would you like to reserve any time for rebuttal?
`MR. BRADLEY: Yes, Your Honor, I would like to reserve 15
`minutes, please.
`JUDGE COTTA: Okay. And counsel for Patent Owner, you're
`entitled to the last word today, if you wish, would you like to reserve any of
`your time?
`MR. RAICH: I would, Your Honor, I'd like to reserve 10 minutes.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`
`
`3
`
`

`

`IPR2019-00865
`Patent 9,795,604 B2
`
`
`JUDGE COTTA: Okay. Before we begin there are a few things that
`I'd like to cover. First, on behalf of the Board, we'd like to thank you all for
`your flexibility in participating in this all video hearing. Given that this is a
`departure from our typical practice, I first emphasize that our primary
`concern is your right to be heard. So, if at any point during the proceeding
`you encounter technical or other difficulties that you feel undermine your
`ability to adequately represent your client, please let us know immediately.
`Second, when you're not speaking, please mute your microphone to
`make for a clearer record. Third, for the benefit of the court reporter, please
`identify yourself every time you speak. Fourth, we have access to the entire
`record including demonstratives. For the benefit of the record and to enable
`us to follow along better please when referring to each demonstrative paper
`or exhibit do so by slide or page number and give us a few seconds to find it.
`Finally, should you come to a good faith belief that the pace of this
`proceeding prevents you from adequately explaining your position, please
`speak up and we'll consider extending the allotted time.
`Petitioner, you go first as you bear the burden of showing
`unpatentability of the challenged claims. You can begin whenever you're
`ready.
`MR. BRADLEY: Thank you, Your Honors, and good morning again.
`Kirk Bradley on behalf of Petitioner. I would like to start in our slide deck
`at slide 24, please. Slide 24, the '085 Publication anticipates and renders
`obvious all challenged claims. And I want to start here because, really, this
`is the core of all four of Petitioner's independent ground of unpatentability
`for all of its challenged claims.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`4
`
`

`

`IPR2019-00865
`Patent 9,795,604 B2
`
`
`Moving to Slide 25 we see here Claim 1 of the 604 Patent. The main
`thing I want to point out here is that the chemical structure is shown in the
`claim, but there's no dispute that that chemical structure represents the drug
`compound Ibrutinib. And I do want to note for Your Honors also that there's
`a certificate of correction appended to the patents that corrects the stereo
`chemistry shown here. But in any event, there's no dispute that the
`compound itself is Ibrutinib.
`Moving to slide 26. On this slide we've taken the exact language of
`the claim and substituted the chemical compound for the word Ibrutinib and
`then we've broken it down into three parts: the preamble; the one method
`step that recited; and, then the thereby clause. And we power coded these so
`that we can follow along easier.
`On Slide 27, it's really the beginning of the focus of the claim where
`we have the preamble reciting a method of treating chronic GVHD. The
`'085 Publication expressly discloses that limitation, if it's a limitation. I note
`that it's a preamble, the Board doesn't have to decide whether this preamble
`is limiting or not. It doesn't matter because it's expressly disclosed.
`Here we see on Slide 27, paragraph 116 through 120 of the '085
`Publication where the publication describes and defines the word treating. It
`defines it as including inhibiting the disease and for leaving the disease.
`And, in fact, that definition of treating is very similar to the definition of
`treating used in the '604 Patent. It's found in the '604 Patent at column 26
`line 47 to 51. In the '604 patent, it talks about lessening the severity of the
`disease, relieving a condition of the disease and that's the same thing we see
`here in the '085 Publication. In paragraph 120, we see a specific reference to
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`5
`
`

`

`IPR2019-00865
`Patent 9,795,604 B2
`
`a therapeutically effective amount, which is an amount that's sufficient to
`assess the treatment of the disease.
`Moving to Slide 28 we can see that in the '085 Publication the
`treatment of diseases includes methods of treating Graft Versus Host
`Disease. That's the disease recited in Claim 1. It says that in paragraph 98
`of the '085 Publication.
`Now, I'll note that paragraph 98 of the '085 Publication references
`Graft Versus Host Disease and it doesn't specify acute or chronic. But
`looking here at slide 29, it's well-known persons of skill in the art including
`both Patent Owners and Petitioner's expert that GVHD only has two types,
`acute and chronic. The experts spoke, said so during this trial, also the art of
`record, for example the Shimabukuro reference which is Exhibit 1003 at
`page 7, even that one says, "GVHD has been divided into two forms, acute
`and chronic." In fact, the '604 Patent makes the same point at column 28,
`lines 53 to 54. And it says, quote, "GVHD presents in both acute and
`chronic forms."
`So, what does that mean for that? What that means is when the '085
`Publication discloses, expressly discloses administering Ibrutinib to treat
`GVHD, a person of skill in the art immediately knows that that disclosure is
`disclosure of acute and chronic GVHD.
`Looking at slide 30 we can see here at the top, this is a quote from the
`Bristol Meyers case by the Federal Circuit and here the Federal Circuit says,
`"The disclosure of a small genus, for example GVHD. The disclosure of a
`small genus may anticipate the species acute and chronic even if the species
`has not been cells recited." And the idea is that a person of skill in the art
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`6
`
`

`

`IPR2019-00865
`Patent 9,795,604 B2
`
`would immediately through GVHD and immediately know that's acute,
`that's chronic. Anticipation can still be found.
`Moving to slide 31 we can see here is that the '085 Publication
`expressly discloses a treatment of GVHD is accomplished by administering
`a therapeutically effective amount of Ibrutinib, but also importantly, it's
`inherent in any event. The Bristol Meyers Squibb case makes clear that,
`"Newly discovered results of known processes directed to the same purpose
`are not patentable because the results are inherent."
`Another case cited in our brief is the King Pharmaceuticals case. In
`that case, there was a preamble much like the one we have here. That
`preamble recited a method of increasing the bio-availability of Copaxone , a
`different drug. That preamble to put off circuit health (phonetic) was
`inherent. The Federal Circuit said that when you administer Copaxone with
`(inaudible), it inherently achieves that result. The same thing is true here. It
`expressly disclosed and it's inherent.
`Moving to slide 32, it's not only expressly disclosed and inherent for
`purposes of anticipation, but also, it's readily obvious. It would have been
`obvious to a person of skill in the art reading the '085 Publication to
`appreciate as a disclosure of administering Ibrutinib to treat GVHD in
`conflict to treating chronic GVHD.
`JUDGE COTTA: Counsel, not to interrupt you, but I guess before we
`get too far down the road of obviousness, I'd like to touch a little bit on
`enablement and specifically, what's required to enable the disclosure of the
`'085 Publication and treatment of a graft versus host disease.
`MR. BRADLEY: Yes, Your Honor. If Your Honor would turn
`please to Slide 36. Slide 36 is a summary of the Patent Owner's argument
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`
`
`7
`
`

`

`IPR2019-00865
`Patent 9,795,604 B2
`
`relating to enablement and we can see here at the top of the slide that in the
`Patent Owner response they argued that the '085 Publication is not enabling
`because it lacks guidance and working examples that that's what they said.
`But then in their sur reply, they say, Patent Owner does not require a
`working examples, or proof of efficacy. So, I'm unclear whether Patent
`Owner even contends anymore that working examples are required, but
`clearly they're not.
`If we move to slide 37, we see, first of all --
`JUDGE COTTA: My understanding of it was that Patent Owner was
`talking about the lack of guidance and working examples as one of the
`Wands factors, the guidance provided by the prior art publication. Is that --
`do you have a different understanding?
`MR. BRADLEY: I'm, frankly, a little unclear of what exactly they're
`arguing with enablement, but I think regardless of their position, it's readily
`counteracted, and if we look at slide 37, we can see the beginning of that.
`Slide 37 shows at the top that prior art publications and patents are presumed
`to be enabled. So, out of the gate the '085 Publication is presumed to be
`enabled.
`And now, let's turn to the enablement standard itself. At the bottom of
`slide 37, we quoted from the In re Gleave case by the Federal Circuit. And
`the Federal Circuit says that a prior reference is enabling if a person of
`ordinary skill knows how to use the method in light of the reference, would
`know how to practice that method; would know how to carry it out. That's
`all that's required.
`If we look at slide 38, we can see here that Claim 1, which is the
`foundation for all these claims, Claim 1 requires just one step. It requires
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`
`
`8
`
`

`

`IPR2019-00865
`Patent 9,795,604 B2
`
`administering a therapeutically effective amount of Ibrutinib. That's the
`only step. To enable that, all that we have to have is a person of skill in the
`art has to know how to use that method in light of the reference. Absolutely
`they do. A person of skill in the art would read the '085 Publication and it
`expressly says to administer a therapeutically effective amount of Ibrutinib.
`There's no experimentation needed at all, much less unduly experimentation.
`So, the invention is enabled.
`Going back to Slide 33, we can see here on Slide 33 that I've already
`discussed the preamble and now, I'm moving into that administrative step
`which is the only step, administering to a patient having cGVHD, a
`therapeutically effective amount of Ibrutinib. I just explained how it's
`enabled and now here on Slide 34 we can see it's expressly disclosed in the
`'085 Publication. Paragraph 94 uses the same words in the same order. It
`says -- it talks about administering to a patient a therapeutically effective
`amount of Ibrutinib. On slide 35, we can see on the left-hand side we have
`quote from paragraph 30 of the '085 Publication, and it talks about
`therapeutically effective amounts of Ibrutinib. It includes, for example, as
`we'll see later, 220 milligrams per day. It reflects that those expressly. It
`also reflects the prices within the ranges disclosed here.
`Also, on paragraph 120 of the '085 Publication shown on the right side
`of '535, we can see that the '085 Publication specifically defines
`therapeutically effective amounts. The publication makes clear that this
`means the amount of Ibrutinib that when administered through a mammal
`for treating a disease it's sufficient to affect such treatment for the disease.
`So, we clearly have a disclosure in the '085 Publication of the lone method
`that's required by Claim 1.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`
`
`9
`
`

`

`IPR2019-00865
`Patent 9,795,604 B2
`
`
`If we jump forward now to slide 39, I've checked off that lone method
`step. The only remaining aspect of Claim 1 is the thereby clause tacked on
`at the end. The thereby clause says, "thereby treating the cGVHD in the
`patient."
`Looking at slide 40, we see here what we've argued in our brief which
`is that if thereby clause is nothing more than a non-limiting statement of
`intended purpose. Because it's not limiting, it doesn't -- does not need to be
`disclosed in order to anticipate or for obviousness. Regardless, apart from
`that the '085 Publication expressly and inherently discloses treating the
`cGVHD for the reasons I said earlier in the preamble. So, we have several
`bases here, it's both non-limiting and even if the Board were to find it to be
`limiting it's expressly and inherently disclosed.
`On slide 41, at that top left slide, we see an example of the pertinent
`case law from the Federal Circuit. And here in the Minton decision the
`Federal Circuit makes clear that these work through clauses and a method
`claim are not given patentable weight when it simply expresses the intendant
`results of a process step positively recited. Here, we have a process step
`positively recited of administering through a patient with cGVHD, a
`therapeutically effective amount of Ibrutinib.
`That process that is positively recited the intended result is to treat
`cGVHD. That's the thereby clause is not given any patentable weight. Now,
`we'll go to slide --
`JUDGE COTTA: Is there any need for us to construe this claim
`limitation? Does it affect the outcome in any way?
`MR. BRADLEY: It does not, Your Honor, because the treatment is
`enhanced in processing the claim step so, there's no terms in here that
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`
`
`10
`
`

`

`IPR2019-00865
`Patent 9,795,604 B2
`
`require construction and the Board need not even determine whether it's
`limiting or not. Frankly, respectfully, the way Petitioner would ask the
`Board to deal with the preamble and the thereby clause is to say for the
`preamble, we don't have to determine whether it's limiting or not because it's
`inherently satisfied and is expressly and inherently disclosed in the prior art.
`And the same thing for the thereby clause, the Board should find that it's
`non-limiting, but should go on and find that even if it is limiting, it doesn't
`matter because it's expressly and inherently disclosed in the '085 Publication.
`And so I think like with each of those errors in the quiver, there's the
`preamble and the thereby clause can be readily knocked down.
`Now, I don't want to spend too much time on it because, again, the
`thereby clause is non-limiting and also expressly and inherently disclosed.
`But I do want to mention on slide 42, I do want to mention that the Patent
`Owner tries to make it a big deal about prosecution of this '604 patent. The
`Patent Owner argues that during prosecution the Patent Owner somehow
`expressly relies on the thereby clause in order to get around and while I don't
`want to dwell on it, I want to make the key points because that's just not
`correct. What really happens is the clause adding this thereby clause was
`added after all the substantive rejections had already been listed.
`If we skip ahead to Slide 48 --
`JUDGE COTTA: Counsel, I think that's correct, but during
`prosecution wasn't there also an amendment to Claim 1 that added the same
`limitation at a point when all the substantive limita -- rejections were still
`pending?
`MR. BRADLEY: The claim that was prosecuted during -- excuse me,
`the prosecuted claim was 21. If Your Honor turns to slide 45, slide 45 says,
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`
`
`11
`
`

`

`IPR2019-00865
`Patent 9,795,604 B2
`
`newly added Claim 21, and it was added by an amendment. This is the
`Claim 21, this is the claim that eventually became Claim 1. And what
`happened was on slide 46 we see in response to adding that Claim and the
`other aspects of that amendment, the Patent Office withdrew all of the
`substantive rejections. So, after Claim 21 was added, the Patent Office
`withdrew all the rejections. They withdrew the 112 rejection; they withdrew
`the Section 102 and 103 rejections, that's shown on slide 46 by the Exhibits
`20, 30 at three and four.
`Then on slide 47, we see here that what happened because Claim 21
`was newly introduced, it was provisionally rejected on the grounds of non-
`statutory double patenting. There were several applications pending at the
`same time and whichever one's issued later we're going to get a double
`patenting rejection.
`Moving then to slide 48, now we have the Patent Owner's amendment
`and response in April of 2017. This is at the very end of the prosecution
`which was the last step in this paper. And here the Patent Owner
`acknowledges that the only rejection that's remaining is this provisional
`rejection for double patenting. There are no substantive rejections still
`pending. That was in April of 2017.
`If we move then to slide 49, we're still in that exact same amendment
`and response in April of 27 (sic). And again, the Patent Owner said, there's
`no substantive rejection pending, and that was correct. And we see here
`what they did with Claim 21. At the end of that Claim, with no rejection
`pending on the substance, they struck the last phrase and substituted this
`thereby clause on July (crosstalk) --
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`12
`
`

`

`IPR2019-00865
`Patent 9,795,604 B2
`
`
`JUDGE COTTA: Just to be clear, Counsel, I understand the course of
`prosecution, but I guess you would have us just ignore the amendment to
`the, I could say, the response to the April 22, 2016 office action where the
`patentee amended Claim 1 which is very similar to Claim 21 to delete the
`prevention and add treating, and I believe they also added a thereby treating
`on the patient as well.
`MR. BRADLEY: The purpose of that amendment was to overcome
`the 112 rejection because the Patent Owner had not enabled prevention. It's
`easier to treat a disease than it is to prevent it on the front end. And the
`disclosure in the '604 Patent enabled treatment, but did not enable
`prevention. And so what they did was they realized, oh, we cannot get
`prevention and so what we -- what they did was they rationed the back
`announcement, and said okay, rather than getting prevention which would
`include treatment will only go and get treatment. So, this was a narrowing
`rejection to eliminate the fact that they were not entitled to preventing the
`disease. So --
`JUDGE COTTA: Do you have any authority to support that we
`should treat an amendment to overcome a 112 rejection differently from an
`amendment to overcome a prior art?
`MR. BRADLEY: The authority is the Copaxone and Bristol Meyers
`and even the Allergen Sales cases decided by the parties. In those cases the
`issue was, for example, when Allergen Sales such is the case that Patent
`Owner likes to refer to, in that case the wherein clauses were, quote,
`"explicitly relied on to distinguish over the prior art." The Federal Circuit
`made clear in that case that they were talking about distinguishing over the
`prior art. I don't have a case that expressly says it must be only prior art, but
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`
`
`13
`
`

`

`IPR2019-00865
`Patent 9,795,604 B2
`
`certainly that makes sense when you think about the policy of it all because
`you're looking at what are the substantive rejections? When are you going
`to be able to get and write up what the prior art discloses? And here in
`Claim 1 that we're dealing with in this case, there were no substantive
`rejections pending and they added the thereby treatment clause.
`I'll reiterate also, because I don't want to get too hung up on this
`aspect, this really doesn't even matter because as I've shown, the only five
`publication expressly and narrowly discloses it anyway. And so, I do think
`the prosecution supports our argument that it was not relied on in order to
`get allowance of these claims. Also, on --
`JUDGE COTTA: Can we -- can I -- I just wanted to jump into a
`different topic, and I'm sorry for the quick transition. But I wanted to talk
`specifically about Claims 4, 13 and 15. And as I understand it, you argue
`that the '085 Publication discloses combination therapy, and therefore,
`anticipates Claims 4, 13 and 15.
`And I guess my question is, I could see how this argument might
`apply to Claim 4 which encompasses steroid dependent GVHD, but how
`would it apply to Claims 13 and 15 which are directed to steroid resistant or
`refractory GVHD?
`MR. BRADLEY: Yes, Your Honor. If Your Honor will turn please
`to slide 56.
`JUDGE COTTA: Okay, give me a second.
`MR. BRADLEY: On Slide 56, I want to be clear about the
`anticipation of Claims 4, 13 and 15. There are two reasons why these were
`anticipated. And the first is the point, Your Honor, was just mentioning.
`And that is on slide 57. On slide 57, we have paragraph 121 of the '085
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`
`
`14
`
`

`

`IPR2019-00865
`Patent 9,795,604 B2
`
`Publication. And while this does mention combination therapy that even
`more aptly here, what it references is that Ibrutinib can be used sequentially
`with other drugs. And the potential aspect --
`JUDGE COTTA: Just to be clear here, do you read the sequentially
`there to mean two drugs not used in combination therapy where one drug has
`failed?
`MR. BRADLEY: I read this as, and Dr. Ferrara testified that this
`means that Ibrutinib is being disclosed as a treatment sequentially with
`steroids and he understands that to mean what everyone has been doing in
`the art for decades which is giving steroids as a first line defense and then --
`excuse me, as a first line treatment and then when that failed, if that failed
`moving on to a second line treatment option like Ibrutinib, like other drugs
`that are available sequential in that aspect. And with --
`JUDGE COTTA: I guess my concern with that reading is if you look
`at the first sentence of paragraph 121 it's talking about a combination
`therapy, and then if you look at the second sentence, it talks about such other
`drugs. So, it's building on the combination therapy. So, I'm struggling to
`see how you would see paragraph 121 as supporting using one drug like a
`steroid until it's failed and then switching over as opposed to combination
`therapy where one drug is administered sequentially after another drug.
`MR. BRADLEY: So, in paragraph 121, in that second sentence, Your
`Honor, reference is it talks about contemporaneously or sequentially. And
`all I can say is if we look at slide 59, we can see here that Dr. Ferrara is
`talking about paragraph 124 which specifically mentions the glucocorticoids
`which is a steroid. Gluten (phonetic) specifically talks about glucocorticoid
`context. And here on slide 59 there's an excerpt from Dr. Ferrara's
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`
`
`15
`
`

`

`IPR2019-00865
`Patent 9,795,604 B2
`
`testimony when he's reading it from the '085 Publication where it talks about
`the glucocorticoids and it lists several examples like Prednisone and
`Cortisone, and he says here in the highlighted language, these are all steroids
`that we use to treat graft versus host disease. So, we say it's telling me here,
`meaning the '085 Publication is telling me here that use the Ibrutinib in
`combination with that. And if we look back at 5 -- Your Honor doesn't need
`to flip if you don't want to I can read it, but slides 5 and 6 make very clear,
`the slides 5 and 6 make very clear that for decades prior to the five to eight
`years, physicians, persons of skill in the arts have been using steroids as the
`first line treatment option.
`Dr. Koreth who is the Patent Owner's, expert made clear that steroids
`have been repeatedly used for decades. On top of slide 6, he says that we've
`routinely used steroids as our first go to, I think that is almost universal in
`the field.
`So, looking back at slide 56, slide 56, if you recall a moment ago I
`mentioned that we had two reasons for anticipation of Claims 4, 13 and 15.
`And I'll mention the second one here in a moment. I do want to make clear
`that there's no marked distinction between Claims 4, 13 and 15. Two of
`those claims talks about instances where we have steroid refractory or
`steroid resistant chronic GVHD. Those are of the same ilk and both of those
`are telling you that steroids are just not working to treat the chronic GVHD.
`You get steroids as the first time treatment option and if it's not working
`because the GVHD is resistant or refractory to the steroids, then you move
`on to a second line treatment like Ibrutinib, like other options that have been
`available.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`16
`
`

`

`IPR2019-00865
`Patent 9,795,604 B2
`
`
`The other claim of this group is steroid dependence to GVHD and
`what that means is that the patient is dependent on the steroids. The steroids
`are working, but as soon as you remove the steroids it stops working, they're
`dependent on it. The Patent Owner has not made any distinction between
`these three claims, the parties have treated them together and I think clearly
`so. Those experts have said steroids are the first line defense, everyone
`knows that and not wait for decades. You use these second line treatment
`options only if steroids are not working. And that segue is into the
`anticipation argument that we had set forth and it's shown on slide 56.
`On slide 56, what we have here is a summary of what a person of skill
`in the art would read from the '085 Publication. And if we think back, the
`'08 -- excuse me, the person of skill in the art here, the parties agree this is a
`really knowledgeable person. This person knows chronic GVHD; they
`know treatment options; they know transplantations; they know how GVHD
`works. And when that person is reading the '085 Publication, and they've
`seen reference to Ibrutinib being administered to treat GVHD, they already
`know, oh, we're talking about a second line treatment option. Because we
`know, everyone's known for decades that steroids are the first line options
`and so when you read the '085 and it's talking about Ibrutinib as a BTK
`inhibitor being used as a treatment for GVHD, it's already built in and its
`distinction has thoroughly dependent or refractory or resistance to GVHD
`otherwise, (inaudible). So --
`JUDGE COTTA: I think I understand factually the argument. Can
`you address, briefly, the concern we articulated in the institution decision
`that finding anticipation with respect to these claims draws impermissibly on
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`17
`
`

`

`IPR2019-00865
`Patent 9,795,604 B2
`
`the knowledge of the person of skill in the art and kind of goes beyond
`what's disclosed in the reference?
`MR. BRADLEY: Yes, Your Honor. I think it's -- honestly, it's a
`fairly fine line there between adding the knowledge of a person of skill in
`the art versus reading what the reference tells a person who is a skill in the
`art. The line is that for participation, we have a person of skill in the art, that
`person is for all intents and purposes, a pro who's been working in years
`with GVHD. When that person with that perspective and that knowledge
`base reads the '085 Publication it tells them that Ibrutinib is being used as a
`second line treatment option because it has to be, everyone knows from that
`perspective, everyone knows steroids is the first line. So, just reading at the
`very beginning, okay, we're talking about a second line treatment option.
`And even if that were not the case, but it is, but as I've mentioned, we talked
`at the outset here paragraph 121 and 124 makes it even clearer by
`specifically saying that the Ibrutinib compound in the '085 Publication could
`be administered sequentially with other drugs. And paragraph 124 says
`steroids and Dr. Ferrara here, on Slide 59 says, when I read this, it's, "It's
`telling me here that it can use Ibrutinib in combination with that." And he
`means with the steroids first and perhaps steroids continue, but Ibrutinib is
`given as a second line treatment option when steroids are not being effective,
`whether it's because the GVHD is resistant or refractory or this is more
`dependent. So, that's the difference.
`I will say, Your Honor, that, respectfully, we would ask the Board to
`find these claims anticipated for the two reasons I just mentioned. But in
`addition, we would ask the Board respectfully, to also find that in any event
`it's absolutely obvious, these Claims are absolutely obvious because for all
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`
`
`18
`
`

`

`IPR2019-00865
`Patent 9,795,604 B2
`
`the reasons I've just explained, a person of skill in the art they all know that
`we're talking about one of these drugs, Ibrutinib, one of the others that are
`used for cGVHD patients. You only get to that phase once steroids are not
`working, or once the patient's cGVHD is dependent on the steroids.
`JUDGE COTTA: Can you address for obviousness with respect to
`these claims the reasonable expectation of success and particularly in light of
`Exhibit 2050 which is the consensus conference on clinical practice in
`chronic GVHD which says, and I'm reading from Page 2, it says: "Although
`different treatment options are available for salvage therapy of steroid
`refractory cGVHD, the trial and error system remains to date the only way to
`identify the drug or drug combination effective in an individual patient.
`MR. BRADLEY: I think the answer to that, as I understand Your
`Honor's point, is that there we're talking about a situation where we have a
`known drug, Ibrutinib. It has been known since at least 2006 when a patent
`application was filed covering that drug. Dr.

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket