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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AUROBINDO PHARMA USA, INC.,
`Petitioner,
`
`v.
`
`ANDRX CORPORATION,
`ANDRX LABORATORIES, INC.,
`ANDRX LABORATORIES (NJ), INC.,
`ANDRX EU LTD.,
`ANDRX PHARMACEUTICALS, LLC,
`TEVA PHARMACEUTICAL INDUSTRIES LTD.,
`Patent Owners.
`____________
`
`Case IPR2017-01648
`Patent 6,866,866 B1
`____________
`
`Record of Oral Hearing
`Held: September 24, 2018
`____________
`
`
`
`
`Before SUSAN L.C. MITCHELL, JO-ANNE M. KOKOSKI, and
`DEVON ZASTROW NEWMAN, Administrative Patent Judges.
`
`
`

`

`Case IPR2017-01648
`Patent 6,866,866 B1
`
`
`
`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`STEVEN J. MOORE, ESQUIRE
`Withers Bergman LLP
`1700 East Putnam Avenue
`Suite 400
`Greenwich, Connecticut 06870-1366
`
`LALINDRA SANICHAR, ESQUIRE
`Withers Bergman LLP
`430 Park Avenue
`10th Floor
`New York, New York 10022-3505
`
`
`
`ON BEHALF OF THE PATENT OWNER:
`
`
`DAVID L. CAVANAUGH, ESQUIRE
`DAVIN YIN, ESQUIRE
`Wilmer Hale
`1875 Pennsylvania Avenue, NW
`Washington, D.C. 20006
`
`JONATHAN B. ROSES, ESQUIRE
`Wilmer Hale
`60 State Street
`Boston, Massachusetts 02109
`
`
`
`
`The above-entitled matter came on for hearing on Monday, September
`
`24, 2018, commencing at 1:01 p.m., at the U.S. Patent and Trademark
`Office, 600 Dulany Street, Alexandria, Virginia.
`
`
`
`
`2
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`

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`Case IPR2017-01648
`Patent 6,866,866 B1
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`
`P R O C E E D I N G S
`- - - - -
`JUDGE MITCHELL: Please be seated. Well, good afternoon, everyone.
`We have a final hearing this afternoon in IPR 2017-01648. I am Judge
`Mitchell and seated to my right is Judge Kokoski and appearing remotely is
`Judge Zastrow Newman. And Judge Hulse was -- good morning. Judge
`Hulse was unavailable to be here today and we did put in a panel change
`order but I am guessing you all probably might not have seen it since it was,
`you know, in transit. So anyway, I would like to get appearances for the
`parties on the record so let me start with petitioner.
`
`MR. MOORE: My name is Stephen Moore with Withers Bergman.
`We are representing Aurobindo USA. I am here with my colleague Lalindra
`Sanichar.
`
`JUDGE MITCHELL: Great, thank you, and welcome. And for
`patent owner?
`
`MR. ROSES: Jonathan Roses of Wilmer Hale on behalf of Shionogi.
`With me also at counsel table is David Cavanaugh of Wilmer Hale, David
`Yin of Wilmer Hale and also David Chaves of Chaves IP Law on behalf of
`Andrx and Teva Pharmaceuticals USA.
`
` JUDGE MITCHELL: Great, thank you and welcome. We did
`receive objections to demonstratives from both sides and we have reviewed
`those objections from both petitioner and patent owner. We have decided
`that we will not exclude any particular demonstrative exhibits based on those
`objections. But certainly in each party's respective arguments, you can raise
`those objections and talk to us about why a particular demonstrative is not
`accurate or whatever the objection is.
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`Case IPR2017-01648
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`We certainly don’t want either side to interrupt the other so certainly
`do that in your argument. And, patent owner, you’re certainly free to do,
`you know, raise it whether or not petitioner has raised it in the opening. You
`can make your objection.
`We did set forth our procedure for how we are going to handle the
`oral argument in our oral hearing order but I like to just go over some of the
`logistics as reminders. Each party has 45 minutes of total time to present
`argument. It’s certainly important for the clarity of the record that if you
`refer to a particular exhibit or a particular demonstrative that you list the
`slide number and the number of the exhibit. And that way our record is
`clear and certainly for Judge Zastrow Newman who is our remote judge, she
`can't see what you have got up here on the screen so she is following along
`with her own copy so please make sure you refer to the exhibit and slide
`number.
`Petitioner has the burden of showing unpatentability of the challenged
`claims so the petitioner will go first. And then the patent owner will have an
`opportunity to present its response. So with that, we can get started and
`petitioner, would you like to reserve some of your 45 minutes for a rebuttal?
`
`MR. MOORE: Yes, I would like to reserve 20 minutes.
`
`JUDGE MITCHELL: 20 minutes, okay.
`
`MR. MOORE: If you could just give us one second to get the slides
`set up, I’m sorry.
`
`JUDGE MITCHELL: Sure, sure.
`
`MR. MOORE: I'm sorry.
`
`JUDGE MITCHELL: No, that’s fine.
`
`MR. MOORE: While we are getting that set up, would anyone like a
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`Case IPR2017-01648
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`hard copy of this?
`
`JUDGE MITCHELL: Oh, I would like one. Thank you.
`
`(Recess)
`
`MR. MOORE: Well, if we start at Slide 2, what this is is just a
`summary from the Federal Circuit opinion in Sciele v. Lupin which dealt
`with this exact same patent in another case.
`
`JUDGE MITCHELL: I would like to ask you, I’m sorry to interrupt.
`Can you speak directly into the mic just so --
`
`MR. MOORE: Oh, I’m sorry.
`
`JUDGE MITCHELL: That’s all right.
`
`MR. MOORE: I’m not sure it’s even on.
`
`SPEAKER: It might not be on.
`
`MR. MOORE: No, it's not on. There we go.
`
`JUDGE MITCHELL: There you go.
`
`MR. MOORE: Okay. So what the Sciele court defined this patent as
`so that’s why I'm not saying it, they said it is that basically it deals with
`dosage forms with a mean time to maximum plasma concentration or the
`quote Tmax of the drug which occurs at 5.5 to 7.5 hours after oral
`administration when given on a once a day basis to human patients.
`As far as the other claims, they're all narrower. They either give
`narrower Tmax ranges or they add additional pharmacokinetic parameters
`that are being claimed.
`Now in Slide 3, I’m just saying that just to make it clear on the record
`that we are challenging all Claims 1 through 25.
`Now if we go to Slide 4, this is actually a very important slide because
`Claim 1 is the only independent claim in this patent, only one. And if you
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`Case IPR2017-01648
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`read that claim, it says you have a once a day oral administration of
`Metformin. The dosage form provides a mean time to maximum plasma
`concentration Tmax of the Metformin from 5.5 to 7.5 hours after
`administration following dinner.
`Why is that important? Because 7.5 was actually disclaimed by the
`patent owner. This claim should have issued with 7.0. Now why is that
`important? Because what we have here’s the patent telling you that this
`Tmax range will work even in the range of 7.0 to 7.5.
`What they did is they then went back to the Examiner because he
`came up with a piece of prior art that read into the 7.0 to 7.5 range and said
`oh, well we will just go to a preferred range which is going to be 5.5 to 7.0.
`Now there is a whole bunch of back and forth at the patent office in
`the file history where somehow the patent office doesn’t pick up even
`though they sent the letter in saying that 7.5 should be 7.0, it's never done.
`And it’s published this way, we were sued this way as if the claim actually
`does read 7.5. And we are going to be arguing it as if it goes up to 7.5.
`But the important factor is there is nothing in that patent that tells you
`why going into a smaller range you have anything that is being taught that is
`novel over the prior art because it says 7.0 to 7.5 will give you the same
`result.
`Now if you turn to Exhibit 101, and that column 8, that’s the patent in
`suit, line 66 to column 9, line 18. You will see that the purported inventive
`concept is set forth. That is that the Tmax range recited when given after
`dinner allows a level of Metformin to be greatest during the period of
`gluconeogenesis around 2 a.m.
`Well, that same inventive concept is taught if you do it at 7 to 7:45.
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`Case IPR2017-01648
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`That’s the only thing I’m pointing out about Claim 1. It is very important to
`know that there was an error made. It never published that way.
`Now if we go to Slide 5, this is just showing what the -- this is paper
`12, it’s the institution decision at 22. What this is just telling you is that
`there was a finding that there would be a reasonable likelihood of prevailing
`on its assertion that Claims 1 through 25 of the 866 patent are unpatenable
`over Timmins and Cheng.
`So let’s take a little look at the background. What we have here is two
`patents, two references that we are saying that when combined basically
`teach this invention and that you would be motivated to combine these two
`references. One is called Timmins. That is Exhibit 1003 and the other one
`is Cheng, which is Exhibit 1002. So let’s take a look at each of these
`references singularly.
`And we will go to Slide 8. Now this is coming from paper 28 which
`is actually institution decision at 11 through 13. This is what the board
`found Timmins teaches. What they say is Timmins teaches a biphasic
`controlled release delivery system which provides prolonged gastric
`residence which enables efficient delivery of drugs normally absorbed in the
`gastrointestinal tract.
`Now if you turn -- look at Example 5 of Exhibit 1003, that’s the
`Timmins patent. You’ll see this is a chart appended there. And you can see
`that this controlled release formulation suggests an AUC values that -- and
`it’s an AUC values that bioavailability may be improved when you give it at
`dinner over Metformin IR and that’s important.
`They're comparing to -- the comparison is not to another extended
`release thing here. We are talking about giving a drug twice a day and we
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`Case IPR2017-01648
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`are going to compare our extended release to that. So the important fact is
`what this is saying that the bioavailability of Timmins tells you that you are
`either exceeding or approaching as they say the drug profile of Glucophage.
`So they are just trying to match what is already out there and instead of
`taking it twice a day we are going to do it once a day. And that’s also
`supported by the declaration of I’m going to say Dr. A just to make it short
`so I stay with my 20 minutes and that’s at Exhibit 1019 at 22.
`Now let’s take a look at Cheng. Cheng discloses and this is again
`from paper 28, the institution decision at 15-60. It discloses a controlled
`release pharmaceutical tablet comprising a core including a hyperglycemic
`drug such as Metformin. The semi permeable membrane covering the core
`and at least one passageway in that membrane.
`Now I’m going to direct you to Cheng, Exhibit 1002 at Table 1, that’s
`page 16 of the reference. And you will notice that it shows that after dinner
`administration improved bioavailability if you look at those AUC values,
`you will see the AUC values came up at dinnertime. So again now it’s
`telling me I should be giving this drug at dinner, after dinner.
`Now let’s go to the Slide 10 and this is coming out of paper 28, the
`institution decision. It's noted that Cheng has the same inventive entity as
`the 866 patent and they are citing to the petition at 75. Dr. A asserts that the
`composition and structure of Cheng is essentially identical to that described
`in the 866 patent.
`Now if we are looking at Slide 11, if you see this is coming out of the
`declaration of Dr. A, that’s Exhibit 1019 at the page 192 and you can see
`they are almost absolutely identical. And I don’t think you can dispute that.
`And in fact, we will go to Slide 12, we will look at Dr. Dressman
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`Case IPR2017-01648
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`when I asked her are these things identical? Answer, they are very similar.
`And where do you see any discrepancy or dissimilarity I asked her? And the
`answer is I see very minor differences, mostly after the decimal point. So
`they are very similar. I think most in the art would say they are identical.
`All right.
`So now let’s look at what is our argument on obviousness. Why is
`there obviousness here? Let’s go to Slide 14. Now we are quoting a lot
`from the Sciele case because these have all been adopted by Dr. A. She 100
`percent agrees that with what the panel which was Judge Lourie, Prost and
`Judge Moore found in the Sciele case.
`
`JUDGE MITCHELL: Are we bound by that here?
`
`MR. MOORE: I don’t, you know, you are asking the $100,000
`question. I don’t know the answer. It might be litigated by somebody. I
`don’t know is the real answer but it certainly -- you may say you’re not. I
`would assume you are not only because I’m, that’s the way I’m going. But,
`you know, I do think it is persuasive. Okay. I mean, these were very high
`powered judges who were sitting on that panel and we will talk a little bit
`about that because we have Judge Moore who is, you know, highly educated
`in the field who went through these numbers 1, 2, 3.
`So what they said at the, in the Sciele case is the 866 patent admits
`that Cheng disclose controlled release formulations from 8 to 12. And it
`does, it is right in the specification. And then it says Timmins expressly
`discloses a median Tmax but it also because of the statistics it is giving you,
`it is giving you some of the statistics, you confirm that, figure out the roof,
`the raw, from the raw data you can compute the possible ranges and mean
`Tmax's.
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`Case IPR2017-01648
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`Now Judge Moore just gets out her computer and figures this all out
`because you can. Knowing the minimum and the max and the median, you
`can figure out what the possibility of the ranges of those means were. And
`based on this data they say one skilled in the art would understand that the
`mean Tmax in Timmins must fall between 4.67 and 6.33.
`Now not only that, the next sentence is very important. Counsel for
`Shionogi agreed that the only element missing from Cheng is the Tmax
`range. And that the Timmins discloses a range of possible Tmax's between
`4.67 and 6.33. That I would call classic collateral estoppel. That’s what
`they have said, they should be bound by it.
`
`JUDGE MITCHELL: So where in Timmins is the raw data?
`
`MR. MOORE: The raw data, it’s statistics. They have summary
`statistics in that chart that I pointed out earlier. It gives you the median and
`the minimum and the max. The minimum and max being that this is the
`lowest value that was in that group of 24 and the highest number of that 24.
`
`JUDGE MITCHELL: So that’s the Example 3?
`
`MR. MOORE: Correct.
`
`JUDGE MITCHELL: Okay.
`
`MR. MOORE: So what they said is Timmins thus teaches one skilled
`in the art to lower the Tmax of Cheng. I think we missed one. No, wait a
`second. Okay.
`
`Now this is the slide that they have objected to and I don’t see what
`the objection is. If you look at the patent owners, patent owner response,
`that’s paper 26 at pages 55 to 56, they actually make a request to the board
`for the additional discovery of Dr. Akhlaghi's calculations that support the
`Federal Circuit range because she finds the same range. This data was
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`Case IPR2017-01648
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`supplied to them with our understanding they were going to put it on as an
`exhibit but lo and behold they decided they weren’t going to do that.
`And so we have had to cobble down though the record to show that all
`of this is still sitting on the record of how she did it and why she came up
`with the same numbers. And so what we are looking at here is in the first
`paragraph, things that came from Dr. A's declaration, Exhibit 1019 at
`paragraph 191, Dr. A's deposition exhibit 2011 at 71 lines 2 through 10 and
`page 72 8-12. Dressman's deposition exhibit at 2912 at page 113, lines 7
`through 114, line 11 and petitioners reply to the patent owner's response,
`paper number 26.
`If you put that all together, you will get what is sitting in here because
`they didn’t supply -- they didn’t put the data -- they didn’t want you to see
`the data because the data does support exactly -- what she did is she used a
`random number generator and tried to figure out what are the possibilities
`for these numbers? And then found which ones of those gave you a mean, a
`median of 5 as reported in Timmins.
`And what she found is using her random generator that the arithmetic
`mean and there is a lot of confusion by the way, there is a lot of discussion
`about Dr. A not responding correctly. That’s because the questions were
`never asked right. She kept asking for them to tell her are you talking about
`the arithmetic mean. There are different means of course. There is
`arithmetic mean, there is geometric mean. So and, you know, and what they
`were talking about with mean Tmax, true Tmax and all this other stuff.
`But anyways, she found the arithmetic mean would be around 5.75 as
`a judge by 50 simulations that came up on the random number generator. So
`she comes up with the same numbers, the same range. That is where those --
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`Case IPR2017-01648
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`you would expect what Timmins is teaching you with a team -- the mean
`Tmax would be.
`
`JUDGE MITCHELL: So is the claimed, the claim term mean, what
`do you say that means? Is that an arithmetic mean?
`
`MR. MOORE: That’s what he kept asking, she wanted to make sure
`that they were understood that there is an arithmetic -- yes, it is an arithmetic
`mean and that’s what we are understanding as what they were meaning by
`that as -- and we are talking arithmetic means at this point.
`So now noted by Judge Moore, who evidently if you listen to the oral
`hearing, she did the calculations herself. She could figure the same thing out
`and this is as noted in petitioners reply to patent owner's response, paper 26
`at 11. This comes directly out of that.
`What she stated was we know referencing Timmins that the result
`presented in the table and that’s the table of Timmins are 24 patients to
`whom this was administered after dinner. We also know that the median
`was 5 with a lower limit of 4 and an upper limit of 8. Do you know that it is
`mathematically possible for that result to be -- to result in a mean higher
`than 6.33? And importantly, as she figured out and you would have seen if
`you could have seen Dr. A's data, 98 percent of the 24 different patients and
`the number that can fit into it are right in the claimed range. 5.5 to 7.5.
`So why isn’t the range of 5.5 to 7 obvious in light of these two
`disclosures? Now you see she did go back to what she knows it should be, it
`should be 5.5 to 7. But that was her question and they could not really
`answer it.
`Now the Federal Circuit also concluded that the district court clearly
`erred, remember they have the much higher burden here, you have to show
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`Case IPR2017-01648
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`that there was a clear error and even there they found that there was a clear
`error in its conclusion that there was no motivation to combine Cheng and
`Timmins.
`And again, all this has been adopted by Dr. A and that's again Exhibit
`1006 in the Federal Circuit opinion Sciele.
`Now let’s look at further statements from that Exhibit 1006. Again
`adopted by Dr. A. Timmins explains the improved bioavailability from the
`extended release dosage that releases metformin at a rate likely to provide
`the desired plasma levels for an extended period of time. Timmins also
`identifies a number of benefits and this is why they run towards it. A
`reduction in the dosing frequency providing patient convenience as well as
`an extended period over which the therapeutically beneficial plasma levels
`of drug were maintained.
`Remember, we are trying to get into that gluconeogenesis period
`which is early in the morning. Take it after dinner. Brilliant. And make
`sure it goes over. Okay. And there’s further motivation in that the Tmax
`allows one in the art to approach the drug profile of Glucophage. That’s
`why I point you to the AUC values because we are almost right on top of
`where its either better in terms of Glucophage or about the same. Again we
`don’t have the confidence limits about that.
`Now let’s go to Slide 19. So the court goes further it also looked at
`this formulation. Now remember the Cheng formulation -- the Cheng that
`we are referring to as the prior art, its prior art. It is the same formulation
`that the 866 patent is talking about. Same thing. Except patent owner says
`oh yes, but we have an extra hole in it. Instead of one hole they put two
`holes. Who would have thought that would have, you put another extra hole
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`Case IPR2017-01648
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`in your tablet you might get a little bit more extra release out of that tablet?
`So coupled with the motivation to lower the Tmax as disclosed in
`Timmins, the applications characterization of the predictability and skill in
`the art during prosecution provides further evidence that it would have been
`routine and an obvious design choice to make an extended release dosage
`form.
`So they are looking at the file history. The file history says hey, be
`easy to make this because remember, they're trying to claim every dosage
`form, extended release dosage form and all of history that will be made that
`gives you that Tmax range. That’s what that claim does. It’s insane. But
`that’s what they are doing and in fact I, Judge Lourie was kind of aghast
`when he read it. He says I don’t see the magic bullet here. It’s like you are
`claiming your result not anything patentable.
`Now one point that I just want to make very clearly quickly that was
`sitting in petitioners reply to patent owner's response page 60, paper 26,
`obvious does not require absolute predictability of success. It requires a
`reasonable expectation. Guess what. If I want to get to that Tmax range it's
`not a genius to figure oh, if I didn't drill the hole far enough maybe you
`should drill a little bit more, maybe you should make the diameter a little bit
`larger. I’ll get there. Okay.
`Now we also have a lot of meritless attacks on Dr. A. Understand Dr.
`A is a six year pharm D and if you guys know anything about pharmacists, I
`happen to be one, they have a lot of training in this stuff. So they're jumping
`out here saying she doesn't have experience. She has a PhD in
`pharmaceutical sciences from the University of Sidney. She’s a full
`professor at the University of Rhode Island which is ranked 11th out of 130
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`Patent 6,866,866 B1
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`pharmacy colleges and is the Ernest Mario distinguished chair of
`pharmaceutics.
`Now I assume that’s why they’ve stopped going after her saying she
`doesn’t know anything about pharmaceutics. I mean, my god she was -- she
`is the chair of that, of the pharmaceutics. She is also the director of clinical
`pharmacokinetics and the clinical research laboratories. And her research is
`directly on pharmacokinetics and diabetes. You can't be much more on it.
`Now I will agree, some of those responses are a little bit difficult
`because she was having a hard time understanding what he was talking
`about. And they -- and if -- all I can point out is if you look at the record,
`the record is clear on what she actually does say. Such as no, it’s not
`normal. It’s not normal. She was -- that was the quotation they're using is
`actually referring to them, not to us. They think that would be normal as a
`POSA.
`Let’s go to Slide 23. The patent owner expert agrees that Claims 1
`through 24 of the 866 patent do not require any set formulation, that’s what I
`was just telling you.
`And now let’s go to Slide 25 and if you look at 25, which is the only
`one that has any -- or 24, I’m sorry, 24. This is from Dressman deposition
`Exhibit 2012 at 61. You can see I have asked her some questions and she
`agrees the Claim 25 all of that as far as the defined terms in 25 are -- were
`known in the art prior to that.
`So what you basically have is bunch of dependent claims that start
`citing different pharmacokinetic parameters which would all result from
`getting that Tmax value using the Cheng formulation. You would get, you
`would expect to get those. What they have done is they have tried to claim
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`Case IPR2017-01648
`Patent 6,866,866 B1
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`their product to keep everybody else out of the market.
`Now in terms of knocking experts, look. Let’s -- and look, Dr.
`Dressman is very well qualified in what she does but she is not an expert in
`anti-hypoglycemic drugs. In fact, her only reference that she could find was
`actually related only to hydroxypropylmethalcellulose which is an excipient
`found an almost any tablet. So and I think my time is up or?
`
`JUDGE MITCHELL: You have about 45 seconds until you are into
`your rebuttal.
`
`MR. MOORE: Oh, okay. Okay. So I’m trying to -- the next would
`be showing that how she also backed off of saying and this is from
`Dressman deposition 2012 at 101 and 102 that they start off in their papers,
`if you read the papers they keep saying it is normal. She now has to say
`well, it is not normal because she is actually putting two references that she
`didn’t cite to in her declaration that actually tell you it is not normal.
`And I, I’m terrible at French, I’m sorry. Its Poisson distribution is
`what these things are. These are discreet variables. They don’t have normal
`distribution. Everybody knows that. All right.
`All right. And finally, there is no teaching away here. The intended
`purpose of Cheng Exhibit 1002 at page 2 to 3 is to formulate an anti-
`hypoglycemic drug wherein the bioavailability of the drug is not decreased
`by food and if you look at that 1002 at page 2 to 3. It is only an additional
`objective, understand every objective doesn’t have to be met in a patent.
`You can have different embodiments that meet them.
`But if they only list it as -- if they say an additional objective is to get
`plasma levels of 8 to 12. So their whole argument that Cheng is
`unsatisfactory for its intended purpose of providing the formulation having a
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`Case IPR2017-01648
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`Tmax from 8 to 12 is ludicrous.
`Next. Nor does Timmins disclosure if you look at Timmins 1003, of
`an expanding polymer on the dosage form teach away from the formulation
`of Cheng, 1002. And that an embodiment, it does not -- that does not
`include an expanding polymer particularly as Cheng does not criticize the
`use of expanding polymers.
`Well, all that thing is saying is that one embodiment you don’t need
`an expanding polymer. Okay. That’s not criticism. That’s not teaching
`away. That’s not discrediting using an expanding polymer. And I would
`say to you look at the first claim of that patent. It doesn’t tell you you don’t
`-- can’t have expanding polymers. Okay.
`And finally, in slide -- lets go to slide -- in terms, I’m sorry. I should
`point out that at petitioners reply to patent owners response at 15 gives you
`the thing that I referenced that you really have to under Federal Circuit case
`law you have to criticize, discredit or discourage one and that is not what has
`happened here.
`And as far as secondary considerations, we go to Slide 30 and then to
`31. All I can say is the results, they fail to point out any problem or
`evidence to support that there was a problem before the invention and they
`make no nexus between what they are saying and the actual claims.
`Nobody cares about the commercial product. Many times people
`copy things because they are very successful, because they are very good at
`marketing but you have to show some sort of nexus and that hasn’t been
`shown and I thank you.
`
`JUDGE MITCHELL: Great.
`
`MR. MOORE: And, I’m sorry, how much did I eat into my?
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`Case IPR2017-01648
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`JUDGE MITCHELL: You have 17 minutes.
`
`MR. MOORE: Thank you very much.
`
`(Recess)
`
`MR. ROSES: Good afternoon. May it please the board, I am
`
`Jonathan Roses of Wilmer Hale on behalf of Shionogi. And I would like to
`reserve 10 minutes of my time for rebuttal.
`
`JUDGE MITCHELL: You won't have time for rebuttal because there
`is no -- since you're the patent owner and you don't have an outstanding
`motion your case in chief should be the full 45 minutes at this point.
`
`MR. ROSES: Oh, okay. My apologies.
`JUDGE MITCHELL: That’s all right.
`MR. ROSES: My understanding was the revised practice guides
`allowed for 10 minute of rebuttal but if that's not the case then I'll just use
`my time in the case in chief.
`
`JUDGE MITCHELL: Give us a minute.
`
`MR. ROSES: Of course.
`
`JUDGE MITCHELL: We will, I'm sorry. I'm not -- we can let you
`have certainly have the 10 minutes if you would like to reserve that for
`rebuttal and petitioner can have a couple of extra minutes if you need that
`time. But yes, I will so sorry about that. Hang on.
`
`MR. ROSES: Excellent. No apologies necessary, thank you very
`much. So I'll begin my presentation today by addressing three particular
`points made in petitioner's presentation.
`First, its petitioners position that a POSA would have combined the
`Cheng and Timmins references. But that’s not right. Viewing those
`references as POSA would, to do so would be quote unquote formulation
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`Case IPR2017-01648
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`folly to quote patent owners expert Dr. Dressman.
`Second, the petitioner says a POSA would combine the references in
`an effort to reach a particular mean Tmax value but this is also incorrect. A
`POSA would understand the key teachings of those references would lead to
`a particular anatomical location of release of the drug, not a specific mean
`Tmax value.
`Third, petitioner's analysis stops at the window of mean Tmax values
`they identify. They fail to actually allege that a POSA would target a mean
`Tmax that falls within that window that also falls within the claimed ranges.
`And there's a fundamental point here, and on this point the experts
`agree. That is that a POSA would expect a particular type of distribution for
`the data that underlies the mean Tmax in Timmins. And we explain that
`based on that distribution, the most likely Tmax is one below the claimed
`range.
`Now in addition, petitioners only argument for obviousness of the
`dependent claims is a flawed application of the inherent obviousness
`doctrine that is defeated by its experts own admission. Failing that
`argument, petitioner has asserted no independent rationale for the
`obviousness of the dependent claims.
`Now, petitioner also mentioned the 2012 Sciele decision from the
`Federal Circuit and we understand that the board has already considered the
`implications of that decision and has recognized that the case is relevant.
`Based on that limited record, the decision found a substantial question
`of validity which is more akin to showing a reasonable likelihood of
`prevailing on at least claim. So th

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