UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MYLAN PHARMACEUTICALS INC.
`Petitioner,
`
`v.
`
`SANOFI-AVENTIS DEUTSCHLAND GMBH
`Patent Owner.
`____________
`
`Case IPR2017-01526 (Patent 7,476,652)
`Case IPR2017-01528 (Patent 7,713,930)
`____________
`
`Record of Oral Hearing
`Held September 6, 2018
`___________
`
`
`Before ERICA A. FRANKLIN, ROBERT A. POLLOCK, and
`MICHELLE N. ANKENBRAND, Administrative Patent Judges.
`
`
`
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`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MYLAN PHARMACEUTICALS INC.
`Petitioner,
`
`v.
`
`SANOFI-AVENTIS DEUTSCHLAND GMBH
`Patent Owner.
`____________
`
`Case IPR2017-01526 (Patent 7,476,652)
`Case IPR2017-01528 (Patent 7,713,930)
`____________
`
`Record of Oral Hearing
`Held September 6, 2018
`___________
`
`
`Before ERICA A. FRANKLIN, ROBERT A. POLLOCK, and
`MICHELLE N. ANKENBRAND, Administrative Patent Judges.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Case IPR2017-01526 (Patent 7,476,652)
`Case IPR2017-01528 (Patent 7,713,930)
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`APPEARANCES
`
`ON BEHALF OF THE PETITIONER:
` DOUGLAS H. CARSTEN, ESQUIRE
` JEFF GUISE, ESQUIRE
` ELLIE F. STEINER, ESQUIRE
` RICHARD TORCZON, ESQUIRE
` WILSON SONSINI GOODRICH & ROSATI
` 12235 El Camino Real
` San Diego, CA 92130-3002
` REPRESENTATIVE: Tom Jenkins and Matt Mylan
`
`ON BEHALF OF THE PATENT OWNER:
` ANISH DESAI, ESQUIRE
` ELIZABETH S. WEISWASSER, ESQUIRE
` WEIL GOTSHAL & MANGES, LLP
` 767 5th Avenue
` New York, New York 10153-0119
`
`
`
`
`
`
`
`The above-entitled matter came on for hearing on September 6, 2018,
`commencing at 10:10 a.m., at the U.S. Patent and Trademark Office
`Madison Building, 600 Dulany Street, Alexandria, Virginia, 22314.
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`Case IPR2017-01528 (Patent 7,713,930)
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` (Proceedings begin at 10:10 a.m.)
` JUDGE ANKENBRAND: Good morning, everyone. Today is
`our final hearing in IPR2017-10526 and IPR2017-01528 between
`petitioner Mylan Pharmaceuticals Inc. and patent owner
`Sanofi-Aventis Deutschland GmbH.
` I'm Judge Ankenbrand. I'm joined today by Judge
`Franklin on my right and Judge Pollock on my left.
` Counsel, can you please introduce yourselves and let
`us know who will be making the argument today? We'll start
`with petitioner Mylan.
` MR. CARSTEN: Good morning. My name is Doug Carsten
`from Wilson Sonsini, and I'll be presenting the argument.
` Also with me is lead counsel Jeff Guise, Rick
`Torczon, and Ellie Steiner. And we also have representatives
`from Mylan Pharmaceuticals Inc. here, Tom Jenkins and Matt
`(indiscernable)
`.
` JUDGE ANKENBRAND: Thank you, Mr. Carsten, and good
`morning.
` And how about for patent owner? Who do we have
` today?
` MR. DESAI: Good morning, Your Honors. Anish Desai
`here for patent owner. And with me is also lead counsel
`Elizabeth Weiswasser, and patent counsel Andrew Iskin (phonetic).
` JUDGE ANKENBRAND: Okay.
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` MR. DESAI: We also have a client representative
`here, Stephanie Donahue.
` JUDGE ANKENBRAND: Good morning to you.
` Welcome, everyone. It's good to have you here
`today. We appreciate everyone making the effort to be here
`for the hearing, especially those coming from the West Coast.
`It's quite early.
` We set forth a procedure for today's hearing in our
`trial order. Just to remind everyone, each party's going to
`have 60 minutes of total time to present arguments.
` Petitioner has the burden of showing unpatentability
`and petitioner will go first, and then after that, Mr. Desai
`will proceed for patent owner.
` Mr. Carsten, would you like to reserve any time for
`rebuttal?
` MR. CARSTEN: Yes, Judge Ankenbrand. I'd like to
`reserve 20 minutes for rebuttal.
` JUDGE ANKENBRAND: Okay. During your presentations,
`please remember to identify any demonstrative exhibits by
`reference -- or that you reference by either slide or screen
`number. This will help ensure the clarity and accuracy of
`our transcript.
` One reminder. Objections should be made during your
`own argument time, not during opposing counsel's argument
`time, with one caveat: If anyone begins to discuss
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`information that is covered by the motions to seal and
`proposed protective order, any counsel can stand up and alert
`us to that, and we'll have to have a conversation about
`whether we need to continue down that road or whether we need
`to send some people out of the room that are not privy to
`that information. But we can cross that bridge if we come to
`it.
` I'll try to give each counsel a warning when you're
` reaching the end of your argument time. Sometimes I forget
` to do that. But the numbers will be on the screen behind
` me, and there's also some lights that will tell you when
` you're entering -- getting close to the end, and then when
` you should finish your argument.
` The last thing I want to remind the parties is that
` the hearing is open to the public, and a full transcript of
` the hearing will be made part of the record.
` I think with that, we're ready to begin. So I'll
` just set the clock, and then you can start.
` I'll start the clock whenever you're ready.
` MR. CARSTEN: I'm ready. Thank you.
` Good morning, and may it please the Board. My name
` is Doug Carsten, and I'm presenting on behalf of Mylan
` Pharmaceuticals Inc., the petitioner in two IPRs, these IPRs
` relating to two patents that block legitimate market
` competition and allows Sanofi to reap billions out of U.S.
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` health care consumers.
` What are these two patents about? What's the
` alleged novelty of these two patents? This is an
` interesting case in the sense that there was a prior
` formulation of insulin glargine, the active ingredient on
` the market, Lantus.
` We have that represented as part of our obviousness
` combinations as the 2001 Lantus Label, and the Owens
` reference. The Owens reference is a reference which
` discloses some clinical testing of the Lantus formulation.
` And taking that well-known, well-understood Lantus
` formulation as described in the label and in Owens, and then
` adding a surfactant to it; that's the alleged novelty.
` There are two IPRs here; the 1526 IPR which deals
` with the '652 patent, and the '930 patent which is the basis
` of the 1528 IPR. Both of them have the -- as their priority
` date the earliest priority date September 9, 2002.
` And when you look at representative claims here,
` I've got Claim 1 from each of the two patents, you'll see
` that each of the patents requires insulin glargine, it
` requires a preservative, it requires water, and it requires
` a particular range of pHs, which are acidic.
` The other remaining element is one chemical entity
` which is a surfactant. Now, there are dependent claims as
` well, and some other independent claims which add clarity or
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` get into a little more detail, add other excipients -- zinc,
` et cetera -- but nothing materially changes these
` fundamental requirements in the -- in these claims.
` And both petitions were instituted on all grounds.
` So we've got the label or Owens in combination with one or
` more of Lougheed, Insuman Infusat Label, and the Grau
` reference.
` The prior art label -- I'm now at Slide 7 --
` disclosed every non-surfactant limitation. Here's the
` label. Here's a passage of the label at page 3.
` You see there's insulin glargine, there's
` metacresol -- that's a preservative, there's glycerol,
` there's water, and the pH of approximately 4.
` Everything except for the surfactant limitation,
` that one chemical entity limitation, is present in the
` label.
` Owens -- I'm now at Slide 8 -- similarly discloses
` each and every item that's required by the claim, except for
` that surfactant.
` There's insulin glargine, there's metacresol,
` there's a pH of 4.0; it's every limitation.
` The addition of surfactants was an obvious solution
` to an obvious problem. And insulin glargine's tendency to
` aggregate was an obvious problem.
` Now, let's start with --
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` JUDGE ANKENBRAND: Actually, I'd like to talk to you
`for a moment.
` MR. CARSTEN: Certainly, Judge Ankenbrand.
` JUDGE ANKENBRAND: One thing we're particularly
`interested in hearing from you today is your response to
`patent owner's contention that, within the four corners of
`the Petition, you haven't established a motivation to modify
`the prior art glargine formulations.
` So it would be nice if you could focus on whether
`there was a recognition of an aggregation problem with
`respect specifically to insulin glargine. I know there is
`some evidence that other insulins were prone to aggregation,
`but that's one thing we're interested in hearing about.
` MR. CARSTEN: Certainly. Well, I'm happy to address
`that.
` Insulin glargine, it bears -- it's important to bear
` in mind, insulin glargine was a molecule that was known. It
` was published. It was patented. It was on the market as
` the Lantus formulation as prior art here.
` So it's not as if insulin -- we're dealing with a
` patent on insulin glargine itself. Those patents have
` expired. We're dealing with a patent just on the
` formulation. And -- and so the properties of glargine are
` not unexpected, the properties of glargine were known. And
` in fact, the properties of Lantus were known, as well.
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` There are a host -- and I'd like to turn, if I
` could -- I'm now going to skip over some of the
` fundamentals, which I think it's -- let me just start
` with -- let me just make one quick point, and then I'll turn
` more specifically to the glargine.
` But that is that -- if you turn to Slide 11 in the
` binders -- the background of the Invention section -- this
` is -- this is material that the patentees identified as
` being common knowledge to a person of art -- skill in the
` art.
` JUDGE POLLOCK: Do you have binders for us?
` MR. CARSTEN: I do, and I believe they've already
`been handed out. If not, I apologize, Judge.
` JUDGE POLLOCK: Thank you.
` MR. CARSTEN: I'm now at Slide 11, Judge Pollock.
` This is admitted by virtue of its placement in the
` Background of the Invention section to be basic knowledge
` that a person of skill in the art would have brought to the
` table. It recognizes that acidic pHs increase aggregation
` risks of insulins generally. Not insulin, not human
` insulin, porcine insulin, bovine insulin only; insulins
` generally.
` JUDGE ANKENBRAND: There are two articles cited,
`Brange and Sluzky, do they mention insulin glargine, or are they
`limited to certain types of insulin?
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` MR. CARSTEN: But they do not specifically --
`neither of those two articles specifically mention insulin
`glargine on their face, but they do talk -- the Brange
`reference in 1997 talks about insulins generally and talks
`about differences between insulins batch to batch and
`differences between insulins in terms of species, but
`concludes that all insulins suffer from this problem of
`aggregation.
` It's not -- there's no evidence whatsoever that
`glargine itself is special in a way that would cause a person
`of skill in the art to believe and expect that glargine is
`going to have completely eliminated or avoided the
`aggregation risks that have been known for insulins for --
`since they were discovered.
` I believe that the Brange 1993 reference cites an
`article from 1928 discussing the risks of insulins
`aggregating, and that this -- and I'm actually looking at
`Slide --
` JUDGE ANKENBRAND: Is it Slide 12 that you --
` MR. CARSTEN: Yes. Slide 12. Thank you very much,
`Judge Ankenbrand.
` So this is the Brange 1993 article. And it cites an
`article from 1928 that insulins themselves were -- that
`insulins themselves aggregate. That's a risk of insulins
`generally, and it's confirmed by the patentees themselves in the
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`background of the invention.
` It also talks about hydrophobicity and that causing
` problems with insulins generally.
` And maybe the proof's in the pudding, too. When you
` actually look to see what it was that the patentees thought
` they had invented when they filed this application -- and
` I'm looking now at Slide 15 -- Claim 1 as filed didn't say,
` 'A pharmaceutical formulation of glargine,' they claimed
` broadly. They said, "A pharmaceutical formulation
` comprising a polypeptide selected from a group consisting of
` bovine, porcine, or human insulins, an insulin analogue" --
` that would be glargine, one of many -- "an insulin
` derivative, an active insulin metabolite, and combinations
` thereof."
` They didn't parse out glargine and say, 'glargine's
` special, and it wouldn't have been expect that had it would
` have already solved all that aggregation risk,' instead,
` they're claiming broadly, "Acidic insulin containing
` media" -- that's what's discussed in the patent -- "that
` contain insulins generally."
` And when you look at Slide 14, "The present
` invention" -- at the middle call-out -- "The present
` invention was thus based on the object of finding
` preparations for acid soluble insulins containing
` surfactants which are distinguished by high long-term
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` stability distress due to temperature or physical mechanical
` stressing and tolerate a high stress with hydrophobic
` aggregation nuclei."
` The patent is saying that glargine is one of many
` insulins, at least in connection with the aggregation risk,
` it's not special.
` And I would submit -- if I go to Slide 16, Your
` Honors -- that a POSA would have expected that Lantus would
` have been a particularly susceptible aggregation risk.
` It had an air/water interface. That's the vials
` that it was sold in had that headspace. That's a known risk
` for aggregation.
` The glass vials and rubber stoppers described in the
` label -- which is part of the Petition -- had hydrophobic
` surfaces. That was identified and known as an aggregation
` risk for insulins.
` In Lantus, glargine itself was presented in an
` acidic media. The patentees themselves identified that as a
` risk factor for aggregation in insulins.
` Temperature. The label specifies, you have to keep
` it refrigerated, you can't exceed 86 degrees. If you do,
` throw it out. That's a risk factor for aggregation.
` And in terms of glargine specifically, remember,
` glargine was known. Glargine was identified in the art as
` being monomeric.
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` If we actually look to, I believe it's the Jones
` reference -- I'm at Slide 23 -- we're not writing on a blank
` slate here. The art contains information about glargine and
` about its properties.
` And at Jones reference says, "Insulin analogues,
` such as insulin glargine, are also monomeric compared to
` pharmacological insulin preparations in which insulin is
` usually present as a hexamer." This is from Jones at
` page 1.
` JUDGE ANKENBRAND: Is Jones talking about the
`insulin analogues in a pharmaceutical formulation or just
`before they're put into a pharmaceutical formulation?
` I wasn't -- I'm not really clear on that sentence
`because there it said "pharmacological insulin preparations",
`and I'm not sure whether that means once you have the
`pharmaceutical formulation, perhaps it's in the hexameric
`form, but when you just have the insulin glargine by itself,
`maybe it's in monomeric form.
` MR. CARSTEN: Well, I think that the answer -- so I
`understand the confusion. I think the fact that it's a
`comparator between glargine or analogues generally, including
`glargine, and talking about pharmaceutical preparations,
`pharmacological insulin preparations, I think it is referring
`to the formulated drug product, and I think that's how a
`person of skill in the art would read that.
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` JUDGE ANKENBRAND: And is there any -- I mean, you
`can tell us that -- but is there any evidence in the record
`that one of ordinary skill in the art would read that
`sentence that way?
` MR. CARSTEN: Well, I think that that's the way that
`that the experts have been treating this passage when they
`referred to it and described it.
` Offhand, I don't have a citation to you to the
`record that says exactly that, but I think that's the way
`that the -- that the experts have been dealing with the Jones
`disclosure.
` JUDGE ANKENBRAND: Well, maybe between now and
`rebuttal you can maybe point us to something that indicates
`that the experts were treating the disclosure that way.
`Because I understand patent owner to be arguing that insulin
`glargine in the pharmaceutical preparations was in hexameric
`form, not in monomeric form.
` MR. CARSTEN: Well, I think that's -- certainly
`that's an argument that they've -- that they've submitted.
` But the Brange reference is pretty clear about
`what's going on, and this is also in the Sluzky reference
`that we've cited, which is a Dr. Langer publication on
`insulin.
` And what we can divine from those is that there are
`two pathways, if you'll have it, through which insulins can
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`come together. There is the natural pathway in which
`insulins -- and this -- I think there's a really nice
`illustration of this as Brange 93 at Figure 8. I don't
`believe I have it on a slide.
` But as I recall the slide, if you go over to the --
`to the left-hand portion of the slide, you start with insulin
`as a monomer. It dimerizes, and then creates a hexameric
`structure which precipitates out in crystalline form and can
`be redissolved. It is in equilibrium state.
` And if you go to the right-hand side, if there is a
`bit of a conformational change which exposes a hydrophobic
`pocket, which one would expect to see at a hydrophobic
`interface, for example, or at -- upon exposure to a
`hydrophobic surface, or upon agitation or an increased
`temperature, those -- that causes this hydrophobic region of
`each of them to come together irreversibly and form these
`block aggregates or fibrils. It's a different pathway.
` Now, I think in terms of what we've seen from the
` Brange reference --
` JUDGE POLLOCK: Could I ask a question?
` MR. CARSTEN: Yes.
` JUDGE POLLOCK: Back to Slide 23 again. Just
`looking at the Jones reference.
` MR. CARSTEN: Certainly.
` JUDGE POLLOCK: Why would we not read Jones as
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`saying that the monomeric tendency of glargine is
`contributing to stability? Is it more stable insulin
`delivery?
` MR. CARSTEN: I'm sorry?
` JUDGE POLLOCK: The middle quote seems to be
`suggesting that the monomeric tendency of glargine
`contributes to more stable insulin rather than less stable.
` MR. CARSTEN: Oh, I see. You're reading the second
`sentence. "Monomeric insulin analogues more closely resemble
`endogenous insulin, and thus, may also be a factor in
`providing more stable insulin delivery and action." Are you
`saying that part?
` JUDGE POLLOCK: Mm-hmm.
` MR. CARSTEN: That refers to the pharmacological
`effect of insulin. So insulin, in solution, is in
`equilibrium between these three regions.
` And I can look at the -- you can look at the Brange
`1997 article which talks about how at acidic pHs, monomers
`are dominating as opposed to the existence of dimers and
`hexamers.
` The business end of insulin glargine or insulins
` generally is the monomeric form. When it does its business
` in the body, when it actually interacts with what it
` interacts with in the body, it is in the monomeric form.
` And so when you have a predominant monomeric form,
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` you would expect to see a more stable delivery and action of
` the insulin because it's predominantly in the monomeric
` form.
` Now, the monomeric form is great -- in the sense
` that a person skilled would know that from the Brange 1997
` reference -- monomeric form is great for having stable and
` active insulin delivery. But it's a problem because it is
` when insulins in that monomeric form, that it can open up
` and expose that hydrophobic surface. And that's the point
` that's driven, that a person of ordinary skill in the art
` would see this.
` And if you turn to -- to Slide 24, this is a quote
` from Brange 1993 -- or a passage from 1993 that talks about
` how the monomer is the most likely to denature. To open up
` to expose that hydrophobic binding pocket.
` That's also found in the Brange 1997 reference. It
` is well-understood as a model on the Sluzky reference that I
` mentioned earlier. All of these identify and talk about
` this pathway.
` Now, frankly, I don't think there is any record
` evidence to support the notion that insulin glargine exists
` solely as a hexamer in solution. Every piece of art that
` we've looked at talks about in connection with insulins
` as -- and in this case, in the Jones case insulin
` glargine -- as being preferred to monomeric, or at least
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` having equilibrium between them.
` And that -- that enhancement of monomeric stability
` or presence for glargine would be a risk factor that a
` person of skill in the art would understand and identify.
` I don't believe we need to have shown that a person
` of skill in the art would have known or predicted that
` Lantus formulation would have aggregated. We need to show
` in our Petition, and we did in our petition, that a person
` of skill in the art would have expected that Lantus had a
` significant risk of aggregation. That's what we showed.
` And when Sanofi came back and tried to elevate the
` burden for us saying that there's no record evidence that
` insulin glargine aggregates, we said, well, fine. If you
` want that, too, we can show that, too. Because it was
` aggregating, and the public knew it was aggregating.
` So Judge Ankenbrand, when you asked me, "What about
` insulin glargine would have caused a person of ordinary
` skill in the art to be concerned?" It was aggregating when
` this material was put into commerce, and patients and
` doctors saw it.
` We have the evidence of Dr. Biggs. He reflected his
` own personal experience, subject to cross examination --
` JUDGE ANKENBRAND: That's not prior art, correct?
` MR. CARSTEN: Oh. Dr. Biggs was -- it's not a
`printed publication, but it happened publicly, and before the
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`priority where Dr. Biggs had a report that, using the Lantus
`product consistently with the label by drawing syringes for
`elderly patients and putting them in the refrigerator, that
`there was aggregation in those syringes.
` He took that report, and he did his own test, his
`own experiment -- excuse me -- before the priority date and
`over the weekend confirmed exactly what had been reported to
`him. This is not a one-off secret thing. Then he went ahead
`and actually posted online about these concerns. Now, that
`came after the priority date, granted --
` JUDGE ANKENBRAND: Right. So how is this -- I
`guess, how is this prior art that would have been known to a
`POSA when Dr. Biggs was doing experiments in his house or his
`office or whatever, and then didn't post anything about them
`until after the priority date?
` MR. CARSTEN: Well, I would call the Board's
`attention to the Intercontinental Global Brands case. So in
`Intercontinental Global Brands, this was a case about cookie
`packaging and resealable cooking packaging.
` There was -- Kraft was part of Intercontinental
`Global Brand, and they had done a survey of some consumers,
`and those -- the consumer survey identified concerns or
`problems with existing snap packaging.
` That was a confidential thing. It later was
`published in 2008. But the court, looking at a patent with a
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`2004 priority date, still attributed weight as a motivating
`factor and as evidence of a known problem, this consumer
`survey, which, as far as we can tell, was confidential.
` If Your Honor -- the panel would like more
`information about Intercontinental Global Brands, we're
`happy to submit something.
` JUDGE ANKENBRAND: Did you cite that in your papers?
` MR. CARSTEN: We did cite that in our papers. But I
`think in order to sort of tease out --
` The District Court decision there just mentions the
`survey in passing. To tease out stuff, we had to go on to
`Pacer and find some information from the case in order to try
`to see what was confidential and what was not, or at least
`identify confidential and what was not. And we're happy to
`make a submission on that afterwards.
` But the point is that motivation evidence need to
`come solely from a printed publication, it can come from
`common knowledge. And it was common knowledge at the time
`because of Sanofi's interjection of this product into the
`stream of commerce that a hypothetical person of skill in the
`art would look to these kinds of things.
` We also had, in response to Sanofi's challenge to
` us, we identified a recall. A recall that was -- that
` contained -- that was due to temperatures. Remember, what
` do we know about temperature as it pertains to aggregation?
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` We know that's a risk factor.
` All these data points triangulate to an issue with
` respect to aggregation. The person of skill in the art
` would have seen these things. This was -- this was known as
` of the priority date.
` Moreover, there are the MedWatch reports which we
` identified. And those MedWatch reports identify instances
` of aggregation in the Lantus vials before the -- before the
` priority date here.
` If there are -- as Judge Ankenbrand, you wisely
` counseled me --
` JUDGE ANKENBRAND: I actually do have a question
`about the documents.
` MR. CARSTEN: Certainly.
` JUDGE ANKENBRAND: Of course, they're the subject of
`a motion to strike and a motion to exclude. I guess the
`question is, why were none of these submitted with the
`Petition?
` MR. CARSTEN: Why were --
` JUDGE ANKENBRAND: Why did -- all of the recall
`documents, the MedWatch documents, the consumer complaints,
`none of those were filed until the Reply.
` MR. CARSTEN: That's true.
` JUDGE ANKENBRAND: So I guess one question I have
`is, are these things we should even consider?
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` And two, were they available to Mylan at the time of
`the Petition, and if so, why weren't they submitted as part
`of your case in chief?
` MR. CARSTEN: Well, we had set forth, I think, a
`compelling case that identified that a person of skill in the
`art would have understood and identified a risk of
`aggregation, and expected a risk of aggregation in the Lantus
`formulation.
` Sanofi came back, and they said, "There is no record
`evidence of aggregation." I don't think we ever had the
`burden to come forward with showing that there was actual
`evidence of specific aggregation in a Lantus product.
` JUDGE ANKENBRAND: Let's assume we agree with you on
`that point. Then are all of the documents that were
`submitted with the Reply irrelevant then to the analysis?
` MR. CARSTEN: Not at all. They're not irrelevant.
`Sanofi challenged us in that specific way. They first said
`there's no record evidence, and so we pointed to the label,
`and we pointed to the differentiation between the 5ML and the
`10ML vial that formed a red flag to a person of ordinary
`skill in the art in terms of the storage conditions.
` They -- we had identified the -- when they said,
`"There's no evidence that a person of skill in the art would
`have any understanding that there was aggregation at all," we
`took them at their word, and we -- we put forward a powerful
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`case that showed that that was absolutely incorrect.
` And it does bolster, I think this adds -- it adds
`data points from which a person of ordinary skill in the art
`triangulates back to the same conclusion that we identified
`in our Petition, and that is that Lantus had an appreciable
`and expected risk of aggregation to a person of skill in the
`art as of the priority date.
` Our position, our argument has never changed over
` the course of this entire proceeding. It's remained true to
` what we said in the petition, and we stand by it.
` I think the petition stands on its own is enough,
` but these --
` JUDGE ANKENBRAND: So if we agree with you then -- I
`guess that's what I'm trying to get at. If we agree that the
`Petition is enough standing on its own, then why do we even
`need to reach all of these documents?
` MR. CARSTEN: If -- if Your Honor is telling me
`that -- that --
` JUDGE ANKENBRAND: I'm not saying -- I'm saying
`assume for purpose -- I'm not saying that. I'm saying if --
`hypothetically, if we agreed with you on that point, then why
`do we even need to turn to all of the
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