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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________
`
`REGENERON PHARMACEUTICALS, INC.,
`Petitioner
`
`v.
`
`NOVARTIS PHARMA AG,
`NOVARTIS TECHNOLOGY LLC,
`NOVARTIS PHARMACEUTICALS CORPORATION,
`Patent Owner.
`
`__________
`
`IPR2021-00816
` Patent 9,220,631 B2
`
`__________
`
`Record of Oral Hearing
`Held: July 21, 2022
`__________
`
`Before ERICA A. FRANKLIN, ROBERT L. KINDER, and
`JAMIE T. WISZ, Administrative Patent Judges.
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`571-272-7822
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`Paper 112
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` Date: September 6, 2022
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________
`
`REGENERON PHARMACEUTICALS, INC.,
`Petitioner
`
`v.
`
`NOVARTIS PHARMA AG,
`NOVARTIS TECHNOLOGY LLC,
`NOVARTIS PHARMACEUTICALS CORPORATION,
`Patent Owner.
`
`__________
`
`IPR2021-00816
` Patent 9,220,631 B2
`
`__________
`
`Record of Oral Hearing
`Held: July 21, 2022
`__________
`
`Before ERICA A. FRANKLIN, ROBERT L. KINDER, and
`JAMIE T. WISZ, Administrative Patent Judges.
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`IPR2021-00816
`Patent 9,220,631 B2
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`APPEARANCES:
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`ON BEHALF OF THE PETITIONER:
`
`
`ANISH DESAI, ESQ.
`Weil, Gotshal & Manges LLP
`767 Fifth Avenue
`New York, New York 10153
`(212) 310-8730)
`anish.desai@weil.com
`
`
`
`
`ON BEHALF OF THE PATENT OWNER:
`
`
`CHRISTOPHER PEPE, ESQ.
`Weil, Gotshal & Manges LLP
`2001 M Street, NW
`Washington, D.C. 20036
`(202) 682-7153
`christopher.pepe@weil.com
`
`WILLIAM G. JAMES, ESQ.
`Allen & Overy LLP
`1101 New York Avenue, NW
`Washington, D.C. 20005
`(202) 683-3895
`william.james@allenovery.com
`
`ELIZABETH HOLLAND, ESQ.
`Allen & Overy LLP
`1221 Avenue of the Americas
`New York, New York 10020
`(212) 610-6365
`elizabeth.holland@allenovery.com
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`IPR2021-00816
`Patent 9,220,631 B2
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`The above-entitled matter came on for hearing on Thursday,
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`July 21, 2022, commencing at 11:27 a.m. EDT, at the U.S. Patent and
`Trademark Office, 600 Dulany Street, Alexandria, Virginia.
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`P-R-O-C-E-E-D-I-N-G-S
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`(11:27 a.m.)
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`JUDGE KINDER: Good morning, everyone. I'm Judge Kinder, and
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`with me today on the panel are Judges Franklin and Wisz. Today we're
`going to be hearing oral argument in the case Regeneron Pharmaceuticals as
`Petitioner v. Novartis Pharma AG and two other Novartis entities as Patent
`Owner. The case is IPR2021-00816 involving U.S. Patent 9,220,631.
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`If we could do it initial roll call for Petitioner who's appearing today
`and who's going to be arguing?
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`MR. DESAI: Good morning, Your Honors. Anish Desai. And with
`me at the counsel table is Chris Pepe. And I will be arguing today.
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`JUDGE KINDER: All right, Mr. Desai, thank you.
`
`Patent Owner?
`
`MR. JAMES: Good morning, Your Honors. My name is William
`James. I'll be arguing today. And with me is Elizabeth Holland at Patent
`Owner's counsel table.
`
`JUDGE KINDER: All right, Mr. James, thank you. As you can see,
`we have two judges remote, so when we are presenting today we want to
`take extra time, if you call out an exhibit number, give us just a few extra
`seconds to flip to that exhibit so the judges that are remote can turn to that as
`well, and also give me a few seconds to find it as well.
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`Petitioner has 45 minutes to present its argument in this case and
`Patent owner also has 45 minutes to respond. If by chance we have
`questions and we are feeling like we need extra time to understand the case,
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`we might go over a few minutes, but generally we'll would try to stick to the
`45.
`Petitioner is going to open the hearing by presenting its case regarding
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`the challenged claims. The Patent Owner will respond to the Petitioner's
`argument.
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`The Petitioner may reserve rebuttal time to respond to the arguments
`by Patent Owner. Mr. Desai, how much time do you need today?
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`MR. DESAI: I'll reserve 10 minutes.
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`JUDGE KINDER: Ten minutes of time. Okay. And then after
`Petitioner has replied Patent Owner, you can reserve an amount of time.
`How much time do you want to reserve, Mr. James?
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`MR. JAMES: Your Honor, I'll reserve five minutes.
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`JUDGE KINDER: Five minutes, okay. Give me one second to set
`the timer. So we're looking at 35 minutes for the initial timer. Would you
`like a yellow light warning at like two minutes out? That's up to you.
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`MR. DESAI: Sure, that's fine.
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`JUDGE KINDER: Okay. Two minutes it will be yellow. We talked
`about the need to clearly identify the exhibit if you're referencing it or if
`your references -- excuse me, if you were referencing a slide number, speak
`the slide number clearly, give us a second to flip to that as well.
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`And I think there's that. Unless the parties have any other questions,
`we can get started. Let me make sure my panel doesn't have any questions
`at this time.
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`JUDGE FRANKLIN: I'm having a little trouble hearing the parties.
`Can we do a mic check?
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`MR. DESAI: How is this, Your Honor?
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`JUDGE FRANKLIN: That's good, thank you.
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`MR. JAMES: How is this?
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`JUDGE FRANKLIN: Great, thank you.
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`JUDGE KINDER: All right. If for any reason we become
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`disconnected with those attending virtually, the judges, we'll pause the
`hearing and it won't eat into your time and we'll just deal with that. It
`happens occasionally due to weather or other outages so it's not a big deal.
`Our staff is really good at handling situations like that.
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`Currently, the hearing is about 90 minutes. I said if you go longer I
`think at that time we probably won't take a break unless somebody needs a
`break in between.
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`You know, if somebody does need a break feel free to speak up in
`between presentations and let me know and then we can take a quick break,
`but otherwise I think 90 to 100 minutes we'll try to push through if that's
`okay.
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`case.
`MR. DESAI: Good morning, Your Honors. Thank you very much.
`
`This IPR involves Novartis' '631 patent directed to a prefilled glass syringe.
`Grounds 1 and 2 -- I'm actually on Slide 2 of our demonstratives, grounds 1
`and 2 are the primary grounds, Sigg plus Boulange and Lam plus Boulange.
`Our argument will focus on these two grounds.
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`All right. At this time, Petitioner, you can go ahead and start your
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`Patent 9,220,631 B2
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`Grounds 3 to 10 include additional references for some of the
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`Dependent Claims. Novartis has not made any argument specific to grounds
`three to ten.
`
`Sigg, Lam and Boulange were not before the Office when the
`application for the '631 patent was examined. The parties have gone through
`an extensive ITC investigation that was withdrawn by Novartis, and the ITC
`staff agreed in that case that there was clear and convincing evidence the
`claims were obvious based on these references.
`
`In this IPR --
`
`JUDGE KINDER: Can I ask one quick question? Is there any
`precedent for us giving weight to what ITC staff determined in any
`proceedings?
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`MR. DESAI: No, Your Honor.
`
`JUDGE KINDER: Okay.
`
`MR. DESAI: In this proceeding Regeneron has met its burden of
`showing that the claims of the '631 patent are obvious under the
`preponderance of the evidence standard.
`
`We're going to turn to Slide 5, and I mentioned the prosecution of the
`'631 patent. Claim 1 on the left was rejected as obvious by the examiner
`after numerous office actions and responses. Claim 1 on the right was
`amended to add the words terminally sterilized and then allowed without
`further rejection.
`
`Sigg and Lam were not for the examiner, and those both disclose a
`prefilled terminally sterilized syringe for intravitreal injection containing a
`VEGF antagonist.
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`I'm on Slide 6 now, and this is Sigg. It's WO '877. It is a prior art
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`Novartis publication published in January 2011. The Sigg reference clearly
`discloses vaporized hydrogen peroxide terminal sterilization of a prefilled
`syringe containing a VEGF antagonist and specifically ranibizumab, which
`is also called Lucentis.
`
`Now, there is also a U.S. patent application that corresponds to the
`Sigg reference. This U.S. application was filed on September 20th, 2011
`and it's referred to as a '380 application in our papers. The prosecution
`history of the '380 application is Exhibit 1252.
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`And I bring this up because the relevance of this IPR is that Novartis
`made arguments and submissions during that prosecution that contradict
`positions that it's taken in this IPR, and I will cover that later.
`
`Slide 7, just a little bit more on Sigg, provides an example with
`protein stability results after VHP sterilization to half ML syringe. Table
`one compares control syringes to syringes that went through either a single
`pass or two passes of VHP treatment.
`
`I'm on Slide 8 now. This is Lam. It is a Genentech patent application
`publication. It was published in June 2008. Lam discloses ethylene oxide,
`or EtO, terminal sterilization of a prefilled glass syringe containing Lucentis.
`This is clear from the citations on this slide.
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`JUDGE KINDER: This is Judge Kinder. Can I ask one quick
`question?
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`MR. DESAI: Sure.
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`JUDGE KINDER: What's the biggest difference between Sigg and
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`Lam? I know Patent Owner made one set of distinct arguments on Lam, but
`what -- why do you have Lam as opposed to Sigg? What's the difference?
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`MR. DESAI: The difference is one is VHP sterilization and the other
`is EtO. As far as the difference between the invalidity positions in this case,
`I think there are certain arguments that were made specifically for Lam by
`Patent Owner and some that were made for Sigg but as far as the claims go, I
`don't think there's any claim that is limited to either VHP or EtO. There's
`claims, Dependent Claims that that claim VHP or EtO.
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`JUDGE KINDER: Okay, thank you.
`
`MR. DESAI: So on Slide 9 Lam provides a detailed example. Table
`1 list parameters for sterilization, temperature, dwell time, relative humidity,
`et cetera. Table 2 provides data showing that the protein was intact and
`active after sterilization. And there's also Table three, we couldn't fit it on
`the slide, which discloses stability after two months.
`
`And if we turn to Slide 10 this is the Boulange reference. It's a Becton
`Dickinson publication relating to prefilled glass syringes published in March
`2009. The silicone oil and force limitations in the '631 patent are disclosed
`in Boulange.
`
`Table 5 of Boulange discloses syringes that had baked-on silicone
`applied at 4 micrograms per centimeter squared. That is approximately 40
`micrograms for a 1 ML syringe. The highlighted rows show the forces for
`stopper B1 and stopper C.
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`The break loose forces and slide forces are well below 11 newtons and
`they're also categories in that table that are below 5 newtons.
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`JUDGE KINDER: So this is Judge Kinder. I think you'll probably
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`get into this a little bit more as the presentation goes along, but can you give
`us an overview why you separately relied upon B1 as well as C, one with
`parylene-C and one without? If you made essentially, are you essentially
`relying alternately onto those? That's the way I read the briefing.
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`MR. DESAI: Either stopper would be considered acceptable for this
`combination. I think we put forward the evidence to show why a POSA
`would be motivated to use either of the stoppers. I don't think, you don't
`need to -- we don't need to show both to win this case. If we show one it's
`over. But I think as far as completeness goes they're both acceptable
`stoppers and we felt it was prudent to include both.
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`JUDGE KINDER: Okay. I understand there's several sets of unique
`arguments for being each, right?
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`MR. DESAI: Yes, there are.
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`JUDGE KINDER: So if we agree with Patent Owner on one set of
`those arguments that doesn't necessarily defeat your entire case. Is that what
`you're saying?
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`MR. DESAI: A hundred percent. If we win on stopper B1 that's good
`enough. If we win on stopper C that's good enough, too.
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`JUDGE KINDER: Okay.
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`MR. DESAI: And I'm happy to go straight into that, the stopper
`arguments, because I think that's central to the motivation issue.
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`JUDGE KINDER: No, you can keep going at your own pace.
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`MR. DESAI: Okay. So if I turn to Slide 11 just to cover the USP
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`789, this is prior art to the '631 patent. The '631 patent claims particulate
`matter limitations that were published in this USP 789.
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`On the left is the microscopic method in the USP 789 and the USP it
`explains that sometimes articles cannot be tested by light observation, in
`which case the microscopic methods should be performed. This is the
`motivation for a POSA to comply with the USP 789 microscopic method.
`And the limitations in the claims are drawn directly from the USP 789.
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`So ultimately, the '631 patent did not invent these particulate matter
`requirements for ophthalmologic solutions. They were published by before.
`The '631 patent did not invent baked-on siliconization that's disclosed in
`other references, including Boulange. The '631 patent did not invent
`terminally sterilized a prefilled using VHP or EtO, but that is what they
`wrongly claim.
`
`Now, the motivation to combine, I'm on Slide 12, the motivation to
`combine with Boulange is clear. The prior art describes the incentives to
`minimize silicone oil applied to a syringe barrel. The references cited on
`this slide describe how silicone oil can potentially lead to aggregation,
`deformation and activation of protein structures, and they also discuss the
`need to reduce the amount of silicone oil that is potentially injected into the
`eye.
`That is particularly relevant to Sigg and Lam that disclosed syringes
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`with Lucentis for intravitreal injection. These motivations are not disputed
`by Novartis.
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`I'm going to turn now to the stopper arguments and Patent Owner's
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`primary argument about motivation to combine focuses on the stoppers in
`Boulange. This is somewhat curious given that the '631 patent claims a
`generic stopper and does not describe any specifics about stopper coatings or
`materials.
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`Essentially Patent Owner is arguing that a POSA would not use either
`stopper B1 or stopper C. Your Honors should reject these arguments. B1 is
`coated with parylene-C, which is the invention being touted by Boulange.
`Stopper C is a conventional rubber stopper. A POSA would have motivation
`to use either. And as I mentioned, using either would invalidate the claims
`of the '631 patent.
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`I'll start with stopper C. I'm on Slide 16. Table 5 from Boulange
`shows the forces for a siliconized stopper C. All of the forces are well
`below 11 newtons, and that's the boundary claimed in most of the claims of
`the '631 patent for intravitreal injection.
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`Patent Owner's argument hinges on the highlighted statement that the
`forces stopper C are markedly inferior to that of stopper B1. Another way of
`saying that is the forces for B1 are lower than C. That is not teaching away
`from the claimed invention.
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`The Federal Circuit law is very clear on this point. I'm on Slide 17
`and we cite Mouttet and Gurley in our briefs. These are well-known cases
`on the issue of teaching away, and if we apply these cases to the facts here,
`Mouttet tells us the fact that B1 is a better alternative according to Boulange
`does not make stopper C inept for obviousness.
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`And Gurley tells us that stopper C does not become patentable simply
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`because it has been described as inferior to stopper B1.
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`JUDGE KINDER: Can I ask one question about the inferior
`comment? I note, I think you both are, kind of, arguing around what
`actually that means by inferior, but what is your position? Is it because
`essentially the break loose force almost doubles from 4.7 to 8.4? Is that
`what makes it inferior?
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`MR. DESAI: I believe in Boulange it is describing that B1 is the
`superior, or you could say the C1 is inferior, based on the forces. If you look
`at the table, I'm on Slide 16, you can see that the B1 forces are lower than
`the C forces however and I will get to this point about the doubling of the
`forces.
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`All of these forces, whether it's B or C are acceptable for intravitreal
`injection.
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`So when the assets when it comes to teaching away from the claimed
`invention while Boulange may be touting B1 because it has lower forces that
`doesn't mean C is now unacceptable for intravitreal injection.
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`JUDGE KINDER: What would make one of skill in the art
`understand that that 8.4, for example, would be acceptable at that time?
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`MR. DESAI: Sure, so while --
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`JUDGE KINDER: I know you reviewed your expert on that and
`certainly they say that but what other evidence do you have that that would
`have been expected there?
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`MR. DESAI: Well, the, I mean, the '631 patent itself describes at 11
`newtons or even 20 newtons is acceptable for intravitreal injections.
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`JUDGE KINDER: But that's, sort of, hindsight reasoning, yes?
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`MR. DESAI: The inventor's deposition testimony, and I can point to
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`this, acknowledge that 11 newtons was already known as far as something
`that was acceptable for intravitreal injection.
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`JUDGE KINDER: When you say "already known," like, an industry -
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`MR. DESAI: Exactly.
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`JUDGE KINDER: -- standard or some kind of industry known art?
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`MR. DESAI: Dr. Sigg in his IPR deposition clearly testified, and I
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`have to -- I can pull them pull the cite up, Your Honor, while we're waiting
`for, while I'm listening to Patent Owner's argument, but Dr. Sigg clearly
`testified that 11 newtons was something that was known, not something that
`they came up with.
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`I think another issue is that this is not the first syringe that was being
`used for intravitreal injection. The Macugen PFS was on the market so
`doctors already knew what forces would be acceptable.
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`And if I turn to the argument about forces over time, I'm on Slide 19,
`and this is one of the arguments they've made for stopper C is that because
`the syringe doubles from 4.7 to 8.4 newtons that means that means these
`forces are somehow inconsistent over time.
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`I think number one this argument makes little sense because all of the
`forces are still below 11 newtons, right? And the '631 patent does not claim
`or describe how it forces change over time.
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`Also, we have evidence that confirms that a delta of 4 newtons would
`not matter to an ophthalmologist. The Regeneron's Eylea PFS, for example,
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`has forces that can vary from 5 to 9 newtons, a delta of 4 newtons. And both
`of Patent Owners ophthalmologists agree that that still provides consistent
`forces.
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`In other words, the delta of 4 newtons is not meaningful to an
`ophthalmologist when it comes to intravitreal injection. Patent Owner's
`argument about the doubling of the force is also incorrect because they argue
`that it corresponds to three months of storage time. That's incorrect.
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`As we can see on Slide 20, Boulange's time zero is obviously at the
`time that the syringe was made and time one is after accelerated storage of
`40 degrees Celsius for one month. That corresponds conservatively to 9 to
`13 months storage at 2 to 8 degrees Celsius, which is the normal storage
`temperature for syringes containing a VEGF antagonist. The three-month
`position about the aging would be storage at room temperature.
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`So what we're talking about in Boulange is the forces doubling after
`accelerated aging, which is intended to demonstrate a very long storage
`period time.
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`JUDGE KINDER: Is there any evidence in the record about what the
`typical storage time is for a PFS before usage, required usage?
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`MR. DESAI: There was, Your Honor, with respect to the motion to
`amend because in the motion to amend Novartis was actually trying to add
`shelf life limitations to the claims. And I think we put in evidence from the
`Nema textbook and from the Macugen PFS that those had shelf lives of, I
`think, 12 months or 18 months, 24 months. Those were sort of typical shelf
`lives.
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`But again, the claims that we're dealing with right now do not require
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`any particular break loose force at a particular time. So it was relevant to the
`motion to amend and the claims that were amended to try and add those
`shelf life limitations, but those are not limitations that are in the present
`claims.
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`JUDGE KINDER: Thank you.
`
`MR. DESAI: If I stick with stopper C, and just one more point about
`the case law, in Patent Owner's brief at Page 16 they rely heavily on
`AstraZeneca v. Mylan. And this case I think is easily distinguishable. The
`prior art there taught a control formulation and a novel formulation and the
`Court found that the prior art taught away from the control formulation.
`
` I think Novartis is trying to analogize this to the Boulange reference
`which has C, stopper C, which is effectively the control and B1 which is the
`novel parylene-C. But in that case the Federal Circuit relied on testimony
`that the control formulations, quote, "clearly don't work," and had, quote,
`"huge agglomerates floating around," rendering them, quote, "completely
`unsuitable."
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`That is absolutely not applicable to the stopper C in Boulange, which
`shows that it has acceptable break loose forces and side forces both at time
`zero and after accelerated aging.
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`And, of course, if we look at Slide 18 we know a siliconized rubber
`stopper would work because that's the typical stopper used in a glass syringe
`both before and after the '631 patent. The Nema textbook here shows that,
`talks about the necessity of siliconizing a rubber stopper.
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`The Macugen PFS, as I mentioned, was a commercially available,
`
`terminally sterilized, prefilled syringe containing a VEGF antagonist that
`also used a siliconized rubber stopper. Exhibit 1009 is the label for the
`Macugen PFS and Exhibit 1220 is the FDA submission for the Macugen
`PFS. And Page .229 confirms the use of a siliconized rubber stopper. I
`haven't put that up on the screen because that's confidential Bosch and
`EyeTech information, but it's a part of the record.
`
`And siliconized rubber stoppers continue to be used. That's exactly
`what Novartis ultimately chose for the Lucentis PFS that was commercially
`released in 2016. That's Exhibit 2110.001 and Exhibit 2128.033. So it's a
`little bit disingenuous to be arguing that a POSA would not use a siliconized
`rubber stopper which is stopper C.
`
`If I go to Slide 21, Patent Owner also relies on the statement in
`Boulange that stoppers A and C and Table 7 do not appear acceptable for a
`medical device. This is stoppers A and C in Table 7 were unsiliconized and
`uncoated. Regeneron is never argued that a POSA would use an
`unsiliconized, uncoated stopper.
`
`This is clearly not teaching away from siliconized stopper C. This
`argument is irrelevant and incorrectly presumes that a POSA would treat
`siliconized stopper C and unsiliconized stopper C in Table 7 as the same. A
`POSA would not do that.
`
`JUDGE KINDER: Let me ask you, excuse me, let me ask you a
`question then. If it's saying that stopper C, for example, would be unsuitable
`for a medical device, is it conversely conveyed here that will stopper B1
`with parylene will be acceptable for a medical device?
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`MR. DESAI: I believe that's correct. I mean, I think there's no
`
`question that Boulange is touting stopper B1 for a medical device or a
`prefilled syringe.
`
`I think it's important though to understand that what it's saying stopper
`C is not acceptable it's specifically referring to stopper C in Table 7 which is
`not siliconized and not coated. And so that is very different then a
`siliconized or a coated stopper, which was what you saw in Table 5.
`
`So I think it's absolutely clear. You saw that the Nemo textbook that
`it's understood that you need to coat or siliconize a stopper, a rubber stopper.
`So no one is suggesting in this case anyone would put an unsiliconized or
`uncoated stopper into a syringe.
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`So I think that's why this point about that, you know, the unacceptable
`is irrelevant because no one is making, taking the position that anyone would
`use that kind of uncoated unsiliconized syringe or stopper.
`
`JUDGE KINDER: One more question with respect to Table 7. Why
`would they compare the siliconized stoppers essentially with the
`unsiliconized? Isn't, or excuse me, stopper B1 has the parylene, but why
`would they compare that to something that wasn't siliconized?
`
`MR. DESAI: I think they were trying to isolate the impact of
`parylene-C, right so they could -- the previous table is comparing parylene-C
`coated and a siliconized stopper, so B was parylene-C and it was siliconized.
`Stopper C was siliconized, right?
`
`And now in Table 7 they're trying to say, okay, let's just take a look at
`how parylene-C behaves relative to something with nothing on it. It's just,
`it's basically an experiment to isolate how parylene-C performs.
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`JUDGE KINDER: Okay, thank you.
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`MR. DESAI: So let me turn to stopper B. I think I'll try and cover
`
`this one quickly. Boulange provides the motivation. It talks about
`eliminating silicone on the stopper while at the same time getting decreased
`forces and maintaining a tight seal. That's Slide 22.
`
`The primary argument from Patent Owner is that, well, they'll dispute
`that Boulange touted. They argue that a POSA would be discouraged from
`using it because it would be unsafe or incompatible with a VEGF antagonist.
`The evidence does not support that argument.
`
`On Slide 23 Patent Owner's expert Dr. Dillberger focused on two prior
`art papers, Exhibit 2030 and 2031 and these references do not disclose that
`parylene-C would be toxic or unsafe. Patent Owner's expert ignored
`important parts of the references, and I've highlight them here on the slide.
`Parylene-C has been used as a biologically inert coating and then talks about
`how the results obtains strongly support the thesis that parylene-C is a
`material worth considering.
`
`Slide 24, Patent Owner's response took the position that parylene-C
`would likely leach cytotoxic components and would present serious safety
`issues. And they cited to Dr. Dillberger, but at his deposition he was was
`unwilling to go that far and take and support that position.
`
`And we asked him, "Is it your opinion that parylene-C would have
`been understood to be toxic to use as a stop coating?" Answer, "No. My
`opinion is that it would have been unknown." Clearly not -- he's clearly not
`supporting Patent Owner's more extreme position in their Patent Owner
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`response that it would likely leach cytotoxic components and it would be
`unsafe.
`
`We asked if he was aware of any publications that describe parylene-
`C as unsafe, toxic or pharmaceutically acceptable -- unacceptable as a
`stopper coating in a prefilled syringe. Answer, "I guess not in that context,
`no," and then he pointed to the Kaminska reference, which is Exhibit 2031,
`the one I showed you on the previous slide which talked about how it's a
`promising coating for medical/biomedical applications.
`
`Patent Owner on Slide 25 contends that parylene-C has high
`adsorption, but the problem with that argument is that they were comparing
`parylene-C adsorption to glass adsorption.
`
`As Dr. Cohen, our toxicologist explained, that is not the comparison
`that a skilled person would be making in evaluating parylene-C as a stopper
`coating. The comparison would be protein adsorption relative to other
`remove a lubricants or coatings that are used on stoppers, for example,
`silicone oil.
`
`Dr. Dillberger offered no opinion about how parylene-C's adsorption
`compared relative to those kinds of lubricants or coatings.
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`JUDGE KINDER: This is Judge Kinder. Real quick, I think you
`messed up an exhibit number for Slide 25. The chart, I think, is actually
`Exhibit 2030 just for the record.
`
`MR. DESAI: Oh, I apologize. Thank you. I think the other issue Dr.
`Cohen pointed out how a POSA would understand from the references that
`adsorption of parylene-C can be applied in a manner to minimize adsorption.
`That's Exhibit 1108, Paragraph 29. I think the bottom line, Patent Owner
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`has not presented sufficient evidence to demonstrate that a POSA would be
`discouraged from using parylene-C.
`
`I'm going to turn to --
`
`JUDGE KINDER: Before you get off of parylene-C, I don't know if
`you're going to -- I know you had three arguments, kind of, countering
`Patent Owner's position about the combinability and whether it would be
`used.
`I think the second one was the contact argument, that it wouldn't
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`necessarily be in contact. And I know that's part of Patent Owner's motion
`to exclude.
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`Looking at the Patent Owner's evidence on that in their rebuttal and
`their surreply, they came back and showed a couple parts where it suggests
`that it was surrounding. Do you still maintain that there's no contact?
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`MR. DESAI: No. So, I think the issue here is what Boulange
`discloses. It definitely discloses deposition where it can coat the entire
`stopper, but there's also a disclosure in Boulange which teaches one that you
`don't have to coat all of it. And that's what we've pointed to here on Slide
`26. It talks about at least part of the developed surface which corresponds to
`the contact region is provided with a coating so a POSA would understand
`from that that while you can coat the whole thing and there is disclosure of
`coating it all, you don't have to. And so in that scenario where you don't
`have to the parylene-C would not contact the drug product, or at least, Patent
`Owner hasn't explained how it would contact the drug product. And also
`Mr. Koller explained at 1105, Paragraph 29, how you can coat just the
`contact region with parylene-C.
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`JUDGE KINDER: I understand you could do that and there's
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`alternative embodiments but, you know, you seem to suggest that at least in
`your reply that, you know, there was no contact, and they came back with
`evidence showing that it could just be as likely that there would be contact.
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`MR. DESAI: I don't think that was our intention. I think our point
`was to say that Patent Owner is the one saying you would be discouraged
`and so they would have to show that in all situations it would always
`contact, and our point is that there -- no. There is the option available in
`Boulange to only apply it to the
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