`Trials@uspto.gov
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`571-272-7822
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
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`BEFORE THE PATENT AND TRIAL APPEAL BOARD
`______________
`
`APOTEX INC.,
`Petitioner,
`
`v.
`
`UCB BIOPHARMA SPRL,
`Patent Owner.
`_____________
`
`Case IPR2019-00400
`Patent 8,633,194 B2
`_____________
`
`Record of Oral Hearing
`Held Virtually: Wednesday, April 22, 2020
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`
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`Before ROBERT A. POLLOCK, RYAN H. FLAX, and
`KRISTI L. R. SAWERT, Administrative Patent Judges.
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`Case IPR2019-00400
`Patent 8,633,194 B2
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`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`JITENDRA MALIK, ESQUIRE
`ALISSA PACCHIOLI, ESQUIRE
`JOSEPH JANUSZ, ESQUIRE
`KATTEN MUCHIN ROSENMAN LLP
`550 S. Tryon Street, Suite 2900
`Charlotte, NC 28202
`
`LANCE SODERSTROM, ESQUIRE
`KATTEN MUCHIN ROSENMAN LLP
`575 Madison Avenue, Suite 14
`New York, NY 10022
`
`
`ON BEHALF OF THE PATENT OWNER:
`
`ROBERT COUNIHAN, ESQUIRE
`ERICA SUTTER, ESQUIRE
`FENWICK & WEST LLP
`801 California Street
`Mountain View, CA 94041
`
`JAMES TRAINOR, ESQUIRE
`FENWICK & WEST LLP
`902 Broadway, Suite 14
`New York, NY 10010
`
`
`The above-entitled matter came on for hearing on Wednesday, April 22,
`2020, commencing at 1:00 p.m. EST, by video/by telephone.
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`Case IPR2019-00400
`Patent 8,633,194 B2
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`P R O C E E D I N G S
` JUDGE POLLOCK: Good afternoon. This is
`the final hearing in IPR2019-00400 regarding
`Claims 1 through 11 of U.S. Patent Number
`8,633,194 B2.
` Petitioner is Apotex, Incorporated.
`Patent owner is UCB Biopharma Sprl.
` This hearing is open to the public, and a
`full transcript of the hearing
`will be made part of the record.
` I'm Judge Pollock. With me are Judges
`Flax and Sawert.
` Counsel for Petitioner Apotex, would you
`kindly identify yourself and any colleagues on the
`line.
` MR. MALIK: Good afternoon, your Honors.
`This is Jitendra Malik, counsel, Apotex. With
`me -- with me are Lance Soderstrom, Joe Janusz,
`Alissa Pacchioli, and also Dipu Mukherjee and the
`client, Olga Kalinina.
` JUDGE POLLOCK: Good afternoon, all.
` Counsel for Patent Owner UCB, would you
`kindly identify yourself and any colleagues with
`you.
` MR. COUNIHAN: Yes. Good afternoon, your
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`Honors. This is Robert Counihan of Fenwick &
`West. With me on the phone from Fenwick are James
`Trainor and Erica Sutter, and from UCB are
`Stephane Drouin and Amanda Blanchard.
` JUDGE POLLOCK: Good afternoon. I
`understand the parties have set forth motions to
`exclude, motions to seal, and lodged objections to
`each other's demonstratives. We will not rule on
`the motions today but will address them in our
`final written decision to the extent necessary.
` We also remind the parties that the
`demonstratives are not evidence. We,
`nevertheless, take your objections under
`advisement.
` As set forth in the scheduling order of
`March 11th, 2020, each side has 60 minutes to
`present its case. My colleagues and I will do our
`best to keep track of time, but we suggest that
`the parties do the same.
` You are welcome but not required to argue
`your motions and objections during your allotted
`time. It may, however, be helpful if the parties
`would touch on Dr. Niazi's credibility as was
`raised in the motions practice.
` There also seems to be some uncertainty
`regarding whether the liquid pharmaceutical
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`composition of Claim 1 encompasses single and
`multi-use parenteral formulations which, being liquid,
`might appear reasonable.
` It would be helpful if the parties explain
`their understanding of the scope of Claim 1 and
`the weight we should give to the prior art
`directed to non-oral non-liquid formulations.
` That said, counsel for petitioner, would you like to
`reserve any time for rebuttal?
` MR. MALIK: Yes, your Honor, 30 minutes.
` JUDGE POLLOCK: Counsel for patent owner,
`you may have the last word today if you wish.
`Would you like to reserve any of your time?
` MR. COUNIHAN: Yes, I'd like to reserve
`15 minutes, your Honor.
` JUDGE POLLOCK: Very good. We are looking
`forward to your presentations today, but I would
`like to cover a few more things before we begin.
` On behalf of the board, we thank you for
`your flexibility in participating in this all-
`video hearing. Given that this is a departure
`from our typical practice, I would first emphasize
`that our primary concern is your right to be
`heard. If at any time during the proceeding you
`encounter technical or other difficulties that you
`feel fundamentally undermine your ability to
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`adequately represent your client, please let us
`know immediately, for example, by contacting the
`team member who provided you with the connection
`information today.
` Second, please mute your microphone when
`not speaking.
` Third, please identify yourself each time
`you speak.
` Fourth, we have access to the entire
`record, including demonstratives. When referring
`to each demonstrative, paper, or exhibit, please
`do it by slide or page number and then, and I
`emphasize, please pause a few seconds to allow us
`time to find it.
` Finally, should you come to a good faith
`belief that the pace of this proceeding prevents
`you from adequately explaining your position,
`please speak up and we will consider some
`expansion of your allotted time.
` Petitioner will go first, as it bears the
`burden of showing unpatentability of the
`challenged claims.
` Mr. Malik, given the unusual format of
`these proceedings, we may find it a bit awkward to
`interrupt a question, so I will pose a few which
`you may wish to answer before the end of your
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`presentation.
` First, I am having trouble finding support
`for your argument that the combination of methyl-
`and propylparabens have synergistic rather than
`additive antibacterial effects. Would you please
`explain the basis for that opinion and why you
`believe the synergism is relevant here.
` And, also, given that the antimicrobial
`properties of levocetirizine were unknown, please
`discuss why you believe one of ordinary skill in
`the art would have had a reasonable expectation of
`success in using the claim amounts of parabens.
` With that, Mr. Malik, I believe you have
`the floor.
` MR. MALIK: Sure. Thank you, your Honors.
` Let me just begin by I, obviously,
`understand my time is limited, so I want to get
`right to it, and I want to turn to slide 1 which
`is Claim 1. There -- let me know when you're
`there.
` There is no dispute between the parties
`that the claim normal meaning governs. And as the
`Federal Circuit said in the Interactive Gift
`Express case, which we cited in our papers, the
`analytical focus must begin and remain centered on
`the language of the claims themselves.
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` Let me make one point very clear. You're
`going to hear a lot of things from UCB about
`levocetirizine does this, cetirizine does this.
`What UCB is really trying to do is graft their
`invention story onto the claim.
` The focus of the claims, okay, is what is
`stated right here. It does not cover
`levocetirizine alone. As you can see, it is basic
`in its composition -- sorry -- liquid
`pharmaceutical composition comprising
`levocetirizine, the 9-to-1 methyl-propyl
`limitations wherein said composition is
`substantially free of bacteria.
` Now, Apotex has been making this point
`since its opening petition. The bottom of page
`30, it says, appropriately referenced, that
`substantially bacterial-free property is something
`of the entire composition.
` And as we pointed out at the bottom of
`page 30, nowhere does the claim say that
`levocetirizine alone causes the composition to be
`substantially-free. Rather, it is the composition
`with all of its constituent components that
`results in the overall composition being
`substantially-free.
` Another point that we want to make is
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`regarding the methyl-propylparaben. If you look
`at the ranges in the actual claims or the amounts
`recited, they encompass methyl- and propylparaben
`amounts well above zero.
` I'm going to start by just discussing the
`reasonable expectation of success question that
`you had, how do you have a reasonable expectation
`of success. We cited two cases, the Hospira case
`and the In Re Kao, and that issue was raised by
`the Federal Circuit in both times.
` Let me read what the Hospira case says,
`which I think -- obviously, there's no dispute
`that the -- any antibacterial properties are
`inherent parts of the compound. And let me just
`read in -- what's going on here is, in the Hospira
`case is -- I'm going to read the Federal Circuit
`statement directly.
` "If a property of a composition is, in
`fact, inherent, there is no question of reasonable
`expectation of success in achieving it." That's
`an exact quote. Let me say it again. "If a
`property of a composition is, in fact, inherent,
`there is no comp -- there is no question of a
`reasonable expectation of success in achieving
`it."
` The same was generally found in connection
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`with the In Re Kao case where the food's effect --
`that the Federal Circuit said the board can look
`at the specifications, and if the specifications
`indicate that these are inherent properties of the
`compound, then you, basically, have sufficient
`reasonable expectation of success.
` In Re Papesch, which we also cited, said,
`"From the standpoint of patent law, a compound and
`all of its properties are inseparable. They're
`one and the same thing."
` So, whatever levocetirizine -- its
`properties are, they are. And whatever the
`properties of adding the methyl- and propyl-
`paraben are, when you take the composition,
`whatever the composition's properties are, there's
`a reasonable -- and whether they're inherent or
`not, as the Federal Circuit said in In Re Hospira,
`if the property is, in fact, inherent -- the
`property of the composition is, in fact, inherent,
`there is no question of reasonable expectation of
`success in achieving it.
` So, let's go to slide 25 because I do want
`to discuss the substantially bacterial-free
`limitation and sort of get some discussion of
`unexpected results because I do think that that's
`an important starting point. So, let me know when
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`you're at slide 25. I'm sorry if I said slide 23.
` So, at slide 25, we point out in our --
`and we pointed this out front in our opening
`papers, that Dr. Laskar noted that there was no
`indication in WO '094 or EP '203 that the prior
`art levocetirizine liquid compositions were not
`substantially bacterially-free.
` And the board picked up on the institution
`decision, which we've also included there on page
`17, as the board said, with respect to the
`requirement that the composition is substantially
`bacterial-free, we note Dr. Laskar's testimony.
` But what we did was we went far further
`later on in our reply. Basically, on page 22 of
`our reply, we noted that Dr. Niazi never disputed
`any statement of Dr. Laskar in connection with
`whether the comp -- prior art compositions were
`substantially bacterial-free, but more important,
`Apotex has accurately stated on page 23 that the
`same data and conclusion that Dr. Niazi was
`relying on that shows that the formulation of the
`'194 patent were substantially bacterial-free also
`show that the prior art levocetirizine
`formulations of WO '094 and EP '203 would have
`been substantially free of bacteria. We expressly
`said that. That's in the middle of page 23. UCB
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`in its surreply never challenged that statement.
` So, now it's undisputed that WO '094 and
`EP '203 are substantially bacterial-free. And
`with that, the prior art also is substantially
`bacterial-free. They have no unexpected results
`to -- to present because, as we pointed out in
`page 22 of our reply, to do an unexpected result
`case, you need to, basically, show your unexpected
`results to the closest prior art of record.
` We called UCB out several times on this to
`identify for us the closest prior art of record
`and never identified the closest prior art of
`record. And this isn't really something that UCB
`can dispute because on slide 18 of UCB, they cite
`the Honeywell/Mexichem --
` JUDGE POLLOCK: Mr. Makik, this is -- this
`is Judge Pollock. I'm not quite following your
`argument with respect to the prior art showing no
`bacteria or being substantially bacteria-free
`given that we're not comparing apples to apples in
`terms of the amount of propylparabens and methyl-
`parabens, are we?
` MR. MALIK: Well, the prior art --
` JUDGE POLLOCK: -- would be substantially
`bacteria-free but that doesn't really -- not
`particularly relevant.
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` MR. MALIK: Paragraph 84 of Dr. Niazi's
`declaration, he said that the -- that looking at
`the data in '1 -- on the '194, levocetirizine
`alone showed that the compositions would --
`paragraph 84 showed that the composition was
`substantially -- substantially bacterial-free.
`The same is the case in the paragraph 200.
` So, basically, these compositions also
`have levocetirizine. And the point we're trying
`to make is if they want to meet their burden to
`show unexpected results, the very first thing they
`have to do is first show what is the closest prior
`art. And if they don't show that, the OSI case
`that we've cited in our papers on page 22 says
`that they failed meeting their burden to show
`unexpected results. They have to first identify
`the closest prior art so you can make that
`comparison. They haven't.
` But beyond that, when we expressly said on
`page 23 of our reply paper that the data that
`Dr. Niazi relies on shows that the formulations of
`the -- the prior art formulations, putting
`aside -- you're right; it doesn't show how much
`levocetirizine is in there. It doesn't show how
`much propyl- and methylparaben is in there. But,
`obviously, the person with skill in the art would
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`figure out how much to put in, which is what the
`second part of our case is.
` And, you know, making this comparison to
`the unex -- the unexpected results comparison to
`the closest prior art, that's not something that
`UCB can really dispute. At slide 18, they cite
`the Honeywell case, and Honeywell, what they say
`on slide 18 is all properties of a composition are
`inherent in that composition, but unexpected
`properties may appear -- may cause -- they may
`appear what is obvious not to be obvious.
` Flip over, next page in the Honeywell, on
`page 1356, and you see Honeywell was -- was
`showing -- to show what unexpected results are.
`They cite In Re Baxter. And In Re Baxter, in that
`same case, says unexpected results have to be
`compared to the closest prior art of record. UCB
`will not -- has not shown any comparison to the
`closest prior art of record.
` And the board's decision in OSI said, in
`that case, they failed showing unexpected results
`just as a matter of fact. I mean without making
`that comparison, there's nothing for the board to
`decide whether it's unexpected or expected.
` So, why don't we go to slide 3 because I
`want to discuss the third issue and the liquid
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`formula -- the liquid formula question that I
`think you raised. Let me know when you're on
`slide 3 of our presentation.
` JUDGE POLLOCK: I'm sorry. Would you
`repeat the slide number. Your signal is rough.
` MR. MALIK: I want to go to slide 3.
` JUDGE POLLOCK: Okay. Thank you.
` MR. MALIK: So, slide 3 of our
`presentation generally talks about parabens. We
`just want to give a little bit of history now.
` As we've shown, and there doesn't appear
`to be much dispute between us and UCB, parabens
`are ideal preservatives. They have a broad
`spectrum of antimicrobial activity. As Dr. Niazi
`said on paragraph 63, they've been proven over
`decades of usage. As the handbook says, they are
`widely used.
` Going on to slide 4, that gets us to
`WO '094, which is the syrup composition. Now,
`obviously, EP '203 and WO '094 are our primary
`grounds. Those are good formulations. There's no
`question that a syrup is a solution formulation.
`We dealt with that extensively in our reply
`looking at the file history, which was a
`discussion of Remington's.
` Syrups are also the preferred embodiment.
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`We made that point also within the papers.
`EP '203 is also a liquid product.
` So, what do we know from WO '094? We know
`from WO '094 that parabens are compatible with
`levocetirizine because the formulation of the
`syrup has levocetirizine dichloride --
`dihydrochloride with methyl- and propylparaben.
`We know they're widely used, as we discussed on
`the last page. They're also proven over decades.
` What both Dr. Niazi and Dr. Laskar both
`agree is that there's no amounts here. And I
`refer you to Laskar paragraph 84 and Dr. Niazi
`paragraph 121 where they both note that WO '094 is
`silent as to the amount.
` And neither expert has taken the position
`that you would remove the paraben from this.
`Dr. Niazi in paragraph 55 says you play it safe.
`Dr. Laskar, paragraph 94, same thing. I'd also
`refer you to his deposition transcript page 54,
`lines 17 through 23.
` So, you, basically, have shown that
`levocetirizine is compatible with methyl- and
`propylparaben.
` And if you will then skip to slide 6,
`which is the Handbook of Pharmaceutical
`Excipients -- let me know when you're there.
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` JUDGE POLLOCK: I'm sorry. I was on mute.
`Yes, we're there.
` MR. MALIK: On slide 6. Slide 6 shows the
`Handbook of Pharmaceutical Excipients. Now, yes,
`that leads me to the question that you put at the
`beginning, these are parenteral formulations, but
`parenteral formulations are liquid formulations.
`The 9-to-1 ratio here that's in the papers, 0.18
`percent to .02 percent, is a 9-to-1 ratio. There
`is no dispute between the experts as it relates to
`ground one that the relevant entry is oral
`solutions and suspensions.
` Now, you asked about parenteral solutions.
`You're right that these are parenteral solutions,
`but as we pointed out in the papers, the 9-to-1
`ratio is seen again and again and again in a wide
`variety of formulations. And, yes, there are some
`solid formulations, for example, tablets, but you
`do see them being used as shown in our papers,
`various formulations. Dr. Laskar talked about it
`in paragraph 88.
` And the response we got from UCB is each
`one was subsequently attacked -- this is
`different; this is different; this is different.
`But in In Re Merck, the Federal Circuit said you
`cannot defeat obviousness -- I mean obviousness
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`cannot be defeated by attacking each one of the
`references individually.
` As a group, each one of these shows a
`9-to-1 ratio using wide variety of dosage forms.
`Yes, some are solid, and the board can decide how
`much weight that it wants to give to a solid
`versus a liquid if this is a liquid pharmaceutical
`composition, but the fact remains is, if you look
`at what we presented and also what was in the
`Niazi series, we now have more than 40 with all
`different dosage forms.
` And, so, what you -- what Apotex is saying
`is that a person of ordinary skill in the art,
`knowing that 9-to-1 is seen over and over again in
`a wide variety of dosage forms, that would be
`something that would be -- would have been obvious
`to the POSA to use.
` The next thing that we then have to deal
`with is, well, the claim, also -- Claim 1 I'm
`focused on, recites a specific amount of paraben,
`specifically the methyl- to propylparaben. So, we
`have the ratio, and now we have the amount. So,
`we're going to get to the amount.
` And if you take a look at the entry for
`methylparaben and simply do the math, by 9-to-1 to
`the level as provided in the handbook, there's no
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`dispute that the ranges overlap. And, so,
`obviously, that's one piece of evidence that's
`important.
` But the next piece that's important is
`whether or not the parabens under the DuPont case
`are a result-effective variable, i.e., is this
`something that a person of ordinary skill in the
`art would, indeed, look to to modify. And we've
`said yes, we believe it is.
` Both the experts agree that -- bear with
`me one second while I direct you to the correct
`page. If you wouldn't mind turning to page 18 --
`slide 18. I'm sorry.
` JUDGE FLAX: Counsel, this is Judge Flax.
`I'm sorry to interrupt your argument. But one of
`the things in this case that I'm very interested
`in is the idea that you've got a "consisting
`essentially of" clause in the middle of your
`claim. So, what is the basic and novel property
`of the invention that's being claimed and what's
`the evidence of it?
` MR. MALIK: So, I think what was in the
`papers was a dispute was raised about whether
`other preservatives were the scope of the claim
`and specifically with respect to sugar and syrup,
`WO '094 and the 9-to-1 cetirizine hydrochloride
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`formulation in the Niazi series of the syrup
`formulation.
` And, so, what essentially happened is we
`had established that syrups are, by virtue of the
`fact that they are syrups, the sugar content
`causes it to be substantially bacterial-free.
` And let me just give you a couple of
`citations for the record where you can read this.
`And Dr. Niazi effectively conceded that because
`the '094 was a syrup, that it would be, in his
`view, substantially bacterial-free. Citations,
`Dr. Niazi's transcript at 1043 --
` JUDGE FLAX: Counsel, this is Judge Flax
`again. Are you arguing right now that the basic
`and novel property of the invention is that it is
`substantially bacterial-free? Is that it?
` MR. MALIK: No, what I'm arguing -- what
`I'm arguing is, I guess, that the basic and novel
`property for the "consisting essentially of" would
`be, I guess, that the 9-to -- the 9-to-1 ratio --
`the only thing the "consisting essentially of"
`impacts is the 9-to-1 ratio of the methyl- to
`propylparaben. The "consisting essentially of"
`limitations only focuses on element two of the
`claim.
` So, to the extent that whatever they
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`contend is the novel and basic property, it'd be
`limited just to whether or not the 9-to-1 ratio of
`methyl- to propylparaben would be unknown in the
`prior art.
` JUDGE FLAX: So, that's an interesting
`statement that you're making. This is Judge Flax
`again. The case law that I've seen when it
`discusses "consisting essentially of" refers to
`the basic and novel property of the invention
`being affected.
` So, in this situation, we've got a
`somewhat unusual circumstance where the
`"consisting essentially of" appears midstream in
`the claim. So, do you want us to focus only on
`these two preservatives that are being claimed and
`whatever basic and novel property they might add
`to the invention, or should we be considering the
`basic and novel property of the invention as a
`whole -- or properties of the invention as a
`whole?
` MR. MALIK: I think it's the -- it's the
`invention as a whole that's relevant, obviously.
`But I think the Amgen versus Amneal case is
`helpful figuring out what happens when you have a
`"comprising" followed by a "consisting" or a
`"consisting essentially of." As cited in our
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`reply paper, the Amgen came out one week before we
`filed our reply paper, so that's why it wasn't in
`our opening paper.
` What Amgen said is that when you have a
`"consisting" followed by a "consisting essentially
`of," okay, the way you do it is look at the claim,
`look at the context of the claim, and then look at
`the intrinsic evidence. That's how you figure out
`what the full scope of the claim is.
` So, in the case of the claim, "consisting
`essentially of" is 9-to-1 methyl- to propyl-
`paraben. The levocetirizine is outside of the
`"consisting essentially of." It's element one.
`The composition, said composition being
`substantially bacterial-free, that means that the
`levocetirizine is adding to whatever is
`substantially bacterial-free.
` But what ultimately happened -- why a
`dispute happened is whether or not other -- other
`elements within the claim, within the composition,
`whether they could add to the "wherein said
`composition is substantially bacterially-free."
` Now, I will point out one thing. So,
`obviously, this occurred because of whether or not
`sugars would be a preservative. I do want to read
`one thing in -- as we were kind of surprised
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`because it never really appeared anywhere in
`patent owner's complete response --
` JUDGE POLLOCK: Mr. Malik, this is Judge
`Pollock. Just to clarify, are you taking the
`position that "consisting essentially of" modifies
`the 9-to-1 ratio but not the amount of the
`parabens?
` MR. MALIK: It's the 9-to-1 ratio and the
`amounts, everything after "consisting essentially
`of."
` JUDGE POLLOCK: Okay. Thank you.
` MR. MALIK: Yes. So, the first question
`is are sugars even preservatives. And I'm going
`to read what's on page 12 of UCB's response,
`complete response. This is about eight lines
`down. "To control the risk of microbial
`contamination, a POSA could -- may consider many
`options, such as using sugars or other excipients
`that are not preservatives but, nevertheless,
`create an environment that is unsuitable for
`microbial growth."
` So, in their complete response on page 12,
`they said sugars were not even preservatives, but
`Dr. Ni -- and what Dr. Niazi said during the --
`during his cross, said, "Well, there's the
`'comprising.' Sugars are included." Okay? Well,
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`then they came back and they focused on
`"consisting essentially of" and said, "Well, other
`preservatives are not included -- are excluded by
`the 'consisting essentially of,'" and that's where
`the whole alcohol dispute came around.
` I guess the question is -- is are we
`giving "consisting essentially of" any meaning,
`and what is it would be one way to perhaps ask the
`question. And the -- what we envision is -- I
`think, actually, you can see (inaudible) agree on
`this -- I'm looking at slide 9 in UCB's
`presentation, and they kind of tell us what it
`would mean. Right here.
` There's methyl- propylparaben, and they
`basically said it's these two, and there's ethyl-
`and butylparaben. This is what "consisting
`essentially of" would exclude. And this -- this
`slide is actually pretty consistent with the
`evidence. Sugars are preferred embodiment, can't
`exclude an embodiment. They also put, by the way,
`sugars right here even outside of the
`preservatives. Alcohol, which Dr. Laskar spent a
`fair amount of time on, is a preservative. They
`say it right here.
` So, I have a hard time thinking that it
`doesn't -- that doesn't -- that it excludes other
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`preservatives. That's the point he made in our
`reply brief.
` And then as far as the -- what "consisting
`essentially of" would exclude, it would be the
`other parabens. And that's also consistent with
`specifications of '194 patent --
` JUDGE FLAX: Okay. So, counsel, this is
`Judge Flax again. So, this argument makes it
`important for you to explain to us what the basic
`and novel properties of the invention are, right,
`because if the only basic and novel property of
`the invention is stopping bacterial contamination,
`and it seems like the -- the part of this
`formulation that does that has to only be methyl-
`paraben and propylparaben.
` If the basic and novel property is
`something other than stopping bacterial
`contamination, then the "comprising" language
`of the preamble opens up this claim to all sorts
`of other ingredients, including sugars, including
`alcohols, including anything else you want, even
`if it has an effect on bacterial contamination.
` So, this is not something that either
`party brought up in their initial briefing on
`claim construction. I see it's been argued
`extensively amongst the parties as the case has
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`proceeded, especially during deposition.
` So, could you explain it to us now, what
`do you want us to take into the final decision in
`terms of what the basic and novel property is.
` MR. MALIK: I think the basic and novel
`property is whether or not the overall composition
`with its constituent components, including
`levocetirizine, the 9-to-1 ratio of methyl- to
`propylparaben in the weight ratio with whatever
`else is allowed within the word "comprising."
` And as we pointed out, examples 2 and
`examples 4 in the '194 patent, as Dr. Laskar
`pointed out, have enough alcohol in it where they
`themselves would actually be considered
`antimicrobial, that that comp -- the issue is
`whether that composition as a whole is
`substantially bacterial-free.
` Does that answer your question?
` JUDGE FLAX: So, is -- your position is
`that it needed to be substantially bacterial-
`free. That's the basic and novel property.
` MR. MALIK: Yes, that would be what --
` JUDG