Paper No. 56
`Trials@uspto.gov
`
`571-272-7822
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
`
`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
`_____________
`
`
`
`Before ROBERT A. POLLOCK, RYAN H. FLAX, and
`KRISTI L. R. SAWERT, Administrative Patent Judges.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Trials@uspto.gov
`
`571-272-7822
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
`
`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
`_____________
`
`
`
`Before ROBERT A. POLLOCK, RYAN H. FLAX, and
`KRISTI L. R. SAWERT, Administrative Patent Judges.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Case IPR2019-00400
`Patent 8,633,194 B2
`
`
`
`
`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.
`
`
`
`
`2
`
`
`
`
`Case IPR2019-00400
`Patent 8,633,194 B2
`
`
`
`
`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
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`3
`
`
`
`
`Case IPR2019-00400
`Patent 8,633,194 B2
`
`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
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`4
`
`
`
`
`Case IPR2019-00400
`Patent 8,633,194 B2
`
`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
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`5
`
`
`
`
`Case IPR2019-00400
`Patent 8,633,194 B2
`
`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
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`6
`
`
`
`
`Case IPR2019-00400
`Patent 8,633,194 B2
`
`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.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`7
`
`
`
`
`Case IPR2019-00400
`Patent 8,633,194 B2
`
` 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
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`8
`
`
`
`
`Case IPR2019-00400
`Patent 8,633,194 B2
`
`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
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`9
`
`
`
`
`Case IPR2019-00400
`Patent 8,633,194 B2
`
`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
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`10
`
`
`
`
`Case IPR2019-00400
`Patent 8,633,194 B2
`
`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
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`11
`
`
`
`
`Case IPR2019-00400
`Patent 8,633,194 B2
`
`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.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`12
`
`
`
`
`Case IPR2019-00400
`Patent 8,633,194 B2
`
` 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
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`13
`
`
`
`
`Case IPR2019-00400
`Patent 8,633,194 B2
`
`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
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`14
`
`
`
`
`Case IPR2019-00400
`Patent 8,633,194 B2
`
`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.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`15
`
`
`
`
`Case IPR2019-00400
`Patent 8,633,194 B2
`
`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.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`16
`
`
`
`
`Case IPR2019-00400
`Patent 8,633,194 B2
`
` 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
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`17
`
`
`
`
`Case IPR2019-00400
`Patent 8,633,194 B2
`
`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
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`18
`
`
`
`
`Case IPR2019-00400
`Patent 8,633,194 B2
`
`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
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`19
`
`
`
`
`Case IPR2019-00400
`Patent 8,633,194 B2
`
`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
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`20
`
`
`
`
`Case IPR2019-00400
`Patent 8,633,194 B2
`
`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
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`21
`
`
`
`
`Case IPR2019-00400
`Patent 8,633,194 B2
`
`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
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`22
`
`
`
`
`Case IPR2019-00400
`Patent 8,633,194 B2
`
`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,
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`23
`
`
`
`
`Case IPR2019-00400
`Patent 8,633,194 B2
`
`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
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`24
`
`
`
`
`Case IPR2019-00400
`Patent 8,633,194 B2
`
`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
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`25
`
`
`
`
`Case IPR2019-00400
`Patent 8,633,194 B2
`
`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
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
