UNITED STATES PATENT AND TRADEMARK OFFICE
` ____________________
` ETON PHARMACEUTICALS
` Petitioner
`
`Page 1
`
` -VS-
`
` EXELA PHARMA SCIENCES, LLC,
` Patent Owner
` ___________________________
` U.S. Patent No. 10,478,453
` PGR2020-00064
`
` Board Members: Judge Jenks
` Judge Mitchell
` Judge Paulraj
`
` TELEPHONE CONFERENCE
` Tuesday, September 21, 2020 - 2:00 p.m. CST
`
`Reported by:
`Alyssa A. Repsik
`Job No. 28559
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
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`Eton Ex. 1083
`1 of 34
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`Eton Pharmaceuticals v. Exela Pharma Sciences - PGR2020-00064
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` ____________________
` ETON PHARMACEUTICALS
` Petitioner
`
`Page 1
`
` -VS-
`
` EXELA PHARMA SCIENCES, LLC,
` Patent Owner
` ___________________________
` U.S. Patent No. 10,478,453
` PGR2020-00064
`
` Board Members: Judge Jenks
` Judge Mitchell
` Judge Paulraj
`
` TELEPHONE CONFERENCE
` Tuesday, September 21, 2020 - 2:00 p.m. CST
`
`Reported by:
`Alyssa A. Repsik
`Job No. 28559
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`Eton Ex. 1083
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` APPEARANCES
` HAYNES & BOONE, LLP
` 180 N. LaSalle Street, Suite 2215
` Chicago, Illinois 60601
` MR. RALPH J. GABRIC, ESQ.
` ralph.gabric@haynesboone.com
` MR. EUGENE GORYUNOV, ESQ.
` Eugene.Goryunov@haynesboone.com
` MS. JUDY HE, ESQ.
` Judy.He@haynesboone.com
` Appeared on behalf of the Petitioner;
`
`
` FISH & RICHARDSON, P.C.
` 3200 RBC Plaza
` 60 South Sixth Street
` Minneapolis, MN 55402
` MS. DOROTHY P. WHELAN, ESQ.
` whelan@fr.com
` MS. ALANA C. MANNIGE, ESQ.
` mannige@fr.com
` MS. CHRISTINA D. BROWN-MARSHALL, ESQ.
` brown-marshall@fr.com
` MS. BETSY FLANAGAN, ESQ.
` betsy.flanagan@fr.com
` Appeared on behalf of the Patent Owner.
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` P R O C E E D I N G S
` JUDGE JENKS: Hello. Good
` afternoon. This is a conference call in PGR
` 2020-00064 involving Patent No. 10,478,453.
` I'm Judge Jenks, and I'm joined
` today by Judge Mitchell and Judge Paulraj as
` well.
` So let me begin --
` MR. GABRIC: Good afternoon.
` JUDGE JENKS: Good afternoon.
` Let me begin with the appearances of counsel.
` Who do I have on the call for
` Petitioner and who will be speaking?
` MR. GABRIC: You have Ralph
` Gabric on the call. I'll be speaking for
` Petitioner. And joining me on the call for
` Petitioner are Eugene Goryunov and Judy He.
` Sorry, Eugene. I apologize.
` MR. GORYUNOV: That's all
` right. It's not the simplest last name in the
` world.
` MR. GABRIC: Why don't I just
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` call you EG?
` Sorry about that, Your Honor.
` JUDGE JENKS: Anybody else?
` MR. GABRIC: Not for
` Petitioner. Not for Petitioner. No, not from
` Petitioner.
` JUDGE JENKS: Okay. So Patent
` Owner, who do we have on the phone and who will
` be speaking?
` MS. WHELAN: Good afternoon,
` Your Honor. This is Dorothy Whelan. I will --
` I'm speaking on behalf of Patent Owner, Exela.
` And I'm joined by my Fish & Richardson
` colleagues, Betty Flanagan, Christina
` Brown-Marshall, and Alana Mannige.
` JUDGE JENKS: Excellent. So
` another question, is there a court reporter on
` the call, and if so, will the party responsible
` for the court reporter file a copy of the
` transcript with the Board as an exhibit?
` MR. GABRIC: Yes, Your Honor,
` there is a court reporter on the call and
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` Petitioner will file the transcript.
` JUDGE JENKS: Thank you.
` Thank you very much.
` Petitioner, you've requested this
` call seeking authorization to file a reply for
` two Patent Owner preliminaries, a preliminary
` response?
` MR. GABRIC: Correct.
` JUDGE JENKS: Specifically,
` you're wishing to reply to certain points
` raised by Patent Owner in their preliminary
` response.
` Can you elaborate for us what it is
` you want and what it is you're hoping to
` achieve?
` MR. GABRIC: Yes. Yes, Your
` Honor. And feel free to jump in if I get too
` much in the weeds. I'll try to avoid it.
` But on the first point we'd like to
` respond to, and it's an argument that, quite
` frankly, we did not anticipate, is the argument
` that there's a lack of particularity with the
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` petition. And there's two primary arguments I
` believe the Patent Owner makes.
` First, that the Patent Owner says
` it's not very clear what Sandoz product we're
` relying on. Is it the label? Is it the
` product that was in the package? And I had
` thought, and I want to confirm, that it's the
` Sandoz label, that's -- that's what we're
` relying on with the grounds one through three.
` It's the four corners of the label.
` Now, having said that, you know, I
` will point out, the attributes of the product,
` the Sandoz product is part of the knowledge of
` the person of ordinary skill in the art. But
` for purposes of the ground, we are relying on
` the four corners of the label.
` The other -- and I'd like to make
` that point clear to the extent that that would
` be helpful to the Board and when they -- to
` decide they want to grant the petition.
` The other area is the Patent Owner
` is attacking our reliance on the knowledge of a
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` person of ordinary skill in the art to provide
` the motivation and teachings to modify the
` product disclosed by the Sandoz label.
` And what the petition does, I
` believe, and I would like to clarify it in a
` reply, is recite chapter or verse the various
` casings in the prior art that would have
` motivated a person of ordinary skill to
` optimize the products caused by the Sandoz
` label. There's basically two main things going
` on in this case:
` There's the oxidation problem, as
` the Patent Owner puts it, and then there's the
` aluminum problem, as the Patent Owner puts it.
` And what was known in the art as set forth in
` the petition is that L-cysteine, which is the
` product of the Sandoz label, was a known
` oxygen-sensitive drug. That was known. I
` don't believe there's any dispute about that.
` And what the petition does is it
` also explains what also was known, what -- what
` comes along with L-cysteine being subject to
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` oxidative degradation. It breaks down to
` L-cysteine, which was also disclosed in the art
` and was also disclosed in the art that
` L-cysteine precipitates, forms a precipitate
` and it was also known in the art, you don't
` want to precipitate in an injectable product
` like the product, Sandoz label.
` It was also known that another
` degradation product, it also is in the claim,
` is pyruvic acid. That was also known.
` It was also known in the art, as we
` said on the petition, and one of ordinary skill
` would know, is that there are ways to deal with
` oxidative -- oxygen-sensitive drugs like
` L-cysteine; you manufacture them in a
` substantially oxygen-free environment.
` Normal ways to do that: Use a
` blanket of nitrogen or argon, as we explain in
` our petition; remove dissolved oxygen; store in
` a container that has low oxygen.
` And our petition takes you through
` that chapter and verse that these are known
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` affect, result variables to prevent oxidation
` of a product: Control the amount of oxygen in
` the manufacturing of the environment, control
` the amount of oxygen in the headspace, control
` the amount of dissolved oxygen.
` And we take that -- I believe we
` take the Board through that in the petition
` very clearly, but I would like to clarify that
` in case there's any doubt in the Board's mind.
` And it -- what was also known in the
` art is the expected result is when you take
` these steps to control the amount of oxygen
` during a manufacturing process and storage, is
` you substantially prevent oxidative degradation
` of an oxygen-sensitive product like L-cysteine.
` And so the claims recite pyruvic
` acid; a minimum amount of pyruvic acid and
` L-cysteine. And the expected result is that
` you prevent oxidative degradation of
` L-cysteine, you have low amounts of L-cysteine
` and pyruvic acid.
` So these are result, affective
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` variables, control the amount of oxygen to get
` an expected result, less degradation products
` of L-cysteine.
` JUDGE JENKS: Okay.
` MR. GABRIC: Now the other
` issue that's raised by the Patent Owner is,
` well, they say, you know, the Sandoz label
` discloses a low PH level of 1.2 -- a 1.2 to
` 2.5, and one skilled in the art wouldn't be
` worried about oxidation at that PH level.
` Well, that's debauched by the Sandoz label; the
` Sandoz label says nitrogen replaces air.
` So here is a low PH product and the
` label says, we're removing air, replacing with
` nitrogen. And what's going on, we know that
` the reason that was done is because oxidative
` degradation of L-cysteine is still an issue
` even at lower PHs.
` And so we'd like to respond to that
` argument as well in the Patent Owner reply.
` It's in our petition, but we'd like to clarify
` that.
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` So now the other problem or issue is
` the aluminum problem. And what we disclosed in
` our petition is there's really three sources of
` aluminum. And we disclose this with
` particularity. It could be in the excipients,
` the materials for the drug product; it could
` come in during the manufacturing process or
` aluminum can leak from the glass vial.
` These are all known contributing
` factors of aluminum. It was also known that
` you want to get rid of aluminum.
` And so what do you do? Well, you
` manufacture the product in an aluminum-free
` environment. You use excipients that don't
` have aluminum and you package it in a glass
` vial that's coated. It's called a
` SCHOTT-coated vial that substantially prevents
` leaking aluminum.
` And so one skilled in the art with
` that knowledge would know that I could optimize
` the Sandoz labeled product to reduce aluminum
` to the claimed levels by simply packaging it in
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` a glass vial coated as SCHOTT -- a coated
` SCHOTT glass vial, and the expected result is
` low aluminum levels.
` So that's the particularity that is
` set forth in the petition, you know, but we
` would like a chance to kind of take the Board
` through the petition at a very high level and
` it -- where TopLyo SCHOTTS pointed out where
` this stuff can be found.
` JUDGE JENKS: Okay.
` MR. GABRIC: I threw a lot at
` you, Judge. I'm sorry.
` JUDGE JENKS: That's okay. My
` question is, is just what are -- you know, what
` makes -- you know, you're basically arguing the
` points you've made or, you know, you're trying
` to reinforce the points you've made. That
` doesn't tell me why there's good cause to file
` this reply.
` MR. GABRIC: Well, the good
` cause -- well, it's kind of a catch 22, Your
` Honor. I think it's in there. And if I were
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` to get a decision on the petition saying it's
` not there, I'd be saying, well, how did they
` miss it? Maybe I should have helped them out a
` little more and pointed out where exactly these
` materials are.
` And that's relying on good cause, is
` the Patent Owner does a pretty good job of
` basically making an argument that, you know,
` gee wiz, you're just relying on the knowledge
` of ordinary skill in the art to fill in the
` gaps that teaches in prior art these are not
` result, affective variables. And our petition
` is, yes, they are result, affective variables.
` So we wanted, too, to point that out.
` JUDGE JENKS: Okay. So let me
` hear from Patent Owner.
` What is your petition and response
` here?
` MS. WHELAN: Well, it says --
` Mr. Gabric actually gave a very nice summary of
` what's in the petition. And I did hear him
` repeatedly say, "well, as explained in the
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` petition," "as we pointed out in the petition."
` I mean, obviously, we, as Patent
` Owner, have a very different view of the prior
` art in the patent than he does. But I haven't
` heard anything that justifies a reply.
` I think the Board is capable with
` what's set forth in the petition, and the
` preliminary response set out the parties'
` positions. And I think the Board is certainly
` capable of reading both and coming to its own
` conclusion. So I just haven't heard any need
` for a reply brief here.
` MR. GABRIC: If I may, Your
` Honor?
` JUDGE JENKS: Yes. Please, go
` ahead.
` MR. GABRIC: Yeah. Yeah. So
` another thing I overlooked, and I did want to
` point out that what we have not had a chance to
` respond to, is the Patent Owner seems to make
` the argument that one skilled in the art
` wouldn't appreciate that removing aluminum
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` would somehow impact the oxidation of
` L-cysteine.
` And our position, and what we would
` like to explain to the Board is, look, there
` were two problems and two known solutions, and
` one of ordinary skill in the art would address
` the aluminum problem by packing the product in
` a glass vial that doesn't reach aluminum.
` And then it would address the
` oxidation problem by removing oxygen. And
` whether you would solve the oxygen problem
` knowing what impact it would have on the
` aluminum problem and vice versa really is
` immaterial.
` Because if you address both problems
` according to the way taught by the prior art,
` it really isn't material whether one problem
` affects the other problem.
` JUDGE JENKS: Okay. Let me --
` just seeing if my panel has any other questions
` they'd like to ask.
` So, at this point, I'd like to put
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` the parties on hold and I'd like to confer with
` my panel to see what we're -- how we're going
` to proceed. So please hold on and we'll be
` back shortly.
` MS. WHELAN: Thank you.
` (Pause in proceedings.)
` JUDGE JENKS: All right.
` We're back.
` So we have Petitioner still here?
` MR. GABRIC: Yes, you do, Your
` Honor. And I didn't know if we were supposed
` to -- there was three grounds in the E-mail.
` But anyway, we didn't address the other two.
` JUDGE JENKS: Okay. And do
` you want -- would you like to address the other
` two right now? I mean --
` MR. GABRIC: It's up to you.
` I can do it real fast.
` JUDGE JENKS: Absolutely. Why
` not?
` MR. GABRIC: Okay. Okay.
` Good enough.
`
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` The second thing we wanted to do is
` to respond on the notion that the Allergy
` process allegedly was not public use. And we
` wanted to point out that the batch records are
` signed by Allergy employees and those batch
` records are not marked confidential; nor are
` the certificates of analysis of Allergy Labs
` marked confidential.
` And the Patent Owner speculates that
` there was some implied confidentiality
` restrictions, and the record just doesn't
` support that.
` And what the Patent Owner points to
` are some preliminary test results from a
` third-party laboratory with the Sandoz product
` that are marked confidential. That overlooks
` the fact that the batch records themselves for
` the process are not marked confidential, and
` those batch records are signed by employees of
` Allergy Labs and there is no restriction of
` confidentiality of those employees.
` And the testimony of Mr. Johnson, in
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` his declaration, that they took no steps -- I
` think there were -- the first was his, but they
` took no steps to keep this confidential. But
` that was the second point we wanted to address.
` JUDGE JENKS: Okay.
` MR. GABRIC: And then the
` third point was the state of the art on the
` aluminum problem at the time of the alleged
` invention.
` The Patent Owner relies on an
` examiner's reasons for allowance in the '453
` patent, and we would like to point out to the
` Board this same examiner, in some related
` applications to this patent that have claims to
` the low aluminum levels, has recently started
` rejecting similar claims based on some of the
` same rationals in our petition.
` The Patent Owner cited our petition
` in these related applications, and the examiner
` looks like he has had a change of heart in his
` belief that there's unexpected results here.
` JUDGE JENKS: Okay. So --
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` MS. WHELAN: Your Honor, at
` this time, I would like to address a couple of
` points here.
` JUDGE JENKS: Absolutely.
` MS. WHELAN: First of all, the
` Allergy process and the public use, I think,
` once again, this is grounds that the Petitioner
` covered in the petition.
` I mean, I think having a reply here
` is tantamount to making replies, you know,
` routine as a matter of course. We're just not
` seeing the basis for it. I'm certainly not
` seeing the need for 12 pages.
` Regarding the aluminum problem, if
` I'm hearing Mr. Gabric correctly, it sounds
` like he's proposing introducing new arguments
` and new evidence, which we would object to as
` being improper.
` MR. GABRIC: May I briefly
` respond to the last point?
` JUDGE JENKS: Sure.
` MR. GABRIC: Yeah. This
`
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` examiner rejection came in after we filed the
` petition; it was in July of 2020, and so it was
` an intervening event between the filing of our
` petition and the filing of the Patent Owner
` reply.
` And, in my mind, when the Patent
` Owner couched the examiner's reasons for
` allowance in the '453 patent, that now are
` highly in question given the intervening
` submission of the petition and related
` applications where the same examiner now is
` saying, well, yeah, I don't think this is
` unexpected after all, I think we're entitled to
` it, to bring it to the Board's attention given
` it's an intervening event.
` MS. WHELAN: And we certainly
` disagree.
` JUDGE JENKS: Okay. All
` right.
` MS. WHELAN: Assuming it's
` true.
` JUDGE JENKS: We hear you. So
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` this is what we're going to do. We're going to
` give Petitioner basically six pages to respond
` to your preliminary response.
` Patent Owner will then also have an
` opportunity to file a third reply, also six
` pages. And let me give you the time frame for
` this.
` We're thinking maybe -- I'm just
` looking at my calendar here. So today is the
` 21st. How about if Petitioner provides us with
` their reply by the 28th of September, and then
` Patent Owner can file their sur-reply by the
` 5th of October. That gives everybody basically
` seven days.
` Now, I'm going to limit Petitioner's
` response -- to anything that you're responding
` to, please be cognizant to tell us where in the
` record in your petition you reference this
` various evidence.
` MR. GABRIC: Correct.
` JUDGE JENKS: So we can make
` sure that you're not bringing in new evidence.
`
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` With respect to this last part,
` where you have -- there's intervening arguments
` that are in front of the examiner, you can
` expand it a little bit, but try to keep it with
` what's in the record.
` MS. WHELAN: But, Your Honor,
` that isn't in the record.
` JUDGE JENKS: Oh, that
` isn't --
` MR. GABRIC: Yeah. This
` office -- this office action was not issued
` until July -- July of 2020, so it was -- it was
` after we filed the petition. But before the
` Patent Owner filed their Patent Owner response
` and the Patent Owner response, knowing that
` this examiner had a change of heart, decided to
` rely on the examiner's reason of allowance in
` the '453.
` So I don't know how the Board wants
` to handle that, but those are the facts. So --
` MS. WHELAN: I mean, I think
` that's a mischaracterization of the facts. And
`
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` also, look, it arose clearly after the
` petition, that's too bad. It's a -- you know,
` that's poor timing maybe, but that's clearly
` new evidence.
` MR. GABRIC: Well, you were
` aware of it when you filed the Patent Owner
` response and you kind of opened the door, if
` you ask Petitioner.
` MS. WHELAN: But this is
` not -- these replies, first of all, are not
` supposed to be given as a routine matter any
` way, and to allow continuous supplementation of
` the record is not fair to the Patent Owner.
` JUDGE JENKS: So we're going
` to let him bring -- we're going to let
` Petitioner bring this in. You will have --
` Patent Owner will have a chance to file
` their -- file a response, and this is with the
` sur-reply, and then we can sort it out as we're
` -- once we have all the information in front of
` us.
` MS. WHELAN: One
`
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` clarification, then, please?
` JUDGE JENKS: Mm-hmm.
` MS. WHELAN: Would we be able,
` as Patent Owner, to be able to introduce new
` evidence?
` JUDGE JENKS: If it's in
` response to something that's coming in with
` the -- to the -- if it's in response to
` Petitioner's reply, yes.
` MS. WHELAN: Okay. Thank you.
` JUDGE JENKS: All right. So I
` was also asked that -- hold on.
` Petitioner, we noticed there's
` another PGR floating around, which is
` PGR2020-0068.
` Are you -- will you be making
` similar arguments in that case as well.
` MR. GABRIC: Yeah, that's a
` very good question. The answer is yes.
` JUDGE JENKS: Okay.
` MR. GABRIC: It's very similar
` to this situation.
`
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` JUDGE JENKS: All right. And,
` you know, we're getting this for our knowledge
` here.
` MR. GABRIC: Yeah. And to
` give you a heads up, there's one more PGR
` that's coming down the pipes real soon on
` another patent in this family.
` JUDGE JENKS: Okay. All
` right. Well, all right. So let's see. We
` have -- do we have any other concerns or
` comments?
` Let me start with Petitioner here.
` MR. GABRIC: Well, you know,
` I -- I do object to them getting to do new
` evidence; we're not similarly situated. You
` know, they kind of invited this. They had this
` office action. They were aware of it and they
` doubled down on the examiner's reasons for
` allowance.
` And then to give them wholesale
` right to introduce new evidence where
` Petitioner has not kind of behaved in a similar
`
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` manner just doesn't seem right, but I'll just
` make my objection for the record.
` JUDGE JENKS: Okay. Patent
` Owner, do you have --
` MS. WHELAN: And I would also
` state my objection to the record because I
` don't think it's proper that this, even here in
` the reply, that this new evidence should come
` in. But again, I'll just state my objection
` for the record. I understand where the Board
` has come down on this.
` I would also request that, to the
` extent that the Board is considering
` authorizing a reply to our Patent Owner
` response in the other PGR, I would, with all
` due respect, rather see the specific grounds
` that Petitioner -- explaining why Petitioner
` would need a reply there.
` The two replies are -- the two
` Patent Owner responses are somewhat different,
` and so rather than again grant a reply as a
` matter of course, I'd like to see the specific
`
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` reasons for why the reply is being requested so
` that we can respond to that.
` JUDGE JENKS: Well, at this
` point, no -- you know, no reply has been
` requested as far as I can see today.
` But when that time comes, then
` hopefully we'll -- we'll certainly give you an
` opportunity to comment on it.
` MS. WHELAN: Thank you.
` JUDGE JENKS: Any other
` concerns?
` MR. GABRIC: No. Thank you to
` the Board for your time today. Appreciate it.
` JUDGE JENKS: Okay.
` MS. WHELAN: And I want to
` thank you for the Patent Owner's response.
` JUDGE JENKS: Okay. So I
` thank the parties for attention and attendance
` this afternoon.
` I will be issuing an order
` memorializing this conference call and we will
` also have the transcript on file eventually.
`
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` So thank you so much.
` We are adjourned.
` - - -
` (Thereupon, at 3:32 p.m. the
` conference call was concluded.)
` - - -
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` C E R T I F I C A T E
` I hereby certify that the
` proceedings and evidence are contained fully
` and accurately in the stenographic notes taken
` by me on the hearing of the within cause, and
` that this is a correct transcript of the same.
`
` ================================
` Alyssa A. Repsik, Court Reporter
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`TransPerfect Leg
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