throbber
1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`Job No. 3244671
`
`Telephone Conference - February 28, 2019
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
`
` _____________________________
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
` _____________________________
`
` NEPTUNE GENERICS, LLC
`
` PETITIONER
`
` V.
`
` AVENTIS PHARMA, S.A.
`
` PATENT OWNER
`
` _______________________________
`
` CASE NO. IPR2019-00136
`
` PATENT NO. 5,847,170
`
` FILED: MARCH 26, 1996
`
` ISSUED: DECEMBER 8, 1998
`
` INVENTORS: HERVÈ BOUCHARD,
`
` JEAN-DOMINIQUE BOURZAT, ALAIN COMMERÇON
`
` TITLE: TAXOIDS, THEIR PREPARATION, AND
`
` PHARMACEUTICAL COMPOSITIONS CONTAINING THEM
`
` _______________________________
`
` TELEPHONE CONFERENCE
`
` FRIDAY, FEBRUARY 28, 2019, 12:03 P.M. CENTRAL STANDARD TIME
`
` BEFORE JUDGES TIMOTHY G. MAJORS AND
`
` TINA HULSE
`
`Veritext Legal Solutions
`800-336-4000
`
`Page 1
`
`NEPTUNE GENERICS EX. 1056 Page 1 of 31
`
`

`

`1
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`10
`11
`
`12
`
`13
`
`14
`15
`16
`17
`18
`19
`20
`21
`
`22
`
`23
`
`24
`
`Job No. 3244671
`
`Telephone Conference - February 28, 2019
`
` APPEARANCES:
` VENABLE, LLP
` DANIEL J. MINION
` 1290 Avenue of the Americas, 20th Floor
` New York, New York 10104
` Phone: (212) 218-2538
` Email: dminion@venable.com
`
` On behalf of the Patent Owner.
`
` SKIERMONT DERBY, LLP
` ALEXANDER E. GASSER
` 1601 Elm Street, Suite 4400
` Dallas, Texas 75201
` Phone: (214) 978-6600
` Email: agasser@skiermontderby.com
` On behalf of Neptune Generics, LLC.
` SKIERMONT DERBY, LLP
` MIEKE K. MALMBERG
` 800 Wilshire Boulevard, Suite 1450
` Los Angeles, California 90017
` Phone: (213) 788-4500
` Email: mmalmberg@skiermontderby.com
` (Pro hac vice application to be submitted)
` On behalf of Neptune Generics, LLC.
`
` * * * * * *
`
` Christina Basis-Prinzi
` Certified Shorthand Reporter and
` Registered Professional Reporter
` CSR No. 084-001769
` One North Franklin Street, Suite 3000
` Chicago, Illinois 60606
` Phone: (312) 442-9087
`
`Veritext Legal Solutions
`800-336-4000
`
`Page 2
`
`NEPTUNE GENERICS EX. 1056 Page 2 of 31
`
`

`

`Job No. 3244671
`
`Telephone Conference - February 28, 2019
`
` THE COURT: Would counsel please identify
`
`themselves?
`
` MR. GASSER: Alex Gasser for the Petitioner.
`
` MS. MALMBERG: Mieke Malmberg for the Petitioner.
`
` THE COURT: And for patent owner?
`
` MR. MINION: Good afternoon, your Honor. This is
`
`Daniel Minion on behalf of patent owner, Sanofi.
`
` THE COURT: Hello, Mr. Minion. Anyone else on
`
`line for the patent owner?
`
` MR. MINION: Just me, your Honor.
`
` THE COURT: All right. I take it that's everyone
`
`then.
`
` Did you get what you need, Court Reporter?
`
` THE COURT REPORTER: Yes. And like I said, if
`
`they could just state their names before they speak just so I
`
`make sure I have everything straight, that will help me a
`
`lot.
`
` THE COURT: We'll do our best.
`
` THE COURT REPORTER: Thank you so much, Judge.
`
` THE COURT: Why don't we go ahead and begin then.
`
` We're here today based on a request for a
`
`conference from the petitioner. This is in regards to
`
`IPR2019-00136, Neptune Generics vs. Aventis.
`
` What we will go ahead and do, since petitioner
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`Veritext Legal Solutions
`800-336-4000
`
`Page 3
`
`NEPTUNE GENERICS EX. 1056 Page 3 of 31
`
`

`

`Job No. 3244671
`
`Telephone Conference - February 28, 2019
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`requested this call -- and we just did the email, and so we
`
`know the general nature of the request, but we'll open the
`
`floor up to petitioner's counsel. And then, Mr. Minion,
`
`you'll have an opportunity to respond.
`
` MR. GASSER: Thank you, your Honors. This is Alex
`
`Gasser for petitioner, Neptune.
`
` As we indicated in our email from last week,
`
`petitioner requests authorization to file a reply brief to
`
`patent owner's preliminary response. Our request for
`
`authorization is pursuant to 37 CFR, Section 42.108(c).
`
` As we indicated in our email, there are
`
`three general areas that we think are appropriate for a reply
`
`brief and that they're good grounds to have such a reply
`
`brief on the subjects. The primary area, which our
`
`understanding is, the PTAB generally does regularly consider
`
`replies for the Section 327(d) discretionary input for
`
`arguments and issues relating to prior arguments that were
`
`presented to the patent office, whether through an
`
`examination or a formal IPR petition. I think our -- our
`
`main arguments focus on that particular prong.
`
` Also, in addition to that, we do believe that
`
`there is additional reason to allow a reply brief on the
`
`314 -- Section 314 arguments -- the discretionary arguments,
`
`as well as just one legal, critical issue that permeates
`
`Veritext Legal Solutions
`800-336-4000
`
`Page 4
`
`NEPTUNE GENERICS EX. 1056 Page 4 of 31
`
`

`

`Job No. 3244671
`
`Telephone Conference - February 28, 2019
`
`patent owner's entire patent response regarding the
`
`standard -- the proper standard for obviousness.
`
` But just, very briefly, launching into the first
`
`prong of the reason for good cause for a reply brief would be
`
`the 325(d) arguments which focused primarily on the
`
`earlier -- the differences between the earlier IPR petition
`
`filed by a different party, Mylan Pharmaceutical, against the
`
`same patent by Sanofi.
`
` There are several issues relating to the 320, but
`
`the arguments that we could not have reasonably anticipated
`
`(sic). Just briefly for review, our petition at present --
`
`Neptune's petition relies on what we call (inaudible)
`
`reference --
`
` THE COURT REPORTER: What reference was that? I'm
`
`sorry.
`
` MR. GASSER: I'm sorry. Commercon,
`
`C-o-m-m-e-r-c-o-n.
`
` THE COURT REPORTER: Thank you.
`
` MR. GASSER: Commercon reference which is
`
`Exhibit 1009. And the Neptune petition relies on this
`
`primary reference as a guide to take our lead compound which
`
`is Paclitaxel and there's one change to the side chain. And
`
`then we'll rely on this to inform a person of ordinary skill
`
`in the art what portions of the remaining molecule should be
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`Veritext Legal Solutions
`800-336-4000
`
`Page 5
`
`NEPTUNE GENERICS EX. 1056 Page 5 of 31
`
`

`

`Job No. 3244671
`
`Telephone Conference - February 28, 2019
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`maintained, which portions remain flexible. And this,
`
`essentially, locks down about 90 percent of the molecule and
`
`gets us about 90 percent of the way to the claimed singular
`
`compound.
`
` And, additionally, the Neptune petition focuses
`
`on prior arguments for testimony relating to starting
`
`material to generate Paclitaxel analogs, which is the 10 gap
`
`starting material which also motivates changing the C-7 and
`
`C-10 positions on the Paclitaxel lead compound.
`
` Now, essentially, one of Mylan's 325(d) arguments
`
`is that Mylan's prior petition duplicates our reliance on the
`
`Commercon reference. And just in view of what I just
`
`described as how we're relying on the Commercon reference, we
`
`don't believe we should have reasonably anticipated that
`
`Sanofi would have argued that our petitioner's reliance on
`
`Commercon was duplicated in the Mylan petition.
`
` And, basically, Sanofi focuses just on the fact
`
`that the Mylan petition relies on different pieces of prior
`
`art to show that different functional groups at the C-7 and
`
`C-10 positions could be switched out.
`
` And given our very different approaches and
`
`reliance on Commercon and the fact that the Commercon
`
`reference itself, of course, was not even part of the Mylan
`
`petition, we think that warrants a response.
`
`Veritext Legal Solutions
`800-336-4000
`
`Page 6
`
`NEPTUNE GENERICS EX. 1056 Page 6 of 31
`
`

`

`Job No. 3244671
`
`Telephone Conference - February 28, 2019
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
` THE COURT: Mr. Gasser, this is Judge Majors.
`
` And I will confess that I have not read through
`
`all of your papers in great depth yet, but I did not
`
`understand or did not see it as the principal point that
`
`patent owner was making in terms of the -- the prior argument
`
`being advanced was Commercon -- it seemed to me they were
`
`saying, Okay, maybe you start with a different reference and
`
`a different lead compound that's going to be modified or
`
`substituted in certain ways, but at some point in the
`
`process, you're going to get to the same intermediate which
`
`is -- as I understand it, is going to be further modified
`
`using the -- and I may be forgetting. But if it's the cancer
`
`(inaudible) reference for the same reasoning that was
`
`advanced in the earlier Mylan petition, what do you have to
`
`say about that?
`
` MR. GASSER: Right. And I'd say those are two
`
`separate arguments which each independently warrants a
`
`response or a reply that couldn't have been anticipated.
`
` With respect to the Commercon argument, that is
`
`actually specifically identified at the top of Page 24 of
`
`patent owner's response where they say, Neptune uses
`
`Commercon for the notion that the C-7 and C-10 positions are
`
`flexible. And they're saying, Well, Mylan pointed to other
`
`art to argue that the C-7 and C-10 positions were available
`
`Veritext Legal Solutions
`800-336-4000
`
`Page 7
`
`NEPTUNE GENERICS EX. 1056 Page 7 of 31
`
`

`

`Job No. 3244671
`
`Telephone Conference - February 28, 2019
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`for substitution. So they're basically conflating Commercon
`
`and how we're relying on Commercon for different arguments
`
`that Mylan made in their petition.
`
` And my point is that given how differently we
`
`relied on Commercon as opposed to the arguments that are in
`
`Mylan, that is one aspect that warrants a response. And
`
`given the difference in how we rely on those and make those
`
`arguments, that is a significant difference that, A, we
`
`couldn't have anticipated and, B, warrants a response.
`
` Now, going back to your point, that would be the
`
`second -- a second reason for addressing the 325(d) argument,
`
`which is Sanofi's conflating the lead compound analysis,
`
`which is basically what I believe you were referring to.
`
` So they basically say, Well, even though we start
`
`with different lead compounds, Mylan's petition -- the
`
`arguments in Mylan's petition conflate with ours because you
`
`basically end up with Compound 20 and use that as a, sort of,
`
`jumping-off point. That's one of their other arguments in
`
`the 325(d) section.
`
` And the response is, Well, that would be a very
`
`difficult argument for us to have anticipated because, first
`
`of all, we obviously start off with a very different lead
`
`compound, Paclitaxel. And the arguments that Mylan made
`
`regarding Comp 20 is they argued that Comp 20 should be the
`
`Veritext Legal Solutions
`800-336-4000
`
`Page 8
`
`NEPTUNE GENERICS EX. 1056 Page 8 of 31
`
`

`

`Job No. 3244671
`
`Telephone Conference - February 28, 2019
`
`lead compound just right out of the gate, and the PTAB
`
`thought that was really unwarranted and basically determined
`
`that Mylan basically didn't successfully even start getting
`
`out of the gate because they didn't have a basis for arguing
`
`why Comp 20 should be a correct lead compound.
`
` And so given those fundamental differences, that
`
`would be one additional reason why, you know, a -- a reply
`
`brief would be warranted and, we think, helpful to address
`
`some of those distinctions.
`
` THE COURT: Why don't you talk quickly on the
`
`314 issue.
`
` MR. GASSER: Sure.
`
` THE COURT: As I understand it, the -- I mean,
`
`it's petitioner's position that the patent owner in some way
`
`is misstating what the law of obviousness is.
`
` MR. GASSER: Right. And those are maybe the two
`
`quicker issues, at least the 314 issue. And that one has to
`
`do with the fact that patent owner relied on a PTAB decision
`
`that issued a month or two after our petition was filed. And
`
`so, obviously, we couldn't have anticipated responding to
`
`that.
`
` And this all relates to their 314 argument that a
`
`related District Court action to which Neptune was not a
`
`party, in effect, addresses the same arguments involving the
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`Veritext Legal Solutions
`800-336-4000
`
`Page 9
`
`NEPTUNE GENERICS EX. 1056 Page 9 of 31
`
`

`

`Job No. 3244671
`
`Telephone Conference - February 28, 2019
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`same prior art. And we would -- we believe it'd be fair and
`
`appropriate for us to reply to that, given that we couldn't
`
`have anticipated a response to that. Basically, because --
`
`among other things, we think a reply is warranted because
`
`that case relies on the identical parties to an IPR and a
`
`related District Court action, the same experts, and the same
`
`exact prior art. And we don't have that situation. And we
`
`think it would be appropriate for us to reply and distinguish
`
`those. So that's the second, sort of, major area that we
`
`believe a reply would be appropriate.
`
` And the third and final response for which a reply
`
`would be warranted is the -- I would say an invitation by
`
`Sanofi for the PTAB to commit legal error by insisting that a
`
`particular property of the claimed Paclitaxel, namely that it
`
`has increased activity -- anticancer activity for drug
`
`resistant strains if that expected property is not present,
`
`then there cannot be prima facie obviousness. And that is a
`
`gross misstatement of the law regarding obviousness at the
`
`prima facie stage. It effectively confuses and merges the
`
`expectation of success at the prima facie stage with
`
`unexpected results or unexpected results that are secondary
`
`considerations that are entertained only after a prima facie
`
`case with obviousness is demonstrated.
`
` And the cases that Sanofi cites for the general
`
`Veritext Legal Solutions
`800-336-4000
`
`Page 10
`
`NEPTUNE GENERICS EX. 1056 Page 10 of 31
`
`

`

`Job No. 3244671
`
`Telephone Conference - February 28, 2019
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`proposition that properties should be expected -- if you look
`
`closely at the cases, those relate to cases where an actual
`
`claim limitation -- or there's either -- it's either relating
`
`to claims that include a particular use -- a method of use or
`
`a method of treatment or particular claim limitations
`
`regarding such a particular benefit or property. We don't
`
`have those in this case.
`
` The two claims at issue relate to the naked
`
`compound itself, as well as a composition for that compound.
`
`And there is ample Federal Circuit case law -- well, we
`
`identified in our opening brief, Otsuka, which says, Hey,
`
`look, when you're dealing with a compound claim, you just
`
`look at the -- it's the scope of the claim that determines
`
`reasonable expectation of success. And when it's a compound,
`
`a reasonable expectation of success is defined by a person of
`
`ordinary skill expectation to synthesize that compound and
`
`that's it.
`
` THE COURT: I'll go ahead and cut you off,
`
`Mr. Gasser. I think we understand petitioner's position.
`
` Mr. Minion, would you like to respond?
`
` MR. MINION: I would. Thank you, your Honor.
`
` I'll address the issues in the same order starting
`
`with the 325(d) issue. The issue considering typically
`
`whether a reply is warranted or good cause is shown really
`
`Veritext Legal Solutions
`800-336-4000
`
`Page 11
`
`NEPTUNE GENERICS EX. 1056 Page 11 of 31
`
`

`

`Job No. 3244671
`
`Telephone Conference - February 28, 2019
`
`comes to the point of reasonable foreseeability. We have, as
`
`counsel for petitioner, acknowledged they did address the
`
`issue of 325(d). And I think the problem -- or the reason
`
`for reply suggested by petitioner was that they did not
`
`foresee our argument that the references cited were
`
`cumulative and the arguments were substantially the same.
`
`And that really comes down to a strategic decision on
`
`petitioner's part to basically come in and summarily say,
`
`This is a different prior art combination; therefore, there
`
`is no 325(d) issue. And just summarily state that, We have a
`
`different lead compound; therefore, it's on the threshold.
`
`Discretionary issues should not be warranted. But those
`
`issues go straight to the heart of 325(d). And I think for
`
`those purposes we submit that they should not get a reply
`
`argument.
`
` On the 314(a) issue, I think there was a
`
`suggestion that -- that the -- that 314(a) issues were not
`
`foreseeable. In fact, in the petition on Pages 34 through
`
`36, petitioner addressed the District Court decision,
`
`acknowledged the District Court bound and upheld the
`
`validity. They actually attached the opinion of the District
`
`Court decision as Exhibit 1049, and also specifically
`
`addressed Section 314 in Footnote 3 in Paragraph 78.
`
` THE COURT: I'll interrupt you for a second,
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`Veritext Legal Solutions
`800-336-4000
`
`Page 12
`
`NEPTUNE GENERICS EX. 1056 Page 12 of 31
`
`

`

`Job No. 3244671
`
`Telephone Conference - February 28, 2019
`
`Mr. Minion, there. I understood petitioner to be saying not
`
`so much that 314(a) potential discetionary denial was not
`
`foreseeable but that some recent decision from the PTAB,
`
`specifically invoking 314(a) because of the stage of the
`
`litigation proceedings, was sufficiently advanced that the
`
`PTAB should essentially step away.
`
` MR. MINION: That's the basic gist of what I
`
`understood they are asserting was unforeseeable on 314(a) --
`
` THE COURT: Well, it --
`
` MR. MINION: -- because --
`
` THE COURT: Go ahead.
`
` MR. MINION: I'm sorry, your Honor, to interrupt.
`
` But in that case, when we are talking about
`
`whether -- weighing whether the District Court proceeding has
`
`advanced to a certain stage, really, that's not applicable
`
`here. We actually had a decision from the District Court.
`
`So the issue is -- the issue is whether -- that we need to
`
`reopen up the attack on the validity of this patent after the
`
`District Court has already held the patent valid using the
`
`same -- substantially the same arguments and substantially
`
`the same prior art. So that the specific case that they're
`
`having an issue with and the timing of that I don't think is
`
`really relevant. They're obviously aware of the issue of
`
`314(a) and the discetionary -- or the threshold discretionary
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`Veritext Legal Solutions
`800-336-4000
`
`Page 13
`
`NEPTUNE GENERICS EX. 1056 Page 13 of 31
`
`

`

`Job No. 3244671
`
`Telephone Conference - February 28, 2019
`
`-- discretion of the board to deny the 1201 petition even if
`
`it's from a petitioner that's filing their first petition.
`
` And, in fact, I mean, that's really what --
`
`petitioner addressed that very issue on Pages 34 through 36
`
`in saying that, Yes, we acknowledge that the District Court
`
`upheld the validity of this patent, but we think that
`
`decision is irrelevant. They clearly foresaw the potential
`
`impact of the District Court decision on the threshold
`
`discretionary issues here, 314(a).
`
` THE COURT REPORTER: Was this Mr. Minion just
`
`speaking, please, for the court reporter?
`
` MR. MINION: Yes.
`
` THE COURT REPORTER: Thank you.
`
` MR. MINION: Yes, it was.
`
` THE COURT: Thank you, Mr. Minion. I interrupted
`
`you earlier on 314(a). Do you have anything further to say
`
`on that? Or do you want to move on to this legal issue
`
`about, I guess, expectation of success versus unexpected
`
`results?
`
` MR. MINION: Yes. I think, your Honor -- I think
`
`I can move on to the last issue. And, frankly, we have the
`
`right standard. I'll say that right off the bat. I'm
`
`capable -- or I'm confident that the board is fully capable
`
`to assess petitioner's obvious contentions and understand the
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`Veritext Legal Solutions
`800-336-4000
`
`Page 14
`
`NEPTUNE GENERICS EX. 1056 Page 14 of 31
`
`

`

`Job No. 3244671
`
`Telephone Conference - February 28, 2019
`
`legal analysis as to unexpected results.
`
` As to their argument that unexpected results
`
`really are applicable to method of use claims, it's pretty
`
`standard law and most patent practitioners recall In Re:
`
`Papesch which very clearly states a compound and its
`
`properties are inseparable. So just showing that a prima
`
`facie showing that a structure was obvious is insufficient to
`
`render that claim invalid. One needs to have a reasonable
`
`expectation that the claimed compound would have the
`
`properties inherent to that compound.
`
` But as I say, I think on these issues, purely
`
`legal issues, replies, my understanding, are very rarely
`
`granted.
`
` THE COURT: Thank you, Mr. Minion.
`
` Anything further for patent owner?
`
` MR. GASSER: Just very briefly.
`
` MR. MINION: I'm sorry. Nothing for now. This
`
`was Dan Minion.
`
` THE COURT REPORTER: Thank you.
`
` THE COURT: Mr. Gasser, I'll let you have a very
`
`brief response on the points that Mr. Minion raised, if you'd
`
`like.
`
` MR. GASSER: Sure, just very briefly.
`
` I would point out that different PTAB board
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`Veritext Legal Solutions
`800-336-4000
`
`Page 15
`
`NEPTUNE GENERICS EX. 1056 Page 15 of 31
`
`

`

`Job No. 3244671
`
`Telephone Conference - February 28, 2019
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`decisions have pointed out that, you know, even though
`
`petitioners addressed 325(d) issues in a petition, the boards
`
`don't expect a petitioner to necessarily foresee and address
`
`every potential counterargument in a petition. And I'm just
`
`quoting directly from Indivior, Inc. vs. Rhodes
`
`Pharmaceuticals, IPR2018, 795 --
`
` THE COURT REPORTER: I'm sorry? What was after
`
`795?
`
` MR. GASSER: Paper 19. IPR2018, dash, 795.
`
` THE COURT REPORTER: Thank you.
`
` MR. GASSER: And then, additionally, I think your
`
`Honor nailed it about the 314 issues. We're just focusing on
`
`the fact that they're relying on -- patent owner relies on a
`
`case that issued after our petition was filed, and they don't
`
`just cite it, they rely on it and expound on it for an entire
`
`page. And I think, in fairness, we should be able to respond
`
`to that.
`
` And then just, lastly, petitioner acknowledges
`
`that as a general rule the board does not necessarily provide
`
`replies based on pure issues of law. However, I think in
`
`this case, given the central focus of patent owner's
`
`preliminary response on the activity relating to drug
`
`resistance and the fact that they are relying on Federal
`
`Circuit case law that relates to claims with methods of use
`
`Veritext Legal Solutions
`800-336-4000
`
`Page 16
`
`NEPTUNE GENERICS EX. 1056 Page 16 of 31
`
`

`

`Job No. 3244671
`
`Telephone Conference - February 28, 2019
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`for other treatment limitations, we do have a clear
`
`difference in opinion and it's a fundamental issue that
`
`permeates their entire preliminary response.
`
` And, certainly -- certainly, the petitioner does
`
`not take issue with the fact that unexpected results can
`
`certainly relate to a simple compound claim. But, again,
`
`that relates to matters outside of the prima facie case of
`
`obviousness and not at the prima facie obviousness stage.
`
` And I would simply direct the board -- if they're
`
`not going to consider a reply brief on this, I would direct
`
`the board to the Bristol-Myers Squibb vs. Ativa
`
`Pharmaceutical case, 752 F3d 967, stating that, Unexpected
`
`properties do not upset an already established motivation to
`
`modify a prior art compound based on expected properties of
`
`the compound, as well as In Re: Dillon, 919 F2d 688 --
`
` THE COURT REPORTER: Would you say the citation
`
`again on Dillon?
`
` MR. GASSER: 919 F2d 688.
`
` THE COURT REPORTER: Thank you.
`
` MR. GASSER: Which states that basically
`
`unexpected results have no place at the prima facie stage.
`
`It's obvious that they come into play in secondary
`
`considerations on obviousness. And that is all I have on
`
`that point for now, your Honor.
`
`Veritext Legal Solutions
`800-336-4000
`
`Page 17
`
`NEPTUNE GENERICS EX. 1056 Page 17 of 31
`
`

`

`Job No. 3244671
`
`Telephone Conference - February 28, 2019
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
` THE COURT: Two quick points before I go on hold
`
`for a moment so I can chat with Judge Hulse. Whoever
`
`arranged for the court reporter, can you please have the
`
`transcript filed? And, second -- and, second, Petitioner, if
`
`we do agree and we do grant the request for additional
`
`briefing at this stage, how many pages of briefing is
`
`petitioner asking for?
`
` MR. GASSER: I think that we can get these done in
`
`a pretty short order. I would say five pages for the 325(d).
`
`Perhaps, one page for the 314. And one page for the
`
`obviousness issues. That would be a total of seven pages.
`
` THE COURT: Okay. All right. Let's go on hold
`
`for -- hopefully, it won't be more than a couple of minutes.
`
`And Judge Hulse and I will come back on shortly and let you
`
`know what our decision is.
`
` MR. GASSER: Thank you.
`
` (A recess was taken.)
`
` THE COURT: Hello, this is Judge Majors again. I
`
`have had a chance to talk to Judge Hulse. Here's our
`
`decision on petitioner's request:
`
` Petitioner, we're going to authorize an additional
`
`filing of no more than five pages. I'm not going to specify
`
`how you want to apportion or how petitioner should apportion
`
`those five pages. You can use them however you want. But I
`
`Veritext Legal Solutions
`800-336-4000
`
`Page 18
`
`NEPTUNE GENERICS EX. 1056 Page 18 of 31
`
`

`

`Job No. 3244671
`
`Telephone Conference - February 28, 2019
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`would encourage you to not dwell on the Legal Issue Number 3
`
`or the legal matters. If there is a case or two you want to
`
`flag for us, that's fine. But it's probably unnecessary to
`
`spend too much of your briefing on that issue.
`
` Any questions about that?
`
` MR. GASSER: This is Alex Gasser. Thank you. I
`
`understand. The five pages with respect to however we want
`
`to apportion our three, sort of, general areas that we
`
`discussed on the call -- I appreciate that.
`
` THE COURT: Correct. And in terms of a due date,
`
`unless you have some reason that it can't be filed by next
`
`Thursday, that is going to be the date that we set. Is that
`
`doable?
`
` MR. GASSER: I think that should work. Thank you,
`
`your Honor.
`
` MR. MINION: This is Dan Minion for patent owner.
`
` Are you -- is the board open to a request for a
`
`surreply if we see a need?
`
` THE COURT: Not at this time. Let me clarify
`
`that. I'm not going to say one way or the other whether
`
`we're open to it. I think it's premature at the moment.
`
`Let's see what petitioner's filing says. And if after
`
`reading it patent owner believes that there really is a need
`
`for some additional briefing, then we can schedule a
`
`Veritext Legal Solutions
`800-336-4000
`
`Page 19
`
`NEPTUNE GENERICS EX. 1056 Page 19 of 31
`
`

`

`Telephone Conference - February 28, 2019
`
`Job No. 3244671
`
`conference to talk about it.
`
` But as a general matter -- I'm sure you can find
`
`decisions of the board both ways. But as a general matter,
`
`those are usually not a lot of preinstitution. But, again,
`
`lets wait and see at this point what is in the filing.
`
` MR. GASSER: I understand, your Honor. Thank you.
`
` THE COURT: All right. Well, unless there is
`
`anything further from any of the parties, why don't we go
`
`ahead and adjourn. And the -- we'll prepare -- the board
`
`will prepare something in writing. I don't know whether it
`
`will come via email or a content of the proceeding order at
`
`this point, but we'll try to get that out very quickly.
`
` MR. GASSER: This is Alex Gasser. Thank you very
`
`much, your Honors.
`
` THE COURT REPORTER: Could you tell me about the
`
`transcript? What we need to do so I know?
`
` MR. GASSER: This is Alex Gasser. I think what
`
`we'll do is -- basically, if you could, I'd say, in an
`
`expedited manner, provide me with a copy of the transcript.
`
`And then I will coordinate with counsel for patent owner on
`
`preparing an errata sheet that we will then jointly submit to
`
`the board as a next exhibit.
`
` So from your end, if you can just prepare the
`
`transcript and forward it to us, that will be great. Then I
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`Veritext Legal Solutions
`800-336-4000
`
`Page 20
`
`NEPTUNE GENERICS EX. 1056 Page 20 of 31
`
`

`

`Job No. 3244671
`
`Telephone Conference - February 28, 2019
`
`think we'll take it from there.
`
` THE COURT REPORTER: When do you need it by?
`
` THE COURT: This is Judge Majors and Hulse. We
`
`are going to drop off. There's no criticality to you filing
`
`that ASAP. Just when it's ready. Thank you.
`
` THE COURT REPORTER: Sorry, Alex.
`
` MR. GASSER: No worries. In light of that, if
`
`there is no hard date to get that on file, I guess we can
`
`just have it in the ordinary course.
`
` When do you think that you would be able to get it
`
`to us in the ordinary course?
`
` THE COURT REPORTER: Normal delivery is either
`
`eight or ten days.
`
` MR. GASSER: I'd prefer to have it more expedited
`
`than that.
`
` THE COURT REPORTER: How about a week? Do you
`
`want next Friday?
`
` MR. GASSER: Why don't we go for a week?
`
` THE COURT REPORTER: Yes.
`
` MR. GASSER: And this is a relatively short
`
`transcript. If there's a way to just, sort of, knock it out
`
`and just get it over with, I would appreciate that.
`
` THE COURT REPORTER: I do appreciate that. I'm
`
`going to have to contact somebody because there 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
`
`Veritext Legal Solutions
`800-336-4000
`
`Page 21
`
`NEPTUNE GENERICS EX. 1056 Page 21 of 31
`
`

`

`Job No. 3244671
`
`Telephone Conference - February 28, 2019
`
`terminology here I am quite unfamiliar with it. Because they
`
`mentioned some drug names.
`
` MR. GASSER: We can talk either off line --
`
` THE COURT REPORTER: Okay. Let's do that.
`
` MR. GASSER: Mr. Minion, if you want to drop off,
`
`I can keep the court reporter on the line and go over certain
`
`terms that may not have been immediately apparent -- what we
`
`were referring to.
`
` MR. MINION: I'm going to drop off.
`
` (The conference adjourned at
`
` 12:40 p.m.)
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`Veritext Legal Solutions
`800-336-4000
`
`Page 22
`
`NEPTUNE GENERICS EX. 1056 Page 22 of 31
`
`

`

`Job No. 3244671
`
`Telephone Confe

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

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.

throbber

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.

Become a Member

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

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket