`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
` BEFORE PATENT TRIAL AND APPEAL BOARD
`
`APOTEX INC., APOTEX CORP., and,
`ARGENTUM PHARMACEUTICALS LLC
`Petitioners,
`v.
`NOVARTIS AG.,
`Patent Owner.
`
`Case IPR2017-00854
`Patent 9,187,405 B2
`__________________________________________
`
`Teleconference
`August 25, 2017
`1:00 p.m.
`
`Transcript of Proceedings
`
`Apotex v. Novartis
`IPR2017-00854
`NOVARTIS 2020
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`212-279-9424
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`Veritext Legal Solutions
`www.veritext.com
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`212-490-3430
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` Is there anyone on the line for
`3 Petitioner Argentum? Okay.
`4 And is there a court reporter
`5 today?
`6 THE COURT REPORTER: Yes, good
`7 afternoon. Lisa Sansone from
`8 Veritext.
`9 HON. POLLOCK: Good afternoon,
`10 Lisa.
`11 We ask the party engaging the
`12 court reporter to file a copy as an
`13 exhibit when it becomes available.
`14 Ms. Love, I believe you have
`15 called this conference, please begin.
`16 MS. LOVE: Thank you, Your
`17 Honor. So I thought I would just move
`18 down the list of proposed motions as
`19 they appear in the paper that we
`20 filed. The first one is a request for
`21 authority to file a motion to amend
`22 the claim. This is something we get
`23 of right, but is concluded here
`24 because I know that the Board wants us
`25 to confer with you before we proceed.
`
`A P P E A R A N C E S:
`
`1 2
`
`3 4
`
`Presiding:
`5 The Honorable ROBERT A. POLLOCK,
` Administrative Patent Judge
`
`6 7
`
`Attorneys for Petitioner:
` STEVEN W. PARMELEE, ESQ.
`8 MICHAEL T. ROSATO, ESQ.
` Wilson Sonsini Goodrich & Rosati
`9 701 Fifth Avenue, Suite 5100
` Seattle, WA 98104-7036
`10 Email: sparmellee@wsgr.com
` mrosato@wsgr.com
`
`11
`12 Attorneys for Patent Owner:
` JANE M. LOVE, PhD
`13 ANDREW BLYTHE, ESQ.
` Gibson, Dunn & Crutcher, LLP
`14 200 Park Avenue
` New York, New York 10166-0193
`15 Email: jlove@gibsondunn.com
` ablythe@gibsondunn.com
`
`16
`17 ALSO PRESENT:
` JUDGE LORA M. GREEN
`18 JUDGE CHRISTOPHER N. KAISER
` * * *
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`19
`20
`21
`22
`23
`24
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` HON. POLLOCK: Okay, very good.
`3 MS. LOVE: Should I move on?
`4 HON. POLLOCK: Please.
`5 MS. LOVE: So the second one is
`6 a motion for a protective order and in
`7 this case, Your Honor, we have
`8 inventors of this patent that are in
`9 Switzerland. There may be a point
`10 that comes along in the case where we
`11 may need to deal with documents coming
`12 out of Switzerland and for that
`13 reason, we have given to the
`14 Petitioners in this case a draft
`15 amended -- a revised protective order
`16 that adds to the default protective
`17 order, some additional language to
`18 expressly deal with privacy laws.
`19 HON. POLLOCK: Okay.
`20 MS. LOVE: And we have not yet
`21 heard back from Apotex, but we only
`22 sent it a few days ago. But if we can
`23 reach agreement, we want authority to
`24 be able to submit a stipulated
`25 protective order in the case.
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`12
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` HON. POLLOCK: I am Judge
`3 Pollock along with Judges Green and
`4 Kaiser. This is a pretrial conference
`5 for IPR2017-00854 requested by Patent
`6 Owner Novartis. We also received a
`7 Patent Owner's list of proposed
`8 motions which we presume forms the
`9 basis for this call. I would like to
`10 start with a roll call. Who do I have
`11 on for Patent Owner Novartis?
`12 MS. LOVE: Good afternoon, Your
`13 Honor. This is Jane Love from Gibson
`14 Dunn, lead patent counsel for
`15 Novartis, Patent Owner.
`16 HON. POLLOCK: Who do I have on
`17 for Petitioner Apotex?
`18 MR. PARMELEE: Good morning,
`19 Your Honor. This is Steve Parmelee
`20 for Apotex, and I believe I also have
`21 Mike Rosato.
`22 Mike, are you there?
`23 MR. ROSATO: Yes, I am here.
`24 MR. PARMELEE: Okay, thank you.
`25 HON. POLLOCK: Good afternoon.
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` concerning putting the number adjacent
`3 to the EX abbreviation for exhibits.
`4 And in that case, they were not
`5 pleased, but they chose not to impose
`6 penalties on the Petitioner's reply in
`7 this case.
`8 But I would submit since
`9 Argentum has already seen that the
`10 Board is not in agreement with that
`11 type of abbreviation but that they
`12 went forward and did it in this case
`13 that they should now be penalized by
`14 allowing us to have additional words.
`15 HON. POLLOCK: You want a tit
`16 for tat punishment as it were. You
`17 don't have anything particular you
`18 want to say, you just want more words
`19 because they had more words?
`20 MS. LOVE: Well, I think that is
`21 the very minimum for fairness here if
`22 there was further punishment
`23 especially for Argentum who clearly
`24 had notice of this infraction. And,
`25 you know, leave it to the Board to
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`12
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` HON. POLLOCK: Very good. And I
`3 presume we don't have an issue until
`4 we know whether or not we have an
`5 agreement, correct?
`6 MS. LOVE: That is correct, Your
`7 Honor.
`8 HON. POLLOCK: And number three?
`9 MS. LOVE: Number three is a
`10 request to extend the word limit for
`11 Patent Owner's submission by we would
`12 request 439 extra words. And I can
`13 explain the basis for the request.
`14 HON. POLLOCK: Precisely 439?
`15 MS. LOVE: Well, yes, Your
`16 Honor. I will explain why. So in
`17 going through more carefully the two
`18 petitions that we have which are
`19 almost substantially identical,
`20 Argentum and Apotex, one member of our
`21 team noted that they in a number of
`22 cases, hundreds of cases ran together
`23 the abbreviation of an Exhibit EX
`24 period or EX along, right next to,
`25 adjacent to the numbers that identify
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` decide what the punishment could be.
`3 Certainly striking the last 439 words
`4 of their petition is one possibility,
`5 as it is for Apotex their last 304
`6 extra words is another possibility.
`7 Of course striking the petition
`8 completely is a third possibility.
`9 HON. POLLOCK: We will take that
`10 under advisement. How about number
`11 four?
`12 MS. LOVE: Number four, Your
`13 Honor, concerns Ground 3 in this case.
`14 Ground 3, if you will recall is
`15 instituted based on a reference for
`16 Kovarik that was published in 2010.
`17 It is a reference that is after the
`18 initial filing date in this case. And
`19 the 405 patent arises from a series, a
`20 short series of a PCT, well, a
`21 priority date from a foreign
`22 application but then a PCT followed by
`23 a continuation, followed by a
`24 divisional. And, therefore, I don't
`25 think it's disputed that the
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`12
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` the number of the exhibits. And I had
`3 noticed this when we first went
`4 through it, and it turns out that
`5 there has been a number of cases that
`6 the Board has decided on this exact
`7 issue of Petitioners doing that and
`8 some other evasions of the word limit
`9 in order to give themselves more space
`10 in order to make the argument in the
`11 petition.
`12 And here we looked at Apotex's
`13 petition which had as we counted 304
`14 extra words and Argentum's petition
`15 had 439 extra words. And we would
`16 request that the Board allow us to
`17 elongate our filing by 439 extra
`18 words, that being the larger of the
`19 two.
`20 And I point out as well that
`21 Argentum had actually been a party in
`22 another IPR, and that is IPR number
`23 2016-00204, where there was an issue
`24 regarding the exact same manipulation
`25 as the Board called it there
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` believed that the 112 piece of the
`3 analysis was really the issue of the
`4 ground and, therefore, thought that it
`5 was outside the scope of 311b, yes,
`6 Your Honor.
`7 HON. POLLOCK: So why can't you
`8 make this in the Patent Owner's
`9 response particularly if we were to
`10 give you 439 extra words to do it
`11 with? Why do you need a motion?
`12 MS. LOVE: Because we believe
`13 that it takes a little more space and
`14 analysis then we would want to give up
`15 in our actual paper and because this
`16 is a statutory issue, a jurisdictional
`17 issue, we believe that we are taking
`18 away from the short amount of time and
`19 the short amount of space that Patent
`20 Owner has in order to defend the
`21 patentability of the claims in this
`22 patent.
`23 We have two other grounds and
`24 this particular one Ground 3 is really
`25 we believe not a meritorious issue
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`12
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` application in each of the filing is
`3 substantially identical.
`4 And here there was an amendment
`5 that was submitted several months
`6 after the last filed application in
`7 this case which is application
`8 14257342 which was filed on April 21,
`9 2014. Several months after that date,
`10 an amendment was put on file by the
`11 applicant which for the first time
`12 introduced negative limitation which
`13 is really an issue -- one of the
`14 issues that the Board analyzes in the
`15 institution decision, whether or not
`16 that negative limitation has written
`17 description support under 112 in the
`18 application itself.
`19 And the Board came to the
`20 conclusion that there was a question
`21 of whether or not Patent Owner did
`22 have 112 written description support
`23 and instituted this ground by focusing
`24 on this last filing date of April 21,
`25 2014 and determining that the Kovarik
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` that we need to argue about but rather
`3 a jurisdictional one. And indeed we
`4 believe the authority prejudiced us
`5 because we've had to spend time during
`6 these three months to figure out by
`7 doing the requisite research and
`8 looking at the Board's precedent, as
`9 well as the federal circuit precedent
`10 that we believe this fact pattern is
`11 actually outside the scope of 311b.
`12 HON. POLLOCK: Very good.
`13 Number five.
`14 MS. LOVE: Number five, Your
`15 Honor, is to preserve our rights in
`16 case the United States Supreme Court
`17 finds that IPRs as a whole are
`18 unconstitutional. So we would like
`19 authority to preserve the record in
`20 this case that we would seek on
`21 similar grounds a motion to dismiss
`22 the entire proceeding as
`23 unconstitutional.
`24 HON. POLLOCK: All right. Are
`25 you aware of any other panel of the
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`12
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` reference was before that date and,
`3 therefore, would be considered prior
`4 art. And we would like authority to
`5 file a motion to terminate Ground 3 on
`6 the basis that the analysis under 112
`7 is outside the scope of 35 U.S. Code
`8 311(b) and that requires that "a
`9 Petitioner in an inter partes review
`10 may request to cancel as unpatentable
`11 one or more claims of a patent only on
`12 the grounds that could be raised under
`13 Section 102 or 103 and only on the
`14 basis of prior art consisting of
`15 patent or printed publications."
`16 We would argue that this ground
`17 is a combination of a 112 and then a
`18 102 ground, and it's not, therefore,
`19 only on Section 102 and 103 or 103.
`20 HON. POLLOCK: Dr. Love, you
`21 made this argument in the Patent Owner
`22 preliminary response, correct?
`23 MS. LOVE: We referred -- well,
`24 we made an argument that was very
`25 short that pointed out that we
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` They only used 11,700 words out of the
`3 14,000 they had available to them. So
`4 we would oppose this request, and we
`5 don't think what we have done is an
`6 attempt to evade a word limit at all.
`7 The motion, number four, the
`8 motion to terminate Ground 3 is
`9 outside the scope of the statute. We
`10 think that Patent Owner addressed this
`11 in the POPR. The Board had already
`12 considered it and has instituted on
`13 that ground. We think there's plenty
`14 of precedent for allowing this ground
`15 to continue and, therefore, we would
`16 oppose such a motion for the Board
`17 to -- if we oppose the request then we
`18 would oppose such a motion.
`19 And the motion to dismiss based
`20 on constitutional rights, again
`21 consistent with Your Honor, we have
`22 not seen any motions like this before
`23 the Board, so we would ask that this
`24 not be -- that the Patent Owner not be
`25 provided with an opportunity to
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` Board granting such a motion in any
`3 other case?
`4 MS. LOVE: I'm not, Your Honor.
`5 HON. POLLOCK: Anything else
`6 before Petitioner has a say?
`7 MS. LOVE: No, Your Honor.
`8 HON. POLLOCK: All right. Mr.
`9 Parmelee, are you speaking for
`10 Petitioner Apotex?
`11 MR. PARMELEE: Yes, I am, Your
`12 Honor. Thank you. Do you want me to
`13 just go through the list and respond
`14 to these comments?
`15 HON. POLLOCK: That would be
`16 fine.
`17 MR. PARMELEE: Okay, thank you.
`18 Number one, the motion to amend, I
`19 don't think I've heard a reason
`20 articulated, but I assume the Board
`21 will want to inquire further on that
`22 after we get done speaking.
`23 The second one, the motion for a
`24 protective order and the motion to
`25 seal it looks to me like in the draft
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` separately address this. There's
`3 surely room in one of the documents
`4 that they intend to file that allow
`5 them to preserve this argument. And
`6 that is all I have, Your Honor.
`7 HON. POLLOCK: Okay. Dr. Love,
`8 any final words?
`9 MS. LOVE: Yes, Your Honor. As
`10 to the motion to extend the word
`11 limits, there are a couple of other
`12 cases where the Board has in various
`13 circumstances considered sanctions
`14 regarding the spacing conduct using EX
`15 adjacent to the numbers. And one is
`16 in Axon which is IPR2017-00375.
`17 Another is Snap-on Tool, case IPR
`18 2015-01242. And a third is EMC Corp.
`19 IPR2017-00429. And that shows that
`20 the Board has a number of cases
`21 identified what is the accepted normal
`22 spacing pursuant to 37 CFR 42.6a2 ii
`23 and that the collapsing of the exhibit
`24 and the number is something that the
`25 Board deems to be unusual.
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`12
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` that I have seen there's a lot more
`3 changes from the standard default
`4 protective order. And so we are
`5 having to go through and analyze the
`6 differences and we'll be back in touch
`7 with Patent Owner to see why those
`8 other changes are needed.
`9 The third point, the motion to
`10 extend the Patent Owner word limit, I
`11 guess that is premised on the fact
`12 that we cite to exhibits, our practice
`13 is to use EX and then the number. I
`14 don't know that the Board requires a
`15 particular format, but so it does seem
`16 to be like a tit for tat as Your Honor
`17 mentioned. They already get 14,000
`18 words, the same that we had in our
`19 petition. Plus if they are
`20 envisioning filing a motion to amend,
`21 they get another 25 pages.
`22 So I really don't think -- and I
`23 would point out again in their POPR,
`24 they didn't even come close to using
`25 all of their word limit that they had.
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` patentee needed to establish
`3 conception and reduction to practice
`4 in order to prove a priority date in a
`5 102(e) type situation. And there were
`6 shifting burdens of proof.
`7 There are other precedence that
`8 it also discussed in that Magnum Oil
`9 Tools case, for example, that
`10 reinforces the fact that the burden of
`11 persuasion has to remain with the
`12 Petitioner in an IPR. And that is yet
`13 another reason that we would seek to
`14 have the ability to more fulsomely
`15 address the issue in terms of a motion
`16 to terminate Ground 3.
`17 Here the 112 question arises,
`18 but in reality the specifications are
`19 all the same at the beginning all the
`20 way through to the final application
`21 that was filed that became the 405
`22 patent. So the 112 decision becomes
`23 binary. It either does meet 112 and
`24 the issue disappears or it fails 112
`25 and that becomes dispositive to the
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` HON. POLLOCK: I am sorry,
`3 Dr. Love, you started to fade out for
`4 me. Would you go back 20 seconds and
`5 repeat that, please?
`6 MS. LOVE: Yes. The fact that
`7 are at least four decisions from the
`8 Board shows that they believe that
`9 there are accepted spacing
`10 requirements or normal spacing
`11 pursuant to 37 CFR Section 42.6a (2)
`12 romanette (ii) and that they have
`13 considered even the possibility of
`14 sanctions for that type of conduct.
`15 HON. POLLOCK: Okay. And the
`16 cases were the Axon, Snap-on and EMC.
`17 What was the fourth one?
`18 MS. LOVE: The fourth one was
`19 the Argentum case that I read into the
`20 record earlier, and I can repeat it,
`21 it is IPR2016-00204. I'd also point
`22 out that the preliminary response that
`23 we filed has no bearing -- the length
`24 of that has no bearing on what we need
`25 to do in the next round in order to
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` patentability of the claims and,
`3 therefore, the Board ends up writing a
`4 decision on a 112 patentability issue
`5 which is directly outside the scope of
`6 311b.
`7 It seems to me that the only
`8 time it's proper for there to be an
`9 examination of 112 written description
`10 support is when either there are
`11 multiple priority dates with different
`12 disclosures as in a series of a
`13 continuation in parts which is not the
`14 case here or as in the Dynamic
`15 Drinkware case that I mentioned which
`16 is examining a 102(e) case where the
`17 patentee is putting forward conception
`18 and reduction to practice evidence in
`19 order to effectively swear behind a
`20 reference.
`21 HON. POLLOCK: All right.
`22 MS. LOVE: I'm sorry, Your
`23 Honor. So I would request that we in
`24 order to address the issues that I
`25 have described be granted the
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`12
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` complete our record for defending the
`3 patentability of our claim.
`4 HON. POLLOCK: Fair enough.
`5 MS. LOVE: Then I would like to
`6 point out in terms of number four, the
`7 motion to terminate Ground 3, the
`8 Board relied in the institution
`9 decision on a case called in re:
`10 Magnum Oil Tools. And the Board
`11 quoted from that case a statement that
`12 reads, "The patentee bears the burden
`13 of establishing that its claimed
`14 invention is entitled to an earlier
`15 priority date than an asserted prior
`16 art reference."
`17 But when one looks at that case,
`18 that quotation is actually about a
`19 different case. It comes from a case
`20 called Dynamic Drinkware which is a
`21 Federal Circuit decision 800 F.3d
`22 1375. And in that case the situation
`23 that is being discussed is
`24 distinguishable from our case. The
`25 case discussed there is when a
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` CERTIFICATION
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`1 2
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`3 4
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` I, Lisa Sansone, a Notary Public for
`5 and within the State of New York, do
`6 hereby certify:
`7 That the within transcript of the
`8 foregoing proceedings is a true and
`9 accurate transcription of my stenographic
`10 notes.
`11 I further certify that I am not
`12 related to any of the parties to this
`13 action by blood or marriage, and that I am
`14 in no way interested in the outcome of
`15 this matter.
`16 IN WITNESS WHEREOF, I have hereunto
`17 set my hand this 29th day of August, 2017.
`18
`19
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` <%Signature%>
`20 LISA SANSONE
`21
`22
`23
`24
`25
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`12
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` authority to file a motion to
`3 terminate Ground 3 as a separate
`4 document.
`5 HON. POLLOCK: All right. Thank
`6 you very much, Counsel. We will take
`7 this under advertisement and an order
`8 will issue shortly.
`9 MR. PARMELEE: Thank you, Your
`10 Honor. This is Steve Parmelee. I
`11 just reverting back to the word count
`12 issue, I hate to get into a little
`13 back and forth here but even looking
`14 at the exhibit dot and/or the exhibit
`15 number, our petition only had 13,584
`16 words. So if you add the 304 extra
`17 spaces that Patent Owner said she
`18 needs then we still are under the word
`19 count for our petition. So there
`20 really is no need based on that
`21 argument. Thank you, Your Honor,
`22 that's all I have.
`23 HON. POLLOCK: All right,
`24 Counsel. I think that is all for
`25 today. Thank you very much.
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` MR. PARMELEE: Thank you.
`3 MS. LOVE: Thank you, Your
`4 Honor.
`5 (Time noted: 1:25 p.m.)
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`[& - board]
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`&
`& 2:8,13
`1
`10166-0193 2:14
`102 11:13,18,19
`20:5 21:16
`103 11:13,19,19
`11,700 16:2
`112 10:17,22 11:6
`11:17 12:2 20:17
`20:22,23,24 21:4,9
`13,584 22:15
`1375 19:22
`14,000 15:17 16:3
`14257342 10:8
`1:00 1:18
`1:25 23:5
`2
`
`2 18:11
`20 18:4
`200 2:14
`2010 9:16
`2014 10:9,25
`2015-01242 17:18
`2016-00204 7:23
`2017 1:17 24:17
`21 10:8,24
`25 1:17 15:21
`29th 24:17
`3
`3 9:13,14 11:5
`12:24 16:8 19:7
`20:16 22:3
`304 7:13 9:5 22:16
`311 11:8
`311b 12:5 13:11
`21:6
`35 11:7
`37 17:22 18:11
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`4
`405 9:19 20:21
`42.6a 18:11
`42.6a2 17:22
`439 6:12,14 7:15
`7:17 9:3 12:10
`5
`5100 2:9
`7
`
`701 2:9
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`8
`800 19:21
`9
`9,187,405 1:14
`98104-7036 2:9
`a
`abbreviation 6:23
`8:3,11
`ability 20:14
`able 5:24
`ablythe 2:15
`accepted 17:21
`18:9
`accurate 24:9
`action 24:13
`actual 12:15
`add 22:16
`additional 5:17
`8:14
`address 17:2
`20:15 21:24
`addressed 16:10
`adds 5:16
`adjacent 6:25 8:2
`17:15
`administrative 2:5
`advertisement
`22:7
`
`advisement 9:10
`afternoon 3:12,25
`4:7,9
`ag 1:10
`ago 5:22
`agreement 5:23
`6:5 8:10
`allow 7:16 17:4
`allowing 8:14
`16:14
`amend 4:21 14:18
`15:20
`amended 5:15
`amendment 10:4
`10:10
`amount 12:18,19
`analysis 11:6 12:3
`12:14
`analyze 15:5
`analyzes 10:14
`andrew 2:13
`apotex 1:6,6 3:17
`3:20 5:21 6:20 9:5
`14:10
`apotex's 7:12
`appeal 1:4
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`art 11:4,14 19:16
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`b 11:8
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`17:12,20,25 18:8
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`board's 13:8
`burden 19:12
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`burdens 20:6
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`c 2:2
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`doing 7:7 13:7
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`e
`e 2:2,2 20:5 21:16
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`crutcher 2:13
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`date 9:18,21 10:9
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`distinguishable
`19:24
`divisional 9:24
`document 22:4
`documents 5:11
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`explain 6:13,16
`expressly 5:18
`extend 6:10 15:10
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`extra 6:12 7:14,15
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`f
`f.3d 19:21
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`fourth 18:17,18
`fulsomely 20:14
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`g
`gibson 2:13 3:13
`gibsondunn.com
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`hand 24:17
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`9:13 12:6 13:15
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`identical 6:19 10:3
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`ipr 7:22,22 17:17
`20:12
`ipr2016-00204
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`ipr2017-00375
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`ipr2017-00429
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`ipr2017-00854
`1:13 3:5
`iprs 13:17
`issue 6:3 7:7,23
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`issues 10:14 21:24
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`jane 2:12 3:13
`jlove 2:15
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`kaiser 2:18 3:4
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`l
`language 5:17
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`lot 15:2
`love 2:12 3:12,13
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`[love - present]
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`6:6,9,15 8:20 9:12
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`m 2:12,17
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`o
`office 1:2
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`prejudiced 13:4
`preliminary 11:22
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`premised 15:11
`present 2:17
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`preserve 13:15,19
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`presiding 2:4
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`pretrial 3:4
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`question 10:20
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