Case 1:18-cv-12029-ADB Document 464 Filed 09/02/22 Page 1 of 96
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`1
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` UNITED STATES DISTRICT COURT
` DISTRICT OF MASSACHUSETTS
`
`_________________________________
`
`TEVA PHARMACEUTICALS
`INTERNATIONAL GMBH, et als,
`
` Plaintiff, Civil Action
` No. 1:18-cv-12029-ADB
`
`v.
`
`
`
`
` August 15, 2022
`
`ELI LILLY AND COMPANY,
`
`Defendant. Pages 1 to 96
`_________________________________
`
`TRANSCRIPT OF MOTION HEARING
`BEFORE THE HONORABLE ALLISON D. BURROUGHS
`UNITED STATES DISTRICT COURT
`JOHN J. MOAKLEY U.S. COURTHOUSE
`ONE COURTHOUSE WAY
`BOSTON, MA 02210
`
`
`
`JOAN M. DALY, RMR, CRR
`Official Court Reporter
`John J. Moakley U.S. Courthouse
`One Courthouse Way, Room 5507
`Boston, MA 02210
`joanmdaly62@gmail.com
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`1
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` UNITED STATES DISTRICT COURT
` DISTRICT OF MASSACHUSETTS
`
`_________________________________
`
`TEVA PHARMACEUTICALS
`INTERNATIONAL GMBH, et als,
`
` Plaintiff, Civil Action
` No. 1:18-cv-12029-ADB
`
`v.
`
`
`
`
` August 15, 2022
`
`ELI LILLY AND COMPANY,
`
`Defendant. Pages 1 to 96
`_________________________________
`
`TRANSCRIPT OF MOTION HEARING
`BEFORE THE HONORABLE ALLISON D. BURROUGHS
`UNITED STATES DISTRICT COURT
`JOHN J. MOAKLEY U.S. COURTHOUSE
`ONE COURTHOUSE WAY
`BOSTON, MA 02210
`
`
`
`JOAN M. DALY, RMR, CRR
`Official Court Reporter
`John J. Moakley U.S. Courthouse
`One Courthouse Way, Room 5507
`Boston, MA 02210
`joanmdaly62@gmail.com
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`Case 1:18-cv-12029-ADB Document 464 Filed 09/02/22 Page 2 of 96
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`2
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`APPEARANCES:
`
`FOR THE PLAINTIFFS:
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`Douglas J. Kline
`Robert Frederickson , III
`Elaine Herrmann Blais
`Eric T. Romeo
`Molly R. Grammel
`Goodwin Procter, LLP
`100 Northern Avenue
`Boston, MA 02210
`617-570-1000
`Dkline@goodwinlaw.com
`rfrederickson@goodwinlaw.com
`eblais@goodwinlaw.com
`eromeo@goodwinlaw.com
`mgrammel@goodwinlaw.com
`
`Natasha E. Daughtrey
`Goodwin Procter LLP
`601 S. Figueroa Street
`Los Angeles, CA 90017-5704
`213-426-2500
`Email: NDaughtrey@goodwinlaw.com
`
`FOR THE DEFENDANT:
`
`Charles E. Lipsey
`Ryan P. O'Quinn
`Finnegan, Henderson, Farabow, Garrett & Dunner, LLP.
`1875 Explorer Street
`Reston, VA 20190
`571-203-2700
`Charles.lipsey@finnegan.com
`oquinnr@finnegan.com
`
`William B. Raich
`Danielle A. Duszczyszyn
`Yoonjin Lee
`Finnegan Henderson Farabow Garrett & Dunner, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
`202-408-4142
`Danielle.duszczyszyn@finnegan.com
`Yoonjin.Lee@finnegan.com
`William.Raich@finnegan.com
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`Case 1:18-cv-12029-ADB Document 464 Filed 09/02/22 Page 3 of 96
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`3
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`APPEARANCES (cont.):
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`Andrea L. Martin
`Burns & Levinson LLP
`125 Summer Street
`Boston, MA 02110
`617-345-3000
`Email: Amartin@burnslev.com
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`Case 1:18-cv-12029-ADB Document 464 Filed 09/02/22 Page 4 of 96
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`P R O C E E D I N G S
`(The following proceedings were held in open
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`court before the Honorable Allison D. Burroughs, United
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`States District Judge, United States District Court, District
`
`of Massachusetts, at the John J. Moakley United States
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`Courthouse, One Courthouse Way, Boston, Massachusetts, on
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`August 31, 2022.)
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`THE CLERK: This is Civil Action 18-12029, Teva
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`Pharmaceuticals, et al., v. Eli Lilly and Company. Will
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`Counsel identify yourselves for the record.
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`MR. KLINE: Your Honor, for Teva, Doug Kline of
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`Goodwin. Together with me, my partners Robert Frederickson,
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`Elaine Blais, Natasha Daughtrey, Molly Grammel, and Eric
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`Romeo is here with me, all from Goodwin. And with us from
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`the client as well, Your Honor, we have Mr. Colin Regan,
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`Ms. Lori Wolfe, and Mr. Joe Rice.
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`THE COURT: Mr. Kline, are you sure you have enough
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`lawyers to get it done today?
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`MR. KLINE: I'm not sure, Your Honor. I might just
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`call the office should I need some assistance.
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`THE COURT: You can call reinforcements if you need
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`them, right?
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`MR. KLINE: Yes.
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`MR. LIPSEY: Good morning, Your Honor. Charles
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`Lipsey with Finnegan Henderson for Defendant Eli Lilly and
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`Case 1:18-cv-12029-ADB Document 464 Filed 09/02/22 Page 5 of 96
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`Company. As well as I am joined by my colleagues from
`Finnegan Henderson, Mr. William Raich, Danielle Duszczyszyn.
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`In the back of the room, Ryan O'Quinn, Yoonjin Lee --
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`MS. MARTIN: Good morning, Your Honor. Andrea
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`Martin from Burns & Levinson.
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`MR. LIPSEY: We'll try to make do with a smaller
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`number. I'm sorry, also Mr. Mark Stewart from Eli Lilly is
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`here.
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`THE COURT: It's hard not to think of the saying
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`how many lawyers does it take to screw in a light bulb,
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`right?
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`So I'm happy to do this today in any order or any
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`way that you want if you've given it any thought.
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`MR. KLINE: We have thoughts, Your Honor. With
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`respect -- two of the motions are Teva's motions. The Motion
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`for Summary Judgment regarding Judicial Estoppel informs --
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`impacts many of the rest of the arguments that I think the
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`Court would hear today, so we'd like to go first on that.
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`With respect to -- and at any moment that it's appropriate,
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`we can do the Motion for Summary Judgment of Known Equitable
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`Conduct.
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`With regard to Lilly's motions, I'm sure Lilly will
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`have a view. It's our view, Your Honor -- if we could have
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`the screen just a moment for our side. It's our view,
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`Your Honor, that the Court perhaps need not hear Lilly's
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`Case 1:18-cv-12029-ADB Document 464 Filed 09/02/22 Page 6 of 96
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`motions because Lilly itself conceded in its reply briefs on
`the briefing that there are genuine disputes of material fact
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`relevant to the issues in the briefs that they cited in their
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`documents. For this motion they conceded that 90 percent of
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`the material facts -- 10 percent of the material facts remain
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`disputed with respect to written description. They conceded
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`15 percent of the material facts are still disputed.
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`And with respect to their enablement motion, they
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`conceded 20 percent of their material facts are undisputed.
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`And that's right from their briefs, Your Honor. I assume
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`Lilly will have a different view. But in any event ....
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`MR. LIPSEY: If I may, Your Honor, that was in
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`response to complaints about the volume of our Rule 56
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`submission. And the whole purpose of this hearing, we hope,
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`is to demonstrate for Your Honor how the entitlement to
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`relief on the motions that are now before you really is
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`focused on a relatively limited number of facts which are
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`generally undisputed.
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`In that regard, we disagree that their judicial
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`estoppel motion disposes of anything, and we can get into why
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`that is. We think that the motions for invalidity under the
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`written description requirement and enablement requirement of
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`112 are really dispositive of the case, and we would like to
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`go first on those.
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`THE COURT: Okay. Do you want to start with the
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`Case 1:18-cv-12029-ADB Document 464 Filed 09/02/22 Page 7 of 96
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`judicial estoppel? Is that where you want to start?
`MR. KLINE: Yes, we do, Your Honor. Thank you.
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`THE COURT: How long do you people think you want
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`this morning?
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`MR. KLINE: It's six motions, Your Honor. I would
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`think we could certainly spend a few hours on these matters
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`if the Court had that kind of time available.
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`THE COURT: A few hours.
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`MR. KLINE: Until the lunch break, Your Honor.
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`THE COURT: That's good.
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`MR. KLINE: Okay.
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`THE COURT: Now we're getting there. Let me just
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`say I think we counted more than a thousand pages of briefing
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`on these motions, and what is legitimately in dispute is much
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`smaller than the number of pages actually warranted. So if
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`you think of my attention span as a universe, you've already
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`used up some significant percentage of that universe as I
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`have plowed through the minutia of facts that were not
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`actually disputed. So take it from there.
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`MR. KLINE: Excellent, Your Honor. And needless to
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`say, we certainly would encourage the Court, on any motion
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`that we begin to address, to ask questions and give us the
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`Court's thoughts on where you think we should focus.
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`THE COURT: Okay.
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`MR. KLINE: So my partner, Mr. Frederickson, will
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`Case 1:18-cv-12029-ADB Document 464 Filed 09/02/22 Page 8 of 96
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`present for Teva regarding judicial estoppel.
`MR. FREDERICKSON: Good morning, Your Honor. We
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`have some slides. May I approach?
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`THE COURT: Sure.
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`(Pause.)
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`THE COURT: Let me just ask you a question,
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`Mr. Frederickson, before we start.
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`MR. FREDERICKSON: Sure.
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`THE COURT: So isn't it right that something can be
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`known and obvious but still difficult and unpredictable?
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`MR. FREDERICKSON: Can something be known and
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`obvious but still difficult and unpredictable? No,
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`Your Honor, I disagree with that. I agree with the legal
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`conclusion that something can be obvious and also be not
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`enabled or violate the written description requirement. But
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`in terms of the very specific facts we have at issue in this
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`case, the way that Lilly presented its evidence in the IPRs
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`wasn't constrained to any limitations about whether it was
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`known or obvious. It was what a person of ordinary skill in
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`the art would have understood as a factual matter to be
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`routine and conventional, so we've tried to tailor this
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`motion in particular to those very specific factual
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`inquiries.
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`The larger legal question, and to the extent that
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`there's other facts, as Your Honor alluded to, there are
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`Case 1:18-cv-12029-ADB Document 464 Filed 09/02/22 Page 9 of 96
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`other facts at issue with respect to the written description
`enablement defenses, those are fair game for Lilly. That's
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`at least Teva's position.
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`But the five facts that we've identified in our
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`motion, we think those ought to be deemed established and
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`Lilly should be precluded from contradicting them either by
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`virtue of the summary judgment record or, more importantly,
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`in front of the jury at trial.
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`THE COURT: Okay. Go ahead.
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`MR. FREDERICKSON: Okay. As Your Honor may
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`remember from the history of this case, there was originally
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`nine patents at issue. There was 6 composition of matter
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`patents, and this is on slide 2, and 3 method of treatment
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`patents. And right around when the case was filed, Lilly
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`filed these petitions for inter parties review in front of
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`the patent office, arguing that most importantly for purposes
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`of the instant motion, that the composition of matter patents
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`were invalid.
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`The composition of matter patents were directed
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`towards antibodies, in particular antibodies that binded to
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`and antagonized the protein in the body associated with head
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`pain called CGRP. The method in treatment patents, in
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`contrast, are directed towards methods -- specific methods,
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`and one method in particular, of using those antibodies to
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`treat headache pain by antagonizing CGRP.
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`Case 1:18-cv-12029-ADB Document 464 Filed 09/02/22 Page 10 of 96
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`And what Lilly did in the composition of matter
`IPRs is it constructed this factual predicate, the five facts
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`that I've alluded to. We've put on the screen the
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`illustration of the logic that Lilly was trying to convince
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`the patent office in front of the -- during the IPR
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`proceedings. The.
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`Startling premise for Lilly's argument was that
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`there was a class of antibodies that were well known to
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`scientists in the field. These were called anti-CGRP
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`antagonist antibodies. They were not humanized antibodies.
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`They had not been made for therapeutic purpose. But what
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`Lilly had convinced the patent office and had argued to the
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`patent office was that that particular class of antibodies
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`was well known to scientists in the field as of 2005.
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`That was Lilly's factual predicate -- first factual
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`predicate, that these antibodies existed and they were known
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`to scientists in the field. What Lilly did was it then took
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`other prior art relating to techniques to make a therapeutic
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`antibody. These are called humanization techniques to make
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`it less likely that the antibody would produce an immune --
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`adverse immune response, and screening techniques, the
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`ability for an antibody -- or a person of skill in the art to
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`figure out that an antibody was, in fact, an antagonist.
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`THE COURT REPORTER: You are going to have to slow
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`down.
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`Case 1:18-cv-12029-ADB Document 464 Filed 09/02/22 Page 11 of 96
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`MR. FREDERICKSON: I'm sorry. I tend to talk fast.
`I will slow down.
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`MR. RAICH: And Lilly cited a slew of prior art on
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`that second component of its obviousness case that there was
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`this prior art that persons of skill in the art would
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`understand that those techniques were routine, conventional,
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`well known, and predictable to people of skill in the art.
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`And from those two factual premises, Lilly asked the patent
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`office to reach a conclusion that the claimed antibodies,
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`which were humanized anti-CGRP antagonist antibodies were
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`obvious.
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`Now, to do that, Lilly needed to convince the
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`patent office of a couple of things. The first was that
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`there would have been a motivation in the art to combine the
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`well known class of the nonhuman antibodies with these
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`screening and humanization techniques.
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`The second was that there would have been a
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`reasonable expectation of success. That is, a person of
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`skill in the art would have saw that -- those two distinct
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`pieces of prior art and thought, "I can make this work. I
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`can take these nonhuman antibodies, I can apply these
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`screening humanization techniques, and I can get to the
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`claimed antibody."
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`And to do that, Lilly created these -- started with
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`these five factual propositions on slide number 4. These are
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`Case 1:18-cv-12029-ADB Document 464 Filed 09/02/22 Page 12 of 96
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`the same facts that we've identified in our judicial estoppel
`motion as being what we're asking the Court to estop Lilly
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`from doing in this proceeding.
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`The first is that the class of anti-CGRP
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`antagonists was well known in the art, that statement is a
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`direct quote from Lilly's petition. That's the opening
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`paper. You filed an IPR proceeding to get the proceedings
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`kicked off, and it's a direct quote and a direct finding from
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`the patent office itself.
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`Number two is the methods for making these
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`anti-CGRP antagonist antibodies. Lilly argued and convinced
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`the patent office that they were routine and conventional to
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`a person of skill in the art. And why that's important,
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`Your Honor, is because, as you allowed to in your opening
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`remarks, there's already a huge record in this case.
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`And why we think this motion ought to be addressed
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`first and why it's important to the case is it helps the
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`Court for its purposes and for the jury's purposes to clear
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`some of the low hanging fruit and some of the brush. This is
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`a very technical case and the level of skill in the art is
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`very high. These are Ph.D. scientists with years and years
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`and years of experience in the field. And so to put
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`ourselves and the jury in the mindset of what that person of
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`skill in the art knew, what better evidence than the
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`arguments that Lilly advanced to the patent office and the
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`Case 1:18-cv-12029-ADB Document 464 Filed 09/02/22 Page 13 of 96
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`patent office accepted?
`The same with facts number 3 and 4, we've put those
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`into the bucket regarding the humanization techniques. That
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`is, the process from taking a nonhuman antibody and making it
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`more human-like -- that's basically what humanization
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`means -- was something that people and scientists in this
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`field did regularly and routinely using well established
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`techniques, and they were able to do it in a way that
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`maintained the properties of the antibodies, the antagonist
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`properties of the antibodies. That's fact number 4.
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`And then the final fact which I think bears very
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`heavily on the enablement motion in particular is the
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`screening component of generating and finding an antagonist
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`antibody. What Lilly argued to the patent office was that
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`these screening techniques were again very convenient, very
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`conventional, and very routine to persons of ordinary skill
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`in the art.
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`It was from those five factual predicates that it
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`was known that the antibodies existed, were easy to use, that
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`it was conventional to humanize them and conventional to
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`screen them, that the patent office adopted Lilly's arguments
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`and validated the challenged claims in six of Teva's patents.
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`I won't go through all of the quotes on slide 5. We put them
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`in our briefing.
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`But the bottom line is we started this case with
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`Case 1:18-cv-12029-ADB Document 464 Filed 09/02/22 Page 14 of 96
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`nine patents asserted on behalf of Teva, we're down to three,
`and the reason for that is that Lilly was able to validate
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`the challenged claims in the composition and matter patents
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`through the IPR proceedings.
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`While that was all going on, this case was stayed,
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`again at Lilly's request. We put up slide 6, a timeline
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`slide, just to reorient ourselves to the four-year history of
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`the case. It was filed about this time in 2018. Shortly
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`thereafter, Lilly filed the petitions, particularly the
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`composition and method -- the method of treatment patent and
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`IPRs and sought a stay.
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`And in seeking a stay, one of the arguments Lilly
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`advanced was that even if some of these challenge -- some of
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`the claims that it was challenging survived, the Court would
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`have the benefit of the board's reasoning and factual
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`findings for purposes of streamlining this case.
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`And so here we are four years later, and after a
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`17-month stay, the record and the IPRs will -- I suffice to
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`say larger than the thousand pages Your Honor alluded to, and
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`the patent office issued detailed findings about what was the
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`state of the prior art as of 2005. And that's a critical
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`issue that Your Honor's going to need to grapple with in
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`resolving the 112-related issues and the jury's going to need
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`to grapple with. Slide 7 illustrated why there's so much
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`overlap.
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`Case 1:18-cv-12029-ADB Document 464 Filed 09/02/22 Page 15 of 96
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`I put up the factors that finders of fact when
`Courts consider -- when considering obviousness, enablement,
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`and written description challenges to patents. The
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`obviousness inquiry is reasonably straightforward. You start
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`at the date of the patent or maybe the day before the patent
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`was filed, and it asks the Court to assess, "Well, what would
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`a person of ordinary skill in the art have known about the
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`state of the antibody engineering and CGRP as of this 2005
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`date? And from that date would that person have concluded
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`that the invention that Teva claimed, these anti-CGRP
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`antagonistic antibodies, were they obvious?"
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`And so it looks to the level of skill in the art,
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`the scope and content of the prior art, and the differences
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`between what's in the patents and what was known in the prior
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`art. Fast forward to today, and what Lilly is arguing is
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`something different but related insofar as it also depends on
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`what a person of ordinary skill would have known about the
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`state of the antibody engineering by the 2005 priority date.
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`Again, I put the facts up for enablement and
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`written description, that the factors -- the factually
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`intensive factors that the Court considers, and most, at
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`least half of the enablement factors start at, "Well, who is
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`this person of skill in the art and what did this person know
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`about CGRP, about CGRP antibodies, and about the techniques
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`for making and using them?"
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`Case 1:18-cv-12029-ADB Document 464 Filed 09/02/22 Page 16 of 96
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`Well, we know a lot of that already based on the
`records from the IPRs. And that's the record that Teva hopes
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`that the Court embraces in some respect and allows us to get
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`the benefit on that so we don't have to litigate and
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`relitigate these exact issues over and over again in
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`different contexts under different legal proceedings and
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`certainly put Teva in a position where it's arguing -- it has
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`to reestablish facts that Lilly established in front of the
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`jury in the IPR proceedings.
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`And so we get to today's case and Lilly's
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`incentives have changed. Now, the issue isn't so much what
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`did a person of ordinary skill in the art know and what was
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`obvious to that person, but did Teva do a good enough job in
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`its patent application to describe its invention and method
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`of treatment to enable others to make and use the invention?
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`Those inquiries depend on, as I just alluded to,
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`what the state of the art was. And so what Lilly does in
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`this case is, despite its argument to the patent office that
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`this class of nonhuman antibodies were very well known, Lilly
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`submitted testimony, or at least proffered testimony from
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`experts, trying to disparage the state of the prior art,
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`saying there was a minimal level of knowledge in the prior
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`art.
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`Now, we're not trying to stop Lilly from advancing
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`all of the arguments that are in its lengthy expert reports,
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`Case 1:18-cv-12029-ADB Document 464 Filed 09/02/22 Page 17 of 96
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`but at least with respect to the state of the prior art
`regarding anti-CGRP antagonist antibodies, it shouldn't be
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`able to contradict its prior statements that the patent
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`office accepted that that class was well known.
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`The same thing for some of the processes at place.
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`The processes for making these antibodies and for humanizing
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`these antibodies and for screening these antibodies, those
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`were routine, according to Lilly, at the time of 2005. And
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`if they were routine and conventional, and predictable for
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`purposes of arguing that Teva's patents were obvious, then
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`they have to be routine, conventional, and predictable for
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`purposes of the enablement and written description inquiry.
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`It's the same person of ordinary skill in the art, it's the
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`same level of skill in the art, it's the same journal
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`articles that are at issue, and so what Lilly has done in
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`this case is taken two different positions on the facts. We
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`can argue about the conclusions to be drawn from that facts,
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`and those are the later motions, but it's taking different
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`positions on the facts. And that's why we think this case is
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`suitable for judicial estoppel.
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`I've put the legal standard on the slides,
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`Your Honor. I'm sure you're familiar with it and we've
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`briefed it. It has two primary components that the positions
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`be directly inconsistent and that the person has succeeded in
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`dissuading the prior adjudicator to accept its prior portion.
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`Case 1:18-cv-12029-ADB Document 464 Filed 09/02/22 Page 18 of 96
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`18
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`Lilly's principal argument is that the legal
`context between what was going on in the IPR proceedings is
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`different from the legal context here. And that's frankly,
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`Your Honor, from Teva's perspective, the exact problem. We
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`agree that the legal context is different, and so the
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`conclusions that people can draw from facts based on
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`enablement or written description, those can differ.
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`But the facts themselves shouldn't change, and
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`that's exactly what Lilly is trying to do here. We've put up
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`on the screen a quote from page 12 of Lilly's opposition
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`where it argues that "This Court has illustrated there's no
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`inconsistency with common facts leading to different
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`findings." We agree with that statement. We just don't
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`think it fairly reflects what's going on in this proceeding.
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`And so what Teva tried to do is identify very
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`specific and dare I say restrained specific factual matters
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`that the Court could determine based on the IPR record have
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`been established for purposes of this case to allow the
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`parties to go ahead and litigate all the other facts that
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`still remain in dispute from the -- as you can see in the
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`summary judgment papers.
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`And the question will ultimately be for the Court
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`and for the jury, "Has Lilly determined and proven by clear
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`and convincing evidence that the method of using a humanized
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`version, which is a well known and conventional technique to
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`Case 1:18-cv-12029-ADB Document 464 Filed 09/02/22 Page 19 of 96
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`19
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`antiviral engineers of a well known class of molecules, has
`that been adequately described and enabled to accept this
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`patent specification in view of the level of skill in the
`
`art?"
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`I've put, again, the standard for enablement and
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`written description on the screen just to really reemphasize
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`that they do depend pretty significantly on the state of the
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`prior art and the level of skill of the prior art. And maybe
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`this addresses your -- the question that you started off with
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`the best because I do think the enablement inquiry may be the
`
`most important part of the judicial estoppel component
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`because what enablement does is it creates a spectrum of
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`experimentation.
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`And the Court says, "Based on the spectrum." On
`
`one hand, there is undue experimentation, and that's invalid
`
`and not enabled. On the other hand of the spectrum is
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`routine experimentation. That is experimentation that
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`persons of skill in the art would normally do in their field
`
`of endeavor. It could be time-consuming. You have may have
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`to iterate through it and do some repetition. But if a
`
`person of ordinary skill in the art thinks it's routine, then
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`it's enabled.
`
`And so we have two sides of a spectrum that the
`
`Court ultimately will need to evaluate, very fact-intensive
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`inquiries -- and I'll talk about those next time I stand
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`Case 1:18-cv-12029-ADB Document 464 Filed 09/02/22 Page 20 of 96
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`20
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`up -- about where on the spectrum the level of
`experimentation required to practice Teva's patents stands.
`
`And what Lilly did was when it said that
`
`humanization was routine, when it said that screening
`
`techniques were routine, it put that level of experimentation
`
`on my left, but on the side of routine experimentation that a
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`patent specification does not need to describe with the same
`
`level of detail because a person of ordinary skill in the art
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`would know how to do it.
`
`And we make that point again through -- on slide 13
`
`here, which again is attempting to illustrate the issues with
`
`what Lilly's trying to do. This is their reply statement,
`
`56.1 reply statement, on page 12 where they're trying to get
`
`to the point that Your Honor asked, that just because
`
`something was routine and conventional does not mean it was
`
`predictable, not costly, and not labor-intensive.
`
`But that's the problem because they're going to
`
`want to argue to the jury to take the technique for
`
`humanization, for example. It does take some time to
`
`humanize an antibody and it is expensive, and they want to
`
`argue to the jury that because it takes time and because it's
`
`expensive, it's undue experimentation.
`
`Where at the same time in front of the patent
`
`office, they convinced the patent office that that exact same
`
`technique, which took time and required experimentation, was
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`Case 1:18-cv-12029-ADB Document 464 Filed 09/02/22 Page 21 of 96
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`21
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`routine and conventional. And it's telling because, in their
`local Rule 56.1 statement -- I didn't highlight it, but at
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`the second-to-bottom line, there's a citation to the
`
`Tomlinson declaration.
`
`Dr. Tomlinson was one of Teva's experts in the IPR.
`
`And this question about whether and to what extent
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`humanization was routine or not routine was actually
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`litigated in front of the IPR, and Teva did submit a
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`declaration explaining that humanization generally required
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`four to six months of work and a total cost of a half a
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`million dollars. The purpose for that was because the patent
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`office would need to decide, "Well, would a person of
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`ordinary skill in the art be motivated to humanize these
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`anti-CGRP antagonist antibodies?"
`
`THE COURT REPORTER: Slow down. Slow down.
`
`MR. FREDERICKSON: I'm sorry.
`
`MR. RAICH: And there was competing evidence on
`
`both sides. Lilly taking the position that it was routine,
`
`Teva taking the position that it did involve some expense and
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`did take some time, and Lilly prevailed.
`
`And so having litigated that issue fully in front
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`of the patent office and having the patent office issued its
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`ruling against Teva and for Lilly, Teva's position is simply
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`that the parties ought to operate within the constraints of
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`that factual record.
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`Case 1:18-cv-12029-ADB Document 464 Filed 09/02/22 Page 22 of 96
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`22
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`There's some suggestion -- and I'll skip ahead to
`slide 15. There's some suggestion that the words "routine,"
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`"conventional," and "well known" have special meanings when
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`you're talking obvious case law versus 112 case law, and
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`that's just not the case, Your Honor. What Lilly, again, was
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`trying to do was trying to give the patent office confidence
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`that these techniques would be table staged for a person of
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`ordinary skill in the art; that they would be able to
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`accomplish them easily; they would come top of the mind to be
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`able to humanize and screen; and they'd be able to do it
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`without encountering any major problems.
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`And so Lilly chose these words deliberately because
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`when something is routine and conventional, it's just a
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`regular course of performing. It's habitual, mechanical. It
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`doesn't have any special challenges associated with it that
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`would dissuade a person of ordinary skill in the art from
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`undertaking those activities.
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`And just being mindful of the time, Your Honor,
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`I'll answer any questions, but that's really the gist of the
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`argument is that Lilly went ahead and created this robust
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`factual record that a person of skill in the art, this very
`
`qualified and very educated and very experienced person,
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`would know how to do these techniques because he or she would
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`have done them routinely and conventionally.
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`And now they've created a record, at least as a
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`Case 1:18-cv-12029-ADB Document 464 Filed 09/02/22 Page 23 of 96
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`23
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`starting point, and they're trying to create a record that
`these techniques were actually time-consuming, difficult,
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`unpredictable, and that just seems completely inconsistent
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`with the record that they established in the patent office.
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`I'm happy to answer any questions.
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`THE COURT: Got it.
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`MR. RAICH: Thank you, Your Honor. Bill Raich from
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`Finnegan for Eli Lilly, and we also have demonstratives.
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`(Pause.)
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`MR. RAICH: Your Honor, respectfully, Teva's motion
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`on judicial estoppel should be denied. It's procedurally
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`improper and it's legally and factually flawed. If I could
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`have slide 2. So as Mr. Frederickson indicated, the IPRs
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`involved different legal framework. And what Teva is seeking
`
`to do wrongly is take arguments and findings made under the
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`legal framework of obviousness and apply them to different
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`statutory bases of written description and enablement.
`
`The Supreme Court has made clear that in the
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`context of judicial estoppel, legal context really, really
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`matters. And where there may appear at first blush to be
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`inconsistency, when you look at the facts, there is no
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`inconsistency, and especially that's the case here. And I'll
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`get into that in just a minute.
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`Second of all, the IPRs involve different patents.
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`Teva cites no case, not a single case, where judicial
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`Case 1:18-cv-12029-ADB Document 464 Filed 09/02/22 Page 24 of 96
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