`Case: 1:16-cv-00651 Document #: 135 Filed: 08/07/18 Page 1 of 90 PageID #:5037
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`1
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`IN THE UNITED STATES DISTRICT COURT
`NORTHERN DISTRICT OF ILLINOIS
`EASTERN DIVISION
`
`Docket Nos. 16 C 651
` 17 C 7903
`
`Chicago, Illinois
`July 16, 2018
`10:17 a.m.
`
`)))))))))
`
`HOSPIRA, INC.,
`
`Plaintiff,
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`vs.
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`FRESENIUS KABI USA, LLC,
`
`Defendant.
`
`VOLUME 1A
`TRANSCRIPT OF PROCEEDINGS - Bench Trial
`BEFORE THE HONORABLE REBECCA R. PALLMEYER
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`APPEARANCES:
`
`For the Plaintiff:
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`For the Defendant:
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`Also Present:
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`JENNER & BLOCK LLP
`BY: MR. BRADFORD P. LYERLA
`MR. YUSUF ESAT
`MR. AARON A. BARLOW
`MR. REN-HOW H. HARN
`MS. SARA T. HORTON
`353 North Clark Street
`Chicago, Illinois 60654
`
`SCHIFF HARDIN LLP
`BY: MR. IMRON T. ALY
`MR. JOEL M. WALLACE
`MS. TARA L. KURTIS
`MR. KEVIN M. NELSON
`233 South Wacker Drive, Suite 6600
`Chicago, Illinois 60606
`
`SCHIFF HARDIN LLP
`BY: MR. AHMED M.T. RIAZ
`666 Fifth Avenue, 17th Floor
`New York, New York 10103
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`Mr. Michael P. Bauer, Hospira
`Mr. Ryan Daniel, Fresenius Kabi
`Mr. Ali Ahmed, Fresenius Kabi
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`Case: 1:16-cv-00651 Document #: 135 Filed: 08/07/18 Page 2 of 90 PageID #:5038
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`2
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`Court Reporter:
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`FRANCES WARD, CSR, RPR, RMR, FCRR
`Official Court Reporter
`219 S. Dearborn Street, Suite 2144D
`Chicago, Illinois 60604
`(312) 435-5561
`frances_ward@ilnd.uscourts.gov
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`Case: 1:16-cv-00651 Document #: 135 Filed: 08/07/18 Page 3 of 90 PageID #:5039
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`3
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`THE CLERK: 16 C 651, Hospira versus Fresenius Kabi
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`USA; and 17 C 7903, Hospira versus Fresenius Kabi USA, for
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`bench trial.
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`MS. HORTON: Good morning, your Honor.
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`Sara Horton for plaintiff.
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`THE COURT: Good morning.
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`MR. ALY: Good morning.
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`Imron Aly for Fresenius Kabi.
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`THE COURT: Good morning.
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`Okay. I think we are ready to go.
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`Do you want to make some very brief, like
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`five-minute, opening statements? Then we can start hearing
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`evidence.
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`MR. ALY: Your Honor, I have about a 20-minute
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`opening statement, if that will be all right.
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`THE COURT: I can live with 20 minutes.
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`MR. ALY: All right. And there is one issue to
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`raise before that, because it's a witness timing issue.
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`That is, we had a subpoena to one of the inventors
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`Hospira controlled, Dr. Robert Cedergren. And we are told he
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`is not here today. Hospira told us yesterday that he
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`wouldn't be here today.
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`It may work out. The odds are it will work out,
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`because of the timing and the shortened day today, but it's
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`not something I would have gambled with, with a federal
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`Case: 1:16-cv-00651 Document #: 135 Filed: 08/07/18 Page 4 of 90 PageID #:5040
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`subpoena out there. So we wanted to raise it, because we
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`don't want to be in a situation of having to call a witness
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`and not having him here.
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`THE COURT: What's the explanation for the witness
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`not complying with the subpoena, just out of curiosity?
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`MR. LYERLA: Your Honor, this is my fault, and I
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`will take the blame.
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`We have had conversations back and forth about
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`these subpoenas. We have subpoenaed two of their witnesses.
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`They have told us one of people we have subpoenaed on their
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`side is not going to be available at all this week, somebody
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`who is still employed by them.
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`Now, as to Dr. Cedergren, he does not work for
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`Hospira. He hasn't worked for Hospital in ten years. We are
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`trying to accommodate a nonparty witness.
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`So we originally had scheduled him, I believe, for
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`Wednesday, because we thought we would call him in our case.
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`They told us that they wanted to call him in their case.
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`We said, can you guarantee Monday, that you will
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`call him on Monday? And we could not get confirmation that
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`they would call him on Monday.
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`So I just looked at the witnesses and looked at
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`what was going to happen today, looked at the fact that we
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`are starting a little bit later. We are ending a little bit
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`early today. And it became obvious to me that he wasn't
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`Aly - opening statement
`Case: 1:16-cv-00651 Document #: 135 Filed: 08/07/18 Page 5 of 90 PageID #:5041
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`5
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`going to make the stand today, So I told him to come
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`tomorrow. And I promised Mr. Imron he would be available
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`first thing tomorrow. And I don't know why that should be a
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`problem. And I predict it won't be a problem.
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`THE COURT: I am sure it's not.
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`Let's move on.
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`MR. ALY: Your Honor, may it please the Court?
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`THE COURT: Sure.
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`MR. ALY: We will introduce our client
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`representatives as well.
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`Mr. Ali Ahmed and Mr. Ryan Daniels are from
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`Fresenius Kabi, in court today.
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`THE COURT: Good morning.
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`OPENING STATEMENT ON BEHALF OF THE DEFENDANT
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`MR. ALY: Your Honor, we have all heard the saying,
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`don't reinvent the wheel. That's what this case is about.
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`Here you will see on Slide 2 -- and I have got
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`copies, if you would like me to hand them up, but I am just
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`going to go through them for now -- that Hospira will show
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`you a bottle, and that's what this case is about.
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`It's not about the drug. That's old. It's not
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`about the formula the drug comes in. That's old.
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`The claims here are about a glass vial that's
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`sealed, that contains dexmedetomidine and salt water. The
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`name of that drug is Precedex.
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`Aly - opening statement
`Case: 1:16-cv-00651 Document #: 135 Filed: 08/07/18 Page 6 of 90 PageID #:5042
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`6
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`There is a plethora of prior art that had done the
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`same thing.
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`There is a 20-microgram-per-milliliter
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`concentration version of this drug in an ampoule. That's
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`what we are looking at, is a picture of an ampoule.
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`THE COURT: Right.
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`MR. ALY: And that was in 1988, 30 years ago.
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`There was a veterinary product with 500 micrograms
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`per milliliter, and that was done around 2000.
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`In 1999, there was a 100 microgram per milliliter,
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`Precedex, with the instruction saying, "diluted to 4
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`micrograms per milliliter."
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`Now, this drug is an anesthetic. It is used in
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`surgery. It had been used that same way for 30 years.
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`So the big invention in this case is, what kind of
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`a container would I use, when the prior art had used a sealed
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`glass container to host dexmedetomidine, dexmed, in water?
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`The answer is, it turns out to be exactly the same
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`thing that had already been done for 30 years; that is, they
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`put Precedex in a container with nothing but salt water, in a
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`sealed Type 1 glass with a rubber stopper.
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`THE COURT: And these other packages I am looking
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`at also contain the diluted version.
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`MR. ALY: So the first and the second one were the
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`diluted version.
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`Aly - opening statement
`Case: 1:16-cv-00651 Document #: 135 Filed: 08/07/18 Page 7 of 90 PageID #:5043
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`The third one needed to be diluted. And that's
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`what the transition was in this case.
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`THE COURT: I see.
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`MR. ALY: I am going to focus now on that third
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`one. It's called Precedex concentrate. That's the one that
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`was available since 1999. Hospira sold it. Hospira had the
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`monopoly on that, because it had patent rights to it.
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`That one was the one that had 2 milliliters of
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`drug, and the concentration was, as you will hear throughout
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`the case, 100 micrograms per milliliter.
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`It came -- that prior art from 1999 came in
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`2 milliliter glass vials, and the label had it approved also
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`for glass ampoules.
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`The opportunity, and therefore what Hospira was
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`sitting there choosing to do, was to say, rather than having
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`somebody else have to dilute it, why don't we do the dilution
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`for them? Because in the Precedex concentrate, because it's
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`concentrated, somebody would have to dilute it.
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`How would they dilute it? In a hospital, they
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`would add more salt water. Remember the concentrate already
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`had the drug in salt water, called saline. Now, at the
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`hospital, they were going to add more salt water.
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`That's the invention that's defined here. The
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`closest prior art we will hear a lot about is Precedex versus
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`the Precedex premix, the concentrate versus the premix.
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`Aly - opening statement
`Case: 1:16-cv-00651 Document #: 135 Filed: 08/07/18 Page 8 of 90 PageID #:5044
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`8
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`No surprise that the invention has a sealed glass
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`container. It's just diluted for it already. And the
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`difference is that there is a seal on the finished product
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`rather than a seal on the concentrated.
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`Why did this happen? How did this happen?
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`There are already patents on dexmedetomidine, and
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`this is the patent that Farmos filed, because Farmos invented
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`dexmedetomidine and the containers to put it in. They had a
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`patent on the drug itself and what to do with it in 1988.
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`That patent Hospira had rights to and enjoyed the benefits of
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`on the market.
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`2013 is when that patent was expiring, and Hospira
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`was coming to see that their rights were going to come to an
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`end on their one and only branded product at the time.
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`So they did something that some people do in the
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`industry; and that is, wait to see when a patent expires and
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`try to get another patent on something else to protect and
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`extend the brand, get another patent, a second or third
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`generation, to try to keep that monopoly going on such a
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`product that was profitable for them. And that is called
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`lifecycle management.
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`That's a common strategy that's done, taking
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`something and prepackaging it. We don't have to just talk
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`about the argument. Hospira's internal documents explain --
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`this is from 2006 -- that the goal that they had was to
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`Aly - opening statement
`Case: 1:16-cv-00651 Document #: 135 Filed: 08/07/18 Page 9 of 90 PageID #:5045
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`protect the market from generic competition when the patent
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`expires. And they knew that that was coming up in 2013.
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`But they also knew in 2006 that what containers to
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`use was going to be an issue if they went down the road of
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`trying plastic. Now, there are reasons people would want to
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`try plastic. It doesn't break, and maybe it's flexible. You
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`can hang it easier than a glass premix.
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`The challenge is, dexmedetomidine and plastic don't
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`go together. They are like oil and water. And that's what
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`the expert testimony will show and the evidence will show.
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`And Hospira knew that in 2006. They internally
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`published reports saying, plastic is going to be a problem;
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`but compared to glass, no major issues. That's what they
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`knew. That's what they had tested. That's what they
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`expected, even before setting down a path of doing the
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`formulation work.
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`Nonetheless, and, in fact, at the time when they
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`were looking for patents, I should point out, in 2006, the
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`patents they wanted to get were on what plastic, because that
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`would be something interesting, if they could have done that,
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`something to talk about.
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`All they wanted was either a plastic bag or maybe a
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`new terminal sterilization technique that would help, because
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`that might change something about how the drug had been used.
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`In this case that doesn't change. It's still
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`Aly - opening statement
`10
`Case: 1:16-cv-00651 Document #: 135 Filed: 08/07/18 Page 10 of 90 PageID #:5046
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`glass. It's still Type 1 glass. It's still a sealed rubber
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`stopper that's coated, and still using the same terminal
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`sterilization, which is heating it, that they had always
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`done.
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`Claims, nonetheless, come out with a ready-to-use
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`claim with a glass container. Now, how did that happen? How
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`did the patent office say, if I'm looking at this Precedex
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`concentrate -- which they did -- did this happen?
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`Well, the patent office said it was obvious. The
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`claim was obvious. But Hospira responded by saying, here are
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`secondary considerations. In other words, Hospira provides
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`additional evidence to help inform this obviousness analysis.
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`But in this case, your Honor, in this trial, as
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`Hospira confirmed at the pretrial conference, they will be
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`putting on no evidence of secondary considerations at all.
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`We get a chance to look at these patents with a fresh look on
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`that obviousness analysis.
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`We will show references that talk about how
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`ready-to-use was really common sense, common knowledge. But
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`there is a prior art that's better than that, even in this
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`case, and that is, people out in the field were trying to do
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`it themselves and wanted an option for the marketing people
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`to have done it for them.
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`Some of the claims -- there is only two claims
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`asserted, Claim 8 of the '049 and Claim 6 of the '106 patent,
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`Aly - opening statement
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`Case: 1:16-cv-00651 Document #: 135 Filed: 08/07/18 Page 11 of 90 PageID #:5047
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`and they tack on additional numbers, additional properties
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`that go hand in hand with whatever else is claimed.
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`Here is the example from Claim 8 of the
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`'049 patent. That depends on Claim 1. So when we look at
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`Claim 8, it's claiming that 4 micrograms per milliliter. We
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`saw that was already what Precedex concentrate should be
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`diluted to, and they tack on here that the pH should be about
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`2 to 10.
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`One asks, what did they do to get that pH? The
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`answer is, nothing. They just put the drug in the same salt
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`water it had always been. And we know that because -- it's
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`not that we even have to test it -- the prior art published
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`the information about what the pH was, 4.5 to 7, well within
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`the range that's claimed of 2 to 10.
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`That brings us to the second claim, Claim 6 of the
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`'106 patent. And in that claim they add and tack on this
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`limitation to the combination of the ready-to-use glass
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`container. And this is the limitation I think, your Honor,
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`we are going to be spending most of the case talking about.
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`We called it the 2 percent limitation in-house, and
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`what it shows is that the stability of the product, meaning
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`how much product is there, should not go down more than
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`2 percent, and the time point they picked is five months.
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`It's not related at all to FDA studies. It's not
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`related at all to any regulatory requirement. They just had
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`Aly - opening statement
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`Case: 1:16-cv-00651 Document #: 135 Filed: 08/07/18 Page 12 of 90 PageID #:5048
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`a test. This is what it showed, and that's what they put
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`into the claim.
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`The challenge here for them is going to be, what
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`did they do differently than the prior art to obtain that
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`particular feature?
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`Did they change the formulation? No.
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`Did they change the container? No.
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`So what is it that they did that was different?
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`And the answer is going to be, nothing.
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`That's why we are going to show that this would be
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`an obvious combination, and it's a property that goes with
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`that obvious combination.
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`The two different ways of showing that a property
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`can be obvious in view of an obvious combination. Those are
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`the two we are talking about. One is if it's expected, and
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`the second is inherent. And there will be evidence on both
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`of those.
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`In other words, a person of ordinary skill in the
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`art would have expected this 2 percent property because of
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`its super stability, and it would have been an inherent
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`property, because once the tests show, if you put it in 4
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`micrograms per milliliter, that is going to have the inherent
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`property of 2 percent. And surprisingly, even the other
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`side's experts will say the same thing.
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`Now, there is an issue as far as reasonable
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`Aly - opening statement
`13
`Case: 1:16-cv-00651 Document #: 135 Filed: 08/07/18 Page 13 of 90 PageID #:5049
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`expectation of success. And, your Honor, several slides now
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`are going to focus on one issue, and I will explain where it
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`fits in. It's for an IND. The IND is an Investigational New
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`Drug Application. I will show what that cover page looks
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`like on Slide 20.
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`And what an IND is, is a company that wants to do
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`clinical trials -- this is where they are going to administer
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`a product to humans out in the world -- they have to put an
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`IND together and explain what product they are going to use
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`and how they are going to use it and any animal and human
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`data they already have.
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`And Farmos, the real inventors here, did exactly
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`all of those things in 1989 and submitted to the FDA
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`paperwork, a box full of paperwork, saying, here we have an
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`IND that explains what product we are going to use and what
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`it's going to be used for and what it had already been known
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`to do. That's in 1989.
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`That's where that ampoule comes into play, which
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`was 20 micrograms per milliliter of the ready-to-use, or RTU.
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`Now, an IND -- we have to be up front -- is
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`normally not prior art. Normally it's confidential.
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`Normally it's going to be in the FDA.
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`But here, that's different for two reasons. The
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`IND is prior art, and those are the two issues that are going
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`to be disputed in the case.
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`Aly - opening statement
`14
`Case: 1:16-cv-00651 Document #: 135 Filed: 08/07/18 Page 14 of 90 PageID #:5050
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`And I will go back to that Slide 19 to show one way
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`that it can be prior art is 102(f), which is that the
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`invention was transferred to Hospira, the patentee. The idea
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`being, a company cannot buy an invention from somebody else
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`and then try to get a patent on the same thing. That's the
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`law in 102(f), and that's what happened here.
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`Farmos came up with the invention, put it together,
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`put in an IND. It changed hands over the years, and Hospira
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`ended up obtaining it.
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`And once they have it, whether it's through a gift
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`or a purchase, that's Hospira's, and they can't get a patent
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`on the same combination, a sealed glass container with
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`dexmedetomidine.
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`A second way that an IND can be prior art is by
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`prior sales, where there are commercial transactions. One
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`cannot commercially benefit from a patent and then -- from an
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`invention and then try to patent it later and get an
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`extension on their benefit over time. There are two of
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`those, 1994 and 2004.
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`What we will see with this IND timeline on Slide 21
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`is that Farmos comes up with the IND, submits it in 1989.
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`And they already had a patent, '214 patent.
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`Then Orion acquires the company in 1990. Now
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`Abbott gets involved in 1994 and buys the IND from Orion.
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`Hospira buys the same IND from Abbott ten years later, and
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`Aly - opening statement
`15
`Case: 1:16-cv-00651 Document #: 135 Filed: 08/07/18 Page 15 of 90 PageID #:5051
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`then Hospira files patents on it eight years after that,
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`which go back to day one and back to the sealed glass
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`container with dexmedetomidine in salt water.
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`The IND sale is something that's disputed. Like
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`many issues, Hospira disputes them, and the dispute here
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`is -- I am not sure I understand the dispute, because they
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`say the "License and Supply Agreement" is the title of the
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`document.
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`Of course, you don't judge what's transferred by a
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`title of the document. We judge it by what the terms of the
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`agreement are.
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`And when we look to what Orion and Abbott said
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`contemporaneously, not during litigation, they told the
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`FDA -- here I am showing on Slide 22. The evidence will show
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`that Orion told Abbott that there was a transfer of the IND,
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`that they were transferring all rights, and that it was going
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`to be ownership that was going to be conveyed, because Abbott
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`agreed to accept ownership. All of that was represented to
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`the FDA.
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`Then, in 2004, when it was Abbott's sale to
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`Hospira, they did the same thing. They told the FDA, here is
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`a transfer of ownership, and it's going to be transferring
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`all rights, and that's where they are giving them all over to
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`Hospira for that IND.
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`Now, the IND is important for several reasons. I
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`Aly - opening statement
`16
`Case: 1:16-cv-00651 Document #: 135 Filed: 08/07/18 Page 16 of 90 PageID #:5052
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`am going to highlight two of them and not go into all of the
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`detail that the evidence will show.
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`But one I want to talk about is how advanced it
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`was, on Slide 25.
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`We have an expert, a medical doctor, Dr. Maile,
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`will explain just how far advanced the IND was, what kind of
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`data it included, and the fact that the product was already
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`established.
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`As far as the IND documentation and that box of
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`materials, Mr. Lankau will be our first witness, and he will
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`explain that the IND was actually sold those two times from
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`Farmos all the way to Hospira in 2004.
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`The second reason that the IND will be important is
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`because it has stability data within it that, if it's prior
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`art, counts as a publication. Then the stability data that's
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`included in there will be something of the discussion today.
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`The key is assay percentage. We are taking
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`measurements on the drug and saying, how does it work over
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`time? And as shown here, the number goes up and down, but it
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`stays right around where it started.
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`And here is where they have -- Hospira has -- and
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`it's in dispute, again -- saying that no one could reach a
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`conclusion because a biostatistician would need to look at
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`this data and tell us, through a statistical point of view,
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`not a COSA, but a statistician's point of view, what can be
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`Aly - opening statement
`17
`Case: 1:16-cv-00651 Document #: 135 Filed: 08/07/18 Page 17 of 90 PageID #:5053
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`done from this?
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`A person of ordinary skill in the art would look at
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`the data and conclude that it's really unchanged over time.
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`It's part of the measurement.
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`A common sense analogy would be taking measurements
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`of a 10-pound weight. If you take a measurement of the same
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`exact weight three days in a row -- in this case, we know it
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`doesn't change -- you are going to get multiple measurements,
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`because nothing is going to be exactly precise all of the
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`time.
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`But what does a person of ordinary skill in the art
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`do? It's what everybody else would do: Take an average.
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`And the average, we are going to learn, in the science world
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`is a regression analysis, and that's what everybody did in
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`the case. And when they did to all the samples, the
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`regression showed no loss of more than 2 percent at the
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`five-month mark in any formulation.
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`This is an example of what we are going to see, but
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`for now I am going to go to Slide 30, just to conclude on
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`obviousness, to say that everyone had already used Type 1
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`glass. Everyone had already used the sealed container,
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`either an ampoule or a coated stopper, and everyone had
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`already used dexmed in saline.
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`So when we conclude and say, what happened here?
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`The answer is that we have got a situation of obviousness,
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`Lyerla - opening statement
`18
`Case: 1:16-cv-00651 Document #: 135 Filed: 08/07/18 Page 18 of 90 PageID #:5054
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`and a person of ordinary skill in the art would already know
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`to combine the prior art to obtain the four micrograms per
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`milliliter, already diluted. The container they would put it
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`in would be a sealed Type 1 glass container with a coated
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`rubber stopper, which is exactly what had always been done.
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`Hospira did nothing more than reinvent the wheel.
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`So at the close of the case, we will ask your Honor
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`to find the claims that are asserted invalid.
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`Thank you.
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`THE COURT: Thank you.
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`Response?
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`MR. LYERLA: Yes, your Honor. Can I have a minute
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`to get a few things?
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`THE COURT: Sure.
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`(Brief pause.)
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`OPENING STATEMENT ON BEHALF OF THE PLAINTIFF
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`MR. LYERLA: Good morning, your Honor.
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`May it please the Court? Brad Lyerla on behalf of
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`Hospira.
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`I would like to introduce our client
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`representative, Mr. Michael Bauer, who's seated with us this
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`morning.
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`I also should introduce Mr. Peter Phaneuf. He is
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`our hot-seat fellow who will change the images for us and so
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`forth.
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`Lyerla - opening statement
`19
`Case: 1:16-cv-00651 Document #: 135 Filed: 08/07/18 Page 19 of 90 PageID #:5055
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`As you have heard, Hospira asserts two patent
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`claims in this trial -- the '106, Claim 6; the '049, Claim 8.
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`FK stipulates that it infringes each of these
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`claims. However, in the final pretrial order, it alleges
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`that the claims are invalid, and it offers five arguments.
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`I'm not sure if those five arguments are still the
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`arguments that Mr. Aly plans to make, based on his opening
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`statement, but I am going to respond to those five arguments,
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`because those are the ones identified in the final pretrial
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`order.
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`Now, three of these arguments may not receive much
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`attention during the trial. We will see about that. They
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`are indefiniteness, enablement, and inventorship.
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`They may be afterthought-type arguments. I can't
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`really tell, but I will address those at the end, if I have
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`time.
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`Most of the evidence during the trial I expect will
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`have to do with FK's two main arguments, the on-sale bar and
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`inherency.
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`Now, for context, the Amneal trial in Delaware last
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`year was largely about inherency. That's the case we tried
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`before Judge Andrews. And that was about inherency.
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`Amneal lost on inherency.
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`FK 's on-sale bar is a new argument that they came
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`up with earlier this year, after they learned that Amneal had
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`Lyerla - opening statement
`20
`Case: 1:16-cv-00651 Document #: 135 Filed: 08/07/18 Page 20 of 90 PageID #:5056
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`lost on inherency.
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`Before I go to on-sale and inherency, I would like
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`to say a few words about the inventors and the invention.
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`Neither of the inventors works for Hospira any
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`longer. Both left almost a decade ago, well before the
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`patents were filed for. But both will testify.
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`The first named inventor Dr. Priyanka Roychowdhury,
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`now works for Amgen, where she is a drug formulator.
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`Dr. Rob Cedergren, the other named inventor, now
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`works for Zoetis, an animal healthcare pharmaceutical
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`company. And he is appearing here under subpoena from FK.
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`And as we discussed a little earlier, he will be here
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`tomorrow morning.
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`Dr. Cedergren was the leader of the project to
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`create a premix Precedex. And to be candid, he doesn't
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`remember a lot from that. He will testify that the best
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`evidence of how the invention was developed can be found in
`
`the lab notebooks and the inventor reports.
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`Dr. Roychowdhury, in contrast, has a good memory of
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`the premix project. She was the principal drug formulator
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`and took over as lead after Dr. Cedergren left Hospira in
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`2008.
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`Now, the inventors will both tell you that their
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`biggest challenge was the very low concentration of dex. It
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`wasn't simply a matter of diluting the Precedex concentrate
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`Lyerla - opening statement
`21
`Case: 1:16-cv-00651 Document #: 135 Filed: 08/07/18 Page 21 of 90 PageID #:5057
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`from 100 mics to 4 mics per milliliter to be ready to use.
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`It had to be formulated initially at 4 mics and it had to be
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`stable for the shelf life. No one had attempted that before.
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`So what is the problem with low concentration?
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`Well, let's consider the known risks of loss of
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`potency.
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`Can we see the slide, please.
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`All right. This slide identifies the ways that a
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`drug can lose potency. And when Dr. Roychowdhury testifies,
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`she will use this slide, I believe, and explain it.
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`I will highlight for you and preview for you that
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`there are four ways on this slide that are discussed, that
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`identify and describe ways in which a drug can lose potency.
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`The first is adsorption. If your Honor will look
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`above the beaker labeled "Adsorption," what you see is a
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`molecule of dexmedetomidine, and it is adhering to the inside
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`of the container. So when a molecule adheres to the inside
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`of the container, the drug can lose potency, and that's
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`called adsorption.
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`The second beaker is labeled "Absorption." You can
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`see a little picture above that beaker. And it shows a
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`molecule of, let's imagine, dexmedetomidine, and it is
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`partially absorbed into the inside of the container. And
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`that is another way in which a drug can lose potency.
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`The third beaker depicts degradation. And here we
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`Lyerla - opening statement
`22
`Case: 1:16-cv-00651 Document #: 135 Filed: 08/07/18 Page 22 of 90 PageID #:5058
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`show a molecule of dexmedetomidine, if we can imagine, and it
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`is being degraded by -- here we show sunlight as an example.
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`And finally, the last beaker is labeled
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`"Contamination." And contamination can result from ordinary
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`process impurities. Something gets inside the container,
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`inside the seal, gets into the drug formulation, interacts
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`with the dexmedetomidine and cause the dexmedetomidine to
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`degrade in such a way that potency is lost.
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`So these were the concerns that were on the
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`inventors' minds as they began to tackle the problem of
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`creating a premix Precedex that would be shelf-life stable
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`over a suitable period of time.
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`Can I see the next slide, please.
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`Now, this slide is -- it's a very simple slide. We
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`simplified it greatly, and I own up to that. But this slide
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`is meant to illustrate why loss of potency is magnified very
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`significantly in low concentration drug formulas.
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`So on the left we see a 4-microgram-per-milliliter
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`depiction, if you will, and there are four little dots there
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`representing dexmedetomidine molecules.
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`And on the right, we have a beaker with 100 dots,
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`and that represents Precedex concentrate, which is
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`100 micrograms per milliliter.
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`So one could easily see that if you lose one dot
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`from the beaker on the left, you have lost 25 percent of your
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`Lyerla - opening statement
`23
`Case: 1:16-cv-00651 Document #: 135 Filed: 08/07/18 Page 23 of 90 PageID #:5059
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`potency.
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`If you lose one dot from the right, you have lost
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`1/100 of your potency. That's just meant to illustrate in a
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`straightforward and, I hope, simple way that the problem of
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`loss of potency in the case of a very low concentration is a
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`much greater problem than in higher concentrations.
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`This is the challenge that the inventors were faced
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`with as they began on the premix project.
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`Now, the solution that they came up with is this
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`(indicating). This is the solution. And the solution is the
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`entirety of this. It's not just the drug formulation inside
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`the container.
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`Judge Andrews, in the prior trial, didn't figure
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`that out until about the third day of the trial. So I am
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`telling you right at the beginning of this trial, it's not
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`just that. It's the formulation inside the container, but
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`it's the container itself and it's the stopper and it's the
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`sealing system. We came to call this the "container system"
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`in the last trial. That plus the formulation inside the
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`container is the entirety of the invention.
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`The challenges presented by this were not
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`insignificant. You are going to hear, for example, that FK,
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`in its own formulation in creating its own premix product,
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`struggled and had issues. In fact, had issues even when it
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`was copying Hospira's already existing drug product.
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`Lyerla - opening statement
`24
`Case: 1:16-cv-00651 Document #: 135 Filed: 08/07/18 Page 24 of 90 PageID #:5060
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`So it is a very common thing in trials like this
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`for the defendant to disparage the invention and talk about
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`how silly it is and how obvious it is and so forth and so on.
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`But the
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