Case: 1:16-cv-00651 Document #: 81-4 Filed: 01/16/18 Page 1 of 6 PageID #:2477
`Case: 1:16-cv-00651 Document #: 81-4 Filed: 01/16/18 Page 1 of 6 PageID #:2477
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`EXHIBIT 4
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`EXHIBIT 4
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`Case: 1:16-cv-00651 Document #: 81-4 Filed: 01/16/18 Page 2 of 6 PageID #:2478
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` RAO TATA-VENKATA
` IN THE UNITED STATES DISTRICT COURT
` FOR THE NORTHERN DISTRICT OF ILLINOIS
` EASTERN DIVISION
`HOSPIRA, INC., )
` )
` Plaintiff, )C.A. No.
` )1:16-cv-00651
`vs. )
` )
` )
`FRESENIUS KABI USA, LLC., )
` )
` )
` Defendant. )
`____________________________)
` IN THE UNITED STATES DISTRICT COURT
` FOR THE DISTRICT OF DELAWARE
`HOSPIRA, INC., )
` )
` Plaintiff/Counterclaim )C.A. No.
` Defendant. )15-cv-697-RGA
`vs. )
` )
`AMNEAL PHARMACEUTICALS, LLC )
` )
` Defendant/Counterclaim )
` Plaintiff. )
`____________________________)
` VIDEOTAPED DEPOSITION OF RAO TATA-VENKATA
` Wednesday, November 9, 2016
` Chicago, Illinois
`Reported By:
`TRICIA J. FLASKA, CSR, RPR
`JOB NO. 115353
`
`TSG Reporting - Worldwide 877-702-9580
`
`

`

`Case: 1:16-cv-00651 Document #: 81-4 Filed: 01/16/18 Page 3 of 6 PageID #:2479
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`48 hours, correct?
` A Yes.
` Q Okay. So it's not 24 hours?
` A Yes.
` Q Okay. And there's -- and it refers to data
`on file.
` Do you see that?
` A Yes.
` Q And so that's referring to an internal
`Hospira study?
` A Yes.
` Q Okay. And that's a study that would have
`been performed within the R&D group?
` A Yes.
` Q Okay. And so it's actually 48 hours that
`this is available -- that this is stable, correct?
` A That is correct.
` Q Okay. Now, you also said that it would --
`would have been unexpected for a formulation of
`dexmedetomidine to be stable in a glass container at
`a -- what you called a low concentration, correct?
` A Yes.
` Q Okay. Now, the range in the Wu Declaration
`and in the patent we saw was up to 50 micrograms per
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`outcome?
` Q Yeah.
` A That was the purpose of the experiment.
` Q You didn't have an expectation --
` A Yes.
` Q -- ahead of time?
` A Yes.
` Q Okay. But you previously said that you
`would have expected that, for a low concentration
`product in a glass vial, it would not show stability
`because of the low concentration, correct?
` MR. RAY: Objection. Mischaracterizes
`testimony.
`BY MR. WALLACE:
` Q Is that not your testimony?
` A No.
` Q Maybe I got it wrong.
` A No, the 100 microgram per mil is a
`concentration that we -- we had whatever data we had
`as far as stability is concerned.
` Q Okay.
` A When we go to low concentrations, things --
`phenomena can occur at low concentrations that will
`not -- can occur at low concentrations that do not
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`milliliter.
` Do you remember that?
` A Yes. Yes.
` Q Okay. So would you consider anything less
`than 50 micrograms per milliliter a low
`concentration?
` A The term "low concentration" is very broad
`unless it's actually defined. What do you mean by
`that? Tell me.
` Q Well, you said there was an expectation of
`-- of -- that it wouldn't be stable in a glass
`container at a low concentration.
` A Right.
` Q And the claims of the patent go up to 50
`micrograms per milliliter.
` So my question is: Is that 50 micrograms
`per milliliter included in your expectation for a
`lack of stability?
` A The data was generated across a range from
`one microgram per mil to 50 microgram per mil.
`So --
` Q Right.
` A -- if -- if your question is what
`expectations did we have -- did we have about the
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`occur at high concentrations.
` Q Okay.
` A And that would have to be only determined
`and confirmed with studies.
` Q Okay. And were you aware of any studies
`involving concentrations of dexmedetomidine at a
`concentration of less than 100 micrograms per
`milliliter in a glass container before you began
`your work -- or before Hospira began its work --
` A No.
` Q -- on dexmedetomidine?
` A No.
` Q Okay. Okay. I'll give you the next
`document.
` (Exhibit 17 marked for identification.)
`BY MR. WALLACE:
` Q I'm giving you what's been marked as
`Defendant's Exhibit -- or Exhibit 17 --
` A Okay.
` Q -- documents bearing the Bates number
`Hospira00308480 through 308778.
` A Yes.
` Q And I can tell you this is only the first
`300 pages of this document because it actually is a
`
`TSG Reporting - Worldwide 877-702-9580
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`Case: 1:16-cv-00651 Document #: 81-4 Filed: 01/16/18 Page 4 of 6 PageID #:2480
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`2,000-page document, but I --
` A Okay.
` Q -- we chopped it down for -- for ease of
`carrying it around.
` Have you ever seen this document before?
` A Yes. I -- as you said, it's a very large
`document. I scrolled through it very quickly.
` Q Okay. And this is the Investigational New
`Drug Application for Dexmedetomidine, correct?
` A Yes.
` Q And the name of the drug is identified in
`box 5 on the front page, correct?
` A Yes.
` Q Okay. And so an investigational new drug
`application is the application even before any
`clinical studies can be run, correct?
` A Yes. Yes.
` Q Okay. And this is -- this was data that
`was available to -- to -- that was used by Abbott in
`order -- in order to develop its clinical program,
`correct?
` A Yes.
` Q Okay. And this is data that would have --
`that was in -- that was available to Hospira's
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` A Yes.
` Q Okay. So this is stability data that was
`generated on these products --
` A Yes.
` Q -- correct? Okay.
` So let's turn to that stability data. It's
`internal page three hundred and about -- well, it's
`about 278, but I'll tell you the Bates number at the
`bottom ends in 8761. It's most of the way to the
`back.
` A Yes.
` Q You see there's a cover sheet, "Stability
`data" -- you know what, I'm sorry. I jumped too far
`ahead.
` It's actually, we're going to start on page
`-- the number ends in 751. And it says, "Stability
`data from batch NI027L1 is enclosed."
` Do you see that?
` A Yes.
` Q Okay. And so we turn to the next page,
`page Bates number 8752 of Exhibit 17 --
` A Yes.
` Q -- and we see an identification of the same
`batch number, NI027L1.
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` RAO TATA-VENKATA
`regulatory group in order to maintain the new drug
`application and the regulatory file for
`dexmedetomidine, correct?
` A That would be available with the Regulatory
`Affairs, yes.
` Q Okay. Available with the Regulatory
`Affairs within Hospira, correct?
` A Right.
` Q Okay. I want to jump ahead -- I'm sorry --
`first we'll look at the Table of Contents, and you
`can see the Table Of Contents extends on for several
`pages and describes both -- well, protocols,
`chemistry, manufacturing, pharmacology, toxicology
`and many other studies.
` Do you see that?
` A Yes.
` Q Okay. And included with -- within those,
`if you look on page 2 of the Table of Contents,
`which is -- ends in Bates number 8483 under section
`7, you see chemistry, manufacturing and control
`data?
` A Yes.
` Q Okay. And you see that the second to last
`entry here is stability?
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` Do you see that?
` A Yes.
` Q And the strength is 20 micrograms per
`milliliter.
` Do you see that?
` A Yes.
` Q This is a product manufactured in September
`of 1987?
` A Yes.
` Q Okay. And I want you to look down at the
`entry three package. It's packaged in a clear,
`colorless, glass ampoule.
` Do you see that?
` A Yes.
` Q And as you described earlier, an ampoule is
`a glass container that's sealed on itself, correct?
` A Yes.
` Q So it's a completely sealed glass
`container, right?
` A Yes.
` Q Okay. And we see, in part 2 here, the
`conditions of storage.
` Do you see that?
` A Yes.
`
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`TSG Reporting - Worldwide 877-702-9580
`
`70
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`

`

`Case: 1:16-cv-00651 Document #: 81-4 Filed: 01/16/18 Page 5 of 6 PageID #:2481
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` Q And it was stored for up to 12 months at
`25C?
` A Yes.
` Q And that's considered a room temperature
`storage condition?
` A Yes.
` Q And that's the same type of storage
`conditions that were used in the -- the Wu
`Declaration, correct?
` A Yes.
` Q And it's the same storage conditions that
`were used for the submission of the Precedex premix
`to the FDA?
` A Along with other conditions, but this is
`one of the conditions.
` Q Yes. Okay. And it says, "The results are
`presented in table 1."
` Do you see that?
` A Uh-huh.
` Q And so if we turn to Bates number 8756, we
`find table 1.
` You see that, Doctor?
` A Yes.
` Q Okay. And we see that at the initial time
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` Do you see that?
` A Yes.
` Q Stored at 25C?
` A Yes.
` Q And here the assay is 98 percent again,
`correct?
` A Uh-huh.
` Q So it's identical to the initial assay of
`-- for this sample, correct?
` A Yes.
` Q Okay. And then if we turn -- if we go to
`the next line, we have nine month data for the same
`sample, correct?
` A Yes.
` Q And we see the assay is a hundred percent?
` A Yes.
` Q So it's still -- it has not lost potency at
`this point, correct?
` A Yes.
` Q And then we see 12 month data here.
` Do you see that, the line for 12 months?
` A Yes.
` Q And we're back, again, at 97 percent assay.
` You see that?
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`point, the assay here is 98 percent.
` Do you see that?
` A Yes.
` Q And do you understand that the assay refers
`to the amount of dexmedetomidine as compared to the
`claimed concentration of 20 micrograms per
`milliliter?
` A Yes.
` Q Okay. And then we see that, after two
`months of being stored at 25C, the result is 97
`percent of assay, correct?
` A Yes.
` Q So it has lost no more than one percent of
`concentration, correct?
` A Yes.
` Q Okay. And then the next entry is three
`months of 25C and the assay is, again, 97 percent,
`correct?
` A Yes.
` Q So, again, it has lost no more than one
`percent from the initial assay, correct?
` A Yes.
` Q Okay. If we turn to the third entry, we
`have six months data.
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` A Yes.
` Q So it has lost no more than one percent
`from the -- from when it was initially placed on
`stability, correct?
` A Yes.
` Q Now, to be clear, a 20 microgram per
`milliliter concentration of dexmedetomidine falls
`within the range that is claimed in the patents that
`we looked at before, correct?
` A Yes.
` Q So there was data that would provide an
`expectation for stability of dexmedetomidine in a
`sealed glass container at a concentration of less
`than 100 micrograms per milliliter, correct?
` A According to this data that's here, yes.
` Q Okay. And this is an IND, correct?
` A Yes.
` Q So an IND is data that is provided to the
`FDA?
` A Yes.
` Q So it is accurate data, presumption is that
`it's accurate data?
` A The date is accurate.
` Q Okay. If we turn, now, to the page ending
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`TSG Reporting - Worldwide 877-702-9580
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`71
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`

`

`Case: 1:16-cv-00651 Document #: 81-4 Filed: 01/16/18 Page 6 of 6 PageID #:2482
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`in 8761, we have stability data on another batch of
`product. This is -- I'm sorry, it's -- if you turn
`to 762, you see a batch number, OK029L1.
` Do you see that?
` A Yes.
` Q Okay. So that's a different batch from the
`one we were just looking at, right?
` A Yes.
` Q Okay. And, again, this is a -- packaged in
`a glass ampoule again, right?
` A Yes.
` Q This is a sealed glass container, correct?
` A Yes.
` Q Okay. And, I guess, if you look back at
`page 761, it identifies this as a 20 microgram per
`milliliter injection.
` Do you see that?
` A Yes.
` Q Okay. And if we look on page 8765, there's
`a heading, "Seven Shelf Life."
` Do you see that?
` A Yes.
` Q And in the IND it reads, "A shelf life of
`12 months is proposed based on the results of the
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`having been used in clinical trials, correct?
` A Yes.
` Q Okay. So these would be used in human
`patients to provide sedation?
` A Yes.
` Q Okay. And the batch OK029L1 is being used
`in clinical trials in The United States, correct?
` A Yes.
` Q And if we turn to page Bates number ending
`in 8777. It's the second to last page. It's turned
`on its side. Actually, I can't read that. Not
`going to worry about it. I can't read that data.
`It's on its side, so...
` MR. RAY: Is that the end of this document?
` MR. WALLACE: That's the end of this document.
` MR. RAY: Can we take a quick break?
` MR. WALLACE: Sure.
` THE VIDEOGRAPHER: We're off the record. The
`time is 4:14 p.m.
` (Recess held.)
` THE VIDEOGRAPHER: We're back on the record.
`The time is 6:19 (sic) p.m.
` MR. WALLACE: I'll ask the court reporter to
`mark the next document.
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`batch NI027L1 stability report September 1988 when
`stormed at -- stored at room temperature."
` Do you see that?
` A Yes.
` Q So this is data provided to the FDA saying
`that when dexmedetomidine at, a concentration of 20
`micrograms per milliliter, will be shelf stable for
`12 months; is that correct?
` A Yes.
` Q And was that consistent with the data we
`just looked at for the batch NI027L1?
` A Yes.
` Q And if we look on the next page, we see an
`ongoing stability study for batch OK029L1.
` Do you see that?
` A Yes.
` Q And they are proposing both room
`temperature and accelerated conditions, correct?
` A Yes.
` Q Okay. And if we turn to page in -- with --
`with the Bates number ending 8768, the heading
`"Stability Studies."
` A Yes.
` Q Each of these two batches are identified as
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` (Exhibit 18 marked for identification.)
`BY MR. WALLACE:
` Q Handing you what's been marked as Exhibit
`18, which bears production numbers Hospira00001187
`through 1881. And is what appears to be the prior
`approval supplement for the Precedex premix product.
` A Yes.
` Q Do you see that?
` A Uh-huh.
` Q Do you -- did you review this or portions
`of this for your deposition today?
` A Yeah, I think this is the one I was
`actually glancing through, not this.
` Q Okay. Well, this is -- this is the
`submission that was given to the FDA --
` A DA.
` Q -- for the Precedex premix products,
`correct?
` A Yes.
` Q Okay. And this was submitted on October
`12th, 2012.
` You see that?
` A Yes.
` Q Okay. So this is after the patents had
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`TSG Reporting - Worldwide 877-702-9580
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