throbber
STEADYMED LTD., VS UNITED THERAPEUTICS CORPORATION,
`
`Ruffolo, Robert on 08/19f2016 Page 296
`
`BY MR. POLLACK:
`
`Q.
`
`Yeah.
`
`I was just asking whether or
`
`not United Therapeutics was allowed by the FDA
`
`to add information about
`
`the use of a high pH
`
`glycine diluent, whatever that may be,
`
`to their
`
`—— to their label.
`
`MR. DELAFIELD:
`
`Same objections.
`
`THE WITNESS:
`
`E don‘t know
`
`anything about that at all, and reading a
`
`couple of paragraphs on this letter that
`
`don't even define some of the abbreviations
`
`usedr
`
`I can‘t ~e
`
`I can‘t do anything with
`
`this. This doesn't mean anything to me.
`
`BY MR. POLLACK:
`
`Q.
`
`Well, do you see ~v let's take a
`
`look at the second full paragraph on page 8.
`
`A.
`
`Q.
`
`The which?
`
`The -~
`
`The one beginning with "More the
`
`point."
`
`"More to the point."
`
`I want to a take
`
`a look at
`
`the second sentence.
`
`Do you see
`
`there it says:
`
`"when we approve the addition of
`
`this information to Remodulin‘s label
`
`in
`
`September 2013."
`
`Do you see where I'm reading?
`
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`Elisa Dreier Reporting Corp., A U.S. Legal Support Company
`950 Third Avenue, New York, NY 10022
`(212) 557w5558
`
`UT Ex. 205a
`P296
`SteadyMed v. United Therapeutics
`iPRZDiB-OOOGG
`
`|PR2020-00770
`
`United Therapeutics EX2007
`Page 2301 of 7335
`
`IPR2020-00770
`United Therapeutics EX2007
`Page 2301 of 7335
`
`

`

`STEADYMED LTD., VS UNITED THERAPEUTICS CORPORATION,
`
`
` Ruffolo, Robert on 08/19/2016 Page 297
`
`
`
`A.
`
`Q.
`
`Yes,
`
`I do.
`
`Okay. Reading that,
`
`am I correct
`
`that the FDA approved adding certain
`
`information to Remodulin #— that's the same
`
`product we‘ve been talking about -- to the
`
`labeling of Remodulin;
`
`is that fair?
`
`MR. DELAFIELD:
`
`Same objections.
`
`THE WITNESS:
`
`I guess so.
`
`I
`
`don't know.
`
`BY MR. POLLACK:
`
`Q.
`
`Okay. That's what the letter says;
`
`right?
`
`A.
`
`That‘s ~~
`
`
`MR. DELAFIELD:
`
`Same objection.
`
`BY MR. POLLACK:
`
`Q.
`
`I know you don't know
`
`independently, but
`
`in the letter that's what it
`
`says?
`
`MR. DELAFIELD:
`
`Same objection.
`
`THE WITNESS: That's what,
`
`two
`
`sentences out of a 10—page letter 1 never
`
`saw before that’s related to something I
`
`didn't prepare for.
`
`It doesn't mean
`
`anything to me.
`
`BY MR. POLLACK:
`
`
`
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` Elisa Dreier Reporting Corp., A U.S. Legal Support Company
`950 Third Avenue, New York, NY 10022
`(212) 557~5558
`
`UT Ex. 2058
`P297
`SteadyMed v. United Therapeutics
`iPR2015—00006
`
`|PR2020-00770
`
`United Therapeutics EX2007
`Page 2302 of 7335
`
`IPR2020-00770
`United Therapeutics EX2007
`Page 2302 of 7335
`
`

`

`
`STEADYMED LTD., VS UNZTED THERAPEUTICS CORPORATION,
`
`Ruffolo, Robert on 08/19/2016
`
`Page 298
`
`Q.
`
`A.
`
`Okay.
`
`In fact,
`
`the only thing that means
`
`anything to me is the signature of Janet
`
`Woodcock, who's a good friend of mine.
`
`Lil
`
`Q.
`
`Okay. That‘s the same Janet
`
`Woodcock ~—
`
`A.
`
`Q.
`
`Yes.
`
`m— that you refer to in your
`
`declaration?
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`correct?
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`Correct.
`
`She‘s the author of this letter?
`
`She's the signatory of this letter.
`
`Letter is issued with her approval;
`
`That‘s correct.
`
`Okay. And if we go back to page 8?
`
`Okay.
`
`Okay.
`
`In Janet Woodcock's letter,
`
`she says “We" and by 'we' she‘s referring to
`
`the FDA?
`
`MR. DELAFIELD: Objection.
`
`Calls for speculation.
`
`Lacks foundation.
`
`Relevance. Outside the scope of his
`
`declaration.
`
`THE WITNESS: Which ”we"?
`
`“We
`
`
`
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`25
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`
`
`Elisa Dreier Reporting Corp., A 3.8. Legal Support Company
`557—5558
`950 Third Avenue, New York, NY 10022
`(212)
`P298
`
`UT'EX.2058
`SteadyMed v. United Therapeutics
`iPRZOiB-OOOOG
`
`|PR2020—00770
`
`United Therapeutics EX2007
`Page 2303 of 7335
`
`IPR2020-00770
`United Therapeutics EX2007
`Page 2303 of 7335
`
`

`

`STEADYMED LTD., VS UNITED THERAPEUTICS CORPORATION,
`
`Ruffolo, Robert on 08/19/2016
`
`Page 299
`
`did not take these acts"?
`
`BY MR. POLLACK:
`
`Q.
`
`Yes, or we did 11 all of the
`
`”we's.“
`
`"We approved.”
`
`”We did so in the
`
`interest."
`
`That's referring to the FDA; right?
`
`MR. DELAFIELD:
`
`Same objections.
`
`THE WITNESS:
`
`I guess so.
`
`I
`
`suppose she would.
`
`BY MR. POLLACK:
`
`Q.
`
`Right?
`
`It's a letter from the FDA;
`
`is that fair?
`
`A.
`
`Yeah.
`
`MR. DELAFIELD:
`
`Same objections.
`
`BY MR. POLLACK:
`
`Q.
`
`A.
`
`Q.
`
`A.
`
`Okay. And it says here ~—
`
`I should point out.
`
`Uh—hnh.
`
`Letters come from the FDA that
`
`don‘t represent the entire FDA opinion. During
`
`the entire NBA process, you get letters from
`
`the FDA. That's ~w that's a ——
`
`Q.
`
`Yeah. This is an official response
`
`to a citizen‘s petition?
`
`
`
`
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`MR. DELAFIELD:
`
`Same objection.
`
`......__ .___
`
`
`
`._1
`
`Elisa Dreier Reporting Corp., A U.S.
`950 Third Avenue, New York, NY 10022
`
`Legal Support Company
`(212) 557—5558
`
`P299
`
`UT'EX.2058
`SteadyMed v. United Therapeutics
`IPRZDiSiMOOB
`
`|PR2020-00770
`
`United Therapeutics EX2007
`Page 2304 of 7335
`
`IPR2020-00770
`United Therapeutics EX2007
`Page 2304 of 7335
`
`

`

`STEADYMED LTD., VS UNITED THERAPEUTICS CORPORATION,
`Page 300
`Ruffolo, Robert on 08/19/2016
`
`I4
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`(\1
`
`bib
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`16
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`l?
`
`18
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`19
`
`2O
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`21
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`22
`
`23
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`
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`THE WITNESS: Again,
`
`I don't
`
`know.
`
`BY MR . POIJTJACK:
`
`Q.
`
`A.
`
`Q.
`
`You don't know what
`
`those are?
`
`Yeah.
`
`I‘m sorry.
`
`Okay. And they say here they made
`
`a label change; right?
`
`They did so in the interest of
`
`"providing healthcare providers with up—to—date
`
`information on the use of high glycine diluents
`
`and not out of the concern that the
`
`administration of IV treprostinil with a
`
`neutral diluent should always be avoided
`
`because it poses a risk to patients.
`
`The
`
`agency had been concerned about the safety of
`
`neutral diluents" an I'm sorry.
`
`”If the agency had been concerned
`
`about
`
`the safety of neutral diluents, it could
`
`have revised the labeling to require the use of
`
`high pH glycine diluents only and taken steps
`
`to raise awareness about
`
`the effect that choice
`
`of diluent has on the risk of 8815."
`
`Now,
`
`in the case of the changes
`
`that we're talking about here that were
`
`approved by the FDA,
`
`the manufacturing changes,
`
`
`
`Elisa Dreier Reporting Corp., A U.S. Legal Support Company
`950 Third Avenue, New York, NY 10022
`(212} 557—5558
`P300
`
`UT‘EX.2058
`
`SteadyMed v. United Therapeutics
`lPR2015—00005
`
`|PR2020-00770
`
`United Therapeutics EX2007
`Page 2305 of 7335
`
`IPR2020-00770
`United Therapeutics EX2007
`Page 2305 of 7335
`
`

`

`STEADYMED LTD., vs UNITED THERAPEUTICS CORPORATION,
`Page 301
`Ruffolo, Robert on 08/19/2016
`
`
`
`b.)
`
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`don't know what the agency is saying here.
`
`
`Elisa Dreier Reporting Corp., A U.S. Legal Support Company
`557—5558
`950 Third Avenue, New York, NY 10022
`(212)
`
`9301
`
`UT'EX.2058
`
`SteadyMed v. United Therapeutics
`IPRZOifi-ODOOS
`
`|PR2020-00770
`
`United Therapeutics EX2007
`Page 2306 of 7335
`
`those Changes don‘t even appear on the label;
`
`correct?
`
`MR. DELAFIELD:
`
`Same objections.
`
`THE WITNESS: That's correct.
`
`BY MR. POLLACK:
`
`Q.
`
`Right. Here we're talking about
`
`changes that were approved by the agency that
`
`do appear on the label; correct?
`
`MR. DELAFIELD:
`
`Same objections.
`
`THE WITNESS:
`
`I don't know.
`
`I
`
`don't remember it from the label.
`
`I
`
`reviewed the label.
`
`I don‘t remember this.
`
`BY MR. POLLACK:
`
`Q.
`
`Okay. But here the agency is
`
`saying,
`
`just because we approved it on the
`
`label,
`
`that doesn’t mean we endorsed your
`
`statements about
`
`the effect of these high pH
`
`glycine diluents; isn't that what they‘re
`
`saying?
`
`MR. DELAFIELD: Objection.
`
`Vague. Mischaracterizcs the document.
`
`Relevance.
`
`Lacks foundation. Outside the
`
`scope of his declaration.
`
`THE WITNESS:
`
`To be honest,
`
`I
`
`%
`
`IPR2020-00770
`United Therapeutics EX2007
`Page 2306 of 7335
`
`

`

`STEADYMED LT3., VS UNITED THERAPEUTICS CORPORATION,
`
`Ruffolo, Robert on OSXIS/2OIE Page 302
`
`You know,
`
`I‘m sorry.
`
`In a IO-page letter,
`
`looking at a couple of paragraphs,
`
`I don‘t
`
`know what
`
`they mean.
`
`I don't know what
`
`they're referring to.
`
`I don't know what
`
`their intent is. And this is an area that I
`
`have not been involved with beEore.
`
`BY MR. POLLACK:
`
`Q.
`
`Okay. Well, you said you had some
`
`regulatory expertise.
`
`Based on your regulatory expertise,
`
`can you explain what's being described here?
`
`MR. DELAFIELD:
`
`Same objections.
`
`Asked and answered.
`
`THE WITNESS:
`
`I Said I had a
`
`great deal of regulatory expertise. But
`
`I
`
`also said that I didn't know everything
`
`about regulatory affairs and that there were
`
`people in regulatory affairs that knew more
`
`than me and many who knew lessr but this is
`
`something that I have not had to deal with.
`
`And this is —- again,
`
`I don't
`
`know what this is.
`
`BY MR. POLLACK:
`
`Q.
`
`Okay.
`
`I’m only asking this because
`
`earlier I believe you stated the opinion that
`
`
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`
`Elisa Dreier Reporting Corp., A U.S. Legal Support Company
`950 Third Avenue, New York, NY 10022
`(212} 557w5558
`
`UT Ex. 2058
`19-302
`SteadyMed v. United Therapeutics
`|PR201600006
`
`|PR2020-00770
`
`United Therapeutics EX2007
`Page 2307 of 7335
`
`IPR2020-00770
`United Therapeutics EX2007
`Page 2307 of 7335
`
`

`

`ll '
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`
`by approving United TherapeuLics' changes from
`
`fl to a percent,
`
`the FDA was endorsing that as
`
`a change in purity. And you seem to have the
`
`expertise to opine on that or that was your
`
`View that there was an endorsement, or maybe I
`
`misunderstood you.
`
`And yet here you‘re not able to
`
`tell me whether the FDA considers an approval,
`
`as they did here,
`
`to be an endorsement.
`
`A.
`
`They ——
`
`MR. DELAFIELD: Objection.
`
`Mischaracterizes testimony. Relevance and
`
`outside the scope of his declaration.
`
`THE WITNESS:
`
`The area I
`
`testified to before I've had a great deal of
`
`experience in at every level with the FDA.
`
`BY MR. POLLACK:
`
`Q.
`
`A.
`
`Uh-huh.
`
`This I have not had any experience
`
`and I know for —-
`
`I know that the FDA does not
`
`like to make changes in specifications unless
`
`they believe they are significant.
`
`I don't
`
`know what Janet is saying about whatever label
`
`—— labeling Change she's talking about.
`
`Q.
`
`Well, you said earlier that you had
`
`
`
`
`
`UT Ex. 2058
`P.303
`SteadyMed v. United Therapeutics
`|PR2D16~OOODB
`
`|PR2020-00770
`
`United Therapeutics EX2007
`Page 2308 of 7335
`
`IPR2020-00770
`United Therapeutics EX2007
`Page 2308 of 7335
`
`

`

`STEADYMED LTD., VS UNITED THERAEEUTICS CORPORATION,
`Ruffolo, Robert on 08/19/2016
`
`Page 304
`
`reviewed the label?
`
`A.
`
`Q.
`
`I did review the label, yeah.
`
`Okay.
`
`If you reviewed the label,
`
`you saw a discussion about what diluents should
`
`be used with Remodulin?
`
`MR. DELAFIELE: Objection.
`
`Lacks foundation.
`
`THE WITNESS:
`
`It -—
`
`MR. DELAPIELD: Outside the
`
`scope of his declaration. Relevance.
`
`THE WITNESS: Wellr and because
`
`it was outside the scope, it‘s not an area
`
`that I would have focused on.
`
`I focused on
`
`other parts of the label, and I do know a
`
`good deal about labeling negotiations as far
`
`as NBA approval.
`
`This in Citizen‘s petition I
`
`don't
`
`«w is an area that I have not been
`
`involved with, not focused on, and I don‘t
`
`have the experience in. What I testified to
`
`I have great deal of experience in. Sorry.
`
`BY MR. POLLACK:
`
`Q.
`
`Yeah. Okay, But in regard to
`
`whether or not the FDA endorses statements made
`
`by applicants, what‘s your evidence of that?
`
`x]
`
`\D
`
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`
`Elisa Dreier Reporting Corp., A U.S.
`950 Third Avenue, New York, NY 10022
`P304
`
`Legal Support Company
`(212) 557n5558
`
`UT'EX.2058
`SteadyMed V. United Therapeutics
`[PR201600006
`
`|PR2020-00770
`
`United Therapeutics EX2007
`Page 2309 of 7335
`
`IPR2020-00770
`United Therapeutics EX2007
`Page 2309 of 7335
`
`

`

`STEADYMED LTD., VS UNITED THERAPEUTICS CORPORATION,
`
`Ruffolo, Robert on 08/19/2016 Page 305
`
`MR. DELAFIELD: Objection.
`
`Mischaracterizes his testimony. Relevance.
`
`THE WITNESS:
`
`The applicant
`
`can't make a change without
`
`the FDA'S
`
`agreement and approval.
`
`BY MR. POLLACK:
`
`Q.
`
`A.
`
`Uh-huh.
`
`And when they do that in the
`
`context of a specification,
`
`they wouldn't
`
`permit it if they didn't believe it was
`
`significant and important enough to do so.
`
`I have no idea what this letter is
`
`talking about, and I don't even understand the
`
`argument that's being made here. Again, maybe
`
`if I studied this for a couple of days but, you
`
`know,
`
`this is not something I've seen or been
`
`involved with.
`
`Q.
`
`Okay. But you don't have any
`
`statements, articles, documents, evidencing
`
`that the FDA endorses statements made by
`
`applicants merely because they approved the
`
`change?
`
`MR. DELAFIELD: Objection.
`
`Vague. Asked and answered. Relevance.
`
`LaJ
`
`U':
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`
`
`THE WITNESS:
`
`The FDA doesn’t
`
`
`
`Elisa Dreier Reporting Corp., A U.S. Legal Support Company
`950 Third Avenue, New York, NY 10022
`(212) 557—5558
`
`UT Ex, 2058
`P805
`SteadyMed v. United Therapeutics
`IPRZOiE-OOOOB
`
`|PR2020-00770
`
`United Therapeutics EX2007
`Page 2310 of 7335
`
`IPR2020-00770
`United Therapeutics EX2007
`Page 2310 of 7335
`
`

`

`STEADYMED LTD., VS UNITED THERAPEUTICS CORPORATION,
`Ruffolo, Robert on 08/19/2016
`
`Page 306
`
`allow change unless they agreed with that
`
`[\J
`
`change and approved that change. That's
`
`
`
`their job.
`
`BY MR. POLLACK:
`
`Q.
`
`A.
`
`Sure.
`
`And with respect to specifications
`
`and release of batches and all of the pre—NDA
`
`work and NBA work,
`
`their approval is required
`
`and that approval is so important that itts
`
`what allows you to sell a new product. That‘s
`
`a big deal.
`
`Q.
`
`A.
`
`Uh—huh.
`
`So that acknowledgement by the FDA
`
`is important, it has a legal meaning, and it's
`
`not done trivially.
`
`Q.
`
`A.
`
`Q.
`
`A.
`
`Okay.
`
`I understand that.
`
`So ~~
`
`But that's not what I asked you.
`
`Well, but, again,
`
`I have no idea
`
`what you're asking me.
`
`I‘m sorry.
`
`Q.
`
`A.
`
`Q.
`
`Oh.
`
`I was asking if you had any —~
`
`I can‘t say it in any other words,
`
`Sure.
`
`I was asking if you had any
`
`documentation regarding the statement you just
`
`
`
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`made. Not —— not your w~ not your opinion but
`
`
`
`.—l
`
`Elisa Dreier Reportin Corp., A U.S. Legal Support Company
`950 Third Avenue, New York, NY 10022
`(212) 557,5555
`
`P306
`
`UT'EX.2058
`SteadyMed v. United Therapeutics
`|PR2016-00006
`
`|PR2020-00770
`
`United Therapeutics EX2007
`Page 2311 of 7335
`
`IPR2020-00770
`United Therapeutics EX2007
`Page 2311 of 7335
`
`

`

`STEADYMED LTD., VS UNITED THERAPEUTICS CORPORATION,
`
`Ruffolo, Robert on 08f19/2016 Page 307
`
`
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`what —— do you have any documents with those
`
`statements on them from the FDA?
`
`Do you have
`
`any other written materials from anyone ——
`
`Well —-
`
`—— sugporting those statements?
`
`MR. DELAFIELD:
`
`Same objections.
`
`A.
`
`Q.
`
`Compound.
`
`THE WITNESS: There are numerous
`
`documents that detine the changes that we
`
`spoke about earlier, and I've referenced
`
`those, on how sponsors deal with the FDA and
`
`what
`
`the FDA requires.
`
`So, yes,
`
`there are documents
`
`that lay out what the FDA requires.
`
`And as I said earlier,
`
`the
`
`changes that were made by UTC with respect
`
`to the manufacturing process,
`
`the starting
`
`material,
`
`those are defined in FDA and ICH
`
`documents as major changes requiring
`
`validation, documentation, and ultimately
`
`approval by the FDA.
`
`So, yeah,
`
`those documents exist,
`
`and I've cited them.
`
`BY MR. POLLACK:
`
`Q.
`
`Well, actually —~
`
`
`
`Elisa Dreier Reporting Corp., A U.S. Legal Support Company
`557—5558
`950 Third Avenue, New York, NY 10022
`(212)
`P30?
`
`U1'EX.2058
`SteadyMed v. United Therapeutics
`|PR2016®OOOS
`
`|PR2020-00770
`
`United Therapeutics EX2007
`Page 2312 of 7335
`
`IPR2020-00770
`United Therapeutics EX2007
`Page 2312 of 7335
`
`

`

`
`
`
`
`A.
`
`Q.
`
`A.
`
`This is ~—
`
`Uh—huh.
`
`You know, again,
`
`I don't even know
`
`what this is.
`
`Q.
`
`This is just a document regarding
`
`the same product that we‘re talking about
`
`in
`
`this case; right?
`
`MR. DELAFIELD: Objection.
`
`Argumentative.
`
`THE WITNESS: Yeah.
`
`It's ——
`
`BY MR. POLLACK:
`
`Q.
`
`A.
`
`Yeah. Okay.
`
`I understand from the title it’s
`
`the same product we're talking about, but
`
`I
`
`don't know what they're talking about.
`
`Q.
`
`Okay.
`
`Looking back at Exhibit
`
`*—
`
`what was called Exhibit 2005,
`
`the letter from
`
`the ——
`
`A.
`
`Q.
`
`Oh, yeah.
`
`—— from United Therapeutics to the
`
`As we discussed earlier,
`
`there were
`
`two other major amendments that were made;
`
`right? One regarding the
`
`of the
`
`product and one regarding the location of the
`
`
`
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`22
`
`23
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`24
`
`25
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`
`
`
`
`P308
`
`UT‘EX.2058
`SteadyMed V. United Therapeutics
`IPR2016—00006
`
`|PR2020-00770
`
`United Thera
`
`peutics EX2007
`Page 2313 of 7335
`
`IPR2020-00770
`United Therapeutics EX2007
`Page 2313 of 7335
`
`

`

`
`facility?
`
`MR. DELAFIELD: Objection.
`
`Mischaracterizes the document.
`
`THE WITNESS: Yes,
`
`that‘s
`
`correct.
`
`BY MR. POLLACK:
`
`Q.
`
`Okay. Given that those —— thOSe
`
`two were changes requiring major amendments in
`
`the first place, how do we know that changing
`
`the spec from
`
`was also a major
`
`amendment?
`
`Is there any indication that they
`
`considered that to be a major amendment?
`
`A.
`
`Sure .
`
`MR. DELAFIELD: Objection.
`
`Compound. Vague‘
`
`BY MR. POLLACK:
`
`Q.
`
`At
`
`What's the indication?
`
`You —— the dOCumentS that t've
`
`cited consider those changes to be amendment.
`
`They specifically address changes in
`
`specifications.
`
`Q.
`
`Can you —— can you show me where it
`
`says that a change in purity from.§§ to
`
`
`
`percent is considered a major amendment?
`
`
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`They wouldn't have listed something
`Al
`
`
`P309
`
`UT'EX.2058
`
`SteadyMed v. United Therapeutics
`iPR2015-00005
`
`|PR2020-00770
`
`United Therapeutics EX2007
`Page 2314 of 7335
`
`IPR2020-00770
`United Therapeutics EX2007
`Page 2314 of 7335
`
`

`

`1
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`/////////
`
`
`
`g
`
`as a change in purity from
`
`
`
`percent.
`
`That‘s not what guidelines do.
`
`They talk about
`
`changes in specifications, which that would ——
`
`would be.
`
`
`
`
`Q.
`
`Okay.
`
`Can you show me where they
`
`say a change —— in the documents you've
`
`cited -— a change increasing the minimum HPLC
`
`assay purity is a major amendment?
`
`MR, DELAFIELD: Objection.
`
`Vague.
`
`THE WITNESS:
`
`The increasing the
`
`stringency of a —~ of a specification is not
`
`a major amendment. What is a major
`
`amendment was the change in the process,
`
`the
`
`change in the starting material.
`
`Those are
`
`major changes, and those major changes
`
`resulted in an increase in purity that the
`
`FDA ultimately approved.
`
`MR. POLLACK:
`
`I'm going to mark
`
`as Ruffolo Deposition Exhibit 11.
`
`{Document marked for
`
`identification purposes as Ruffolo
`
`Exhibit 11.)
`
`TH WITNESS:
`
`Thank you.
`
`BY MR. POLLACK:
`
`
`
`
`
`Ul‘Ex.2058
`P.310
`SteadyMed v. United Therapeutics
`EPR2016-00006
`
`|PR2020-00770
`
`United Therapeutics EX2007
`Page 2315 of 7335
`
`IPR2020-00770
`United Therapeutics EX2007
`Page 2315 of 7335
`
`

`

`
`ST
`
`LAJYMED LTD., VS UNITED THERAPEUTICS CORPORATION,
`Page 311
`Ruffolo, Robert on 08/19/2016
`
`Q.
`
`Ruffolo —— and Ruffolo 11 is a
`
`document entitled "Patent Owner Response to
`
`Petition.”
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`document?
`
`Yes.
`
`Have you seen this document before?
`
`Yes,
`
`I believe I have.
`
`Okay. When did you see this
`
`A.
`
`I saw this maybe a year ago. Oh,
`
`I'm sorry. This is the response. This is not
`
`the ——
`
`Q.
`
`Yeah.
`
`I don't want to trick you or
`
`anything.
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`A.
`
`Right. Yeah.
`
`If you turn to the last page?
`
`Yeah.
`
`You'll see it‘s dated July 6, 2016?
`
`Oh, okay.
`
`Sorry.
`
`I would have
`
`read this in the last couple of weeks.
`
`Q.
`
`Oh, okay. Were you involved at all
`
`in creating Ruffolo Deposition Exhibit 11?
`
`A.
`
`0-
`
`A.
`
`document.
`
`No,
`
`I was not ~~
`
`Okay.
`
`e— involved in the creation of this
`
`
`
`
`
`
`Lu
`
`U1
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`()1
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`
`Elisa Dreier Reporting Corp., A U.S. Legal Support Company
`557—5558
`950 Third Avenue, New York, NY 10022
`(212)
`P311
`
`U1'EX.2058
`
`SteadyMed v. United Therapeutics
`EPRZOiG-OOODS
`
`|PR2020-00770
`
`United Therapeutics EX2007
`Page 2316 of 7335
`
`IPR2020-00770
`United Therapeutics EX2007
`Page 2316 of 7335
`
`

`

`STEADYMED LTD., VS UNITED THERAPEUTICS CORPORATION,
`Page 312
`
`Ruffolo, Robert on 08/19/2016
`
`Q.
`
`Okay. And had you read this
`
`document at any time before you wrote your
`
`final draft of your declaration?
`
`A.
`
`I don't believe so because I
`
`believe my document was submitted on this day
`
`because it was the day before a family vacation
`
`where I had to finish mine.
`
`So I don't know if
`
`I could have read this in advance.
`
`Q.
`
`Okay.
`
`Let me ask you.
`
`Did you read any prior drafts of
`
`Ruffolo Deposition Exhibit 11?
`
`
`
`
`A.
`
`Q-
`
`A.
`
`Q.
`
`Oh.
`
`NO.
`
`Okay.
`
`No.
`
`So Ruffolo Deposition Exhibit 11
`
`you first read in preparation for today's
`
`deposition?
`
`A.
`
`Q.
`
`Yes,
`
`that's correct.
`
`Okay. Was there anything in
`
`Ruffolo Deposition Exhibit ll that you
`
`disagreed with?
`
`A.
`
`Q.
`
`Could you be more specific?
`
`Well, did you see any mistakes
`
`or —— let me start with that. Did you see any
`
`mistakes in Ruffolo Deposition Exhibit 11?
`
`
`
`LA.)
`
`(Jl
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`25
`
`Elisa Dreier Reporting Corp., A U.S. Legal Support Company
`950 Third Avenue, New York, NY 10022
`(212) 557—5558
`P312
`
`UT‘EX.2058
`
`SteadyMed v. United Therapeutics
`iPRZOiS—OOODB
`
`|PR2020-00770
`
`United Therapeutics EX2007
`Page 2317 of 7335
`
`IPR2020-00770
`United Therapeutics EX2007
`Page 2317 of 7335
`
`

`

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`STEADYMED LTD., VS UNITED THERAPEUTICS CORPORATION,
`Page 313
`Ruffolo, Robert on 08/19/2016
`
`A.
`
`Q.
`
`Not that I recall.
`
`Okay. Did you see opinions or
`
`statements that you thought were maybe just
`
`slightly inaccurate?
`
`A.
`
`Can you be more specific on whose
`
`opinions you‘re talking about?
`
`Q.
`
`Yeah. Any of the opinions that
`
`were written in here by -- this was submitted
`
`—— this was submitted by United Therapeutics.
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`I understand.
`
`Okay.
`
`Yeah.
`
`Were any of the statements in here
`
`—— I assume this was —— these were written by
`
`United Therapeutics attorneys.
`
`Were there any statements in this
`
`document that you looked at and said, well,
`
`I
`
`don'L know if I compleLely agree with —~
`
`Okay.
`
`“w that statement?
`
`MR. DELAFIELD: Objection.
`
`A.
`
`Q.
`
`Vague.
`
`
`
`THE WITNESS: This document, as
`
`I recall, quotes some opinions from —— from
`
`either Dr. Winkler or from the —— the Board,
`
`
`Elisa Dreier Reporting Corp., A U.S. Legal Support Company
`557—5558
`950 Third Avenue, New York, NY 10022
`(212)
`
`R313
`
`Ui'EX.2058
`SteadyMed v. United Therapeutics
`|PR2016-00006
`
`|PR2020-00770
`
`United Therapeutics EX2007
`Page 2318 of 7335
`
`IPR2020-00770
`United Therapeutics EX2007
`Page 2318 of 7335
`
`

`

`STEADYMED LTD., VS UNITED THERAPEUTICS CORPORATION,
`Ruffolo, Robert on 08/19f2015
`
`Page 314
`
`
`
`
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`ll
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`that Board.
`
`BY MR. POLLACK:
`
`Q.
`
`The Board?
`
`The Board that's mm
`
`that‘s hearing this case?
`
`A.
`
`Many of those I wouldn‘t have
`
`agreed with.
`
`Q .
`
`A.
`
`to mine ~—
`
`Q.
`
`A.
`
`Okay.
`
`Obviously the opinions that relate
`
`Uh—huh.
`
`—— my declaration and the opinions
`
`that relate to Dr. Williams' declaration I do
`
`agree with.
`
`Q.
`
`Okay.
`
`So there was nothing ——
`
`there were no statements in here that United
`
`Therapeutics was advancing that you thought,
`
`I
`
`don't —— I don't completely with that?
`
`A.
`
`Not that I recall.
`
`MR. DELAFIELD: Objection.
`
`Asked and answered.
`
`BY MR. POLLACK:
`
`Q.
`
`Let me just —— I just wanted to
`
`
`
`check one thing with you.
`
`Tf you turn to page 34?
`
`A.
`
`Okay.
`
`Elisa Dreier Reporting Corp., A U.S. Legal Support Company
`950 Third Avenue, New York, NY 10022
`{212) 557~5558
`
`UT Ex. 2058
`9314
`SéeadyiVIed v. United Therapeutics
`IPRZD1650006
`
`|PR2020-00770
`
`United Therapeutics EX2007
`Page 2319 of 7335
`
`IPR2020-00770
`United Therapeutics EX2007
`Page 2319 of 7335
`
`

`

`STEADYMED LTD., VS UNITED THERAPEUTICS COR?ORATTON,
`
`Ruffolo, Robert on 08/1912016
`Page 315
`r___m__mm
`
`Q.
`
`At
`
`the top of the page,
`
`this is
`
`under a heading that says "The '393 Patent
`
`Product is Structurally and Functionally
`
`Distinct from Moriarty's Product."
`
`A.
`
`0.
`
`A.
`
`Q.
`
`A.
`
`Yes,
`
`I see that.
`
`Okay.
`
`Do you know what that means?
`
`I believe I do.
`
`What —— what does it mean?
`
`"structurally different" I believe
`
`means a difference in the chemical that was
`
`produced as a result of the reaction, and
`
`“functionally” I believe means :he clinical or
`
`perhaps patient significance. That's —— that‘s
`
`my understanding.
`
`Q.
`
`Is there a difference between the
`
`approved Moriarty treprostinil product that was
`
`shown clinically that‘s different from the '393
`
`product?
`
`MR. DELAFIELD: Objection,
`
`Vague.
`
`Compound. Outside the scope of his
`
`declaration.
`
`THE WITNESS: Not —— not to my
`
`knowledge.
`
`BY MR. POLLACK:
`
`
`
`And you said that —- we were
`Q.
`
`
`Elisa Dreier Reporting Corp., A U.S. Legal Support Company
`950 Third Avenue, New York, NY 10022
`{212) 557—5558
`
`UT Ex. 2058
`9315
`SteadyMed v. United Therapeutics
`lPR2016—00006
`
`|PR2020-00770
`
`United Therapeutics EX2007
`Page 2320 of 7335
`
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`25
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`IPR2020-00770
`United Therapeutics EX2007
`Page 2320 of 7335
`
`

`

`
`
`mentioning structurally.
`
`Is there a difference between the
`
`structure of treprostinil as made by the
`
`Moriarty product and the structure of
`
`treprostinil as made by the ’393 patent?
`
`A.
`
`Yeah, As
`
`I —— as 2 indicated,
`
`structure to me represents the result of the
`
`chemical reaction, and the purity of the
`
`material produced by '393 is higher and the
`
`levels of
`
`of the impurities are
`
`lower in the '393 process compared to Moriarty.
`
`Q.
`
`Let me ask you a hypothetical.
`
`If the -— here you point out that
`
`the difference in purity is
`
`
`
`percent; right?
`
`A.
`
`That’s ——
`
`MR. DELAFIELD: Objection.
`
`Vague.
`
`THE WITNESS: That‘s —~ yes,
`
`that's from my declaration.
`
`BY MR. POLLACK:
`
`Q.
`
`Okay.
`
`Is that a fair
`
`characterization of your declaration that's
`
`made on page 3%? A_§fl percent difference in
`
`average purity?
`
`A.
`
`Yes,
`
`I believe it is.
`
`
`
`
`
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`21
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`22
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`23
`
`24
`
`25
`
`
`
`P315
`
`UT'EX.2058
`SteadyMed V. United Therapeutics
`|PR2016—00006
`
`|PR2020-00770
`
`United Thera
`
`peutics EX2007
`Page 2321 of 7335
`
`IPR2020-00770
`United Therapeutics EX2007
`Page 2321 of 7335
`
`

`

`
`
`Q.
`
`Okay. And in your View,
`
`is that
`
`being used to show that the ‘393 product is
`
`structurally different from the Moriarty
`
`product?
`
`A.
`
`Yes,
`
`in that it contains .-
`
`less impurity than the Moriarty process.
`
`Q.
`
`Okay. Let me ask you.
`
`If instead of E percent
`
`difference, what if the difference was Ea
`
`percent? Would that still be a structural
`
`difference,
`
`in your View?
`
`MR. DELAFIELD: Objection.
`
`Calls for speculation. Outside the scope of
`
`his declaration.
`
`THE WITNESS:
`
`If it was a, that
`
`would represent about a.§fi percent
`
`reduction. Yeah,
`
`that m» that would be
`
`important to me.
`
`BY MR. POLLACK:
`
`Q.
`
`Okay. What about a fig percent
`
`difference? Would that be a structural
`
`difference,
`
`in your View?
`
`MR. DELAFIELD:
`
`Same objections.
`
`THE WITNESS: That would be
`
`about a g percent —— would be, yeah, a
`
`
`
`
`
`
`
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`10
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`
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`20
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`21
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`22
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`23
`
`24
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`25
`
`P317
`
`UT'EX.2058
`
`SteadyMed v. United Therapeutics
`|PR2016-09006
`
`|PR2020-00770
`
`United Therapeutics EX2007
`Page 2322 of 7335
`
`IPR2020-00770
`United Therapeutics EX2007
`Page 2322 of 7335
`
`

`

`
`I—____
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`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`percent reduction in overall impurities.
`
`Maybe.
`
`I don't know.
`
`I'd have to think
`
`about that.
`
`BY MR. POLLACK:
`
`Q.
`
`Okay. What if it were a
`
`percent difference in impurity? Would that ——
`
`between the '393 and treprostinil product,
`
`would that be a structural difference,
`
`in your
`
`View?
`
`MR. DELAFIELD:
`
`Same objections.
`
`THE WITNESS: Well, certainly if
`
`I have to think about EH, I'd have to think
`
`about
`
`
`BY MR. POLLACK:
`
`and I haven't thought about that.
`
`Q.
`
`Do you —— you're giving an opinion
`
`that fig is a structural difference.
`
`I'm trying to figure out where is
`
`that borderline between structural difference
`
`and one that's not a structural difference.
`
`MR. DELAFIELD:
`
`Same objections.
`
`THE WITNESS:
`
`I don‘t know, but
`
`I do believe that a 5% percent reduction
`
`in —— in purity is.
`
`I don't know what
`
`the
`
`cutoff is at the low end, but I'm confident
`
`
`
`
`that _
`
`
`percent reduction in purity is.
`
`
`P318
`
`UT'EX.2058
`SteadyMed v. United Therapeutics
`iPR2016-00006
`
`|PR2020-00770
`
`United Therapeutics EX2007
`Page 2323 of 7335
`
`IPR2020-00770
`United Therapeutics EX2007
`Page 2323 of 7335
`
`

`

`
`STEADYMED LTD., vs UNITED TEERAPEUTICS CORPORATION,
`
`Ruffclo, Robert on 08/19/2316
`
`Page 319
`
`BY MR. POLLACK:
`
`Q.
`
`Okay. Are there -- is there a
`
`number that I could give you that you would
`
`agree that that would be too small a difference
`
`to make a structural difference?
`
`MR. DELAFIELD: Objection.
`
`Relevance. Outside the scope.
`
`Lacks
`
`foundation.
`
`THE WITNESS: You know, not w~
`
`if you‘re asking me can I set the lower
`
`limit?
`
`BY MR. POLLACK:
`
`
`
`
`Q.
`
`A.
`
`Yeah.
`
`I'm telling you, I‘d have to think
`
`about that.
`
`T haven't thought about that, and
`
`I don‘t know off the top of my head what it
`
`would be.
`
`Q.
`
`In your View,
`
`is there no lower
`
`limit?
`
`MR. DELAFIELD: Objection.
`
`Asked and answered.
`
`THE WITNESS: There is a lower
`
`limit to everything.
`
`I just don't know
`
`where it is off the top of my head.
`
`BY MR. POLLACK:
`
`10
`
`ll
`
`12
`
`13
`
`14
`
`15
`
`
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`Elisa Dreier Reporting Corp., A U.S. Legal Support Company
`950 Third Avenue, New York, NY 10022
`(212} 557—5558
`
`UT Ex. 2058
`P-3‘s9
`SteadyMed v, United Therapeutics
`IPRZOifi-OOOOS
`
`|PR2020-00770
`
`United Therapeutics EX2007
`Page 2324 of 7335
`
`IPR2020-00770
`United Therapeutics EX2007
`Page 2324 of 7335
`
`

`

`STEADYMED LTD., VS UNITED THERAPEUTICS CORPORATION,
`Page 320
`Ruffolo, Robert on 08/19/2016
`
`Q.
`
`A.
`
`You haven‘t
`
`thought of that?
`
`No.
`
`MR. DELAFIELD:
`
`Same objections.
`
`BY MR. POLLACK:
`
`Q.
`
`What if there were no difference in
`
`the average purity for the Moriarty process and
`
`the ’393 process? How would your opinion
`
`change then?
`
`MR. DELAFIELD: Objection.
`
`Vague. Calls for speculation.
`
`THE WITNESS: Well, first off,
`
`there isn't no difference. There is a
`
`difference in the purity of treprostinil
`
`that's higher and a difference in the
`
`overall level of impurities that are lower
`
`in the ‘393 process. _So the hypothetical
`
`doesn't mean anything to me.
`
`BY MR. POLLACK:
`
`Q.
`
`I understand, but I'm asking you to
`
`give an opinion based on my hypothetical and
`
`you‘re here as an expert.
`
`So ——
`
`MR. DELAFIELD;
`
`Same objections.
`
`BY MR. POLLACK:
`
`Q.
`
`A.
`
`«m I'd like to you do thaz.
`
`So if you're asking me are two
`
`[\l
`
`He
`
`12
`
`13
`
`14
`
`16
`
`l?
`
`18
`
`19
`
`2O
`
`21
`
`22
`
`23
`
`
`
`
`
`
`
`
`
`Elisa Dreier Reporting Corp., A 0.8. Legal Support Company
`950 Third Avenue, New York, NY 10322
`(212) 557w5558
`P320
`
`UT'EX.2058
`
`SteadyMed v. United Therapeutics
`IPR2016-00006
`
`|PR2020-00770
`
`United Therapeutics EX2007
`Page 2325 of 7335
`
`IPR2020-00770
`United Therapeutics EX2007
`Page 2325 of 7335
`
`

`

`STEAUYMED LTD., VS UNITED THERAPEUTICS CORPORATION,
`Page 321
`Ruffolo, Robert on 08/19/2316
`
`identical preparations?
`
`Q.
`
`A.
`
`Uh—huh.
`
`Is there a difference between two
`
`identical preparations?
`
`Q.
`
`Wellr
`
`they're two different
`
`processes; right?
`
`A.
`
`Q.
`
`Well ~~
`
`But let's say they give around the
`
`same average purity.
`
`A.
`
`Then there could be a difference
`
`depending on which contaminant —— which
`
`contaminants are or aren‘t different, which
`
`ones are elevated or which are lower, and I
`
`wouldn‘t know that in a hypothetical example.
`
`Q.
`
`How come you don't know that?
`
`MR. DELAFIELD: Objection.
`
`THE WITNESS: Because I can‘t ——
`
`MR. DELAFIELD: Calls for
`
`speculation.
`
`THE WITNESS: Because I can‘t
`
`make it up.
`
`BY MR. POLLACK:
`
`Q.
`
`A.
`
`Okay.
`
`You're asking me to make up
`
`information that doesn't exist and I
`
`m— that's
`
`k)
`
`LJJ
`
`Ln
`
`Oi
`
`
`
`19
`
`2G
`
`21
`
`
`
`
`
`
`
`Elisa Dreier Repor:ing Corp., A U.S. Legal Support Company
`557—5558
`950 Third Avenue, New York, NY 10022
`(212)
`P321
`
`UT'EX.2058
`
`SteadyMed v. United Therapeutics
`iPRZDiB-ODDOB
`
`|PR2020-00770
`
`United Therapeutics EX2007
`Page 2326 of 7335
`
`IPR2020-00770
`United Therapeutics EX2007
`Page 2326 of 7335
`
`

`

`STEADYMED LTD., VS UNITED THERAPEUTICS CORPORATION,
`Page 322
`Ruffolo, Robert on 08/19/2016
`
`
`
`not how I think.
`
`Q.
`
`So,
`
`in your opinion, it's not just
`
`a difference in purity, but also the exact
`
`identity of each of those impuri:ies that ——
`
`A.
`
`Q.
`
`A.
`
`Sure.
`
`—— matters to the claim?
`
`Sure.
`
`MR. DELAFIELD: Objection.
`
`Calls for speculation.
`
`BY MR. POLLACK:
`
`Q.
`
`A.
`
`Okay.
`
`Absolutely. Absolutely.
`
`It‘s what
`
`I referred to as the ~— the characteristic
`
`impurities.
`
`Just to give you an example.
`
`If
`
`two processes that were different and had
`
`exactly the same purity, but one of them had a
`
`very high l

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