1
`
`- VOLUME 1 -
`IN THE UNITED STATES DISTRICT COURT
`IN AND FOR THE DISTRICT OF DELAWARE
`NOVARTIS PHARMACEUTICALS
`CIVIL ACTION
`CORPORATION and NOVARTIS
`AG,
`Plaintiffs,
`
`NO. 14-1043 (RGA)
`CIVIL ACTION
`
`NO. 14-1196 (RGA)
`CIVIL ACTION
`
`NO. 14-1289 (RGA)
`
`::::::::::::::::::::::::::::::::
`
`vs.
`BRECKENRIDGE
`PHARMACEUTICALS INC.,
`Defendant.
`------------------------
`NOVARTIS PHARMACEUTICALS
`CORPORATION and NOVARTIS
`AG,
`Plaintiffs,
`
`vs.
`ROXANE LABORATORIES,
`INC.,
`Defendant.
`------------------------
`NOVARTIS PHARMACEUTICALS
`CORPORATION and NOVARTIS
`AG,
`Plaintiffs,
`
`vs.
`PAR PHARMACEUTICAL,
`INC.,
`Defendant.
`
`Wilmington, Delaware
`Monday, August 29, 2016
`8:38 o'clock, a.m.
`- - -
`BEFORE: HONORABLE RICHARD G. ANDREWS, U.S.D.C.J.
`
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`NOVARTIS EXHIBIT 2107
`Par v Novartis, IPR 2016-00084
`Page 1 of 8
`
`
`
`- VOLUME 1 -
`IN THE UNITED STATES DISTRICT COURT
`IN AND FOR THE DISTRICT OF DELAWARE
`NOVARTIS PHARMACEUTICALS
`CIVIL ACTION
`CORPORATION and NOVARTIS
`AG,
`Plaintiffs,
`
`NO. 14-1043 (RGA)
`CIVIL ACTION
`
`NO. 14-1196 (RGA)
`CIVIL ACTION
`
`NO. 14-1289 (RGA)
`
`::::::::::::::::::::::::::::::::
`
`vs.
`BRECKENRIDGE
`PHARMACEUTICALS INC.,
`Defendant.
`------------------------
`NOVARTIS PHARMACEUTICALS
`CORPORATION and NOVARTIS
`AG,
`Plaintiffs,
`
`vs.
`ROXANE LABORATORIES,
`INC.,
`Defendant.
`------------------------
`NOVARTIS PHARMACEUTICALS
`CORPORATION and NOVARTIS
`AG,
`Plaintiffs,
`
`vs.
`PAR PHARMACEUTICAL,
`INC.,
`Defendant.
`
`Wilmington, Delaware
`Monday, August 29, 2016
`8:38 o'clock, a.m.
`- - -
`BEFORE: HONORABLE RICHARD G. ANDREWS, U.S.D.C.J.
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
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`NOVARTIS EXHIBIT 2107
`Par v Novartis, IPR 2016-00084
`Page 1 of 8
`
`
`
`54
`
`Partridge - direct
`Partridge has both a throat ailment and
`discovered when he got to Delaware he needs a
`root canal, and hot tea is able to soothe those
`conditions.
`I just wanted the Court's
`permission to bring a thermos of tea.
`THE COURT:
`Sure.
`MR. SORENSON:
`Your Honor, may I
`
`approach?
`
`Sure.
`THE COURT:
`MR. SORENSON:
`Your Honor, for the
`record, defendants call Dr. John Partridge.
`May
`I approach?
`
`My name is Chris
`I'm sorry.
`Sorenson and I am with Merchant & Gould,
`representing Breckenridge in this case.
`THE COURT:
`All right.
`Dr.
`Partridge, come on up.
`... JOHN PARTRIDGE, having
`been duly sworn as a witness, was
`examined and testified as follows...
`MR. SORENSON:
`May it please the
`
`Court?
`
`BY MR. SORENSON:
`
`DIRECT EXAMINATION
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`NOVARTIS EXHIBIT 2107
`Par v Novartis, IPR 2016-00084
`Page 2 of 8
`
`
`
`Partridge - cross
`the next section in five minutes.
`Okay.
`Can we put up part slide
`
`217
`
`12, please.
`BY MR. SOLANDER:
`And this is a patent that you said
`Q.
`in your direct testimony would have motivated a
`person of ordinary skill in the art to make
`changes to rapamycin; is that right?
`To make changes at I believe it's
`A.
`
`C40.
`
`Now, all of the
`All right.
`Q.
`patents on this slide are from one company; is
`that right?
`American Home Products?
`Yes.
`And once upon a time, it was
`A.
`Ayerst, and then it was Wyeth Ayerst, and then
`it's was a whole bunch of names, but it
`eventually became American Home Products, which
`is a holding company.
`Today it's Pfizer; is that right?
`Q.
`Yes.
`And they were taken out by
`A.
`Pfizer, so it's now Pfizer.
`Okay.
`And those workers at
`Q.
`American Home Products were undoubtedly very
`knowledgeable about rapamycin and making
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`NOVARTIS EXHIBIT 2107
`Par v Novartis, IPR 2016-00084
`Page 3 of 8
`
`
`
`218
`
`Partridge - cross
`derivatives of rapamycin; is that correct?
`Scientists there?
`That's an interesting question
`A.
`because of all the chaos that went on with those
`companies, but, yes.
`They would have
`information about rapamycin and making analogs.
`And they were experimenting with
`Q.
`modifications at groups other than the C40
`group; is that right?
`Yes.
`A.
`And they were also making the
`Q.
`types of changes even when they were working on
`C40 that were different than the small
`conservative changes that you suggest; is that
`right?
`
`And they made large changes in C40
`A.
`and maintained the immunosuppressant activity.
`Okay.
`So let's look at some of
`Q.
`these slides.
`If I could see some of -- some of
`these patents.
`If I could see Partridge slide 13.
`The Caufield patent.
`You testified in this patent they
`were making changes to the bottom of the
`
`Thank you.
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`NOVARTIS EXHIBIT 2107
`Par v Novartis, IPR 2016-00084
`Page 4 of 8
`
`
`
`Partridge - cross
`
`228
`
`it.
`
`And that's an opinion that you
`Q.
`gave in this case; is that right?
`Part of your
`expert report?
`It starts out, I am aware.
`Yes.
`A.
`And when you were working in
`Yes.
`Q.
`the drug field and making "me too" compounds, it
`was always the goal to get a patent; isn't that
`right?
`
`It was always the goal to write up
`A.
`a body of work and hand it to someone in the
`Patent Office of my company, and however they
`did things, to either get a patent or not get a
`patent, with the U.S. Patent and Trademark
`Office.
`I didn't have anything to do with that.
`But the only way to make your boss
`Q.
`happy and to make money there was to have
`obtained a patent on the compound; is that
`right?
`
`If those were useful
`Yes.
`A.
`compounds, my boss would be happy.
`Okay.
`And let's switch gears.
`Q.
`You can take that down.
`You would agree that as of
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`NOVARTIS EXHIBIT 2107
`Par v Novartis, IPR 2016-00084
`Page 5 of 8
`
`
`
`229
`Partridge - cross
`October 1992, rapamycin was sufficiently water
`soluble to be used as an immunosuppressant drug;
`is that correct?
`It was apparently water soluble,
`A.
`but it was water soluble enough, yes.
`So as of October 1992, one of
`Q.
`ordinary skill knew that it was not necessary to
`modify rapamycin water solubility for its
`immunosuppressant activity to be realized; is
`that correct?
`For rapamycin itself, yes.
`A.
`Now, do you agree with Dr. Fung,
`Q.
`that rapamycin was known to be toxic in October
`of 1992?
`
`I am in agreement that all of
`A.
`these immunosuppressive compounds are toxic.
`And you did not know when you
`Q.
`arrived at your opinions in this case whether
`the cause of rapamycin toxicity was known in
`October of 1992; is that right?
`I simply know that in general,
`A.
`immunosuppressive compounds are all toxic,
`yes.
`
`Q.
`
`Okay.
`
`And you don't know what
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`NOVARTIS EXHIBIT 2107
`Par v Novartis, IPR 2016-00084
`Page 6 of 8
`
`
`
`250
`
`Partridge - cross
`Right.
`So you have one journal
`Q.
`article that says one thing and one journal
`article that says another, the same journal?
`The
`No, not quite the same thing.
`A.
`first Baumann paper which I'm familiar with went
`into great detail showing the binding element
`and effector element, and this drawing is a
`great variance with that paper, and this
`publication is like some sort of, for me, some
`sort of odd summary of the other three
`publications.
`And I disagree with this drawing.
`Okay.
`And you would agree with me
`Q.
`that this part of the FKBP binds with the -- the
`interaction with the immunophilin; is that
`correct?
`
`Interacts with the FKBP,
`Yes.
`A.
`binding protein or immunophilin, yes.
`So you would agree that the C40
`Q.
`hydroxyl and the C28 hydroxyl groups interact
`with the immunophilin group via hydrogen bonding
`between rapamycin and FKBP?
`That's a very complex subject, but
`A.
`in some sense based on the latest information,
`there is an interaction.
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`NOVARTIS EXHIBIT 2107
`Par v Novartis, IPR 2016-00084
`Page 7 of 8
`
`
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`251
`
`Partridge - cross
`And the hydrogen bonding between
`Q.
`C40 and C28, that was known, sorry, between the
`C40 hydroxyl and the C28 hydroxyl of rapamycin
`and the FKBP protein was known as of
`October 1992; is that correct?
`Yes.
`That was the Schreiber and
`A.
`John Colarti.
`
`No further
`
`MR. SOLANDER:
`questions, your Honor.
`THE COURT:
`
`All right.
`
`Any
`
`redirect?
`
`Honor.
`
`MR. SORENSON:
`
`Briefly, your
`
`REDIRECT EXAMINATION
`
`BY MR. SORENSON:
`Now, Dr. Partridge, do you
`Q.
`remember all of those tables from DTX-434 that
`counsel just showed you, those compounds?
`That would be the 17 patents
`A.
`
`table.
`
`Each and every one of those
`Q.
`patents was on our hypothetical chemist's
`workbench in October of 1992; is that correct?
`Yes, sir.
`A.
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`NOVARTIS EXHIBIT 2107
`Par v Novartis, IPR 2016-00084
`Page 8 of 8
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