637
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`___________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`___________________
`
`COALITION FOR AFFORDABLE DRUGS X LLC,
`
`v.
`
`ANACOR PHARMACEUTICALS, INC.,
` Patent Owner.
`
` Petitioner,
`
`Case No.: Unassigned
`
`Patent No.: 7,767,657
`
` Patent No.: 7,582,621
`
`IPR2015-01776
`
`IPR2015-01780
`
`IPR2015-01785
`
`DEPOSITION OF NARASIMHA MURTHY, Ph.D
`
`
`
`
`
`
`
`
`
`Taken at the instance of the Patent Owner at
`
`Courtyard Marriott, 7225 Sleepy Hollow Drive,
`
`Southaven, Mississippi, on Saturday, September 17,
`
`
`
`2016, beginning at 9:01 a.m.
`
`
`GINGER H. BROOKS, CCR #1165
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`CRR, RPR, CCR, CLR, RSA
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`CFAD v. Anacor, IPR2015-01776
`ANACOR EX. 2207 - 1/125
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`___________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`___________________
`
`COALITION FOR AFFORDABLE DRUGS X LLC,
`
`v.
`
`ANACOR PHARMACEUTICALS, INC.,
` Patent Owner.
`
` Petitioner,
`
`Case No.: Unassigned
`
`Patent No.: 7,767,657
`
` Patent No.: 7,582,621
`
`IPR2015-01776
`
`IPR2015-01780
`
`IPR2015-01785
`
`DEPOSITION OF NARASIMHA MURTHY, Ph.D
`
`
`
`
`
`
`
`
`
`Taken at the instance of the Patent Owner at
`
`Courtyard Marriott, 7225 Sleepy Hollow Drive,
`
`Southaven, Mississippi, on Saturday, September 17,
`
`
`
`2016, beginning at 9:01 a.m.
`
`
`GINGER H. BROOKS, CCR #1165
`
`CRR, RPR, CCR, CLR, RSA
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`CFAD v. Anacor, IPR2015-01776
`ANACOR EX. 2207 - 1/125
`
`
`
` 638
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`APPEARANCES:
`
`
`PETER A. GERGELY, ESQ.
`
`KATHLEEN E. OTT, ESQ.
`
`Merchant & Gould
`
`1801 California Street, Suite 3300
`
`Denver, Colorado 80202-2654
`
`pgergely@merchantgould.com
`
`kott@merchantgould.com
`
`COUNSEL FOR PETITIONER
`
`MICHAEL KENNEDY, ESQ.
`
`EVAN KRYGOWSKI, ESQ.
`
`Covington & Burling, LLP
`
`850 Tenth Street, NW
`
`Washington, DC 20001-4956
`
`ekrygowski@cov.com
`
`mkennedy@cov.com
`
`COUNSEL FOR PATENT OWNER
`
`
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`
`
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`
`
`VIDEOGRAPHER: Brent Shorter
`
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`CFAD v. Anacor, IPR2015-01776
`ANACOR EX. 2207 - 2/125
`
`
`
` 639
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`INDEX
`
`Style and Appearances.....................637
`
`Index
`
`
`
`639 ..................................
`
`
`
`Certificate of Deponent .................760
`
`
`
`
`
`Certificate of Court Reporter ............761
`
`
`
`EXAMINATIONS
`
`
`
`Examination By Mr. Kennedy ...............640
`
`
`
`
`
`Examination By Mr. Gergely ...............751
`
`
`
`EXHIBITS
`
`
`
`Exhibit 1070-1 Declaration of Murthy .....644
`
`
`
`in Support of Petitioner's
`
`Reply to Patent Owner's
`
`Response
`
`
`
`Exhibit 1070-2 Declaration of Murthy .....645
`
`
`
`in Support of Petitioner's
`
`Reply to Patent Owner's
`
`Response
`
`
`
`Exhibit 1044-1 Declaration of Murthy .....646
`
`
`
`in Support of Petitioner's
`
`Reply to Patent Owner's
`
`Response
`
`
`
`Exhibit 2157 Previously Marked ...........717
`
`
`
`
`
`Exhibit 1 Calculation ....................740
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`CFAD v. Anacor, IPR2015-01776
`ANACOR EX. 2207 - 3/125
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`VIDEOGRAPHER: This is the Video
`
`Deposition of Dr. Narasimha Murthy, taken in the
`
`matter of "Coalition for Affordable Drugs X, LLC,
`
`versus Anacor Pharmaceuticals, Incorporated."
`
`Today's date is September the 17th, 2016. The time
`
`now is 9:01 a.m.
`
`Counsel may introduce themselves for the
`
`record.
`
`MR. KENNEDY: Mike Kennedy with Covington
`
`and Burling, LLP, for the patent owner, and with me
`
`is my colleague, Evan Krygowski.
`
`MR. GERGELY: Peter Gergely and Kathy Ott
`
`from Merchant & Gould representing the petitioner.
`
`VIDEOGRAPHER: The court reporter will now
`
`swear in the witness.
`
`NARASIMHA MURTHY,
`
`having been first duly sworn, was examined and
`
`testified as follows:
`
`EXAMINATION BY MR. KENNEDY:
`
`Q.
`
`A.
`
`Q.
`
`Good morning, Dr. Murthy. How are you?
`
`Okay.
`
`Now, you've had your deposition taken in
`
`this matter May 4 and 5, 2016, and then redirect on
`
`May 12th, 2016; is that correct?
`
`A.
`
`Right.
`
`CFAD v. Anacor, IPR2015-01776
`ANACOR EX. 2207 - 4/125
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`Q.
`
`Have you had any -- have you given any
`
`depositions in any matter since then?
`
`A.
`
`Q.
`
`No.
`
`Was that the first time you had ever been
`
`deposed, the May depositions in this case?
`
`A.
`
`Q.
`
`In this case, yes.
`
`Yes. So it's fair to say you're generally
`
`familiar with how depositions work at this point by
`
`virtue of your experience in May?
`
`A.
`
`Q.
`
`Right.
`
`Like, for example, you understand the role
`
`of the court reporter, the videographer, that I'm
`
`asking questions or answering them, all that stuff?
`
`A.
`
`Q.
`
`Sure.
`
`And you understand that the oath you just
`
`took has the same force and effect as if you're in a
`
`court of law, right?
`
`A.
`
`Q.
`
`I do.
`
`Is there any reason you can think of, such
`
`as medications you're on, that you can't testify
`
`fully and truthfully today?
`
`A.
`
`Q.
`
`No, I don't have a reason.
`
`Now, since May, have there been any
`
`changes to your professional background and
`
`credentials? Like, for example, I saw you were
`
`CFAD v. Anacor, IPR2015-01776
`ANACOR EX. 2207 - 5/125
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`promoted to full professor in the last couple of
`
`months, right?
`
`A.
`
`Q.
`
`That's correct, yes.
`
`Well, congratulations on that.
`
`Any other changes to your professional
`
`background or qualifications since May?
`
`A.
`
`Q.
`
`Not really.
`
`So the CV that's in the record at Exhibit,
`
`I think, 1009, that's still current?
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`That's correct.
`
`Except for your current job title?
`
`Yeah.
`
`Did you bring any documents with you to
`
`the deposition today?
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`I just brought my declarations.
`
`Okay. Can I see those?
`
`Okay.
`
`Did you make any notes on these -- and
`
`just for clarity, these are your reply declarations,
`
`correct?
`
`A.
`
`Q.
`
`That's right.
`
`You've submitted a number of declarations
`
`in this case, right?
`
`A.
`
`Q.
`
`Pardon me?
`
`You've submitted a number of declarations
`
`CFAD v. Anacor, IPR2015-01776
`ANACOR EX. 2207 - 6/125
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`in these inter partes review proceedings, correct?
`
`A.
`
`Q.
`
`Right.
`
`What we're going to talk about today,
`
`unless I state otherwise, is your reply
`
`declarations.
`
`A.
`
`Okay.
`
`MR. KENNEDY: And, just for the record,
`
`those are Exhibit 1044 in IPR2015-1776, Exhibit 1070
`
`in IPR2015-1780, and Exhibit 1070 in IPR2015-1785.
`
`Q.
`
`(By Mr. Kennedy) Now, Dr. Murthy, I see
`
`you've made a few notes here and there in these
`
`declarations?
`
`A.
`
`Q.
`
`Yeah.
`
`Generally speaking, what was the purpose
`
`of those notes? We can go over them in detail
`
`later. I'm just curious.
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`If you just point to a particular thing --
`
`Oh, sure.
`
`-- I can tell you what it is.
`
`Well, the first one I come to is in the
`
`1044 declaration, paragraph 62, you've underlined
`
`and made some notes about halfway down the page.
`
`A.
`
`Yeah. By reading, I just noted that there
`
`were a couple of typos, so I just made -- made a
`
`note on it.
`
`CFAD v. Anacor, IPR2015-01776
`ANACOR EX. 2207 - 7/125
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`Q.
`
`So the notes you made in these copies of
`
`the reply declarations were in the nature of typos?
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`Mostly.
`
`Fixing typos?
`
`Mostly.
`
`Did you review all three declarations in
`
`preparation for the deposition?
`
`A.
`
`Q.
`
`Yes, I did.
`
`Other than typos, are there any notes in
`
`here that you made?
`
`A.
`
`I don't think, not that I can recollect.
`
`MR. KENNEDY: We may come back to these
`
`later, but let me -- let's do this: Why don't we
`
`mark these three declarations, and I think for
`
`purpose -- and you guys can correct me if we've been
`
`handling this a different way. I think what we can
`
`do is we'll refer to the declarations for the '621
`
`patent, 1776, as just Exhibit 1044, and maybe if the
`
`court reporter could -- actually, that one doesn't
`
`need to be marked. These two, I think, are going to
`
`need to be marked.
`
`I'd like the reply declaration in the 1780
`
`proceeding to be marked as Exhibit 1070-1.
`
`(Exhibit 1070-1 marked for
`
`identification.)
`
`CFAD v. Anacor, IPR2015-01776
`ANACOR EX. 2207 - 8/125
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`MR. KENNEDY: I'd like the declaration in
`
`the 1785 proceeding to be marked as Exhibit 1070-2.
`
`(Exhibit 1070-2 marked for
`
`identification.)
`
`Q. (By Mr. Kennedy) Okay. So I'll hand
`
`these to the witness.
`
`So Dr. Murthy, the three declarations you
`
`brought with you today that we just marked, are
`
`those true and complete copies of your reply
`
`declarations and these three IPR proceedings?
`
`A.
`
`Q.
`
`Yes.
`
`And let's start with Exhibit 1044, if you
`
`could turn to page 65 of that declaration.
`
`A.
`
`Q.
`
`A.
`
`Yes.
`
`And that -- is that your signature page?
`
`No. This is -- this is not the
`
`signed copy. I didn't get the signed copy.
`
`Q.
`
`A.
`
`Q.
`
`version?
`
`A.
`
`Q.
`
`Oh. Can I see what you have?
`
`I just got the --
`
`Okay. But is this -- is this the final
`
`That's the final version.
`
`Okay. I suppose for purposes of good
`
`order, why don't we just mark our copy? It's going
`
`to get confusing, but -- so I'd like to mark this
`
`CFAD v. Anacor, IPR2015-01776
`ANACOR EX. 2207 - 9/125
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`as, I guess, Exhibit 1044-1.
`
`(Exhibit 1044-1 marked for
`
`identification.)
`
`Q (By Mr. Kennedy) I'm handing this to the
`
`witness.
`
`copy?
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`Can you go to the signature page of that
`
`Yes.
`
`Is that your signature, sir?
`
`This is my signature.
`
`You signed this declaration on
`
`August 23rd, 2016?
`
`A.
`
`Q.
`
`That's correct.
`
`And you understood when you were signing
`
`the declaration, you were attesting that everything
`
`in the declaration is true and correct under the
`
`penalty of perjury, right?
`
`A.
`
`Q.
`
`Correct.
`
`And you understand, likewise, today,
`
`you're testifying under the penalty of perjury,
`
`correct?
`
`A.
`
`Q.
`
`Yes.
`
`Now, I think you mentioned you reviewed an
`
`unsigned copy of the same declaration, and you noted
`
`a few errors.
`
`CFAD v. Anacor, IPR2015-01776
`ANACOR EX. 2207 - 10/125
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`Does the copy you brought with you that
`
`we've marked as Exhibit 1044 contain all the errors
`
`and typos that you found?
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`Right, whatever I found is marked in this.
`
`We'll review that in more detail later.
`
`Okay.
`
`Now, let me ask you this: Can you
`
`generally describe the process of preparing these
`
`three reply declarations?
`
`A.
`
`Q.
`
`A.
`
`It's clearly mentioned in my declaration.
`
`They are in paragraph four.
`
`Yes. That's right. So, basically, the
`
`drafting process involved in light of the patents
`
`and literature, and after several teleconferences
`
`and giving my input, the counsel and myself
`
`together, we interchange the draft back and forth
`
`and made all the necessary changes and made up the
`
`final -- final version for signature.
`
`Q.
`
`So when -- you mentioned several
`
`conferences.
`
`A.
`
`Q.
`
`Right.
`
`That -- did those precede either you or
`
`your attorneys putting pen to paper for the reply
`
`declarations?
`
`A.
`
`Right.
`
`CFAD v. Anacor, IPR2015-01776
`ANACOR EX. 2207 - 11/125
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`Q.
`
`And was that the same process for all
`
`three of the declarations?
`
`A.
`
`Q.
`
`That's correct.
`
`Who wrote the first draft of the reply
`
`declarations?
`
`A.
`
`Q.
`
`The first draft was written by my counsel.
`
`And how many drafts went back and forth
`
`before you signed the reply declarations?
`
`A.
`
`I can't remember the exact number, but we
`
`made several changes over a period of time. To give
`
`you a number, it could be like four versions or five
`
`versions.
`
`Q.
`
`And you said you made changes to those
`
`drafts during the process?
`
`A.
`
`Q.
`
`That's correct.
`
`Are there any particular changes that jump
`
`out at you that you made to drafts written by your
`
`attorneys?
`
`A.
`
`I remember I made a number of additions
`
`and revisions. I can't recall exactly, you know,
`
`point by point, but if you just point to a
`
`particular paragraph, then I can just tell you what
`
`additions so -- I mean, if I made any changes on
`
`that paragraph or not.
`
`Q.
`
`Sure. Let's go to 42.
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`Do you remember making any edits to
`
`paragraph 42 in Exhibit 1044?
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`(Examining.) No.
`
`Let's try 70.
`
`(Examining.)
`
`Do you remember making any edits to
`
`paragraph 70 in Exhibit 1044?
`
`A.
`
`(Examining.) We discussed about this --
`
`this paragraph, but there was no edits. I agree
`
`with what my counsel has written.
`
`Q.
`
`Let's pick another one at random.
`
`How about 90?
`
`90?
`
`Yeah.
`
`(Examining.) No, all this was discussed.
`
`A.
`
`Q.
`
`A.
`
`I don't think there was any need to make any changes
`
`on this paragraph.
`
`Q.
`
`Well, one -- one reason you wouldn't have
`
`had any changes to this paragraph 90 is because it
`
`kind of gets into mycology issues, right, and you're
`
`not a mycologist?
`
`A.
`
`Well, I'm not a mycologist to the extent
`
`of understanding -- you know, the structural
`
`differences and, you know, in-depth information
`
`about fungal organisms, but this route, general
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`information on my background knowledge, so it
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`doesn't require a mycologist to understand this
`
`paragraph.
`
`Q.
`
`Well, let me ask you about that. So
`
`paragraph 90, which I picked, talks about a
`
`reference called Elewski, which is in the record as
`
`Exhibit 2070.
`
`Do you see that?
`
`Yes.
`
`When did you first become aware of the
`
`A.
`
`Q.
`
`Elewski reference?
`
`A.
`
`Again, I cannot recall when it was
`
`exactly, but I think this was one of the citations
`
`in the response, patent owner's response, and that's
`
`why I reviewed this document. Otherwise, in
`
`general, I'm quite aware of Dr. Elewski's work in
`
`this area of treatment of fungal infections.
`
`Q.
`
`A.
`
`What do you know about Dr. Elewski?
`
`She's a clinician, and she has published a
`
`number of papers on the treatment of nail diseases.
`
`Q.
`
`When was the first time you became aware
`
`of her work?
`
`A.
`
`Q.
`
`A.
`
`Of her work?
`
`Yes.
`
`I would say about six years ago, when I
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`was -- when I was putting together a grant proposal
`
`on the -- in the nail diseases.
`
`Q.
`
`Tell me about the grant proposal. What
`
`was it about? What were you trying to get a grant
`
`for?
`
`A.
`
`I was trying to get a grant for a new
`
`technique of delivering antifungal drugs into and
`
`across the nail plate for treating onychomycosis.
`
`Q.
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`And how did you find out about her work?
`
`Well, in the --
`
`Through literature search or --
`
`It's through my search.
`
`When was the first -- was that the first
`
`literature search you had ever performed concerning
`
`antifungals?
`
`A.
`
`My search and my -- my experience with
`
`antifungal drugs goes back to 2002, 2003, when I was
`
`doing my post-doc., but particularly, when I was
`
`looking at the clinical papers and papers about
`
`different types of drugs that I can choose as
`
`candidates for my project, that's when I came across
`
`Dr. Elewski's paper.
`
`Q.
`
`A.
`
`Q.
`
`Are you an expert in mycology, sir?
`
`I'm not an expert in mycology.
`
`By the way, do you have -- do you still
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`have the drafts of your reply declarations?
`
`A.
`
`Q.
`
`Drafts of reply declarations?
`
`Yeah. I think you said there was a
`
`back-and-forth drafting process with your attorneys.
`
`A.
`
`Q.
`
`A.
`
`Right.
`
`Do you still have those drafts?
`
`I didn't try to preserve them, but it
`
`could be there. Some may be there. I'm not sure.
`
`I didn't bring them with me.
`
`MR. KENNEDY: Okay. Counsel, to the
`
`extent they're still in Dr. Murthy's possession, I'd
`
`ask that those drafts be produced. And I understand
`
`this comes up at every deposition, but I just want
`
`to make a record that I think we have a disagreement
`
`about the interpretation of Rule 26 in the context
`
`of IPRs.
`
`MR. GERGELY: And I understand the
`
`request, and we've objected before, and we'll object
`
`to the request as well this time under Rule 26.
`
`MR. KENNEDY: Okay.
`
`Q. (By Mr. Kennedy) So you understand you've
`
`submitted three reply declarations in connection
`
`with these three IPR proceedings, correct?
`
`A.
`
`Q.
`
`Correct.
`
`And I'm happy to mark the other two signed
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`copies, but can -- in order to make the deposition
`
`more efficient, can we agree that unless otherwise
`
`specifically stated, my questions and your answers
`
`concerning Exhibit 1044, which is the declaration
`
`for the '621 patent, apply equally to all three?
`
`A.
`
`Q.
`
`Sure.
`
`Do you see any issue with proceeding in
`
`that fashion?
`
`A.
`
`Q.
`
`No.
`
`So, generally speaking, I expect we'll be
`
`working off Exhibit 1044 and the signed version of
`
`1044-1?
`
`A.
`
`Q.
`
`Sure.
`
`And do you have any reason to believe that
`
`Exhibits 1044 and 1044-1 are different in any way?
`
`The only reason I ask is you brought an
`
`unsigned copy. I just want to make sure that
`
`there's no dispute later about what exactly we're
`
`looking at.
`
`A.
`
`Q.
`
`I don't think that.
`
`Okay. Now, in the process of preparing
`
`your reply declarations, can you think of any
`
`literature or other reference you cited that was not
`
`provided to you by counsel?
`
`A.
`
`No.
`
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`Q.
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`So you didn't do any of your own
`
`literature research or other self-directed research
`
`to prepare your reply declarations?
`
`A.
`
`I looked at literature. I looked at, you
`
`know, information from different sources, but --
`
`Q.
`
`A.
`
`Like what?
`
`In -- like the research papers and
`
`textbooks and such things that I -- I generally read
`
`before I -- I put anything on paper.
`
`But in this declaration, because it's a
`
`continuing -- it's a reply declaration, I didn't
`
`have to really bring in a new citation for it. We
`
`just used the citations that we had provided earlier
`
`and the citations that were in the response.
`
`Q.
`
`A.
`
`Q.
`
`You mentioned textbooks.
`
`That's right.
`
`So you reviewed textbooks in preparation
`
`for or as part of the process of preparing these
`
`declarations?
`
`A.
`
`I have a practice of generally going back
`
`and checking to -- and I check the boxes and facts
`
`from the textbooks. So if you call that a review,
`
`yes, I did it.
`
`Q.
`
`A.
`
`What textbooks?
`
`Like "Remington Pharmaceutical Sciences"
`
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`is one book that I generally refer. My own book on
`
`the nail, "Topical Nail Products and Ungual Drug
`
`Delivery."
`
`Q.
`
`Did you review Anacor's Patent Owner
`
`Response in order to prepare these reply
`
`declarations?
`
`A.
`
`Q.
`
`response?
`
`A.
`
`Q.
`
`Yes, I did.
`
`When did you first review the patent owner
`
`That was the month of July.
`
`Did -- did you review a declaration
`
`submitted by a Dr. Ryder?
`
`A.
`
`Declaration, that's correct, by Ryder,
`
`yes, I did.
`
`Q.
`
`Did you review a declaration of a
`
`Dr. Majella Lane?
`
`A.
`
`Q.
`
`I did.
`
`Did you review a declaration of a
`
`Dr. Mahmoud Ghannoum?
`
`A.
`
`Q.
`
`I did.
`
`I would hope so. It's cited in your reply
`
`declarations.
`
`A.
`
`Q.
`
`Yeah.
`
`Did you review a declaration of
`
`Dr. Maibach?
`
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`A.
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`Q.
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`counsel?
`
`you?
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`Yes, I did.
`
`And those were all provided to you by
`
`That's correct.
`
`Approximately when were they provided to
`
`I believe third or fourth week of July.
`
`Is the third or fourth week of July
`
`approximately when you began working on these reply
`
`declarations?
`
`A.
`
`Q.
`
`Yes.
`
`Now, in your view as stated in your reply
`
`declarations, the Austin reference alone provides a
`
`reasonable expectation of success to treat
`
`onychomycosis, correct?
`
`A.
`
`Q.
`
`Correct.
`
`Can you go to paragraph 44? So I'm
`
`looking at the last para- -- the last sentence where
`
`you read, "Thus for a POSITA seeking an antifungal
`
`compound for treatment of onychomycosis, this
`
`information alone would provide a reasonable
`
`expectation that tavaborole would be successful."
`
`Do you see that?
`
`Right.
`
`Now, just so we're on the same page, when
`
`A.
`
`Q.
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`you use the phrase "this information" --
`
`A.
`
`Q.
`
`Uh-huh (affirmative response).
`
`-- you're referring solely to molecular
`
`weight and minimum inhibitory concentration?
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`Correct.
`
`And I may use the acronym "MIC."
`
`Correct.
`
`Do you understand that --
`
`Uh-huh (affirmative response).
`
`-- means minimum inhibitory concentration?
`
`Yes.
`
`And your view -- your opinion as stated in
`
`your reply declarations is the MIC and the molecular
`
`weight of a compound or -- strike that.
`
`In your opinion as stated in your reply
`
`declaration, "The MIC and molecular weight of
`
`tavaborole as reported in Austin is all a POSITA
`
`would have needed in order to reasonably expect
`
`successful development of a safe and effective drug
`
`to treat onychomycosis," correct?
`
`A.
`
`The information that's -- that's provided
`
`in Austin is all what a POSITA would need to -- to
`
`take the molecule further and develop a potential
`
`medication for the treatment of onychomycosis.
`
`Q.
`
`So I'm going to pass you what has
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`previously been put in the record as Exhibit 1001
`
`in, I assume, the 1776 proceeding. This is the '621
`
`patent.
`
`A.
`
`Q.
`
`Okay.
`
`You recognize this as the patent at issue
`
`in one of the three proceedings, correct?
`
`A.
`
`Q.
`
`claims --
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`Correct.
`
`My questions will be confined to the
`
`Correct.
`
`-- at the end of the patent.
`
`Uh-huh (affirmative response).
`
`By the way, I feel like I should know
`
`this, are you the inventor on any United States
`
`patents that have issued?
`
`A.
`
`Q.
`
`No, I'm not.
`
`Let's turn -- but you know what "claims"
`
`are, right?
`
`A.
`
`Q.
`
`Yeah.
`
`So why don't we just turn to the claims.
`
`And I'd just like to look at claim one,
`
`and I'd just like to quickly go limitation by
`
`limitation and just confirm that you believe Austin
`
`alone teaches the limitation and provides a
`
`reasonable expectation of success in practicing the
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`claim.
`
`So claim one would be a method of treating
`
`an infection in an animal.
`
`Do you see that?
`
`Your view is Austin alone teaches that
`
`limitation, correct?
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`Just a second.
`
`Sure.
`
`(Examining.) Correct.
`
`Correct?
`
`That's correct.
`
`And then the next part of the claim, "Said
`
`method comprising administering to the animal a
`
`therapeutically effective amount of," and then it
`
`gives a formula.
`
`We're agreed that this claim is referring
`
`to tavaborole, correct?
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`You mean the second one or the first one?
`
`Still in claim one.
`
`Okay.
`
`I've moved on to where it says "... said
`
`method comprising administering to the animal a
`
`therapeutically effective amount of
`
`1,3-dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole..."
`
`Do you see that?
`
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`A.
`
`Q.
`
`Yeah.
`
`And we agree that the second part of what
`
`I just said, it refers to tavaborole, correct?
`
`A.
`
`Q.
`
`Yeah.
`
`So you believe Austin alone discloses
`
`comprising administering to the animal a
`
`therapeutically effective amount of tavaborole,
`
`correct?
`
`A.
`
`Q.
`
`Correct.
`
`And you also believe that Austin discloses
`
`an amount of tavaborole sufficient to treat said
`
`infection, correct? That's the last part of claim
`
`1. A verbal response would be preferred.
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`I'm just reading.
`
`Oh, sure.
`
`Can I get the question again?
`
`Sure.
`
`You agree that Austin alone discloses
`
`using an amount of tavaborole sufficient to treat
`
`said infection as dis- -- as recited by claim 1?
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`Yes.
`
`Now, let's look at claim 4.
`
`Okay.
`
`And claim 4 is a dependent claim that
`
`reads as follows: "The method of claim 1, wherein
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`said infection is onychomycosis."
`
`Do you see that?
`
`Correct.
`
`And you'd agree that Austin alone
`
`A.
`
`Q.
`
`discloses a method that would treat onychomycosis as
`
`recited by claim 4, correct?
`
`A.
`
`Q.
`
`Correct.
`
`A method, according to claim 1, that would
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`treat onychomycosis, right?
`
`A.
`
`Q.
`
`Correct.
`
`Now, let's look at claim 6, which depends
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`from claim 4 and claim 1, claim 6 reads, "the method
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`of claim 4, wherein said onychomycosis is tinea
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`unguium."
`
`Do you see that?
`
`Correct.
`
`Now, your position in your reply
`
`A.
`
`Q.
`
`declaration is that Austin alone discloses and
`
`provides a reasonable expectation of success in
`
`treating onychomycosis that is tinea unguium as
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`recited by claim 6, correct?
`
`A.
`
`Q.
`
`Correct.
`
`And you can put that aside. And with
`
`apologies for it being so bulky, I would like to
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`pass you what has already been marked as
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`CFAD v. Anacor, IPR2015-01776
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`Exhibit 1001 in the other two IPR proceedings at
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`issue here.
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`MR. KENNEDY: Actually, I apologize. Can
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`I have one of those copies? It would just make
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`things go faster.
`
`Q. (By Mr. Kennedy) Now, you recognize the
`
`'657 patent is the one at issue in the other two IPR
`
`proceedings, the 1780 and 1785 proceedings, right?
`
`A.
`
`Q.
`
`Right.
`
`And I'd like to start with claim 1. And
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`again, my questions will be confined to the claims
`
`on the very last page of the patent -- well, second
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`to last page. There's a Certificate of Correction.
`
`I'm sorry about that.
`
`A.
`
`Q.
`
`Okay.
`
`Now, looking at claim 1, it says as
`
`follows: "A pharmaceutical formulation
`
`comprising" -- again, you see a formula that we can
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`agree is tavaborole or a salt thereof.
`
`Do you see that?
`
`Right.
`
`Now, your view as stated in your reply
`
`A.
`
`Q.
`
`declarations, is that Austin alone teaches a
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`pharmaceutical formulation comprising tavaborole,
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`correct?
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`A.
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`Q.
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`Correct.
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`Then moving on, claim 1 also requires a
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`pharmaceutically acceptable excipient in the
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`pharmaceutical formulation.
`
`Do you see that?
`
`Correct.
`
`Now, your view is it would be obvious in
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`A.
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`Q.
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`view of Austin alone to make a pharmaceutical
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`formulation with pharmaceutically acceptable
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`excipients, correct?
`
`A.
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`Q.
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`Correct.
`
`And then claim 1 goes on to say, "wherein
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`said pharmaceutical formulation is for topical
`
`administration to an animal suffering from an
`
`infection by a microorganism."
`
`Do you see that?
`
`Correct.
`
`And you'll agree that your view as stated
`
`A.
`
`Q.
`
`in your reply declarations is that Austin alone
`
`teaches that final limitation of claim 1, correct?
`
`A.
`
`Q.
`
`Correct.
`
`Let's move on to para- -- or claim 14.
`
`Claim 14 reads as follows: "The formulation of
`
`claim 1, wherein the microorganism is a fungus or a
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`yeast."
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`Do you see that?
`
`Yes.
`
`And your view in your reply declarations,
`
`A.
`
`Q.
`
`is that Austin alone renders obvious the additional
`
`limitations of claim 14 where the microorganism is a
`
`fungus or a yeast, correct?
`
`A.
`
`Q.
`
`Correct; correct.
`
`Let's move on to claim 18: "The
`
`formulation of claim 14, wherein said fungus or
`
`yeast is a dermatophyte."
`
`Do you see that?
`
`Correct.
`
`And your opinion as stated in your reply
`
`A.
`
`Q.
`
`declarations is that Austin alone renders obvious
`
`claim 18 that I've just recited, correct?
`
`A.
`
`Q.
`
`Correct.
`
`Let's go to claim 19. "The formulation of
`
`claim 14, wherein said fungus or yeast is a member
`
`selected from tinea unguium, Trichophyton rubrum,"
`
`or I think it's just called "T rubrum," and the
`
`third one which I'm not going to try to pronounce,
`
`but three dermatophytes.
`
`Do you see that?
`
`Yes.
`
`And your view is that Austin alone -- your
`
`A.
`
`Q.
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`CFAD v. Anacor, IPR2015-01776
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`view in your reply declarations is that Austin alone
`
`renders obvious claim 19 with those additional
`
`limitations, correct?
`
`A.
`
`Q.
`
`Correct.
`
`Finally, let's go to claim 22, which
`
`reads, "The formulation of claim 1, wherein the
`
`infection is onychomycosis."
`
`Do you see that?
`
`A.
`
`Q.
`
`Uh-huh (affirmative response).
`
`And again, your view in your reply
`
`declarations is that Austin alone renders obvious a
`
`pharmaceutical formulation with tavaborole,
`
`pharmaceutically acceptable excipients where the
`
`infection to be treated is onychomycosis, correct?
`
`A.
`
`Q.
`
`Correct.
`
`Okay. You can put that aside.
`
`Okay. Can you go back to your
`
`declaration, paragraph 70? And I'm looking at the
`
`first sentence where you say, "Contrary to
`
`Dr. Lane's opinion, at least as early as 2005, nail
`
`penetration of antifungal drugs was predictable."
`
`Do you see that?
`
`Yes.
`
`What do you mean by "predictable"?
`
`Predictable is like if you -- antifungal
`
`A.
`
`Q.
`
`A.
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`CFAD v. Anacor, IPR2015-01776
`ANACOR EX. 2207 - 29/125
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`drugs in the -- yeah, given a molecule, should be
`
`able to predict if the molecule would be able to
`
`penetrate across the nail plate or not.
`
`Q.
`
`Okay. So if I have a molecule that is --
`
`has a molecular weight of 299 daltons and you don't
`
`know anything else about it, would it penetrate the
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`nail plate or not?
`
`A.
`
`The molecule -- the lower molecular weight
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`would penetrate much better than the higher
`
`molecular weight, so the penetrability of the
`
`permeation goes on decreasing with increasing
`
`molecular weight, so that -- that answers the
`
`question, I think.
`
`Q.
`
`Well, not exactly. I asked you a very
`
`specific question.
`
`I have a molecule that weighs 299 daltons.
`
`I don't know anything else about it, but I need to
`
`know if it's going to get through the nail plate or
`
`not, so what -- is it going to get through the nail
`
`plate?
`
`A.
`
`Yeah. Given the molecular weight, there
`
`would be a certain extent of penetration into and
`
`across the nail plate for the molecule of 299
`
`daltons.
`
`Q.
`
`Is it going to be -- so you say, "a
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`certain extent of penetration." Is it going to be
`
`enough for efficacy?
`
`A.
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`That depends on the MIC value of the
`
`molecule.
`
`Q.
`
`So if it was 299 daltons but it had -- it
`
`was very potent, you might say it would be
`
`effective, like it had a very low MIC value?
`
`A.
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`If it's highly potent, then penetration of
`
`a little amount of drug would be sufficient to treat
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`the -- treat the fungus.
`
`Q.
`
`So what if it were 150 daltons but it were
`
`barely potent at all, would the penetration be
`
`sufficient or not to be efficacious?
`
`A.
`
`Question again, please.
`
`MR. KENNEDY: Would you read back the
`
`question, please?
`
`(Record read.)
`
`THE WITNESS: I think you need to be more
`
`specific -- specific about this "barely potent."
`
`What do you mean by --
`
`Q. (By Mr. Kennedy) Well, let me ask you
`
`this: I'm trying to understand your reply opinions
`
`that the only information -- you can correct me if
`
`I'm wrong, but it seems like the thrust of your
`
`reply declarations is that the only information you
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`nee
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