Case 1:15-cv-13099-FDS Document 143 Filed 06/19/17 Page 1 of 136
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` UNITED STATES DISTRICT COURT
` DISTRICT OF MASSACHUSETTS
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`Civil Action
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`No. 15-13099-FDS
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`) ) ) ) ) ) ) ) )
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`PURDUE PHARMA L.P., et al.,
`Plaintiffs
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`vs.
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`COLLEGIUM PHARMACEUTICAL, INC.,
`Defendant.
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`BEFORE: THE HONORABLE F. DENNIS SAYLOR, IV
`
`MARKMAN HEARING
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`John Joseph Moakley United States Courthouse
`Courtroom No. 2
`1 Courthouse Way
`Boston, MA 02210
`
`June 1, 2017
`9:00 a.m.
`
`Valerie A. O'Hara, FCRR, RPR
`Official Court Reporter
`John Joseph Moakley United States Courthouse
`1 Courthouse Way, Room 3204
`Boston, MA 02210
`E-mail: vaohara@gmail.com
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`Purdue 2024
`Collegium v. Purdue, PGR2018-00048
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`1
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` UNITED STATES DISTRICT COURT
` DISTRICT OF MASSACHUSETTS
`
`Civil Action
`
`No. 15-13099-FDS
`
`) ) ) ) ) ) ) ) )
`
`PURDUE PHARMA L.P., et al.,
`Plaintiffs
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`vs.
`
`COLLEGIUM PHARMACEUTICAL, INC.,
`Defendant.
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`BEFORE: THE HONORABLE F. DENNIS SAYLOR, IV
`
`MARKMAN HEARING
`
`John Joseph Moakley United States Courthouse
`Courtroom No. 2
`1 Courthouse Way
`Boston, MA 02210
`
`June 1, 2017
`9:00 a.m.
`
`Valerie A. O'Hara, FCRR, RPR
`Official Court Reporter
`John Joseph Moakley United States Courthouse
`1 Courthouse Way, Room 3204
`Boston, MA 02210
`E-mail: vaohara@gmail.com
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`Case 1:15-cv-13099-FDS Document 143 Filed 06/19/17 Page 2 of 136
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`APPEARANCES:
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`For The Plaintiffs:
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`Jones Day, by CHRISTOPHER M. MORRISON, ESQ., 100 High
`Street, Boston, Massachusetts 02110;
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`Jones Day, by GREGORY A. CASTANIAS, ESQ. and JENNIFER L.
`SWIZE, ATTORNEY, 51 Louisiana Avenue, N.W., Washington, D.C.
`20001-1700;
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`Jones Day, by PABLO D. HENDLER, ESQ. And SHEHLA WYNNE,
`Ph.D., 250 Vesey Street, New York, New York 10281-1047;
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`JOHN J. NORMILE, ESQ., 222 East 41st Street, New York,
`New York 10017-6702;
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`For the Defendant:
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`Robins Kaplan LLP, by CHRISTOPHER P. SULLIVAN, ESQ.,
`JACOB M. HOLDREITH, ESQ., KELSEY J. THORKELSON, ATTORNEY, and
`CHRISTOPHER A. PINAHS, ESQ., 2800 LaSalle Plaza, 800 LaSalle
`Avenue, Minneapolis, Minnesota 55402.
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`Robins Kaplan LLP, by OREN D. LANGER, ESQ., 399 Park
`Avenue, Suite 3600, New York, New York 10022;
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`Robins Kaplan LLP, by MATTHEW P. CARDOSI, ESQ.,
`800 Boylston Street, Boston, Massachusetts 02199.
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`ALSO PRESENT:
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`Bruce J. Koch, Purdue - Assoc. General Counsel
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`PROCEEDINGS
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`THE CLERK: All rise. Court is now in session in
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`the matter of Purdue Pharma, et al. vs., Collegium
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`Pharmaceutical, Inc., Civil Action Number 15-13099.
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`Counsel, would you please identify yourself for the
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`record.
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`MR. MORRISON: Good morning, your Honor,
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`Chris Morrison from Jones Day on behalf of the plaintiffs.
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`Let me introduce John Normile, partner in our New York
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`office; Pablo Hendler, partner in our New York office;
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`Jennifer Swize, partner in our D.C. office; Shehla Wynne,
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`associate in our New York office; we have summer associate
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`with us, Liz Merski, and we have a client with your
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`permission sitting at counsel table this morning.
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`THE COURT: Good morning, all.
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`MR. HOLDREITH: Good morning, your Honor,
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`Jake Holdreith from Robbins, Kaplan for Collegium. You'll be
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`hearing from three of us today, myself, next to me,
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`Ms. Thorkelson from our Minneapolis office, and next to her,
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`Mr. Langer, from our New York office. We also have here
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`Mr. Chris Pinahs from our Minneapolis office, and Matt, can
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`you introduce yourself, please.
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`MR. CARDOSI: Matthew Cardosi, local counsel from
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`Robbins, Kaplan as well.
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`THE COURT: Good morning, all. I hope whatever we
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`do here today doesn't drive your summer clerk out of the
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`practice of law.
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`All right. The first order of business for me is,
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`I'm not sure where I put it, but the motion to basically seal
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`the courtroom in this proceeding. I'm not sure I understand
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`this, frankly. I guess I'll start with court proceedings and
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`court filings are presumptively open. There's a relatively
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`heavy burden to justify closing or sealing, and any such
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`order needs to be narrowly tailored to fit the issue in
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`question.
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`To state the obvious, this is a patent case. A big
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`part of this is claim construction. Patents are, of course,
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`public. The claim construction process is -- I'm not sure
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`I've ever seen any nonpublic information. I mean, it's
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`largely intrinsic, of course, you know, what the claims and
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`specifications and so forth say. If there's extrinsic
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`evidence, it tends to be dictionaries or what a person of
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`skill in the art would understand.
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`This dispute obviously involves FDA-approved
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`pharmaceuticals. I confess, I understand that process less,
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`but I assume that there is at least a large public component
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`of that, and I suppose to the extent that we're doing, you
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`know, a level of tutorial or whatever that perhaps we're
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`getting into other things, but I guess I'm not sure why we
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`need to get into trade secrets, confidential studies,
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`customer information, things that are normally secret, so
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`what I propose, and it's not clear to me, of course, that the
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`gallery is filled with members of the press who are dying to
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`sit in on this and report it, but putting that aside, what I
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`would propose to do is proceed as normal, and if we get to
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`something that is genuinely confidential that we can stop and
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`pause and either do it at sidebar or clear the courtroom or
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`something, but I guess I'm struggling to see why either, why
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`we're getting into it at all, and if we are, why it's
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`anything other than a tiny fraction of what it is that we
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`have to talk about. That's the first point.
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`The second point is I think there were at least two
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`filings in which redacted memoranda were filed but no
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`unredacted memoranda was ever filed. Collegium's motion for
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`summary judgment, I think the basic memo of law and the
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`affidavit were filed redacted but never unredacted.
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`It makes it hard for me to read the unredacted thing
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`because it isn't on file, and there is also a Purdue
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`document, I think it's the reply memorandum, reply to the
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`Collegium's responsive memorandum. In any event, I didn't
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`write it down, but I believe there's one Purdue memorandum,
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`so I need those on file again as well.
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`Again, the public filings ought to have the bare
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`minimum redaction necessary. For example, if the unredacted
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`version says the company did a study and the study showed X,
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`you wouldn't redact that the company did a study or the words
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`that the study showed, you would redact X, you would redact,
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`you know, assuming it was confidential, so it should be as
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`narrow as possible, but, in any event, let me hear your
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`reactions to that before we go any further, and I guess the
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`third other introductory point of business is what order we
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`do this in.
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`It's not clear to me which comes first, claim
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`construction or summary judgment, and for want of a better
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`plan, I'm inclined to let the plaintiffs go first because
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`they're the plaintiffs, but I'm willing to hear you all on
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`that. Let me turn to Purdue Pharma.
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`THE COURT: Yes, again --
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`MR. HENDLER: Pablo Hendler.
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`THE COURT: Yes, Mr. Hendler.
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`MR. HENDLER: It is my understanding that the
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`confidential information that may be present in these slides
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`and presentation today is that of Collegium's.
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`THE COURT: Okay. Is it a hard G or soft G,
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`Collegium? Collegium? Collegium?
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`MR. HOLDREITH: Your Honor, I've heard it all three
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`ways. I've become accustomed to saying Collegium but we have
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`two folks from the company.
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`THE COURT: I'm going to let them speak. I'm making
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`a factual finding. All right. Tell me how to pronounce the
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`name.
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`MR. HOLDREITH: I would say Collegium, your Honor.
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`THE COURT: Is that right, Collegium?
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`UNIDENTIFIED SPEAKER: Yes.
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`THE COURT: You're nodding, Collegium. Okay.
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`MR. HENDLER: So in terms of confidentiality issues,
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`that I would leave to Collegium's counsel.
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`THE COURT: Okay.
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`MR. HENDLER: In terms of the order of the
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`proceedings, the parties have conferred about that, and
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`unless your Honor has a different view, we've reached an
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`agreement at least in terms of the general order of the
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`presentation.
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`THE COURT: Okay. I'll accept your agreement,
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`that's fine. And what is that order?
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`MR. HENDLER: We're going to start initially with
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`the abuse-deterring patents.
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`THE COURT: Okay.
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`MR. HENDLER: And start with a claim construction
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`issue, then because that issue ties into the summary
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`judgment, not infringement.
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`THE COURT: So we'll go by patent.
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`MR. HENDLER: Right. We're trying to tie things
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`together that make sense to keep together.
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`THE COURT: Okay.
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`MR. HENDLER: Then we've got another claim
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`construction issue, which is indefiniteness, then I believe
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`we then turn to the '933 patent, the second family in this
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`case, and we'll start with a claim construction issue, and
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`we'll move to the collateral estoppel argument and then
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`finally the non-infringement summary judgment motion on that
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`patent.
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`THE COURT: All right.
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`MR. HENDLER: The parties have also, will endeavor
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`to try to get this done in the time allotted, between 9 and 1
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`or whatever the Court said. We know the Court was willing to
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`extend to the afternoon, late afternoon. We'll try our best
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`to get it done so we won't have to do that.
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`THE COURT: I would like to clip along at a brisk
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`pace, if possible. We do have a lot to cover.
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`MR. HOLDREITH: Yes, Jake Holdreith from Robbins,
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`Kaplan.
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`THE COURT: Yes.
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`MR. HOLDREITH: On the confidentiality, I generally
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`would like to follow every one of your Honor's suggestions,
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`and we will try to be very careful on redacting only the
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`minimum necessary when we file. I do have unredacted copies
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`of the summary judgment motion and fact statements here. I
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`had understood that they had been carried over and filed with
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`the clerk's office. I apologize that they weren't
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`transmitted to your Honor, but I could hand up unredacted
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`copies of those right now.
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`THE COURT: Why don't you do that.
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`MR. HOLDREITH: As to today's proceedings, one of
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`our good friends from the press is here today. We've spoke,
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`we've met each other at other proceedings, and claim
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`construction presents no issues of confidentiality. That
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`should be open to the public. The collateral estoppel motion
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`presents no issues of confidentiality. We can keep that
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`open.
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`The non-infringement motions, there are some details
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`of the manufacturing process which are confidential. FDA in
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`its filing process has a statutory process where those are
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`kept confidential, and they're not available in response to
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`FOIA requests, and so I think we've reached an understanding
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`with our colleague from the press that he is content to be
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`excused when we discuss the manufacturing process.
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`THE COURT: All right. Again, that will be as
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`narrow as possible. He does have a right constitutionally to
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`be here.
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`MR. HOLDREITH: Yes.
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`Have I fully addressed the confidentiality issue?
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`THE COURT: I think so, yes.
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`MR. HOLDREITH: We agreed on the order of
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`presenting, and I think we ought to be able to be done by
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`one, and I don't remember if there's anything else.
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`THE COURT: Okay. What I propose is I'm going to
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`treat this like a trial, which is we'll take a very brief
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`break at 10:30 and a very brief break at noon to let people
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`use the bathroom, but otherwise let's keep going.
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`All right. The floor is I was going to say yours
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`but whoever gets to go first. All right. Mr. Hendler.
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`I should add, don't be afraid to keep it simple or
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`worry about talking down to me. I have some familiarity with
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`OxyContin, otherwise it's fairly limited.
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`MR. HENDLER: Understood, your Honor. So, your
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`Honor, we start off, as we all know, the two families at
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`issue here, one is what we've been calling the
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`abuse-deterring patents, and the other one is the '933
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`patent, which is the one that is related to the other patent
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`that was recently sued on and consolidated with this action.
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`We can skip over this. These are ultimately the
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`issues I think we've addressed, but we'll get to them as we
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`go. Some just basic background, your Honor.
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`Purdue's OxyContin, the original OxyContin, is an
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`extended release oxycodone formulation for treating pain. It
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`was approved in 1995. It was quickly a groundbreaking
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`treatment, very successful in the marketplace; however, I
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`think as we all know, it became attractive to abusers, and
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`the reason it became attractive to abusers, at least one
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`reason was oxycodone is a powerful opioid, but the tablets
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`could be readily crushed. You could take a beer bottle and
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`then turn it into dust and then either inhale it, smoke it,
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`mix it with water and inject it.
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`As a result of the abuse of problems and the
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`devastating consequences of that, Purdue sought to develop a
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`new OxyContin. That new OxyContin is a completely new
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`formulation designed from the ground up, so to speak.
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`It was approved in 2010, and after about three years
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`on the market and data collected from the abuse and further
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`studies, the FDA approved certain labeling in the product.
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`The labeling refers to the package insert that comes with
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`every bottle of OxyContin or prescription drug. It tells you
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`how to use it, what to do with it, et cetera, and on that
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`label, it includes information about the abuse-deterring
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`features of OxyContin, and it was the first drug, opioid
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`drug, to have achieved that.
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`Now, as a result of Purdue's achievements there,
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`other companies have followed suit to prepare their own
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`formulation. Some are pure generics, and others are sort of
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`in this hybrid world. I say hybrid because it is not a
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`completely new drug application that Collegium has filed,
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`rather, it's what's referred to as a paper NDA.
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`They do some of their own testing, but they also
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`copy and rely on some of the testing of others, including in
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`this case, Purdue for OxyContin. That product contains as
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`the active oxycodone myristate. That is a salt of OxyContin.
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`It contains myristic acid, which we will get to later on, and
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`to which we assert is an irritant and other ingredients.
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`Now, Collegium's NDA claims various mechanisms by
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`which Xtampza may deter abuse, and we submit one of those
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`mechanisms is by causing irritation.
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`Now, throughout the course of the proceedings and in
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`the papers, you may see references to a Dr. Steven Byrn.
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`Dr. Byrn is a professor of chemistry, of medicinal chemistry,
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`at Purdue University, which is unrelated to the plaintiffs,
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`and he has studied in this field for years, including having
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`conducted a number of FDA-sponsored studies in the area of
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`evaluating abuse-deterring mechanisms.
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`I raise this because a significant point here is
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`that the defendants, who have brought four summary judgment
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`motions, have offered no expert testimony, no expert
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`declaration, in fact, frankly not even any fact declarations
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`to support their positions, and we submit that certainly on
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`summary judgment, that is not enough.
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`Now, we can skip that slide, so here are some
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`representative claims of the abuse-deterring patents. As you
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`will see, the claims are directed to an oral dosage form, for
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`example, either a capsule or a tablet and consisting of four
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`recited ingredients.
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`Case 1:15-cv-13099-FDS Document 143 Filed 06/19/17 Page 13 of 136
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`You have a drug susceptible to abuse, for example,
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`oxycodone; you have a modified or sustained release carrier,
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`that's the ingredient that helps to extend the release of the
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`drug; you have an effective amount of an irritant to impart
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`an irritating sensation; and the claim continues, to an
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`abuser upon administration of said dosage form after
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`tampering.
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`So, in other words, this ingredient should an abuser
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`be able to crush the tablet or the capsule or otherwise use
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`it in a way that they ought not to be using it by tampering
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`with it and abusing it, the idea is that the irritant will
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`impart an irritating sensation to discourage further abuse,
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`and, finally, there is one or more pharmaceutical excipients.
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`Clearly, the sustained release carrier and the
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`irritant are pharmaceutical excipients, so this is reference
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`to additional pharmaceutical excipients that may be present.
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`So, the focus here, at least for this part of the
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`proceedings, both for claim construction and the summary
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`judgment motions relating to the abuse-deterring patents has
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`to do with the highlighted clause, "an effective amount of an
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`irritant to impart an irritating sensation" for the '497
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`Claim 1 up on top or "a burning sensation" in the '717 Patent
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`Claim 1 on the bottom.
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`Let's first address the issue of "irritant," and
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`this issue is tied to the summary judgment of
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`Case 1:15-cv-13099-FDS Document 143 Filed 06/19/17 Page 14 of 136
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`non-infringement that Collegium has brought. It is in large
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`measure predicated on Collegium's proposed claim
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`construction.
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`Now, the term "irritant" the plaintiffs submit is a
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`straightforward term. I don't know that one needs a person
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`of ordinary skill in the art's understanding of what it
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`means, but that's certainly how claim construction proceeds
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`from their vantage point, and the constructions are very
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`similar on the face, anyway.
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`Plaintiffs say, "It's a compound that imparts an
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`irritating or burning sensation." Collegium, and focusing on
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`the difference, "a compound used to impart an irritating or
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`burning sensation." Now, on the face of things, that looks
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`very similar.
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`The problem becomes is once you drill down a little
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`bit, and what Collegium is arguing is that "the used" two
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`words invoke an intent requirement, in other words, that it
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`is not an irritant unless the original formulator who
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`designed the formulation intentionally included the compound
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`for the purpose of causing irritation.
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`And so that if, for example, a compound that's in
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`the formula actually causes irritation, even if that's
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`undisputed by all, if it was originally included in the
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`formulation for some other purpose, Collegium would say that
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`is not an irritant per the patent, and, therefore, their
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`Case 1:15-cv-13099-FDS Document 143 Filed 06/19/17 Page 15 of 136
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`product would not infringe.
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`THE COURT: All right. I'm struggling with this,
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`so, I mean, to sort of get my arms around it conceptually,
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`presumably, the whole point of this is because you intend,
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`you know, the drug to be therapeutically effective, right, so
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`you put things in because you expect them to be
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`therapeutically effective, you expect them to be released
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`over time, you expect them to have an irritant, and there's
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`binders or whatever else you need to put into a pill.
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`If it turns out that something that's in there
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`accidentally, accidentally has a therapeutic effect or
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`accidentally imparts an irritating sensation, you haven't
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`invented that, right, that's an accident.
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`I'm having trouble. Of course, the party inventing
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`something and producing something intends these certain
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`things, right, otherwise why are you doing it, why do you get
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`the patent? You haven't invented it if it's a mere accident.
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`I'm struggling to understand the difference here.
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`MR. HENDLER: Sure. Your Honor, the law is that for
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`direct infringement, accidental infringement is nonetheless
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`infringement.
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`THE COURT: Right, I understand that.
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`MR. HENDLER: And so what we would say is if someone
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`includes -- if someone's product has these four ingredients,
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`regardless of whether they intended the irritant, what
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`Case 1:15-cv-13099-FDS Document 143 Filed 06/19/17 Page 16 of 136
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`becomes the irritant to actually serve as the irritant, the
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`fact is it still contains an irritant. It doesn't change the
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`fact that the formulation itself has an irritant, and if it's
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`in the right amount, an effective amount to cause this
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`irritation, then the answer is, well, it satisfies the
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`literal scope of the claim.
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`Now, this, you know, may then, as your Honor perhaps
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`alluded to, may raise some questions about validity, although
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`we're not aware of any validity issues here, but the fact
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`remains that if it does these things, literally it falls
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`within the scope of the claims. That's why accidental
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`infringement is still infringement.
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`THE COURT: All right. So if Collegium puts in a
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`compound, puts in a gel, let's say, in its pills, and to
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`everyone's surprise, the gel winds up being an irritant, not
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`in some gigantic dose but in the dose used in the pill, that
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`would constitute infringement you say whether or not
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`Collegium intended that, that's the idea?
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`MR. HENDLER: Correct. I think in this case what we
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`will see is whether or not there is an intent requirement.
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`We believe the evidence shows that there is still
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`infringement even with an intent requirement.
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`THE COURT: Okay. Go on, I'm sorry.
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`MR. HENDLER: I think we've largely covered that,
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`and so let's, for claim construction, let's start with the
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`Case 1:15-cv-13099-FDS Document 143 Filed 06/19/17 Page 17 of 136
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`claim. Again, I think we talked a little bit just now is
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`that it requires among these things an effective amount of an
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`irritant. There's no intent aspect in the language of the
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`claim. An irritant is an irritant, and, again, whether it's
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`intentional or not, the question, does it satisfy that
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`language?
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`The specification doesn't define the term,
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`"irritant." When the specification defines terms, it does so
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`fairly explicitly. It says, "The term, "aversive agent" is
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`defined for purposes of the present invention to mean," "The
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`term, "tampered dosage form" is defined for purposes of the
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`present invention to mean," and so on. The inventors, when
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`they wanted to define something, they said is defined for
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`purposes to mean, to mean something.
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`Now, that language stands in stark contrast to what
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`the specification says about irritant. The specification
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`says that the term "irritant" as used herein includes a
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`compound used it impart an irritating or burning sensation,
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`et cetera.
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`09:26AM
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`Now, there's two points that I'd like to make with
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`this. One, it doesn't use the language, the same language
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`that the inventors used when they wanted to define a term.
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`It doesn't say, "The term "irritant" is defined to mean."
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`I understand that the language "is defined to mean"
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`doesn't need to be in every patent, in every specification in
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`Case 1:15-cv-13099-FDS Document 143 Filed 06/19/17 Page 18 of 136
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`order for there to be a definition, but, in this context,
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`where the inventors said something is defined to mean
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`something else, we submit that it is different in this
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`language. When they used different words here, there's a
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`reason for it.
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`Now, the other point I think is significant in the
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`sense that what this says is the term "irritant," as used
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`herein includes. Well, "includes" like the term, like the
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`patent term "comprising" is open-ended, it is not a limiting
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`term.
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`A definition or a description of something that says
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`this compound or this class of compound includes A, B, C and
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`D doesn't mean that it's limited to A, B, C and D, and this
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`is another reason why this is not a limiting definition, as
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`Collegium argues.
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`Collegium says that's a definition, but we submit
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`for reasons I just said that Collegium cannot meet the
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`exacting standard that is placed on them to find lexicography
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`here, to find a true limiting definition. There's no clear
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`and unambiguous limiting phrase.
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`Now, in its responsive claim construction brief,
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`Collegium sort of matter of factually says, "Here's a list of
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`definitions that the patent includes, and none of this is
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`disputed." Well, it is disputed, and to show sort of what we
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`just talked about in context here, this is what Collegium
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`Case 1:15-cv-13099-FDS Document 143 Filed 06/19/17 Page 19 of 136
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`says the terms have been defined in the patent to mean.
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`The problem is that plaintiffs, contrary to what
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`Collegium has told the Court, we're not running from the
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`specification, we're embracing every word in the
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`specification. Collegium, on the other hand, seems to be
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`omitting terms, so as we just saw, the specification says
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`that the term, "aversive agent" is defined for purposes of
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`the present invention to mean a bittering agent, an irritant,
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`et cetera. Compare that to what the specification says for
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`irritant, "The term "irritant" as used herein includes."
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`This is language that is from the specification, and
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`I don't know why it was excluded, but this is really what it
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`says, and comparing the two here, one can see the
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`differences.
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`Now, Collegium then turns to the doctrine of
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`disavowal or that there was a surrender during prosecution,
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`and, again, the standards for disavowal are the same as they
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`are for the lexicography. The standard is it's an exacting
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`standard.
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`There must be a clear and unmistakable surrender of
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`patent scope, and what Collegium points to is this portion of
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`the specification, and I believe it's an earlier application
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`in the same family during the prosecution, excuse me, and in
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`which the examiner had rejected a claim based on some
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`combination of prior art references, including something
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`Case 1:15-cv-13099-FDS Document 143 Filed 06/19/17 Page 20 of 136
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`called Blum.
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`The applicants in response amended the claim as
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`shown to include the language that the irritant is a
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`sequestered irritant, in other words, the irritant is somehow
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`kept within the tablet until some later time. It is
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`sequestered, and so Collegium then puts in a quote, and the
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`first paragraph here is what's important where they talk
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`about this Blum reference, and they say, oh, that clearly
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`demonstrates a surrender.
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`Well, again, the portion that Collegium omitted from
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`its quote in its briefs is the first sentence here, "However,
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`a careful reading of Blum shows a complete lack of any
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`teaching or suggestion to incorporate an irritant in
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`sequestered form into a pharmaceutical composition."
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`The underlining is from the original, so what
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`plaintiffs, what plaintiffs, the applicants were doing here
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`was differentiating Blum on the basis of whether it was
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`sequestered or not, not whether there was an intent that
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`there had to be an intent to include the irritant for that
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`particular purpose.
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`This has nothing to do with the issue at hand, and
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`it's certainly not a clear and unmistakable surrender of an
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`accidental inclusion of an irritant.
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`THE COURT: I'm sorry, during the prosecution the
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`word, "sequestered" was included; is that right?
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`Case 1:15-cv-13099-FDS Document 143 Filed 06/19/17 Page 21 of 136
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`MR. HENDLER: In the earlier prosecution, in this
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`particular claim, in this particular application, the term
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`"sequestered" was added.
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`THE COURT: And in this context, "sequestered"
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`means?
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`MR. HENDLER: I'm sorry, your Honor, it means
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`something that is kept within the dosage form for some period
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`of time, for example, if you don't want it coming out in the
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`stomach, maybe you delay it so it comes out later on in the
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`G.I. system.
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`THE COURT: Okay. And that's so a normal user, that
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`is a legitimate user of the pill, it would not release in the
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`stomach and cause irritation there, the idea is only the
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`abuser getting -- the only person trying to crush it?
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`MR. HENDLER: The answer is it would be for both.
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`In other words, that you may not want to send an abuser, you
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`know, to the hospital, for example, but you do want them to
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`have this sense that, you know, this isn't something you
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`ought to be doing.
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`THE COURT: Okay.
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`MR. HENDLER: So, again, this has nothing to do with
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`the issues here. So, ultimately our view is the term,
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`"irritant" is a fairly straightforward term. It means
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`exactly what one would think it means. There's nothing
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`magical about it, and the idea of including intent strikes me
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`as a back way to try to get beyond the courses that say
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`accidental infringement is still infringement.
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`Now, this may be a good time if your Honor would
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`like to either switch or we can continue on this issue and
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`then give it over to the defendant.
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`THE COURT: I think it probably makes sense going
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`back and forth issue by issue.
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`You're Mr. Langer; is that right?
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`MR. LANGER: Yes, your Honor. Good morning, your
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`Honor, Oren Langer on behalf of Collegium. I'll be
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`responding to the claim construction issue regarding the word
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`"irritant," and Mr. Holdreith will follow up with respect to
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`the summary judgment of non-infringement on that issue.
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`There are three critical points for the Court to
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`understand throughout the entire argument related to the
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`term, "irritant." Collegium's point and Collegium's argument
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`is that it simply means -- it means what the patent says it
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`means, in this case, "a compound used to impart an irritating
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`or burning sensation to an abuser administering a tampered
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`dosage form of the present invention."
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