Case 2:15-cv-01455-WCB Document 182 Filed 09/02/16 Page 1 of 125 PageID #: 5724
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF TEXAS
`MARSHALL DIVISION
`
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`ALLERGAN, INC., * CIVIL ACTION NO.
` *
` Plaintiff, * 2:15-cv-1455-WCB
` * (LEAD CASE)
`VS. *
` *
`TEVA PHARMACEUTICALS USA, *
`INC., ET AL., * Marshall, Texas
` * August 26, 2016
` Defendants. * 8:29 a.m.
`
`
`---------------------------------------------------------------
`
`REPORTER'S TRANSCRIPT OF CLAIM CONSTRUCTION HEARING
`BEFORE THE HONORABLE WILLIAM C. BRYSON
`UNITED STATES FEDERAL CIRCUIT JUDGE
`
`
`---------------------------------------------------------------
`
`A P P E A R A N C E S
`
`FOR THE PLAINTIFF: JONATHAN ELLIOT SINGER
` FISH & RICHARDSON - SAN DIEGO
` 12390 El Camino Real
` San Diego, California 92130
`
` SUSAN MORRISON COLETTI
` FISH & RICHARDSON - WILMINGTON
` 222 Delaware Avenue, 17th Floor
` Wilmington, Delaware 19899
`
`COURT REPORTER: BRENDA HIGHTOWER SMITH, CSR, RPR, FCRR
` Official Court Reporter
` Eastern District of Texas
` Texarkana Division
` 500 N. State Line Avenue
` Texarkana, Texas 75501
` brenda_smith@txed.uscourts.gov
`
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`(Proceedings recorded by mechanical stenography, transcript
`produced on CAT system.)
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF TEXAS
`MARSHALL DIVISION
`
`
`ALLERGAN, INC., * CIVIL ACTION NO.
` *
` Plaintiff, * 2:15-cv-1455-WCB
` * (LEAD CASE)
`VS. *
` *
`TEVA PHARMACEUTICALS USA, *
`INC., ET AL., * Marshall, Texas
` * August 26, 2016
` Defendants. * 8:29 a.m.
`
`
`---------------------------------------------------------------
`
`REPORTER'S TRANSCRIPT OF CLAIM CONSTRUCTION HEARING
`BEFORE THE HONORABLE WILLIAM C. BRYSON
`UNITED STATES FEDERAL CIRCUIT JUDGE
`
`
`---------------------------------------------------------------
`
`A P P E A R A N C E S
`
`FOR THE PLAINTIFF: JONATHAN ELLIOT SINGER
` FISH & RICHARDSON - SAN DIEGO
` 12390 El Camino Real
` San Diego, California 92130
`
` SUSAN MORRISON COLETTI
` FISH & RICHARDSON - WILMINGTON
` 222 Delaware Avenue, 17th Floor
` Wilmington, Delaware 19899
`
`COURT REPORTER: BRENDA HIGHTOWER SMITH, CSR, RPR, FCRR
` Official Court Reporter
` Eastern District of Texas
` Texarkana Division
` 500 N. State Line Avenue
` Texarkana, Texas 75501
` brenda_smith@txed.uscourts.gov
`
`
`(Proceedings recorded by mechanical stenography, transcript
`produced on CAT system.)
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`Case 2:15-cv-01455-WCB Document 182 Filed 09/02/16 Page 2 of 125 PageID #: 5725
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`A P P E A R A N C E S
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`FOR THE PLAINTIFF: JOSEPH ANTHONY HERRIGES
` FISH & RICHARDSON - MINNEAPOLIS
` 60 South Sixth Street
` 3200 RBC Plaza
` Minneapolis, Minnesota 55402
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` CLAIRE ABERNATHY HENRY
` WARD, SMITH & HILL
` 1507 Bill Owens Parkway
` Longview, Texas 75604
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`FOR THE DEFENDANT
`TEVA PHARMACEUTICALS: MILES J. SWEET
` KELLOGG HUBER HANSEN TODD EVANS &
` FIGEL
` 1615 M Street NW, Suite 400
` Washington, DC 20036
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` LOUIS BRADY PADDOCK
` NIX PATTERSON & ROACH - TEXARKANA
` 2900 Saint Michael Drive, Suite 500
` Texarkana, Texas 75503
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`FOR THE DEFENDANT
`MYLAN PHARMACEUTICALS: DOUGLAS H. CARSTEN
` CHRISTINA E. DASHE
` WENDY L. DEVINE
` WILSON SONSINI GOODRICH &
` ROSATI - SAN DIEGO
` 12235 El Camino Real, Suite 200
` San Diego, California 92130
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` ANN G. PHILLIPS
` WILSON SOMSINI GOODRICH &
` ROSATI - AUSTIN
` 900 South Capital of Texas Highway
` Las Cimas IV, Fifth Floor
` Austin, Texas 78746
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`Case 2:15-cv-01455-WCB Document 182 Filed 09/02/16 Page 3 of 125 PageID #: 5726
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`A P P E A R A N C E S
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`FOR THE DEFENDANT
`MYLAN PHARMACEUTICALS: ALLEN FRANKLIN GARDNER
` GILLAM & SMITH
` 303 South Washington Avenue
` Marshall, Texas 75670
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`FOR THE DEFENDANT
`AKORN, INC.: MICHAEL R. DZWONCZYK
` AZADEH KOKABI
` SUGHRUE MION
` 2100 Pennsylvania Avenue NW, Suite 800
` Washington, DC 20037
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` EARL GLENN THAMES JR.
` POTTER MINTON
` 110 North College Avenue, Suite 500
` Tyler, Texas 75702
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`FOR THE DEFENDANT
`INNOPHARMA, INC.: JOSEPH E. CWIK
` AMIN TALATI & UPADHYE
` 55 West Monroe Street, Suite 3400
` Chicago, Illinois 60603
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` JENNIFER PARKER AINSWORTH
` WILSON ROBERTSON & CORNELIUS
` 909 ESE Loop 323, Suite 400
` Tyler, Texas 75711
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`FOR THE DEFENDANT
`FAMY CARE LIMITED: JOHN D. POLIVICK
` RAKOCZY MOLINO MAZZOCHI SIWIK
` 6 West Hubbard Street, Suite 500
` Chicago, Illinois 60610
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`Case 2:15-cv-01455-WCB Document 182 Filed 09/02/16 Page 4 of 125 PageID #: 5727
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`I N D E X
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` PAGE
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`Appearances....................................... 1-3
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`Proceedings....................................... 5
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`Court Reporter's Certificate...................... 125
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`Case 2:15-cv-01455-WCB Document 182 Filed 09/02/16 Page 5 of 125 PageID #: 5728
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`P R O C E E D I N G S
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`COURT SECURITY OFFICER: All rise.
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`THE COURT: Thank you. Please be seated.
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`We're here on the case of Allergan against Teva, et
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`al. And it's 2:15-cv-1455, a Markman hearing.
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`The way I like to do these, I learned from Judge
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`Payne, is to give you my tentative views on the various issues
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`that are contested. They are tentative.
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`I'm perfectly willing to listen and modify my views,
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`change them altogether, as the situation may suggest. But I
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`think it's useful rather than having each of you stand up and
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`go on for a while about your positions with no idea of what it
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`is that I'm focused on.
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`It's much more efficient, I think, for me to give you
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`an idea of where I am tentatively and then for you to shoot at
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`it -- excuse me -- if you have any complaints about my
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`position. Which at least half of you, in all likelihood, will
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`have.
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`And let me say, also, that I know you have slides
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`here and so forth and lawyers love to work from slides. And I
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`hope you won't feel too much anxiety, but I prefer to work
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`directly from argument rather than from slides. I really don't
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`think having a slide show and having lawyers read from the
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`slides is helpful, at least it's not helpful to me. So I would
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`rather hear argument on the -- on the issues.
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`Case 2:15-cv-01455-WCB Document 182 Filed 09/02/16 Page 6 of 125 PageID #: 5729
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`So let me give you at the outset the tentative views.
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`And some of these will be more sketchy than others. But you
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`will at least have an idea of where I'm going with respect to
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`each of these issues.
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`Let me ask, first, we have a number of people, I
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`gather, that are going to be speaking. I would ask you two
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`things: One, to let me know now which issues each of you will
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`be planning to address. And two, when each of you stands up,
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`even if you have spoken before, please identify yourself.
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`Because, otherwise, the courtroom deputy and the court reporter
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`will have a hard time figuring out who's who with as many
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`players as we have.
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`So why don't you tell me -- I have a list of I think
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`it's four people on the defense side and one on the Plaintiff's
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`side who are going to speak. Is that correct?
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`Mr. Singer is going to speak for the Plaintiffs?
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`MR. SINGER: Yes. Good morning, Your Honor.
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`THE COURT: On all issues; is that correct?
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`MR. SINGER: I drew the short straw, and I'm speaking
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`on all of them.
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`THE COURT: Very good.
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`Now, we have four, I think, for the defense. Why
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`don't you tell me which issue each of the four of you will
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`address?
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`MR. CARSTEN: Good morning, Your Honor. My name is
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`Case 2:15-cv-01455-WCB Document 182 Filed 09/02/16 Page 7 of 125 PageID #: 5730
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`Doug Carsten on behalf of Mylan. I'll be addressing the "dry
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`eye," "KCS" indefiniteness terms, as well as the
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`"therapeutically effective" term.
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`THE COURT: All right.
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`Next up.
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`MR. CWIK: Good morning, Your Honor. Joe Cwik on
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`behalf of InnoPharma. And I'm going to be talking about the
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`"second topical ophthalmic emulsion" term.
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`THE COURT: Okay.
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`MR. DZWONCZYK: Good morning, Your Honor. Mike
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`Dzwonczyk on behalf of Akorn. And I will address the "about"
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`term and the "restoring" and "enhancing tearing" terms.
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`THE COURT: Very good.
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`MR. POLIVICK: Good morning, Your Honor. My name is
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`John Polivick on behalf of Famy Care. And I will be addressing
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`the "only peptide present" term.
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`THE COURT: All right.
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`MR. POLIVICK: And the "administering" terms.
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`THE COURT: "Administering," all right.
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`Okay. So that works out pretty well. Because I can
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`take them roughly in the order of the defense lawyers who will
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`be speaking to those issues rather than having us bouncing up
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`and down. I think we can do this efficiently.
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`So the first issue I think that I want to discuss
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`will be the definition of "dry eye," "dry eye disease," "dry
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`eye syndrome," and "keratoconjunctivitis."
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`After that, I can stay with Mr. Carsten and discuss
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`"therapeutic efficacy."
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`After that, I think it makes sense to do the "about,"
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`"restoring," and "enhancing" points.
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`Then "second topical emulsion."
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`And finally, "only peptide" and "administering."
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`So let's take it in that order.
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`Now, as for my tentative views, I do not think at
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`this point that there is fatal indefiniteness in the
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`definitions of either "dry eye," "dry eye disease," "dry eye
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`syndrome" to the extent that each of those terms needs to be
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`addressed, or "keratoconjunctivitis sicca."
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`I acknowledge that there is some lack of clarity,
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`lack of certainty, lack of precision in the definitions of each
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`of those terms, particularly "dry eye," "dry eye disease," "dry
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`eye syndrome." But that is not unknown in the medical area.
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`And I think there is sufficient confluence of views as to the
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`meanings of those terms that they satisfy the requirements of
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`the Nautilus case of giving fair notice to a person of ordinary
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`skill in the art as to what is encompassed within the claims.
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`"Keratoconjunctivitis" seems to me is more
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`straightforward. It is generally pretty well understood what
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`that condition entails. And I don't think there's a whole lot
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`of room for argument on that one as to indefiniteness.
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`"Efficacy," "therapeutic efficacy," again, I don't
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`think that's a matter of fatal indefiniteness either. My sense
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`is that it's a little hard to know whether this treatment
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`should be deemed to be treating the underlying disease or
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`condition as opposed to treating the symptoms given the
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`particular way that this drug operates. But I'm not sure that
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`really matters.
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`And on that, I will be interested in hearing some
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`argument. But I think "efficacy" is a term that is
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`sufficiently clear that that would survive the indefiniteness
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`challenge.
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`And I feel the same way about "enhance" and
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`"restore." I think the -- the notion of enhancement is to make
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`something greater or better. "Restore" contains within it a
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`notion of making something more like it was before, returning
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`to the status quo ante, or at least in part returning to the
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`status quo ante. And those terms, it seems to me, are clear
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`enough to survive the indefiniteness attack.
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`The "second topical ophthalmic emulsion," it seems to
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`me if I understand the argument here, it is that the two
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`emulsions that are discussed, one of them, the second, does not
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`have a description of all of the other constituents in the
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`emulsion and, therefore, you can't compare it to the first.
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`I -- I think the context of the claim, including
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`reference to the specification, makes it pretty clear that
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`we're talking about an emulsion that differs from the first
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`only with respect to the items that are called out in the
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`claim. And all other -- all other constituents are held to be
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`equal between the two.
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`So I don't find any fatal indefiniteness there.
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`The "about" term -- I think I'm returning now to a
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`term that we were going to discuss in connection with
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`"restoring" and "enhancing." But in any event, this is a term
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`that has always given me a lot of trouble in patents.
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`The patent doctrine typically says, at least in most
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`instances, that the term "about" is -- means approximately, and
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`that's that. I never found that entirely satisfactory. What
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`is "approximately"? Well, it means -- well, it means "about."
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`That's not very helpful.
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`It's particularly unhelpful in a context in which the
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`"about" covers some feature that's really critical to the
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`question of infringement or not. And there is no easy measure
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`of what the -- the limitations of the spectrum of the -- that
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`the "about" covers can be found.
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`I will want to hear from the Plaintiffs on this as to
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`what guidance I can look to to know what the limits of the term
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`"about" are in this context so that I will be able to decide
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`whether there is infringement or not if something is not at the
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`1.25 and .004 numbers -- 005, excuse me -- .05. If those
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`are -- numbers are not exactly or within a measurable
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`precision, the numbers of the constituents, how broad is the --
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`does the "about" sweep?
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`I don't think "about" means precisely. I'm not sure
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`what that means in the context of chemical formulation, because
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`there's no such something in the real world as precise. So I
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`just find that argument not to be persuasive.
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`Cyclosporine A, the only peptide present, on this
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`issue I didn't find that the materials that I was given gave me
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`a whole lot of help on what the relationship is between
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`cyclosporine A and the derivatives and metabolites. And I will
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`be interested in hearing more on that.
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`But my tentative view is that derivates and
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`metabolites are typically present in any kind of formulation.
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`And that that would not be enough to constitute other peptides
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`within the meaning of the claims.
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`"Administered," now, this is a little tricky, because
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`I think "administered" is a term that has different meanings,
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`depending on context. I had a case which has been cited by the
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`parties recently -- in fact, it's a still pending case --
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`called Erfindergemeinschaft against Lilly, in which I construed
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`"administer" broadly enough to cover a physician who is
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`prescribing a course of treatment and supervising a course of
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`treatment.
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`I'm not sure that the word "administer" necessarily
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`sweeps that broadly when you get to a specification such as the
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`ones in this case involving administration to the eye, where
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`the suggestion seems to me to be that the administration is
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`something that operates directly on the body or a part of the
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`body. It's very difficult to say in that context, it seems to
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`me, that a person who is simply writing a prescription is
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`administering an emulsion to the eye. But I will hear further
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`argument on that, of course.
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`Okay. Those are the issues as I understand it. I
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`gather that we are in agreement on "substantially no detectable
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`concentration of cyclosporine A." Which is the term that I
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`gather that you've reached agreement on. And I've accepted
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`that -- that claim construction.
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`So, what I would like to do is start, then, with I
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`guess it's Mr. Carsten.
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`I assume that you are probably not thrilled with my
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`approach, my tentative definition, so I will let you go first.
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`And Mr. Singer, if there are issues on which you feel
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`aggrieved, then you should go first. On issues on which the
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`Defendants feel aggrieved, we'll have them go first. And I'll
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`let you-all decide who is the more aggrieved.
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`MR. CARSTEN: I think on this one, Your Honor, it's
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`22
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`pretty plain who the more aggrieved party is.
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`23
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`THE COURT: I'm -- I'm in agreement with you of that
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`at least.
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`MR. CARSTEN: Thank you, Your Honor.
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`THE COURT: All right.
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`MR. CARSTEN: So I very much appreciate the manner in
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`which you conduct these Markman hearings, Your Honor. I think
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`this is a very orderly way, and I like the back and forth on
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`each term.
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`THE COURT: I stole it from Judge Payne in case --
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`Judge Payne does this -- he does me one better, though. He
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`provides a written summary of each of his tentative views,
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`which it seems to me is more helpful. However, I'm not as
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`efficient as Judge Payne, so I am scrambling to get it into
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`oral form. But in any event, there you are.
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`MR. CARSTEN: Well, thank you, Your Honor.
`
`Again, Doug Carsten on behalf of Mylan. May it
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`14
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`please the Court.
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`15
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`These terms, Your Honor, do not have common plain and
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`16
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`ordinary meanings. There have been lots of attempts to
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`17
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`standardize these meanings: "Dry eye disease," "dry eye
`
`18
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`syndrome," "dry eye," "KCS."
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`19
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`We've cited in our papers -- and I believe I can cite
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`20
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`to the record if it's helpful to the Court -- ECF No. 167-3,
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`21
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`the Calman declaration at Exhibit C. Allergan, the Noecker
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`22
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`declaration, 155-48 at Exhibit M. EC 1 -- ECF 167-4, Calman
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`23
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`declaration at Exhibit D. ECF 155-12.
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`24
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`All of these papers beginning in 1998, continuing in
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`2000, continuing into 2006, continuing to 2007, directly
`
`
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`Case 2:15-cv-01455-WCB Document 182 Filed 09/02/16 Page 14 of 125 PageID #: 5737
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`specify confusion in the art over these terms and the use of
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`the terms.
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`This is, perhaps, pre Nautilus. Before the Supreme
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`Court weighed in, Your Honor. I might agree with you that
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`these terms are not indefinite in the sense that one can cobble
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`together in some sense a series or string of words that you can
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`proffer as a construction. But that -- that law has changed.
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`THE COURT: I wonder how we would deal with a variety
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`of medical conditions as to which there is a general agreement
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`10
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`as to the core of what the condition is, at least
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`11
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`symptomatically? We may not know etiology, but we --
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`12
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`symptomatology, we understand generally. But there's
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`13
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`disagreement as to whether particular features are part of that
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`14
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`disease or not.
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`15
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`Diseases come to mind, schizophrenia. Doctors have
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`struggled for many years over what schizophrenia really is, but
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`17
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`they have a general understanding of the symptoms. Nobody
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`really has an understanding of the causes, but there's some
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`speculation.
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`But if you came up with a patent on a drug that was
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`21
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`effective with respect to the core disease concept of
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`22
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`schizophrenia, I would not find it invalid because I couldn't
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`23
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`tell you with great precision what schizophrenia means. That's
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`24
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`what I think we've got here as far as I can see.
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`We've got a pretty good general agreement about what
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`Case 2:15-cv-01455-WCB Document 182 Filed 09/02/16 Page 15 of 125 PageID #: 5738
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`"dry eye" is. We particularly have an even better agreement,
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`as far as I can see, about "keratoconjunctivitis." But we have
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`some disagreements around -- around the borders.
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`It does not strike me that this is a profound lack of
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`any agreeable concept as to what the -- the disease is. So
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`you're going to have to persuade me that there's just -- this
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`is just -- a person of skill in the art would just throw their
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`hands up and say, I have no idea even what the general core
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`notion is here.
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`10
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`MR. CARSTEN: Your Honor, in the schizophrenia
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`11
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`hypothetical, I don't believe you have patentees standing
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`12
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`before you saying this is not a palliative medication. These
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`13
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`patent claims are not directed to palliative treatment.
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`14
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`Rather, these claims are specifically directed and only
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`15
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`directed to treating the underlying disease.
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`16
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`Now, "dry eye disease," "dry eye syndrome," "dry
`
`17
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`eye," come from myriad of sources, myriad etiologies.
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`18
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`Including etiologies that would not, according to the experts
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`19
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`in this case, be amenable to treatment by virtue of
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`20
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`administering an anti-inflammatory.
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`21
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`So let's say we've got a pirate -- not like the
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`22
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`nasty, smiley pirates. Maybe -- maybe, you know, a Disney-type
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`23
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`pirate who's out on a ship, doesn't have any carrots. He's got
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`24
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`a Vitamin A deficiency. His crew has a Vitamin A deficiency.
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`He happens not to have carrots, but he's got RESTASIS, for
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`Case 2:15-cv-01455-WCB Document 182 Filed 09/02/16 Page 16 of 125 PageID #: 5739
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`whatever reason. He administers --
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`THE COURT: It's not going to do him any good.
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`MR. CARSTEN: He administers RESTASIS. That's not
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`going to treat anything that -- that suffering -- or that his
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`crew is suffering from.
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`THE COURT: Right.
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`And there are certain types of schizophrenia as to
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`which my hypothetical drug probably would not be effective.
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`Because schizophrenia is a collection of maladies, as I think
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`10
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`we now understand.
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`11
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`But if the drug is effective with respect to some
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`12
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`significant subset of that collective group of maladies, then I
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`13
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`don't think that it's fair to say that schizophrenia has no --
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`14
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`has no meaning --
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`MR. CARSTEN: Well, we're not --
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`THE COURT: -- has no meaning that we can discern.
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`MR. CARSTEN: Well, we're not saying that "dry eye
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`18
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`disease," "dry eye syndrome," "dry eye" itself and "KCS" don't
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`19
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`have meanings. The problem is they have too many meanings.
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`20
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`And there's no sign post in this patent to direct one to which
`
`21
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`meaning is being used.
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`22
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`In fact, Dr. Calman at his deposition was asked:
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`23
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`What do you think this means?
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`24
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`His said: Well, I got this meaning, but this is --
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`his name is Andy -- this is Andy's personal view. I don't
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`Case 2:15-cv-01455-WCB Document 182 Filed 09/02/16 Page 17 of 125 PageID #: 5740
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`consider myself arrogant enough to know what Allergan was
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`saying in -- by virtue of this specific legally effective
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`document that's going to be used to forestall generic
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`competition.
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`THE COURT: Well, what about the American Academy of
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`Ophthalmology's definition of "dry eye"? Why isn't that an
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`acceptable definition?
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`They say definition -- and this is back in I think
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`2000, if I recall correctly. 2000, yeah: A group of disorders
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`10
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`of the tear film that are due to reduce tear production or
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`11
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`excessive tear evaporation that is associated with ocular
`
`12
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`discomfort and/or visual symptoms and may cause disease of the
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`13
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`ocular surface.
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`14
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`Very -- I'm sorry. I'm going too fast. Let me --
`
`15
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`let me slow down and do that again.
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`16
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`And by the way, for the benefit of the court
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`17
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`reporter, if we're reading materials let's slow down, as I just
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`18
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`didn't. That's a perfect illustration of how not to do it.
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`19
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`20
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`MR. CARSTEN: I agree, Your Honor.
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`THE COURT: Also, let's try to avoid talking over one
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`21
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`another. That's something that I'm often as much at fault or
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`22
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`more, but we'll try to avoid that.
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`23
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`But the definition is: A group of disorders of the
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`24
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`tear film that are due to reduced tear production or excessive
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`25
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`tear evaporation that is associated with ocular discomfort
`
`
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`Case 2:15-cv-01455-WCB Document 182 Filed 09/02/16 Page 18 of 125 PageID #: 5741
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`and/or visual symptoms and may cause disease of the ocular
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`surface.
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`That's a definition. Why isn't that definite enough
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` 4
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`for present purposes?
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`MR. CARSTEN: It is a definition. And pre Nautilus,
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`it might be a suitable one. The problem, though, Your Honor,
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` 7
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`is that's one of many attempts to try to standardize a
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` 8
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`definition. But it just hasn't taken.
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`10
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`11
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`And we know that from --
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`THE COURT: How do you know it hasn't taken?
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`MR. CARSTEN: We know that from the contemporaneous
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`12
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`literature. The people with -- the clinicians, boots on the
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`13
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`ground reporting --
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`14
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`15
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`16
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`THE COURT: Other than --
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`MR. CARSTEN: -- reporting --
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`I'm sorry, Your Honor.
`
`THE COURT: Other than Dr. Calman saying that that
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`18
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`was his personal definition, what -- what do you have that is
`
`19
`
`evidence that this is just a source of enormous confusion and
`
`20
`
`chaos in the field?
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`21
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`MR. CARSTEN: If I may, Your Honor, the citations to
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`22
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`the record that I entered previously. But let me, if I may,
`
`23
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`just read a couple of these. I think they are telling and
`
`24
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`instructive, Your Honor.
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`25
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`Here is one of the articles from 1998: The terms
`
`
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`Case 2:15-cv-01455-WCB Document 182 Filed 09/02/16 Page 19 of 125 PageID #: 5742
` 19
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`used in this field are often confusing. Some of them being
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`very loosely defined and others having a historical usage that
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`
`differs from the contemporary meaning.
`
` 4
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` 5
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`1998.
`
`Maybe it's gotten better in 2000, Your Honor, but
`
` 6
`
`apparently not: For years in 2000 there has been considerable
`
` 7
`
`confusion regarding the definition of "dry eye."
`
` 8
`
`Here's from 2006, and it certainly would have gotten
`
` 9
`
`better by then one would think: Panelists unanimously agree
`
`10
`
`that the label "dry eye" reflects neither patient symptoms nor
`
`11
`
`necessarily the pathogenic mechanism of the disease. Panel
`
`12
`
`members also agree that diagnosing patients with dry eye may be
`
`13
`
`misleading to both colleagues and patients.
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`14
`
`Your Honor, this is not a situation -- and I wouldn't
`
`15
`
`be standing here if I really didn't believe that there's
`
`16
`
`absolute boots on the ground reported evidence of confusion
`
`17
`
`among these terms. These terms may be one can discern what
`
`18
`
`Allergan means.
`
`19
`
`But how -- how in the course of the patent within the
`
`20
`
`four corners does one identify when -- when one choose -- when
`
`21
`
`Allergan chooses, voluntarily elects and opts to claim using
`
`22
`
`these terms and provide you zero guidance as to what they mean
`
`23
`
`in the --
`
`24
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`25
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`THE COURT: What about keratoconjunctivitis?
`
`For the benefit of the court reporter, that's
`
`
`
`Case 2:15-cv-01455-WCB Document 182 Filed 09/02/16 Page 20 of 125 PageID #: 5743
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`K-E-R-A-T-O-C-O-N-J-U-N-C-T-I-V-I-T-I-S.
`
` 2
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` 3
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` 4
`
`MR. CARSTEN: Wow. Impressive, Your Honor.
`
`THE COURT: What about that? Do you --
`
`MR. CARSTEN: I think spelling bees are certainly
`
` 5
`
`your forte, Your Honor.
`
` 6
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` 7
`
`THE COURT: No, no, not the spelling.
`
`What do you think about the specificity, the
`
` 8
`
`inadequacy of the -- of the term as sufficiently definite?
`
` 9
`
`MR. CARSTEN: In terms of historical roots, I
`
`10
`
`certainly think in terms of the indefiniteness argument that
`
`11
`
`that's the weakest one we've got. The strongest one for
`
`12
`
`Allergan.
`
`13
`
`That, historically, was -- was targeting or talking
`
`14
`
`about a particular type of Sjogren's inflammatory ailment. But
`
`15
`
`over time, that changed. Over time "KCS" was being used
`
`16
`
`interchangeably with "dry eye disease" and "dry eye syndrome"
`
`17
`
`and just "dry eye."
`
`18
`
`In fact, one need look no further than the
`
`19
`
`specification of this very patent to see that Allergan itself
`
`20
`
`in the patent is using "KCS" as a proxy to talk about a -- an
`
`21
`
`absolute or partial deficiency in aqueous tear production.
`
`22
`
`This is from the patent-in-suit at Columns 2 through 55 and --
`
`23
`
`24
`
`THE COURT: Are you talking about the '111 patent?
`
`MR. CARSTEN: Yes, the '111 patent-in-suit. From
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`25
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`Columns 2:55 to 3:11: Other conditions that can be treated
`
`
`
`Case 2:15-cv-01455-WCB Document 182 Filed 09/02/16 Page 21 of 125 PageID #: 5744
` 21
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`with cyclosporine components include an absolute or partial
`
` 2
`
`deficiency in aqueous tear production, paren,
`
` 3
`
`keratoconjunctivitis sicca, or KCS, close paren.
`
` 4
`
`You know, cyclosporine, above that in that same
`
` 5
`
`passage that I cited --
`
` 6
`
`THE COURT: And where -- I'm sorry. Where are you
`
` 7
`
`right now in the '111? What column?
`
` 8
`
`MR. CARSTEN: I am at -- I am at Column 3, towards
`
` 9
`
`the top, at Line 2: Other conditions that can be treated.
`
`10
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`11
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`12
`
`Just let me know when you have it, Your Honor.
`
`THE COURT: Yeah, I have it. Thank you.
`
`MR. CARSTEN: Other conditions that can be treated
`
`13
`
`with cyclosporine components include an absolute or partial
`
`14
`
`deficiency in aqueous tear production, paren,
`
`15
`
`keratoconjunctivitis sicca, or KCS, close paren.
`
`16
`
`It is using KCS, or keratoconjunctivitis sicca, to
`
`17
`
`refer directly to absolute or partial deficiency in aqueous
`
`18
`
`tear production. That's not talking about a particular brand
`
`19
`
`of inflammatory ailment like Sjogren's disease or one type of
`
`20
`
`Sjogren's disease. Rather, it's using it as a bucket in which
`
`21
`
`a whole host and panoply of conditions that lead to decreased
`
`22
`
`tear production are being lumped together with no this, that,
`
`23
`
`or the other guidance.
`
`24
`
`Under Nautilus and under Dow that's a problem, Your
`
`25
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`Honor.
`
`
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`Case 2:15-cv-01455-WCB Document 182 Filed 09/02/16 Page 22 of 125 PageID #: 5745
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`THE COURT: All right. Why don't we --
`
`MR. CARSTEN: If I may --
`
`THE COURT: Go ahead.
`
`MR. CARSTEN: Your Honor, so in addition, when one
`
` 5
`
`reads the briefs, it's pretty clear to us at any rate that even
`
` 6
`
`Allergan doesn't know what it is -- what it is they're talking
`
` 7
`
`about with respect to when they use "dry eye disease" or when
`
` 8
`
`they use "KCS."
`
` 9
`
`I mean, "KCS" is a subset of dry eye disease, they
`
`10
`
`say in their reply brief. And for the opening brief it says,
`
`11
`
`"KCS" is a partial synonym of dry eye disease. It's
`
`12
`
`substantively -- the definition of KCS is a partial synonym of
`
`13
`
`dry eye disease is substantively indistinguishable from
`
`14
`
`Allergan's own construction.
`
`15
`
`In the opening brief, dry eye disease is an
`
`16
`
`inflammatory disease affecting millions of people. That's the
`
`17
`
`opening brief at Page 2. The -- Allergan's reply brief at Page
`
`18
`
`2, although KCS is an inflammatory disease, dry eye is not so
`
`19
`
`limited.
`
`20
`
`So in the -- between the opening brief and the reply
`
`21
`
`brief, apparently dry eye disease went from being an
`
`22
`
`inflammatory disease to being not limited to an inflammatory
`
`23
`
`disease.
`
`24
`
`The positions are all over the map, Your Honor. And
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`25
`
`that's the problem we have here. This indefiniteness, it
`
`
`
`Case 2:15-cv-01455-WCB Document 182 Filed 09/02/16 Page 23 of 125 PageID #: 5746
` 23
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`pervades not only the patent, but the briefing on the patent.
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` 2
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`And it's compounded because Allergan is sitting here
`
` 3
`
`saying, my claims are directed not to treating a symp
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