271
`
`CIVIL ACTION
`
`NO. 15-164-LPS
`
`CIVIL ACTION
`
`NO. 15-193-LPS
`
`::
`
`::
`
`- - -
`Wilmington, Delaware
`Tuesday, May 23, 2017
`Bench Trial - Volume B
`- - -
`HONORABLE LEONARD P. STARK, Chief Judge
`- - -
`
`BEFORE:
`APPEARANCES:
`
`MORRIS NICHOLS ARSHT & TUNNELL, LLP
`BY:
`MARYELLEN NORIEKA, ESQ.
`and
`
`Valerie G. Gunning
`Official Court Reporter
`
`Brian P. Gaffigan
`Official Court Reporter
`
`IN THE UNITED STATES DISTRICT COURT
`IN AND FOR THE DISTRICT OF DELAWARE
`- - -
`COSMO TECHNOLOGIES LIMITED, VALEANT
`PHARMACEUTICALS INTERNATIONAL, and
`VALEANT PHARMACEUTICALS LUXEMBOURG
`S.A.R.L.,
`Plaintiffs,
`v
`ACTAVIS LABORATORIES FL, INC.,
`Defendant.
`-------------------------------------
`COSMO TECHNOLOGIES LIMITED, VALEANT
`PHARMACEUTICALS INTERNATIONAL, and
`VALEANT PHARMACEUTICALS LUXEMBOURG
`S.A.R.L.,
`Plaintiffs,
`v
`ALVOGEN PINE BROOK, LLC,
`Defendant.
`
`:
`:
`:
`:
`
`::
`
`::
`
`:
`:
`:
`:
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`Cosmo Ex 2025-p. 1
`Mylan v Cosmo
`IPR2017-01035
`
`
`
`CIVIL ACTION
`
`NO. 15-164-LPS
`
`CIVIL ACTION
`
`NO. 15-193-LPS
`
`::
`
`::
`
`- - -
`Wilmington, Delaware
`Tuesday, May 23, 2017
`Bench Trial - Volume B
`- - -
`HONORABLE LEONARD P. STARK, Chief Judge
`- - -
`
`BEFORE:
`APPEARANCES:
`
`MORRIS NICHOLS ARSHT & TUNNELL, LLP
`BY:
`MARYELLEN NORIEKA, ESQ.
`and
`
`Valerie G. Gunning
`Official Court Reporter
`
`Brian P. Gaffigan
`Official Court Reporter
`
`IN THE UNITED STATES DISTRICT COURT
`IN AND FOR THE DISTRICT OF DELAWARE
`- - -
`COSMO TECHNOLOGIES LIMITED, VALEANT
`PHARMACEUTICALS INTERNATIONAL, and
`VALEANT PHARMACEUTICALS LUXEMBOURG
`S.A.R.L.,
`Plaintiffs,
`v
`ACTAVIS LABORATORIES FL, INC.,
`Defendant.
`-------------------------------------
`COSMO TECHNOLOGIES LIMITED, VALEANT
`PHARMACEUTICALS INTERNATIONAL, and
`VALEANT PHARMACEUTICALS LUXEMBOURG
`S.A.R.L.,
`Plaintiffs,
`v
`ALVOGEN PINE BROOK, LLC,
`Defendant.
`
`:
`:
`:
`:
`
`::
`
`::
`
`:
`:
`:
`:
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`
`APPEARANCES: (Continued)
`PAUL HASTINGS, LLP
`BY:
`MELANIE R. RUPERT, ESQ.,
`DAVID M. CONCA, ESQ.,
`NICHOLAS A. TYMOCZKO, ESQ.,
`JOSEPH O'MALLEY, ESQ.,
`SCOTT F. PEACHMAN, ESQ.,
`ANDREW J. COCHRAN, ESQ., and
`MI ZHOU, ESQ.
`(New York, New York)
`Counsel for Plaintiffs Valeant
`Pharmaceuticals International, and
`Valeant Pharmaceuticals Luxembourg S.A.R.L.
`MORRIS NICHOLS ARSHT & TUNNELL, LLP
`BY:
`MARYELLEN NORIEKA, ESQ.
`and
`IRELL & MANELLA, LLP
`BY: GARY FRISCHLING, ESQ., and
`YITE JOHN LU, ESQ.
`(Los Angeles, California)
`Counsel for Plaintiff Cosmo
`Technologies Limited
`PHILLIPS GOLDMAN McLAUGHLIN & HALL, P.A.
`BY:
`JOHN C. PHILLIPS, JR., ESQ., and
`DAVID A. BILSON, ESQ.
`and
`GOODWIN PROCTOR, LLP
`BY:
`JOHN T. BENNETT, ESQ.,
`SAMUEL SHERRY, ESQ., and
`SHAOBO ZHU, ESQ.
`(Boston, Massachusetts)
`and
`GOODWIN PROCTOR, LLP
`BY: ELIZABETH J. HOLLAND, ESQ.,
`NAOMI BIRBACH, ESQ.
`(New York, New York)
`Counsel for Defendant
`Actavis Laboratories FL, Inc.
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`APPEARANCES: (Continued)
`
`273
`
`SHAW KELLER, LLP
`BY: DAVID E. FRY, ESQ., and
`KAREN E. KELLER, ESQ.
`and
`AXINN, VELTROP & HARKRIDER, LLP
`BY: MATTHEW J. BECKER, ESQ., and
`JASON MURATA, ESQ.
`(Hartford, Connecticut)
`and
`AXINN, VELTROP & HARKRIDER, LLP
`BY: TODD MARABELLA, ESQ.
`(Boston, Massachusetts)
`and
`AXINN, VELTROP & HARKRIDER, LLP
`BY: BRETT GARRISON, ESQ.
`(Washington, District of Columbia)
`Counsel for Defendant
`Alvogen Pine Brook, LLC
`
`- oOo -
`P R O C E E D I N G S
`(REPORTER'S NOTE: The following bench trial was
`held in open court, beginning at 8:35 a.m.)
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`(Dr. Fassihi left the courtroom.)
`MR. CONCA: Thank you, Your Honor.
`THE COURT: Okay.
`MR. CONCA: Your Honor, defendants' motion for
`judgment under 52(c) should be denied because it suffers
`from several fundamental flaws.
`First, it ignores the extensive affirmative
`documentary evidence that the defendants' products are
`macroscopically homogeneous, which includes numerous ANDA
`product development documents reflecting the substantial
`efforts that defendants made to design their products and
`their manufacturing process for making them so that the
`blended excipients will be homogeneous throughout the
`manufacturing process, and so that the resulting tablets
`will likewise remain homogeneous. These documents,
`including defendants' own extensive use of internal active
`ingredient uniformity testing, including express admissions
`in these documents that the defendants themselves use active
`ingredient uniformity testing with results routinely close
`to a hundred percent as a surrogate to demonstrate excipient
`homogeneity in the product blend.
`For example, PTX-230 at page 4 states, "In
`addition, the final blend was also found to be homogeneous
`based on the results of blend uniformity studies and had
`good compressibility."
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`
`PTX-228 at 193. "To assess homogeneity of
`the blend, blend uniformity sampling will still be
`performed."
`
`Further, both defendants' documents establish
`that the tablet compression was designed to minimize
`segregation of the homogeneous product blends created during
`their respective manufacturing processes, during those
`mixing processes.
`Alvogen's PTX-228 at 170, "The compression
`process must provide the desired dose in each tablet by
`avoiding segregation of the uniform blend." And Actavis'
`PTX-230. "This process of blending in a series of steps
`ensured homogeneous mixing of nine milligrams of active
`ingredient in 300 milligrams of blend as evidenced by blend
`uniformity data and content uniformity data from the core
`tablet."
`
`These ANDA documents are legal representations
`to FDA and defendants can't deviate from them without
`amending their ANDAs.
`THE COURT: Where is the documentary evidence
`that it is macroscopically homogeneous as viewed by the
`naked eye?
`
`MR. CONCA: The documentary evidence includes
`defendants' witness testimony, but the documentary evidence
`itself is the photographs that the defendants' experts took
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`292
`
`proposed; correct?
`MR. CONCA: It is the construction that we
`proposed. Actually, what the plaintiffs said was we think
`it's plain and ordinary meaning. The defendants had
`proposed a much narrower construction that looked at
`specific elements and was more akin to a microscopic
`homogeneity. So what we said was, it's not that. It's
`something more akin to a naked eye. And that made sense.
`And I believe Your Honor understood that in the context of
`the prior art that was being cited in this case, which were
`formulations like Savastano that had a layered formulation,
`and the layered formulation was being distinguished from the
`matrix-type composition of the invention, which involved a
`single uniform tablet core. And that's consistent with what
`the example in the specification says, Your Honor. The
`specific mixing of different excipients, including
`excipients of different sizes, granules and powders, mixing
`them, blending them, and compressing them into
`macroscopically homogeneous tablets.
`So the idea that the naked eye test is the only
`test is just not correct.
`THE COURT: If it's not the only test, do you
`agree that it is a test, that it is a relevant
`consideration?
`MR. CONCA: It's certainly relevant information
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`
`
`293
`
`for someone to consider, and Dr. Davis did consider that
`along with the defendants' experts. He considered that in
`the form of the photos that the defendants have said and we
`expected will say are representative of their products when
`viewed by the naked eye, and that includes when viewed by
`the naked eye of skilled formulators, which are these two
`gentlemen who took these photos, Your Honor.
`THE COURT: There is nothing -- is there
`anything in the record as to why the plaintiffs didn't just
`simply have their own expert do his own naked eye test?
`MR. CONCA: There is nothing in the record as to
`why the plaintiffs did not do that. There was sufficient
`evidence in the defendants' ANDA documents and in the
`defendants' witness testimony to demonstrate the homogeneity
`of the entire structure, which is all of this blending, all
`of these compression steps designed to make segregation a
`hundred percent uniformity testing, surrogate, use of
`surrogate content uniformity testing to demonstrate blend
`uniformity, to demonstrate tablet uniformity. These are
`admissions by defendants that we would submit are, if not
`equal, better than a relatively subjective view of these
`tablet cores as Your Honor has seen so far through the
`pictorial evidence.
`THE COURT: The evidence is though, I think,
`that it would have been very easy. You had experts. You
`
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`315
`
`Dr. Mullen talked about this raisin bread
`analogy, and if you had a loaf of raisin bread and you took
`one slice of it, you might see a raisin. You might see one
`raisin. It doesn't mean that that loaf of raisin bread
`doesn't have raisins homogenously distributed throughout.
`And what you're seeing on this tablet is yellow lecithin
`that's distributed throughout the tablet core.
`THE COURT: If the yellow lecithin is not
`distributed uniformly, then does Actavis infringe?
`MR. CONCA: If the yellow lecithin is, indeed,
`not distributed uniformly, which I don't think is the case
`here, then it would be an excipient that's not uniformly
`distributed and therefore we would have a
`non-macroscopically homogeneous composition, but we don't
`have that. We have lecithin that is uniformly distributed
`throughout the blend and throughout the tablet cores.
`THE COURT: All right. On the Alvogen tablet,
`as I said, I didn't see yellow, but I thought I saw some
`craters or dimples or striations.
`What do I do with that?
`MR. CONCA: I think you conclude what Dr. Joshi
`concluded, which is that all of the beads are not in one
`particular section of those tablets. The fact that Alvogen
`uses drug-layered and then mixes them very, very carefully
`to get a uniform blend and then designs a tableting process
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`
`to make sure that that uniform blend is not segregated
`during tableting, that you end up with a macroscopically
`homogeneous core that comprises beads and powders blended
`together, which is what the patent talks about, at least to
`the extent of different sized excipients being mixed
`together and blended.
`THE COURT: Have you come across any documents
`of the defendants that are in evidence that mention
`homogeneity?
`
`MR. CONCA: I have. This is the document that I
`mentioned initially, which is PTX-228, page 193. To assess
`the homogeneity of the blend, blend uniformity sampling will
`still be performed.
`THE COURT: That is --
`MR. CONCA: That's the pre-blend and, of course,
`we have the documentary evidence and the witness testimony
`that talks about how that uniform blend is made into tablets
`without segregation.
`THE COURT: This document itself, the sentence
`you're referring to, is a pre-tableting process; is that
`correct?
`
`MR. CONCA: This sentence refers to the
`pre-tableting process, and I will get to the specific
`documents on the tablets as well as specific testimony on
`the tablets as soon as I can.
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`MS. HOLLAND: No, Your Honor.
`MR. BECKER: No, Your Honor.
`MR. CONCA: No, Your Honor.
`THE COURT: All right. Well, the matter before
`the Court then is defendants Actavis and Alvogen's motions
`for judgment of noninfringement pursuant to Federal Rule of
`Civil Procedure 52(c). And after careful consideration of
`the record and the governing law, the Court has decided to
`grant both motions; and I will explain the reasoning for
`that conclusion.
`As an initial matter, the Court finds that
`these motions are ripe for decision and rejects plaintiffs'
`request articulated today for an opportunity to make written
`submissions in opposition to the motions.
`The record is not that large. We heard maybe
`four or five hours of evidence. And the issues in dispute
`on infringement are narrow.
`The Court heard extensive opening statements just
`yesterday and also made clear yesterday that today would
`begin with argument on defendants' motions, should plaintiffs
`choose to close their case-in-chief on infringement, as
`they did choose to do after proposing a stipulation which
`the Court entered.
`The Court then heard extensive argument this
`morning on defendants' motions and gave both sides every
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`opportunity to point to whatever it wished to in the
`evidentiary record.
`Plaintiffs have been fully and fairly heard,
`and there is no need to delay the Court's decision on the
`pending motions by allowing further submissions on the
`motion.
`
`Turning to the motion. The legal standard I
`think is undisputed and is clear. As the Third Circuit
`explained in the EBC decision, 618 F.3d at 272. In
`considering whether to grant judgment under Rule 52(c),
`the District Court applies the same standard of proof and
`weighs the evidence as it would at the conclusion of the
`trial. Accordingly, the Court does not view the evidence
`through a particular lens or draw inferences favorable to
`either party.
`The Court has considered the testimony of the
`witnesses plaintiffs called both live and by deposition, the
`documentary evidence admitted, and its own visual inspection
`of the tablets of Actavis and Alvogen's proposed generic
`products and the stipulations. And the Court has also
`considered the credibility of the witnesses who testified
`as it is permitted to do under Rule 52 as the fact-finder.
`The burden of proof is on the plaintiffs to
`prove by a preponderance of the evidence that every element
`of the asserted claims is present in defendants' ANDA
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`Cosmo Ex 2025-p. 11
`Mylan v Cosmo
`IPR2017-01035
`
`
`
`334
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`products, and the Court finds that the plaintiffs have
`failed to meet this burden.
`We'll go claim by claim.
`So, first, plaintiffs have failed to prove by a
`preponderance of the evidence that Actavis infringes claim 9
`of the '888 patent.
`The only element in dispute here is the
`"macroscopically homogeneous composition" element.
`The Court adopted plaintiffs' proposed
`construction for this term, which is, "a composition of
`uniform structure throughout as observed by the naked eye."
`Plaintiffs had not proven that the active
`ingredient or excipients in Actavis's tablet are uniformly
`distributed as viewed by the naked eye. Plaintiffs, in
`fact, presented no evidence of anyone examining the Actavis
`tablets with his or her naked eye.
`Plaintiffs' expert, Dr. Davis never examined the
`tablets with his naked eye. Instead, he only reviewed
`defendants' experts photographs of bisected tablets. While
`those photographs may be representative of the tablets,
`they are not a good substitute for looking at the tablets
`themselves.
`
`There is no reason in the record as to why
`plaintiffs did not have any expert undertake the simple task
`of examining tablets himself or herself and providing an
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`01:04:52
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`Cosmo Ex 2025-p. 12
`Mylan v Cosmo
`IPR2017-01035
`
`
`
`335
`
`opinion as to whether they looked to be a composition of
`uniform structure throughout.
`There is no explanation in the record for why
`plaintiffs did not even bother to provide samples of
`defendants' ANDA product to Dr. Davis.
`The Court itself looked at the tablets in
`evidence, PTX-24, with its naked eye and found that they do
`not, to a lay observer at least, appear to be "a composition
`of uniform structure throughout."
`Instead, they appear to have yellow dots that
`are not uniformly distributed throughout. The Court's
`observation combined with plaintiffs' expert's
`non-observation of the actual tablets is circumstantial
`evidence that the Actavis tablets are not macroscopically
`homogeneous under the Court's construction.
`The plaintiffs rely on uniformity testing, blend
`uniformity and content uniformity, but these pre- and
`post-tableting tests test only for the amount of active
`ingredient and not also for the arrangement of the active
`ingredient or the amount or arrangement of excipients.
`The Court is not persuaded by plaintiffs'
`evidence, including their expert Dr. Davis, to draw the
`inferences they ask the Court to draw from the uniformity
`testing.
`
`Plaintiffs rely on Actavis documents but only
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`01:06:13
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`01:07:38
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`Cosmo Ex 2025-p. 13
`Mylan v Cosmo
`IPR2017-01035
`
`
`
`336
`
`one document they point to even speaks of homogeneity and
`that document is referring to uniformity studies on the
`blend for tableting. I believe that is PTX-230 at 4.
`Plaintiffs rely on the testimony of Actavis
`witnesses, but that testimony does not prove a uniform
`structure throughout. Instead, at most, it establishes
`uniform distribution in the blend.
`In other words, plaintiffs rely largely on
`combination of Actavis's goal of a uniform nonsegregated
`distribution of all ingredients and Actavis's statements
`about its product in testing that relate to the
`pre-tableting or post-tableting period, but the claims here
`specifically require a composition in a final product that
`has uniform structure throughout, and in that context, the
`inferences plaintiffs ask the Court to draw from their
`evidence are unpersuasive.
`Turning now to the Alvogen product.
`Plaintiffs have also failed to prove by a
`preponderance of the evidence that Alvogen infringes claim 6
`of the '888 patent. The analysis is largely the same, and
`where it is the same, I'm not going to repeat it at this
`point. It is the same dispute, the same claim construction,
`the same lack of evidence of observation with the naked eye
`by a plaintiffs' witness.
`Here, again, the Court looked at the Alvogen
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`01:09:07
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`Cosmo Ex 2025-p. 14
`Mylan v Cosmo
`IPR2017-01035
`
`
`
`337
`
`tablets in evidence, PTX-25, with its naked eye and found
`that they do not to this lay observer appear to be a
`composition of uniform structure throughout. Instead,
`they have holes or bumps that are not evenly distributed
`throughout.
`
`The Court's observation combined with the
`plaintiffs' expert non-observation of the actual tablets is
`circumstantial evidence that the Alvogen tablets are not
`macroscopically homogeneous under the Court's construction.
`As with respect to Actavis, with respect to
`Alvogen, plaintiffs rely on Alvogen documents but only one
`they point to even speaks to homogeneity, and that document
`is referring to blend uniformity. I believe it is PTX-228
`at page 193.
`
`And with respect to Alvogen, there is not even
`evidence that Alvogen intends to end up with a uniform
`composition throughout. Instead, the evidence is that
`Alvogen uses two different structures: active ingredient
`beads mixed with a separate excipient structure.
`So the Alvogen documents and the witness
`testimony from Alvogen witnesses on which plaintiffs rely
`do not significantly help them in meeting their burden.
`So with respect to the '888 patent, the
`plaintiffs have failed to meet their burden.
`Plaintiffs have also failed to prove by a
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`01:10:27
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`01:10:30
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`Cosmo Ex 2025-p. 15
`Mylan v Cosmo
`IPR2017-01035
`
`
`
`340
`
`detect the presence of stearic acid. The undisputed fact is
`that plaintiffs had samples of Actavis's ANDA product and
`the fact that another of plaintiffs' experts did do a
`battery of tests on those samples.
`So that is the analysis and the basis for the
`finding of noninfringement.
`Rule 52(c) states a judgment on partial findings
`must be supported by findings of fact and conclusions of
`law as required by Rule 52(a). Consistent with this rule,
`it is the Court's preference to issue written findings of
`fact and conclusions of law, and I will give the parties an
`opportunity to assist the Court in doing just that.
`Specifically, I want you all to meet and confer,
`and by the end of the day tomorrow get me a joint status
`report indicating the timing and the length of the written
`submissions that you propose to give the Court to allow me
`to issue written findings of fact and conclusions of law.
`I will ask that tomorrow you also attach a
`proposed form of order with respect to the briefing and also
`any other order or judgment that you think I should be
`entering based on my decision today.
`Are there any questions about that from Actavis?
`MS. HOLLAND: No, Your Honor.
`THE COURT: And from Alvogen?
`MR. BECKER: No, Your Honor.
`
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`01:15:13
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`Cosmo Ex 2025-p. 16
`Mylan v Cosmo
`IPR2017-01035
`
`
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