1
`
`- VOLUME 1 -
`
` IN THE UNITED STATES DISTRICT COURT
` IN AND FOR THE DISTRICT OF DELAWARE
` - - -
`
`CIVIL ACTION
`
`RECKITT BENCKISER
`PHARMACEUTICALS INC., RB
`PHARMACEUTICALS LIMITED,
`and MONSOL RX, LLC,
` Plaintiffs,
` vs.
`TEVA PHARMACEUTICALS
`USA, INC.,
`NO. 14-1451 (RGA)
` Defendant.
`
`
`
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`
` Wilmington, Delaware
` Tuesday, November 3, 2015
` 8:30 o'clock, a.m.
`
` - - -
`BEFORE:
`HONORABLE RICHARD G. ANDREWS, U.S.D.C.J.
` - - -
`
`:::::::::::::
`
`
` Valerie J. Gunning
` Leonard A. Dibbs
` Official Court Reporters
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`A P P E A R A N C E S :
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` W O M B L E C A R L Y L E S A N D R I D G E & R I C E , L L P
` B Y : M A R Y W . B O U R K E , E S Q .
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` - a n d -
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` T R O U T M A N S A N D E R S L L P
` B Y : D A N I E L A . L A D O W , E S Q .,
` J A M E S M . B O L L I N G E R , E S Q .
` C H A R A N J I T B R A H M A , E S Q .
` ( N e w Y o r k , N e w Y o r k )
`
` C o u n s e l fo r P la t in t if f s
` R e c k it t B e n c k is e r P h a r m a c e u t ic a ls , I n c .
` a n d R & B P h a r m a c e u t ic a ls L im it e d
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` R I C H A R D S , L A Y T O N & F I N G E R , P .A .
` B Y : S T E V E N J . F I N E M A N , E S Q .
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` - a n d -
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` L A T H A M & W A T K I N S L L P
` B Y : D A N I E L G . B R O W N , E S Q .
` ( N e w Y o r k , N e w Y o r k )
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`A P P E A R A N C E S ( C o n t in u e d ) :
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` L A T H A M & W A T K I N S L L P
` B Y : J A M E S K . L Y N C H , E S Q .
` ( S a n F r a n c is c o , C a lifo r n ia )
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` - a n d -
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` L A T H A M & W A T K I N S L L P
` B Y : B R E N D A L . D A N E K , E S Q . a n d
` E M I L Y M E L V I N , E S Q .
` ( C h ic a g o , I llin io s )
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` - a n d -
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` L A T H A M & W A T K I N S L L P
` B Y : B . T H O M A S W A T S O N , E S Q .
` ( S a n D ie g o , C a l ifo r n ia )
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`
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` C o u n s e l fo r D e fe n d a n t s
` P a r P h a r m a c e u t ic a l, I n c . a n d I n t e lg e n x
` T e c h n o l o g ie s C o r p .
`
` W I N S T O N & S T R A W N , L L P
` B Y : G E O R G E C . L O M B A R D I , E S Q .
` M I C H A E L K . N U T T E R , E S Q .
` ( C h ic a g o , I llin o is )
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`A P P E A R A N C E S ( C o n t in u e d ) :
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` W I N S T O N & S T R A W N , L L P
` B Y : D A V I D P . D A L K E , E S Q . a n d
` S T E P H E N R . S M E R E K , E S Q .
` ( L o s A n g e l e s , C a lifo r n ia )
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` - a n d -
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` W I N S T O N & S T R A W N , L L P
` B Y : M E L I N D A K . L A C K E Y , E S Q .
` ( H o u s t o n , T e x a s )
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` C o u n s e l fo r D e fe n d a n t
` W a t s o n L a b o r a t o r ie s
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` P R O C E E D I N G S
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` ( P r o c e e d in g s c o m m e n c e d in t h e
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`c o u r t r o o m , b e g i n n in g a t 8 : 3 0 a . m .)
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` T H E C O U R T : A ll r ig h t . G o o d m o r n in g ,
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`e v e r y o n e . P le a s e b e s e a t e d .
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`I j u s t w a n t e d t o s a y t h a t I d id
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`lo o k a t t h e r e s u m e s ’ o f a ll o f t h e e x p e r t s a n d I
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`d id r e a d t h e a m e n d e d s t a t e m e n t o f f a c t s , w h ic h I
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`t o o k t o b e m o s t ly r e s o lv in g lim i t a t io n s s o t h a t
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`t h e r e w a s n o q u e s t io n t h a t t h e y 'r e n o t in
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`d is p u t e . S o w it h t h a t , I 'm r e a d y t o g o .
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`P la in t iff, a r e y o u r e a d y ?
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`M S . B O U R K E : Y e s , y o u r H o n o r . W e
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`a r e .
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`r e a d y ?
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`H o n o r .
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`T H E C O U R T : A n d d e f e n d a n t s , y o u 'r e
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`M R . L O M B A R D I : Y e s , w e a r e , y o u r
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`T H E C O U R T : A ll r ig h t . L e t 's h a v e
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`a n o p e n in g s t a t e m e n t .
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`M R . L A D O W : G o o d m o r n in g , y o u r
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`H o n o r . D a n L a d o w fo r t h e p la in t iffs .
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`Your Honor, opioid addiction is a
`major public health challenge, one that has
`grown to epidemic proportions with the increased
`use of painkillers, and this has led to a surge
`in addiction with a tripling of overdose deaths
`in recent years. And the plaintiff, Reckitt
`Benckiser Pharmaceuticals, which is now known as
`Indivior, but we'll be using Reckitt Benckiser
`Pharmaceuticals, or RBP through the proceedings,
`that's how all the documents are denominated, is
`the pioneer in opioid addiction treatment, and
`it has been a world leader in this treatment
`space for over 20 years.
`Our co-plaintiff, MonoSol Rx, is
`the pioneer in the new area of pharmaceutical
`prescription films, and together, the two
`companies are addressing this crisis in
`addiction with the medication that's the subject
`of this case.
`In 2002, the FDA approved RBP's
`opioid dependence treatment product, Suboxone
`tablets, which contain two active ingredients,
`buprenorphine and naloxone.
`Buprenorphine is an opioid that
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`can satisfy cravings and reduce opiate drug
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`abuse and it's safer than other opioids, and
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`naloxone is an opiate antagonist or opioid
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`blocker that when taken orally does not produce
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`an effect, but it's an abuse deterrent, so that
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`if the patient abuses the drug and tries to
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`inject it, it can put the patient into
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`withdrawal.
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`Now, the tablets were a huge
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`advance in treatment, but they had different
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`disadvantages, the tablet dosage form, such as
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`dissolution time, taste, subject to crumbling
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`and being subject to abuse and diversion, such
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`as by crushing them and trying to inject them or
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`snort them or something like that.
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`Now, to provide patients with a
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`significantly better dosage form and improved
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`dosage forms, RBP's addiction medication experts
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`joined forces with MonoSol's film technology
`20
`experts to make Suboxone sublingual film, which
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`is a new dosage form.
`22
`And you see here on the slide what
`23
`this product look like. On the right-hand side,
`24
`there's a picture of the eight-milligram film.
`3 of 144 sheets
`
`8
`And as you may recall from the Markman
`proceedings, it's placed in the mouth of the
`patient, it's mucoadhesive, it sticks under the
`tongue and then it dissolves rapidly in the
`mouth, and the buprenorphine active ingredient
`is absorbed through the oral mucosa.
`Now, compared to tablets, Suboxone
`film dissolves faster, tastes better, does not
`crumble, and is less readily diverted and abused
`than tablets, and because of these advantages,
`it's preferred by both doctors and patients, and
`it's the leading medication for opioid
`dependence. And it's the very success of the
`film, your Honor, that has brought us here
`today, and it's why the defendants have copied
`it.
`
`Now, prescription, prescription
`pharmaceutical films are a new dosage form.
`The major reason why they're so recent is that
`making them is very complex and they present
`challenges in formulation and manufacturing that
`are very different from tablets. And, in fact,
`no prescription pharmaceutical films were
`approved by FDA prior to just 2009. This is not
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`like technology that has been around for
`decades. This is new stuff.
`Now, defendants are going to point
`to things like Listerine strips and Chloraseptic
`strips that became available in the early to
`mid-2000s, but these are not prescription
`pharmaceutical films that need FDA approval and
`have to meet the uniformity standards that are
`associated with FDA approval.
`And, in fact, sublingual film, the
`commercial product at issue here, was the very
`first sublingual film approved by the FDA in
`2010, and this dosage form is so new, that these
`cases before this Court right now are the very
`first ANDA cases that involve a prescription
`pharmaceutical film.
`Going to the patents, as your
`Honor knows, there are three Orange Book patents
`at issue in the case. Each of the three patents
`relates to a different aspect of pharmaceutical
`film innovation that resulted in Suboxone film,
`and the infringement and validity issues for
`each patent are really separate and distinct.
`To just briefly introduce the
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`want to balance the properties of adhesion, the
`mucoadhesion in the mouth, dissolution, the good
`tear resistance, the strength of the film, that
`what you can do is include about 50 to
`75 percent of low molecular weight polyethylene
`oxide, which you are going to hear a lot about,
`your Honor, or PEO, optionally combined with a
`small amount of a higher molecular weight PEO,
`with the remainder of the polymer component
`contains a cellulosic polymer like HPMC. So it
`provides this polymer profile that you need to
`do this.
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`patents, the '514 patent solved the drug content
`uniformity problem in pharmaceutical
`prescription films. And as you can see here in
`this excerpt on the top, if you have a failure
`to achieve -- this is an excerpt from the
`patent -- a high degree of accuracy with respect
`to the amount of active in the cut film, this
`can be harmful to the patient. Of course, for
`safety reasons and efficacy reasons, you want
`the patient to get the right dosage.
`And when the patent was filed, the
`inventors noted that about that world regulatory
`authorities required that the dosage amounts in
`dosage forms not vary by more than about ten
`percent of the desired amount of the active, and
`concluding that that basically mandates
`uniformity in the film. And what the present
`invention of the '514 provides, as it says in
`that last excerpt highlighted, is exceptionally
`uniform film products when attention is paid to
`reducing the aggregation of the compositional
`components.
`I'm going to say a very brief, and
`really a very brief word about the '832 patent
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`since it at least relates in part to commercial
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`success, which you'll be hearing about in this
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`trial, but I'm not going to address it any
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`The defendants' two main
`further because infringement and validity of the
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`invalidity arguments are indefiniteness and
`'832 is going to be done in December.
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`obviousness. And before addressing
`THE COURT: All right.
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`indefiniteness, a little background first about
`MR. LADOW: This '832 patent is
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`the cast film process that relates to the
`basically directed to the Suboxone film
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`pharmaceutical films that we're talking about.
`formulation, and the patent reports the
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`And basically that process, as Dr. Langer will
`inventor's surprising discovery about the
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`explain, consists of about five basic steps.
`absorption of buprenorphine, which was contrary
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`It's obviously a lot more complicated, but there
`to prior art teachings about pH partition
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`are about five basic steps.
`theory, which you'll hear more about in
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`So the first one is that you
`December, and led directly to Suboxone film.
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`dissolve one or more polymers into a solvent and
`And as the first excerpt
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`then you mix it.
`indicates, the point of the patent was to
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`Step two, the active ingredient is
`provide a new dosage form, a film dosage, that
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`mixed in, and you do that to form a, what's
`would be bioequivalent to Suboxone tablets,
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`called a casting solution or a casting
`which had been on the market for some years.
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`dispersion.
`The '150 patent, the '150 patent
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`Step three, the casting solution
`is relating to a polymer profile for fast
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`is then cast by a roller, as you see here, onto
`dissolving, mucoadhesive pharmaceutical films,
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`a sheet in a continuous casting process, as
`and it provides a pharmaceutical polymer profile
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`for Suboxone film. And it teaches that if you
`depicted on the slide.
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`Now, the '514 patent, the asserted
`claim are the ones that you see here, there's
`one independent claim, 62, and then four
`dependent claims, infringement of this patent,
`your Honor, is going to be addressed in
`December. We're just doing validity in this
`trial.
`
`Plaintiffs' expert on the validity
`of the '514 patent is professor Robert Langer.
`He's an MIT Institute professor. He has over a
`thousand articles and issued patents and he's
`one of the most decorated scientists in our
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`country. He's an expert in the chemical
`engineering and pharmaceutical drug delivery
`forms.
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`though it has already been dried is contrary to
`the specification, it's contrary to common sense
`and how one of ordinary skill would understand
`this. What it really is, is a belated claim
`construction argument that we think should be
`rejected. And as Dr. Langer will testify, a
`person of ordinary skill in the art would have
`no trouble understanding the meaning of these
`claims in this context with reasonable
`certainty.
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`Turning to the defendants'
`obviousness argument, your Honor, a key
`challenge in film technology was the problem of
`achieving what we're going to refer to, and
`you're going to hear a lot about, drug content
`uniformity, or DCU, in a pharmaceutical film.
`In particular, prescription pharmaceutical film
`that has to be approved by the FDA.
`Drug content uniformity must be
`maintained throughout the manufacturing process
`in order to meet FDA requirements and ensure
`proper dosing just as we talked about before so
`the patient gets the right amount of the drug,
`not too much, not too little. It has to be safe
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`And then a conveyor belt moves the
`sheet through a controlled drying process,
`drying out the solvent, and this results in a
`dry film which is then cut into individual
`dosage units as you can see in the bottom
`illustration.
`These are the claim terms we've
`highlighted that relate to the indefiniteness
`issue that defendants have raised with respect
`to this patent.
`So as you can see on the top, it's
`a drug delivery composition. It's independent
`claim 62. Cast film comprising a flowable water
`soluble film forming matrix. And I'm going to
`skip down to the last clause, where the flowable
`film-forming matrix is capable of being dried
`without loss of substantial uniformity, and
`that the uniformity subsequent to drawing and
`casting of the matrix is this plus and minus
`ten percent of the desired amount that I
`mentioned before.
`Now, Watson, defendants contend
`that the claims are indefinite because they say
`a final dried cast film cannot be flowable or
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`and efficacious.
`have a viscosity or be capable of being dried.
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`This was a major challenge
`But the final cast film is not required to be
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`because, as Professor Langer will explain, there
`flowable, as the defendants assert.
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`are quite a few forces or gradients that can
`As Dr. Langer will explain, the
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`cause aggregation or migration of an active
`reference to flowable here in the claims can't
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`during the process, during those five steps that
`mean that the final dried solid film is
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`I described in making a cast film, including
`flowable. That wouldn't make sense to anybody
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`during mixing and including during casting and
`let alone a person of ordinary skill in the art
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`drying. And all of these different forces and
`of this technology. Instead, what flowable
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`gradients can cause aggregation that results in
`clearly means is that the polymer matrix must be
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`lack of uniformity of a film. And it was the
`flowable during the casting process, as I showed
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`'514 patent that was the first to solve this
`on the other slide.
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`drug content uniformity problem in
`And the film is a cast film
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`pharmaceutical films.
`because it was made by a casting process.
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`The '514 patent recognized, as Dr.
`That's why it's called a cast film. And the
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`Langer will explain to you, that by rapidly
`final film, whose uniformity, as I said, must be
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`increasing viscosity and locking in the, locking
`within ten percent of the desired amount, is, as
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`in the active in place together with using
`the claim says, subsequent to casting and drying
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`controlled drying procedures to avoid
`of the matrix.
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`aggregation, that you could produce the film
`So the defendants' argument that
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`having the requisite uniformity and drug content
`the claim is indefinite because it supposedly
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`uniformity.
`requires the impossible that the final dried
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`And as we see here in this
`film also be flowable and that it also have
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`viscosity and be capable of being dried even
`excerpt, the patent is the '514 patent talks
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`about uniform films having equally sized dosage
`units with substantially equal amounts of
`compositional components, such that, skipping
`down to the last highlighted section, each
`individual dosage film unit will contain the
`proper predetermined amount of the drug. And as
`we said, claim 62 requires that that amount be
`within, not vary by plus or minus of ten percent
`of the label or desired amount.
`Now, you're going to hear from the
`defendants, of course, and their experts, and
`they are going to tell you that everything about
`pharmaceutical films was obvious, even including
`how to get drug content uniformity in a
`pharmaceutical film, but it's just not the case.
`And Dr. Langer is going to testify to that based
`on his years and decades of experience in the
`field. And it's also contradicted by numerous
`articles in the area that both recognize the
`problem of drug content uniformity and that it
`was a major challenge, and give MonoSol credit
`for solving it.
`And just as an example, here's a
`2011 article written by one of defendants' own
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`experts, Dr. McConville. And what does he say?
`Since the early development of medicated films,
`content uniformity has been a major challenge
`for the pharmaceutical scientist. And he refers
`to Yang.
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`uniformity during casting and drying. It's just
`not addressed. Chen's examples only mention
`homogeneity in the context of mixing excipients
`for the casting dispersion before the active
`ingredient is even added to it.
`And the data in Chen, there's no
`data supporting drug content uniformity, but the
`data in Chen, to the extent there is any, that
`could speak to this issue which is Figure 5,
`which we'll hear more about, shows, if it shows
`anything, that Chen's films lack the drug
`content uniformity required by the claims of the
`'514 patent.
`So for these reasons and others
`that you will hear from Dr. Langer, the '514
`patent is not obvious. Rather, it solved a
`difficult problem that others tried and failed
`to solve, drug content uniformity.
`This is the '150 patent, your
`Honor. The asserted claims against Watson are
`claims 1 and 4. The infringement of claims 10
`and 13 by Par are meant to be tried in December,
`and the validity of all four claims are at issue
`in this trial.
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`Yang is one of the MonoSol
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`inventors, so we're talking about the '514
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`patent, indicated that self-aggregation was one
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`of the main reasons why films usually show poor
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`uniformity, and is crediting MonoSol and Yang
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`with solving that problem.
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`Now, it's because achieving drug
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`content uniformity in a prescription
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`pharmaceutical film was, in fact, a real
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`challenge, a real-world challenge, and one first
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`solved by MonoSol that defendants argued
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`obviousness arguments in this case must file.
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`None of the prior art that they cite teaches how
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`to solve that problem. The main reference that
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`the defendants rely on is a reference called
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`Chen. There are a couple Chen references, but
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`your Honor, basically relates to what's labeled
`they are essentially the same.
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`here as limitation number four, relating to PEO
`Chen does not teach anything, as
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`Dr. Langer will testify, about how to maintain
`molecular weight. And what the claim requires
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`Plaintiffs' expert on the
`infringement of the '150 patent is Dr. Lon
`Mathias. He's emeritus from the University of
`Southern Mississippi, co-founder and director of
`the Polymer Science Center and an expert in the
`characterization of polymers. He is the only
`witness giving an opinion on infringement.
`Dr. Yau, whose picture is
`underneath, is a longtime Dow chemical company
`scientist, who is one of the leading experts in
`the world on analytical technique called GPC, or
`gel permeation chromatography. Dr. Yau is the
`co-author of the standard textbook on the
`subject and he did some tests that Dr. Mathias
`is relying on for his infringement analysis.
`So this is claim 1 of the '150
`patent, which is being asserted against Watson.
`We've checked off some boxes in terms of
`limitations that are acknowledged to be
`infringed.
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`is that the PEO -- you see in the prior
`limitation that the polymer component can have
`75, has 75 or more percent PEO and up to
`25 percent of the cellulosic polymer.
`So then if we go down to the
`fourth limitation, it says that the PEO
`comprises, as the Markman order said, basically
`two sets of PEOs, and one set is low molecular
`weight PEOs and another set is higher molecular
`weight PEOs where the molecular weight of the
`lower weight set is 100,000 to 300,000, this is
`all in daltons, an atomic unit of weight, and
`the molecular weight of higher molecular weight
`PEOs are in the range of 600,000 to 900,000,
`with the final requirement being that the lower
`molecular weight portion, so the one that
`averages a hundred to 300,000, is about
`60 percent or more of the whole polymer
`component.
`Now, the PEO that Watson uses is a
`PEO that's called Polyox N80 that's sold by Dow.
`And when that Polyox N80 is analyzed using GPC,
`the gel permeation chromatography I mentioned
`before, infringement is established. GPC
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`analysis is required to determine if the accused
`polymer sample meets the required molecular
`weight ranges of the claim.
`What GPC testing does is that it
`separates the molecules by size and it produces
`a bell curve showing a molecular weight
`distribution from low molecular weight on the
`left going to higher molecular weight on the
`right. And if you draw a vertical line or a
`partition on this molecular weight distribution
`curve at 600,000 daltons -- and, by the way, the
`6.0 doesn't line up with the 600,000 because
`it's a log scale on the bottom and the 6.0 is
`actually more than 600,000, so that should not
`confuse anyone.
`So if you draw that partition, as
`Dr. Mathias will explain, the PEOs that are to
`the left, that 98 percent portion, has a
`viscosity average molecular weight that falls
`within the low molecular weight range of the
`claims, and the, about two percent to the right
`of the partition falls within the higher
`molecular weight range of the claims.
`And the -- he will also testify
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`that that two percent of the high molecular
`weight is not a negligible trace or, in the
`Court's words, stray amount from the Markman
`order in this formulation because the much
`higher molecular weight molecules are long chain
`molecules and they get entangled with others,
`and so they have a disproportionate effect. So
`it's not two percent of apples to apples, it's
`two percent of elephants to mice. And so it has
`a disproportionate effect on the, on the
`formulation, and is not stray for that reason.
`Dr. Mathias will also testify that
`when the cellulosic polymer, which is not shown
`on this chart, is taken into account, that the
`lower molecular weight PEO makes up 60 percent
`or more of the whole polymer component,
`including the cellulosic polymer and the rest,
`and all of the PEO.
`Now, defendants are going to tell
`you that the mathematical GPC values of 95,895
`viscosity average molecular weight for the low
`molecular weight set of PEO and the mathematical
`value of 900,318 for the higher molecular
`weight set fall just outside the claims. But as
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`Dr. Mathias will testify, those numbers would be
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`understood by anybody in the field as meaning a
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`100,000 and 900,000 due to sample variability,
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`and thus would be understood to be within the
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`range of the claims. And overall, the analysis
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`that we've described, you'll hear testimony that
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`this is an accepted scientific approach for
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`determining fractions in a molecular weight
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`distribution.
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`And as our experts will also
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`explain, the applicable average molecular
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`weight, which I will talk about more in a
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`minute, is viscosity average molecular weight.
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`And for these reasons, as Dr. Mathias will
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`testify, Watson's proposed films infringe
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`claim 1 of the patent.
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`Now, Watson asserts that its
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`proposed films don't have the higher molecular
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`weight set of PEOs, the 600,000 to 900,000, and
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`they assert that they don't infringe because
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`they use one type of PEO, a Polyox N80. In
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`effect, the one bottle that we had talked about
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`during the Markman. But as the Court held in
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`the, in the opinion on the Markman, the source
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`of the PEOs, whether from one bottle or
`two bottles, isn't relevant, and what's really
`relevant is, are the two discrete sets in the
`formulation? And that's what we were looking at
`with the molecular weight distribution.
`And Polyox N80, as you'll hear,
`has, in fact, as I just showed you with that
`bell curve, a very wide molecular weight
`distribution, which is common for commercially
`made polymers, and, in fact, it's made by
`blending batches of PEO.
`The PEOs are differing molecular
`weight that comprise the distribution fall into
`discrete sets that meet the limitations of the
`claim. So, in other words, Polyox N80 itself is
`a combination of discrete polymers, sets, which
`meet the limitations of the claim, and as shown
`by the testing on the last slide, this one
`bottle of Polyox has a molecular weight
`distribution that covers and meets the
`requirements of the claims.
`I'm going to turn now to the
`validity issues on the '150 patent. Plaintiffs'
`expert is Dr. Robert Prud'homme, who has been a
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`long tenured professor at Princeton University.
`He's a past president of the U.S. Rheological
`Society. He has been a longtime member of the
`Dow Technical Academy Advisory Board, and he's
`an expert in the development of pharmaceutical
`dosage forms.
`The defendants' two main
`invalidity arguments are obviousness and
`indefiniteness, and I'm going to take the second
`one first.
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`The Court construed the claims of
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`the '150 patent to refer to an average molecular
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`weight, and the patent does not expressly
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`specify what type of molecular weight average
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`that is going to be. And the defendants want to
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`say that because it does not specify and because
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`there are different ones that in theory could
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`apply, that it's indefinite.
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`Now, while there are in theory
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`different average molecular weight labels that
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`testify that a person of ordinary skill would
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`understand that viscosity average molecular
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`weight is the appropriate molecular weight
`11/03/2015 11:47:14 PM
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`measurement here, and this is partly because, as
`the person of ordinary skill would appreciate,
`the file history shows that the Dow PEO product,
`and this is the Flick reference in the file
`history, is sold by viscosity. And they would
`also know that viscosity average molecular
`weight is the most common and precise way to
`use, the measurement to use for this kind of
`polymer.
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`And the person -- you'll probably
`hear from the defendants that there are other
`average molecular weight labels, such as MN, or
`number average molecular weight or MZ, which is
`another kind of a label, but as you'll hear from
`our witnesses, these are irrelevant to our case,
`and the reason for that is, is that MN is very
`much tilted or skewed to the low, to the low
`molecular weight molecule because it's
`emphasizing numbers, so there's a lot more of
`the low stuff, whereas MZ is very much skewed to
`the high molecular weight molecules.
`So someone trying to determine
`what should be used here, somebody who
`understands the nomenclature, those exist in the
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`molecular weight. And, in fact, the weight
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`molecular weight as Dow does and as would make
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`measurement, the boundaries of the claim would
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`with reasonable certainty, and the claims are
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`not indefinite.
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`Turning to obviousness of the '150
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`patent, another challenge in making a
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`pharmaceutical film is trying to find the right
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`blend of polymers to provide the desired film
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`properties.
`Now, your Honor, there are many,
`many polymers that can be used in these films.
`At least 30, I think, are listed in one of the
`patents. And PEO, polyethylene oxide, is just
`one of them. And then even when you talk about
`PEO, it's not, it's not like you just buy a
`single one. There's -- there's a very broad
`spectrum, a broad range of PEOs that are
`available