1
`
`IN THE UNITED STATES DISTRICT COURT
`IN AND FOR THE DISTRICT OF DELAWARE
`- - -
`
`CIVIL ACTION
`
`NO. 14-1451 (RGA)
`
`:
`:
`:
`
`::
`
`::
`
`::
`
`:
`:
`
`::
`
`:
`
`RECKITT BENCKISER
`PHARMACEUTICALS INC., RB
`PHARMACEUTICALS LIMITED,
`and MONOSOL RX, LLC,
`Plaintiffs,
`
`vs.
`DR. REDDY'S LABORATORIES
`S.A. and DR. REDDY'S
`LABORATORIES, INC.,
`Defendants.
`
`- - -
`Wilmington, Delaware
`Monday, November 7, 2016
`8:32 o'clock, a.m.
`- - -
`BEFORE: HONORABLE RICHARD G. ANDREWS, U.S.D.C.J.
`- - -
`
`APPEARANCES:
`WOMBLE CARLYLE SANDRIDGE & RICE, LLP
`BY: DANA SEVERANCE, ESQ.
`
`-and-
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`Hawkins Reporting Service
`715 North King Street - Wilmington, Delaware 19801
`(302) 658-6697
`FAX (302) 658-8418
`
`Mylan v. MonoSol
`IPR2017-00200
`MonoSol Ex. 2013
`
`1 of 152 sheets
`
`Page 1 to 1 of 419
`
`01/14/2017 01:04:49 PM
`Page 1
`
`

`

`APPEARANCES (Continued):
`
`2
`
` TROUTMAN SANDERS LLP
` BY: DANIEL A. LADOW, ESQ. And
` JAMES MOORE BOLLINGER, ESQ.
` (New York, New York)
`
`-and-
`
`COVINGTON & BURLING LLP
` BY: JEFFREY LERNER, ESQ.
` (Washington, D.C.)
`
` Counsel for Plaintiffs
`
` BAYARD, P.A.
` BY: RICHARD D. KIRK, ESQ.
`
`-and-
`
` GOODWIN PROCTER LLP
` BY: ELAINE HERMMANN BLAIS, ESQ.:
` ROBERT FREDERICKSON, III, ESQ.,
` MOLLY R. GRAMMEL, ESQ.,
` ALEXANDER LU, ESQ. and
` KATHRYN KOSINSKI, ESQ.
` (Boston, Massachusetts)
`
`-and-
`
`Hawkins Reporting Service
`715 North King Street - Wilmington, Delaware 19801
`(302) 658-6697 FAX (302) 658-8418
`
`3
`
`APPEARANCES (Continued):
`
` GOODWIN PROCTER LLP
` BY: IRA J. LEVY, ESQ. and
` ROBERT V. CERWINSKI, ESQ.
` (New York, New York)
`
`
` -and-
`
` GOODWIN PROCTER LLP
` BY: JOHN COY STULL, ESQ.
` (Washington, D.C.)
`
`
` Counsel for Defendants
` Dr. Reddy's Laboratories S.A.
` and Dr. Reddy's Laboratories,
` Inc.
`
`- - -
`
`12
`
`3
`
`45
`
`6
`7
`
`89
`
`10
`11
`12
`
`13
`14
`
`15
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`22
`23
`24
`
`12
`
`3
`
`4
`
`5
`
`6 7
`
`8
`
`9
`
`10
`
`11
`
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
` P R O C E E D I N G S
`
`4
`
` (Proceedings commenced in the
`courtroom, beginning at 8:32 a.m.)
`
` THE COURT: All right. Good morning,
`everyone. Please be seated. Let's begin.
`Actually, I don't need to have introductions. Let's
`start.
`
`MR. LADOW: Your Honor, may we
` hand up some slides?
`THE COURT: Yes. And, by the way,
` I did sign the two stipulations a few minutes
` ago that you submitted over the weekend or
` Friday, so they are all signed.
`MR. LADOW: Thank you.
` (Ms. Severance handed slides to
` the Court.)
`MR. LADOW: Good morning, your
` Honor. You know I'm Dan Ladow from Troutman
`Sanders for the plaintiffs, and we're here today
`just addressing the '150 patent. The two other
` patents are being addressed as you know in the
`later trial days, and as the Court will recall,
`Hawkins Reporting Service
`715 North King Street - Wilmington, Delaware 19801
`(302) 658-6697 FAX (302) 658-8418
`
`5
`Dr. Reddy's Laboratories acquired two ANDAs from
` Teva and they've substituted in. We'll be
` referring here to Teva's ANDA and the accused
` products as Dr. Reddy's or DRL's accused
` products in ANDA.
` The asserted claims that we're
`dealing with are independent Claim 1 of the '150
`patent and dependent Claims 4, 5, 8 and 9. And
` we're going to be presenting two experts to
` provide testimony. The first will be Dr. Lon
`Mathias on infringement. You are familiar with
` him. You have his CV, which is PTX-42, he's
` an emeritus professor at the University of
` Southern Mississippi and an expert in polymer
` science.
` Our expert on validity is Robert
`Prud'homme, who is a professor at Princeton for
`a number of decades with vast experience in the
` field and is also an expert in polymer science
` and pharmaceutical formulations, and his CV is
` PTX-43.
` Turning to the patent, as the
` Court notes from the prior cases, the '150
`patent and its claims are generally directed to
`Hawkins Reporting Service
`715 North King Street - Wilmington, Delaware 19801
`(302) 658-6697 FAX (302) 658-8418
`
`12
`
`3
`
`45
`
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`Page 2 to 5 of 419
`
`2 of 152 sheets
`
`Page 2
`
`Hawkins Reporting Service
`715 North King Street - Wilmington, Delaware 19801
`(302) 658-6697 FAX (302) 658-8418
`01/14/2017 01:04:49 PM
`
`

`

`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`6
` a rapidly dissolving film containing an
` analgesic opiate, and the films of the patent
` have a particular polymer profile that's meant
` to balance a number of different film
` properties, such as fast dissolution,
` mucoadhesiveness, tear resistance and
` flexibility.
` And going right to the claim of
` the patent, the Court is familiar with the
` claim. I just want to highlight in the
`left-hand column we've done sort of a shorthand
` for some of the limitations and it can be
` regarded as having these five categories of
` limitation.
` And there's no dispute in the case
` that as far as limitations 1 and 2, the
` mucosally adhesive film and the analgesic opiate
` active, that the Dr. Reddy's proposed product meets
` those limitations.
` Limitations 3, 4 and 5 define the
` polymer profile of the product that the claim
`provides. And the evidence will show that DRL's
` proposed product meets the limitations as to 4
`and 5 as to the PEO molecular weight limitations
`Hawkins Reporting Service
`715 North King Street - Wilmington, Delaware 19801
`(302) 658-6697 FAX (302) 658-8418
`7
` and we expect that particular showing to be
` uncontested.
` So the dispute on infringement
`ultimately will focus on limitation 3, and that
` limitation requires that there be greater than
` 75 percent polyethylene oxide and up to
`25 percent hydrophilic cellulosic polymer within
` this water soluble polymer component.
` And in its formulation, DRL uses a
` polymer called polyvinyl pyrrolidone or PVP.
` It's also sold under trade names like Povidone
` or Kollidon, and they use this as a substitute
`for the hydrophilic cellulosic polymer in their
` product. And we contend, plaintiffs contend
` that DRL's use of this PVP satisfies this
` limitation number three under the doctrine of
`equivalents. They contest that DOE applies and
`they also assert that they don't infringe based
` on an argument having to do with dedication to
` the public and they have a prosecution history
` estoppel argument.
` So the infringement case really
`revolves around the doctrine of equivalents, and
` as the Court is aware, the legal standard for
`Hawkins Reporting Service
`715 North King Street - Wilmington, Delaware 19801
`(302) 658-6697 FAX (302) 658-8418
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`8
`that is applied here, would be whether the PVP's
` and the PEOs in Dr. Reddy's product are
` insubstantially different from the claimed
`polymer component in the claims or, to put it in
`the other way of the test in the case law, that
`they perform substantially the same function in
` substantially the same way to provide
` substantially the same result.
` And the evidence will show that
` the answer to these questions is yes, that the
` use of PVP by Dr. Reddy's is insubstantially
` different from the use of a hydrophilic
` cellulosic polymer.
` Just briefly, this is from Dr.
` Reddy's ANDA, and it shows the three grades of
` PEO that is used in their products. So the
`claims require that you have PEO that's between
` a hundred and 300,000, as you'll recall, so
` the first two categories, the first two grades
` of PEO that are listed there fall within
` that requirement, and then the claim also
` requires some of the same molecular rate PEO,
`between 600,000 and 900,000, and they are using
` the 900,000 grade. In fact, these are the
`Hawkins Reporting Service
`715 North King Street - Wilmington, Delaware 19801
`(302) 658-6697 FAX (302) 658-8418
`9
` same grades of PEO that are used in Suboxone
` film.
` Now, this is another excerpt from
` DRL's ANDA, and it compares the ingredients in
` the proposed generic product, which is the
` middle column, to -- and this, by the way, is
` JTX-11 at 38. This compares the proposed
` generic product in the middle column to the
` ingredients in the reference listed drug, and,
` of course, the reference listed drug is the
`Suboxone film that they are proposing to make a
` generic version of.
` And then in the right column, you
` can see that the function is -- a function is
` described in the ANDA to each of the
` ingredients. And it's pretty evident from
` looking at this that Dr. Reddy's simply copied
`the polymer profile in the reference listed drug
`save for their substitution of this povidone, or
` Plasdone is another trade name. They use two
`grades of PVP, so they substituted PVP for some
` hydroxypropyl methylcellulose, or HPMC in the
`brand product. And the evidence will show that
` these two are functionally equivalent.
`Hawkins Reporting Service
`715 North King Street - Wilmington, Delaware 19801
`(302) 658-6697 FAX (302) 658-8418
`01/14/2017 01:04:49 PM
`Page 3
`
`3 of 152 sheets
`
`Page 6 to 9 of 419
`
`

`

`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`10
` And if we just confine ourselves
`to what we're seeing on the screen here in this
`part of the ANDA, you can see that they're both
` described as having the function of being a
` binder.
` And, in fact, as their ANDA
` indicates, Dr. Reddy's understood the proposed
`product using this PVP, as you might expect, to
`be substantially equivalent to the brand product
`that they were trying to make a generic version
` of.
` In other words, they expected that
`their proposed generic version of Suboxone film,
` which merely substitutes the PVP for the HPMC,
` would perform in substantially the same way as
` the brand product and therefore would be
` equivalent.
` Now, if we look at -- you'll hear
` testimony from Dr. Mathias about more details
` about the polymer profile and every aspect of
` the polymer profile is identical. In Dr.
` Reddy's product, as we can see here, they have
`the low PEO with the grades that they are using.
`They have the high, higher molecular weight PEO.
`Hawkins Reporting Service
`715 North King Street - Wilmington, Delaware 19801
`(302) 658-6697 FAX (302) 658-8418
`11
` 60 percent of the low. They have more than
` 60 percent of the low as part of the polymer
` component satisfying that 60 percent or more
` limitation, and they have greater than
` 75 percent PEO in the polymer component, which
` is another aspect of the polymer profile. And
` then they have the PVP, as I said, instead of
` the hydrophilic cellulosic polymer.
` But Dr. Mathias will be presenting
` evidence on all of these. And basically what
`they would have you believe is that substituting
` one binder, the PVP for the HPMC, would allow
`them to escape infringement, but this is exactly
`why we have the doctrine of equivalents, so that
` an infringer who is using, who makes a
` substantial -- insubstantially -- who makes an
`insubstantial change from what is covered by the
`patent does not escape infringement. And at the
`end of this case, we expect that there will be a
` check in that last box on that basis.
` And if we had just confined
` ourselves to the ANDA, as I said, we would see
` that both the PVP and the HPMC were listed as
`having the same function as being a binder. But
`Hawkins Reporting Service
`715 North King Street - Wilmington, Delaware 19801
`(302) 658-6697 FAX (302) 658-8418
`01/14/2017 01:04:49 PM
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`12
` Dr. Mathias' analysis will show that actually,
` these polymers provide, have a number of
`different functions in the film, and influence a
` number of different film properties. And, in
` fact, their functions are substantially
` equivalent.
` Now, I'm sure you're going to hear
` from our colleagues on the other side that the
`chemical structure of PVP and HPMC is different,
` but what matters is not whether the chemical
`structure is the same, but whether they have the
` same functional equivalents in the product,
` which is what Dr. Mathias' evidence will show.
` And so that will show that because they have
` that equivalence, that it meets the cellulosic
` limitation under the doctrine of equivalents.
` I mentioned that DRL also has a
` defense based on dedication to the public and
` the legal standard there is whether the
` unclaimed subject matter is identified in
` the patent as an alternative to a claim
` limitation.
` So as you know, the claimed
`polymer profile uses at least two grades of PEO,
`Hawkins Reporting Service
`715 North King Street - Wilmington, Delaware 19801
`(302) 658-6697 FAX (302) 658-8418
`13
` so you have the lower molecular weight and the
`higher molecular weight, the hundred thousand to
`300,000, the 600,000 to 900,000. And DRL points
` to some examples in the patent, which we've
`illustrated here, where, for example, in the top
`left of Figure 38, there's a couple examples of
` PEO and PVP, and there's in this E series of
`examples in the patent, there are some instances
` where PVP is being used with PEO, and the
` section of the slide on the right is also from
` this E series.
` And every time PVP is used in the
` patent with PEO, there's only one grade of PEO
` that's used. It's never the situation in the
` patent where you're using two different grades
` of PEO with PVP while there is a discussion in
` the patent that mirrors the claims where using
` two grades of PEO with HPMC, and that's
` particularly in columns 17 to 18 of the
` patent.
` So the '150 patent simply doesn't
` disclose PVP as an alternative to hydrophilic
` cellulosic polymer in the claimed polymer
`profile of the patent, meaning using two or more
`Hawkins Reporting Service
`715 North King Street - Wilmington, Delaware 19801
`(302) 658-6697 FAX (302) 658-8418
`
`Page 10 to 13 of 419
`
`4 of 152 sheets
`
`Page 4
`
`

`

`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`14
` grades of PEO where there's a higher molecular
` weight grade, high molecular weight of 600,000
` to 900,000, and a lower grade and for that
` reason, the dedication to the public analysis
`can't apply because PVP is never disclosed as an
`alternative to that formulation anywhere in the
` patent.
` Dr. Reddy's also has a prosecution
` history estoppel argument which, of course,
` requires a clear and unmistakable surrender of
` the subject matter at issue, but what the
`evidence will show is that the applicants never
`distinguish any prior art on the ground that it
` contain PVP or did not contain cellulosic
` polymer.
` And if I can turn briefly to
`validity, just, I guess a couple nights ago, Dr.
` Reddy's withdrew its other obviousness
` defenses.
` So as I understand it, the only
` invalidity defense is obviousness that you'll be
` hearing today that really falls into two
` categories. There's an attack on obviousness.
` That's based on asserting certain pieces of
`Hawkins Reporting Service
`715 North King Street - Wilmington, Delaware 19801
`(302) 658-6697 FAX (302) 658-8418
`15
`prior art where the priority date of the patent
`is assumed to be May 2003. Then, in an approach
`that will sound familiar, because it's the same
`thing you heard in the Watson Par trial, Doctor
` Reddy's is also alleging that there's a Yang
` reference which is actually the parent, parent
` application to the '150 Patent that was
` published after this May 2003 date and that lacks
` priority and so that the actual priority date of
` the patent should be 2008. And that's something
` that you already rejected last year.
` So, just in terms of the state of
` the art, as of May 2003, prescription
` pharmaceutical films were a new field of
`pharmaceutical development and manufacturing and
` there was a number of different variables to
`consider at the time. There was no established
` film in place and it wasn't until years later
` that we have the first prescription
` pharmaceutical films approved and the brand
` product here, Suboxone film was the first
`sublingual prescription film, that wasn't until
` 2010, to give some idea of the movement of the
` field. A challenge in making a pharmaceutical
`Hawkins Reporting Service
`715 North King Street - Wilmington, Delaware 19801
`(302) 658-6697 FAX (302) 658-8418
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`16
` film at that time back in 2003 was trying to
`find the right blend of polymers to provide the
` optimal film properties that one would want.
`And there's a number of different polymers that
` could be used and that were used in the prior
`art. Many different ones. And one of the ones
`that there are some examples of in the prior art
`and you'll be hearing about them today, involve
` PEO. PEO itself is sold in a wide range of
` molecular weights from very low all the way up
` to 8 million. And so the particular polymer
` profile that's in the patent is just what's
` shown in these narrow bands here. It's, as we
` said, the hundred, the 300,000 molecular weight
` that's going to be at least 60 percent of the
` polymer component and then some of the higher
`molecular weight of the 600,000 to 900,000. And
` prior to the '150 Patent nobody taught this
` polymer profile in the prior art. There was
` simply no teaching of it. You'll hear from
`Doctor Prud'homme about that. There was simply
`no teaching about how to balance film properties
` using a profile like that.
` And the prior art I believe that
`Hawkins Reporting Service
`715 North King Street - Wilmington, Delaware 19801
`(302) 658-6697 FAX (302) 658-8418
`17
`you'll be hearing about today is basically three
` references; Chen, which doesn't teach using
` PEO's of difference molecular weights at all.
` There's a reference called Verma, which is
` actually a film coating on a capsule where the
` film coating itself doesn't contain an active
` ingredient and it also doesn't teach the at
` least 60 percent of the low PEO. And then
`there's an older reference called Schiraldi that
`was in front of the examiner when the patent was
`prosecuted, patent was issued over it. And that
` patent, Schiraldi, focuses on very high
`molecular weight films in the range of three to
` five million molecular weight. And Doctor
` Prud'homme will testify a person of ordinary
` skill in the art simply would have had no
` teaching, no motivation from these pieces of
` prior art or from the general knowledge in the
`area to combine, to combine them to try to come
`up with the polymer profile of the claims. And
` the Defendant's arguments in this regard,
` essentially rely on starting out with the '150
`Patent, seeing what the polymer profile that it
` has, and then looking back into the prior art
`Hawkins Reporting Service
`715 North King Street - Wilmington, Delaware 19801
`(302) 658-6697 FAX (302) 658-8418
`01/14/2017 01:04:49 PM
`Page 5
`
`5 of 152 sheets
`
`Page 14 to 17 of 419
`
`

`

`18
`and picking from isolated places out of context,
`different aspects of it, so that they can makeup
` the target that's already been defined. And
`that kind of hindsight analysis of course is not
` how obviousness can be found.
` And for all of these reasons
` Doctor Prud'homme will testify that the person
` of ordinary skill wouldn't have had any
` expectation of success in combining these
` disparate pieces of art and using different
` limitations or different elements of them that
` have been plucked together using a hindsight
` analysis.
` As to the Yang reference, Yang
`only becomes a piece of prior art if the patent
` is not entitled to the May 2003 priority date
` which you've already found. And so actually
` what they're doing here is presenting the same
`expert on the same issue with the same arguments
` that the Court rejected the last time and we
` don't see any reason why the result should
`change this time. They have -- they seem to be
` raising an argument that somehow the Court's
`ruling that a hydrophilic cellulosic polymer are
`Hawkins Reporting Service
`715 North King Street - Wilmington, Delaware 19801
`(302) 658-6697 FAX (302) 658-8418
`19
` up to 25 percent of a hydrophilic cellulosic
` polymer changes the priority analysis. But we
` don't see any reason why that should be so and
`that the Court should reject the same arguments
` by the same expert that the Court has already
`heard and vetted in the prior case. Thank you,
` Your Honor.
`THE COURT: All right. Thank you,
` Mr. Ladow.
`MR. LEVY: May I approach, Your
`
` Honor?
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`THE COURT: Yes.
`MR. LEVY: Thank you. Thank you,
` Mr. Ladow. Your Honor, good morning. My name
` is Ira Levy and I am here representing Doctor
` Reddy's. I'd like to focus the Court's
` attention this morning on the key issues to be
` addressed today in the context of the '150
`Patent and focus on what is actually in dispute
` between the parties. Your Honor, the evidence
` you will hear today and the testimony -- the
`evidence you will see and the testimony you will
` hear today will show that Doctor Reddy's
` proposed ANDA formulation simply does not
`Hawkins Reporting Service
`715 North King Street - Wilmington, Delaware 19801
`(302) 658-6697 FAX (302) 658-8418
`01/14/2017 01:04:49 PM
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`20
`infringe the asserted claims of the '150 Patent.
`The evidence we submit will similarly show that
` the asserted claims of the '150 Patent are
` obvious whether the priority date is 2003 or
`2008. And Your Honor, I will address the issue
` and specifically of the 2003 priority date
` during the course of the opening.
` Testifying today for Doctor
`Reddy's will be Doctor Mansoor Amijii, a witness
` we know is also familiar to the Court. Doctor
`Amijii will both testify on non-infringement as
` well as validity and his testimony will
` establish three things. First, Your Honor,
`based upon the stipulated facts and Plaintiff's
` concession in this case, there is no literal
`infringement by the proposed ANDA product. And
`while there's no literal infringement, it still
` appears in the pre-trial order.
` Second, Your Honor, Doctor
`Amijii's testimony, the evidence supporting his
` testimony will establish that contrary to the
` arguments we just heard, there is no
` infringement under the Doctrine of Equivalence
` for exactly the three reasons, any one of the
`Hawkins Reporting Service
`715 North King Street - Wilmington, Delaware 19801
`(302) 658-6697 FAX (302) 658-8418
`21
` three reasons that Mr. Ladow mentioned. And
` that is the disclaimer rule, that is the file
` history estoppel as well as the fact that the
` polymer used by Doctor Reddy's is, as a matter
` of fact, not equivalent or not substantially
` different from the claimed polymer.
` And finally, Your Honor, it will
` establish invalidity of the patent-in-suit.
` Let's start, Your Honor, where we
` must, in a patent case, the asserted claims of
` the '150 Patent. Now, as Mr. Ladow mentioned,
` we've got Claim 1 at issue and I believe you
` went through the elements of the claim and
`pursuant to the stipulation signed by the Court,
` we have four dependent claims still at issue.
` So again, we will agree that the elements of
`Claim 1 of the '150 Patent are fairly well laid
` out and I don't want to spend the Court's time
` running through them again. I will highlight
` Claims 4, 5, 8 and 9, the dependent claims in
` this case. And Claim 4 requires an additional
` pharmaceutical additive. Claim 5 includes the
` addition of one or more sweeteners. Claim 8,
` one or more flavors and Claim 9, one or more
`Hawkins Reporting Service
`715 North King Street - Wilmington, Delaware 19801
`(302) 658-6697 FAX (302) 658-8418
`
`Page 18 to 21 of 419
`
`6 of 152 sheets
`
`Page 6
`
`

`

`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`22
`buffers. I highlight these because obviously on
` non-infringement, because Doctor Reddy's'
` product does not have the HCP that is required
`by the claim, we don't infringe Claim 1 as well
` as all the dependent claims. But from an
`invalidity point of view, the prior art you will
`hear testified about today includes and teaches
` one of ordinary skill in the art all of the
` additional elements that are in the dependent
` claims.
`
`THE COURT: So are you saying that
`from the infringement point of view these things
` are not at issue?
`MR. LEVY: We believe these -- not
` in the accuse product. Now, the Court has
` issued, as we know, claim construction in this
`case. And one issue in that claim construction
` is critical to both the infringement case and
` the validity case. And specifically as the
` Court is aware, the limitation, at least one
` water soluble polymer component consisting of
` polyethylene oxide in combination with a
` hydrophilic cellulosic polymer has been
`construed by the Court to be the exact language
`Hawkins Reporting Service
`715 North King Street - Wilmington, Delaware 19801
`(302) 658-6697 FAX (302) 658-8418
`23
`of the claim with an important emphasis that it
` excludes products that do not have HCP. In
`other words, the claim absolutely requires HCP.
` And in joint trial Exhibit 6, the Markman
` opinion, to be clear in doing so, I am holding
`that these claims do not encompass water soluble
`polymer components that do not contain any HCP.
` So against that background, let's
` turn to what you'll hear from Doctor Amijii
`about infringement. Your Honor, as I mentioned
`before, literal infringement is not an issue in
` this case and we will ask for a Rule 52(c)
` verdict at the end of their case in chief.
` There is a stipulated fact, 153, that the
` proposed ANDA products do not contain an HCP.
` We believe that ends the issue on literal
` infringement.
` Turning to the Doctrine of
` Equivalents, there are three reasons why
`Doctrine of Equivalents is not available in this
` case to the Plaintiffs. And these reasons
` really make sense in the context of what the
`Doctrine of Equivalents is. If you recall, Your
` Honor, the Doctrine of Equivalents searches
`Hawkins Reporting Service
`715 North King Street - Wilmington, Delaware 19801
`(302) 658-6697 FAX (302) 658-8418
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`24
` beyond the literal language of the claims to
` find infringement and is restricted in very
` specific ways. One is by something called the
` dedication disclosure doctrine, the other is
` prosecution history or prosecution disclaimer
` and finally there needs to actually be an
` equivalent.
` And why do these matter?
`Particularly, why do the first two matter? The
`first two matter because the purpose of a claim
`is in large part a public notice function. One
`of ordinary skill in the art needs to be able to
` pick up the patent, look at the file history,
` look at the language chosen by the applicant,
`look how the applicant described their invention
` and look at the arguments that the applicant
`made to the patent office in order to secure an
` allowance of the patent and understand and
`appreciate that which the applicant has claimed
` as their invention. And when you have a
` situation as we do here, as for example, the
` Federal Circuit explained in Johnson versus
`Johnston, subject matter, if it's in there, it's
` described as an alternative. Again, as the
`Hawkins Reporting Service
`715 North King Street - Wilmington, Delaware 19801
`(302) 658-6697 FAX (302) 658-8418
`25
` evidence will show it is here and it is not
` claimed, that is then left to the public.
` And this analysis, again, as
` equally applicable here is done on a very
` specific basis, again, in Johnson versus
` Johnston citing the old Maxwell case, in the
` reference here they disclosed steel substrates
` and they cannot invoke the Doctrine of
` Equivalents to extent it's an aluminum
` limitation to encompass steel. They cannot
` assert the Doctrine of Equivalents.
` Your Honor, what happened in this
`case is PVP, the polymer that is used by Doctor
` Reddy's is disclosed as an alternative to HCP
` but is simply not claimed. That action
` dedicated those and the others that are
` identified by applicant in their patent to the
` public.
` Surrender of non-polyethylene
` oxide in HCP films. Your Honor, again, is
` intimately familiar with these patents, having
` dealt with them extensively through trial,
` through multiple Markman proceedings, through
`multiple proceedings and the like. And what you
`Hawkins Reporting Service
`715 North King Street - Wilmington, Delaware 19801
`(302) 658-6697 FAX (302) 658-8418
`01/14/2017 01:04:49 PM
`Page 7
`
`7 of 152 sheets
`
`Page 22 to 25 of 419
`
`

`

`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`
`26
`will hear today and what Dr. Amiji will testify
` is about the prosecution history, and as I
`mentioned earlier, it makes sense to look at the
` prosecution history, because you will see the
`specificity of the arguments that the applicants
` made in order to gain allowance. They
` emphasized how important it is that this
` invention is narrowed to HCP and PEOs in the
`ratios defined and the molecular weight defined.
` Your Honor, they left a trail of bread crumbs
` that a person of ordinary skill in the art can
`pick up and follow in order to see what it is at
`the end of that trial, and what's at the end of
` that trial is a claim that is very narrow and
` very specific and a claim that does not
` encompass the PVP that is used by Dr. Reddy's.
` And finally, your Honor, to wrap
`up the issue of noninfringement, you will also,
`you know, as Mr. Ladow mentioned, you will hear
` a little bit about the chemistry between the
` HCPs, which actually are a class of compounds
`and not just a single compound and povidone, or
` PVP, which is a single structural product.
`You'll hear about their
`Hawkins Reporting Service
`715 North King Street - Wilmington, Delaware 19801
`(302) 658-6697 FAX (302) 658-8418
`27
` differences. You will hear and you will see
` that plaintiffs and Dr. Mathias have actually
`failed to establish equivalence, and we suggest
` that listening carefully to Dr. Mathias'
` analysis will show the infirmities in the work
` he has done in order to argue his support for
`infringement under the doctrine of equivalents.
` And, finally, your Honor, again, I
` just want to emphasize that the three reasons
`that there is no infringement under the doctrine
` of equivalents are each independent of each
` other.
` Let's turn to invalidity, your
`Honor. Dr. Amiji will testify, we submit, that
`the evidence will show that the claims at issue
` in this case would have been obvious either
` under a 2003 priority date or under a 2008
`priority date. And specifically, your Honor, it
` is Dr. Reddy's position, as you will hear
`through the testimony and read in the briefing,
` that the Court's claim construction analysis
` and, in particular, the analysis of the HCP
`limitation, did, in fact, materially change the
`situation and does raise the issue again of the
`Hawkins Reporting Service
`715 North King Street - Wilmington, Delaware 19801
`(302) 658-6697 FAX (302) 658-8418
`01/14/2017 01:04:49 PM
`
`1
`2
`3
`4
`5
`6
`7
`8
`9