`
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`IN THE UNITED STATES DISTRICT COURT
`IN AND FOR THE DISTRICT OF DELAWARE
`- - -
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`
`
`1
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`CIVIL ACTION
`
`NO. 19-1551-CFC-SRF
`
`::::::::::
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`NOVO NORDISK INC. and NOVO
`NORDISK A/S,
`
`Plaintiffs,
`
`vs.
`MYLAN INSTITUTIONAL LLC,
`Defendant.
`
`
`
`
` - - -
`Wilmington, Delaware
`Wednesday, September 9, 2020
`9:00 o'clock, a.m.
`***Telephone conference
` - - -
`
`BEFORE: HONORABLE COLM F. CONNOLLY, U.S.D.C.J.
` - - -
`
`APPEARANCES:
`
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`BY: BRIAN P. EGAN, ESQ.
`
`-and-
`
`Valerie J. Gunning
`Official Court Reporter
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`MYLAN INST. EXHIBIT 1116 PAGE 1
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`APPEARANCES (Continued):
`
` FENWICK & WEST LLP
` BY: JEFFREY J. OELKE, ESQ.,
` RYAN P. JOHNSON, ESQ. and
` LAURA T. MORAN, ESQ.
` (New York, New York)
`
` Counsel for Plaintiffs
`
` RICHARDS, LAYTON & FINGER, P.A.
` BY: FREDERICK L. COTTRELL, III, ESQ.
`
` -and-
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`PERKINS COIE LLP
`BY: SHANNON M. BLOODWORTH, ESQ. and
`BRANDON M. WHITE, ESQ.
`(Washington, D.C.)
`
` -and-
`
`PERKIN COIE LLP
`BY: AUTUMN N. NERO, ESQ.
` (Madison, Wisconsin)
`
`Counsel for Defendant
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` P R O C E E D I N G S
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`(The following telephone conference was held
`beginning at 9:00 a.m.)
`
`THE COURT: All right. Good morning, everyone.
`Plaintiff, would you identify counsel, please?
`MR. EGAN: Good morning, Your Honor. This is
`Brian Egan from Morris Nichols on behalf of Novo Nordisk
`plaintiffs.
`Joining me on the call today are Jeff Oelke,
`Ryan Johnson and Laura Moran from the Fenwick & West law
`firm, and Mr. Oelke will be handling the argument today.
`MR. OELKE: Good morning, Your Honor.
`THE COURT: All right. Good morning. And your
`name again, please?
`MR. OELKE: Jeff Oelke, Your Honor.
`THE COURT: Okay. Great. Okay. And then from
`the defense, please?
`MR. COTTRELL: Good morning Your Honor. Fred
`Cottrell for defendant Mylan at Richards, Layton & Finger,
`and on the phone with me from Perkins Coie, Shannon
`Bloodworth, Brandon White and Autumn Nero, and our client is
`on from Mylan, Preston Imperatore.
`And Mr. White will be speaking on behalf of
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`Mylan, although any time anybody jumps in, I will expect
`they'll introduce themselves.
`THE COURT: Great. Thank you very much.
`All right. Plaintiff, you're up.
`MR. OELKE: Good morning, Your Honor. Jeff
`Oelke from Fenwick & West for the Novo Nordisk plaintiffs.
`Now, today, this claim construction proceeding
`really concerns only one issue as to one patent, and that
`patent is the '833 patent, and the issue is whether the
`preamble of the method claims in that patent are central
`enough to the invention that they should be construed as
`limitations.
`Now, in order to look at the issue, it really
`helps to look at how the method of reducing deposits and
`reducing clogging, how those method claims came about, and
`it came about, Your Honor, because the active ingredient in
`Victoza, liraglutide, the initial work that was done on that
`was what led to discovery over years in which the actual
`peptide itself, liraglutide, turned out to be a very
`difficult molecule to formulate. It couldn't be made into
`an oral dosage form, so they had to come up with a way to
`put it into an injectable solution and to put it into early
`clinical trials.
`So when the work was done on the discovery of
`the molecule, it was passed out to the formulation team, and
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`the formulation team then had this difficult issue because
`liraglutide turned out to be very ornery, a very difficult
`molecule to formulate. It had issues relating to stability,
`Your Honor. It aggregated or fibrillated, so it intended to
`come together in solution and cause basically a cloudy
`result, which was unacceptable, even for purposes of
`conducting clinical trial.
`So the formulation group had to come up with a
`way to deal with that stability problem and they did that by
`balancing out the pH, and they did that on very small scale
`batches, and those initial small scale batches of
`liraglutide in formulation were sufficient to conduct these
`initial clinical trials. Those initial clinical trials were
`Phase 1 and Phase 2, but they were successful and they were
`promising, and so what Novo Nordisk decided was we have to
`quickly from a bench scale to a manufacturing scale on
`manufacturing equipment.
`And so when they took it up to manufacturing
`equipment on a production scale, what they found is they had
`a problem with their formulation, and that problem really
`and its solution goes to the heart of the preambles in the
`method claims 23, 26 and 29.
`Now, an injectable formulation for a peptide
`like liraglutide has a series of different ingredients in
`it. It has a buffer, it has -- which controls pH. It has a
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`preservative. It could have other things, but one excipient
`that it has to have, it turns out, is something called an
`isotonic agent. At least depending on the other ingredients
`in the solution, the isotonic agent, it turned out, was
`necessary. And what is an isotonic agent? Well, that's
`what the '833 patent really is about.
`Peptide formulations like liraglutide, they get
`injected subcutaneously, Your Honor, so under the skin, and
`they can cause irritation that can be painful. The isotonic
`agent is really addressing that. It's trying to balance out
`the osmotic pressure of the formulation so that it is
`balanced with, the formulation is balanced with the skin,
`the tissue that's it's going to be injected into, and that
`will decrease the issues with pain and with rashes and skin
`irritation, and that's important for an injectable
`formulation of something like liraglutide that is for
`treating diabetes because the patients that are going to be
`injecting this formulation are going to be doing it
`chronically, Your Honor. They're going to be doing it, you
`know, in many cases for the rest of their lives.
`So having an isotonic agent is really there to
`help with this issue. And before the invention of the '833
`patent, the early initial small scale batches, what the Novo
`Nordisk formulation team did, they used a very common
`isotonic agent, mannitol, in those early formulations and
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`they worked for those initial batches and for those initial
`clinical trials, but as I said, when they scaled up, they
`found they had a problem, and the problem wasn't because of
`liraglutide in those first formulations, the problem was
`mannitol. It was causing deposits on the manufacturing
`equipment. It was causing deposits on the actual injection
`devices. It was causing clogging on the needle.
`So the people in manufacturing went back to the
`formulation team and said, look, we have a problem, and can
`you help us with this problem? We're constantly having to
`shut down our equipment and clean the equipment. It's
`leading to all kinds of inefficiencies and problems not only
`with our equipment, but with the products. And so the
`formulation team said, well, let's look at what we can do
`about mannitol, because we discovered mannitol is what's
`causing these deposits.
`So they tried a series of other isotonic agents
`and possibilities to replace mannitol in order to reduce the
`deposits, to reduce the clogging, and that's really what the
`preamble to these claims concerned.
`So these tests included simulated filling
`studies. They did 24-hour runs on actual production
`equipment with 14 different isotonic agents, potential
`isotonic agents, and what they found is some of them left
`deposits like mannitol, some of them left more deposits than
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`mannitol, and some of them didn't leave any deposits at all.
`They also did clogging tests with actual injection devices
`where they would look at a device on a daily basis and
`report whether there was any clogging or deposits or residue
`drops on the needles of those injection devices, and they
`did that for each of the 14 isotonic agents in solution.
`So based on all of these tests, what the
`inventors found was that propylene glycol emerged as a clear
`favorite. It didn't cause any of the issues that mannitol
`was causing, and in comparison to all of the other possible
`agents, it was the clear favorite.
`And, in fact --
`THE COURT: Hold up just one second.
`MR. OELKE: Sure.
`THE COURT: So PG they discovered, doesn't
`cause, to use your words, any of the issues caused by
`mannitol. What are the issues? What does mannitol cause?
`MR. OELKE: It causes deposits on the
`manufacturing equipment. It cause deposits in the needle
`and the injection devices. Basically, mannitol was
`crystallizing out when it was used on these large scale
`batches, and what they found is propylene glycol did not
`cause those deposits.
`THE COURT: And the deposits, the underlying
`cause of the deposit is the clogging or rather the
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`crystallization of mannitol. Is that right?
`MR. OELKE: Yes. The crystallizing of mannitol
`is causing those issues, Your Honor, so it's causing the
`problems with the deposits on the equipment. It's causing
`clogging in the devices. They are having to throw devices
`out, yes. So it was mannitol crystallizing that was causing
`those issues.
`THE COURT: So why isn't that the real thrust of
`the patent, the meaning of it, what is the vitality of the
`invention? It's not the results of the deposits that occur
`on particular types of equipment, it is the crystallization
`of the mannitol that's really the essence of the invention,
`or rather the essence of the problem that the invention
`solves. Right?
`MR. OELKE: Your Honor, the crystallizing of the
`mannitol is the deposits. That's what is the deposit. So I
`think that is what the essence of the invention is, is the
`reducing of those deposits by reducing the crystallizing of
`the mannitol.
`So --
`THE COURT: So let's say we even did that. So
`let's say the essence of the invention is to prevent
`mannitol from forming deposits. Okay? That maybe I could
`agree with you.
`What about, why is it important, or why is it
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`the essence of the invention that I look to the material are
`which the deposits on formed? Why does it matter if it's an
`injection device versus production equipment? I mean, that
`seems to be just a consequence of or a result if you apply
`the invention to a particular surface or within a
`particular, within a particular surface in the case of a
`device.
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`MR. OELKE: Your Honor, as to these particular
`method claims, I think the idea is that they were trying to
`take into account all of those different possibilities, and
`that's why there's three sets of claims. There's a set for
`reducing deposits on production equipment. There's a set
`for reducing deposits on a final product, and there's a set
`for reducing clogging of injection devices.
`So they actually tried to have those three
`different categories of methods, and without the preamble,
`those particular claims are identical, and so without --
`THE COURT: I know, and that's what I'm
`struggling with. They are identical except for these
`preambles, and I know, and your best argument as far as I'm
`concerned is claim differentiation. But what I'm struggling
`with is you could, if I take your position in this case and
`I applied it in a lot of other contexts, it seems it would
`allow for, you know, in some cases almost an infinite
`propagation of claims for which there's really no
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`substantive difference.
`So like, for instance, you know, just to make up
`a hypothetical here, so somebody invents soap and a certain
`type of soap, right, and they say, okay. So I'm going to
`have the soap, let's say it cleans glass, but it could also
`clean leather. It can also clean formica. It can also
`clean granite. And you are telling me you get -- but the
`claims are about the method of making this soap.
`And so what you are telling me, you can get a
`different claim for the same soap that's manufactured in the
`same manner simply by limiting in a preamble the description
`of the method as being applied to glass, as being applied to
`leather, as being applied to formica, as being applied to
`rubber, and what? You get ten claims or 50 claims just
`because, you know, you vary the surface area to which the
`soap is applied. That doesn't seem right.
`So help me out with that. I mean, again, I know
`claim differentiation is coming. Leave that alone. It just
`doesn't seem right that you could just, you know,
`essentially propagate claims by varying the type of surface
`to which the method or the formulation the method creates is
`applied.
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`MR. OELKE: Your Honor, I think one of the
`things to consider is if you look at the body of those
`claims, and they are identical, you could have a situation
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`where you replace an isotonicity agent with propylene glycol
`where it does reduce deposits, let's say, on, for instance,
`production equipment that doesn't cause clogging.
`So, in other words, all of those things were
`observed by the inventors of the '833 patent, but they are
`different problems that arose, and depending on what
`isotonicity agent you're replacing, it may be that it only
`reduces deposits on production equipment and reduces
`deposits on a product that doesn't cause clogging. So in
`that way, the preamble actually adds an additional
`requirement that ends up varying the scope of whether or not
`the replacement meets that final requirement or not.
`THE COURT: Isn't that just a result?
`MR. OELKE: I think it goes to the essence of
`the invention, Your Honor, and I know those -- I realize the
`result and the essence, all of these standards for
`preambles, they're not that far apart in some cases, but I
`think it goes to the essence of the invention.
`If you look at the specification, this concept
`of reducing deposits or reducing clogging is throughout the
`specification, so if you --
`THE COURT: Point me in the specification to
`where the written description differentiates how the method
`would be employed in reducing the production equipment
`deposits from reducing injection device deposits.
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`MR. OELKE: Well, I don't think it does that,
`Your Honor. It calls -- I mean, it calls them out
`differently and there were different tests conducted. So if
`you look in Example 1, they did conduct clogging tests and
`they did conduct simulated filling tests, and so in that
`way, the results were different.
`Some of the --
`THE COURT: Well, I think the results are --
`see, that's what I'm getting at is. I think if it's pure
`results -- like I think you agree, right, if it's purely a
`consequence or a result, then we're not talking life,
`vitality or meaning and we're not in a limiting situation.
`Right? Do you agree with that?
`MR. OELKE: I agree that if it's an intended
`use, it's not, it's not a limitation. That's what the cases
`say, Your Honor, but I think this goes beyond that.
`THE COURT: Well, no, no. I want to make
`sure -- hold on, hold on.
`MR. OELKE: Yes.
`THE COURT: But now what you've just described
`though, you say there are occasions in the written
`description where there's discussion of observations that
`the results differed or you had different results. You had
`some results with respect to injection devices. You had
`some results with respect to production devices, but I think
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`what you are conceding, I think you have to, right, is
`there's no discussion in the written description that
`differentiates the manner in which the method is employed to
`cause different results. Is that right?
`MR. OELKE: Your Honor, I don't think that the
`inventors know why specifically one isotonic agent performed
`better than another with respect to, say, the clogging test
`or why propylene glycol turned out to be better for the
`simulated filling test and the clogging test. You know,
`they were empirical results. That's what they determined
`doing these tests. But they did see that some agents
`performed better with respect to clogging tests, some
`performed better with respect to the simulated filling
`tests.
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`THE COURT: Okay.
`MR. OELKE: Do you want me to proceed, Your
`
`Honor?
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`THE COURT: Sure.
`MR. OELKE: Okay. So just to finish out on the
`things that you look to for purposes of determining whether
`a preamble should be construed as a limitation, you know,
`you look through the claim language itself. And I think as
`you point out, claim differentiation showed that these
`claims are identical if you strip them of their preambles,
`and that would suggest they should be construed differently.
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`Their scope should be construed such that they are different
`claims, and to do that, the preambles need to be construed
`as limitations.
`In addition, if you look at claim 24, for
`instance, it's a dependent claim than claim 23, and there,
`the body of the claim is referring to the reduction in
`deposits on the production equipment. So that is in the
`body of claim 24.
`So if you don't give effect to the preamble of
`claim 23 from which 24 depends, then all of the body of
`claim 24 makes little sense because claim 24 is actually
`talking about the things in the preamble of claim 23.
`Namely, reduction in deposits on production equipment.
`Then if you go past the claims themselves,
`Your Honor, and you look at the specification, I won't go
`into this in great detail, but the abstract --
`THE COURT: You mean written description?
`MR. OELKE: Correct, Your Honor.
`THE COURT: All right.
`MR. OELKE: So looking at the claim construction
`issue, you look to the intrinsic evidence and the issue of
`the specification.
`Now, the written description includes those
`examples that we discussed. It also includes Example 3 in
`which they tested liraglutide-containing formulations with
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`propylene glycol and tested them against
`liraglutide-containing formulations that contained mannitol
`and found propylene glycol was clearly superior.
`They looked at -- if you look at the field of
`the invention, it says, the present invention further
`relates to methods for reducing the clogging of injection
`devices by a peptide formulation and for reducing deposits
`on production equipment during production of a peptide
`formulation. The summary -- that's at column 1, lines 23 to
`26.
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`The summary of the invention says, the present
`inventors have discovered a peptide formulation containing
`propylene glycol at certain concentrations exhibit reduced
`deposits in production equipment. That's column 1, lines 53
`to 55.
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`So it's really throughout the specification
`these are hallmarks of limiting statements with respect to
`these method claims.
`Now, there are other claims in the patent to the
`formulations themselves, but as to these method claims,
`these really go to what led to this invention, and that was
`figuring out a way to reduce the deposits, because that is
`the problem that was plaguing the production department.
`And, finally, if you look at the file history,
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`Your Honor.
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`THE COURT: Actually, hold on.
`MR. OELKE: Yes.
`THE COURT: Actually, you gave me pause again
`because, you know, what you said was essentially -- I'd love
`to have a Live Note in front of me, but I think you said
`essentially, the essence of the invention is getting rid of
`the deposits.
`MR. OELKE: Correct.
`THE COURT: And which to me begs the question
`that I'm struggling with, then why does it matter where the
`deposits are? That seems to be not part of the essence. I
`think this is where I struggle with your position, is that
`at the end of the day, yes, it gets rid of the
`crystallization, or it gets rid of the deposits. I'm with
`you. That sounds like the essence. But then whether it's
`on production equipment or whether it's on an injection
`device seems to me to be a result that you can -- it's one
`potential purpose or application of the invention as to
`that, that particular surface. That's where I'm most
`troubled.
`
`MR. OELKE: I understand, Your Honor, and I
`think -- I don't think the scientists were able to look at
`all of their work and say, well, this is why it's causing a
`problem in the production equipment as opposed to this is
`why it was causing a problem in the injection devices, but
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`they did see differences as to those.
`So they were having problems with the production
`equipment and that certainly was a major issue for them, and
`they were having problems with mannitol and on the devices
`themselves. But when they actually went and tested the 13
`other agents, they found some of them were okay for
`production equipment but still caused problems in the
`injection devices, so they were not getting -- there were
`certain isotonic agents that were working fine for
`production equipment that didn't work as well on the devices
`when they tested them, and so there was a differentiation as
`far as the results that they achieved.
`And I think those three sets of claims, you
`know, acknowledge that. Claim 23 really is about production
`equipment, and claim 26 and 29, those are about final
`products -- well, 29 is about clogging. So it's clogging.
`THE COURT: The only reason, the only reason
`they are different is because in the preamble it says it's
`going to be different. Other than that, it doesn't tell me
`how they're different other than it's a stated purpose.
`Right? I mean, there's nothing else that distinguishes
`these claims.
`MR. OELKE: Well, the body of the claims are the
`same, Your Honor, but I think that actually supports they
`should be construed differently. And if you look at the
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`dependent claims, claim 24 certainly refers to what's in the
`preamble of 23 and claim 27 certainly refers to what's in
`the preamble of claim 26. So the dependent claims actually
`also support that these independent claims 23, 26 and 29
`should be given effect as to the preambles being
`limitations.
`THE COURT: All right. Do you want to wrap up?
`MR. OELKE: Sure. Your Honor, I think based on
`the claims themselves and the fact that without reference to
`the preambles, you strip the preambles of these claims and
`you look at the dependent claims, that the claims clearly
`support that the preambles should be construed as
`limitation.
`If you look at the specification, the discussion
`of reducing the deposits is throughout the specification,
`and if you look at the file history, there's a statement in
`the file history in which they actually distinguish a prior
`art reference on the basis of reducing deposits. So for all
`of those reasons, we think the limitation, claim preamble
`for claim 23, 26 and 29 should be read as limitations and
`given their plain and ordinary meaning.
`Thank you, Your Honor.
`THE COURT: Thank you. Let's hear from the
`
`defense.
`
`MR. WHITE: Thank you, Your Honor. This is
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`Brandon White from Perkins Coie on behalf of the Mylan
`defendants.
`So, of course, our position is that claims 23,
`26 and 29 of the preamble, are not limiting. In those three
`claims, they're each method claims. The method in the
`context of a patent is a set of instructions or steps.
`So here in each of those claims, each method
`recites but a single step. It's the replacing step that we
`see in the body of the claims. The claims differ only in
`the preamble as we've discussed.
`I think the problem with the preambles is they
`do not tell one what to do. They do not offer a step, an
`instruction, or otherwise differentiate what the method is.
`Instead the preamble tells the person of skill in the art,
`the person practicing this method, what might happen when
`that method is performed and that replacement step is
`performed.
`
`So I think the starting point for this analysis
`really should be the default position that we see in a
`number of cases, whether it's the Catalina case, for
`example, that preambles describing the use of an invention
`generally do not limit the claim. That's the starting point
`that preambles are generally not treated as limitations.
`I think that's important for a couple of
`reasons. It kind of sets the framework for the analysis,
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`but it also would tell the claim drafter that you would not
`put the essence, the critical portion of your invention in
`the preamble, understood that that type of preamble language
`is generally not a limitation.
`THE COURT: Right. But, you know, help me out.
`Right? I guess I have a real hard time with the case law
`here.
`
`So you're right, there are a bunch of cases that
`say mere purpose, not limiting, but then there's a line of
`cases that say, yes, but if the preamble recites the meaning
`and gives life to the patent, well, then, it is limited. So
`how do I reconcile those two lines of cases?
`MR. WHITE: Sure, and I think we could agree
`that the case law is maybe not crystal clear. I think you
`can look at a couple of examples. You know, one case
`discussed in the brief related to a rotary deck, a rotary
`cutter deck, and that's the language in the preamble and it
`goes on in the body of the claim, describes the structure of
`a rotary cutter deck, this type of mower, that really
`wouldn't make sense. It needs that rotary cutter deck in
`the preamble to make sense to describe it as the structure
`that's described in the body. And that's an example, I
`think, where the --
`THE COURT: Right. But the Federal Circuit is
`not limiting preambles to preambles that give structure.
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`MYLAN INST. EXHIBIT 1116 PAGE 21
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`Right? I mean, it says life, vitality or essence. It's not
`limited to structure. Right?
`MR. WHITE: So I agree and, you know, that's one
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`22
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`example.
`
`THE COURT: I mean, because they could have.
`Right? That's what they could have said. They could have
`said, look, is a preamble provides the structure or
`necessary structure, that it's automatically, right, or it's
`limiting or the general rule or presumption is it's
`limiting, but that's not what the cases say. Right?
`So help me out. How do I distinguish this? If
`it's the purpose of the invention or the intended use, then
`it is not limiting, but if it gives meaning and describes
`the essence of the invention, it is limiting. Can you help
`me?
`
`MR. WHITE: I could try. The claims here relate
`to a method where you end up with a GLP-1 agonist
`formulation. That's, you know, that's what we would view as
`the heart of the invention. You end up with a GLP-1 agonist
`formulation.
`The recitations that we see in the preamble, a
`reduction in clogging, a reduction, a reduction in deposits,
`that's simply the purpose. That happened -- that may happen
`as we heard from plaintiff sometimes with different --
`whether it's in equipment or needles, it doesn't always
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`happen.
`
`So in terms of giving life, vitality or meaning,
`I don't think those claims do it. We can look at, you know,
`I think some of the examples that we see in the case --
`THE COURT: But can I just ask you, is that
`argument, is that argument more of like a, I don't know, an
`enablement issue or maybe, I don't know, indefiniteness,
`that, you know, it doesn't really tell a POSITA how to
`perform the method?
`MR. WHITE: I think there certainly could be
`issues in this claim with enablement and written description
`in the way it's worded, but I don't know that whether or not
`the preamble as a limitation impacts that issue. I do think
`there are 112 issues with these claims, but I don't think
`the preamble --
`THE COURT: No. My question is, is your
`argument, is your argument better considered in the context,
`you know, that it doesn't tell -- the fact that it may or
`may not cause the result, you can't figure out from the
`claims whether it's going to cause the result or not, isn't
`that something argued in a different context than whether
`the preamble is limiting or not?
`MR. WHITE: Well, I certainly think we could --
`you know, that issue comes up in 112. I do think it's
`important with respect to the life, vitality or meaning in
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`terms of what the method actually claims what are the method
`steps. I mean, we don't need to resort to the preamble to
`understand what the method is. It's a method of preparing a
`GLP-1 agonist formulation where you replace a prior agent
`with propylene glycol. That's the method. That's what the
`person of skill in the art reads and understands this claim
`to be.
`
`THE COURT: All right. You know, I struggle
`with your position when it comes to claim differentiation,
`and to a lesser extent, antecedent basis, these other claims
`and each of these claims have an antecedent basis in the
`preamble.
`
`So let's start with claim differentiation. I
`mean, look, right, I'm supposed to presume the claims are
`valid. The only thing that differentiates these three
`claims is the preamble, so I've got to give meaning to them
`in order to fulfill my obligation to presume that the claims
`are valid. Why don't you lose just on that ground alone?
`MR. WHITE: Sure. I think I will start with the
`proposition that claim differentiation is not a hard and
`fast rule. We see that in Bristol-Myers Squibb and we have
`that on slide 12 from our slides.
`That doctrine isn't applied blindly where there
`really isn't a
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