UNITED STATES COURT OF APPEAL
`FOR THE FEDERAL CIRCUIT
`------------------------X
`IN RE:
` ARMODAFINIL PATENT LITIGATION
` CEPHALON, INC., ET AL.,
` Petitioner,
` Appeal No.:
` 2013-1360
` Vs.
` WATSON LABORATORIES, INC., ET AL.,
` Respondent.
`------------------------X
` June 3, 2014
`HELD AT: UNITED STATES COURT OF APPEAL
` 717 Madison Place, N.W.
` Washington, D.C. 20439
`BEFORE: HONORABLE TORONTO,
` Judge
`APPEARANCES: JIM HERTZ, ESQ.
` Attorney for the Appellants
` MR. LIPSEY, ESQ.
` Attorney for the Respondent
`TRANSCRIBER: CAMELLIA GRAHAM
`
`212-267-6868
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` INDEX
`
` W I T N E S S E S
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`PETITIONER: RE RE V.
`WITNESS DIRECT CROSS DIRECT CROSS D. J
`
`RESPONDENT: RE RE V.
`WITNESS DIRECT CROSS DIRECT CROSS D. J
`
` E X H I B I T S
`
`PETITIONER:
`IDENTIFICATION DESCRIPTION I.D. IN EV.
`
`RESPONDENT:
`IDENTIFICATION DESCRIPTION I.D. IN EV.
`
`3
`
`1
` THE COURT: We got a total of four cases
`2
`today. Two cases are submitted on the brief and we
`3
`have two cases for oral argument. Our first case is
`4
`In Re Armodafinil Patent Litigation, Nos. 2013-1360-
`5
`1361 and 1364 thru 1371, a consolidation of a number
`6
`of cases.
`7
` Mr. Hertz, you may proceed, sir.
`8
` MR. JIM HERTZ: Good morning, Your Honors.
`9
`Jim Hertz. May it please The Court. I'm arguing on
`10
`behalf of all of the appellants.
`11
` First principles prove the invalidity of
`12
`Cephalon's patent on Form 1, the crystal. And that's
`13
`because - - advances that occur in the ordinary course
`14 without real innovation are legally obvious. And
`15
`that's what we have here. There's a key piece of
`16
`prior art, it's the 855 Patent from way back in 1990
`17
`and it teaches three key things. First,it teaches
`18
`that if you take Armodafinil and you recrystallize it
`19
`in a specific solvent, ethanol, you're going to get
`20 white crystals. That's what it teaches. That's
`21
`Preparation 1. Two, it teaches, you can take
`22
`Preparation 1 and put it in a pharmaceutical
`23
`composition to treat sleep disorders. Number three,
`24
`it teaches that they successfully use that
`25
`pharmaceutical composition in human clinical trials to
`
`4
`
`1
`actually treat successfully sleep disorders and the
`2
`patent says it is a particularly valuable compound in
`3
`that regard.
`4
` THE COURT: Can I ask you this?
`5
` MR. HERTZ: Sure.
`6
` THE COURT: Suppose that I thought that the
`7
`district judge focused in part incorrectly on
`8
`expectations of achieving a particular structure that
`9
`is Form 1 which rather than focused on whether there
`10 was a motivation to take the steps that if, in fact,
`11 would lead to letting it be characterized through - -.
`12 Where do I go with that conclusion? Is that a basis
`13
`for a remand for fact finding with the right to
`14 motivation question?
`15
` MR. HERTZ: I don't think so, Your Honor. I
`16
`think you can take that and you can rule as a matter
`17
`of law that the patent is invalid, and here's why: We
`18
`do think that district court focused on the wrong
`19
`thing, whether or not the XRPD Patent was predictable.
`20
`It is beyond dispute. It is no longer contested on
`21
`this appeal that the 855 Patent created a motivation
`22
`for one, of skill and the art; two, run the experiment
`23
`that would be necessary to find the most stable
`24
`relevant--
`25
` THE COURT: [Interposing] There's one fact
`5
`
`1
`I'd like you to address --
`2
` MR. HERTZ: Sure.
`3
` THE COURT: -- which, at least, potentially
`4
`looms large. Which you addressed, I think in one-
`5
`half sentence in your great brief.
`6
` MR. HERTZ: Ok.
`7
` THE COURT: The fact that for ten years
`8
`evidently the motivation was insufficient for people
`9 who do that. Now you say something - I think the only
`10
`thing you say about that is that you were forbidden to
`11
`use it during that time which I don't understand how
`12
`that squares with 271E - was it 1 or 2? Whatever that
`13
`American Tegra provision is - it allows research use
`14
`reasonably related to a potential FDA application
`15
`among others. So why isn't, at least potentially, the
`16
`sheer fact that for ten years nobody actually was
`17
`sufficiently motivated to go and do this a significant
`18
`fact?
`19
` MR. HERTZ: Two points. First, in reality,
`20
`Cephalon created Form 1 immediately. They did it back
`21
`in 1990 and then they shelved it and didn't file for a
`22
`patent application until 2003. So, factually, it
`23
`happened right away. So there, that shows you the
`24 motivation existed. Number two, they had a patent on
`25
`this compound and they didn't actually have an NBA
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`approved application. There was no motivation for
`anybody to work with this compound until the time came
`when you could start actually filing and within a
`reasonable way, and that happens- -
` THE COURT: [Interposing} That's what I just
`said in the part I don't understand. I suppose there
`was some chance somebody would have said this is not
`patentable because it's obvious. But there is,
`evidently, some chance that the PTO would say, no,
`this is patentable. So, why wasn't this in somebody
`else's interest either to go and do a new drug
`application? Perhaps it would have been barred by the
`dominant patent from actually marketing it. But
`that's real economic value. You can negotiate about
`it with the dominant patent owners.
` MR. HERTZ: I think you're incorrect about
`that, Your Honor, because there was a patent on
`Armodafinil that prevented anybody from working with
`it in any form.
` THE COURT: But that's what I asked you
`about the American Tegra 271E2. Just explain to me.
` MR. HERTZ: Sure, sure.
` THE COURT: It seems to me, if you're
`thinking about filing an FDA application, you're
`allowed to - -
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`because back in the prior art in 2003 - -
` THE COURT: [Interposing] Let me just state
`the actual - - before you say that
` MR. HERTZ: Sure.
` THE COURT: Is there a time period where
`there's a zone prior to utilization under the patent
`and yet under the rags you're permitted to experiment
`with it? Is there some kind of gap there?
` MR. HERTZ: You can actually start your
`experimentation early --
` THE COURT: Right.
` MR. HERTZ: -- because there's nothing
`stopping you --
` MALE VOICE1: Right.
` MR. HERTZ: -- from doing it. But there's
`no motivation to do so because the patent on the
`Armodafinil itself and the regulatory exclusivity,
`keeps you off the marketplace. But, let - -
` THE COURT: [Interposing] I do just want to,
`I guess, point out that the one thing that you say
`about this - seems to me - on Page 21 of your Reply
`Brief says you were blocked from working with them. I
`think we've just come to the point where you now agree
`that that's just not correct. You might not have had
`enough of an economic motivation. But, you were not
`
`7
`
`9
`
`1
` MR. HERTZ: It's the way the regulations
`2 work. Okay, first, when somebody gets an NBA
`3
`application on file, and they actually get approval-
`4
`and that's Cephalon - they actually get regulatory
`5
`exclusivity for a period of time so nobody can -
`6
`patent or no patent - nobody can sell a generic form
`7
`of it.
`8
` THE COURT: Can they experiment with it
`9
`though?
`10
` MR. HERTZ: They can but only when it makes
`11
`sense, right? You're not going to start working - if
`12
`you're not going to be allowed to get on the
`13 marketplace until say -- I don't have the dates at
`14
`hand because this wasn't initially addressed. If
`15
`you're not going to be allowed to get on the
`16 marketplace until, say, 2005, no matter what, because
`17
`of regulatory exclusivity, there's really no incentive
`18
`to start working back in 1990, 1995, 2000. Whenever
`19
`the date is that the regulatory exclusivity expired,
`20
`that's when it started to make sense to start moving
`21
`forward, and not until then because of regulatory
`22
`exclusivity and patent protection on the Armodafinil
`23 molecule itself.
`24
` We know that Form 1 actually is something
`25
`produced in the ordinary course. And we know that
`
`1
`legally blocked from researching with the Armodafinil
`2
`itself.
`3
` MR. HERTZ: For all practical purposes, Your
`4
`Honor, when there's a patent on Armodafinil, yes, you
`5
`could start under the safe harbor to start working.
`6
`And maybe people did. And we wouldn't know whether
`7
`they got Form 1 immediately or not because it wouldn't
`8
`be something that would be published, number one. For
`9
`all practical purposes, when there's a blocking
`10
`patent, there's o incentive to start doing the work
`11
`until that blocking patent moves out the way. We
`12
`challenged the crystal patent. We didn't challenge
`13
`the blocking patent on Armodafinil itself. Okay. So
`14 we never did that. We only challenged the crystal
`15
`patent. But look at the prior art too. By 2003 or
`16
`2002 --
`17
` THE COURT: Is there any precedent from our
`18
`Court that claims polymorphic forms of known crystals
`19
`or is this a case of first impression?
`20
` MR. HERTZ: This, I believe, is a case of
`21
`first impression in the following way: There has been
`22
`no case like this before where the prior art literally
`23
`says we crystalized an ethanol - and you're going to
`24
`get white crystals - and then somebody comes along and
`25
`says I should have a patent on a particular form based
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`on my measurements of XRPD. That has never happened
`before. That has never happened before. There's some
`older cases, long before KSR, which deals with
`situations where the prior art didn't actually teach
`that the compound could be produced as the crystal.
`So this is unique first impression. Certainly the
`first post-KSR case that could deal with this.
`Conventional techniques from 2003 - -
` THE COURT [Interposing] And you're
`arguing, finally, that the patent on - - would render
`patentable all forms of polymorphic forms of
`structures?
` MR. HERTZ: Yeah and really in ways that
`really can't be defended in a practical matter, Your
`Honor. Right now today, for instance, there's an
`entire through-put method to create crystals in large
`quantities. Just try every variation. Under the
`District Court's reasoning, it's repeat. It's
`automated. Under the District Court's reasoning, each
`crystal that gets spit out of this through-put
`situation, is a separately patentable invention
`because you can't predict the XRPD Patent in advance.
`It's just not logical.
` THE COURT: What's the percentage of time
`that you've come up with Form 1?
`
`12
`1
`of motivation would have been without the unduly
`2
`particularized focus.
`3
` MR. HERTZ: Well, I think the motivation is
`4
`no longer even contested. Everyone's agreeing now
`5
`that the 855 Patent created a motivation to find and
`6
`obtain the most stable readily available crystals. So
`7
`that's no longer on the table as far as I'm concerned.
`8
`But to your point, when I read through the opinion,
`9
`you're right, sometimes the District Court says
`10
`structurally, structure. You need to predict
`11
`structure. Sometimes the Court just says, it wasn't
`12
`predictable to get Form 1. He means the same thing in
`13
`both instances. Because when he just says Form 1, he
`14
`has already defined Form 1 is the particular crystal
`15 with that particular structure. So it seems to me
`16
`that the only fair reading of this opinion is the
`17
`entire foundation was you had to predict an XRTD
`18
`pattern which Pfizer, Cuban, Sentara [phonetic],
`19
`Titanium [phonetic], what they all tell you is an
`20
`obvious stock doesn't suddenly become patentable
`21
`because you measure an inherent property. That's just
`22
`not sensible.
`23
` THE COURT: What is it about the disclosure
`24
`of ethanol in the crystallization process, what's its
`25
`role in leading to Form 1?
`
`11
`
`13
`
`1
` MR. HERTZ: Ninety percent.
`2
` THE COURT: Is it 90?
`3
` MR. HERTZ: Yeah. Look, nobody disputes
`4
`that conventional techniques will produce Form 1,
`5
`especially if you use ethanol as taught by the prior
`6
`art. Our experts did it seven out of seven times.
`7
`Cephalon used the prior art technique, they admitted,
`8
`typical bench-top screening, and they got it 90
`9
`percent of the time. Thirty out of 34 times. That's
`10
`KSR. Worthy invention produce itself in the ordinary
`11
`course without innovation; that's what happened.
`12
`Ninety percent of the time practically in the prior
`13
`art, you produce Form 1. And the District Court
`14
`really did just ask the wrong question. The District
`15
`Court said, "Was it predictable to come up with the
`16
`inherent properties of Form 1, this XRT in fact?"
`17
` THE COURT When I read the District Court's
`18
`opinion and started thinking about it and then went
`19
`back to look at it, it seems to me that some of the
`20
`things the District Court said in findings were not
`21
`dependent on the notions that what needs to be
`22 motivated and predictable was a particular structure
`23 with a particular ethnic faction pattern. But some of
`24
`them were and it all seemed kind of intermixed. So I
`25 was left thinking I'm not quite sure what the finding
`
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` MR. HERTZ: Different solvents will
`sometimes produce different crystals, and ethanol is
`particularly good at producing Form 1.
` THE COURT: Does the prior art disclose that
`it's going to lead you to Form 1?
` MR. HERTZ: What the prior art discloses is
`that if you use ethanol, you're going to get white
`crystals 90 percent of the time. Thirty out of 34
`times, you're going to get Form 1.
` THE COURT: Is it really 90 or is it higher?
` MR. HERTZ: Based on the record, Your Honor,
`it's 90.
` THE COURT: Ok.
` MR. HERTZ: Or it could be higher if you
`took -- it's 90. It's in that neighborhood.
` THE COURT: At the time that the patent was
`issued, was it known in New York that the
`crystallization process with the use of ethanol would
`lead to 90 percent Form 1?
` MR. HERTZ: No. That's part of the routine
`conventional experimentation that people would do from
`the patent. And so if in the ordinary course you
`follow up on the patent and you get Form 1 - -
` THE COURT: [Interposing] Well, couldn't you
`be motivated then to even get to that? I mean you can
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`14
`1
`achieve many different types of structures through the
`2
`crystallization.
`3
` MR. HERTZ: Because the FDA taught in 1987
`4
`they required you to ensure that you had the most
`5
`stable crystal. It's conventional that you have to
`6
`use the most stable crystal for a pharmaceutical
`7
`formulation because if you don't, during manufacturing
`8
`or storage, it could convert to something else.
`9
` THE COURT: Okay, you're into your rebuttal
`10
`time.
`11
` MR. HERTZ: I will reserve the rest of my
`12
`time for rebuttal.
`13
` THE COURT: We'll put you back a few minutes
`14
`because we took you over your rebuttal.
`15
` MR. HERTZ: Thank you, Your Honor.
`16
` THE COURT: All right.
`17
` THE COURT: Mr. Lipsey [phonetic]?
`18
` MR. LIPSEY: Thank you. Good morning and
`19 may it please The Court. Aside from the details and
`20
`findings of the trial courts that are for an
`21
`inconvenient truth which stand in the way of the grand
`22
`policy arguments that Appellants want to make - but
`23
`first--
`24
` THE COURT: Well, Mr. Lipsey, let me ask you
`25 what looks to me like an inconvenient truth for you
`15
`
`1
`and that is where opposing counsel closed. The FDA
`2
`guidelines from 1987, it says - it uses the word
`3
`"should" an appropriate analytical procedure should be
`4
`used to determine whether polymorphic occurs. How do
`5
`you reconcile that '87 guideline with your position
`6
`about unpredictability of polymorphics?
`7
` MR.LIPSEY: The same issue arose in the
`8
`Aberthy [phonetic]-Sandors case. There was an FDA
`9
`guidance that said what the properties ought to be of
`10
`an extended release formula and the court there said
`11
`that identified the goal but it didn't identify the
`12 means of achieving it; and that's exactly the same
`13
`problem here. Those guidelines came out in 1987. --
`14
`from doing what the FDA says would be nice. You
`15
`always found the most stable form. You would never
`16
`see the debacles like the retonagray [phonetic]
`17
`situation where they didn't find the most stable form;
`18
`and you wouldn't see the situations referred in the
`19
`Gardner and SEMA publication in 2004 where it says
`20
`almost every company refer in its history to
`21
`unexpected and undesirable results.
`22
` THE COURT: If it's not night follows day,
`23
`in excess of 90 percent seems, to me, to be pretty
`24
`predictable.
`25
` MR. LIPSEY: And that is where The Court has
`
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`been led astray. Any legitimate analysis of
`obviousness ends where the invention begins. The
`statute specifically says- -
` THE COURT: With white crystals. Which, in
`fact, at least nine out of ten times, are Form 1.
` MR. LIPSEY: Not so. Not so. And the trial
`court specifically found that and that's the second
`inconvenient truth. The first one is the claim. It's
`not just the Form 1. It's the pharmaceutical
`composition consisting essentially in it. The second
`is the trial court specifically found that Pages 832
`to 41, that the product of 855 Preparation 1 was not
`Form 1, and the analysis there is quite compelling.
`The evidence showed that the instantaneous melting
`point of Form 1 was from 159 to 164 degrees and the
`instantaneous melting point for Preparation 1 is
`actually reported there and it was 153 to 154, much
`closer to Form 2. And that shows that you don't get -
`- But in fact, the very first time that process was
`conducted, you got something else. Those findings are
`not clearly erroneous. In fact, wait, there was no
`indication on the face of that patent to do anything
`else.
` THE COURT: Did your testing, in fact, show
`90 percent?
`
`17
`1
` MR. LIPSEY: The work that the inventors and
`2
`the patent owner did in developing the invention -
`3
`none of which is prior art - did show that a large
`4
`number of conditions can be used to prepare Form 1 as
`5 well as two other forms that appear and, I believe,
`6
`the word was frequently. Although, not nearly as much
`7
`as Form 1.
`8
` That, Your Honor, unfortunately, is using
`9
`stuff the inventor discovered against him to establish
`10
`obviousness. And there are, indeed, authorities in
`11
`this area. One of them is from the International
`12
`Trade Commission.
`13
` THE COURT: Well, it's not exactly. It's
`14
`using what the inventor disclosed which is a solvent,
`15
`right? And a resolve, the white crystal, and looking
`16
`at it and saying what that solvent produces in that
`17 white crystal is, in fact, Form 1.
`18
` MR. LIPSEY: It is not. That's exactly what
`19
`the trial court found. What came out of Preparation 1
`20
`as described in that patent was not Form 1. Now, if
`21
`you went to go look to do the research project to see
`22 whether it was polymorphicism, which was not
`23
`predictable at the time; and this showed that the
`24
`structures could be made, might be, which was not
`25
`predictable at the time; and if so how they could be
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`1 made, which was not predictable; and if so, what the
`2
`properties were, which was not predictable. If you
`3
`did all that research, that was the research project
`4
`that led to the discovery of Form 1.
`5
` THE COURT: But is predictability the true
`6
`test here. Shouldn't we be looking at whether there
`7 was a reasonable expectation of success? Especially
`8
`given the fact that secondary considerations were not
`9
`-- evidence for secondary considerations were excluded
`10
`in the case?
`11
` MR. LIPSEY: Agreed. A reasonable
`12
`expectation of success from the prior art. The prior
`13
`arch stopped when the inventive acts began. And even
`14
`the Supreme Court says predictability is a factor.
`15
` THE COURT: Wouldn't one skilled in art know
`16
`to have motivation to further the crystallization
`17
`process because that process was pretty well known in
`18
`the art and the prior art disclosed that the use of
`19
`ethanol would aid in the crystallization process?
`20
` MR. LIPSEY: As the evidence showed that the
`21
`trial court found, there are a huge number of
`22
`variables beyond saying ethanol that affect the
`23
`crystallization. There are different grades of
`24
`ethanol. It is the absolute ethanol done in dilute
`25
`concentrations with slow cooling that gives you Form
`19
`1
`1. That was in our patent interview when they went to
`2
`duplicate the example of, not our patent, but the
`3
`prior art, those were the conditions they used, and
`4
`the other conditions they used. When we used--
`5
` THE COURT: [Interposing] The factors are
`6
`grade of ethanol, cooling rate and temperature, right?
`7
` MR. LIPSEY: Grade, cooling rate,
`8
`impurities, particularly impurities which can have a
`9
`great effect on what you get in the crystallization
`10
`and that's throughout the District Court opinion, if
`11
`you take a look through there. All of those
`12
`parameters, starting temperature, ending temperature,
`13
`solvent choice, solvent concentration, impurities.
`14
`All of those have an effect and, indeed, they were
`15
`characterized by both sides. Dr. Dan Steen [phonetic]
`16
`in his 2002 book said there's a vast variety of
`17
`conditions that can affect a crystallization, and for
`18
`any polymorphic system, it is indeed difficult
`19
`assuming I have a particular factor that might
`20
`dominate. Dr. Sooner [phonetic], also in 2002, because
`21 many variables influence crystallization and because
`22
`some many of the agents and processes are available,
`23
`testing is an extremely tedious process and industry
`24
`does not have the time or resources to test hundreds
`25
`of thousands of combinations to achieve an optimize
`
`20
`
`1
`product.
`2
` That was the state of the art. There were a
`3
`vast array of conditions that were known to affect the
`4
`crystallization. And, indeed, we cited a SEMA article,
`5
`I think it was Petersen and SEMA in our brief, that
`6
`sometimes even with identical conditions you can- -
`7
` THE COURT: So it's an amazing coincidence
`8
`that 30 out of 34 times, you came up with Form 1.
`9
` MR. LIPSEY: That was the invention, Your
`10
`Honor. That was what the inventors found. That was
`11
`entirely unknown and unpredictable from the prior art.
`12
`And, as I said, the ITC Case of certain drops of
`13
`crystal and material, dealt with this issue and
`14
`concluded that the inability of the prior art to
`15
`predict the structure of the crystal was fatal to the
`16
`obvious contention there. And that's been the law.
`17
`That's the standard application of garden variety
`18
`pharmaceutical patent law. And nothing- -
`19
` THE COURT: [Interposing] Can you put aside
`20
`cases - I realize that's putting aside a lot - explain
`21 why it makes sense - if the following facts are true
`22
`here. Why does it make sense if the prior art says
`23
`here is a process, somebody who would run the process
`24 with some number of possible variations of details. I
`25
`don't know what the number would be. And it turns out
`
`21
`
`1
`that they would almost always get this particular
`2
`structure. Why - and suppose they are sufficiently
`3 motivated to do that by a desire for stability. You
`4 might not always want the most stable but you would
`5
`want to see what the more stable thing is. Why in the
`6
`world would there be a patent for that when it seems
`7
`awfully like that the world would produce it without a
`8
`patent?
`9
` MR. LIPSEY: The problem with that analysis
`10
`is that it is forbidden by 35 USC 103A, last sentence,
`11
`patentability shall not be negative by the manner in
`12
`which it was made. And if you back away from that,
`13
`what the courts would be proposing is that patents
`14
`would be awarded to the inept, the inefficient or the
`15
`unlucky who dither for weeks and months before finding
`16
`something and denied to the adept, efficient and lucky
`17
`who happen, perhaps, to find it quickly. You cannot
`18
`use what the inventor found out as if it were in the
`19
`prior art. Now stepping back also on the policy
`20 matter, there is a flip side to this unpredictability,
`21
`which means there's no free lunch under the patent
`22
`law. The patent office has noted in that side
`23
`presentation that was cited in Lupin 3 [phonetic],
`24
`because of the unpredictability, it is highly unlikely
`25
`that a generic claim can possibly issue. These
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`22
`1
`claims, because it's some unpredictable, are very,
`2
`very narrow, directed to the specific product they
`3
`get. And for that reason, are usually easily avoided.
`4
`And in this case, the defendants have chosen not to do
`5
`that
`6
` THE COURT: How do you practice a prior art
`7
`of crystallizing without running into the 90 percent
`8
`percentile each time you do that? It seems to me that
`9
`if you practice a prior art and you use ethanol in the
`10
`crystallization process, that 90 percent of the time,
`11
`you're going to end up with Form 1. How do you avoid
`12
`that? See you're arguing that Form 1 has to exist in
`13
`the mixture to begin with.
`14
` MR. LIPSEY: What I'm saying is that Form 1
`15
`did not exist in the prior art in Prep 1 in the trial
`16
`court- -
`17
` THE COURT: [Interposing] But your argument
`18
`about predictability almost make it certain that Form
`19
`1 has to exist within the mixture in order to achieve
`20
`Form 1 like through the crystallization process.
`21
` MR. LIPSEY: Not so at all, Your Honor.
`22 When a person of ordinary skill in the art looking at
`23
`that disclosure, has no idea if there even are
`24
`polymorphic forms, and no idea how to make them or
`25 what they're going to be, and certainly no idea of
`23
`
`1
`which ones--
`2
` THE COURT: [Interposing] It's well known in
`3
`the art that if you take the compound and you go
`4
`through further crystallization, that you're either
`5
`going to end up with one form amorphic or a uni-
`6 morphic or you're going to have a pot of morphic
`7
`structures.
`8
` MR. LIPSEY: Not necessarily. You could do
`9
`that experiment 55 times and not see any different
`10
`form and you could do it the 56th time and get a
`11
`different one. In a point of fact, when you look at
`12
`the work that Hollingsworth did here, he -- in one of
`13
`them, he went to purify the material in ethanol.
`14
`Happen to use a slightly higher concentration and what
`15
`did he get? He got something that was 90 percent Form
`16
`2. That is not the invention.
`17
` The Court has to look at the evidence and
`18 make an evidence-based determination here of what the
`19
`capabilities of the person who is doing the art work.
`20
`And that person did not know what to do. What range
`21
`of conditions were going to be determinative; what
`22
`range of solvents were going to be determinative?
`23 What was going to be required to make polymorphic
`24 materials; which, by the way are made, they are not
`25
`naturally occurring. And it is that degree of
`
`24
`
`1
`predictability which made what these inventors found
`2
`when they stepped into the crystal of graphic unknown,
`3
`unobvious. And there is no decision that this Court
`4
`will find looking back where a court has found a man-
`5 made new crystal form identified by structure that was
`6
`not predictable to have been obvious. And - -
`7
` THE COURT: How could a person skilled in
`8
`the art post 1987, post a motivation from the
`9
`government, given the identification of this solvent
`10
`within the patent, not have known to take the steps
`11
`required to crystalize?
`12
` MR. LIPSEY: If you simply do what's in that
`13
`example, the example tells you, you get something
`14
`else. You get those white crystals with an
`15
`instantaneous melting point of 153, 154. That's what
`16
`you get. Maybe there are other things you can do.
`17 Maybe there are other things you can do, other
`18
`solvents, other conditions, other temperatures. Maybe
`19
`you can get something else. That's what research is.
`20
`And the outcome of that was notoriously unpredictable
`21
`at the time this invention was made. There may come a
`22
`day when it's more predictable. This science is
`23
`exploding. And add to the case of molecular biology -
`24
`- where we saw that art developed to the point where
`25
`things that were not predictable became predictable.
`
`25
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`That day may come. That day had not come at the time
`this invention - -
` THE COURT: [Interposing} I'm going to ask
`you again because I don't believe you answered my
`question. How does your practice see the prior art,
`crystallization of ethanol, without 90 percent of the
`time ending up with Form 1?
` MR. LIPSEY: All it says is ethanol. It
`doesn't tell you which grade; it doesn't tell you
`which temperature. If you use the new nature of
`ethanol, you get Form 2 all of the time. It's a
`question of doing a research project to try to find
`out what range of possible crystal instructions exist
`and what their properties are, and when you find one,
`it cannot legitimately- -
` THE COURT: You seem to be avoiding the
`evidence in the record that if you use ethanol in the
`crystallization process, you're going to end up with
`polymorphic structures that if they undergo further
`crystallization, you're going to end up with this
`compound 90 percent of the time.
` MR. LIPSEY: If you undergo further
`crystallizations with specific solvents, that true.
`If you undergo further crystallizations with dematrix
`[phonetic] ethanol, that's not true. And nobody knew
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`26
`1 whether it was polymorphic. And if so, what the
`2
`alterations had to be made in order to create these
`3
`polymorphics into what the properties would be.
`4
` THE COURT: How did the persons conducting
`5
`your client's experiment decide what form of solvent
`6
`to use?
`7
` MR. LIPSEY: The record reflects that what
`8
`happened here is what often happens. Nobody knew
`9
`there was a problem. They were developing a product.
`10
`All of a sudden, there started to be different
`11
`properties in the lots they were looking at. Couldn't
`12
`figure out what was going on. They did a research
`13
`study and the inventor used his intuition and insight
`14
`and selected a collection of solvents to use and did
`15
`the experiment.
`16
` THE COURT: How many different solvents did
`17
`he use?
`18
` MR. LIPSEY: