IN RE GABAPENTIN PATENT LITIGATION — Oral Argument

0:40 Judge Lourie 061572.

0:41 It's always again .

0:53 We have four principal briefs here.

0:57 Two of them have been labeled as containing confidential matter.

1:01 And there's a lot of material that has been so labeled.

1:06 It's always a difficulty on appeal because we have to ask questions in public.

1:12 And we have to have an opinion.

1:14 And we noticed that a lot of the so-called confidential material was in the court's opinion.

1:25 So we'd like to ask you all whether anything here is really confidential and wrong.

1:32 Appellant Attorney You're not extracting yourself for the plaintiff?

1:35 I think one of the briefs that's under seal is our opening brief, our initial brief.

1:39 And there is nothing in there that has to be kept under seal.

1:42 I apologize.

1:42 The reason that it was sealed was because it was filed before we could coordinate with the defendant's counsel about what information they wanted to keep confidential.

1:52 But there's no reason that anything in there has to be kept confidential.

1:57 Judge Lourie Any different comments?

2:00 We agree.

2:01 Your Honor, we don't press any confidentiality.

2:05 Thank you very much.

2:07 Mr. Blumenfeld, Unit 2.

2:09 Thank you, Your Honor.

2:09 Appellant Attorney Jack Blumenfeld for the plaintiffs.

2:21 May it please the court.

2:23 On a motion for summary judgment, the district court cannot disregard relevant evidence, can't weigh evidence.

2:30 And here, the district court did both.

2:33 As a result, we were not given a chance to try our infringement claim, even though we had two experts who testified that there was infringement in their opinion.

2:43 And even though TEPA's own opinion was that there was infringement in their opinion.

2:45 And even though TEPA's own evidence was consistent with those opinions.

2:49 And in holding that Warner-Lambert couldn't try to prove that TEPA's gabapentin has less than 20 parts per million of anion of a mineral acid,

3:01 the court, the district court, disregarded several pieces of crucial evidence.

3:07 And I would like to address two of them briefly.

3:10 First, it's undisputed that before the 482 patent,

3:15 issued in 2000, TEPA's gabapentin had less than 20 parts per million of total chloride.

3:23 It had six to seven parts per million.

3:25 That's an undisputed fact.

3:26 It's undisputed that after the patent issued, TEPA changed its process in the spring of 2000,

3:32 and that the process, the part of the process where the mineral acid was removed,

3:40 using an excess of TDA, was not changed.

3:44 And therefore,

3:45 the process did not increase the acidic chlorides.

3:50 TEPA's own data showed that,

3:53 and if you look at the chart that's on our opening brief, page 24,

3:57 it shows that the pH before the change, after the change,

4:00 was in the same range, didn't change.

4:04 Based on that evidence, our chemistry expert, Professor Bartlett,

4:08 testified that the acidic chloride levels did not increase in TEPA's gabapentin starting in 2000.

4:15 Now, the district court mentioned Warner Lambert's contention on that point twice in its opinion,

4:22 but didn't address it anywhere in the analysis.

4:25 Judge Moore Was there any sort of Dalbert motion below?

4:28 Appellant Attorney There was no Dalbert motion below, and in fact,

4:31 as we put in our reply brief, Your Honor,

4:34 there was a representation by the defendants

4:39 that they were only challenging the limits of precision,

4:43 they were not challenging the validity of the data.

4:45 Judge Moore They had gone beyond that unappealed, I suppose.

4:47 Appellant Attorney They had gone beyond that unappealed,

4:48 but they expressly told Judge Liflin to ignore any challenges to validity

4:53 because those created fact issues and were not appropriate on summary judgment.

4:57 But we put out all of the data also on the TEPA process,

5:03 the six to seven parts per million,

5:05 the change, which didn't change the excess of TDA,

5:09 in our opening brief in this court,

5:11 and none of that was contested in the answering brief either.

5:15 Judge Moore Let me just pause it for a minute.

5:16 Suppose that I agree with your claim construction,

5:19 and I understand that you tested five TEPA samples post-process change,

5:25 and I'm looking in particular at the appendix at 1659,

5:29 which is the chart that shows the titrated pH and all the way through.

5:35 And so by my calculation, four of the five samples could not possibly,

5:42 if we assume that you did write what you say you did,

5:45 and all of that,

5:45 four of the five samples would not possibly have more than 20 parts per million of acidic chloride.

5:53 Appellant Attorney That's correct, Your Honor.

5:54 In fact, I think all five couldn't possibly have that.

5:56 Judge Moore Well, the fifth one, hold on.

5:58 The fifth one, though, if we agree that it's plus or minus five error rate in the parts per million,

6:07 which I think your expert, Mr. Bartlett, was the one who suggested that's what it is,

6:11 plus or minus five, am I right?

6:13 Yes.

6:14 Okay.

6:15 So the fifth one, it seems to me that if you add plus or minus five BPMs there,

6:22 it could possibly be over 20.

6:24 Appellant Attorney If you look at our, I believe it's our opening brief at page 36,

6:31 we graphed the plus or minus five, and I believe even for that,

6:36 with the plus five, it falls below 20.

6:39 But certainly taking your point, there can be no question

6:43 that four of the five samples were below 20.

6:46 Judge Moore And so here's my question to you.

6:48 At what point do you think we ought to say that you have established your burden

6:54 such that summary judgment should be granted?

6:56 Suppose in this case it's four of five, do you think that's a clear showing if I say four of five?

7:02 What if it was one of five?

7:04 Appellant Attorney Both.

7:05 Judge Moore I know those are not the facts, but...

7:07 Appellant Attorney I understand, Your Honor, but what we had here was more than one thing.

7:11 And what we had to show was that there was a genuine issue of fact,

7:15 because it was their motion.

7:17 And what we showed was, one, that TEPA had six to seven parts per million,

7:21 and the process change didn't affect that.

7:23 And on the point Your Honor is making...

7:25 Judge Moore I know all the other points you're going to point me to,

7:27 but I just want you to focus, and just my little hypothetical,

7:29 which I know is not these exact facts,

7:31 but I'm trying to understand where to draw the line in that regard.

7:34 And I know you're pointing me to the other arguments and saying

7:36 we don't have to make this decision.

7:37 And I appreciate that, but I just want to know,

7:40 if it was one of five, do you think that's a clear showing?

7:41 Do you think that would have been enough?

7:42 Appellant Attorney I think where we are is that if the evidence was sufficient

7:46 that a chemist could give an opinion that TEPAs got repentant

7:53 had less than 20 parts per million, that would be sufficient.

7:55 We clearly had that here.

7:57 I think we would be in a situation...

7:58 Judge Moore So Mr. Bartlett had testified via deposition or transcript or whatever

8:03 that because one of the five showed TEPA's product below 20 parts per million,

8:09 that he concludes there was...

8:11 Therefore there's infringement.

8:13 Appellant Attorney Well, there's, at least in my understanding,

8:16 there's nothing that requires that in order to prove infringement

8:19 that it would infringe 100% of the time.

8:22 That if we could show that some of TEPA's gabapentin was infringing,

8:26 that would be sufficient to prove infringement.

8:29 There might be remedy issues that flow from that,

8:34 but if you prove that there's infringement some of the time, that's sufficient.

8:39 And so I think if there was one of five,

8:41 yes, we could put on an infringement case.

8:44 Luckily for us, we don't have that situation here.

8:47 I think we have a much clearer case.

8:50 And the point that you made, Judge Moore,

8:53 was the second point I was going to make on evidence that wasn't considered

8:57 because on the PH testing, Judge Liefland looked at one hypothetical example

9:03 of 18 parts per million and did plus or minus five.

9:07 The actual evidence wasn't 18...

9:09 Did he give plus or minus five or just plus?

9:11 Well, he did. He said 13 to 23.

9:14 It could be anywhere between 13 and 23,

9:16 but he said it could as easily be over 20 as below 20.

9:20 Putting aside whether that's correct or whether it's more likely than not,

9:23 if it's 18, that it's below 20,

9:26 as Judge Moore said, four of these five samples were way below 18.

9:31 Three of them fell in the range where the PHs were higher

9:35 than the standard for six parts per million.

9:38 Judge Lourie He said two samples that show 18.

9:40 As you say, aside from whether 18 is less than 20,

9:43 are indistinguishable from samples containing 23 or more.

9:48 But according to the margin of error, they could also be 13.

9:52 Appellant Attorney It could also be 13.

9:54 And I think one of the points we made in our briefing,

9:56 I think it's correct, is that we didn't have to prove this to a certainty.

10:01 We had to prove it to a preponderance of the evidence.

10:05 And it was sufficient to prove that it was more likely than not.

10:10 Even at 18, we think it's more likely than not.

10:12 But even if you take into account the limits of precision

10:15 for four of the five samples,

10:17 there is no question that they were below 20.

10:22 The third point that I wanted to make was,

10:24 in addition to disregarding that evidence,

10:29 the district court did weigh evidence

10:31 because TEVA put in its subtraction test results through its expert.

10:36 We put in our comparative PH tests.

10:38 And Dr. Bartlett testified that, in his opinion,

10:42 the PH test was a better way to go than the subtraction test

10:46 because you didn't have to make any assumptions.

10:48 It was clean. You tested something.

10:50 You didn't have to assume certain things were there or not there.

10:53 Both Dr. Bartlett and Dr. Davies, our analytical chemists,

10:56 opined from the PH testing that TEVA's gabapentin

11:00 had less than 20 parts per million of an anion of a mineral acid.

11:05 Nothing equivocal about their testimony.

11:06 And what Dr. Bartlett said, and this is page 8, 14, 55, and 56,

11:13 was that the PH test results flatly contradict

11:16 the subtraction test results that TEVA used.

11:18 This was a classic battle of experts

11:22 where both of our experts testified that TEVA samples

11:25 have less than 20 parts per million,

11:27 even within the limits of precision.

11:29 And the judge, on summary judgment, disregarded that

11:34 and accepted the subtraction test results.

11:36 And under the Glaxo-Abbott-Suntiger cases from this court,

11:41 which we cited in our brief,

11:44 you can't grant summary judgment of non-infringement

11:49 by weighing one side's expert testimony over the others,

11:52 and that's what we believe happened here.

11:55 Judge Lourie Are you saying that summary judgment in your favor should have been rendered

11:59 or that it should go back to a trial?

12:02 Appellant Attorney No, we didn't move for summary judgment,

12:05 and there were points on which the defendants said

12:08 that they would challenge our data.

12:10 They said they were not challenging it on summary judgment,

12:13 but that they would challenge it if we got past the summary judgment.

12:16 The isoelectric?

12:18 Well, the isoelectric point never came up below,

12:21 but there were other issues on which they said

12:23 they were going to challenge the validity of our data.

12:25 Judge Moore Just out of curiosity, I realize this is not your appeal,

12:28 and they didn't actually make an appeal,

12:30 but I've been trying to figure out,

12:31 do I have to decide the adjuvants, claim construction,

12:34 issue depending on how we come out on the first issue?

12:38 If we were to rule in your favor on the first issue,

12:42 would I have to reach the second issue,

12:44 or do you think we have to reach both of them?

12:47 I'm guessing I know what they're going to say.

12:49 I'm just curious what you think.

12:50 Appellant Attorney No, and we don't think that you have to reach the adjuvant issue

12:53 assuming that you reverse on the burden of proof issue,

12:57 and there are a couple reasons for this.

12:58 One, this is Rule 54 judgment,

13:01 and there's nothing about the adjuvant issue

13:03 that relates to the burden of proof issue.

13:05 Judge Moore Well, he certified the order for the adjuvant claim construction

13:09 and the summary judgment of non-affirmation from APOTEX,

13:12 which is not in the case anymore.

13:13 It was all certified up to us, so...

13:15 Appellant Attorney But on the issues that these defendants have,

13:17 that was not...

13:18 The denial of summary judgment on the adjuvant issues

13:21 that they're raising were not part of the 54 judgment,

13:25 but maybe more importantly, they're not dispositive of the case

13:28 because even on the titanium dioxide,

13:31 not all of the accused products

13:32 use titanium dioxide.

13:34 On the modified maize starch,

13:36 only one of the many accused products

13:38 uses what they claim to be modified maize starch.

13:41 Judge Lourie As a matter of judicial economy, it was argued

13:44 that the claim construction was decided,

13:48 and if we were to find in your favor

13:51 the issue would still be live

13:53 and wouldn't it aid the parties

13:56 as well as the judicial economy to decide it?

13:59 Appellant Attorney Well, on the claim construction,

14:02 it might.

14:03 There are factual issues that will be involved,

14:05 I think, on infringement and any of that.

14:08 Judge Lourie Which we wouldn't decide anyway.

14:10 We'll save the rest of your time.

14:12 Thank you.

14:13 If you'd like to do that.

14:14 Yes, sir.

14:15 Mr. Lee, you have determined to split your time with Mr. Howe.

14:19 Yes, sir.

14:20 And it's between you and any time you run over

14:25 is at his expense.

14:28 Appellee Attorney Thank you, Your Honor.

14:29 I'd like to address the point of reference

14:32 about the Teva process before and after the change.

14:37 I think this issue was dealt with substantially below.

14:40 The problem is that the Teva pH measurements,

14:43 everybody agrees, were too imprecise.

14:46 Judge Moore Everyone agrees?

14:48 I don't think that Mr. Blumenfield,

14:51 if he was to get a chance to come right back up right now,

14:53 would agree.

14:53 Am I wrong about that?

14:54 Are you saying that he agreed that the pH was too imprecise

14:57 because he said everybody?

14:58 Appellee Attorney I'm saying that the experts below,

15:02 testified that the method that Teva used to determine pH

15:06 was too imprecise to be able to tell what the

15:12 acid chloride level was.

15:15 Sorry, I cut you off prematurely.

15:17 Go ahead.

15:17 In fact, those values ranged all over the place

15:22 within a relatively small range,

15:25 but they were not dispositive of themselves,

15:28 and that's why plaintiffs,

15:31 they're experts conducting new tests.

15:33 Judge Moore So are you suggesting,

15:34 just so I understand where you're going with this,

15:36 that in the absence of a precise measurement

15:39 of parts per million,

15:41 there can be no proof sufficient

15:43 to overcome summary judgment

15:46 that the infringing,

15:48 potentially infringing products do in fact infringe?

15:52 Are you saying that they can't prove the exact number,

15:54 they can't survive summary judgment?

15:57 Appellee Attorney I'm not saying they have to prove an exact number in all cases.

16:00 What I am saying is

16:01 when the imprecision is very great,

16:05 it's obvious you can't use such numbers,

16:07 and I believe that that is true

16:08 of the kind of routine laboratory test measurements

16:11 that Teva made during its process controls.

16:14 But I also believe that it's,

16:16 I'm sorry,

16:16 I also believe that it's true

16:18 of the testing that was performed by the Venice experts,

16:23 which they admitted was imprecise

16:25 to the order of 10 parts per million

16:27 when you are trying to measure a number

16:29 which is only 20 parts per million.

16:30 Judge Moore When you say imprecise to 10 parts per million,

16:32 you mean plus or minus five, right?

16:35 Appellee Attorney That's not exactly what the defendant's expert said,

16:38 but that's the way the judge construed it,

16:40 and we're willing to stay with that for the purpose of the...

16:43 Judge Moore Okay, well, would you agree then

16:44 that four of the five Teva samples that they tested

16:47 showed a pH that would put the parts per million,

16:51 even plus five, below 20?

16:55 Appellee Attorney I would not, Your Honor.

16:58 I would agree that if you start

17:00 at a pH of 7.0,

17:02 6, and we draw this nice curve

17:03 that they have on page 36 of their appeal brief,

17:05 that that's what it looks like,

17:07 that one of the samples is indeterminate

17:11 and four of them fall within the 18 PPM.

17:14 But it all depends on what you compare it to.

17:17 But you raised that issue below.

17:19 We did raise it.

17:20 Judge Moore Not for purposes of summary judgment.

17:22 You said, and I have the site right here,

17:25 your admission that you would not challenge

17:27 the validity of their pH testing

17:30 for purposes of summary judgment.

17:32 So I understand your isoelectric point completely.

17:35 It may be valid, may not be valid.

17:36 It's a fact question for someone below to figure out.

17:40 But you kind of waived that for summary judgment purposes.

17:43 I understood that.

17:44 Appellee Attorney I'm not sure I understand that,

17:46 but I certainly don't agree that we waived it.

17:48 We are not challenging the validity of the patent.

17:51 What we're challenging is that the test method

17:55 that they used was imprecise

17:57 and I'm trying to show by reference

18:00 to the zero point.

18:02 Judge Moore Here's your admission on page 9307.

18:06 First, Tevis experts vehemently dispute.

18:08 They don't just dispute, they vehemently do so.

18:10 The validity of the data he relies on.

18:13 But I want to ignore that dispute.

18:15 Those factual issues are in dispute

18:18 but should not be part of this motion

18:19 and we, you, can ignore them.

18:22 So you're telling the judge below,

18:24 ignore the dispute over the validity of their pH per

18:29 for these purposes.

18:30 Appellee Attorney No, Your Honor.

18:31 I think what we were saying is

18:32 we do not dispute the numbers that he got.

18:36 We don't dispute that.

18:37 There's absolutely no dispute that

18:38 whatever numbers they reported,

18:40 that those are the numbers that they got

18:42 and we're willing to accept that.

18:45 What we're not willing to accept is that

18:46 those numbers are valid numbers for comparison

18:50 in this particular very imprecise pH test.

18:54 Judge Moore And that's all fact.

18:56 You may be right.

18:57 You may not be right.

18:58 Yes.

18:59 This is summary judgment.

19:00 Yes, Your Honor.

19:01 Everything you're arguing with me right now is fact.

19:04 Appellee Attorney They are facts, Your Honor,

19:05 but they are facts that go to whether or not

19:09 this particular kind of pH testing

19:11 could ever be the kind of evidence

19:14 that a jury could accept

19:16 and make a reasonable judgment of.

19:18 What we're saying is not

19:20 that you should pick 7.06 the way they did

19:22 or pick 7.19 which was an acceptable number

19:26 or 7.14.

19:27 What we're saying is

19:29 because it makes all the difference in the world

19:32 which number you pick

19:33 and because there is nothing in the record,

19:39 the prosecution history, the pattern,

19:41 anything which suggests what the number is

19:43 that you start with

19:44 and you couple that with the imprecision,

19:47 the admitted imprecision of this test,

19:49 you wind up with a test which

19:51 the judge was completely right

19:53 is not capable of proving infringement

19:56 of the defendant's products.

19:57 Judge Moore Well, the .13 pH dispute

20:00 was not before the lower court, was it?

20:02 When he made the summary judgment motion.

20:05 So why should we even be considering that?

20:07 It wasn't raised below,

20:08 it wasn't decided upon

20:09 the lower court of appeals.

20:11 Appellee Attorney We argued below, Your Honor,

20:13 that there was an improper comparison

20:14 between the defendant's products

20:18 and not the patent,

20:20 but the plaintiff's product.

20:22 And the judge took that

20:24 in its very narrowest sense and said

20:26 it doesn't matter whether the test,

20:32 the sample of neutral gamma pendant

20:34 was plaintiff's product

20:36 or whether it was somebody else's product.

20:38 I'm not disputing that.

20:40 We're not saying it's because it was their product.

20:43 We're saying it's because

20:44 that had nothing to do with the patent.

20:47 That particular sample

20:48 could have taken any one of,

20:50 a number of samples

20:51 and because of the imprecision of the test method,

20:54 it all depends on what sample you pick.

20:57 This particular sample

20:58 could never have been used by a reasonable jury

21:01 and the reason is because it was not

21:04 what Borner Lambert calls it over and over,

21:06 a gold standard.

21:07 It was not a standard at all.

21:09 It was not available to any of the defendants

21:12 for testing purposes

21:13 before this litigation.

21:15 Still not available.

21:16 Judge Moore Was that issue raised below the district court?

21:20 Appellee Attorney That issue of whether it was available

21:22 was not raised below.

21:23 But the issue of whether there was a proper comparison

21:26 to that particular sample

21:28 that was raised below.

21:29 And we believe that the,

21:31 that we are allowed to raise alternative grounds

21:33 in support of the same argument

21:35 that they failed to burden the group.

21:39 Judge Moore Can I ask you the adjuvant's question

21:41 or are you guys splitting the time?

21:43 No, the adjuvant's question is mine.

21:44 Okay, so do I need to reach this issue

21:47 depending on how I come out?

21:49 Either way, what is your position

21:51 on whether we need to reach the claim construction issue

21:53 using the adjuvant's?

21:55 Appellee Attorney If you support the,

21:59 Judge Liefland's opinion,

22:00 you do not need to reach the adjuvant issue.

22:03 If you do not support it,

22:04 I believe you do have to reach the adjuvant issue

22:06 because it is dispositive as to all,

22:09 I think, but one of the samples

22:12 and that was a captioned sample.

22:15 Judge Lourie The distinction between whether we support

22:16 the judge's decision or not,

22:19 why don't we reach it in either event?

22:21 Well, it depends upon whether we're going or we may not.

22:24 We'll send it back.

22:26 That's my point.

22:28 We should deal with it either way.

22:31 Appellee Attorney If you're going to remit,

22:34 I think that it is,

22:35 I think it's proper and it's probably efficient

22:38 to consider the adjuvant argument now.

22:42 And I would just like to say

22:44 on the adjuvant argument that

22:46 we think that the judge correctly determined

22:48 that titanium dioxide is an adjuvant

22:51 and it's an exception.

22:52 It's one of the eight no-no adjuvants

22:54 that you can't put into a formulation.

22:57 Where he erred was saying that

22:59 titanium dioxide in a capsule shell

23:02 or in a tablet coating

23:03 was not an adjuvant for purposes of Claim 7

23:07 because it was not intimately admixed

23:11 with the GABA pendant.

23:12 And this was an error for at least four or five reasons.

23:17 First of all, the record is completely barren

23:20 of any reason why

23:23 excipients in coatings or shells

23:25 should be excluded.

23:26 There is nothing in the specification,

23:29 in the claim, in the prosecution history,

23:33 Judge Liston points to nothing.

23:35 Judge Moore I definitely understand your point about

23:37 the mix, whether it's in the mix, basically.

23:40 And here's my question.

23:42 Could it still be in the mix

23:44 despite the fact that it's in the shell

23:45 or a coating around the shell,

23:47 as I understand some of the products use?

23:49 It all depends on when it's digested in your stomach

23:53 before it reaches your bowels and takes effect.

23:55 It all depends on whether or not

23:56 it's going to cause more than 0.2%

23:59 instability in the GABA patent.

24:01 Isn't that the issue?

24:02 No, I don't think it is, Your Honor.

24:03 Appellee Attorney In the GABA text,

24:07 which was not appealed,

24:09 and so is the law of the case,

24:11 the judge found that any amount

24:14 of any one of those eight adjuvants,

24:16 including titanium dioxide, any amount,

24:20 was removed,

24:22 the formulation from the scope

24:24 of that coating.

24:26 And what we're saying is,

24:27 we have some of this stuff in our...

24:29 Judge Moore Any of those...

24:30 Did he say any of them anywhere

24:32 or any of them in the mix?

24:34 Appellee Attorney No, he did not reach the issue

24:37 of where they were.

24:38 He just said,

24:39 if you have any of these eight

24:41 in any amount,

24:43 that they are...

24:45 that that formulation does not follow

24:47 in the scope of that.

24:47 Judge Moore And here's why maybe we shouldn't

24:50 reach that issue either,

24:51 because maybe that part of it

24:52 is infringement and not

24:53 a planned construction

24:54 and tell me if I'm wrong about this,

24:56 but isn't it possible

24:57 that if you put these things

24:58 in your coating,

24:59 they may or may not,

25:01 depending on how the product is digested,

25:03 affect the stability of GABA patent?

25:06 And that seems to me

25:07 to be pretty infringement analysis.

25:08 Appellee Attorney I understand that point,

25:09 Your Honor,

25:10 but Judge Liflin,

25:13 in his decision which was not appealed,

25:14 went beyond that.

25:15 He said,

25:16 I don't have to consider

25:18 whether any of these materials

25:21 actually affect

25:22 the lactan formation

25:25 in the capsule in the tablet.

25:28 They have disclaimed

25:32 any formulation

25:33 which contains those excipients

25:36 and therefore,

25:36 it doesn't matter whether

25:38 it's a minuscule amount,

25:39 a minimus amount,

25:40 any amount

25:42 will remove that claim,

25:44 that formulation from infringement.

25:47 That was not appealed.

25:48 That is the law of the case.

25:50 Now what we're saying is,

25:51 the evidence shows

25:52 at least with respect to tablets,

25:54 there is sufficient evidence

25:57 in the record

25:57 that shows with respect to tablets,

25:59 Warner Lambert itself

26:02 tested titanium dioxide

26:04 as a colorant

26:05 in the tablet coating,

26:08 found that it was inconsistent

26:10 with stability

26:11 and instead put talc

26:13 in their tablet coating.

26:16 That's part of the record.

26:18 Judge Liflin relied on it

26:19 and on that basis,

26:21 he should have said,

26:21 well, you know,

26:23 titanium dioxide

26:24 in a tablet coating

26:26 is an excipient

26:27 for purposes of Claim 7.

26:29 The only evidence

26:31 that he points to

26:32 for why these titanium dioxide

26:36 in a coating

26:37 could not be considered

26:38 to be an adjuvant

26:40 has to do with capsule shells.

26:42 And that evidence we submit

26:44 was improper

26:44 because all he was saying was,

26:46 Neurontin capsules

26:48 contain some titanium dioxide,

26:50 therefore,

26:52 that's not how I should

26:53 consider the claim.

26:54 He should not have done that.

26:55 He should not have looked

26:56 at what the commercial product was

26:57 in order to determine

26:58 what the claim was.

27:00 I've used up almost all my time

27:02 and I want to ask...

27:02 Judge Lourie You were answering the question,

27:05 so we'll give Mr. Hogg

27:07 five minutes

27:09 and if needed,

27:11 we'll add a couple of minutes

27:12 and we'll be done.

27:15 Okay.

27:16 You've got more than ten minutes.

27:20 Appellee Attorney I understand.

27:21 I would point to

27:23 the Trondland Declaration,

27:25 which Judge Lithland

27:26 referred to where he said

27:27 talc had 20 times less of an effect

27:29 on lactam formation

27:30 than titanium dioxide.

27:32 They also include gelatin,

27:34 which is an ingredient

27:35 in the capsule shells,

27:36 in the list of ingredients

27:37 in the Trondland

27:38 and Gebhardt Declarations.

27:44 And I would say that

27:46 in the Gebhardt Declaration,

27:54 it's one of the categories

27:56 of excipients,

27:57 which Gebhardt says is relevant,

27:59 is coloring agents.

28:00 Well, the coloring agents

28:01 are only going to occur

28:02 in the coating

28:03 or in the capsule shells.

28:05 I think that there's no way

28:08 that these claims should...

28:09 Judge Lourie You're not using

28:10 the colleague's time,

28:11 you won't understand.

28:11 Appellee Attorney I understand your argument.

28:13 The other issue

28:14 that I want to talk with

28:15 was our alternative argument

28:16 about the construction

28:19 of the claim

28:20 to 20 parts per million

28:22 of a mineral acid,

28:25 but I will cede that time to...

28:29 Thank you.

28:29 Judge Lourie You have 15 minutes,

28:31 so we'll give Mr. Haag two minutes.

28:36 Amicus Attorney Good morning, Your Honors.

28:37 I would like to address, of course,

28:38 the question of claim construction

28:39 of anion of a mineral acid,

28:41 key to this whole case,

28:42 central to everything.

28:44 Down below,

28:45 the court construed the term

28:47 precisely as Wernher Lambert

28:48 asked it to

28:50 and said that anion of a mineral acid

28:52 means anion derived from a mineral acid.

28:55 The court reported process limitations

28:57 into that phrase.

28:58 And it was in error.

29:00 The claim term,

29:01 the court said,

29:02 was ambiguous in the claim.

29:03 And in fact,

29:04 at 886,

29:05 it says it supports

29:06 both sides' position.

29:07 The court then went

29:08 to the specification

29:08 and said the specification

29:10 is no aid to me

29:11 because this phrase,

29:12 this term,

29:13 is nowhere to be found

29:15 in the specification.

29:16 It's not defined

29:17 in the specification.

29:18 And that's the fact.

29:19 So then the judge

29:20 went to the file history.

29:22 And what the judge below did

29:23 is he picked certain portions

29:25 of that file history

29:26 that he found

29:27 to be supportive

29:28 of Wernher Lambert's position.

29:30 And as it's very,

29:31 I think,

29:32 set forth in our brief,

29:34 step by step,

29:35 we go through the file history,

29:36 but our position is simply this.

29:37 The claim term is not ambiguous.

29:40 It's plain and clear on its face.

29:42 It's an anion

29:43 less than 20 ppm,

29:45 which is a weight measure,

29:47 of an anion

29:49 of a mineral acid.

29:51 There's nothing ambiguous about that.

29:53 This is about anions.

29:54 Less than 20 ppm of anions.

29:57 Not less than 20 ppm

29:59 of mineral acids.

30:01 And by the way,

30:02 that phrase,

30:02 anion of a mineral acid,

30:04 is really a limited phrase.

30:06 It's not all anions.

30:07 It's anions of a certain class.

30:09 A class meaning anions

30:12 that are capable

30:12 of forming a mineral acid.

30:14 Judge Moore You don't want us

30:15 to read in derived from,

30:17 which, fine,

30:18 I'm not going to.

30:19 But you don't want us,

30:20 then you do want us

30:21 to read in capable.

30:22 We're capable.

30:23 Because the question is,

30:25 what does of mean, right?

30:26 Is that what it comes down to?

30:27 I mean,

30:27 what does the word of mean here?

30:29 Because it's anion

30:30 of a mineral acid.

30:32 And you want me to say

30:33 it's capable of being linked.

30:34 And he wants me to say

30:36 Amicus Attorney Well, that was the phrase

30:37 I'm trying to explain

30:38 what we think it means.

30:39 It's the same as saying

30:40 a metal of group three

30:41 of the periodic table.

30:42 I think that's a metal

30:44 that comes from somewhere.

30:45 In this case,

30:47 the anion

30:47 is connected

30:48 to the mineral acid.

30:49 It's a subset

30:50 of all anions.

30:51 Namely,

30:51 an anion

30:52 that comes,

30:53 you know,

30:54 it's capable,

30:56 it's capable

30:56 is the best phrase

30:56 we came up with

30:58 of forming

30:59 a mineral acid

31:00 like chloride

31:00 if it's hydrochloric acid,

31:02 phosphate

31:02 if it's phosphoric acid,

31:04 so on and so forth.

31:05 The specification,

31:06 Collins 5,

31:07 lines 27 to 29.

31:08 It is the only place

31:10 you see the language,

31:11 the phrase

31:11 less than 20 ppm.

31:13 And it talks

31:14 about hydrochloride

31:16 admixtures.

31:18 That's the only thing

31:19 that could arguably

31:20 support this claim term,

31:21 but clearly

31:22 it doesn't

31:22 because a hydrochloride

31:24 admixture

31:24 is gabapentin

31:25 hydrochloride.

31:26 And that's

31:27 Judge Lourie what we're looking

31:27 for.

31:27 The very next

31:28 sentence reads

31:29 the same also

31:30 applies to

31:31 other mineral

31:33 acids.

31:33 Amicus Attorney Correct.

31:34 So,

31:34 for example,

31:35 if it was boron,

31:37 it would be

31:37 hydrochloric acid.

31:38 And so,

31:39 if it's an admixture,

31:42 in other words,

31:43 hydrochloric acid

31:43 is not an admixture,

31:44 it's gabapentin

31:46 hydrochloride.

31:47 And in the context

31:48 of the specification

31:49 we were on

31:50 was looking,

31:50 they're talking

31:51 about the particular

31:52 process that's

31:53 laid out

31:53 in this

31:57 you know,

31:58 they clearly make

31:58 gabapentin hydrochloric.

32:00 By the way,

32:00 just so we're clear,

32:01 bulk gabapentin,

32:02 you can't have

32:04 mineral acid

32:05 or hydrochloric acid

32:06 floating in this

32:07 gabapentin.

32:08 It's immediately

32:09 bound.

32:10 So,

32:11 you don't have

32:12 a mineral acid

32:12 floating there.

32:14 I think

32:15 I'm over

32:15 my two minutes.

32:16 Judge Lourie Thank you,

32:17 Bob.

32:17 Mr. Blumenthal,

32:20 how much

32:21 did he have

32:21 before?

32:22 He has

32:23 three minutes

32:24 to run.

32:26 So,

32:27 I think

32:28 he has

32:28 three minutes

32:29 to run.

32:29 Thank you.

32:30 Appellant Attorney I hope I won't

32:30 need it all.

32:32 I'd like to

32:33 start with

32:33 Mr. Lee's

32:34 first point

32:34 and it's the

32:35 only point

32:35 I'll make

32:36 on the

32:36 pH testing.

32:38 He said

32:38 that Teva's

32:39 own pH

32:39 testing

32:40 was too

32:40 imprecise.

32:42 But,

32:43 Teva's

32:44 pH test,

32:45 they were

32:45 qualitative.

32:46 Those are

32:47 the tests

32:47 that they used

32:48 with the FDA.

32:49 Once they had

32:50 their specification

32:51 set for

32:52 the amount

32:53 of

32:54 chloride ions,

32:56 they switched

32:57 and used

32:57 pH

32:58 with the FDA.

32:59 It was good enough

33:00 for them

33:01 to test their product

33:02 for patient use.

33:03 So,

33:03 to come in

33:04 and say

33:04 that Teva's

33:05 just unreliable,

33:06 it's all over

33:07 the place

33:07 when you've

33:08 used it

33:08 with the FDA,

33:09 I don't think

33:09 it really works.

33:10 On the

33:11 adjuvant issue,

33:15 it really,

33:19 what Judge

33:20 Lippland

33:21 found

33:21 was that

33:22 it had

33:22 to be

33:23 mixed

33:23 with the

33:23 gabapentin.

33:24 And I think

33:24 that is

33:25 consistent

33:25 with the

33:26 specification

33:27 and with

33:27 the file

33:27 history.

33:28 Because

33:29 when the

33:32 specification

33:32 talks

33:33 about

33:34 the

33:35 adjuvants

33:36 at the

33:36 bottom

33:37 column

33:42 of the

33:42 compositions,

33:43 it doesn't

33:44 ever talk

33:44 about adjuvants

33:45 in the

33:46 capsule shells

33:47 or in the

33:48 coatings.

33:48 There's not

33:49 a word

33:49 about that.

33:50 And when

33:50 you look

33:50 at Dr.

33:51 Tromlin's

33:51 declaration

33:52 which they

33:52 pointed to,

33:53 it's

33:54 an A659-660

33:55 of the

33:56 appendix,

33:57 he has

33:58 a footnote

33:58 in there

33:58 about the

33:59 things

33:59 that he's

34:00 added to

34:00 the

34:00 gabapentin

34:01 and it

34:01 says

34:02 excipient

34:03 mixed

34:03 with

34:03 gabapentin.

34:04 That's

34:05 what he was

34:05 talking about.

34:06 TIO2 is

34:06 on there.

34:07 He's

34:07 not

34:07 talking

34:08 about it

34:08 being

34:08 in the

34:09 capsule

34:09 shell,

34:09 he's

34:09 talking

34:10 about it

34:10 being

34:10 mixed

34:11 with

34:11 the

34:11 gabapentin.

34:12 And the

34:12 rest of

34:13 what Mr.

34:13 Lee

34:13 said

34:14 Dr.

34:14 Tromlin,

34:14 you're

34:14 Judge Moore suggesting

34:15 that the

34:15 judge's

34:16 claim

34:16 construction

34:16 below when

34:17 he said

34:18 intimately

34:18 mixed with

34:19 gabapentin

34:20 that requires

34:21 it to

34:21 be only

34:22 something

34:22 inside

34:22 the capsule

34:23 shell.

34:23 That's

34:24 the way

34:24 you understand

34:25 his claim

34:25 construction.

34:26 Appellant Attorney That's

34:26 the way

34:27 that I

34:28 understood

34:29 his claim

34:29 construction

34:30 that has

34:30 to be

34:30 mixed

34:31 with

34:31 the

34:32 gabapentin

34:32 itself.

34:33 Now,

34:34 the rest

34:35 of what

34:36 Mr.

34:36 Lee

34:36 was

34:36 arguing

34:36 sounded

34:37 to

34:37 me

34:38 not

34:38 like

34:38 claim

34:38 construction

34:39 but like

34:39 a fact

34:40 issue

34:41 that,

34:42 at least

34:43 after today,

34:43 he may

34:44 want to

34:44 raise if

34:44 we're

34:44 back on

34:45 remand as

34:45 to whether

34:46 things are

34:47 mixed with

34:48 the gabapentin

34:48 if they're

34:50 put in

34:50 the coating

34:51 of the

34:51 shell.

34:51 My

34:52 understanding

34:52 was that

34:52 that was

34:53 not the

34:53 claim

34:53 construction.

34:54 Can't

34:54 Judge Moore they mix

34:55 with the

34:55 gabapentin

34:55 during the

34:56 digestive process?

34:58 Appellant Attorney Well,

34:58 except that the

34:58 claims really

34:59 are directed

34:59 to the

35:00 stability

35:01 for a year

35:02 during storage.

35:03 That's

35:04 what the

35:04 claims talk

35:04 about,

35:05 not what

35:05 happens

35:05 in the

35:06 body,

35:06 and I

35:06 don't

35:06 think

35:07 that's

35:07 contested

35:07 by either

35:09 side.

35:10 On the

35:12 claim

35:12 construction

35:12 issue,

35:14 it does

35:15 say an

35:15 anion of

35:16 mineral acid,

35:17 and claim

35:17 11 says

35:18 where the

35:18 mineral acid

35:19 is hydrochloric

35:20 acid.

35:21 If they

35:21 intended to

35:22 say total

35:23 chloride,

35:24 why would

35:25 they have

35:25 a claim

35:26 that says

35:26 an anion

35:28 of hydrochloric

35:28 acid as

35:29 opposed to

35:29 just saying

35:30 chloride

35:31 anions?

35:33 I think

35:40 it's

35:40 a

35:40 proxy,

35:41 and you

35:41 have to

35:42 look at

35:42 what is

35:42 this patent

35:43 about.

35:43 This

35:44 patent

35:44 isn't

35:45 about

35:46 hydrochloric

35:47 acid

35:47 causing

35:47 formation.

35:53 That's

35:53 what

35:53 they're

35:53 trying

35:54 to

35:54 avoid.

35:54 There

35:55 are

35:55 three

35:56 declarations

35:56 in the

35:57 record

35:57 in prosecution

35:58 history,

35:58 one in

35:59 1993 from

36:00 Dr.

36:00 Herman,

36:01 one in

36:01 1996 from

36:02 Dr.

36:03 Gebhardt,

36:03 one in

36:03 1999 from

36:04 Dr.

36:05 Trondland.

36:05 Every

36:06 one of

36:06 them talks

36:07 about how

36:08 it's

36:08 the hydrochloric

36:09 acid that

36:10 causes the

36:11 instability,

36:11 it's

36:12 the hydrochloric

36:12 acid that

36:13 causes the

36:13 lactam

36:14 formation,

36:14 and that

36:15 you have

36:16 to keep

36:17 the

36:17 gabapentin

36:18 below 20

36:19 parts per

36:20 million of

36:20 hydrochloric

36:21 acid measured

36:22 by its

36:22 anion.

36:23 That's

36:23 what the

36:24 patent is

36:24 about,

36:25 and that's

36:25 what the

36:25 claims are

36:26 about,

36:26 that's

36:26 what the

36:26 specification

36:27 is about.

36:28 If you

36:28 look at

36:28 column 2

36:29 where it

36:30 talks

36:30 about how

36:30 to make

36:31 this,

36:31 it says you

36:33 add concentrated

36:34 mineral acid,

36:36 you create

36:36 gabapentin

36:37 hydrochloric,

36:38 then you put

36:38 it through

36:39 a process

36:39 to remove

36:40 the hydrochloric

36:41 acid.

36:41 That's what

36:42 was being

36:42 removed,

36:43 that's what

36:43 was causing

36:43 the problem,

36:44 that's what

36:45 the patent

36:45 is about.

36:46 Unless

36:47 the court

36:48 has further

36:48 questions,

36:49 that's all I

36:50 have.

36:50 Judge Lourie Thank you,

36:51 Mr. Blumenfeld.

36:52 Case will be

36:52 taken under

36:53 advisement.