[00:00:00] Speaker 02:
Observant among you will notice that there are only two of us.

[00:00:04] Speaker 02:
Judge Stone was stranded by weather out of town, but she will hear the recording of the argument and be a full participant in the case.

[00:00:17] Speaker 02:
So we will proceed.

[00:00:19] Speaker 02:
This is Brigham and Women's Hospital versus Perigo, 2017, 1950.

[00:00:24] Speaker 02:
Mr. Gargano.

[00:00:27] Speaker 01:
Thank you, Your Honor.

[00:00:36] Speaker 01:
Good morning and may it please the court.

[00:00:38] Speaker 01:
There are two issues that I'd like to talk about on appeal today.

[00:00:41] Speaker 01:
The first is the district court's grant of judgment as a matter of law that Parigo's Fomota Dean Complete product did not infringe claims of the 137 patent.

[00:00:52] Speaker 01:
And then the second issue is the district court's denial of judgment as a matter of law that the asserted claims are invalid for either anticipation or obviousness.

[00:01:02] Speaker 00:
Just ask about your jurisdictional question.

[00:01:05] Speaker 01:
Yes.

[00:01:05] Speaker 00:
Even if I were to agree with you that at the motions panel stage there were mistakes made, once it went back, what could we do about that?

[00:01:17] Speaker 00:
Isn't that law the case?

[00:01:20] Speaker 01:
Well, we agree that there is no jurisdictional issue.

[00:01:24] Speaker 01:
We agree that at the time

[00:01:27] Speaker 01:
the December order was entered, there were still outstanding issues.

[00:01:32] Speaker 01:
And that outstanding issue was primarily the enhancement of damages issue.

[00:01:36] Speaker 01:
And that's what the panel, that's what the- Why does that reopen everything?

[00:01:39] Speaker 00:
I mean, the trial court said that the J-Mall motions were untimely filed, right?

[00:01:45] Speaker 01:
The district court did say that, correct.

[00:01:47] Speaker 00:
Right.

[00:01:47] Speaker 00:
So we effectively set aside that conclusion and told her to decide the J-Mall motions, even though that appeal was never briefed or decided by a panel.

[00:01:59] Speaker 01:
It was decided by a panel, Your Honor.

[00:02:01] Speaker 01:
There was an initial motion to dismiss this appeal.

[00:02:05] Speaker 00:
Right, I saw that.

[00:02:06] Speaker 01:
That was decided by Judge Wallach.

[00:02:08] Speaker 00:
And in response to the motion for reconsideration, the argument was made, well, we have the second appeal that sort of reactivates things.

[00:02:18] Speaker 00:
But why wasn't that second appeal?

[00:02:21] Speaker 00:
Wouldn't that have been limited to, A, was she wrong about the untimeliness of the Jamal motions?

[00:02:27] Speaker 00:
And B, was she wrong to deny the extension of your right to appeal?

[00:02:32] Speaker 00:
And then C, was she wrong about the enhancement?

[00:02:35] Speaker 01:
Right.

[00:02:35] Speaker 01:
Well, because this court found that she was not correct in dismissing or ruling that our motions were untimely.

[00:02:46] Speaker 01:
So that set aside everything.

[00:02:48] Speaker 00:
Where did we make that finding?

[00:02:49] Speaker 01:
You made that finding in a panel decision, I believe that was in June of 2017.

[00:02:58] Speaker 01:
It's an issued opinion.

[00:02:59] Speaker 00:
No, we just said that it wasn't a final judgment when it came up.

[00:03:05] Speaker 00:
And so we deactivated the appeals.

[00:03:08] Speaker 00:
Where did we say her ruling with respect to timeliness of the JMO violence was wrong?

[00:03:14] Speaker 01:
That was in the June decision.

[00:03:16] Speaker 01:
That was in the June decision.

[00:03:18] Speaker 01:
that her ruling on timeliness was, was wrong because the December order was not a final opinion because the enhancement of damages issues as it relates to the right to appeal, the right to appeal.

[00:03:33] Speaker 01:
And then, and then there was a, a, a, another order entered by the district court.

[00:03:40] Speaker 01:
And we timely appealed from that.

[00:03:43] Speaker 01:
That was her, that was her April, her April decision, the judge's April decision.

[00:03:50] Speaker 00:
All right, go ahead.

[00:03:53] Speaker 01:
Okay.

[00:03:53] Speaker 01:
Now, should this court affirm the non-infringement finding, the court does not need to address all the other issues in this case because the patent in this case has expired.

[00:04:02] Speaker 01:
However, should this court disagree with the infringement finding, then you need to turn.

[00:04:06] Speaker 02:
Are there no pending further litigation on this patent?

[00:04:11] Speaker 01:
No, there isn't, Your Honor.

[00:04:12] Speaker 01:
And there are no further applications or patents pending it as well.

[00:04:17] Speaker 00:
So even though you filed a counterclaim and are pressed for declaratory judgment, you are waiving that?

[00:04:24] Speaker 00:
In other words, you're saying if we agree that there's no infringement, you don't want us to decide the validity question.

[00:04:30] Speaker 01:
That's correct.

[00:04:31] Speaker 01:
I mean, it does not have any real impact because the patent is expired.

[00:04:36] Speaker 00:
But in that case, though, if we're not deciding that question, we would have to vacate the invalidity finding, right?

[00:04:45] Speaker 01:
That's correct.

[00:04:45] Speaker 01:
That's correct.

[00:04:46] Speaker 00:
OK.

[00:04:47] Speaker 01:
I'm going to address the invalidity issues first.

[00:04:51] Speaker 01:
I've set aside four minutes for this, because that's the subject of our appeal.

[00:04:56] Speaker 01:
And I'll reserve my time, of course.

[00:04:58] Speaker 01:
If you have questions on either infringement or invalidity, I'll take those at any time.

[00:05:03] Speaker 01:
I'd like to raise three quick points on invalidity.

[00:05:06] Speaker 01:
With respect to both anticipation and obviousness, the prior art need not show symptom relief data.

[00:05:14] Speaker 01:
And the symptom relief data in this case are the five

[00:05:17] Speaker 01:
immediate and sustained relief or as we refer to them in our briefs as ISR limitations.

[00:05:23] Speaker 01:
They don't need to disclose that to invalidate the claims.

[00:05:26] Speaker 01:
Instead, the claims are invalid if the prior art teaches effective amounts of the H2 blockers and N acids that would provide the immediate and sustained relief.

[00:05:40] Speaker 01:
The second point is the claims are obvious because the prior art in this case does not teach a way from combining

[00:05:47] Speaker 01:
and acids in H2 blockers to treat episodic heartburn.

[00:05:51] Speaker 01:
And the third issue on invalidity is that Perigo would be at least entitled to a new trial on the question of anticipation by Davis, because the jury failed to address this in the first instance.

[00:06:04] Speaker 00:
What?

[00:06:05] Speaker 00:
All right.

[00:06:07] Speaker 00:
So putting aside the corroboration issue, which we can still address, but if Davis is prior

[00:06:14] Speaker 00:
Why shouldn't we read the Court's judgment to say that no reasonable jury could conclude that Davis anticipates?

[00:06:24] Speaker 01:
And that the reason, Your Honor, is that both parties submitted evidence on Davis and then it went to the jury.

[00:06:31] Speaker 01:
The jury then found that the patent was entitled to an earlier priority date, which the district court then overruled.

[00:06:39] Speaker 01:
So the record is full of evidence.

[00:06:42] Speaker 01:
to show that no reasonable juror could have found that Davis does not anticipate the claims of the 137 patent.

[00:06:51] Speaker 01:
So the record is already fully developed on Davis.

[00:06:55] Speaker 01:
And we submit that the record is such that no reasonable juror could come back and find that Davis does not anticipate the claims of the 137 patent.

[00:07:08] Speaker 00:
But that's different from saying it should have gone to the jury.

[00:07:13] Speaker 01:
Correct.

[00:07:13] Speaker 01:
That is different than saying it should have gone to the jury.

[00:07:15] Speaker 00:
So what you're saying is, to the extent that the judge is ruling, was that even if Davis is prior art, it shouldn't go to the jury because no reasonable jury can conclude that that's wrong.

[00:07:27] Speaker 01:
Correct.

[00:07:30] Speaker 01:
Now, turning to the issue of immediate and sustained relief in the prior art,

[00:07:37] Speaker 01:
This Court's decisions make it clear that merely discovering and claiming the results of known methods of treatment directed to the same condition are not patent.

[00:07:49] Speaker 01:
That's clear.

[00:07:50] Speaker 01:
And those cases are cited in our briefs at pages 46 to 47 and 51 through 52 in our opening brief.

[00:07:58] Speaker 01:
And here, the 137 patent claims the single step of orally administering antacids in H2 blockers

[00:08:06] Speaker 01:
in effective amounts to treat episodic heartburn and to provide immediate and sustained relief.

[00:08:12] Speaker 01:
And the 137 patent explicitly discloses that certain dosages of antacids and H2 blockers will actually provide that immediate and sustained relief.

[00:08:22] Speaker 01:
When you look at the prior art, these references teach co-administering antacids and H2 blockers, and they also teach overlapping dosage amounts

[00:08:33] Speaker 01:
or the same or similar dosage amounts as those disclosed in the 1 through 7 patent as providing immediate and sustained relief.

[00:08:42] Speaker 01:
The prior art provides these overlapping or similar ranges of active ingredients used in the same method of treating the same disease.

[00:08:50] Speaker 01:
That renders the claims invalid.

[00:08:54] Speaker 01:
Now, BWH argues that this position is somehow irreconcilable with

[00:08:59] Speaker 01:
a position on non-infringement, and that's simply not the case.

[00:09:02] Speaker 00:
It is just the opposite, right?

[00:09:05] Speaker 02:
I'm sorry.

[00:09:05] Speaker 02:
Are you arguing inherency or just result of known steps?

[00:09:11] Speaker 01:
Yes.

[00:09:12] Speaker 01:
So for anticipation, we're arguing inherency.

[00:09:15] Speaker 01:
And that was clear at the district court level.

[00:09:17] Speaker 01:
It's not a new argument, as BWH contends.

[00:09:19] Speaker 01:
The jury was actually charged on inherency.

[00:09:24] Speaker 01:
With respect to obviousness, we're asking the court to follow its decisions

[00:09:28] Speaker 01:
in the Alcon Research case, the Richardson-Vicks case, the Novo Nordis case, which says, look, if you have a known method of treating a known disease and you claim a result, it's not patentable that the result that, it's not patentable to simply claim the result.

[00:09:48] Speaker 01:
And in this case, the method that is taught in 137 patents simply orally administering H2 blockers

[00:09:58] Speaker 01:
and antacids in effective amounts.

[00:10:00] Speaker 01:
That was squarely in the prior art.

[00:10:02] Speaker 00:
But didn't you argue just the opposite with respect to infringement?

[00:10:05] Speaker 01:
Well, the difference here, Your Honor, is with respect to infringement... So your answer is yes, but you're going to explain why.

[00:10:10] Speaker 01:
Yes, I'm going to explain why.

[00:10:11] Speaker 01:
And the reason why it's different on infringement is that the accused product had different dosage amounts than the prior art.

[00:10:18] Speaker 01:
The prior art has dosage amounts that overlap and are the exact same as those in the 137 patent.

[00:10:24] Speaker 01:
With respect to the accused product,

[00:10:26] Speaker 01:
much lower dosage amounts.

[00:10:28] Speaker 01:
The dosage amounts of antacids are much lower.

[00:10:31] Speaker 01:
And, in fact, famotidine, or the H2 blocker dosage amount, there's not even a disclosure in the 137 patent about what that should be.

[00:10:40] Speaker 01:
So you can't just simply rely on effective dosage amounts with respect to the accused product.

[00:10:47] Speaker 01:
You can rely on that with respect to the prior art.

[00:10:51] Speaker 01:
I see I'm well into my rebuttal time.

[00:10:54] Speaker 02:
All right, we'll save it for you.

[00:10:55] Speaker 01:
Thank you.

[00:10:56] Speaker 02:
Are you intending to save any amount, any time for a cross-appeal?

[00:11:06] Speaker 03:
Yes, I'm going to start with ten minutes and then five minutes for rebuttal.

[00:11:10] Speaker 02:
Is that okay?

[00:11:12] Speaker 02:
Rebuttal only in the cross-appeal.

[00:11:15] Speaker 03:
That's correct.

[00:11:17] Speaker 03:
May it please the Court?

[00:11:19] Speaker 03:
I'd like to talk about infringement first.

[00:11:22] Speaker 03:
In particular, the

[00:11:24] Speaker 03:
And the fact that the jury verdict in this case found infringement, willful infringement, and ruled for that verdict was taken away on the basis that the district court believed that the immediate relief required by the claim had not been demonstrated for the accused formulation.

[00:11:45] Speaker 03:
And that's not the case.

[00:11:46] Speaker 03:
The evidence on this was extensive.

[00:11:49] Speaker 03:
And the district court, in reviewing it,

[00:11:51] Speaker 03:
only looked at a part of it.

[00:11:53] Speaker 03:
And so I'd like to go through that evidence quickly and identify a couple things.

[00:11:58] Speaker 02:
But I just wanted to... The accused formulation had an antacid in it.

[00:12:02] Speaker 02:
How could it not be providing immediate release?

[00:12:05] Speaker 03:
That's absolutely correct.

[00:12:07] Speaker 03:
And in fact, during the trial, that was a undisputed issue.

[00:12:13] Speaker 03:
In fact, their testimony at trial on invalidity was directed specifically to claiming that

[00:12:20] Speaker 03:
every N-acid shown in the prior art provided immediate relief.

[00:12:26] Speaker 03:
And the statement by my colleague today where that there was a difference in dosage in the accused products as compared to the prior art is the very first time that issue has been raised as a non-infringement position, as you'll see in the briefs and the trial record below.

[00:12:44] Speaker 03:
The reality is that when you look at figure seven from the NDA, it shows a pH drop, I'm sorry, pH increase of two orders of magnitude within two minutes.

[00:12:57] Speaker 03:
And it, but more importantly, it also shows that the pH of the composition, the accused formulation was the same, performed the same as an acid, demonstrating that

[00:13:11] Speaker 03:
the equivalence between those two, an exact match.

[00:13:15] Speaker 03:
In addition to that evidence, we submitted evidence from two tests, 110 and 127, that demonstrated that within the first 15 minutes of dosing, the largest portion of the test clinical patients received adequate relief that was discarded during the JMAW process as a different parameter.

[00:13:39] Speaker 03:
It is a different parameter.

[00:13:41] Speaker 03:
then what the claim calls for, which is onset of relief, onset relief actually is undisputed, occurs before adequate relief.

[00:13:48] Speaker 03:
And in fact, Pat talks about a significant period of time between those two events.

[00:13:53] Speaker 03:
So when you show adequate relief, substantial adequate relief after 15 minutes, it's reasonable for the jury to infer onset of relief within the about five to 10 minutes of the claim.

[00:14:05] Speaker 03:
As I said, everybody in the courtroom during the trial understood that

[00:14:10] Speaker 03:
provide immediate relief.

[00:14:12] Speaker 03:
That was the testimony of their witnesses.

[00:14:14] Speaker 03:
That was the testimony of our witnesses.

[00:14:16] Speaker 03:
In addition, I'd like to.

[00:14:18] Speaker 00:
But was there ever any testimony from your expert or otherwise that the relief would fall within the 5 to 10 minutes?

[00:14:27] Speaker 03:
Yes, there was.

[00:14:29] Speaker 03:
Who?

[00:14:29] Speaker 03:
Dr. Wolf testified to that effect.

[00:14:32] Speaker 03:
And it's at A-7859.

[00:14:38] Speaker 03:
And he's talking about figure seven.

[00:14:40] Speaker 03:
He says the bold dash line, which is at the two-minute mark, refers to the an acid in each preparation, whether it's fact, which is the combination therapy, or an acid alone.

[00:14:51] Speaker 03:
The increase in pH occurs very quickly.

[00:14:55] Speaker 03:
So therefore, the onset of relief would occur around that time.

[00:14:59] Speaker 03:
And that's that two-minute mark.

[00:15:01] Speaker 00:
But I thought on cross-examination he conceded that there's not an exact correlation between

[00:15:09] Speaker 00:
in acid reduction and relief?

[00:15:11] Speaker 00:
And that's a different question.

[00:15:14] Speaker 03:
What he did say is that pain relief is a more complicated subject.

[00:15:19] Speaker 03:
And clearly, full adequate relief, as described in the patent, takes longer than the about to 5 to 10 minutes.

[00:15:26] Speaker 03:
And you'll see actually in the Purdue decision that's cited in the briefs, they talk about onset of relief being a more standardized way of looking at these types of phenomena in medical treatment.

[00:15:38] Speaker 03:
And that's a case involving painkillers.

[00:15:41] Speaker 03:
But the onset of relief, when he said that it was a more subtle point for full relief, that's true.

[00:15:50] Speaker 03:
But onset of relief here, I think the evidence was rather conclusive.

[00:15:54] Speaker 03:
Dr. Byrne testified to that effect also, that the evidence demonstrated that onset of relief occurred within the first 5 to 10 minutes.

[00:16:02] Speaker 02:
Regarding validity, opposing counsel says

[00:16:07] Speaker 02:
that this is a method of providing immediate and sustained relief by orally administering a compound that provides immediate relief and another one that provides sustained relief, and the rest of it is all surplusage.

[00:16:21] Speaker 02:
It's all a result.

[00:16:23] Speaker 02:
It's all the inherent result of what you get from administering these two compounds.

[00:16:29] Speaker 03:
I'd like to, and that's their position.

[00:16:34] Speaker 03:
Quite frankly, the claim is more complex than that.

[00:16:37] Speaker 02:
And isn't it anticipated by Davis?

[00:16:42] Speaker 03:
No, no.

[00:16:43] Speaker 03:
And the reason it's not anticipated by Davis on the merits is that Davis doesn't disclose anything about treating episodic heartburn, which is a method of treatment.

[00:16:53] Speaker 03:
And the Perricone case makes clear that even if you had a known compound, but if it's for a new treatment, that's patentable.

[00:17:02] Speaker 03:
Perricone says that.

[00:17:04] Speaker 03:
So it's not just claiming the result, because episodic heartburn was a defined term in this case.

[00:17:10] Speaker 03:
Their expert that presented this to the jury testified that heartburn is heartburn.

[00:17:15] Speaker 03:
It doesn't matter.

[00:17:16] Speaker 03:
But the court's definition on this is quite clear.

[00:17:18] Speaker 03:
Episodic heartburn excludes disease states.

[00:17:23] Speaker 03:
And therefore, that's what Davis is all about, disease states.

[00:17:27] Speaker 03:
And therefore, it doesn't disclose it.

[00:17:29] Speaker 03:
But there's other reasons Davis doesn't anticipate it.

[00:17:32] Speaker 03:
The second reason is that

[00:17:34] Speaker 03:
It doesn't disclose the treatment as needed, which is in nursing vernacular PRN, where you treat against symptoms.

[00:17:43] Speaker 03:
Davis doesn't disclose any treatment regimen whatsoever, so it doesn't provide that capability.

[00:17:51] Speaker 03:
Davis does not include any teaching that would capture the notion of relief that is what's called sustained relief, which would last just as long or longer.

[00:18:03] Speaker 03:
Which is what the surprising synergy here is that we are better discovered.

[00:18:08] Speaker 02:
Davis discloses treating symptoms of excess stomach acidity.

[00:18:13] Speaker 03:
Yes.

[00:18:13] Speaker 02:
Which an antacid would do.

[00:18:16] Speaker 03:
Yes.

[00:18:17] Speaker 02:
And with an H2 antagonist, which Priorat shows, provides sustained relief.

[00:18:26] Speaker 03:
It does not.

[00:18:27] Speaker 03:
The Priorat, as antagonist is this incredible drug, very successful.

[00:18:32] Speaker 03:
People looked at it closely for decades to see what they could do with it.

[00:18:37] Speaker 03:
And it was tested routinely with antacids and proven over and over again that when you simultaneously dose with an antacid, the absorption of the tagamate drops substantially.

[00:18:48] Speaker 03:
40% is that what Dr. Steinberg said.

[00:18:51] Speaker 03:
That's classically teaching away.

[00:18:53] Speaker 02:
But there are references that show no interference.

[00:18:57] Speaker 03:
Not no interference.

[00:18:58] Speaker 03:
I disagree with that.

[00:19:00] Speaker 03:
less interference, Don and Dessinger.

[00:19:04] Speaker 03:
But Dessinger shows 30% drop with another compound called nizotidine.

[00:19:09] Speaker 03:
Don shows 10% drop with rinitidine, which is what I think Dessinger shows.

[00:19:14] Speaker 03:
But what you see uniformly through all the publications from during this entire relevant time period up through the mid-90s is that everybody talks about the absorption problem.

[00:19:27] Speaker 03:
The France patent that they cited against us says, we have a solution, granulation.

[00:19:31] Speaker 03:
The Davis patent says, yes, here's this big problem.

[00:19:34] Speaker 03:
We have a solution, control the pH around the parietal cell.

[00:19:37] Speaker 03:
They're all proposed solutions, but they're all proposed solutions for the specific treatment of serious ulcer disease.

[00:19:47] Speaker 03:
Not one of them talked about, well, why don't we try something that actually might be useful for people who are suffering this very mild discomfort associated with

[00:19:56] Speaker 03:
what we call dietary indiscretions, the wrong food before, you know, at dinner.

[00:20:02] Speaker 03:
And that's what Dr. Wolff discovered, is that when you use this medicine in that combination for episodic heartburn, in the ratios that he identified, and he was able to demonstrate that you extended the relief from the H2 as opposed to... But there are two issues I'd like to jump on.

[00:20:23] Speaker 03:
One is the invention date.

[00:20:25] Speaker 03:
Because

[00:20:26] Speaker 03:
Quite frankly, Davis isn't even prior art.

[00:20:29] Speaker 03:
And the record shows pretty clearly that the Davis reference is was after the published, well after Dr. Wolff's work.

[00:20:43] Speaker 03:
Wolff, Dr. Wolff testified a corroboration was dictated to the jury.

[00:20:47] Speaker 03:
The jury found corroboration and found that the invention date was earlier than Davis.

[00:20:51] Speaker 03:
It was premised on evidence of his own work.

[00:20:56] Speaker 03:
his recordings of the clinical studies by the patients themselves who collected it, and also the information that's found in the patent, published, I mean, filed four months later, which included a recitation of those same examples that are found in his notebook, confirming the accuracy of those.

[00:21:13] Speaker 02:
And then finally... Is that an unwitnessed notebook?

[00:21:17] Speaker 03:
It's an unwitnessed notebook.

[00:21:20] Speaker 03:
It fit the definition of that was the jury instruction to the jury on corroborating evidence, a document or testimony of another with personal knowledge.

[00:21:33] Speaker 03:
And so the instruction on that was clear.

[00:21:36] Speaker 00:
Unlike the Procter & Gamble case, we're not just talking about a page or two from a notebook.

[00:21:41] Speaker 03:
No.

[00:21:41] Speaker 00:
We're talking about the entirety of his life.

[00:21:42] Speaker 03:
The entire record of his clinical studies and the analysis.

[00:21:47] Speaker 03:
And then he went out afterwards and he got affidavits from them.

[00:21:50] Speaker 03:
And he said, could you confirm what took place with those clinicals, the dates and everything?

[00:21:54] Speaker 03:
They signed them, notarized them, submitted them.

[00:21:56] Speaker 03:
They weren't entered, but they were discussed.

[00:21:58] Speaker 03:
The other reason Davis shouldn't be considered is because this inherency argument never presented to the jury.

[00:22:04] Speaker 03:
And they shouldn't be entitled to present brand new arguments for the first time on appeal.

[00:22:10] Speaker 03:
The whole comparison to the 137 patent that's in their brief never presented to the jury.

[00:22:15] Speaker 03:
The jury had no information about that.

[00:22:17] Speaker 03:
Now, can I just spend a minute or two on obviousness, or I could address more?

[00:22:21] Speaker 02:
You have almost four minutes to use.

[00:22:24] Speaker 03:
I'll just use, I have to address the obviousness argument, because the obviousness, I have two words for obviousness, gird and concomitant.

[00:22:38] Speaker 03:
Their theory of obviousness was predicated on the PDR being combined with these other references.

[00:22:44] Speaker 03:
And the PDR, their argument was, and their expert testify says,

[00:22:47] Speaker 03:
It's GERD.

[00:22:49] Speaker 03:
It discloses the use of these medicines for GERD.

[00:22:51] Speaker 03:
And that's the same as episodic heartburn.

[00:22:54] Speaker 03:
But the definition of episodic heartburn clearly precludes that.

[00:22:57] Speaker 03:
GERD was a disease.

[00:22:59] Speaker 03:
Episodic heartburn is a painful condition associated with non-disease state.

[00:23:05] Speaker 03:
The other aspect of it was concomit.

[00:23:09] Speaker 03:
That's a word that I just heard for the first time in this case.

[00:23:13] Speaker 03:
They argued.

[00:23:14] Speaker 02:
I mean, it might even be concomitant.

[00:23:16] Speaker 03:
Concomitant would probably be better.

[00:23:18] Speaker 03:
They said it means simultaneous.

[00:23:21] Speaker 03:
They argued to the jury, simultaneous.

[00:23:23] Speaker 03:
But if you read the PDR antagonist, it clearly says concomitant use of antacids is fine.

[00:23:29] Speaker 03:
Simultaneous should be avoided.

[00:23:32] Speaker 03:
And their witness, their expert, had to concede that that demonstrated that there was no

[00:23:39] Speaker 03:
They were not synonymous, and therefore the PDR doesn't support the obvious in this case.

[00:23:44] Speaker 03:
Clearly, the unexpected results here were substantial.

[00:23:48] Speaker 03:
The whole industry knew you couldn't combine these things.

[00:23:51] Speaker 03:
There's never been a successful drug based on the combination of H2 with an an acid for ulcer treatment.

[00:24:01] Speaker 03:
The only successful one is the one that Dr. Wolf developed.

[00:24:03] Speaker 03:
Thank you, and I'll reserve the rest time.

[00:24:09] Speaker 01:
I'd like to address the infringement or non-infringement issues, Your Honor.

[00:24:15] Speaker 00:
Can I first ask a question about inherency?

[00:24:18] Speaker 00:
As high as I might, I could not find you making that argument to the jury.

[00:24:22] Speaker 01:
So we made the argument through the expert, Dr. Tornay, who argued that, or not argued, who testified that the effect, the amounts of antacid and H2 blockers in all the prior, Davis,

[00:24:37] Speaker 01:
de Seger and the Don reference, which are largely the three primary references.

[00:24:42] Speaker 01:
He testified that those were effective amounts and that's how we know we would get immediate and sustained relief.

[00:24:48] Speaker 01:
That was his testimony.

[00:24:49] Speaker 01:
And they never contested that at trial.

[00:24:54] Speaker 01:
Their position was the prior art doesn't disclose any symptom relief data, therefore it can't anticipate or it can't render the claims obvious.

[00:25:02] Speaker 01:
They never addressed

[00:25:03] Speaker 01:
the dosage amounts.

[00:25:04] Speaker 00:
But that's the exact same argument you made on the other side in infringement.

[00:25:08] Speaker 00:
You can't infringe because there's no symptom relief data.

[00:25:11] Speaker 01:
That's exactly right.

[00:25:13] Speaker 00:
But you don't need symptom relief data if you want to prove it.

[00:25:16] Speaker 01:
And the reason for that is the case law on obviousness and anticipated, you still have to have immediate and sustained relief.

[00:25:26] Speaker 01:
It's how you go about showing it.

[00:25:28] Speaker 01:
For invalidity, you can show it by pointing to the effective amounts that overlap with the ranges in the 137 patent, and that's exactly what we did at trial.

[00:25:38] Speaker 01:
With respect to infringement, you can show it in a number of different ways.

[00:25:41] Speaker 01:
The way they should have done it was actually take our product and test it, but they never did that.

[00:25:45] Speaker 01:
I suspect they didn't do that because the dosage amounts were so low, they knew they would not get immediate and sustained relief.

[00:25:51] Speaker 01:
So what they did is they tried to do it through some third-party product.

[00:25:55] Speaker 01:
The problem was the third-party product did not have in the NDA the same parameters of the claim limitations in the 137 patent.

[00:26:03] Speaker 01:
And I think more importantly, Dr. Wolf admitted that immediate and sustained relief, when you read the claim, you need to have all five components of immediate and sustained relief must be felt by the person who takes the drug.

[00:26:17] Speaker 01:
And Dr. Wolf admitted on cross-examination

[00:26:20] Speaker 01:
that there was no evidence of any one patient in either Pepsib completes NDA or in Paragos A NDA that that one person got all five components.

[00:26:32] Speaker 01:
That admission is critical.

[00:26:34] Speaker 01:
That admission is not infringement.

[00:26:37] Speaker 01:
And following this Court's cases from Johns Hopkins, the Qualcomm, Parker-Vision v. Qualcomm case, and the Smith v. Garlock case, that was exactly enough

[00:26:49] Speaker 01:
for the district court to overturn the jury verdict.

[00:26:51] Speaker 01:
Now, the district court actually went in and looked at the evidence that they submitted, BWH.

[00:26:56] Speaker 01:
They looked at study 98.

[00:26:58] Speaker 01:
And study 98, study 98 measured esophageal pH.

[00:27:06] Speaker 01:
It didn't study heartburn relief.

[00:27:08] Speaker 01:
And more importantly, there's no evidence that those patients were suffering from heartburn during the 5 to 10 minutes.

[00:27:14] Speaker 01:
Here's what the FDA said about study 98.

[00:27:17] Speaker 01:
And this is in the record.

[00:27:19] Speaker 01:
at 7046, and this is a quote, neither the occurrence nor the severity of heartburn or other symptoms were recorded, and no analyses were done to correlate those observations with the pH recordings.

[00:27:35] Speaker 01:
In other words, simply because they had some pH readings and they were graphed, the FDA said that doesn't supplement or take the place of

[00:27:45] Speaker 01:
actually testing it to see whether or not you get immediate relief within 5 to 10 minutes.

[00:27:50] Speaker 01:
And that's what the district court relied on in granting Jamal.

[00:27:54] Speaker 01:
And then with respect to the symptom relief studies that my colleague referred to, protocols 110 and 127, again, he said that they measured relief within the first 15 minutes.

[00:28:06] Speaker 01:
Not true.

[00:28:07] Speaker 01:
The first measurement was done at 15 minutes, and it measured adequate relief.

[00:28:13] Speaker 01:
And Dr. Wolf, their expert, admitted on cross-examination that adequate relief is not analogous to the immediate relief in the 137 patent.

[00:28:23] Speaker 01:
And he specifically stated its onset versus adequate relief, different parameters.

[00:28:29] Speaker 01:
And that's in the record at page 7, 8, 4, 6.

[00:28:33] Speaker 00:
And that's exactly what the district... But it wasn't, I mean, clearly we've got adequate relief that was measured by clinical studies.

[00:28:41] Speaker 00:
And why isn't the reduction, the pH reduction in acid enough to allow the jury to conclude that the relief started sooner?

[00:28:54] Speaker 01:
Because there was no link between the adequate relief at 15 minutes and the pH.

[00:29:01] Speaker 01:
Those were two separate studies, and Dr. Wolf did not bridge the gap.

[00:29:05] Speaker 01:
He did not say that the pH study in 98

[00:29:09] Speaker 01:
tells me that those who get adequate relief at 15 minutes would get it earlier, and this means within 5 to 10 minutes.

[00:29:17] Speaker 01:
And there was no doctrine of equivalence issue in this case.

[00:29:19] Speaker 01:
They waived doctrine of equivalence.

[00:29:21] Speaker 01:
There was simply nothing to fill that gap.

[00:29:24] Speaker 01:
And I understand that adequate relief at 15 minutes might seem close to getting relief within about 5 to 10 minutes, but they have to show that they get relief within 5 to 10 minutes, and they fail to do so.

[00:29:37] Speaker 02:
Thank you, counsel.

[00:29:39] Speaker 01:
Thank you, Your Honor.

[00:29:40] Speaker 02:
Mr. Bolger has a little more than two minutes on the cross appeal.

[00:29:44] Speaker 03:
Thank you very much.

[00:29:49] Speaker 03:
The statement that the quote from the FDA that was just read into the record, if you look at the entire quote at the beginning, it says it's talking about something called rescue myelanta, which was used during the test protocol.

[00:30:03] Speaker 03:
And that was during when patients would suffer

[00:30:07] Speaker 03:
during in-between sessions, they would take Rescue Mylanta, which is an antacid, and that quote has to do with the fact that it wasn't recorded, and therefore that undermined that particular part of the study.

[00:30:18] Speaker 03:
It did not in any way affect the table, I'm sorry, the Figure 7 data, which goes to the pH drop within two minutes and the logical conclusion.

[00:30:28] Speaker 03:
Now remember, this is a JMAW motion.

[00:30:31] Speaker 03:
The verdict came in on infringement.

[00:30:34] Speaker 03:
The standard on this is that

[00:30:36] Speaker 03:
We get all the inferences to our favor, reasonable inferences.

[00:30:41] Speaker 03:
It's clearly a reasonable inference to have the jury conclude based on data that's collected at the 15-minute mark for what transpired in the first 15 minutes as reflecting immediate relief within that time period.

[00:30:55] Speaker 03:
Specifically, on the, the court also granted a provisional new trial.

[00:31:03] Speaker 03:
We believe that was a mistake because the

[00:31:06] Speaker 03:
evidence on this was all one-sided.

[00:31:08] Speaker 03:
We've put in all the evidence.

[00:31:10] Speaker 03:
They had no rebuttal.

[00:31:11] Speaker 03:
They didn't have a witness get up there and say, it's not immediate.

[00:31:14] Speaker 03:
They didn't have a witness who in any way contested any of the evidence that we presented on this.

[00:31:19] Speaker 03:
And therefore, there's no need to do a retrial if the court agrees with us that the JMAW was improvidently granted.

[00:31:26] Speaker 03:
And the First Circuit law on this indicates that there's less deference.

[00:31:31] Speaker 03:
So it's abusive discretion standard.

[00:31:33] Speaker 03:
But it is less deference to that.

[00:31:35] Speaker 03:
And here, in their reply brief, they didn't even oppose that aspect of it, the great weight of the evidence prong of a new trial.

[00:31:44] Speaker 03:
They said that there was prejudice, and there was clearly no prejudice in this regard.

[00:31:49] Speaker 03:
That's the rest of my time.

[00:31:50] Speaker 03:
If you have any questions, I would be glad to try to address them.

[00:31:55] Speaker 02:
Thank you.

[00:31:56] Speaker 02:
No questions?

[00:31:56] Speaker 03:
Thank you, Your Honor.