[00:00:00] Speaker 00:
Janssen Pharmaceuticals Inc.

[00:00:01] Speaker 00:
versus Mylan Laboratories.

[00:00:04] Speaker 00:
Mr. Whirlinger.

[00:00:06] Speaker 04:
Good morning, your honor.

[00:00:06] Speaker 04:
May it please the court?

[00:00:09] Speaker 04:
This is an unprecedented case involving an unprecedented patent.

[00:00:13] Speaker 04:
The district court found that Mylan encourages infringement of Janssen's PP3M misdose regimen.

[00:00:20] Speaker 04:
which requires the patient to miss a dose in order to infringe.

[00:00:24] Speaker 03:
Can I ask you a kind of procedural question before we get down to the merits?

[00:00:28] Speaker 03:
I get the impression from your briefing that not only the drug at issue here, but also the indicated methods of using it are not patented.

[00:00:37] Speaker 03:
That is correct.

[00:00:38] Speaker 04:
And that is one of the primary issues we have in this case, that these products use a known drug

[00:00:46] Speaker 04:
in a known way for a known purpose.

[00:00:47] Speaker 03:
OK, so I guess if that's the case, then why couldn't you just sell the drug without the specific label recommending this reinstatement method?

[00:00:58] Speaker 04:
So is that why we didn't carve it out?

[00:01:01] Speaker 03:
Yeah.

[00:01:02] Speaker 04:
Out of the label.

[00:01:05] Speaker 04:
Yeah.

[00:01:05] Speaker 04:
So there's nothing about that in the record.

[00:01:07] Speaker 04:
And I think my candid response to you is we didn't think it was necessary to carve it out, because section 2.3 is not necessary for the indicated usage of the product.

[00:01:15] Speaker 04:
you can use the product when the product is used as prescribed and that includes the warning not to miss doses and to take the product exactly as your doctor tells you to.

[00:01:27] Speaker 04:
You're never going to get into section 2.3.

[00:01:29] Speaker 03:
And is it too late to do anything about that if you were to not prevail on this appeal?

[00:01:35] Speaker 04:
Interested no, I appreciate that my candid answer is I don't have an answer I'm unfortunately an appellate lawyer not an FDA regulatory lawyer, and it would be very dangerous for me to start speculating Well, that's what I'm asking you because I'm an appellate judge and not There's true interest in that you know maybe we can do a 28j or something, but that is far beyond my bailiwick

[00:01:56] Speaker 00:
But what I do know, Your Honor, is that there are striking parallels between... The label says if you miss a dosage, follow this protocol, right?

[00:02:04] Speaker 00:
It doesn't give you an optional protocol.

[00:02:07] Speaker 04:
So when you're talking about Section 2.3 itself, it is in direct language, but I think that if is very important, Judge Dyke, and I think that if is what brings us to HCMP.

[00:02:16] Speaker 04:
Because as I said, you have to miss a dose in order to infringe.

[00:02:20] Speaker 04:
Janssen admits that.

[00:02:22] Speaker 04:
Dr. Somi admits that.

[00:02:23] Speaker 04:
That's at appendix page 1992, lines 19 and 21.

[00:02:28] Speaker 04:
And if you'll indulge me, I think HCMP is very instructive.

[00:02:31] Speaker 04:
And I'd like to walk through the parallels between that case and this one.

[00:02:36] Speaker 04:
I am at 940 F3 at 701.

[00:02:40] Speaker 04:
This is the court addressing horizon-specific intent

[00:02:44] Speaker 04:
The court said Horizon maintains that activists' labeling tracks closely with the asserted claims, thereby reflecting activists' specific intent to induce infringement.

[00:02:53] Speaker 04:
That's Jansen's argument in this case.

[00:02:56] Speaker 04:
That's the red brief pages 12 and 26 through 28.

[00:03:00] Speaker 04:
That was the district court's holding, appendix pages 20 through 25.

[00:03:05] Speaker 04:
Continuing, the court said Although Horizon recognizes that not every user will need to apply sunscreen, insect repellent, or another topical medication,

[00:03:12] Speaker 04:
It contends that when such need arises, activist's instructions will lead to an infringing use.

[00:03:19] Speaker 03:
But the difference, and I think, maybe I don't remember everything in HCBMP, but here the claim here is already conditional.

[00:03:29] Speaker 03:
So you've got the claim that's already conditional.

[00:03:33] Speaker 03:
So I think that's somewhat different.

[00:03:36] Speaker 04:
The claim is, I guess I'm not entirely following, Your Honor.

[00:03:39] Speaker 04:
Is there a specific limitation that you're thinking is conditional that would distinguish this?

[00:03:43] Speaker 03:
Yeah.

[00:03:43] Speaker 03:
I mean, the claim says, if this, then this.

[00:03:47] Speaker 03:
So the claim is our, you know, the claim

[00:03:50] Speaker 03:
itself is conditional.

[00:03:51] Speaker 03:
Right.

[00:03:51] Speaker 04:
I don't know if, I don't recollect if the claim uses the word if, but it does, what it does say is that the patient misses a dose.

[00:03:58] Speaker 04:
That is very true, but I don't think that's any different than what you had in HCNP because the claim there required the person to apply the topical medication, wait, and then apply a sunscreen or an insect repellent or some other type of medication on top of it.

[00:04:17] Speaker 04:
And what this court said in HCNP is that

[00:04:19] Speaker 04:
You do not, the claimed method is not mandatory or required for the indicated usage of the product.

[00:04:28] Speaker 04:
It's merely permissive and for that reason there is no encouragement.

[00:04:32] Speaker 04:
You have the same thing here and in fact something more.

[00:04:35] Speaker 00:
I'm not following this.

[00:04:39] Speaker 00:
The label tells you don't miss dosages but it says if you do miss a dose, follow this protocol.

[00:04:44] Speaker 00:
Ryan?

[00:04:45] Speaker 04:
Correct.

[00:04:46] Speaker 04:
It does.

[00:04:46] Speaker 04:
And that's really not any different from the label that you had in HCMP.

[00:04:50] Speaker 03:
Well, the HCMP label didn't instruct the actual subsequent application of the sunscreen.

[00:04:58] Speaker 03:
It just said, it simply advised that if you are so inclined, wait first.

[00:05:04] Speaker 03:
So it was different than the instruction that we have in this claim.

[00:05:07] Speaker 03:
I mean, I think it's different.

[00:05:09] Speaker 04:
Sure.

[00:05:09] Speaker 04:
Well, I think it's different in the sense that

[00:05:12] Speaker 04:
in HZNP it was permissive, there was indifference as to whether or not you went on to the claimed method whereas here there's outright discouragement.

[00:05:22] Speaker 04:
Don't do it.

[00:05:23] Speaker 04:
But when you actually get into the instructions that you had in HZNP, wait until the area is completely dry before covering with sunscreen, applying insect repellent or covering.

[00:05:35] Speaker 04:
notion of waiting to apply that medication, that's not an if.

[00:05:45] Speaker 04:
It's if in the sense, if you're going to do it, follow this.

[00:05:49] Speaker 04:
It said it was an if-then instruction that is on page 702 of the court's opinion.

[00:05:54] Speaker 04:
And another extremely important aspect that the court pointed out in HCMP is substantial non-infringing uses.

[00:06:00] Speaker 04:
And here, if Mylan's products are used as they are instructed, you don't just have substantial non-infringing uses, you have complete non-infringing uses.

[00:06:10] Speaker 04:
And I think another notable aspect of this regimen is that in order to practice Claim 5, you actually have to have non-infringing use in the first instance.

[00:06:20] Speaker 04:
The patient has to be on the indicated PP3M therapy and then stop before you can even have infringement.

[00:06:32] Speaker 04:
So if I may, I'd like to briefly touch on inevitability and divided infringement before spending some time on obviousness, because I think there's some issues to talk about there.

[00:06:43] Speaker 03:
On inevitability, I really do just have three very... Can I ask you just about the use of the word inevitability?

[00:06:49] Speaker 03:
It was a little puzzling.

[00:06:50] Speaker 03:
Everybody used it, including the district court judge.

[00:06:52] Speaker 03:
But why are we so concerned about having to prove that the direct infringement was inevitable?

[00:06:59] Speaker 03:
I thought the standard was preponderance, more likely than not.

[00:07:03] Speaker 03:
So what in our case law requires inevitability?

[00:07:07] Speaker 04:
So inevitability was the theory that Janssen put forward in order to prove its burden

[00:07:14] Speaker 04:
And I think the reason we spoke of inevitability is because this is an Ash Waxman case.

[00:07:18] Speaker 04:
We're talking about a hypothetical infringement.

[00:07:20] Speaker 04:
And what they were trying to show is that based upon the label, if you were to put the drug on the market, it would inevitably lead to infringement.

[00:07:28] Speaker 04:
And I believe that is the language that the court used in Takeda and Vanda, which is where I think this is coming from.

[00:07:35] Speaker 04:
And my very brief points to you on this are that inevitable non-adherence, which was the main point that Jansen relied upon,

[00:07:42] Speaker 04:
does not amount to inevitable infringement because the patient still has to come back, they still have to come back within the window, and the provider still has to keep them on PP3M, and they still have to show up for all three dosages.

[00:07:55] Speaker 04:
Unless all of that happens, you don't have infringement, and Janssen has conceived that point.

[00:08:03] Speaker 04:
In the interest of time, I am actually going to rest on my briefs on divided infringement unless any of you have specific questions on that issue.

[00:08:10] Speaker 03:
Well, do you want to go to Dr. Kohler's testimony and your assertion about him with regard to infringement?

[00:08:17] Speaker 04:
Sure, I can briefly touch on that.

[00:08:18] Speaker 04:
I do think it's very well laid out in the briefs, but our point is that everybody agreed that Dr. Kohler's testimony was going to be limited to secondary consideration.

[00:08:26] Speaker 03:
No, it is well laid out in your brief.

[00:08:27] Speaker 03:
I appreciate that.

[00:08:28] Speaker 03:
I don't need the background.

[00:08:30] Speaker 03:
What I want to know is why the district court's got a footnote in a very thorough opinion in which she says she recognizes there's an issue with that, and she says there's other testimony as well, and she relies on the other testimony as well.

[00:08:45] Speaker 03:
So why isn't that effectively harmless error?

[00:08:49] Speaker 04:
Because the other testimony comes from Dr. Somi and Dr. Berger, and neither of them get Janssen to where they need to be in terms of showing inevitable completion of the practice, if this were to be put on the market.

[00:09:01] Speaker 00:
Your own expert testified that he supervised utilization of the protocol, right?

[00:09:10] Speaker 04:
Very important point here.

[00:09:11] Speaker 04:
He supervised an attempt of it.

[00:09:14] Speaker 04:
It failed.

[00:09:15] Speaker 04:
and the problem is you can't get a non-adherent patient to show back up for all three shots.

[00:09:21] Speaker 04:
The district court thought that attempting infringement was tantamount to infringement, and that's legal error.

[00:09:27] Speaker 04:
You have to practice all limitations, or in this case, you have to show that all limitations would inevitably be practiced.

[00:09:33] Speaker 00:
Did he testify that the protocol was not followed when he supervised it?

[00:09:38] Speaker 00:
Could you show me where he said that?

[00:09:40] Speaker 00:
He said that at...

[00:09:46] Speaker 04:
Appendix page 2160, and I believe this is lines 21 through 25.

[00:09:51] Speaker 04:
I believe his testimony was true.

[00:09:57] Speaker 03:
Sorry, 2160 or 2160?

[00:09:59] Speaker 04:
2160, yes.

[00:10:00] Speaker 04:
He testified.

[00:10:01] Speaker 04:
And even the district court recognized this point.

[00:10:05] Speaker 04:
She said, I'm not buying it.

[00:10:08] Speaker 04:
I still think the attempt is enough.

[00:10:09] Speaker 04:
But the district court recognized that that was his testimony.

[00:10:12] Speaker 00:
So 2160, where does he show that?

[00:10:15] Speaker 04:
What I have here on my outline is that it is on lines 21 through 25, Your Honor.

[00:10:24] Speaker 04:
And I regret I do not have that one in front of me, so I can't tell you precisely what it says as I stand here.

[00:10:28] Speaker 00:
He says they tried, but they were unsuccessful.

[00:10:32] Speaker 04:
Correct.

[00:10:33] Speaker 04:
They didn't complete it because the patient wouldn't show up for all the shots.

[00:10:36] Speaker 01:
How would the logistics go if we could we consider

[00:10:42] Speaker 01:
excluding the testimony of Dr. Kohler.

[00:10:45] Speaker 01:
And if we did, how would that affect the case?

[00:10:50] Speaker 04:
Sure.

[00:10:50] Speaker 04:
Well, I think our position is that the testimony of Dr. Somi and Dr. Berger is inadequate as a matter of law to satisfy the requirement of showing direct infringement by third actor.

[00:11:02] Speaker 04:
So in that sense, you could just reverse.

[00:11:04] Speaker 04:
I don't even think you need to fake it.

[00:11:05] Speaker 04:
But if there were some concern about doing that in the first instance, I think Fakature would also do it.

[00:11:10] Speaker 01:
Do we have the discretion to disregard, say, we're just going to disregard the testimony because the trial court erred in looking at it?

[00:11:18] Speaker 04:
I think you absolutely did, yes.

[00:11:21] Speaker 04:
So I am starting to get into my rebuttal time, but I do want to touch obviousness.

[00:11:24] Speaker 04:
And if I need to sacrifice some of my rebuttal time to do that, I will.

[00:11:28] Speaker 04:
Our point to you here is that the district court committed the exact same methodological errors that this court recently rejected in Janssen versus Teva, which involved Janssen's PP1M product and a number of the same lawyers that you have before you here today.

[00:11:43] Speaker 04:
And I want to highlight three of the specific errors the court committed that line up with Janssen versus Teva.

[00:11:49] Speaker 04:
And I'm looking specifically at paraphrasing 97F4 at 928.

[00:11:54] Speaker 04:
The first is that the district court tackled the prior

[00:11:59] Speaker 04:
one by one based upon differences in the individual references and claims, not considering the art as a whole.

[00:12:06] Speaker 04:
And this tainted the court's consideration of the PP1M art as it was applied to the PP3M art.

[00:12:12] Speaker 04:
You can see this specifically at appendix pages 43, 45, 52, and 60.

[00:12:17] Speaker 04:
Second major error is that the court failed to consider the perspective of the skilled artisan capable of deducing what references suggest or applying ordinary creativity.

[00:12:28] Speaker 04:
the district court reduced this down to an invocation of common sense, which it proceeded to reject.

[00:12:34] Speaker 04:
That is on appendix pages 43 through 44.

[00:12:37] Speaker 04:
And it discounted references, specifically the JAMA reference, due to the absence of safety or pharmacokinetic data, despite the fact that claim five is not limited by any such data.

[00:12:50] Speaker 04:
And you can see this at appendix pages 46, 50, and 59.

[00:12:56] Speaker 04:
These were not harmless errors.

[00:12:58] Speaker 04:
They impacted multiple issues, which we believe would have gone our way under the correct KSR rubric.

[00:13:05] Speaker 04:
This specifically goes to the structure of the PP3M MISTOS regimen, which is taught in the Sistina label.

[00:13:12] Speaker 04:
Again, the court

[00:13:14] Speaker 04:
pushed aside the ART based upon the fact that the PP1M ART did not involve PP3M.

[00:13:23] Speaker 04:
There's also the issue of using PP1M loading doses that is taught in the JAMA reference to use PP1M before initiating PP3M maintenance therapy.

[00:13:33] Speaker 04:
This was disregarded due to the errors related to pharmacokinetic data.

[00:13:37] Speaker 04:
Resuming maintenance therapy without first stabilizing, again, that is in PP1M.

[00:13:42] Speaker 04:
And then very briefly, the four to nine month window, we have an issue here where we had made a range argument, where we never even got a decision.

[00:13:51] Speaker 04:
Janssen admits that.

[00:13:52] Speaker 04:
They suggest that you can just deal with that as a matter of law.

[00:13:55] Speaker 04:
We've laid out in our briefs why you can't.

[00:13:57] Speaker 04:
We think on this issue alone, vacatur is required.

[00:14:00] Speaker 04:
Unless there are any further questions, I will reserve the remainder of my time for rebuttal.

[00:14:04] Speaker 00:
We'll give you two minutes.

[00:14:05] Speaker 04:
OK, I appreciate that, Judge.

[00:14:07] Speaker 00:
Thank you.

[00:14:20] Speaker 02:
Good morning, Your Honors.

[00:14:21] Speaker 02:
May it please the court?

[00:14:22] Speaker 02:
Aaron Fisher for Janssen.

[00:14:24] Speaker 03:
Are you enough of an FDA lawyer to answer the question I posed to your friend?

[00:14:28] Speaker 02:
I am not enough of an FDA lawyer to know whether it's possible.

[00:14:32] Speaker 03:
The question is if it's possible for Mylan to sell its product without the specific label language.

[00:14:38] Speaker 02:
What I know, and I agree with my friend, that there's no evidence in the record that they tried.

[00:14:44] Speaker 02:
There is, as Your Honors know,

[00:14:46] Speaker 02:
a provision of the Hatch-Waxman Act, Section 7, that allows a generic applicant to attempt to carve out a portion of a label to avoid a patent.

[00:14:58] Speaker 02:
And what the record shows is that was not attempted here.

[00:15:01] Speaker 00:
Could they still do it?

[00:15:03] Speaker 02:
That is beyond my knowledge of FDA procedure.

[00:15:09] Speaker 00:
Let's turn to the infringement question, and let's assume for the moment that the district court heard in relying on this infringement testimony by Dr. Culler, and that the Berger testimony is not sufficient.

[00:15:28] Speaker 00:
So that leaves you with a somni.

[00:15:31] Speaker 00:
Sommi testimony and I'm not sure that's sufficient.

[00:15:36] Speaker 00:
Could you please address that for us?

[00:15:39] Speaker 02:
Yes, I'll address Sommi, but I also want to come back to Berger because there was another passage.

[00:15:43] Speaker 00:
You can do that.

[00:15:44] Speaker 02:
Let's start with Sommi.

[00:15:45] Speaker 02:
With Sommi?

[00:15:46] Speaker 00:
It's not 1955.

[00:15:48] Speaker 02:
Appendix 1955.

[00:15:50] Speaker 02:
Dr. Somi testifies that he has provided guidance, and this is in the context early in his testimony, and we have it in the appendix.

[00:16:01] Speaker 02:
Dr. Somi testified at length about his credentials, and he is a board-certified psychiatric pharmacologist.

[00:16:11] Speaker 02:
who focuses on antiseptic medication, teaches medical residents, nurses, medical students.

[00:16:19] Speaker 00:
I understand that.

[00:16:20] Speaker 00:
But this is a complex protocol with a group of patients who are, by definition, noncompliant in the first place.

[00:16:30] Speaker 00:
And so it may be that you have to show that patients actually complied with this protocol and showed up.

[00:16:39] Speaker 00:
And I'm not sure

[00:16:40] Speaker 00:
that Dr. Somi is really saying that on 1955.

[00:16:46] Speaker 02:
Well, what he says is that in his experience, providing guidance to health care practitioners on what to do when patients have missed a dose of imbeded Trinza, we start with the label, we follow it.

[00:17:00] Speaker 02:
And the label as... Well, the practitioners may follow it.

[00:17:04] Speaker 00:
The question is whether the patients are compliant enough so that the protocol gets followed.

[00:17:10] Speaker 02:
Well, he said his testimony was it was followed.

[00:17:14] Speaker 02:
And then his testimony immediately after that is that I think most health care practitioners, at least that I work with, would start here and would end up following most patients.

[00:17:26] Speaker 02:
And then just sticking with Dr. Somi for a moment, as we know from Vanda, there is no requirement that there be

[00:17:34] Speaker 02:
a past example, there needs to be evidence that it would happen.

[00:17:38] Speaker 02:
And he did testify unequivocally that it would happen.

[00:17:42] Speaker 03:
And where are we in her opinion?

[00:17:44] Speaker 03:
Was she relied on that?

[00:17:45] Speaker 03:
I know she's talking about Dr. Kohler at 35.

[00:17:49] Speaker 02:
Right.

[00:17:49] Speaker 02:
She does not cite those portions of Dr. Stomey's transcript, which is why I wanted to go to a different portion of Dr. Berger that she did cite that was not addressed previously.

[00:17:59] Speaker 02:
And that is not 2160, but it's

[00:18:04] Speaker 02:
66 to 67, starting on 2166 at line 16.

[00:18:16] Speaker 02:
The question was, Dr. Berger, some health care providers do follow label instructions for patients who have missed a dose of PP3N by 49 months, right?

[00:18:24] Speaker 02:
Answer, I'm sure they try.

[00:18:25] Speaker 02:
And you're sure they do, right?

[00:18:26] Speaker 02:
No.

[00:18:27] Speaker 02:
Well, when you say they try, they administer the doses called for by the claim, correct?

[00:18:33] Speaker 02:
I'm sure there are instances in which they try, but if the patient doesn't show up, the regimen cannot be implemented.

[00:18:38] Speaker 02:
Over to the next page.

[00:18:40] Speaker 02:
Sometimes the patients will show up, right?

[00:18:43] Speaker 02:
Sometimes the patients show up, yes.

[00:18:45] Speaker 02:
And that specific testimony over to this next page was cited by the district court at appendix 36.

[00:18:53] Speaker 03:
And I would submit... Well, except can we keep going?

[00:18:56] Speaker 03:
On that, sometimes the patients will show up right.

[00:18:59] Speaker 03:
Sometimes patients show up, yes.

[00:19:01] Speaker 03:
And sometimes the patient will be in a facility where they don't have to show up because they're already there, right?

[00:19:07] Speaker 03:
Answer.

[00:19:07] Speaker 03:
That sometimes happens, yes.

[00:19:09] Speaker 03:
But even in that case, the patient may still refuse it.

[00:19:14] Speaker 02:
So that question went to the fact

[00:19:16] Speaker 02:
Dr. Berger's testimony was that if they don't show up, they won't get the regimen.

[00:19:20] Speaker 02:
Sometimes they're in a hospital, so they don't need to show up.

[00:19:23] Speaker 02:
And he acknowledged that.

[00:19:24] Speaker 02:
But in that situation, they may still refuse it.

[00:19:27] Speaker 02:
But what that goes to is that it's not going to happen all the time.

[00:19:31] Speaker 02:
Nothing in Dr. Berger's testimony establishes that it will never happen.

[00:19:37] Speaker 00:
What he says was- Well, the burden's on you, not on mine.

[00:19:41] Speaker 02:
Well, Dr. Berger testified that the situation is common.

[00:19:47] Speaker 02:
that in his own experience, his residents try to follow the label, and that if you can't do it, if the patient doesn't show up, you can't do it, and sometimes the patient shows up.

[00:19:58] Speaker 02:
And the district court found as fact that it is not credible in light of that, that it would never happen.

[00:20:06] Speaker 02:
Because again, any amount of infringement counts as infringement.

[00:20:11] Speaker 01:
The records closed, and then Dr. Kohler's testimony is introduced, right?

[00:20:17] Speaker 01:
The record was not closed.

[00:20:19] Speaker 01:
It was a bench trial.

[00:20:20] Speaker 01:
So there was no closure of the record.

[00:20:22] Speaker 01:
OK.

[00:20:23] Speaker 01:
But his testimony was introduced for secondary consideration, right?

[00:20:28] Speaker 01:
Yes.

[00:20:29] Speaker 01:
Dr. Kohler was testified on secondary consideration.

[00:20:31] Speaker 01:
And it was introduced by way of deposition?

[00:20:33] Speaker 01:
Is that how it was introduced?

[00:20:34] Speaker 02:
No, he testified live at trial.

[00:20:37] Speaker 02:
And to be clear about Dr. Kohler's testimony, he was testifying that it was the main issue

[00:20:43] Speaker 02:
for secondary considerations was whether there was a nexus between the claims and the benefits of the product.

[00:20:49] Speaker 01:
What I wanted to get at is, did appellant's lawyer get the opportunity to cross-examine him?

[00:20:56] Speaker 01:
I'm sure there was questioning about secondary considerations.

[00:20:59] Speaker 01:
But did he get to cross-examine him on the issue that's in front of us, which is induced infringement?

[00:21:04] Speaker 02:
They did get the opportunity to cross-examine him.

[00:21:07] Speaker 02:
And in fact, they elicited the testimony that he follows the label.

[00:21:12] Speaker 02:
Appendix 3067.

[00:21:13] Speaker 03:
Well, wait a minute.

[00:21:15] Speaker 03:
Wasn't there even a dust-up there?

[00:21:17] Speaker 03:
I think this is in the district court's opinion, where she concedes that they tried to cross-examine him on infringement, and you all objected to that.

[00:21:27] Speaker 02:
They tried to.

[00:21:29] Speaker 02:
We objected to different issues of infringement.

[00:21:31] Speaker 02:
Nobody ever objected to his testimony about whether he practiced this patent.

[00:21:38] Speaker 00:
But he was admitted for a limited purpose, right?

[00:21:41] Speaker 02:
He was a secondary considerations expert.

[00:21:44] Speaker 02:
He never disclosed an infringement opinion.

[00:21:46] Speaker 02:
But he did disclose the opinion that he had practiced this claim.

[00:21:51] Speaker 02:
That was disclosed in his expert report.

[00:21:53] Speaker 02:
He was deposed on it.

[00:21:55] Speaker 02:
There was even an eliminate motion about it that was dropped.

[00:21:59] Speaker 02:
So the fact that Dr. Kohler was going to show up and testify that he had used this claim was well known to everyone and was not a surprise.

[00:22:06] Speaker 00:
Where does he say that in his expert report?

[00:22:10] Speaker 02:
His expert report is not in the appendix.

[00:22:13] Speaker 02:
But it was at page 73 of his expert report.

[00:22:17] Speaker 02:
We can provide that to you.

[00:22:18] Speaker 02:
But again, he was deposed on that.

[00:22:21] Speaker 00:
Is that in the record before the district court?

[00:22:24] Speaker 02:
It's in the record before the district court.

[00:22:26] Speaker 02:
And not only did he testify that he had used it,

[00:22:30] Speaker 02:
He testified that three of his colleagues had used it.

[00:22:33] Speaker 02:
And then there was an eliminate dispute about whether those colleagues were going to be deposed or not.

[00:22:37] Speaker 02:
And there was an agreement that we just wouldn't talk about the colleagues.

[00:22:40] Speaker 02:
We'd only talk about Dr. Kohler's experience.

[00:22:43] Speaker 02:
So there was no surprise.

[00:22:44] Speaker 00:
Was it at that point after the expert report that there was an agreement that he'd only testify about secondary considerations?

[00:22:51] Speaker 02:
There was never such an agreement.

[00:22:52] Speaker 02:
He was only disclosed for secondary considerations.

[00:22:55] Speaker 02:
We did not present him as an infringement expert.

[00:22:57] Speaker 02:
But, and even today... Well, tell me if I'm wrong.

[00:23:01] Speaker 03:
This is what I glean from the record and the briefs that they cite in blue, 44.

[00:23:07] Speaker 03:
Numerous examples were you objected to questions on cross-examination with regard to infringement.

[00:23:15] Speaker 03:
And there appear to be infringement and cross-examination, not what Dr. Kohler testified about.

[00:23:23] Speaker 03:
I maintain my objection.

[00:23:24] Speaker 03:
It goes to infringement.

[00:23:25] Speaker 03:
It's irrelevant to the point the issues Dr. Kohler testified to on direct.

[00:23:31] Speaker 03:
And indeed, at one point you told the district court, so both parties have objected to using testimony elicited in the secondary consideration contest for purposes of infringement.

[00:23:42] Speaker 03:
I think it's pretty clear.

[00:23:43] Speaker 02:
Yes, it's clear that we objected to certain questions that went to infringement, not including the question of whether Dr. Kohler used this method, because that went to secondary considerations.

[00:23:55] Speaker 02:
And nobody

[00:23:56] Speaker 00:
But they were objecting to that, right?

[00:23:58] Speaker 02:
They did not object to that particular testimony.

[00:24:02] Speaker 00:
I mean, there was a whole objection to the line of questioning, right?

[00:24:05] Speaker 02:
Well, he was asked to respond directly to Berger on certain issues, and they objected to that.

[00:24:10] Speaker 02:
But on the basic question of, did Dr. Kohler practice this claim, that was unobjectable.

[00:24:18] Speaker 02:
On appeal, they're not arguing that that was objectionable testimony, that it was not properly disclosed, or that it was inadmissible.

[00:24:25] Speaker 02:
Their argument is, because it was admitted for secondary considerations, the district court can't look to it on the question of whether or not this claim has ever been practiced.

[00:24:35] Speaker 02:
But the district court can look to any evidence in the record on a fact issue that's raised.

[00:24:40] Speaker 00:
But again, we- Well, not if the testimony is admitted only for a limited purpose.

[00:24:45] Speaker 02:
Well, the testimony, it was not admitted only for a limited purpose.

[00:24:50] Speaker 02:
Like any expert, he disclosed certain opinions.

[00:24:54] Speaker 02:
We did not argue that he was an infringement expert, and we still don't argue he was an infringement expert.

[00:25:00] Speaker 02:
But he was an expert who gave admissible testimony that is in the record that if a fact issue is placed at issue,

[00:25:10] Speaker 02:
can be looked at.

[00:25:10] Speaker 02:
There's no requirement that the fact issue cannot be looked at because it was admitted for a different purpose.

[00:25:17] Speaker 02:
But I would go back to emphasize that there is more than enough evidence in this record of direct infringement without Dr. Kohler's testimony.

[00:25:27] Speaker 02:
Because essentially, Mylon's argument is the district court was required to credit Dr. Berger, who said that this would never happen, even though he actually said it might happen sometimes.

[00:25:38] Speaker 02:
He was impeached.

[00:25:40] Speaker 02:
from his cross-examination, his deposition testimony.

[00:25:43] Speaker 02:
His deposition testimony was that his residents had just used it.

[00:25:48] Speaker 02:
He didn't say anything about them failing.

[00:25:52] Speaker 02:
So he didn't say anything in his deposition about his residents failing.

[00:25:58] Speaker 02:
At some point between his deposition and trial, he recalled that they had failed.

[00:26:04] Speaker 02:
And he clarified that at trial.

[00:26:07] Speaker 02:
And the district court was not required

[00:26:10] Speaker 02:
to credit Dr. Berger's testimony.

[00:26:12] Speaker 00:
Did she discredit him on that?

[00:26:14] Speaker 00:
She did.

[00:26:14] Speaker 02:
Where did she do that?

[00:26:16] Speaker 02:
At Appendix 36.

[00:26:19] Speaker 02:
She said, the court simply cannot credit Dr. Berger's testimony that not a single HCP would use the claimed re-initiation dosing regimen.

[00:26:34] Speaker 02:
And that's immediately after quoting

[00:26:37] Speaker 02:
or citing the testimony that I referred to earlier, where he said, sometimes patients do come back.

[00:26:45] Speaker 02:
So this is a fact finding by the district court based on credibility determinations and the record.

[00:26:53] Speaker 02:
And it's extremely commonsensical, because Dr. Berger was suggesting, or Mylan was suggesting, that everybody who ever tried to use this method would fail.

[00:27:05] Speaker 02:
That was not credible.

[00:27:07] Speaker 02:
As Dr. Berger said, sometimes they would succeed.

[00:27:11] Speaker 02:
Perhaps they would fail sometimes, but sometimes they would succeed.

[00:27:15] Speaker 00:
And she did not rely on Dr. Somi's testimony?

[00:27:20] Speaker 02:
Well, she didn't cite Dr. Somi for this point.

[00:27:23] Speaker 02:
She did credit Dr. Somi's testimony in general on induced infringement.

[00:27:28] Speaker 02:
She did not cite the specific passages on direct infringement.

[00:27:32] Speaker 02:
And the reason for that is that Mylan was making an issue of this.

[00:27:35] Speaker 02:
And so she was responding to Mylan's arguments.

[00:27:36] Speaker 03:
Can I just ask you, on page 36, the last sentence of the second full paragraph,

[00:27:42] Speaker 03:
What does she mean by that?

[00:27:43] Speaker 03:
In other words, a patient's inevitable return between four and nine months after misdose is that it is inevitable that an HCP would at least attempt the claim reinitiation regime.

[00:27:57] Speaker 03:
Is an attempt sufficient?

[00:28:00] Speaker 02:
No, an attempt is not sufficient.

[00:28:02] Speaker 03:
Doesn't it sound like she thinks it may be?

[00:28:04] Speaker 02:
Well, I would read that in the context of the testimony that she just cited where Berger conceded

[00:28:11] Speaker 02:
that an attempt will sometimes succeed.

[00:28:17] Speaker 00:
Well, it depends how you read the testimony.

[00:28:19] Speaker 02:
And again, that's also an even if, right?

[00:28:22] Speaker 02:
The first sentence of that paragraph is, I simply cannot credit Dr. Berger's testimony that are not... The burden's on you, right?

[00:28:30] Speaker 02:
Well, the burden is on us, but we can rely on Dr. Berger's evidence.

[00:28:34] Speaker 02:
And Dr. Berger's evidence was this.

[00:28:36] Speaker 00:
Well, she doesn't rely on Dr. Berger's testimony.

[00:28:39] Speaker 02:
She does.

[00:28:39] Speaker 02:
In footnote 14, on appendix 35 of footnote 14, she says, as an initial matter, the court notes that its direct infringement findings do not hinge solely on Kohler's testimony.

[00:28:51] Speaker 02:
There's other evidence in the record, including Dr. Berger's testimony of inevitable infringement.

[00:28:57] Speaker 02:
So she affirmatively relies on testimony.

[00:28:59] Speaker 02:
And that's appropriate, because Dr. Berger testified that this is a common occurrence, that patients return within this window, that in his own experience, his residents have tried to do it, and that sometimes that will work.

[00:29:14] Speaker 02:
So that testimony is very clear that there will sometimes be infringement.

[00:29:21] Speaker 02:
Maybe sometimes it won't work, but sometimes it will.

[00:29:23] Speaker 02:
And for infringement, we don't have to show that it works 100% of the time as a district court note.

[00:29:28] Speaker 03:
By the way, speaking of that, when I asked your friend about the use of inevitability, is that just a standard we use in Hatch-Waxman?

[00:29:37] Speaker 03:
Because it's not the preponderance standard.

[00:29:39] Speaker 02:
Well, I think because in Hatch-Waxman we don't have to show an actual act of infringement, we have to show

[00:29:47] Speaker 02:
that there will be a future act of infringement.

[00:29:49] Speaker 02:
So inevitability is the standard?

[00:29:51] Speaker 02:
The case law talks about inevitability.

[00:29:53] Speaker 02:
I don't think whether it's preponderant.

[00:29:56] Speaker 02:
I think we have to show by preponderance of the evidence that there will be infringement.

[00:30:01] Speaker 03:
OK.

[00:30:01] Speaker 03:
Hypothetically, if somehow we were to think that this was relevant and important, what would we do with that?

[00:30:09] Speaker 03:
What would we do with the finding of the lack of sufficiency of the finding of infringement?

[00:30:13] Speaker 03:
Is it a reversal or a remand?

[00:30:18] Speaker 02:
Well, if you were to find that her credibility determination as to Dr. Berger was not supported, I suppose it would be a remand.

[00:30:29] Speaker 02:
because she certainly had, I guess it would depend on how you, what your basis was for it, but I don't see.

[00:30:37] Speaker 03:
Okay, before your time runs out, can I just ask you to address two points that your friend made?

[00:30:41] Speaker 03:
One, starting with the HCNP case and why that's not compelling or controlling, and the other is to just respond to the points he made about obviousness at the end.

[00:30:53] Speaker 02:
So HCNP, the folding of the HCNP was,

[00:30:59] Speaker 02:
And this is at page 702.

[00:31:02] Speaker 02:
The instructions in Actavis's label only require the first step of the method, nothing else.

[00:31:10] Speaker 02:
So only the first step was induced.

[00:31:13] Speaker 02:
The other step was not required.

[00:31:15] Speaker 02:
In our label, all steps are required.

[00:31:18] Speaker 02:
It says, use the reinitiation regimen in table two.

[00:31:23] Speaker 02:
And table two includes the entire dosing regimen.

[00:31:28] Speaker 02:
So here, all steps are required in the clinical situation that's presented by the claim.

[00:31:37] Speaker 02:
With respect to obviousness, I think the most important point is that a fair reading of the district court's opinion makes clear that there is no narrow reading of prior art references.

[00:31:54] Speaker 02:
To the contrary, the Hartford analysis

[00:31:58] Speaker 02:
is to look in great detail at Mylan's evidence about what a person of skill in the art would have done with the prior art and how they would have attempted to extrapolate it.

[00:32:09] Speaker 02:
And she spent 12 pages of her analysis from 45 to 57 going into great detail about Dr. Forrest's opinions and why they were hindsight driven and not credible.

[00:32:21] Speaker 02:
But she did not narrowly read the documents, the prior art references.

[00:32:27] Speaker 02:
Her finding was entirely based on her assessment of Myelin's presentation of how a person of ordinary skill in the art would have allegedly found this obvious.

[00:32:39] Speaker 02:
And she considered it carefully and rejected it.

[00:32:41] Speaker 02:
So that analysis is not, in any sense, a narrow reading of the prior references.

[00:32:49] Speaker 02:
The actual language of the prior references doesn't figure very prominently in that analysis.

[00:32:55] Speaker 02:
It's all about what Dr. Forrest said.

[00:32:57] Speaker 02:
I'm well over my time, Your Honor.

[00:32:59] Speaker 03:
Can I ask one more question?

[00:33:01] Speaker 03:
Okay.

[00:33:01] Speaker 03:
Just on the obviousness thing, as I understood and outlined it, they make two arguments.

[00:33:06] Speaker 03:
One, the general PP1 versus to PP2 dosing regimen, and the other is a little more complicated.

[00:33:12] Speaker 03:
That was four to nine months.

[00:33:14] Speaker 03:
My understanding is if we agree with

[00:33:17] Speaker 03:
one of those, for example the first, the second doesn't matter, that agreeing to the first ground would be sufficient to sustain the non-obviousness.

[00:33:27] Speaker 03:
Is that right?

[00:33:28] Speaker 02:
Yes, yes, because they have to show the claim is a whole obvious, so if any portion of it is not obvious, then they haven't met their burden.

[00:33:38] Speaker 02:
Okay, thank you.

[00:33:39] Speaker 02:
Thank you.

[00:33:39] Speaker 02:
Thank you.

[00:33:44] Speaker 00:
Mr. Werlinger, you have two minutes.

[00:33:49] Speaker 04:
I want to come right to Dr. Kohler.

[00:33:51] Speaker 04:
As my friend conceded, he was not offered as an infringement expert.

[00:33:54] Speaker 04:
He did not issue an expert report on this point, and we all agree that his testimony was going to be limited to secondary considerations of obviousness.

[00:34:03] Speaker 04:
We tailor our cross-examination based upon that agreement.

[00:34:07] Speaker 04:
The questions we did not ask based upon that concession, based upon that agreement, are just as important as the ones we did ask and were stopped from proceeding due to Janssen's objections, which y'all pointed out.

[00:34:20] Speaker 04:
So if you knock him out, all you have left is Dr. Berger and Dr. Sohn.

[00:34:23] Speaker 04:
I'm going to start with Dr. Berger.

[00:34:25] Speaker 04:
He only testified that people might try the method.

[00:34:30] Speaker 00:
And as my... You seem to say that sometimes they succeeded.

[00:34:34] Speaker 04:
It's a little unclear.

[00:34:36] Speaker 04:
No, I don't think so, Your Honor.

[00:34:38] Speaker 04:
He did say that there is no point where he said

[00:34:42] Speaker 04:
that any of his residents had ever succeeded in bringing it to completion.

[00:34:46] Speaker 04:
And even the district court recognized that on page 35 of his decision, which is why the district court had to hold that an attempt was enough for infringement.

[00:34:57] Speaker 04:
And as my friend conceded, as a matter of law, attempting infringement is not the same thing as infringing.

[00:35:03] Speaker 04:
I want to use my remaining time to quickly come back to obviousness.

[00:35:07] Speaker 04:
I disagree with my friend's characterization of how the district court treated the prior art, and I specifically want to point to page 45, where the court was addressing Dr. Forrest's use of the PP1M art.

[00:35:21] Speaker 04:
She rejected it because, quote, none reference PP3M.

[00:35:25] Speaker 04:
Rather, the thrust of the testimony is that PP1M art could be extrapolated to determine the asserted claims PP3M initiating dosing regimen.

[00:35:34] Speaker 04:
She rejected that proposition and discounted all of the PP1M art because of that.

[00:35:40] Speaker 04:
That is error.

[00:35:41] Speaker 04:
That is what this court rejected in Janssen versus Teva.

[00:35:44] Speaker 04:
And it also rejected the basic proposition previously in Valiant versus Milam, where you said you could look at substantially similar compounds under the KSR analysis.

[00:35:56] Speaker 04:
Is there anyone for questions?

[00:35:58] Speaker 00:
Thank you.

[00:35:58] Speaker 00:
Thank you.