Case 1:20-cv-01630-RGA-JLH Document 85 Filed 10/20/21 Page 1 of 83 PageID #: 1391
`1
`
`IN THE UNITED STATES DISTRICT COURT
` FOR THE DISTRICT OF DELAWARE
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`)
`AMARIN PHARMA, INC., AMARIN
`PHARMACEUTICALS IRELAND LIMITED,)
`MOCHIDA PHARMACEUTICAL CO.,
`)
`LTD.,
`)
`
`
`)
`
`)
`Plaintiffs,
`
`) C.A. No. 20-1630-RGA-JLH
`v.
`
`
`)
`
`)
`
`HIKMA PHARMACEUTICALS USA INC., )
`HIKMA PHARMACEUTICALS PLC, AND )
`HEALTH NET, LLC,
`)
`)
`
`
`
`
`
`
`) J
`
`. Caleb Boggs Courthouse
`844 North King Street
`Wilmington, Delaware
`Thursday, October 14, 2021
`10:00 a.m.
`Oral Argument
`
`Defendants.
`
`BEFORE: THE HONORABLE RICHARD G. ANDREWS, U.S.D.C.J.
`
`APPEARANCES:
`
`FISH & RICHARDSON P.C.
`BY: JEREMY D. ANDERSON, ESQUIRE
`-and-
`BY: MICHAEL J. KANE, ESQUIRE
`(Minneapolis, MN)
`
`
`For the Plaintiffs
`
`
`
`
`
`
`1
`
`IN THE UNITED STATES DISTRICT COURT
` FOR THE DISTRICT OF DELAWARE
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`)
`AMARIN PHARMA, INC., AMARIN
`PHARMACEUTICALS IRELAND LIMITED,)
`MOCHIDA PHARMACEUTICAL CO.,
`)
`LTD.,
`)
`
`
`)
`
`)
`Plaintiffs,
`
`) C.A. No. 20-1630-RGA-JLH
`v.
`
`
`)
`
`)
`
`HIKMA PHARMACEUTICALS USA INC., )
`HIKMA PHARMACEUTICALS PLC, AND )
`HEALTH NET, LLC,
`)
`)
`
`
`
`
`
`
`) J
`
`. Caleb Boggs Courthouse
`844 North King Street
`Wilmington, Delaware
`Thursday, October 14, 2021
`10:00 a.m.
`Oral Argument
`
`Defendants.
`
`BEFORE: THE HONORABLE RICHARD G. ANDREWS, U.S.D.C.J.
`
`APPEARANCES:
`
`FISH & RICHARDSON P.C.
`BY: JEREMY D. ANDERSON, ESQUIRE
`-and-
`BY: MICHAEL J. KANE, ESQUIRE
`(Minneapolis, MN)
`
`
`For the Plaintiffs
`
`
`
`
`
`
`
`Case 1:20-cv-01630-RGA-JLH Document 85 Filed 10/20/21 Page 2 of 83 PageID #: 1392
`2
`
`
`
`
`APPEARANCES CONTINUED:
`HEYMAN ENERIO GATTUSO & HIRZEL LLP
`BY: DOMINICK GATTUSO, ESQUIRE
`-and-
`WINSTON & STRAWN LLP
`BY: CHARLES B. KLEIN, ESQUIRE
`For the Defendants Hikma
`Pharmaceuticals USA Inc. and
`Hikma Pharmaceuticals PLC
`PHILLIPS McLAUGHLIN & HALL
`BY: DAVID A. BILSON, ESQUIRE
`-and-
`HUSCH BLACKWELL
`BY: DON J. MIZERK, ESQUIRE
`For the Defendant
`Health Net, LLC
`
`
`
`*** PROCEEDINGS ***
`
`DEPUTY CLERK: All rise. Court is now in
`session. The Honorable Richard G. Andrews presiding.
`THE COURT: All right. Please be seated. If
`you're fully vaccinated and you want to, you can take your
`mask off.
`
`All right. So this is the motions to dismiss in
`Amarin vs. Hikma and Health Net.
`And for Amarin, for the Plaintiff, who's here?
`MR. ANDERSON: Good morning, Your Honor. Jeremy
`Anderson from Fish & Richardson on behalf of the Plaintiffs,
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`10:05:48
`
`10:05:48
`
`10:05:50
`
`10:05:57
`
`10:06:01
`
`10:06:04
`
`10:06:09
`
`10:06:16
`
`10:06:18
`
`10:06:21
`
`10:06:27
`
`
`
`Case 1:20-cv-01630-RGA-JLH Document 85 Filed 10/20/21 Page 3 of 83 PageID #: 1393
`3
`
`Amarin Pharma, Inc, Amarin Pharmaceuticals Ireland Limited,
`and Mochida Pharmaceutical Company Limited. And with me
`today is my colleague from our Twin Cities' office, Mike
`Kane.
`
`10:06:32
`
`10:06:32
`
`10:06:36
`
`10:06:40
`
`And Your Honor, we also have our clients here
`today. Mr. Jason Marks, general counsel, and Barbara Kurys
`is the Vice President of IP.
`THE COURT: All right. Thank you, Mr. Anderson.
`All right. And for the Defendant, Hikma?
`MR. GATTUSO: Good morning, Your Honor.
`Dominick Gattuso from Heyman Enerio Gattuso & Hirzel on
`behalf of Hikma. I have with me Charles Klein from
`Winston & Strawn who will be arguing on behalf of Hikma.
`And then I also have U.S. general counsel, Sam Park.
`Thank you, Your Honor.
`THE COURT: For a minute -- you said U.S.
`general counsel, I'm like, wait, the Government is here? I
`understand that you mean the general counsel for the U.S.
`part of Hikma.
`MR. GATTUSO: Yes, Your Honor.
`THE COURT: Okay. All right.
`And for Health Net?
`MR. BILSON: Good morning, Your Honor. David
`Bilson of Phillips McLaughlin & Hall. With me in the
`courtroom is Don Mizerk of Husch Blackwell for Health Net.
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`10:06:41
`
`10:06:43
`
`10:06:49
`
`10:06:50
`
`10:06:53
`
`10:06:55
`
`10:06:57
`
`10:07:00
`
`10:07:04
`
`10:07:06
`
`10:07:11
`
`10:07:13
`
`10:07:15
`
`10:07:18
`
`10:07:21
`
`10:07:22
`
`10:07:23
`
`10:07:24
`
`10:07:26
`
`10:07:31
`
`10:07:33
`
`
`
`Case 1:20-cv-01630-RGA-JLH Document 85 Filed 10/20/21 Page 4 of 83 PageID #: 1394
`4
`
`THE COURT: All right. Thank you.
`All right. Why don't we do this, why don't we
`have the motion to dismiss by Hikma first because that's the
`reason why I scheduled the argument in the first place. And
`then when we're done with that, we'll have the Health Net
`motion to dismiss which I expect to be pretty brief.
`All right. So Mr. Klein.
`MR. KLEIN: Good morning, Your Honor. It's nice
`to be back in court. I'd like to start with a high
`level that is probably clear and obvious to Your Honor, but
`it's, nonetheless, very important. And the point is that
`this is a test case. This --
`THE COURT: Well, so you can never be too sure
`about what's clear and obvious, but I did notice that there
`was an Amicus brief filed which, in my world, is not
`something that happens very often. And so, as I did see
`through the periodicals that I get that GSK vs. Teva was
`subject to a request for en banc hearing. Now, most every
`patent case is the subject of a request for en banc
`rehearing because the loser always thinks that they should
`have won.
`
`10:07:37
`
`10:07:40
`
`10:07:42
`
`10:07:47
`
`10:07:50
`
`10:07:55
`
`10:07:58
`
`10:08:06
`
`10:08:11
`
`10:08:20
`
`10:08:23
`
`10:08:26
`
`10:08:29
`
`10:08:34
`
`10:08:38
`
`10:08:42
`
`10:08:47
`
`10:08:53
`
`10:08:58
`
`10:09:01
`
`10:09:03
`
`10:09:05
`
`10:09:08
`
`10:09:13
`
`10:09:17
`
`But it struck me that there was a better than
`usual chance -- of course, the usual chance is in a
`.5 percent, but there was a better than usual chance that
`there might be further proceedings in the Court of Appeals
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`Case 1:20-cv-01630-RGA-JLH Document 85 Filed 10/20/21 Page 5 of 83 PageID #: 1395
`5
`
`
`on this case.
`Do I assume or do you know, are all kinds of
`people filing the Amicus briefs in regards to that case?
`MR. KLEIN: I imagine that will happen. I don't
`think it's happened yet. It might be too early. But as
`Your Honor probably knows, this is the second petition for
`rehearing. There was an initial petition.
`THE COURT: Well, no. I've got them both here.
`I know there's two versions of the opinion --
`MR. KLEIN: Correct.
`THE COURT: -- or I mean of the panel opinion
`with -- and that the second one came a long time after the
`first one, I think. Yeah. So I understand it's a point of
`hot dispute.
`MR. KLEIN: Okay. I can represent that AAM will
`be filing an Amicus in that case as well.
`THE COURT: Okay. I'm not sure who AAM is.
`MR. KLEIN: Oh, that's the Association for
`Accessible Medicines, the Generic Pharmaceutical
`Association.
`
`THE COURT: And they're going to file an Amicus
`
`here?
`
`MR. KLEIN: Correct, yes. And just so Your
`Honor understands what happened in the GSK case, which isn't
`directly related, but it is -- it's in the same ball park of
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`10:09:20
`
`10:09:22
`
`10:09:27
`
`10:09:32
`
`10:09:34
`
`10:09:37
`
`10:09:40
`
`10:09:43
`
`10:09:45
`
`10:09:48
`
`10:09:49
`
`10:09:50
`
`10:09:53
`
`10:09:59
`
`10:10:02
`
`10:10:04
`
`10:10:07
`
`10:10:11
`
`10:10:15
`
`10:10:15
`
`10:10:18
`
`10:10:20
`
`10:10:21
`
`10:10:23
`
`10:10:26
`
`
`
`Case 1:20-cv-01630-RGA-JLH Document 85 Filed 10/20/21 Page 6 of 83 PageID #: 1396
`6
`
`what this case is about, which is there was a carved out
`label. And after the launch, long after the launch, there
`was a lawsuit for induced infringement. And a jury trial --
`and the jury awarded lost profits damages.
`And then it -- you know, it was appealed. And
`the decision came out and the decision caused a lot of
`controversy in the industry, and there was a petition for
`rehearing. I forget when that was, but it was a while ago.
`And then the concerns raised by the Amici and the Appellate,
`Teva were heard by the panel, and they vacated the initial
`decision and then reheard the case. And then they issued
`another decision two days after the report and
`recommendation in this case that expressly said they're
`narrowing the scope of their initial decision, and they
`wanted to make it clear that they're not upsetting the prior
`case law with regard to Section 8. You may be aware of
`that, but just in case you weren't, I just wanted to make
`sure you understood the context.
`And how does that relate to this case? Well,
`the entire pharmaceutical industry, Your Honor, is watching
`this case, and they're watching to see what happens to our
`motion to dismiss and how you're going to rule. And the
`reason they're watching that is because what Hikma did in
`this case was a standard Section 8 carve-out. There were
`two discrete cases, and Hikma completely carved out the
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`10:11:48
`
`10:11:51
`
`10:11:56
`
`10:11:59
`
`1 2 3 4 5 6 7 8 9
`
`10:10:31
`
`10:10:37
`
`10:10:43
`
`10:10:47
`
`10:10:51
`
`10:10:54
`
`10:10:57
`
`10:11:01
`
`10:11:04
`
`10:11:08
`
`10:11:12
`
`10:11:16
`
`10:11:18
`
`10:11:24
`
`10:11:26
`
`10:11:31
`
`10:11:35
`
`10:11:38
`
`10:11:39
`
`10:11:41
`
`10:11:44
`
`
`
`Case 1:20-cv-01630-RGA-JLH Document 85 Filed 10/20/21 Page 7 of 83 PageID #: 1397
`7
`
`
`patented indication.
`And as I'll explain in a moment, there is no
`plausible allegation that Hikma's carved out label is
`actively inducing doctors and patients to use its product to
`reduce cardiovascular death, or reduce cardiovascular risk
`or to use its product in a combination drug therapy with
`statins which is what the claims require.
`And so if these types of flimsy allegations
`based on a carved out label can get past a motion to
`dismiss, alarm bells are going to go off in every generic
`pharmaceutical company in the world because it won't make
`economic sense to do a carved out label if all that means is
`you're going to launch a product, and then you're going to
`get sued, and then the lawsuit is likely to survive a
`pleadings motion. Putting aside the litigation cost
`involved with that, if lightning strikes and the case gets
`to a jury and the jury awards lost profits, those lost
`profits damages are going to far exceed what the generic is
`even going to make on the product.
`So if these allegations -- and I'll explain why
`they're flimsy in a moment, but if these can get past the
`motion to dismiss, there's no question that generics are
`going to think twice about using the Section 8 pathway.
`It's going to mean less generic competition and higher
`prices. And counsel's probably going to come up and say,
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`10:12:05
`
`10:12:06
`
`10:12:09
`
`10:12:13
`
`10:12:17
`
`10:12:21
`
`10:12:26
`
`10:12:28
`
`10:12:31
`
`10:12:34
`
`10:12:37
`
`10:12:41
`
`10:12:46
`
`10:12:49
`
`10:12:54
`
`10:12:58
`
`10:13:02
`
`10:13:05
`
`10:13:08
`
`10:13:11
`
`10:13:15
`
`10:13:18
`
`10:13:22
`
`10:13:25
`
`10:13:28
`
`
`
`Case 1:20-cv-01630-RGA-JLH Document 85 Filed 10/20/21 Page 8 of 83 PageID #: 1398
`8
`
`I'm saying the sky is falling or I'm engaging in hyperbole,
`but this is the exact concern that was raised at the Federal
`Circuit with multiple Amici, and this is why the Federal
`Circuit of the panel backed off vacating the initial
`decision and issued a more narrow decision.
`Now, whether that decision is right or wrong,
`you know, it's subject to that petition for rehearing, and
`I'm certainly not advocating that it was decided correctly.
`But what's clear and express in that new decision is that
`the intent of the majority was to distinguish the Teva case
`from your typical Section 8 carve-out. And in that case,
`the Court did find that there was substantial evidence to
`support a jury verdict that the label, even the carved out
`label taught each and every step of the patented method.
`THE COURT: Well, so let's put GSK aside for a
`second, though. I think, obviously, we'll come back to it,
`but the procedure, I think, is what you're getting to.
`But the procedure here, as I understand it, is
`the Plaintiff takes the label and sort of says all the
`things that would be covered by our patented stuff, they're
`crossed out, and then you get what's left. And so your
`label, leaving possibly aside the paragraph about it's not
`indicated for the cardiovascular indication, is exactly what
`the Plaintiff basically ceded to you; right?
`MR. KLEIN: It's close, but just to be clear, so
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`10:15:08
`
`10:15:14
`
`10:15:27
`
`10:15:32
`
`1 2 3 4 5 6 7 8 9
`
`10:13:31
`
`10:13:35
`
`10:13:38
`
`10:13:45
`
`10:13:49
`
`10:13:52
`
`10:13:54
`
`10:13:56
`
`10:14:00
`
`10:14:04
`
`10:14:09
`
`10:14:13
`
`10:14:17
`
`10:14:22
`
`10:14:26
`
`10:14:35
`
`10:14:41
`
`10:14:45
`
`10:14:51
`
`10:14:57
`
`10:15:02
`
`
`
`Case 1:20-cv-01630-RGA-JLH Document 85 Filed 10/20/21 Page 9 of 83 PageID #: 1399
`9
`
`the Plaintiff doesn't black anything out. What the
`Plaintiff did was after it got its second indication --
`well, let me back up a little bit. When Hikma filed its
`ANDA, there was only the one indication. Okay.
`Then a couple months before our trial in Nevada,
`they got approval for the second indication. Then they
`listed a bunch of patents in the Orange Book, including the
`three at issue here. And they included use codes, which
`Your Honor may be familiar with. So the use codes describe
`the method briefly. And the purpose of that, and this is
`discussed in the Supreme Court Caraco case, the purpose of
`the use code is so that the generic can make an informed
`decision as to whether they can carve out the patented
`method or not.
`And their use codes are all directed to the CV
`indication of use. None of their use codes talk about the
`indication that's in Hikma's label. And so Hikma carved --
`used those use codes and then Hikma proposed the carve-out
`to FDA and carved out everything related to the new
`indication.
`And with regard to that CV limitation of use,
`there's no CV limitation of use in the new VASCEPA label.
`And so it's not as though Hikma carved that out. It doesn't
`exist any more.
`And so -- and under the statute, and I have a
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`10:16:46
`
`10:16:55
`
`10:16:59
`
`10:17:00
`
`1 2 3 4 5 6 7 8 9
`
`10:15:35
`
`10:15:38
`
`10:15:42
`
`10:15:45
`
`10:15:48
`
`10:15:51
`
`10:15:54
`
`10:15:57
`
`10:16:01
`
`10:16:05
`
`10:16:09
`
`10:16:12
`
`10:16:15
`
`10:16:19
`
`10:16:20
`
`10:16:24
`
`10:16:28
`
`10:16:34
`
`10:16:37
`
`10:16:41
`
`10:16:42
`
`
`
`Case 1:20-cv-01630-RGA-JLH Document 85 Filed 10/20/21 Page 10 of 83 PageID #: 1400
`10
`
`slide on this, under the statute, the generic is supposed to
`copy the branded label. The exception being it can carve
`out a patented method. So there is no CV limitation of use
`in the current VASCEPA label.
`THE COURT: But in other words, you could, let's
`just say, hypothetically do a bad carve-out. And if you did
`a bad carve-out, and as a result you were encouraging,
`leaving aside the intent, but you were saying, you know, you
`can do this and actually that's the patented method?
`MR. KLEIN: That's possible, and that's what the
`GSK panel said that is what happened in that case. That the
`carved out -- I think the phrase is a carve-out is not
`skinny enough, right. And that can happen.
`But here we're talking about two very discrete
`indications. And I'm happy to explain why they're discrete,
`if you would like.
`THE COURT: And I think I kind of understand
`that because, though I have looked through the GSK, the
`second GSK opinion at least twice, and it seemed like there
`it was kind of two of the three indications had enough
`overlap. So maybe it was kind of subject to debate as to
`what exactly needed to be carved out, which I guess is if
`the -- if you say the Court of Appeals decision was not
`skinny enough, it would seem to indicate that, you know, in
`the end after a trial, there was a finding that it was a bad
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`10:18:31
`
`10:18:34
`
`10:18:38
`
`10:18:44
`
`1 2 3 4 5 6 7 8 9
`
`10:17:04
`
`10:17:06
`
`10:17:11
`
`10:17:14
`
`10:17:17
`
`10:17:20
`
`10:17:30
`
`10:17:39
`
`10:17:42
`
`10:17:47
`
`10:17:49
`
`10:17:54
`
`10:17:57
`
`10:18:01
`
`10:18:04
`
`10:18:06
`
`10:18:07
`
`10:18:09
`
`10:18:14
`
`10:18:21
`
`10:18:27
`
`
`
`Case 1:20-cv-01630-RGA-JLH Document 85 Filed 10/20/21 Page 11 of 83 PageID #: 1401
`11
`
`
`effort of carve-out.
`But I guess, then, if that's the case, then how
`do I know, maybe that's what you're about to tell me, that
`we don't have a bad effort at carve-out here?
`MR. KLEIN: Because I'll walk through the label
`and I'll walk through the steps of the patent and explain
`it's not even close. It's not even a close call. And I
`have to take off the screen saver, but I've got some slides
`that will help illustrate that. Okay.
`And actually, Your Honor, maybe it's worthwhile
`to put on the screen that GSK provision. I'm going to jump
`around in this slide deck to Slide 32. And if you don't
`have a copy --
`THE COURT: I've got some copies here, but I can
`look at the screen.
`MR. KLEIN: Yeah, right. So we're on Slide 32
`and this is from the recent GSK decision, and you can see
`what the panel said. "Teva failed to carve out all patented
`indications." And then said, "All of the claim limitations
`were contained in the Indication section, the Clinical Study
`section (to which doctors were directly referred by the
`Indication section), and the Dosage and Administration
`section."
`
`Now, there's a debate about whether that's the
`case, but that's what the panel held. And the Indication,
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`10:18:50
`
`10:18:51
`
`10:18:54
`
`10:18:57
`
`10:18:59
`
`10:19:02
`
`10:19:05
`
`10:19:10
`
`10:19:15
`
`10:19:29
`
`10:19:37
`
`10:19:43
`
`10:19:47
`
`10:19:49
`
`10:19:51
`
`10:19:52
`
`10:19:54
`
`10:19:58
`
`10:20:02
`
`10:20:05
`
`10:20:09
`
`10:20:12
`
`10:20:14
`
`10:20:15
`
`10:20:17
`
`
`
`Case 1:20-cv-01630-RGA-JLH Document 85 Filed 10/20/21 Page 12 of 83 PageID #: 1402
`12
`
`and Dosage and Administration sections are typically the two
`sections you look to to see whether the label is inducing
`infringement. Sometimes you look to the Clinical Study
`section, and Your Honor did that in your Sanofi case. But
`when that happens, it's when the indication is referring to
`the Clinical Study section.
`There's no argument here that our Indication
`section or the Dosage and Administration section is inducing
`infringement of any of the patents. And I think that's a
`good starting point for going through some of the background
`here.
`
`10:20:22
`
`10:20:27
`
`10:20:31
`
`10:20:33
`
`10:20:37
`
`10:20:41
`
`10:20:43
`
`10:20:46
`
`10:20:50
`
`10:20:54
`
`10:21:02
`
`10:21:02
`
`10:21:04
`
`10:21:08
`
`10:21:11
`
`10:21:15
`
`10:21:19
`
`10:21:22
`
`10:21:24
`
`10:21:28
`
`10:21:31
`
`10:21:34
`
`10:21:34
`
`10:21:36
`
`10:21:40
`
`And actually, before I get to the background, I
`do want to make one other quick point about the procedural
`posture of this case. I mean, I recognize we're in the
`pleading stage, and sometimes there's an inclination to kick
`the tires and say, Let's see what happens in discovery. But
`nothing's going to change in discovery. This is an AB-rated
`generic drug. The label is what it is.
`They argued we removed the CV indication of use.
`That's not true. Our label never had a CV indication of
`use. It hasn't changed. There's no argument it's going to
`change.
`
`We have press releases and a website that they
`rely on. They've actually been taken down. And regardless,
`the GSK decision, as I'll explain, said that's not
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`Case 1:20-cv-01630-RGA-JLH Document 85 Filed 10/20/21 Page 13 of 83 PageID #: 1403
`13
`
`
`sufficient.
`So unlike the Takeda case, Your Honor, where as
`you may recall, there were allegations that -- that was a
`Judge Robinson case, and then you took it over.
`THE COURT: I remember, about gout patents and
`
`the FMF.
`
`MR. KLEIN: Correct. Right. Right. Yeah.
`And unlike that case -- so Judge Robinson, after
`the Takeda Federal Circuit decision, which you probably have
`seen in all the briefs, granted a motion to dismiss. But
`then Takeda came back and said, Wait a minute. We have
`evidence that there are sales representatives marketing the
`product off label.
`We were before Your Honor on summary judgment.
`You eventually granted summary judgment, but that was not an
`AB-rated drug.
`Here, there are no sales representatives. Hikma
`is not marketing this product. It's automatically
`substituted at pharmacies.
`So discovery is not going to reveal any type of
`off-labelling marketing. Literally, if you were to deny the
`motion to dismiss, we'll be back here in a few months on
`summary judgment with the same evidence. Nothing is going
`to change.
`
`And so --
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`10:21:44
`
`10:21:44
`
`10:21:47
`
`10:21:54
`
`10:21:55
`
`10:21:58
`
`10:22:00
`
`10:22:01
`
`10:22:04
`
`10:22:08
`
`10:22:11
`
`10:22:14
`
`10:22:17
`
`10:22:19
`
`10:22:20
`
`10:22:24
`
`10:22:25
`
`10:22:27
`
`10:22:30
`
`10:22:32
`
`10:22:35
`
`10:22:38
`
`10:22:42
`
`10:22:45
`
`10:22:46
`
`
`
`Case 1:20-cv-01630-RGA-JLH Document 85 Filed 10/20/21 Page 14 of 83 PageID #: 1404
`14
`
`THE COURT: But so, I guess, and I'm sorry to
`interrupt here, but I mean, in some ways it seems to me like
`you're asking me on the motion to dismiss to do summary
`judgment. And in particular, you know, that you want me to
`be looking through the labels and deciding -- you know,
`basing nothing on the arguments back and forth as to whether
`or not somewhere in the label there's each of the elements
`of a claim; right?
`MR. KLEIN: Well, I'm asking you under the -- to
`do that under the 12(b)(6) plausibility standard. It's --
`as a practical matter, the inquiry is not materially
`different than the summary judgment standard. And courts,
`including, you know, Judge Robinson, and then the Bayer
`decision by the Federal Circuit, and the AstraZeneca v.
`Apotex from 2012, they all dismissed these types of
`allegations on the pleadings based on the labelling.
`The label is part of the record. There's no
`dispute about that. And as we go through the label and
`compare it to the claims, in my view, Your Honor, it's not a
`close call. It's not even close.
`And with that, I'll breeze through the
`background because I know you're generally familiar with the
`fact that VASCEPA has two indications. One is for
`cardiovascular issues, and one is for something called
`severe hypertriglyceridemia. So a long way of saying your
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`10:24:25
`
`10:24:27
`
`10:24:32
`
`10:24:34
`
`1 2 3 4 5 6 7 8 9
`
`10:22:48
`
`10:22:51
`
`10:22:59
`
`10:23:04
`
`10:23:14
`
`10:23:26
`
`10:23:32
`
`10:23:36
`
`10:23:38
`
`10:23:40
`
`10:23:45
`
`10:23:48
`
`10:23:52
`
`10:23:55
`
`10:24:03
`
`10:24:06
`
`10:24:09
`
`10:24:11
`
`10:24:14
`
`10:24:18
`
`10:24:22
`
`
`
`Case 1:20-cv-01630-RGA-JLH Document 85 Filed 10/20/21 Page 15 of 83 PageID #: 1405
`15
`
`triglycerides are very high.
`The concern -- there's no dispute about this.
`The concern with severe hypertriglyceridemia is not that
`it's going to cause cardiovascular issues. It's going to
`cause something else called pancreatitis, which is an acute
`condition. It can even kill you. And that indication, the
`first indication that was approved was designed for this
`acute condition, severe hypertriglyceridemia.
`Amarin initially tried to get a cardiovascular
`indication at the same time. FDA rejected it. It required
`a new study. They did this new study called Reduce It, and
`then they got the second indication. So these are discrete
`indications.
`
`10:24:39
`
`10:24:41
`
`10:24:42
`
`10:24:45
`
`10:24:49
`
`10:24:53
`
`10:24:56
`
`10:25:00
`
`10:25:05
`
`10:25:08
`
`10:25:11
`
`10:25:15
`
`10:25:19
`
`10:25:19
`
`10:25:20
`
`10:25:22
`
`10:25:28
`
`10:25:33
`
`10:25:39
`
`10:25:41
`
`10:25:44
`
`10:25:48
`
`10:25:53
`
`10:25:58
`
`10:26:04
`
`THE COURT: Is there anything in the Complaint
`or otherwise, something I can rely on that says kind of what
`the -- and this may be a poor choice of words, but what the
`relative use of the drug for the one indication is versus
`the other indication?
`MR. KLEIN: Well, there's a decision by Judge Du
`in Nevada that -- it's a lengthy decision and it discusses
`all of this. And in fact, the Court held that there was no
`nexus between the Reduce It study that caused -- that
`supported the CV indication and the patents that cover the
`SH indication.
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`Case 1:20-cv-01630-RGA-JLH Document 85 Filed 10/20/21 Page 16 of 83 PageID #: 1406
`16
`
`So we went to trial on that shortly before the
`pandemic, and the Court invalidated all of the patents that
`had covered the SH indication. So you know, that's -- you
`can take public notice of that decision. I don't think --
`THE COURT: So that's the reason why that's not
`covered by any patents is because you've invalidated all of
`them?
`
`MR. KLEIN: Yes, that's correct. That's why
`it's not patented and that's why we launched. We launched
`shortly after the Federal Circuit summarily affirmed the
`invalidity ruling.
`Hikma's label, it's just the old indication.
`And you know, we cite the Supreme Court case here. This is,
`obviously, a pathway that's in the statute. It's been
`blessed by the U.S. Supreme Court, the Section 8 pathway. I
`know Your Honor has dealt with it in the past.
`With regard to the statute, which is a very
`simple statute, I want to emphasize the adverb actively.
`The statute itself requires active inducement, and this goes
`to their argument, which I'll get to later, that silence or
`a failure to put language can somehow actively induce. It
`doesn't make any sense. It doesn't make any legal sense.
`It doesn't make any logical sense.
`And the Courts have said time and time again,
`merely describing an infringing mode is not the same as
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`10:26:04
`
`10:26:07
`
`10:26:10
`
`10:26:14
`
`10:26:16
`
`10:26:19
`
`10:26:24
`
`10:26:25
`
`10:26:26
`
`10:26:30
`
`10:26:32
`
`10:26:34
`
`10:26:38
`
`10:26:42
`
`10:26:44
`
`10:26:47
`
`10:26:50
`
`10:26:52
`
`10:26:58
`
`10:27:02
`
`10:27:08
`
`10:27:11
`
`10:27:13
`
`10:27:15
`
`10:27:19
`
`
`
`Case 1:20-cv-01630-RGA-JLH Document 85 Filed 10/20/21 Page 17 of 83 PageID #: 1407
`17
`
`recommending, encouraging or promoting an infringing use.
`So there has to be active inducement. The label -- and I
`want to focus on the label first. I'll get to the extra
`label stuff after. But the label has to tell doctors and
`patients, you should practice the same method that is
`covered by the patents.
`I want to also emphasize this point because
`sometimes the cases merge two separate elements of active
`inducement. Active inducement requires specific intent, but
`it also requires active steps. It gets a little confusing
`in the ANDA context because the active steps can be used to
`infer specific intent, but these are two separate elements.
`And so to the extent you hear counsel come up and talk about
`specific intent, intents of fact issue, that's irrelevant
`because our motion is based on the absence of active steps
`of actual instructions in the label. Specific intent is a
`separate thing they would eventually need to prove, but
`that's not the focus of our motion today.
`Before I get into the label, Your Honor, I do
`want to emphasize one Black Letter legal principle that may
`have gotten lost in the shuffle with all of the briefs. And
`this is a basic legal principle that in order for them to
`plead induced infringement, they have to plead and
`eventually prove that Hikma is inducing another party to
`perform every single step of the method.
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`10:28:45
`
`10:28:50
`
`10:28:54
`
`10:28:58
`
`1 2 3 4 5 6 7 8 9
`
`10:27:23
`
`10:27:27
`
`10:27:31
`
`10:27:34
`
`10:27:37
`
`10:27:41
`
`10:27:45
`
`10:27:47
`
`10:27:52
`
`10:27:56
`
`10:28:00
`
`10:28:04
`
`10:28:08
`
`10:28:12
`
`10:28:17
`
`10:28:21
`
`10:28:26
`
`10:28:29
`
`10:28:31
`
`10:28:36
`
`10:28:41
`
`
`
`Case 1:20-cv-01630-RGA-JLH Document 85 Filed 10/20/21 Page 18 of 83 PageID #: 1408
`18
`
`So saying we have a generic equivalent, that's
`not teaching how to perform each and every step of the
`patented method. And that's why I have slides comparing the
`label to the patent, so you can see the steps.
`And I'm focusing on independent claims and claim
`elements that cut across all of the claims in the three
`patents-in-suit. And they're not -- and these aren't going
`to be claim construction issues, Your Honor, because they're
`very clear.
`So there are three patents in suit. The first
`one is the '537 patent, and this patent requires, at the
`beginning requires dual drug therapy. You have to take
`Icosapent, but you have to also take a statin. If you're
`not also taking a statin, you're not satisfying an element
`of the claim.
`Then you have to take the drug to reduce
`cardiovascular events. That's the method of treatment.
`And then the patent explains that you have to do
`that in a very specific patient population, a
`hypercholesteremia patient who had not previously
`experienced such an event. This is a very specific patented
`method.
`
`10:29:01
`
`10:29:05
`
`10:29:08
`
`10:29:12
`
`10:29:14
`
`10:29:18
`
`10:29:22
`
`10:29:25
`
`10:29:29
`
`10:29:30
`
`10:29:32
`
`10:29:38
`
`10:29:42
`
`10:29:46
`
`10:29:49
`
`10:29:50
`
`10:29:55
`
`10:29:57
`
`10:30:00
`
`10:30:07
`
`10:30:09
`
`10:30:12
`
`10:30:13
`
`10:30:16
`
`10:30:21
`
`The '861 patent gets even more specific. You
`have to reduce the risk of cardiovascular death. And as
`I'll mention, this is not even an FDA-approved method for
`
`1 2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`
`
`Case 1:20-cv-01630-RGA-JLH Document 85 Filed 10/20/21 Page 19 of 83 PageID #: 1409
`19
`
`VASCEPA. And it's a very specific patented method, and
`again, it has to be in a particular patient population,
`patients with established cardiovascular disease.
`And then the third patent, the '077 patent, this
`was also listed in connection with the CV indication. It's
`a CV method of use. But if you look at the claims, it also
`requires statin use in a particular patient population with
`something called mixed dyslipidemia.
`Now, before I actually get into the label, Your
`Honor, I want to point to an omission in the First Amended
`Complaint that we submit is critical. Now, starting with
`the Warner-Lambert case, and the Bayer Federal Circuit case
`makes this same point, if you don't have FDA approval for
`the patented method, you're, obviously, not inducing
`infringement of the patented method.
`If you don't have FDA approval for a patented
`method, you can't go into the public and you can't say
`practice that method. If you did, it could be off-label
`marketing. It could also be a crime. And the courts have
`talked about that.
`In the First Amended Complaint, Amarin concedes
`the Hikma generic does not have an FDA-approved indication
`for CV risk reduction. What this means, and I don't think
`there's any dispute about this, Your Honor, Hikma can't go
`to the market, can't talk to doctors and patients and say,
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`10:31:34
`
`10:31:38
`
`10:31:42
`
`10:31:45
`
`1 2 3 4 5 6 7 8 9
`
`10:30:25
`
`10:30:29
`
`10:30:34
`
`10:30:36
`
`10:30:40
`
`10:30:44
`
`10:30:47
`
`10:30:51
`
`10:30:54
`
`10:30:58
`
`10:31:02
`
`10:31:04
`
`10:31:08
`
`10:31:13
`
`10:31:16
`
`10:31:18
`
`10:31:20
`
`10:31:23
`
`10:31:27
`
`10:31:30
`
`10:31:31
`
`
`
`Case 1:20-cv-01630-RGA-JLH Document 85 Filed 10/20/21 Page 20 of 83 PageID #: 1410
`20
`
`Take our drug because it will help reduce the risk of
`cardiovascular events. They can't do that. That could be a
`crime, yet they're saying that's what the label is
`encouraging doctors to do.
`So as a threshold point, their theory doesn't
`make sense given that they've conceded our product is not
`even FDA approved for any of the patented methods.
`Now, we get to the label, and you'll see why I
`made these comments at the beginning, that the allegations
`of induced infringement are not even close. So all three
`patents concern reducing cardiovascular risk. The term
`cardiovascular is used twice in the label. Only in the
`section of the label called Patient Information, and this is
`where the label --
`THE COURT: This is the part where it's kind of
`like a warning not to mix?
`MR. KLEIN: Well, kind of, although it's not
`about mixing drugs, but yes. There are these hypothetical
`questions for patients to read. Right. And the
`hypothetical question here is: What are the possible side
`effects of Icosapent, not how do you use the drug. You
`know, how can this harm me?
`And Hikma's label says there are -- Icosapent,
`this drug can cause serious side effects. Heart rhythm
`problems which can be serious and cause hospitalization have
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`10:32:57
`
`10:32:58
`
`10:33:03
`
`10:33:06
`
`1 2 3 4 5 6 7 8 9
`
`10:31:48
`
`10:31:53
`
`10:31:55
`
`10:31:58
`
`10:32:00
`
`10:32:05
`
`10:32:08
`
`10:32:12
`
`10:32:16
`
`10:32:19
`
`10:32:23
`
`10:32:27
`
`10:32:32
`
`10:32:37
`
`10:32:38
`
`10:32:40
`
`10:32:41
`
`10:32:44
`
`10:32:47
`
`10:32:50
`
`10:32:53
`
`
`
`Case 1:20-cv-01630-RGA-JLH Document 85 Filed 10/20/21 Page 21 of 83 PageID #: 1411
`21
`
`hap
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
