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Just finished reading the full transcript. No way, in my opinion, this gets tossed. The Judge bought in to the totality of the circumstances argument. Was wavering for a while but then got it when the significance of the removal of the cv benefit limitation was explained, and put it in the context of all those other drugs who has to keep that limitation.
Agree completely, apart from legal fees the Du case was a shot to nothing for Hikma, there’s a lot more at stake for them with this one. And their legal advice will likely be “who the hell knows with a jury...”.
The judges weren’t buying the idea that this case has wide negative implications for the whole generics system. They were at pains to say that the evidence of infringement here wasn’t confined just to the label, there was a lot more that was presented to the jury and that the jury accepted on the whole, and it wasn’t for them to substitute their own findings of facts in place of the jury’s. I listened to the arguments and didn’t think Teva’s lawyer got kicked around as much as others have said (here and elsewhere), but they certainly didn’t accept his premise which was that no reasonable jury could have reached the verdict this jury did. The judges found ample evidence on which the jury could have come to that conclusion, which is what they said if you listen back to the original oral arguments. The main take away from this case is the primacy of a jury’s finding of facts - that will be Amarin’s burden when it comes to their case. Teva’s big mistake with the GSK case was wording in a press release which the jury accepted was relied upon by doctors when prescribing, the question is whether Amarin will be able to prove that Hikma has acted in an analogous fashion.
$12.20
Breaking News: The Justice Department sued Walmart, saying the company helped fuel the opioid crisis by allowing its pharmacies to fill suspicious prescriptions.
https://www.nytimes.com/2020/12/22/business/walmart-opioid-lawsuit.html?campaign_id=60&emc=edit_na_20201222&instance_id=0&nl=breaking-news&ref=cta®i_id=58833221&segment_id=47602&user_id=40850a4f6d47c42bb1834b6cb9863e87
Doesn’t the same analogy hold with pharmacies facilitating patent infringement?
CHMP meeting highlights link below, vascepa / icosapent ethyl not mentioned- presumably this was expected given where it was listed on the agenda, but I’m just posting the link for info anyway.
https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-7-10-december-2020
Chmp agenda extract -
https://www.ema.europa.eu/en/documents/agenda/agenda-chmp-agenda-7-10-december-2020-meeting_en.pdf
3.2. Initial applications; List of outstanding issues (Day 180; Day 120 for procedures with accelerated assessment timetable)
...
3.2.15. icosapent ethyl - EMEA/H/C/005398
indicated to reduce cardiovascular risk as an adjunct to statin therapy.
Scope: List of outstanding issues
Action: For adoption
To answer my own question, maybe a rehearing or en banc request isn’t technically an “appeal”.
In which case 75 days runs from CAFC decision.
Meant to post this as a reply to the message below, not a new message:
Do Hikma have 75 days to launch from CAFC ruling date or from the date en banc is refused (if it is refused)?
The statute suggests the latter because it only specifically carves out a SC petition, implying any other court option must be exhausted before the 75 days commence.
FDC Act § 505(j)(5)(D)(i)(I)
“In an infringement action brought against that applicant with respect to the patent or in a declaratory judgment action brought by that applicant with respect to the patent, a court enters a final decision from which no appeal (other than a petition to the Supreme Court for a writ of certiorari) has been or can be taken that the patent is invalid or not infringed.”
Do Hikma have 75 days to launch from CAFC ruling date or from the date en banc is refused (if it is refused)?
The statute suggests the latter because it only specifically carves out a SC petition, implying any other court option must be exhausted before the 75 days commence.
FDC Act § 505(j)(5)(D)(i)(I)
“In an infringement action brought against that applicant with respect to the patent or in a declaratory judgment action brought by that applicant with respect to the patent, a court enters a final decision from which no appeal (other than a petition to the Supreme Court for a writ of certiorari) has been or can be taken that the patent is invalid or not infringed.”
I hadn’t spotted the credit! I think you are being overly kind but thank you!
Well done on the submission and as a contributor of a modest $100 I want to thank you regardless of the outcome. I think we’re all realistic that the chances of success are extremely small, but it is worth a go, and you have put important points on the record.
John, until I read your post I thought this was a waste of time and I hadn’t donated to the gofundme. My reading of it was that Du was wrong in her analysis but not “wrong enough”. A commenter on one of the markman blog articles (May 19th) had summarised it for me perfectly – Ion Marques wrote:
“Results of EHA and EPA should have been stadistically compared against each other for any comparison to be valid. Stadistics were only used for EPA against its baseline and DHA against its own, being judge Du the one who compared EPA vs DHA on intution only without stadistical methods and wrongly.”
I had agreed with Marques that Du did her own comparison and used her own intuition, but looking at the Kurabayashi table (and I know I’m now switching between Mori and Kurabayashi), a -6.9 reduction for EPA versus -1.5 for the control group DOES (intuitively) look significant even though it’s not being properly compared against a DHA group. It’s enough for someone to (wrongly) say to themselves “I don’t know who’s wrong and who’s right here and who’s telling me the truth, but if EPA on its own resulted in nearly 5 times the reduction when compared to a control group, then surely it must have been obvious to a POSA (because it seems obvious to me) that EPA on its own would work…”
So look, clearly a trained legal person shouldn’t be using their own “intuition” to decide an extremely technical case, as against the weight of data and facts from experts/POSAs in the area. But the CAFC could have concluded that there were arguments on both sides and that Judge Du was entitled to break the deadlock by using her own common sense and experience and, yes, intuition. That’s what happens in a lot of legal scenarios when there’s conflicting expert evidence and seemingly no clear right or wrong answer.
I now know that Du’s intuitive conclusion was wrong because it’s been explained to me, but if it hadn’t been, I’d have seen nothing wrong with it instinctively. The CAFC panel might have looked at this the same way but they would have been even more sympathetic to Du – to overturn her on the facts they’d have had to decide that not only was she wrong, but she was so wrong that there were NO facts to support her decision or no reasonable Judge could have come to the decision she reached. On the face of it Singer got nowhere near that standard in either briefs or OAs.
But reading your post John, it looks to me you’ve identified a way to ask for an overturn based on mixed questions of fact and law, and not just factual or legal issues alone. My two cents worth is that you are going to have to punch the CAFC in the face with this in the first few sentences. They will be itching to toss this aside a-la “who the hell do these plaintiffs even think they are requesting en banc against a Rule 36, never mind this amicus crap…”
So my suggestion for an opening paragraph is below. I say leave out any normal “We respectfully suggest…” type language. Go straight for the jugular. This is an amicus from a group of investors. They’ll expect us to be going for it aggressively. In fact any overly polite language will be interpreted as weakness and they’ll think we were just taking a flyer. The amicus needs to be extremely angry that so many layers of the legal system continue to get this wrong.
Suggested opening lines:
“The Appeals panel did not properly follow Novo. They either did not understand the essence of Novo, or they did not understand the application of the facts of this case to key elements of the Novo decision. Judge Du was misled (probably deliberately) by defendants’ Counsel. Because of that she made factual errors that amounted to “but-for” material in Novo terms. She then compounded that by improperly weighing her alternative facts against correct ones. The CAFC seemingly didn’t understand Du’s “but-for” errors and seemingly didn’t try to, and they then compounded that by not realising that Novo mandates them to re-evaluate Du’s weighing approach but without re-using her “but-for” mistakes. This case amounts so far to mistake compounded by mistake followed by mistake compounded by mistake. These mistakes will cost hundreds of thousands of American lives. Amarin will not now promote Vascepa in the US for extraordinary and unexpected life changing benefits that were discovered years after these incorrectly invalidated patents were filed, and generics will not be able to sell to that patient population (and certainly can’t promote to it) because that would amount to clear violation of subsequent Amarin patents.”
Anyway I still think it’s a massive long shot but I’m now going to donate $100 to the gofundme based on John’s post.
Good luck to us all!
It’s the latest comment below this article - https://www.markmanadvisors.com/blog/2020/6/29/amarin-what-does-amarins-reply-appellate-brief-say
I can’t find the final CAFC decision but this is worth a listen - http://www.cafc.uscourts.gov/node/25164 - 2019 oral arguments around Teva allegedly infringing on a GSK method of use patent. GSK won at jury trial, lost at district court, and this is the oral argument recording. Checked pacer and Jonathan Singer was involved for GSK!
Case is GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., CAFC No. 18-1976?
Might the case have been GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., CAFC No. 18-1976?
Cmm3rd, many thanks for this and your 7232 post, they really explain things well.
I’m holding out hope that Reyna accepts Du used the prima facia - rebuttal approach (although Hikma claim she didn’t) and votes for Amarin on that basis, and that one or both of the other two, despite being ok with prima facia - rebuttal approach, find that she went even further - when purporting to use the SCs as a check she actually (1) let her prior conclusion on obviousness “bleed into” her consideration of SCs - she didn’t give them their due, as Singer put it, and (2) she impermissibly weighed SCs against each other, thus resulting in burden shifting. If Dyk/Hughes don’t like the idea of conceding on legal error, they could find another way to rule in Amarin’s favour.
So 2 of the potential chances of a win from this panel are:
Chance 1 - Reyna with amrn due purely to disagreeing with prima facia - rebuttal approach (if he accepts that was the approach used by Du - I think he will, his exchange with Singer was all about this), Hughes with amrn for a different reason - eg. he accepts that she weighed SCs against each other and he disagrees with that aspect despite agreeing generally with the prima facia - rebuttal approach. D unlikely to accept she even did this - see his reference to it being a “stray sentence”.
Chance 2 - Reyna as above, one or both of the other 2 dislike the SCs weighing departure, but rather than accept that it happened and/or say it was wrong (that might risk chipping away at the prima facia - rebuttal approach), they instead find another way to find in amrn’s favour - eg. use the clear error of Du saying the expert panel were not aware of Mori. Possible cause for optimism re Dyk on this last point - no rebuttal from him when Singer pointed the error out to him right at the end of Singer’s oral arguments (around 11 minutes in) (D initially thought S said Du made an error by considering whether experts had been aware of Mori, S said no, her error was her finding that they weren’t aware of Mori when actually they were).
It’s an uphill battle but there are different pathways all 3 could follow to find in AMRN’s favor without really undercutting any of their fundamental legal approaches.
My prediction is a Remand decision with wording along the following lines:
This Court does not have sufficient information from her written opinion to be certain, beyond any doubt, of the sequence of Judge Du’s mental reasoning as distinct from her written opinion. Nor can we be sure that, if indeed she did use incorrect sequencing, she would not have reached the same conclusion based on the evidence before her had she followed the correct sequencing.
Further, this Court, having not had the benefit of the direct evidence, is unwilling to overturn the decision because Judge Du’s findings of facts, while potentially incorrect, are not in our view clearly and obviously incorrect, and the briefs/oral arguments highlight significant differences between the parties as to the underlying facts.
We therefore find that the case should be remanded to Judge Du for her to reconsider her decision, and the evidence, based on
(1) clearly separating out the obviousness argument from ones relating to secondary considerations,
(2) clearly first coming to an interim conclusion on obviousness without any initial contemplation whatsoever of secondary considerations,
(3) bearing in mind the very high burden of proof on the defendants when it comes to obviousness; and
(4) bearing in mind that even if she does reach the same interim conclusion on obviousness, she should then evaluate secondary considerations as a check against that interim conclusion, but without weighing them against each other.
My overall reading of all the back and forth today was the panel was trying to tease out with Singer if Du reached only an interim Prima Facia obviousness decision first, then looked at objective indicia, and only then turned her interim decision into a final one. If she did then they think that’s fine and they’ll affirm, citing Novo as binding precedent.
(They may give her the benefit of the doubt if they think it’s more likely than not that she followed the above sequence, even if in their view she could have made that clearer in her written judgement.)
Singer’s point was that she went straight to a final decision and she only looked at OIs as an afterthought, she didn’t give them their proper due.
As an example Singer said she even used her own final (as opposed to interim) conclusion on Prima Facia obviousness to counter one particular SC relating to skepticism - that completely does a go around as against SCs correct role to act as a check against an interim Prima Facia conclusion.
Per Singer she also only concluded that SCs were weak overall by weighing them against each other - that isn’t allowed. Further by using part of her own Prima Facia conclusion to deem at least one of the secondary considerations (skepticism) to be weak, she made a clear factual error by incorrectly saying that amarin’s 2008 panel of experts weren’t aware of Mori when they were.
Per Singer she incorrectly allowed the Prima Facia case to “bleed into” the consideration of SCs (a phrase he used a couple of times) - effectively she used SCs in a confirmation bias sort of way, rather than allowing them to act as a check.
This comes down to the panel trying to second guess what was in Du’s mind - her thought process and the sequencing of her decision making. Is there enough doubt about the approach she used so that they reverse or remand? Or do they give her the benefit of the doubt, that while she might have made it clearer that she didn’t make a “final final” decision until after she considered SCs, on balance the panel accepts that she did (so consider them first) and thus affirms.
It’s a mind reading exercise on Du - was her mind still open as she turned to SCs, or was it already made up. If the former, affirm, if the latter reverse or remand.
Reverse: 45%
Affirm: 20%
Remand: 30%
Settle: 5%
Thanks for the actual reply HK as opposed to the abuse from others. Don’t know what MRC stands for, I was simply positing something. And for what it’s worth I’m very happy it doesn’t hold water.
First and last time I’ll actually post anything on this board!
Hoping I’m very wrong, just throwing the possibility out there for discussion.
Obviousness -
I was involved in a tax related dispute that went to court several years ago where the issue turned, not on what the correct tax answer was, but on what the parties involved believed at the time was the correct tax answer even if that later turned out to be wrong.
It was a contractual dispute about the price of a service, where there was a disagreement about whether the price agreed was inclusive or exclusive of sales tax.
The thought occurred to me, reading the learned comments in this forum, as to whether the Appeals Court could find that inferences not supported by Mori’s study were possibly nevertheless drawn at the time due to Mori. In turn might they say that a researcher could have believed as obvious that EPA would not increase LDL levels even while accepting they should not, based on a correct understanding of Mori, have done so?
Remember that the burden of proof for the appeal is effectively on Amarin. Procedurally how can they now get it into evidence, and have it accepted as factually incontrovertible, that no such researcher could have drawn those incorrect inferences from Mori?
It may not suffice that a leading scientist like Dr Bhatt, or any number of other scientists, can now point out that it would have been an obvious error at the time. If my tax case analogy is valid this could turn on the Court accepting all of the above, but nevertheless saying that a PHOSITA (or a number of them) could have made the error even though many others wouldn’t have, and that suffices for them not to overturn Judge Du’s decision.