Replies to post #262878 on Amarin Corp Plc (AMRN)

[money_man]

Thank you, north. We all owe you (and marjac, and others) a debt of gratitude for lending your expertise.

[jessellivermore]

North....

"From your mouth to God's ears"

Its nice to see you stepping up to the plate...I guess it all depends on what the generics think of Judge Du's "masterpiece." I'm not sure Amarin has the stomach for another go around in the Federal Court snake pit and I know that there are very few on this board that want two see "DU" two..."Revenge of the Death star"...

":>) JL

[north40000]

The rest of the story:Feel free to submit this text and previous text to Cris Sipes and JT at respective email addresses: Anyone or 2 volunteers?

Post-trial settlement agreement is available, particularly when the lower court judgment is not final—e.g., an appeal from that judgment is pending. I will be surprised if you find/think to the contrary.

Note paragraph (c) of FRCP 68, sub-titled “Offer after Liability is Determined”.
H and R liability to A so far is $0.00, but the loss of A’s personal property(its 6 patents containing certain claims that issued with a presumption of validity that embraced activities from which Amarin received or will receive extensive $$ revenue is very real) is damage in terms of $$. The “extent of liability remains to be determined by further proceedings”, namely the appeal to the Fed. Cir.

I have terms that I am considering for such a contract or settlement agreement that I think all parties will agree to. Once signed, the settlement agreement ( it differs from a consent decree) is entered in the docket with no input from the judge, and the case closes, making the appeal moot.

What are the terms of agreement?
A summary, not final:

1) Amarin agrees to license each of R and H to practice all claims of the 6 patents with therapies currently under consideration by the FDA in ANDAs already filed with FDA, but not yet approved. Amarin could even assign the 6 patents to H and R making them owners of those patents, and very willing to sue other generics to keep those generics out of the Marine market. Ownership of the patents could be divided 3 ways, each of A, H and R having a 1/3 interest. Amarin by contract retains its rights to market Vascepa for the Marine indication.


A retains all rights in its remaining ~45 Orange Book patents to enforce against entry by anyone into market to practice or treat for R-I indications and results. Those patents have claims and FDA labels sufficient to embrace both Marine and R-I, so others think. The claims of those patents contain limitations not present in adjudicated claims.

2) A, H and R join in agreement that the district court, Judge D, made errors of fact and law, making her decision unlikely to be upheld on appeal( this sounds and reads well but is useless against the public or others wishing to come to market. I know of no way that litigants can agree that a patent is valid in the face of a district judge who has adjudicated otherwise. This proviso 2 can be left out or deleted for now to see what Federal Circuit does.) Or what D.J. D does in light of 3):

3) A request for reconsideration, no reference to FRCP 68, but with proper signatures in place on paragraph 1) that is enforceable by state court judges:

3) H and R agree to join any timely request for reconsideration filed by A, asking withdrawal by J. D of a) her judgment and decision, and b) issuing a new 1 page opinion that overturns her previous opinion for reasons advanced by(.....) and c) issuing a new judgment that the patents are valid and infringed.
*************
I do not know J. D’s pride in work product, but I think that, faced with all parties to suit agreeing that her original decision, for reasons both in fact and law, was wrong, she might agree to the relief requested.

The delays that might be built into the judicial, FDA and market systems by Cov-19 are unknown as well as unknowable in time length. E.g., work at home, arguments postponed until further notice. Market building by Amarin will be difficult too—DTC ads ineffective as Vascepa Brand builders because new consumers are not traveling anywhere and doctors offices are closed until further notice. More use for Teledoc perhaps. R and H could be forbidden to refer to Vascepa in all marketing ploys they might come up with eventually. I have not figured a way to forbid them and customers from providing product, or refuse to supply doctors or hospitals for treatment of CVDs

Enough for now. These ideas are not final and have not been seen by anyone

******************

Marjac's reply:


I absolutely think that post-trial settlement is possible.

I think the substance of your proposal is brilliant. Intellectually sublime.

One thing though, I think the docketing of the Appeal with the Federal Circuit would divest Judge Du of jurisdiction to reconsider, unless, perhaps, they settle, jointly move for a remand, and then she enters the reconsideration Order.

Do you have good contacts at Amarin[or Covington] to provide with your proposal?

I have not checked bold reply of Marjac.

However, I do recall a case in CCPA where I served as bailiff. An attorney approached the lectern, and said:

Your honors, the parties to this case have settled. This case need not be heard today.

Chief Judge: Do you have signed agreement saying that?

Attorney: Yes, and presents to court to read.

Chief Judge: After reading, passes signed document to colleagues on bench, who nod their heads.

Chief Judge: this case is settled, and will not be heard today. You can go home(to attorney). Next case is.....

[Pharmacydude]

North
Great thoughts and appreciate your input.
As you stated , you don’t know how to separate V vs g sales.
I’m a pharmacist and never in my 28 years of practice have I seen where a pharmacist must dispense molecule a brand X for one indication and molecule a brand Y for another indication but here is the closest thing I’ve seen:

Bupropion (generic name of a chemical that had benefits for depression and smoking cessation).
Many insurance companies would not cover for a smoking cessation medication but would pay for an antidepressant. The manufacturer distributed the drug under two different brand names. Zyban was the name of the drug for smoking cessation and Wellbutrin was the name for depression. If a physician was prescribing for depression he was supposed to use Wellbutrin. Zyban for smoking.
The problem became that when the insurance company rejected Zyban because they did not cover smoking cessation products in general the prescriber would just change to Wellbutrin and claim depression.
What if in your arrangement H and R agreed to sell their drug under a different name like TrigBan? An agreement is reached that the 2 not be listed as interchangeable with the FDA. Pharmacists would have to give what is prescribed. H and R get VHTG market and Amarin keeps CVD.

[ggwpq]

North, what would R & H gain in following your great settlement plan? TIA.

[swg_tdr]

North, in your deal you left off a third Generics party, TEVA. Any complications thereof?

Super work. Amarin should retain you.

[rafunrafun]

So would a settlement now nullify Du's ruling and patents would not be invalidated?

[Biobillionair]

North- I missed this post*** thanks for sharing the likely outcome to Du debacle. I’d like to add generics will likely be partners in AMR 102...at least in US. Amarin can source statin and ezetimibe; a settlement that makes generics a partner in a low cost innovative solution to improve healthcare costs is revolutionary.

BB

***

Post-trial settlement agreement is available, particularly when the lower court judgment is not final—e.g., an appeal from that judgment is pending. I will be surprised if you find/think to the contrary.

Note paragraph (c) of FRCP 68, sub-titled “Offer after Liability is Determined”.
H and R liability to A so far is $0.00, but the loss of A’s personal property(its 6 patents containing certain claims that issued with a presumption of validity that embraced activities from which Amarin received or will receive extensive $$ revenue is very real) is damage in terms of $$. The “extent of liability remains to be determined by further proceedings”, namely the appeal to the Fed. Cir.

I have terms that I am considering for such a contract or settlement agreement that I think all parties will agree to. Once signed, the settlement agreement ( it differs from a consent decree) is entered in the docket with no input from the judge, and the case closes, making the appeal moot.

What are the terms of agreement?
A summary, not final:

1) Amarin agrees to license each of R and H to practice all claims of the 6 patents with therapies currently under consideration by the FDA in ANDAs already filed with FDA, but not yet approved. Amarin could even assign the 6 patents to H and R making them owners of those patents, and very willing to sue other generics to keep those generics out of the Marine market. Ownership of the patents could be divided 3 ways, each of A, H and R having a 1/3 interest. Amarin by contract retains its rights to market Vascepa for the Marine indication.


A retains all rights in its remaining ~45 Orange Book patents to enforce against entry by anyone into market to practice or treat for R-I indications and results. Those patents have claims and FDA labels sufficient to embrace both Marine and R-I, so others think. The claims of those patents contain limitations not present in adjudicated claims.

2) A, H and R join in agreement that the district court, Judge D, made errors of fact and law, making her decision unlikely to be upheld on appeal( this sounds and reads well but is useless against the public or others wishing to come to market. I know of no way that litigants can agree that a patent is valid in the face of a district judge who has adjudicated otherwise. This proviso 2 can be left out or deleted for now to see what Federal Circuit does.) Or what D.J. D does in light of 3):

3) A request for reconsideration, no reference to FRCP 68, but with proper signatures in place on paragraph 1) that is enforceable by state court judges:

3) H and R agree to join any timely request for reconsideration filed by A, asking withdrawal by J. D of a) her judgment and decision, and b) issuing a new 1 page opinion that overturns her previous opinion for reasons advanced by(.....) and c) issuing a new judgment that the patents are valid and infringed.
*************
I do not know J. D’s pride in work product, but I think that, faced with all parties to suit agreeing that her original decision, for reasons both in fact and law, was wrong, she might agree to the relief requested.

The delays that might be built into the judicial, FDA and market systems by Cov-19 are unknown as well as unknowable in time length. E.g., work at home, arguments postponed until further notice. Market building by Amarin will be difficult too—DTC ads ineffective as Vascepa Brand builders because new consumers are not traveling anywhere and doctors offices are closed until further notice. More use for Teledoc perhaps. R and H could be forbidden to refer to Vascepa in all marketing ploys they might come up with eventually. I have not figured a way to forbid them and customers from providing product, or refuse to supply doctors or hospitals for treatment of CVDs

Enough for now. These ideas are not final and have not been seen by anyone

******************

Marjac's reply:


I absolutely think that post-trial settlement is possible.

I think the substance of your proposal is brilliant. Intellectually sublime.

One thing though, I think the docketing of the Appeal with the Federal Circuit would divest Judge Du of jurisdiction to reconsider, unless, perhaps, they settle, jointly move for a remand, and then she enters the reconsideration Order.

Do you have good contacts at Amarin to provide with your proposal?