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NO. This is not the circus. Can't keep coming back.
Correct. Newman & Moore will not change their minds.
HUGE for AMRN.
Bad for Hikma.
I agree. GSK is going to win this case.
It will be good news for AMRN.
Newman & Moore will side with GSK.
Judge Moore & Judge Newman are destroying Teva's lawyer.
I wonder why did Baker Brothers sell 4 mm shares?
Especially with so many positive developments on the horizon.....(Europe, China, COVID, etc.)
It's great to have this fund here. Activists are great in some instances as they can truly help to "unlock" value and keep management focused on the right thing: creation of shareholder value.
Not familiar wit this fund but love the fact they are activists. Their interests will be aligned with retail shareholders: shareholder value.
Interesting post. This has all the makings of a movie.
So many moving parts....
For the record: it is not an en banc hearing.
It will be a rehearing. Same 3 judges.
Moore, Newman and Prost.
It was Judge Moore.
see article below. She did a tremendous job of obliterating the generic's argument on non infringement.
Fed. Circ. Judge 'Bewildered' Teva Got $235M Verdict Nixed
By Britain Eakin
Law360 (September 4, 2019, 6:23 PM EDT) --
A Federal Circuit judge said Wednesday she was bewildered by how Teva Pharmaceuticals persuaded a Delaware federal judge to overturn a $235 million verdict after a jury found it induced infringement of a GlaxoSmithKline LLC drug used to treat heart disease.
U.S. Circuit Judge Kimberly A. Moore said Teva Pharmaceuticals USA Inc. press releases and catalogs that said its generic drug is equivalent to Coreg — along with the drug labels instructing doctors to prescribe it for congestive heart failure — made it a clear-cut case.
"I'm quite frankly baffled. I can't imagine a stronger case for induced infringement," Judge Moore said to Teva Pharmaceuticals attorney William M. Jay of Goodwin Procter LLP. Noting that the jury's verdict got flipped when GSK moved for judgment as a matter of law following a 2017 trial, Moore said, "I'm bewildered as to how you accomplished that."
Judge Moore said two press releases Teva Pharmaceuticals circulated before and after the U.S. Food and Drug Administration approved its generic were enough by themselves to show that Teva had encouraged doctors to use the generic as a Coreg substitute.
Teva attorney Jay argued in response that testimony from a doctor during the trial indicated that physicians read press releases only to determine when a drug is going generic, not that the releases influence or determine how doctors prescribe generic drugs. Teva contends that according to the doctor's testimony, physicians don't know which generic a pharmacy will substitute for Coreg and dispense.
According to Juanita R. Brooks of Fish & Richardson PC, who represents GSK, that same doctor testified that he hadn't read the generic label because the Teva press releases led him to believe the generic drug had been approved for all uses, including congestive heart failure.
"Teva did nothing to disabuse him of that," Brooks said.
U.S. Circuit Judge Sharon Prost pushed back on that, suggesting it was "kind of on him" for not reading the label.
In court filings GSK says Teva targeted doctors who had previously prescribed Coreg with marketing materials, and says the jury rightly concluded Teva purposely encouraged those doctors to use its generic drug in the same way. In court Wednesday, attorney Brooks said Teva "intended to capture the whole market."
GSK's patent covers a method of using carvedilol, the active ingredient in Coreg, for the treatment of congestive heart failure.
In 2007 the FDA approved Teva's application to market generic carvedilol tablets. Teva had relied on a carveout that allowed it only to market the tablets to treat hypertension and left ventricular dysfunction, uses not covered by the GSK patent.
GSK had alleged in its 2014 suit that Teva changed its label in 2011 to include the treatment of congestive heart failure and induced infringement by encouraging doctors to prescribe the generic tablets for that use. Attorney Brooks said Wednesday that Teva's market share didn't increase after it changed the label, which she said is proof the company had already induced infringement.
After finding that Teva induced infringement, a Delaware federal jury found that GSK lost $234.11 million in profits and deserved an additional $1.4 million in royalties.
U.S. District Judge Leonard P. Stark reversed that finding when Teva moved for judgment as a matter of law and said GSK failed to prove that Teva's actions caused physicians to prescribe the generic tablets for heart failure treatment. Even after the label change, the judge said there was evidence that doctors relied on other factors.
According to Teva, the evidence in the case showed that both before and after it launched its generic drug, extensive medical literature, professional guidelines and experience informed doctors about the benefits of using carvedilol to treat congestive heart failure.
Representatives for Teva declined to comment.
Representatives for GSK did not return a request for comment.
The patent-in-suit is U.S. Patent No. RE40,000.
U.S. Circuit Judges Sharon Prost, Pauline Newman and Kimberly A. Moore sat on the panel.
GlaxoSmithKline is represented by Juanita R. Brooks of Fish & Richardson PC.
Teva Pharmaceuticals is represented by William M. Jay of Goodwin Procter LLP.
The case is GlaxoSmithKline LLC v. Teva Pharmaceuticals USA Inc., case number 18-1976, at the U.S. Court of Appeals for the Federal Circuit.
--Additional reporting by Matthew Bultman and Dani Kass. Editing by John Campbell.
GSK v. Teva if you want to listen to the panel of Moore, Newman & Prost hearing this case back in 2019. The recording can be found here:
http://www.cafc.uscourts.gov/oral-argument-recordings/search/audio.html?title=&field_case_number_value=18-1976&field_date_value2%5Bvalue%5D%5Bdate%5D=
appeal is 18-1976
This is a must listen!
As I mentioned before, if there has to be a rehearing, well I like our chances with this panel consisting of Newman & Moore.
Look at what one of the panel judges commented during the hearing at the CAFC. I don't know if Newman or Moore said this:
During an appeals hearing Wednesday in GSK’s suit against Teva, a federal judge on the U.S. Federal Circuit Court's panel in Washington, D.C., said she was “bewildered” by U.S. District Judge Leonard P. Stark’s decision to strike the jury's original verdict.
The Circuit Court judge, who was not identified in a recording of the proceedings, said she couldn’t “imagine a stronger case for induced infringement” of a drug’s patent. Press releases Teva issued before and after its generic Coreg approval presented its copycat as an “equivalent” to the branded drug despite GSK's patent protection, she pointed out.
https://www.fiercepharma.com/pharma/i-m-quite-frankly-baffled-teva-s-235m-patent-infringement-overturn-leaves-judge-bewildered
We will know more based on the oral arguments. Reread GSK's response:
From the filing:
GSK presented substantial evidence Teva’s partial label was not a true section viii carve-out because it left in language that instructed infringement via the post-MI LVD indication.
See GSK's response here: https://fedcircuitblog.com/wp-content/uploads/2020/12/Glaxo_Response.pdf
Correct it's just the original 3: Neman, Moore, & Prost.
Again, I like this panel for us/GSK.
This case has gotten a lot of attention so the judges probably conferred and Newman has to button up the opinion given all the attention.
JMO
Interesting. From the list of oral arguments you can see the Arellano v. Tran case was an en banc hearing.....see all the judges that presided.
Makes me think as was pointed out on this board earlier by birdman that the justices likely conferred regarding GSK v. Teva and perhaps they want Newman just to rewrite/add to her opinion; hence, the rehearing as opposed to an en banc
The panel seems to be focusing in on the partial label the period from 2008 to 2011. - The partial label period.
While a denial of a rehearing would have been ideal, I still like our (GSK's) chances to prevail at rehearing because this panel has Newman and this is the panel that ruled 2 to 1.
There are a lot of eyeballs on this case so perhaps Newman and Moore want to use it as an opportunity to write a better opinion.
Remember Teva's press release from 2007 remained on its website during the partial label period; in addition its product catalogs contained the comparison to GSK's drug.
The other thing I like is that the first trial was a jury trial and the jury came to the conclusion there was substantial evidence before the district court judge took that decision away from the jury. Courts are loathe to take cases away from a jury who sat and weighed the evidence.
I think Newman, Moore and Prost are going to press Teva on this partial label period. Teva says they carved it out whereas GSK says no you did not.
This phrase was telling from GSK's response brief.
GSK showed Teva was wrong on both points.GSK presented substantial evidence Teva’s partial label was not a true section viii carve-out because it left in language that instructed infringement via the post-MI LVD indication.
Maybe Newman will rewrite her opinion to support this notion that this was not a true Section 8 carveout.
The partial label period had press releases, promotional materials, and still language pointing to the patented method.
In short, today's news is not all so bad. If you had to pick a panel: this is an Amarin panel.
Just my two cents.
reread GSK's response brief: https://fedcircuitblog.com/wp-content/uploads/2020/12/Glaxo_Response.pdf
Very helpful thanks. So to get the "full value" we have to hold till close.....we will still be stuck with AMRN. No quickly monetizing/selling this thing upon deal announcement to move on. Hmmmmmm
hopefully it's not a long drawn out close.
Options miss out on the CVR right? (I guess unless one exercises them....)
Just thinking through all this.
A lot of moving parts here.
Thanks.
Dr. Alan Go responded to Dr. Bhatt
Thanks @DLBHATTMD and we hope the MITIGATE Study will provide insights through both its results on IPE and also on the value of its real-world pragmatic trial design that could be applied to other research questions and health care systems @KPHeartDoc
— Alan Go (@asgmd1) February 2, 2021
Thanks for sharing. What date are you targeting for those call options?
I guess I'm wondering when do we expect some report out on MITIGATE?
Generics supply from Terrapharma:
Cantor: $AMRN Overweight PT $10. Hikma publicly noted that its supply is lower than anticipated. For Teva & Reddys "We think like Hikma, supply is an issue" Di?cult/expensive to make. "We think generic competitors will eventually ?gure this out &pursue more pro?table products"
https://twitter.com/TerraPharma1?ref_src=twsrc%5Egoogle%7Ctwcamp%5Eserp%7Ctwgr%5Eauthor
They would never disclose if something was imminent.
You will find out when it hits the tape / publicly released.
You have to read between the lines / tea leaves.
JMO
hahahaha good one. :)
I've read it and I have done my analysis. Not relying on a guy who doesn't own AMRN stock anymore to do that for me.
Thanks but no thanks. :)
I know what I read and I am confident in my interpretation / analysis.
Best wishes.
Beyond incorrect. It's not a simple update.
It's amazing how someone who no longer owns AMRN stock is giving out incorrect information.
Suggest everyone do their own due diligence and do not rely on someone's interpretation who no longer owns stock of AMRN.
JMO
This is his Form 4. https://investor.amarincorp.com/static-files/8cef8c1d-9a50-4482-8cd2-049d5367d05d
Read the footnotes. These sales were effected based on a 10b5-1 Plan previously put in place by him....meaning they were planned sales for a while now and many stemmed from stock options he acquired from the 2011 Stock Incentive Plan. There are strict rules in place on when companies can modify these 10b5-1 plans to guard against insider trading, etc.
Also of note that he still has rights to approx. 1.5 mm shares.
As of the date of this Form 4, the Reporting Person owns or holds the right to acquire an aggregate of 1,537,130 Ordinary Shares of the Issuer in the form of Ordinary Shares, stock options and RSUs outstandingunder the Issuer's stock incentive plans, including but not limited to certain performance-based RSUs that are earned only if certain pre-defined operational milestones are achieved and, in certain cases, then vestonly if the recipient remains with the company for an extended period of time
Multiple reportable transactions are reported in the Form 4 including exercises of previously granted stock options, vesting of previously granted restricted stock units, and sale of certain shares. The marketsales reported in this Form 4 were effected pursuant to a Rule 10b5-1 trading plan previously adopted by the Reporting Person.
) “Company” means Amarin Corporation plc or, from and after a Change of Control, the successor to the Company in any such Change of Control.
Based on today's 8-K, I think a buyout is imminent.
I did some digging and pulled up the proxy statement from June 2020 that contains change of control provisions and severance payments. See below. Note that today's filing applies to Eligible Executives....meaning at the level of Vice President or above. These individuals would not have been covered in the proxy from June of 2020.
Moreover, if you compare the language in today's filing with the change of control language from June it seems Thero now gets paid for 24 months versus 18 before (18 assuming change of control and 12 no change of control) and there is the concept of a Multiplier which was non-existent in the proxy. This is like a special reward I guess for the BO for executives.
What was also interesting is if there is termination outside of the change of control period and without good cause or with good reason for the Executive (perhaps the executive now has to move, or change in exec's role or salary) then the terms seem more favorable with today's filing than those in the proxy from last year. For example last year's filing said 6 months of salary, where as today's says 12 months if you're an executive VP and 9 months if a VP. Thero went from 12 months to 18 months now outside of the change of control period.
Remember VPs were not covered with last year's proxy. This is a way to make certain they are taken care of with a BO.
Fasten your seat belts......things are about to get interesting.
Just my two cents. Putting it all together this seems like a sweetener for execs as the end is near.
https://seekingalpha.com/filing/5027221?utm_medium=email&utm_source=seeking_alpha&mail_subject=amrn-amarin-corporation-plc-sec-filing-proxy-statement-definitive-def-14a-june-1-2020&utm_campaign=rta-stock-filings&utm_content=link-1#D847459DDEF14A_HTM_TOC847459_38
Employment, Change of Control and Severance Arrangements
We have entered into employment agreements or arrangements with each of our named executive officers. These agreements set forth the individual’s base salary, bonus compensation, equity compensation and other employee benefits, which are described above in the “Executive Compensation Discussion and Analysis”. In addition, these agreements provide for severance payments and benefits upon a termination of employment under certain circumstances, as described below.
John F. Thero
In the event that Mr. Thero’s employment is terminated by the Company without cause or he resigns for good reason, he will be entitled to severance as follows: continuation of base salary for twelve (12) months; continuation of group health plan benefits for up to twelve (12) months to the extent authorized by and consistent with 29 U.S.C. § 1161 et seq. (commonly known as “COBRA”) with the cost of the regular premium for such benefits shared in the same relative proportion by the Company and Mr. Thero as in effect on the date of termination; and twelve (12) months of accelerated vesting of all outstanding equity incentive awards to the extent subject to time-based vesting. In lieu of the foregoing, if Mr. Thero’s employment is terminated by the Company without cause or he resigns for good reason, in either case, within twenty-four (24) months following a change of control, he will be entitled to severance as follows: continuation of base salary for eighteen (18) months; continuation of group health plan benefits for up to eighteen (18) months to the extent authorized by and consistent with COBRA with the cost of the regular premium for such benefits shared in the same relative proportion by the Company and Mr. Thero as in effect on the date of termination; a lump sum cash payment equal to the full target annual performance bonus for the year during which the termination occurred; and 100% acceleration of vesting of all outstanding equity incentive awards. Receipt of the severance payments and benefits is subject to the execution and effectiveness of a separation agreement in a form acceptable to the Company which shall include a release of claims against the Company and related persons and entities.
Joseph T. Kennedy
In the event that Mr. Kennedy’s employment is terminated by the Company without cause, he will be entitled to severance as follows: continuation of base salary for six (6) months; continuation of group health plan
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benefits for up to six (6) months to the extent authorized by and consistent with COBRA with the cost of the regular premium for such benefits shared in the same relative proportion by the Company and Mr. Kennedy as in effect on the date of termination; and six (6) months of accelerated vesting of all outstanding equity incentive awards to the extent subject to time-based vesting. In lieu of the foregoing, if Mr. Kennedy’s employment is terminated by the Company without cause or he resigns for good reason, in either case, within twenty-four (24) months following a change of control, then he will be entitled to severance as follows: continuation of base salary for twelve (12) months; continuation of group health plan benefits for up to twelve (12) months to the extent authorized by and consistent with COBRA with the cost of the regular premium for such benefits shared in the same relative proportion by the Company and Mr. Kennedy as in effect on the date of termination; a lump sum cash payment equal to the full target annual performance bonus for the year during which the termination occurred; and 100% acceleration of vesting of all outstanding equity incentive awards. Receipt of the severance payments and benefits is subject to the execution and effectiveness of a separation agreement in a form acceptable to the Company which shall include a release of claims against the Company and related persons and entities.
Steven B. Ketchum, Ph.D.
In the event that Dr. Ketchum’s employment is terminated by the Company without cause, he will be entitled to severance as follows: continuation of base salary for six (6) months; continuation of group health plan benefits for up to six (6) months to the extent authorized by and consistent with COBRA with the cost of the regular premium for such benefits shared in the same relative proportion by the Company and Dr. Ketchum as in effect on the date of termination; and six (6) months of accelerated vesting of all outstanding equity incentive awards to the extent subject to time-based vesting. In lieu of the foregoing, if Dr. Ketchum’s employment is terminated by the Company without cause or he resigns for good reason, in either case, within twenty-four (24) months following a change of control, then he will be entitled to severance as follows: continuation of base salary for twelve (12) months; continuation of group health plan benefits for up to twelve (12) months to the extent authorized by and consistent with COBRA with the cost of the regular premium for such benefits shared in the same relative proportion by the Company and Dr. Ketchum as in effect on the date of termination; a lump sum cash payment equal to the full target annual performance bonus for the year during which the termination occurred; and 100% acceleration of vesting of all outstanding equity incentive awards. Receipt of the severance payments and benefits is subject to the execution and effectiveness of a separation agreement in a form acceptable to the Company which shall include a release of claims against the Company and related persons and entities.
Michael W. Kalb
In the event that Mr. Kalb’s employment is terminated by the Company without cause, he will be entitled to severance as follows: continuation of base salary for six (6) months; continuation of group health plan benefits for up to six (6) months to the extent authorized by and consistent with COBRA with the cost of the regular premium for such benefits shared in the same relative proportion by the Company and Mr. Kalb as in effect on the date of termination; and six (6) months of accelerated vesting on all outstanding equity incentive awards to the extent subject to time-based vesting. In lieu of the foregoing, in the event that Mr. Kalb is terminated without cause or he resigns for good reason, in either case, within twenty-four (24) months following a change of control, he will be entitled to severance as follows: continuation of base salary for twelve (12) months; continuation of group health plan benefits for up to twelve (12) months to the extent authorized by and consistent with COBRA with the cost of the regular premium for such benefits shared in the same relative proportion by the Company and Mr. Kalb as in effect on the date of termination; a lump sum cash payment equal to the full target annual performance bonus for the year during which the termination occurred; and 100% acceleration of vesting on all outstanding equity incentive awards. Receipt of the severance payments and benefits is subject to the execution and effectiveness of a separation agreement in a form acceptable to the Company which shall include a release of claims against the Company and related persons and entities.
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Aaron D. Berg
In the event that Mr. Berg’s employment is terminated by the Company without cause, he will be entitled to severance as follows: continuation of base salary for six (6) months; continuation of group health plan benefits for up to six (6) months to the extent authorized by and consistent with COBRA with the cost of the regular premium for such benefits shared in the same relative proportion by the Company and Mr. Berg as in effect on the date of termination; and six (6) months of accelerated vesting of all outstanding equity incentive awards to the extent subject to time-based vesting. In lieu of the foregoing, if Mr. Berg’s employment is terminated by the Company without cause or he resigns for good reason, in either case, within twenty-four (24) months following a change of control, then he will be entitled to severance as follows: continuation of base salary for twelve (12) months; continuation of group health plan benefits for up to twelve (12) months to the extent authorized by and consistent with COBRA with the cost of the regular premium for such benefits shared in the same relative proportion by the Company and Mr. Berg as in effect on the date of termination; a lump sum cash payment equal to the full target annual performance bonus for the year during which the termination occurred; and 100% acceleration of vesting of all outstanding equity incentive awards. Receipt of the severance payments and benefits is subject to the execution and effectiveness of a separation agreement in a form acceptable to the Company which shall include a release of claims against the Company and related persons and entities.
Ha. Bring it on. We've all been waiting for this.
Do you think it happens before March 31st? or April 30th?
It seems there is a lot of volume in the $8 and $9 calls for next week.
Can you post the link you are looking at?
That's great. More evidence for the current lawsuit. Please keep sending those in to IR at Amarin.
It's direct evidence.
Great post!!
Wow. You should share this with Amarin IR.
Here's something to ponder: if you are Health Net do you continue to operate as is or do you now cease coverage of CV indication for Hikma....
The walls may be closing in on Hikma faster than imagined.
The plot thickens
Adding Health Net was genius. What's this one drug and this lawsuit to Health Net....a nuisance. But to Hikma having rights / access to the REDUCE-IT indication means a lot.
So what better way to choke off the air of Hikma than by bringing in another party who will want nothing to do with this infringement suit. Meaning it compels insurance companies to behave or be on the lookout to sit at the table with Hikma as a party to this lawsuit.
I assure you the general counsel of Health Net today is answering some questions today that will cause this person to do a quick risk calculus on whether it makes sense to continue without changing course.
It's a hornet's nest.
Assuming generics can get the product. My friend just told me CVS in Southern California does not have the generic. It's not available.
Excellent post.
Thanks. This is great. The question is does an insurance firm want to get wrapped in this hornet's nest that Hikma is bringing about. There are hundreds of other drugs.....the insurance company and others who will be on notice now have to be thinking...is this worth it to us?
Hikma what have you dragged us into?
Just great. Let's hope Amarin management can get a deal done (BO) before the market turns south.
Just another thing us investors in AMRN have to worry about derailing our exit plans.
We need Amarin discussed on Wall Street bets reddit forum to bring in new investors to take us higher.
That's where all the younger traders are hanging out and sharing ideas. You should see what they did to Game Stop this week.