HDGabor

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HDGabor

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HDGabor

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HDGabor

01/21/20 7:00 PM

Post #242700 on Amarin Corp Plc (AMRN)

K-

I agree with every letter.

IIRC other poster said the same … unfortunately he is an ESL and his message did not go through…. smile (Just like in case of the litigation).

Best,
G

HDGabor

01/20/20 9:22 PM

Post #242550 on Amarin Corp Plc (AMRN)

May I ask how you know obviousness is non precedential?

Because it could not. Every cases - about patent obviousness - is unique … otherwise it could not be a patent.

Also, do you have any prior example of a decision within one month?

Nope. (It was based on statistic, based on average.)

Best,
G

HDGabor

01/20/20 8:50 PM

Post #242543 on Amarin Corp Plc (AMRN)

these cases have no “due date” and I was wondering how we know the ruling doesn’t come end of year etc.

True: no due date.

The written judgement is normally issued between 3 – 5 months after a trial, however, when cases that are considered non-precedential, written judgements are often issued swiftly, within 1-month.

The case is "simple" (*) a quicker than usual judgement is a real possibility.

(*)
- the topic is limited (inducement and obviousness)
- obviousness is non-precedential
- inducement is basically limited to encourage "at least 12-week"

Best,
G

HDGabor

01/20/20 4:59 PM

Post #242513 on Amarin Corp Plc (AMRN)

A layman summary of the patent case (Part 2; see Part 1 here)
[Mod - who sticked Part 1 - please replace with this]

Plaintiff: Amarin
Defendant: Generics (Hikma & Dr. Reddy)

The litigation is about the MARINE
(i) Patents (obviousness)
(ii) Indication / label (infringement)

REDUCE-IT indication (label); usage (treatment; off-label), study (other than support non-obviousness) and patents are not relevant. (E.g. Existence of direct infringement by physicians – treating patients for CVE is not enough without inducement … and MARINE label (package insert) does not encourage treatment for CVE).
Nothing – other than the MARINE label – is relevant regarding infringement. Hikma JPM presentation (which is not a forecast or Hikma’s expected revenue; see more details about it here or Generics "real aim", (unspecific) intent or knowledge of off-label usage does not matter. (See more below at; “Inducement”)

The topic of the litigation is obviousness and infringement. I will focus on infringement, since I see obviousness as the easier (easy) part, as Generics bear the burden of proving patents are obvious. They refer to small studies, small pieces (as prior art) that are - maximum - good to raise questions, to establish theories but these are not (are far away from) a “clear-and-convincing-evidence(s)”, does not prove anything. Furthermore, many secondary considerations support non-obviousness.

Secondary considerations are a reality check on the determination reached through three factual inquiries [(1) Determining the scope and content of the prior art.; (2) Ascertaining the differences between the claimed invention and the prior art.; (3) Resolving the level of ordinary skill in the pertinent art].
The invention may appear on paper to be obvious, but if reality does not match theory then the invention can be established as being non-obvious.

[“Secondary considerations” often come later (or secondary) in time but it does not mean that it is secondary in importance,” may often be the most probative and cogent evidence in the record”. Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1538 (Fed Cir. 1983).

Courts consider the following secondary considerations in determining obviousness:
(1) The invention’s commercial success,
(2) Long felt but unresolved needs,
(3) The failure of others,
(4) Skepticism by experts,
(5) Praise by others,
(6) Teaching away by others,
(7) Recognition of a problem,
(8) Copying of the invention by competitors, and
(9) Other relevant factors.]

Infringement

The issue is “around” the 12-weeks (but not as most of the people think … see more at contributory and induced infringement below).

Meanwhile the patent contains the explicit definition about treatment duration, admittedly present in all asserted claims (“requires administering icosapent [another name for EPA] to a patient with severe hypertriglyceridemia (TG ≥500 mg/dL) for at least 12 weeks.”) the label does not.

The infringement could be (in this case … other types – e.g.: the Willful Infringement, Literal Infringement – are not a topic):
1. Direct
2. Indirect
2.1. Contributory
2.2. Induced (Inducement)

The Federal Circuit determined that while both physicians and patients could be the direct infringers the ANDA filer could not be but the ANDA filer could be liable for indirect infringement. Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., 845 F.3d 1357 (Fed. Cir. 2017). It is the case here also: “Defendants cannot directly infringe them—as method claims, they can only be infringed if a doctor were to treat a patient using one of Defendants’ ANDA drugs.”. Amarin Pharma Inc. et al v. Hikma Pharmaceuticals USA Inc. et al; D278.

Amarin claimed (i) contributory and (ii) induced infringement (both are indirect). “Plaintiffs allege that Defendants either induce infringement of, or contributorily infringe.” Amarin Pharma Inc. et al v. Hikma Pharmaceuticals USA Inc. et al; D278.

Amarin bear the burden of proving patent infringement.

This is true whether the patent owner initiated the lawsuit by suing for infringement or the accused infringer initiated the suit by seeking a declaratory judgment that it does not infringe the patent or that the patent is invalid or both. Medtronic, Inc. v. Mirowski Family Ventures, LLC, (U.S. Supreme Court, 2013).

(i) Contributory

Generics contributorily infringes a method patent when the Generic: (1) knows its product is “made or especially adapted for use in an infringement of” that method patent; and (2) the product is “not a staple article or commodity of commerce suitable for substantial non infringing use.”
There is no real dispute that Vascepa [V] — and therefore Generics’ ANDA drugs [GV] — are, and can be for legitimate reasons, prescribed for fewer than 12 weeks. That means that reducing triglycerides in less than 12 weeks using Generics’ ANDA drugs is a substantial non-infringing use of those drugs. The existence of this substantial non-infringing use for Generics’ ANDA drugs therefore defeats Plaintiffs’ contributory infringement claim. Because there is no genuine dispute of material fact on this issue, the Court granted Generics summary judgment that, they do not contributorily infringe Plaintiffs’ Asserted Claims. Amarin Pharma Inc. et al v. Hikma Pharmaceuticals USA Inc. et al; D278.

The less than / more than 12 weeks were relevant for this only. Based on experts’ testimony less than 12 weeks treatment exist, it is substantial and the patents do not cover it.

(ii) Inducement

To determine induced infringement the prerequisites are the existence of
(1) Direct infringement (by physician or other health care provider of the patient) AND
(2) Specific intent, encouragement (by Generics) for direct infringement. "inducement requires evidence of culpable conduct, directed to encouraging another's infringement, not merely that the inducer had knowledge of the direct infringer's activities." DSU Med. Corp. v. JMS Co., 471 F.3d 1293, 1306 (Fed.Cir.2006). The culpable conduct is the wording of a drug label (see below).

"In order to prevail on an inducement claim, the patentee must establish first that there has been direct infringement, and second that the alleged infringer knowingly induced infringement and possessed specific intent to encourage another's infringement." ACCO Brands, Inc. v. ABA Locks Mfrs. Co., 501 F.3d 1307, 1312 (Fed.Cir.2007)

Inducement is not about how prescribing doctors use V, how long is the treatment. It is beyond dispute that the majority (>95%) of the physicians prescribe V (and / or will prescribe GV) longer than 12 weeks (Generics have “knowledge of the direct infringer's activities”). but is about why they prescribe it for longer than 12 weeks?

In this type of Hatch-Waxman Act patent litigation, where Generics have filed ANDAs, the question of whether Generics may be held liable for inducing infringement turns on whether Generics “have the specific intent, based on the contents of their proposed labels, to encourage physicians to use their proposed ANDA products” Grunenthal GMBH v. Alkem Labs. Ltd., 919 F.3d 1333, 1339 (Fed. Cir. 2019). in a way that (the physician) infringes the asserted claims. In other words, the Court must ask whether the label encourages, recommends, or promotes infringement. In addition, because the asserted claims are method claims, the “pertinent question is whether the proposed label instructs users to perform the patented method.” AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042, 1060 (Fed.Cir.2010).

The question comes down to whether or not the label is the cause (for longer than 12 weeks treatment) or not, since that is the way how the Generics could commit inducement, the one and only way how Generics could encourage, recommend, or promote infringement (by physicians).

The label does not have to encourage all physicians it is sufficient that Generics' labels will encourage some physicians to prescribe GV to patients for longer than 12 weeks and will thus inevitably lead to infringing uses. "Even if [Defendant] were correct that the [language in the label] may be applied to other dosing regimens, the language ... would inevitably lead some consumers to practice the claimed method." AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042, 1060 (Fed.Cir.2010).

Argument (regarding inducement)

Generics argue they will not induce infringement of the asserted claims because their proposed labelling, which mirrors Amarin’s (MARINE label), does not encourage doctors to prescribe the drug for at least 12 weeks.

(i) Chronic condition

Generics argue, “the most common causes of severe hypertriglyceridemia are not chronic or immutable factors. Rather, the causes can be acute and short-term”. Both parties’ experts agree that this indication is not limited to treating chronic forms of severe hypertriglyceridemia. Doctors can (and do) prescribe Vascepa for non-chronic forms of severe hypertriglyceridemia.

Generic did not disprove – more precisely admitted – that severe hypertriglyceridemia could be chronic. (E.g., genetics could be the cause … what else is chronic if genetic is not …)

Generics argue, that “regardless of whether the condition is chronic, it often does not require drug treatment for at least 12 weeks.”

“often does not require” means it requires in other cases (see below: (ii)

Regarding the treatment of chronic condition, “The Court finds this argument intuitively persuasive—chronic conditions require indefinite treatment

(ii) When taken in conjunction with a lipid-lowering diet, as required by the label, Vascepa® reduces triglyceride levels below 500 mg/dL in only four weeks. Some patients may be able to follow the indication for Vascepa® and Defendants’ ANDA products and lower their triglyceride levels below 500 mg/dL with a short course of the drug in conjunction with diet and exercise, and then maintain such levels through diet and exercise alone.

Amarin’s MARINE study showed that about 21% of patients in the placebo arm were able to achieve and maintain levels below 500 mg/dL with diet and exercise alone. These 21% will not get V but the remaining 79% will.
Meanwhile some patients may be able to lower their triglyceride levels below 500 mg/dL with a short course of the drug in conjunction with diet and exercise, and then maintain such levels through diet and exercise alone … (i) not all of them and (ii) not all of them able to lower their triglyceride levels below 500 mg/dL within 12 weeks.
These should be treated with V for longer than 12 weeks to maintain (or lower) their triglyceride levels below 500 mg/dL in conjunction with diet and exercise.

In this case the label contains “reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia” (aka below TG 500) meanwhile the patent contains “requires administering icosapent [another name for EPA] to a patient with severe hypertriglyceridemia (TG ≥500 mg/dL) for at least 12 weeks.”.

Inducement need not be premised on explicit instructions to perform the infringing method, where the proposed label "would inevitably lead some consumers to practice the claimed invention." In case of “Pulmicort respules”® the label contains “titrate down” meanwhile the patent contains “once daily.” administration. The court concluded that, for patients the downward-titration language would necessarily lead patients to use the drug once daily. AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042 (Fed.Cir.2010)

For patients who could not lower their triglyceride levels below 500 mg/dL within 12 weeks or could not maintain such levels despite “an appropriate lipid-lowering diet and exercise regimen” the treatment will be longer than 12 weeks. … the “lack of result” (triglyceride levels stay above 500 mg/dL at 12 weeks) would necessarily lead patients to use the drug for more than 12 weeks.

(iii) “Indications and Usage” & “Dosage and Administration” section [Sections] vs. full label (package insert)

Generics argue that “[t]he “Indications and Usage” section of Defendants’ labels is silent as to the duration of icosapent drug treatment.”.

The District of Delaware found induced infringement based on a clinical trial described in the label. (Note [Generics noted also]: In that case the “Indications and Usage” section contains an explicit reference: “see Clinical Studies (14)”.) Sanofi v. Glenmark Pharm. Inc., USA, 204 F. Supp. 3d 665 (D. Del.2016). The prescribing physician would read the (full) label before prescribing it to patients … explicit reference to the “Clinical Studies” section is not necessary. Theory of inducement does not require a prescribing physician to look outside the label or go on the type of "scholarly scavenger hunt", all that inducement essentially requires is that a prescribing physician actually read the label.

The “14. Clinical Studies” section is the “ section must discuss those clinical studies that facilitate an understanding of how to use the drug safely and effectively.” Based on MARINE study the prescribing physician will understand that the adequate treatment duration is (at least) 12 weeks.

The label (14. Clinical Studies) encourages, recommends and promotes 12 weeks treatment.
(Note: The label does not contain any data about less than 12 weeks treatment, does not encourages, , recommends or promotes less than 12 weeks treatment.)

(iv) (Primarily) Rely on Takeda Pharm. U.S.A., Inc. v. W.-Ward Pharm. Corp.,785 F.3d 625, 632 (Fed. Cir. 2015) … the proposed labelling lacks specific statements that encourage or will inevitably lead to infringement

The Court is not persuaded. The expert testimony in Takeda (and in Defendants’ supplemental authority (ECF No. 273-1), HZNP Medicines LLC v. Actavis Laboratories UT, Inc., — F.3d. —, 2019 WL 5076226, *15-18 (Fed. Cir. Oct. 10, 2019)), provided an implausible interpretation of the labelling in an attempt to show induced infringement of the asserted patent claims, whereas here, Amarin’s expert testimony offers a plausible interpretation of the labelling that suggests the Court could find induced infringement.

(v) Generics further argued that because of the likelihood of a substantial number of non-infringing uses of GV, inducement cannot be implied or inferred. Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1365 (Fed. Cir. 2003)

Generics are wrong as:
a.) While it is true that in Warner-Lambert there was evidence of significant non-infringing use (as high as 89% of the total) and the Federal Circuit had found that there was no infringement under 35 U.S.C. § 271(b), the case was very different. Importantly the alleged infringing act was not promoted by the label. (Apotex was seeking FDA approval for an equivalent of Warner-Lambert’s Neurontin® (active ingredient gabapentin) to treat partial seizures, but only after the patent protecting Neurontin® for the same use had expired.)
b.) The statute addressing inducement of infringement does not contain a “substantial non-infringing use” restriction.
c.) The Supreme Court of the United States has held the opposite, finding that a person can be liable for inducing an infringing use of a product even if the product has substantial non-infringing use. MGM Studios, Inc. v. Grokster, Ltd., 545 U.S. 913 (2005).

Defendants had been failed two times already.

(i) Summary Judgement was denied as “Plaintiffs’ proffered expert testimony creates a genuine issue of material fact inappropriate for resolution at summary judgment as to “whether the label encourages, recommends, or promotes infringement.”” and ““The purpose of summary judgment is to avoid unnecessary trials when there is no dispute as to the facts before the court.” … The Court finds it more appropriate to consider expert testimony from both sides as to whether induced infringement may be inferred from the labelling at the upcoming bench trial, and resolve the meaning of the labelling at trial.”
(Note: the “burden of proof” to deny Summary Judgement is lower than at trial … Amarin did not have to prove inducement … existing dispute was enough to discuss the inducement at trial.)

(ii) Generics' Motion to dismiss immediately the induced infringement claim (Trial, 01/14) was denied as "the plaintiff has met the initial burden of proof."

- - - - - - - - -
I do not have first have info about the trial (other than Jefferies Daily Coverage – which was silent about how Jonathan Scheinberg (Generics’s expert regarding inducement) examination went on Day 2/3, TheWyseKid’s post on ST and relocatedmetsfan post about Day 2)

but:
- They are ahead of schedule
- The topic was / will be the obviousness (Generics’ experts) on Friday and (at least) on Monday
- The examination of Amarin obviousness experts will come next (?) by late Monday and /or during week Jan 27.
- Looks like Carl Peck, M.D. (Amarin) and Peter R. Mathers (Generics) will not testify (“the Court will let Dr. Peck testify in rebuttal to Dr. Sheinberg if Dr. Sheinberg opines about "the scope of FDA approval reflected in the Vascepa label[.]"”

Maybe the (basic / core) discussion about inducement is over …

- - - - - - - - -

Based on these

I think Amarin’s chance is good; probability of the win is high … however, it is not a sure thing

But my opinion is irrelevant … At the end of the day the only person that opinion matters is the judge.

(Note: I tried to be as clear as I could … if you disagree with something: please check / read my basis, references first.)

Best,
G

ps.: If you are not persuaded by me than read a “respected” Research who concluded

Our takeaway on these points is that Judge Du will find Defendants’ ANDA labels as inducing infringement regarding the “for at least 12-weeks” mention in the Vascepa patent claims.

HDGabor

01/20/20 10:39 AM

Post #242461 on Amarin Corp Plc (AMRN)

h-

No, not Dr. Lavin.

IIRC:
- two experts (one by each side)
- both are regulatory expert
- at least one of them (maybe both) was (were) on FDA payroll (not currently but during his / their carrier)
- originally was planned to testify during the trial but the parties agreed that none of them is necessary / required

Best,
G

HDGabor

01/20/20 8:49 AM

Post #242447 on Amarin Corp Plc (AMRN)

IIRC two experts (one by each side) were "withdrawn" … will not testify during the trial … but I could not recall the names / find the relevant post

Does anybody remember the names? (Could link the relevant post?)

Best,
G

HDGabor

01/20/20 7:31 AM

Post #242442 on Amarin Corp Plc (AMRN)

O-

Unless I missed it, is HDG's analysis still pending??

Yes … I was "lazy" during the weekend (and I would like to cover "everything" … including posts re. infringement - that are bookmarked).

I completely agree … Everyone here understands precisely what this drug is, but this set of commercials does zero to impart any of that awareness to the average Joe.

My thoughts / view: As you wrote "Everyone here understands" … The average Joe (and the average Dr. Joe) does not …

Like it or not the average see Vascepa as one of the fish oil … the real waste of money is to start the campaign with "pure" Vascepa / CVD message …

I think - and I am fine with it - they would like to build it up … teach / educate the public … the "pure" Vascepa / CVD message will be effective when the public will take it as it should be.

Best,
G

HDGabor

01/19/20 2:28 PM

Post #242332 on Amarin Corp Plc (AMRN)

HDGabor would come forth with his reasoning why despite the convincing arguments he is making for AMRN losing the case on inducement

Meanwhile I am ESL Z think my view on the trial(see below) is clear. I do not have any idea how you could interpret it "as AMRN losing the case on inducement" … .

I think Amarin’s chance is good; probability of the win is high … however, it is not a sure thing

I did not say anything else about the outcome …

Best,
G

ps.:

Then you state that you are preparing an analysis for a positive outcome just to withdraw a couple of days later.

withdraw?

HDGabor

01/19/20 10:13 AM

Post #242282 on Amarin Corp Plc (AMRN)

still waiting for your case why AMRN should prevail in the trail

Do not stop …

All you do is refuting any argument

I just point that these argument (at least partially) usually totally are wrong due to wrong basis.

e.g.: TTE- considered my post as an attack … after DD he posted the "same" conclusion … (regarding inducement / label)

Best,
G

HDGabor

01/18/20 2:05 PM

Post #242214 on Amarin Corp Plc (AMRN)

T-

Congratulation. You are not there but closer to the answer …

there was literally NOTHING in the case regarding actual actions taken by the generic makers that constituted live inducement (my boldings) -- it was the label itself that was the culprit in the end

In case of an ANDA litigation the action that constitutes inducement is the label itself … never, ever anything other. Generics encourage (induce) prescribers by the label …. the Court determined inducement - in every cases - based on the label.

If memory serves, there is no issue of contributory infringement here.

Correct … as Amarin's contributory infringement claim was denied, Generics Motion for Summary Judgement (about contributory infringement) was granted due to " "substantial noninfringing uses".

Best,
G

HDGabor

01/18/20 11:52 AM

Post #242185 on Amarin Corp Plc (AMRN)

T- (ps.: MontanaState83)

Barry v. Medtronic, Inc., 914 F.3d 1310, 1334 (Fed. Cir. 2019) (“‘The patentee must also show that the alleged infringer possessed the requisite intent to induce infringement, which we have held requires that the alleged infringer knew or should have known his actions would induce actual infringements.’ ‘Circumstantial evidence can support a finding of specific intent to induce infringement.’ ‘[I]nducement can be found where there is [e]vidence of active steps taken to encourage direct infringement, which can in turn be found in advertising an infringing use or instructing how to engage in an infringing use.’” (citations omitted))

Thx … Your quote says the SAME what I said: know or should have known that the infringement would occur is not enough. Direct infringement is a prerequisite of inducement. ("induce infringement, which we have held requires that the alleged infringer knew or should have known his actions would induce actual infringements")

You can't cherry pick one precedential cite and say THAT's the one that governs everything.

If you read enough documents, makes a deep DD you will realize that most of the case reference based on one (sometimes a combination of more than one), original case.

The case you cited isn't even an ANDA case

The type of the case is irrelevant for the legal standard of inducement.

You, by the way, take the approach I would never have my lawyers take in court. You're the know-it-all who generates ill will with the observers.

Yes, I know I am harsh (is not polite) but it is not intentional. Sorry for I could understand / interpret what I read / quote … I see / understand why you are angry but it is not my fault …

Best,
G

ps.: MontanaState83-

Still working … 3 pages and it is the summary / description of the case / situation only. I read / interpret (!) most of the references (other litigation) … "soon" … please mark the "".

HDGabor

01/18/20 10:59 AM

Post #242174 on Amarin Corp Plc (AMRN)

T-

it hinges largely on whether they know or should have known that the infringement would occur.

Wrong.

inducement requires evidence of culpable conduct, directed to encouraging another's infringement, not merely that the inducer had knowledge of the direct infringer's activities.

DSU Med. Corp. v. JMS Co., 471 F.3d 1293, 1306 (Fed.Cir.2006)

Best,
G

HDGabor

01/18/20 9:07 AM

Post #242159 on Amarin Corp Plc (AMRN)

This is essentially a semantic discussion

If I understand you correctly … all lawyers, judges, courts (inc. U.S. Supreme Court) in the World are wrong, acc. to you "more sensible wording" should be applied … because you are confused, do not understand the existing situation, determination.

LMAO … The Black Knight is nowhere near to you.

Best,
G

FYI: Direct infringement occurs where a claimed method are performed … it is the administration of the drug (by physicians)

HDGabor

01/18/20 5:17 AM

Post #242143 on Amarin Corp Plc (AMRN)

I disagree with you...Docs are not the infringers...nor are the patients, who use the drug...

You disagree with me … and with the Federal Circuit … and with the U.S. Supreme Court

both physicians and patients were the direct infringers, the ANDA filer was liable for inducing infringement by the physicians.

physicians would directly infringe the patent claims, and the generic drug manufacturer defendants would induce such infringement because their drug labeling instructs physicians to follow the patented regimen

Induced Infringement of Method of Treatment Claims: Does “United We Stand, Divided We Fall” Really Apply?

Physicians’ Direction or Control Over Patients’ Drug Administration Results in Finding of Induced Infringement Against Generic Drug Manufacturers

What do you think about: make some DD, check facts before disagree …

Best,
G

HDGabor

01/17/20 4:59 PM

Post #242045 on Amarin Corp Plc (AMRN)

some doctors prescribe such generic Vascepa to their patients for 3 months (>12 weeks), do the generic companies commit induced infringement?

Nope. Existence of direct infringement (prescription by a doctor) is not enough for inducement.

Best,
G

HDGabor

01/17/20 4:57 PM

Post #242044 on Amarin Corp Plc (AMRN)

B-

With Hikma presentation, Judge could reconsider summary judgment that fell in their favor. … This would open up more inducement arguments for Amarin..

Inducement could be committed by the label not by a company presentation.

When the “market” estimates increased ONLY after R-I approval it is the smoking gun regarding inducement of off-labels.

Seriously:
- it was not an estimates (other than the written prescriptions are estimates)
- it was about the past not about the future
- it increased BEFORE R-IT approval … check the footnotes in both presentation

Some help:

Current US market size ($ m) 1

1 IQVIA US MAT October 2019

(i) it is not a revenue for Hikma but the total market
(ii) it was not calculated by the Generics but by IQVIA
(iii) it is not a projection / prediction but a fact (current market … past period)
(iv) MAT is Moving annual total … over the course of the previous 12 months. … aka October 2018 - September 2019 (or November 2018 - October 2019)
(v) $752M is not a Net Revenue but a Gross Revenue … calculated from prescription and WSP ($300+) … and again: by IQVIA
(vi) At the time of IQVIA calculation - October 2019 - the label was MARINE only … no question that the majority of the market belongs to off-label usage but "officially" it is a market size with MARINE label (at October 2019 … and MAT)

It is a number from IQVIA for the previous 12 months.

Best,
G

HDGabor

01/17/20 4:51 PM

Post #242041 on Amarin Corp Plc (AMRN)

O-

If you can, please detail how H-W carve out is beaten back in this case and how you think Judge will rationalize that.

H-W carve out is not relevant (is not a case) in the current litigation … in case of the submitted ANDAs.

Best,
G

HDGabor

01/17/20 4:49 PM

Post #242039 on Amarin Corp Plc (AMRN)

O-

That might break new ground - but how can all the players argue it is incorrect? If docs want to prescribe off-label, they need to use the branded product.

I think that is not possible … furthermore doc could prescribe anything off-label, they do not have to use branded product.

Best,
G

HDGabor

01/17/20 4:43 PM

Post #242037 on Amarin Corp Plc (AMRN)

1) You explained the issues and the risks (possible trouble).

Not exactly … I (tried to) pointed to fata morgana … e.g. inducement (sic!) by off-label (e.g. R-IT) usage; HIKMA "forecast"

The missing link is WHY you think that Amarin will win, despite #1.

I wrote … Coming "soon". Abstract:

I will focus on infringement, since I see obviousness as the easier (easy) part. Meanwhile generics could refer to small studies, small pieces these are - maximum - good to raise questions, to establish theory but these are not (are far away from) a “clear-and-convincing-evidence(s)”.

But first of all I try to clean up the garbage … try to explain what about is the the case / the inducement … (shortly: about the written label … about the interpretation of the written label … nothing more).

Best,
G

HDGabor

01/17/20 4:37 PM

Post #242034 on Amarin Corp Plc (AMRN)

O-

That would likely result in some legal screams/appeals, but would merely formalize the H-W carve out provision, wouldn't it?? How could generics argue that point, since they are presently arguing the opposite?

HWA allow to carve-out an indication (if more than one are on the label) but does not allow to modify the indication. Generis' label has to be (substantially) the same (per indication) as the label of the brand drug.

Best,
G

HDGabor

01/17/20 4:34 PM

Post #242033 on Amarin Corp Plc (AMRN)

This is confusing... but the parties, who are infringing on Amarin's patents are the generics...the Docs are not the infringers

You could be confused but it is not confusing.

- Docs are the DIRECT infringers
- Generics are the indirect (inc. inducement) infringers

by their announcements of their prospective goals of $70 million ....

Seriously: Did you read my post entirely?

To you … and to all: Our disclosed Generics Paragraph IV pipeline
Quote:

Current US market size ($ m) 1

Quote:

1 IQVIA US MAT October 2019

(i) it is not a revenue for Hikma but the total market
(ii) it was not calculated by the Generics but by IQVIA
(iii) it is not a projection / prediction but a fact (current market … past period)
(iv) MAT is Moving annual total … over the course of the previous 12 months. … aka October 2018 - September 2019 (or November 2018 - October 2019)
(v) $752M is not a Net Revenue but a Gross Revenue … calculated from prescription and WSP ($300+) … and again: by IQVIA
(vi) At the time of IQVIA calculation - October 2019 - the label was MARINE only … no question that the majority of the market belongs to off-label usage but "officially" it is a market size with MARINE label (at October 2019 … and MAT)

It is a number from IQVIA for the previous 12 months.

Best,
G

HDGabor

01/17/20 4:29 PM

Post #242029 on Amarin Corp Plc (AMRN)

R-

I see that they burden the proof of infringement but this is inducement does that change the dynamic?

Infringement could be:
1. direct
2. Indirect -> could be

2.1 Contributory
2.2 Induced (inducement)

So: No.

Best,
G

HDGabor

01/17/20 4:24 PM

Post #242025 on Amarin Corp Plc (AMRN)

JL-

First of all:

I did not claim they made any claim...Where did you get the notion I said that.

I did not want to put anything in your mouth, it was simple re. your post

They of course are playing "Mickey the Dunce" and claim they have no reason to believe physicians will convert the scripts off label...

nothing more … nothing bad.

Others on this board have stated that infringement by inducement does not need the label..But merely creating the circumstances where inducement is likely...and this seems to be the case here..Your argument dimisses the importance of common sense and reality..

Yes others stated … but did you realized that my arguments are a citation of Judges / Courts … read again my post(s) … if necessary ask your daughter, she will help you to understand.

I guess we can assume you think Amarin is going to lose the case..

No assumption is necessary … do not have to be a Wizards of Oz to understand a simple sentences … my opinion about the outcome:

I think Amarin’s chance is good; probability of the win is high … however, it is not a sure thing

Best,
G

HDGabor

01/17/20 4:13 PM

Post #242019 on Amarin Corp Plc (AMRN)

O-

If AMRN was silent on >12 weeks or treatment duration in general, could the generics have even filed an ANDA?

(I guess, yes but) Do you mean in the patents? They could filed an ANDA but their chance - to win the patent litigation - would be like a chance of a German spy in a Russian film …

Is it possible Judge awards generics rights to only limited use?

Nope. All (full MARINE) or nothing.

Best,
G

HDGabor

01/17/20 4:08 PM

Post #242015 on Amarin Corp Plc (AMRN)

M-

HDG likes to reiterate the legalese involved here, but he continues to think Amarin's chances of winning are a high probability.

Thx. exactly.

I did not say anything else about the trial outcome other than

I think Amarin’s chance is good; probability of the win is high … however, it is not a sure thing

People mixing opinion with facts … hate to realize fata morgana …

Best,
G

HDGabor

01/17/20 4:03 PM

Post #242013 on Amarin Corp Plc (AMRN)

To Whom It May Concern …

It looks like Amarin Corporation plc pays its CEO less than similar sized companies.

John Thero is paid less than what is normal at similar size companies, and the total shareholder return has been pleasing over the last three years.

Does Amarin Corporation plc's (NASDAQ:AMRN) CEO Pay Matter?

Best,
G

HDGabor

01/17/20 12:51 PM

Post #241933 on Amarin Corp Plc (AMRN)

JL-

They say they are only interested in the NDA (Marine label)...Common sense and reason suggest their real aim or understanding is that clinicians will use their cheaper generic Vascepa for the R-I indication..They of course are playing "Mickey the Dunce" and claim they have no reason to believe physicians will convert the scripts off label...When clearly they and everyone else knows that is what will happen..Precedence clearly indicate this is infringement by inducement...

(i) They did not claim - and they do not have to - claim they have no reason to believe physicians will convert the scripts off label … as they did not claim - re. MARINE indication - they have no reason to believe physicians will prescribe generic Vascepa for longer than 12 weeks
(ii) "real aim", (unspecific) intent or knowledge of off-label usage does not matter …

"inducement requires evidence of culpable conduct, directed to encouraging another's infringement, not merely that the inducer had knowledge of the direct infringer's activities." DSU Med. Corp. v. JMS Co., 471 F.3d 1293, 1306 (Fed.Cir.2006) (en banc)

culpable conduct = label

In this type of Hatch-Waxman Act patent litigation, where Defendants have filed ANDAs, the question of whether Defendants may be held liable for inducing infringement turns on whether Defendants “have the specific intent, based on the contents of their proposed labels, to encourage physicians to use their proposed ANDA products” in a way that infringes the Asserted Claims. Grunenthal GMBH v. Alkem Labs. Ltd., 919 F.3d 1333, 1339 (Fed. Cir. 2019) (citation omitted). In other words, the Court must ask “whether the label encourages, recommends, or promotes infringement.” Id. (citation omitted). And because the Asserted Claims are method claims, the “pertinent question is whether the proposed label instructs users to perform the patented method.” Id. (citation omitted).

No question: MARINE label does not encourage REDUCE-IT indication.

Furthermore, the Hatch-Waxman Act supports / help this "inducement" by Paragraph VIII notice (aka "skinny" or "carve-out" labeling). Generic use this to avoid (e.g. 3-year new clinical study) exclusivity and / or patent litigation (omit the protected use from its generic drug labeling information).

Best,
G

HDGabor

01/17/20 11:25 AM

Post #241901 on Amarin Corp Plc (AMRN)

K-

Watch this at the 22:00 minute mark.

Read this at the first letter: Supreme Court Rules that Patent Owners Bear the Burden of Proving Patent Infringement ...

Best,
G

HDGabor

01/17/20 8:54 AM

Post #241842 on Amarin Corp Plc (AMRN)

demonstrates the intention of the Generics to have Docs infringe by inducement.

As I quoted

"inducement requires evidence of culpable conduct, directed to encouraging another's infringement, not merely that the inducer had knowledge of the direct infringer's activities." DSU Med. Corp. v. JMS Co., 471 F.3d 1293, 1306 (Fed.Cir.2006) (en banc).

Intension without inducement (by the label) does not matter

The Generic's reason for their showing their slide , predicting $700 million revenue,...at the JPM meeting

To you … and to all: Our disclosed Generics Paragraph IV pipeline

Current US market size ($ m) 1

1 IQVIA US MAT October 2019

(i) it is not a revenue for Hikma but the total market
(ii) it was not calculated by the Generics but by IQVIA
(iii) it is not a projection / prediction but a fact (current market … past period)
(iv) MAT is Moving annual total … over the course of the previous 12 months. … aka October 2018 - September 2019 (or November 2018 - October 2019)
(v) $752M is not a Net Revenue but a Gross Revenue … calculated from prescription and WSP ($300+) … and again: by IQVIA
(vi) At the time of IQVIA calculation - October 2019 - the label was MARINE only … no question that the majority of the market belongs to off-label usage but "officially" it is a market size with MARINE label (at October 2019 … and MAT)

Best,
G

HDGabor

01/17/20 7:48 AM

Post #241831 on Amarin Corp Plc (AMRN)

V- (& ziploc_1 & bubbarayjr)

Need to be intentional … the existence of the direct infringement (generic would be used by the medical community) is not enough

ziploc_1: I take this to mean that the label should be clear that Vascepa is NOT for use in chronic diseases...specifically Cardiovascular diseases, Alzheimers, Dry eyes, etc..

The label - clearly - is not for Cardiovascular diseases, Alzheimers, Dry eyes, etc... it is for

indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia

nothing more …

bubbarayjr: will AMRN win if the obviousness claim goes in their favor but the inducement claim does not?

No. Amarin has to win BOTH arguments.

- - - - -
Best,
G

HDGabor

01/17/20 7:31 AM

Post #241825 on Amarin Corp Plc (AMRN)

R-

how is ur feeling on the case so far and do you feel like the entry of the slide help prove intent to comment inducement and non obviousness?

Coming "soon" …

Abstract

I will focus on infringement, since I see obviousness as the easier (easy) part. Meanwhile generics could refer to small studies, small pieces these are - maximum - good to raise questions, to establish theory but these are not (are far away from) a “clear-and-convincing-evidence(s)”.

Best,
G

ps.:

with the rest of the world market we should still have peak revenue of over 2billion I would think. Which should still make it over 10 dollars stock. Do you really think 2 could be the value or is this u being funny?

The $"2" meaning was not the exact value … I did not make any projection about the pps (or fair value of Amarin / Vascepa) because we - nor me nor anybody else on this board - has all, necessary information (e.g. price by country in the EU … everywhere in the world; what will be the governmental subsidy in the EU; etc.) … it is big and complex. Just as an example (based on couldbebetter's post)

I believe that Europe could be 3 million patients and at $2000 a year would mean $6 billion a year in peak revenues making Europe worth $24 billion.

Let's assume "3 million patients and at $2000 a year" is correct … it is $6 billion a year in peak revenues …. AND (based on 25% royalty) Amarin's revenue is $1.5 billion

HDGabor

01/17/20 6:54 AM

Post #241815 on Amarin Corp Plc (AMRN)

So - i stand by my 20$ - my friend - until proven wrong :)

You could not be right …

If trial lost: it will remain about where it is today around 20$

means the current pps contains $0.00 value for the US market (2020-2029).

It will take YEARS' - for Generics - to get anywhere

In case of Lovaza [Do you know what is Lovaza?] generic version was launched within 22 months after District Court ruling (6 months after Appeal Court ruling) and took the 50+% of Lovaza market within 3 months.

Furthermore: do not forget the cost of the 500 Oompa Loompa in the Factory … plus the pension (paid by Amarin) of the retired - since 1912 - Oompa Loompa.

I could not imagine I will see anything below [T]arzan's level, but the life is stranger than fiction … you makes [T]arzan a genius.

HDGabor

01/16/20 11:34 AM

Post #241624 on Amarin Corp Plc (AMRN)

If trial lost: it will remain about where it is today around 20$

You made a typo … "2"$

HDGabor

01/16/20 7:03 AM

Post #241547 on Amarin Corp Plc (AMRN)

r- & Whalatane

Someone please give me a scenario in which a reasonable doctor prescribes V for < 12 weeks.

Dr Reddy seems to me to be making the argument that Vascepa can be prescribed for less then 12 wks for a patient at risk of pancreatitis … Thats my take on Dr Reddy's argument

The 12 weeks is not relevant anymore … it was relevant for contributory infringement claim but that was closed / decided by the summary judgement. There is no real dispute that Vascepa — and therefore Defendants’ ANDA drugs — are, and can be for legitimate reasons, prescribed for fewer than 12 weeks. That means that reducing triglycerides in less than 12 weeks using Defendants’ ANDA drugs is a substantial non-infringing use of those drugs. The existence of this substantial non-infringing use for Defendants’ ANDA drugs therefore defeats Plaintiffs’ contributory infringement claim. Because there is no genuine dispute of material fact on this issue, the Court granted Defendants summary judgment that, they do not contributorily infringe Plaintiffs’ Asserted Claims.

The current claim (the topic during the trial): inducement … whether or not the label could be the cause, since that is the way how the generics could commit inducement.

In this type of Hatch-Waxman Act patent litigation, where Defendants have filed ANDAs, the question of whether Defendants may be held liable for inducing infringement turns on whether Defendants “have the specific intent, based on the contents of their proposed labels, to encourage physicians to use their proposed ANDA products” in a way that infringes the Asserted Claims. Grunenthal GMBH v. Alkem Labs. Ltd., 919 F.3d 1333, 1339 (Fed. Cir. 2019) (citation omitted). In other words, the Court must ask “whether the label encourages, recommends, or promotes infringement.” Id. (citation omitted). And because the Asserted Claims are method claims, the “pertinent question is whether the proposed label instructs users to perform the patented method.” Id. (citation omitted).

Best,
G

HDGabor

01/16/20 6:41 AM

Post #241541 on Amarin Corp Plc (AMRN)

JEFF day 3 - Trial Remains Heated as Expert Testimony Cont's...AMRN in Good Position

Trial Remains Heated as Expert Testimony Cont's...AMRN in Good Position
January 16, 2020

Key Takeaway
Day 3 of AMRN vs. Hikma/Reddy's trial focused on the claim of nonobviousness and examination of the defense's witness. Cross-examination went well for AMRN with the witness faulting several times on AMRN's line of questioning. With the burden of proof already high for obviousness, barring some new evidence or radical interpretation by the Judge, we think AMRN is likely to prevail on upholding the patent.

Insights

Summary: The day began w/ continued direct examination of Hikma/DRL cardiology expert witness Dr. Sheinberg, followed by a relatively brief cross-examination by AMRN. The obviousness portion of the trial commenced w/ Hikma/DRL calling their expert witness Dr. Jay Heinecke, an expert in the field of lipoprotein/lipid disorders. Cross-examination of Dr. Heinecke was contentious to say the least, with many of his claims questioned/disproven and he displayed visible difficulty in answering the defense's questions. 4) Court resumes Fri w/ testimony from the defense's experts Ivan Hofmann and Dr. Edward Fisher (cardiologist). As a reminder - trial will last a total of three weeks to end of January and a decision is expected around March/April 2020.

Initial thoughts on Judge Miranda Du: Throughout the first three days of the trial, Judge Du has been relatively quiet, clearly absorbing and contemplating witness's testimony. In general, we found her to be most attentive during today's cross-examinations. Altogether, she strikes us as someone who is procedural (i.e., by the book) and unlikely to come to an “out of the box” ruling.

The defense's witness had a difficult time demonstrating the patent had clear prior art and in keeping his cool. Recall, when it comes to nonobviousness, the burden of proof lies on the defense to show that there is a clear body of prior art that a person of skill in the field would use to develop the invention/patents that AMRN is asserting. Dr. Heinecke attempted to show prior art for AMRN's primarily asserted claims: 1) EPA at least 96%, 2) at least 12 weeks of duration of treatment, 3) dose of 4 g/day of drug and 4) use in pts w/ TG ≥500 mg/dL. On the first three points, one could see a scenario where an argument (although remote) could be made that prior art describes these claims. The last point was where the expert was most visibly frustrated, with the prosecution highlighting that many of the publications cited as evidence of prior art were not applicable as they did not include pts w/ TG ≥500 mg/dL. The judge and even members of defense were visibly frustrated by the witness' (belligerent) performance during cross-examination.

Rebuttal of AMRN's considerations of nonobviousness also refuted by the expert's own publication. AMRN is also asserting secondary considerations to assist in showing nonobviouness: failure of others, unexpected results, skepticism and long unmet medical need. While the expert contended AMRN failed to meet these considerations, the defense was able to show these were also met, w/ the last point of long unmet medical need addressed with the defense citing the expert's own 2007 publication (one year before AMRN's invention) that states the need for new drugs to reduce cardiovascular disease.

Best,
G

HDGabor

01/15/20 9:58 AM

Post #241202 on Amarin Corp Plc (AMRN)

T-

Any generic that wants to start marketing a generic version NOW will have to contend that their ANDA does not induce infringement on THOSE patents, and that the REDUCE-IT related patents are also NOT obvious

Nope. See HWA Paragraph VIII notice.

Best,
G

ps.:

First week Feb

Amarin will report by late February (or early March) but not by 1st week of February.

HDGabor

01/15/20 9:54 AM

Post #241198 on Amarin Corp Plc (AMRN)

if Amarin settles today, what prevents multiple additional generics from filing tomorrow, the exact same thing what Hikma/ Reddy filed, and argue the exact same points?

Legally? Nothing? … But Amarin will have granted induced infringement claim. … Maybe you missed this in my post

IF the Judge grant induced infringement claim

(i) what prevented multiple additional generics from filing since 7/26/2016? (e.g. the two generics that submitted ANDAs in 2014 but not in 2016)
(ii) what prevented Apotex from filing Paragraph IV notice for all patents, but just for some?
(iii)if Amarin wins today, what prevents multiple additional generics from filing tomorrow, the exact same thing what Hikma/ Reddy filed, and argue the points that were eliminated during this trial? (e.g. written description)

and meanwhile it is not likely, if Amarin loses today nothing will prevents multiple additional generics from filing tomorrow.

Best,
G

HDGabor

01/15/20 8:11 AM

Post #241179 on Amarin Corp Plc (AMRN)

MontanaState83 & amarinbullfromchicago & rosemountbomber (ps.: Biobillionair & Relic & ziploc_1)

If the question on inducement comes down to whether or not the label could be the cause, how does one prove that one way or the other?

Wouldn’t all hell break loose if she dismissed the induced infringement?

The last description of Day 2 posted by HDG sure does not instill mounds of confidence in the outcome.

The question comes down to whether or not the label could be the cause, since that is the way how the generics could commit inducement.

In this type of Hatch-Waxman Act patent litigation, where Defendants have filed ANDAs, the question of whether Defendants may be held liable for inducing infringement turns on whether Defendants “have the specific intent, based on the contents of their proposed labels, to encourage physicians to use their proposed ANDA products” in a way that infringes the Asserted Claims. Grunenthal GMBH v. Alkem Labs. Ltd., 919 F.3d 1333, 1339 (Fed. Cir. 2019) (citation omitted). In other words, the Court must ask “whether the label encourages, recommends, or promotes infringement.” Id. (citation omitted). And because the Asserted Claims are method claims, the “pertinent question is whether the proposed label instructs users to perform the patented method.” Id. (citation omitted).

Since Amarin has to win both argument (inducement & obviousness) the Judge has to grant Amarin inducement theory to avoid generics' entry. [I see obviousness as the easier part. Meanwhile generics could refer to small studies, small pieces these are - maximum - good to raise questions, to establish theory but these are not (far away from) a “clear-and-convincing-evidence”].

Inducement: Meanwhile it is still "in the air", Defendants failed two times
(i) Summary Judgement was denied as

Plaintiffs’ proffered expert testimony creates a genuine issue of material fact inappropriate for resolution at summary judgment as to “whether the label encourages, recommends, or promotes infringement.”

“The purpose of summary judgment is to avoid unnecessary trials when there is no dispute as to the facts before the court.” … The Court finds it more appropriate to consider expert testimony from both sides as to whether induced infringement may be inferred from the labelling at the upcoming bench trial, and resolve the meaning of the labelling at trial.

(ii) Generics' Motion to immediately dismiss the induced infringement claim was denied as "the plaintiff has met the initial burden of proof."

Let's see what will be the Judge's conclusion (if any) after the examination of the defense's expert cardiologist witness. She was not convinced by generics previously as / due to

The Court finds this argument intuitively persuasive—chronic conditions require indefinite treatment.

Defendants primarily rely on Takeda Pharm. U.S.A., Inc. v. W.-Ward Pharm. Corp., … The Court is not persuaded. There is a meaningful distinction between the labelling in this case and the labelling at issue in Takeda … Therefore, Plaintiffs’ proffered expert testimony supplements a plausible interpretation of the labelling, instead of providing an explanation of the labelling not consistent with the labelling, like the expert testimony did in Takeda.

I was not aware of the possibility that Judge could rule during the trial …
After the examination of the defense's expert cardiologist witness the Defendants could request (again) to immediately dismiss the induced infringement claim … and if it will be denied (or without Ds' Motion) Amarin could request to immediately grant the induced infringement claim.

IF the Judge grant induced infringement claim (today / tomorrow ?) the likehood of settlement will increase significantly.

Best,
G

ps.:

Biobillionair: Just check out the full docket and please give your opinion

I won't check … see relocatedmetsfan's posts (#241133 and #241144. It is not about "change in Trig levels to 135" … no way that generics request TG 136, meanwhile V did not get it.

Relic: how would generics get around the EPA purification method patents?

I do not opine on purification (or on composition) patents … but according to my best knowledge these are not a topic in the current case and I do not see any good reason (on Amarin side) to leave it out if these could stop - with 100% certainty - the entry of the generics

ziploc_1: It would be naive to think that in 2014 when the Generics filed their ANDA...they did not see the potential for a wider market than Marine and this played into their motive for filing the ANDA.

Do you think R-IT was obvious? Everybody saw / expected the huge indication / market potential?
How about ANDAs for Lovaza ("MARINE" label)? Do you think generics expected that GSK will make an outcome trial and that will be successful?
Your view isn't naive, but is a biased / "wishful" thinking without any basis and rational.

HDGabor

01/15/20 6:46 AM

Post #241167 on Amarin Corp Plc (AMRN)

Biobillionair & L0tsaluck2000 & dukesking & CalMustang

the market is not $750m with only 12 week scripts; true market is either off label or >12 weeks. Judge needs to see this

They imply they would capture a very large share of a market that is people taking V not people takin V for only 12 weeks. Thus they are implying inducement or the market estimated should reflect only short term V scripts.

Maybe I want to see something that isn’t there. Why do you suppose they put those numbers there?

They are so bold as to list the current market for Vascepa in their JPM slides because they know that is the true market they seek and will infringe upon if they are given a carve out label.

there are 4 million Americans with trigs > 500mg/dL. That market is not $750M.

(i) Generic do not request a carve-out label or label for less than 12 weeks. They requested the MARINE label … but the label <> the patents
(ii) The REDUCE-IT indication and market is not relevant for the case (other than secondary consideration regarding obviousness)
(iii) inducement by generics <> direct infringement by phisicians
(iv) It is beyond dispute that physicians will prescribe V for more than 12 weeks and it will be a direct infringement … however the existence of the direct infringement is not enough to determine inducement by the generics. For inducement: the generics have to encourage (by the label) the direct infringement
(v) The $750M "Current US market size" of Vascepa is not Hikma projection, it is a data from IQVA … as of October 2019 and it is a current size
(vi) IQVA calculate the market size based on WSP … before any discount, rebate, etc. (aka Gross Revenue) and it is a MAT [Moving annual total (MAT) The total value of a variable, such as sales figures for a product, over the course of the previous 12 months. … Nov 2018 - Oct 2019]
(vii) All revenue (market size) before 12/13/2019 (inc. as of Oct 2019) was with MARINE label only … "officially" the revenue was generated by MARINE indication

The current indication, label, usage / treatment knowledge about Vascepa and the market is not relevant regarding generic intent at the time of the ANDA filing … the (2014/) 2016 "status" is relevant … (see. obviousness ...)

I hope it helps … I did my best.

Best,
G

HDGabor

01/15/20 5:28 AM

Post #241162 on Amarin Corp Plc (AMRN)

Thankfulness to Rob Cos

*Front Row*: Hikma/Reddy's Request for Immediate Ruling was Dismissed...
January 15, 2020

Key Takeaway
Day 2 of AMRN trial was a bit more balanced in our view with both parties making strong cases for/against the induced "infringement" claim. Today concluded w/ the Judge dismissing the defendants' request for an immediate ruling on the induced infringement claim citing AMRN has met the initial burden of proof to continue the trial. Although that ruling was in AMRN's favor, we think the induced infringement claim will continue to be argued by the defense.

Summary: Today began w/ direct/cross-examination of AMRN's expert cardiologist Dr. Matt Budoff. Following redirect of AMRN's witness, the defense asked the judge to rule on the induced infringement claim, stating they believe AMRN failed to meet the burden of proof. Following 5-10 min presentations from both parties, the judge indicated she would need more time to formulate her ruling. The day ended w/ the Judge dismissing the defendants' request to rule on the infringement claim citing the initial burden of proof had been met. We continue to think AMRN is in a good position in the case.

A majority of today's proceedings focused on the induced infringement claim and interpretation of the label; there appears to be more room for debate than initially thought, however. Recall, AMRN is claiming HIkma/Reddy's generic label induces infringement on AMRN's patents that cover treatment with Vascepa for 12 weeks or more. During direct examination, AMRN's witness Dr. Budoff reviewed severe hypertriglyceridemia (SHTG), the label, and systematically provided his reasoning as to why a majority of docs prescribing Vascepa would use it for "chronic treatment" thus any generic using the current label would infringe on AMRN's 12wk+ patents.

During cross-examination, the defense noted nothing in the label explicitly indicates Vascepa has to be used for 12wk+ and highlighted AMRN's own internal and expert testimonies that indicated SHTG could be an acute phenomenon and the label does not limit the drug for chronic use only. Dr. Budoff defended his earlier testimony well by stating if the drug is used as indicated by the label, all acute reasons to use the drug would be excluded thus providing a counterargument to the defense. While the judge has not tipped her hand on which way she is leaning through comments or questions, she has shown keen interest throughout the trial in the defense's arguments and to us looks clearly willing to accept to new information. The bottom line is whether the judge would rule in favor of AMRN because a majority of docs will use it chronically - or in favor of generics because there are situations where "acute use" is OK and that is sufficient to not infringe. That said - the Summary Judgment before the trial did suggest the argument by the defense was weak.

The judge appeared to really mull over the defense's motion to immediately dismiss the induced infringement claim. The judge concluded based on Dr. Budoff testimony, which stated if following the label, "most docs" would prescribe generic EPA chronically, the plaintiff has met the initial burden of proof. It will be interesting see how her interpretation may change following examination of the defense's expert cardiologist witness.

Best,
G

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