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"Of course" ... and the best trading strategy is: post on a message board to "get" the "required" price ... It is working " always" ... LMAO & ROFL
N-
I do not want to convince anybody ... feel free (anybody, not you only) to think:
- Hikma launched meanwhile infringement is not a question
- Hikma launched a different product than the one that was approved by the FDA
- etc.
My view is the same: the US market - legally - gone. Amarin - maybe - can do something with the price (or as authorized generic) but it does not worth an investment for me.
I am "waiting" for one thing only, the EU approval in 2021 and the "consequnce" (if any) ... but I think I will see "better" entry point before the EoY, mid-December than the current level.
Best,
G
btw ... my "advise" to sell - anything above 4.50 - looks like reasonable now
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Yes. I interpret "market" as actively promote ... otherwise ALL carve-out generic induce infringement "automatically" (by launch).
Best,
G
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FYI: Monday, 09/28/20 08:01:02 PM
Best,
G
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1.) Yes
2.) Yes
3.) Yes ... with a small correction(s)
i-
I'm not a lawyer either.
Drug Distributors could be liable for contributory infringement only, not for "inducement o[f] infringement" (unless they encourage the prescriber to infringe or promote the patented use ... not likely).
As MARINE indication is a "substantial non-infringing use" contributory infringement claim will not stand against anybody.
Best,
G
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Is it "unusual" that such a high amount of GV is prescribed? I understand that Marine indication itself is not "unusual", but the amount of prescription could be "unusual".
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So manufacturing of generic icosapent ethyl is not "specific action" but encapsulation, packaging and importation then ultimately consumption by patients with the reduce-it indication, is? Or is not?
If jointly the generic icosapent ethyl manufacturers produce more generic icosapent ethyl than is required to treat patients with triglycerides >500, the excess production is intended for sale to patients with the reduce-it indication.
d-
By Hikma taking no action( beyond the label)to prevent this infringement, knowingly supplying to those that will infringe, may constitute an act(s) to induce or indirectly infringe( contributory)
a substantial non infringing use does not guarantee protection from contributory or indirect infringement
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Can you tell me why the court bothered to mention the percentage of infringing use (2.1%) and non-infringing use (97.9%) in Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1365 Fed.Cir.2003?
Do you know any case where significant non-infringing use exists when the percentage of infringing use is significantly higher than one of non-infringing use?
Is it "unusual" that such a high amount of GV is prescribed? I understand that Marine indication itself is not "unusual", but the amount of prescription could be "unusual".
Direct infringement does not have to be by generics.
It is easy to show the existence of direct infringement. Survey to physicians, Symphony Health, IQVIA, etc.
i- 305575
Based on this, anybody should think Hikma's generics is anything but B at that moment. It may become B in the future
And again, when Hikma said "generic equivalent", it was PR of ANDA approval which normally confirms "therapeutically equivalent", correct? Therefore, it can not be "B" codes.
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These are possibilities ... but a long-shot with questionable result.
Generic drug substitution laws vary greatly across the US. A lot of States do not have reference to the Orange Book in the law.
Best,
G
Infringement
First of all: Generics could be “subject” of indirect infringement only … could not be “subject” of direct infringement. (While the United States Patent Act does not directly distinguish "direct" and "indirect" infringement, it has become customary to describe infringement under 35 U.S.C. § 271(a) as direct infringement, while grouping 35 U.S.C. § 271(b) and 35 U.S.C. § 271(c) together as "indirect" ways of infringing a patent.). The patient or physician will infringe the patent directly, the Generics could infringe indirectly only … they are sued for contributory and / or induced infringement only.
Indirect infringement
It could be:
a.) contributory infringement
b.) induced infringement
a.) Contributory infringement
Generic will be liable for contributory infringement due to the launch (sells or offers to sell) IF substantial non-infringing use does not exist.
Substantial non-infringing does not have an exact (measurable) definition, because it does not a question of volume, any reasonable use is a substantial use, even if not commercially viable.
Non-infringing uses are substantial when they are not unusual, far-fetched, illusory, impractical, occasional, aberrant, or experimental.
That practicing the patented method may be the most logical or useful purpose for Appellees’ products does not render the alternative uses ‘unusual, far-fetched, illusory, impractical, occasional, aberrant, or experimental.
it need merely be capable of substantial noninfringing uses.
where a product has substantial noninfringing uses, intent to induce infringement cannot be inferred even when the defendant has actual knowledge that some users of its product may be infringing the patent
it defies common sense to expect that Apotex will actively promote the sale of its approved gabapentin, in contravention of FDA regulations, for a use that (a) might infringe Warner-Lambert's patent and (b) constitutes such a small fraction of total sales.
GlaxoSmithKline LLC v. Teva Pharm. USA, Inc. 2018-1976, 2018-2023 Federal Circuit 2020
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Could be (more likely) ... as to be on the safe(st) side.
GSK / Teva Opinion is (one of) the most rigorous interpretation of circumstantial evidence of inducement. All Generics will revise their materials to avoid the pitfall by Teva. (btw: the 38th JPM presentation is still available ... despite it was cited / referred by Amarin during the trial.
Best,
G
shows Hickma's over 700 million dollar projection for Vascepa
g-
The GSK/TEVA case was the exception, but we do not know how this case will play out in appeal.
d-
If Hikma decides to risk a soft launch they assume the same risk as a full launch
i-
the prescription of Marine indication is substantial does not stand on its own
Non-infringing uses are substantial when they are not unusual, far-fetched, illusory, impractical, occasional, aberrant, or experimental.
Based on this, anybody should think Hikma's generics is anything but B at that moment. It may become B in the future
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It seems that we need to wait one more week.
ANY NON-PANEL JUDGE MAKES A 5.4(b) NOTICE REQUEST
If any non-panel judge makes a 5.4(b) notice request to the original 3 judge panel, the panel has a maximum of 90 days from the date of 5.4(b) notice request or the petition, whichever is later, to inform the non-panel judges whether the panel wants to rehear the case themselves or not.
i
"London, May 22, 2020 – Hikma Pharmaceuticals PLC (Hikma), the multinational generic pharmaceutical company, today announces that its wholly owned U.S. subsidiary Hikma Pharmaceuticals USA Inc. has received approval from the US Food and Drug Administration (FDA) for its Icosapent Ethyl Capsules, 1 gm, the generic equivalent to Vascepa® [1]."
I feel that the above sentence is almost equivalent to FDA's AB-rating.
Hikma's PR:
"Vascepa® is a prescription medicine that is indicated, in part, as an adjunct to diet to reduce triglyceride levels in adult patients with severe ( 500 mg/dL) hypertriglyceridemia."
LONDON, Sept. 3, 2020 /PRNewswire/ -- Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, announces that the US Court of Appeals for the Federal Circuit today upheld a ruling by the US District Court for the District of Nevada finding that Hikma's generic version of Vascepa®1 (icosapent ethyl) 1gm does not infringe any valid claim of six key Amarin-owned patents. Hikma received FDA approval for the product in May 2020 and is working towards a launch.
Vascepa® is a prescription medicine that is indicated, in part, as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. According to IQVIA, US sales of Vascepa® were approximately $1.1 billion in the 12 months ending July 2020.
"We are very pleased with the Federal Circuit's swift decision and to be one step closer to launching a generic version of this important medicine for US patients and healthcare providers, helping us to continue putting better health, within reach, every day," said Brian Hoffmann, President of Hikma Generics. "Today's decision demonstrates Hikma's ability to successfully challenge patents on important medicines and to provide value to our customers and millions of patients across the United States."
The term "in part" is interesting to me.
N-
I am not sure the action of making the generic available in those States doesn't prove intent.
An argument against this obvious outcome would not be overly different from someone on trial for murder saying I didn't kill the victim. Sure I pointed the gun and pulled the trigger but how was I supposed to know that would cause bullet's to come out.
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do you think that TEVA committed induced infringement (promotion with press release, etc)?
do you think previous Hikma's PR is enough to demonstrate or support their induced infringement?
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do you agree with Judge Prost's dissent?
Or do you think Teva v. GSK case is different from Warner-Lambert v. Apotex?
If so, what is different?
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Yes to an extent I agree with you
infringement is not a possibility, it is a certainty
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If the generic companies market their product in a state, that by law, requires a generic substitution there should be no debate as to intent.
(3) "pharmacists and other drug dispensing organizations . . . commonly substitute generic drugs for name brand drugs wherever possible — unless specifically instructed otherwise by the physician writing the prescription," and, "in many states, substitution is mandatory,"
Whether or not these statements are true, and for the purposes of deciding whether or not summary judgment was proper we must assume they are, we have already observed that precedent holds that mere knowledge of possible infringement by others does not amount to inducement; specific intent and action to induce infringement must be proven.
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where a product has substantial infringing uses, can intent to induce infringement be inferred when the defendant has actual knowledge that some users of its product may be infringing the patent?
no substantial non infringement use- no use is allowed AT ALL!
where a product has substantial noninfringing uses, intent to induce infringement cannot be inferred
Even if Warner-Lambert's estimate that 2.1% represents $50 million is correct, it is an inescapable fact that the remaining 97.9% still represents more than 46 times that amount. Especially where a product has substantial noninfringing uses, intent to induce infringement cannot be inferred even when the defendant has actual knowledge that some users of its product may be infringing the patent. Where there are many uses for a product, as the record reflects to be true of gabapentin, and fewer than 1 in 46 sales of that product are for infringing uses, we are not in a position to infer or not infer intent on the part of Apotex without any direct evidence.
where a product has substantial non-infringing uses, intent to induce infringement cannot be inferred even when the defendant has actual knowledge that some users of its product may be infringing the patent
that Apotex is "counting on" sales for off-label uses
o-
no contributory liability would exist despite the presence of a component that, if sold alone, plainly would incur liability.
d-
There’s much more in GSK about evidence of direct infringement via marketing materials and promotional products etc that meet the criteria for direct infringement as well ... Teva met both direct and induced infringement criteria. Only the direct infringement claim involved marketing materials literature and pamphlets. Induced infringement was based on knowledge of, and circumstantial evidence of, Intent
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Somewhere in that ruling it was stated that knowledge of infringement was enough to prove inducement.
Mere knowledge of possible infringement by others does not amount to inducement; specific intent and action to induce infringement must be proven.
Proof of actual intent to cause the acts which constitute the infringement is a necessary prerequisite to finding active inducement.
Inducement requires proof that the accused infringer knowingly aided and abetted another's direct infringement of the patent.
There was ample record evidence of promotional materials, press releases, product catalogs, the FDA labels, and testimony of witnesses from both sides, to support the jury verdict of inducement to infringe the designated claims
prove the intent element [of induced infringement] through circumstantial evidence, just as with direct infringement.
Circumstantial evidence is not only sufficient, but may also be more certain, satisfying and persuasive than direct evidence
I interpret market as the act of selling.
There was ample record evidence of promotional materials, press releases, product catalogs
c-
when gV came out as tier 1, V has to be changed from tier 2 (preferred brand) to tier 3 (non preferred brand)? Who will be tier 2 then? Leave it empty?
i-
The district court applied an incorrect legal standard, for precedent makes clear that when the provider of an identical product knows of and markets the same product for intended direct infringing activity, the criteria of induced infringement are met.
The district court applied an incorrect legal standard, for precedent makes clear that when the provider of an identical product knows of and markets the same product for intended direct infringing activity, the criteria of induced infringement are met.
There was ample record evidence of promotional materials, press releases, product catalogs, the FDA labels, and testimony of witnesses from both sides, to support the jury verdict of inducement to infringe the designated claims for the period of the ’000 reissue patent.
F-
The October agenda tells one thing only: no immediate* answer. (* is only used exceptionally and after agreement with the Rapporteurs when minor issues remain which allow the applicant to respond shortly after the CHMP list of questions and the Rapporteurs to assess the responses within a shortened assessment time.)
I checked the last 4(-5?) agenda and none of the contain any "restart of the clock" after the answer for the LoOI / Day 180 letter. (Meanwhile the "restart of the clock" after the answer for the LoQ / Day 120 letter is part of the agenda.)
Case A.: no answer yet
Case B: answer was submitted ... the application will be in the November agenda
Best,
G