Amarin Corp Plc (AMRN)

[HDGabor]

H-

a substantial (volume implied) use burgeons in excess of any possible real-world demand for that limited skinny label indication. The facts then are that generics are enabling an infringement by proxy.

The available volume (of gV) is irrelevant. (a) Generics are enabling an infringement by one bottle (it should not be "1.000.000" bottles).

(b) The carved out portion could be "sky high", it does not matter.

Generics will not be liable for (until)

(i) contributory infringement: non-infringing use is determined as substantial (You correctly pointed: the percentage volume of sales are not literally applied. IIRC: it does not have to be commercially viable). Furthermore: “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.’”); Toshiba (Fed. Cir. 06/11/12) (aff’g Summ. J. of no contributory infringement).

(ii) inducement: no specific intent or action made by them to induce infringement. GSK / Teva case did not chane this (unless you "pick-up" the part of the Opinion only ...) The full, relevant part:

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.

It is B&W that the inducement was made by promotional materials, press releases, product catalogs, etc. and was not by the launch itself.
All skinny-labeled generics are prescribed, sold for infringing use ... if the launch ("market") itself would be the proof of inducement, skinny-label could not be exist.

Please note:
a.) the action have to be made by the generics itself, 3rd parties' action does not matter
b.) available volume is not counted as action

If SCOTUS were to rule on this definitively we would be well served

Or not ... and SCOTUS's ruling about this is not likely.

the skinny label here really is very skinny and the carved out portion so fat

Does not matter. A law, regulation, etc. is applicable for everybody or for nobody. A solution here requires a case specific answer ... not likely.

Could a court (any) rule in favor of Amarin? Of course ... we know that the court rule "anything" ... But I see / take this as a wishful thinking ... a not likely scenario. (R-IT p-value was bigger than the probability % of this ...)

All together: Unless the generics make a mistake (promotional materials, press releases, product catalogs, the FDA labels, etc ... as inducement) ... it is possible but not likely ... I do not think that the US market could be saved / reestablished by any legal action.

If - it is possible - the US has (will have) any value, it will be a result of the non-legal actions (e.g. authorized generics or price decrease or anything) but the value will be significantly lower than without generics ... if it will be a significant value and will not be a marginal one only.

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re. 312113

So in order to cover drug-drug interaction warnings etc, the FDA felt that the CHF label in entirety should also be incorporated into the skinny label unleashing a Pandora's box of complications.

Meanwhile I do not understand while the FDA ignored the new OB'd patent ('000 with the same use code as the old '069) the label update (by the FDA) was triggered by the withdrawal of the '069 patent (from the OB).
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Best,
G