Amarin Corp Plc (AMRN)

[HDGabor]

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.

Meanwhile is not any , every non-infringing use meet the requirement (only the use on the label “measured”) an existing, FDA approved (for different type of drugs: Vascepa, Lovaza, naicins, fibrates) indication (“MARINE”) is anything, but not far-fetched, illusory, impractical, occasional, aberrant, or experimental. Substantial noninfringing use exists as long as the Generics can offer up noninfringing use without court examination of the magnitude of the use. Furthermore, the MARINE indication (use) was determined as commercial success (it was one of the proven secondary consideration).
Meanwhile not all of non-infringing use (eg. for dry eye) matters – only the approved / labeled one (in this case MARINE) – I am not aware of any case where an approved / labeled indication was determined as NON-sunstantial.

Just like in case of MARINE patents (use for LESS than 12 weeks was determined as substantial despite it is 5% of the total use only) contributory infringement claim (if any) of R-IT patent will be denied.

b.) Induced infringement

To prove inducement of infringement, showing that a patient or physician will directly infringe the patent is necessary (a prerequisite), however the mere knowledge of possible infringement by others did not amount to inducement, the specific intent and action to induce infringement had to be proven. Direct (label) or circumstantial (e.g. promotional material) evidence could prove it, these are the specific intent and action … the evidence that inevitably lead some physicians to (directly) infringe. The proof that any direct infringer was actually persuaded to infringe by the evidence is not necessary, the existence of the evidence is enough. The quantity of available supply or presentation of past … (or let be generous: future) market – meanwhile (could) show / prove Generics economical intent - DOES NOT lead physicians to infringe the patent … these are not legal evidences of infringement. It is similar to “mere knowledge” … a mere expectation of infringement by others did not amount to inducement.

In other words, the non-infringing use (except a “special” circumstance, see below) is irrelevant for inducement. Induced infringement determined – always – based on evidence[s] (specific intent and action) … had not been based on lack of “substantial non-infringing” ever.

The Generics’ label (MARINE indication only) is not a direct evidence; the label will not lead any physicians to infringe the R-IT patents. Circumstantial evidence might be exist in the future (not likely after TEVA / GSK case) but does not exist now.

All together: I do not see how Amarin could block Generics by any (valid) patents.

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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

The case law is the - Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1365 Fed.Cir.2003 - … (not the ASTRAZENECA LP v. Apotex, Inc., 633 F. 3d 1042 - Court of Appeals, Federal Circuit 2010) that cite the case law) addressed a specific question / issue:
Will do the Generics a specific intent or action IN THE FUTURE to induce infringement?(No direct evidence exist, the label does not encourage inducement.)
The answer was:NO.

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.

[emphasis mine]
If substantial noninfringing use does not exist it proves contributory infringement but still does not say anything about induced infringement, since the lack of substantial noninfringing use is not a specific intent or action.

“Translate” for Vascepa:
a.) substantial noninfringing use exist (MARINE indication) -> no contributory infringement and - most likely - the court will NOT assume (without any evidence) that Generics will (anytime in the future) actively promote the infringing use.
b.) But let’s say substantial noninfringing use does not exist (but it is just for this post, since it exists …)
(i) it will be the proof of contributory infringement
(ii) it will not prove inducement, induced infringement will not be determined (without any specific intent or action) due to the lack of substantial noninfringing use

GlaxoSmithKline LLC v. Teva Pharm. USA, Inc. 2018-1976, 2018-2023 Federal Circuit 2020

It has one “new” element. (The other one – full label period; labeled, infringing use – is not a novo. as inducement) the “weight” of circumstantial evidence(s).

It rigorously interpret the evidence and determined that inevitably lead some physicians to (directly) infringe.
Meanwhile it narrow the “playground” (limit the possibilities) of the Generics, it does not forbid skinny-label.
The more likely consequence of the case is that the Generics will test – with extreme scrutiny – every word / context of every material but will not stop them.

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Best,
G