Amarin Corp Plc (AMRN)

[HDGabor]

c-

even if amrn requested to cancel marine label and did it. Fda will still generate an empty label (same as marine) for generics to use.

Exactly.

MARINE label / indication is based on MARINE study and review / approval by the FDA. The indication is not a property of Amarin since July 2012. They could use it exclusively during NCE exclusivity and till it was patented. Not the case anymore ...
(e.g. If a brand product withdrawn from the market because the manufacturer stop the marketing it does not mean that the generics has to stop also. They could use the label / indication independently from the existence of the brand label / indication).
Furthermore, MARINE patents does not have any context with the indication other than protection (exclusivity for the indication). Existence or removal in / from the OB is not relevant anymore.

Teva vs GSK ...

Meanwhile it looks as a good (relevant) news / decision at first sight … it is not in details. (CHF = R-IT, Other = MARINE)

Skinny label period: Induced infringement was not determined due to the label - which was MARINE - but based on Teva (stupid) activities, promotion. They compared the generic to the brand, they promote the AB rating … these were enough for inducement. Unless generic V are stupid also (except Teva who – more likely – will not commit the same mistake again) and will do the same Amarin will have a case … but it is not likely.

Updated label period: FDA request - “identical in content to the approved [GSK Coreg®] labeling (including the package insert and any patient package insert and/or Medication Guide that may be required).” …”the FDA directed Teva to revise its label to include the CHF [R-IT] indication” - is interesting … . It is not usual that the FDA request inclusion of an indication … they are – usually – request safety / warnings update.
Both the FDA and the Teva made a huge error … they did not check that R-IT covered by a new OB’d(?) patent.
Teva was responsible for inducement based on the (R-IT) label (plus the same reason as above)

As the OB is full with R-IT patent it is not likely that FDA request or generics include R-IT indication in the near future ... no inducement.

Other notes / thoughts:
- Generics’ sales forecast – if any … but the referred slides is not that* – or contracted quantity are NOT equesl with inducement … they have to promote, encourage – actively – R-IT method for that (* present yesterday's weather does not a weather forecast for tomorrow ...)
- A generic drug must label exactly like the brand drug label ... for the requested (MARINE) indication but does not have to include all (MARINE + R-IT) indication ... skinny label / carve out exists.
- Side effects / Warning from R-IT study are not inducement … until it does not promote, encourage R-IT indication. Inclusion of A-Fib / Bleeding is far from encourage ... might actually discourage physicians from practicing the R-IT method. A warning is just that —a warning. It is not an instruction.

Maybe it sums up very well ...

Importantly, in Warner-Lambert, unlike Vanda, the alleged infringing act was not promoted by the generic product’s label. In Warner-Lambert, generics provider 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. Warner-Lambert argued, however, that doctors would prescribe the generic product for all uses that Neurontin® was customarily used for, including treatment of neurodegenerative diseases, which was protected by a different patent owned by Warner-Lambert. And it is the patent on methods for treating neurodegenerative diseases that Warner-Lambert alleged was going to be infringed by Apotex’s generic product. This off-label use, Warner-Lambert asserted, would have been known to Apotex since it was public knowledge. The Federal Circuit responded by observing that mere knowledge of possible infringement by others did not amount to inducement, and that specific intent and action to induce infringement had to be proven. The court explained that if a physician, without inducement by Apotex, prescribed a use of gabapentin in an infringing manner, Apotex’s knowledge of the use would be legally irrelevant. Warner-Lambert at 1364.

I think everybody will realize it sooner or later … RIP US market.

Best,
G