Amarin Corp Plc (AMRN)

[HinduKush]

BB
Essentially this boils down to specific intent, motivation, and means to committ murder on the Amarin R-IT patents by the generics. They say they cannot be responsible if they supplied the means "unwittingly" and someone else (the prescribers and pharmacies) committed the act. BUT they are responsible if it can be shown they were fully aware of the possible infringement and did nothing in the labeling to discourage it.

B. Therapeutic Equivalenceand Generic Substitution
When a generic drug is approved by FDA, it receives a therapeutic equivalence code that is entered in the Orange Book beside the drug name to indicate whether it is approved as therapeutically equivalent to the pioneer drug (an “A” code) or not therapeutically equivalent (a “B” code). FDA considers drugs to be therapeutic equivalents if they are pharmaceutical equivalents and if they can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling. Significantly, FDA states that “products classified as therapeutically equivalent can be substituted with the full expectation that the substituted product will produce the same clinical effect and safety profile as the prescribed product.”
With very limited exception, generic drugs approved under an ANDA receive an A-rating when listed in the Orange Book. In this regard, FDA’s therapeutic equivalence requirements are “use agnostic” – meaning that an ANDA approved under a section viii statement (carving out a patented use) receives the same A-rating in the Orange Book as a generic approved for all labeled uses. Thus, under the current system, “skinny labeled” generics are designated by FDA and listed in the Orange Book as being fully substitutable for pioneers irrespective of their labeled uses.

WHAT IF a Hikma/Reddy/Apotex/ label for generic Vascepa stated as a minimum "To be used for 8 weeks only and for triglycerides greater than 500mg/dl"; or better still "To be used for 8 weeks only and for triglycerides greater than 500mg/dl. NOT to be used and not to be considered for use in preventing stroke, heart attack or death, consult your physician before taking for this purpose..."
Now the usual off label prescribing occurs to save money for patients and 3rd party insurance coverage...large volumes of generics are sold, generics see the use and step up production to keep pace. NOW Amarin says there is obvious infringement inducement as teh generic has willingly an deliberately stepped up production both of its API and its distribution channels KNOWING that there couldn't possibly be a market of this size for TG>500 mg/dl amd that there is evidence that patients are refilling multiple times for periods over a year that too with established cardiovasculr disease and clear cut indications under R-IT. Who supplie dteh murder weapon on teh patent, who enabled it and who looked the other way...its all on teh prescribers right?!
There is a fine line and the demand for specific "future" patent labeling is tough to achieve as the CAFC states here:

Finally, the Federal Circuit found that AstraZeneca’s allegation that the FDA would require future labeling amendments to include all FDA-approved indications for rosuvastatin calcium were insufficiently ripe for adjudication to the extent they relied on prospective labeling amendments. Here, the ANDAs affirmatively carved out the patented indications, were limited to unpatented methods for using rosuvastatin calcium, and the Court stated that nothing in the record indicated that the FDA required or would require the labeling amendments asserted by AstraZeneca.

Can this change for Amarin???
HK