Amarin Corp Plc (AMRN)

[HDGabor]

our case isn't off label. off-label is: "the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration".

In our case there is an approved indication which ONLY Amarin owns.

Off-/ On-label use should be "judged" for a given drug ... not for a class of drug. Generics have MARINE indication only ... Vascepa label is irrelevant in this (on-/off-) context

we even might have a good case for "Active Infringement", since generics (Hikma) made statements about billions in revenue if they won the patent case

They did not made any statement like this. Hikma presented the ACTUAL (past 12 months), GROSS (before any discount, debate, etc.) revenue of Vascepa ... with MARINE label only.

The mere existence of direct infringement (by physicians or pharmacy or ins. co. or by anybody) while necessary to find liability for induced infringement, is not sufficient for inducement. As stated in Warner-Lambert in the ANDA context, it is well-established that "mere knowledge of possible infringement by others does not amount to inducement; specific intent and action to induce infringement must be proven."

Generics "primary" method to induce infringement is the label ... their label does not promote, encourage or R-IT indication.

There are always circumstances where a generic could be liable for induced infringement of a patent covering an off-label indication. But that typically requires conduct outside of the label, such as active promotion by Hikma or Dr. Reddy’s of the cardiovascular effects of generic Vascepa. But they are unlikely to do that ...

ASTRAZENECA LP v. Apotex, Inc., 633 F. 3d 1042, 1059 (Fed.Cir. 2010) is irrelevant, is not applicable here ...
The asserted method claims there covered treating respiratory diseases such as asthma by administering "a nebulized dose" of budesonide, i.e., an anti-inflammatory corticosteroid suspended in a liquid to be inhaled, at a frequency of "not more than once per day." An accused infringer's label for a generic version of such an asthma inhaler instructed patients to take the drug "twice daily in divided doses" for a total daily dose of 0.5 mg, and that patients should "downward-titrate to the lowest effective dose." Because the label stated that the lowest available dose was a 0.25 mg vial, titrating down required going down from taking 0.25 mg twice a day to taking it once a day. Thus the patient did not have to consult anything outside of the label to infringe. The instruction would "necessarily lead" to infringement. This was enough for "active steps" taken to "encourage" direct infringement.