Amarin Corp Plc (AMRN)

[johngnatt]

@marjac I can not emphasize enough that generic drugs have to meet the same standards as original patented drug. FDA routinely analyzes drug formulations to ensure they meet the standards. Generic companies do not mess around. The cost of non-compliance is quite severe. They can just shut down the plant and every product at the plant will be shut down. The time it takes to get into compliance again is very long.

Hikma will not dole out an inferior product that does not meet FDA standards. It is just not worth their time and money to cheat. This is a wrong focus.


However, I do have a question for you about the Reduce-It patent.

Based on what we know to date, what is the most compelling evidence to show induced infringement. Does the AstraZeneca v Apotex case shed some light?

Hikma has removed everything that is suggestive of induced infringement, including the AB rating from their promotion.
However, they are definitely relying on the FDA orange book for the doctors to prescribe the GV.

The insurance will also be approving the GV based on the FDA orange book.

The LEGAL question that I have for you is this:

Does Hikma's reliance on FDA orange book AB rating for the drug to be used as alternateive to Vascepa suggestive of induced infringement?