Kiwi, what you listed does not appear to be infringement. So what are they going after Hikma for? Is it that in some CC their CEO was talking about total market penetration, or that somewhere they list some side effects found in R-I?
Proving skinny label infringement can take two paths...
1. Infringement can be proven by an infringing label on the generic product...or by announcements by the generic company as to their product's uses for a patented indication. 2. Infringement can proven by very convincing data on how the product is being used for a patented indication.
In the case of Vascepa, an overwhelming number of prescriptions for generic Vascepa are being used for the patented CVD indication (97%) rather than for the unpatented high triglycerides indication (3%)
IMHO This was NOT the intention of the HW law as agreed on by the conservative Hatch and the liberal Waxman.