AMRNLos analistos parece que estaban digiriendo cosas, ayer mismo: This is how Markman Advisors put it on GSK/TEVA. How could ruling affect Amarin In the GSK v. Teva case, Teva sold a generic version of GSK’s pharmaceutical drug, Coreg®. The active ingredient in Coreg® is carvedilol. GSK’s drug was approved for three indications: hypertension, congestive heart failure (CHF) and post-MI LVD. In 2007, Teva’s generic was initially approved for only two of these indications, and it expressly carved out the CHF indication. Thus, Teva’s label was initially a skinny label. Later on, in 2011, the FDA directed Teva to amend its label to include all three indications, after which its generic was sold with a full label. The case itself turned upon GSK’s assertion of a patent that covered the CHF indication. This was the indication that Teva initially carved out of its generic label before, years later, being instructed by the FDA to add it back in. Despite this, the Federal Circuit reversed the lower court’s ruling, and held that substantial evidence existed for finding that both Teva’s skinny label, at first, and its full label, later on, induced infringement of GSK’s patent covering its CHF indication. Taking the reasoning of this case, it is easy to see a clear pathway for how this might benefit Amarin. Indeed, it is hard to believe that either Hikma or Dr. Reddy’s has read the GSK opinion and not asked their attorneys to advise on how this decision could impact their potential liability from launching generic Vascepa. Both Hikma’s and Dr. Reddy’s generic drugs for Vascepa have been approved only for the severe hypertriglyceridemia indication, but not for the cardiovascular indication. That means, when they launch, they will do so with skinny labels that do not include the cardiovascular indication. Yet, if Amarin could sue, or threaten to sue, either generic for infringement of its cardiovascular patents, that could either stop the generics from launching altogether, or it could potentially lead to the coveted settlement between Amarin and the generics that so deftly eluded the parties during the Nevada litigation. Any potential suit by Amarin against a generic would have to wait until after that generic launches. Unlike the earlier Nevada suit, this potential lawsuit would not be under the Hatch-Waxman Act because it would not be triggered by the filing of an ANDA by either generic. Rather, the theory of liability would be that Hikma’s or Dr. Reddy’s sales under its skinny label, which is limited only to the severe hypertriglyceridemia indication and which carves out the cardiovascular indication, nevertheless induces infringement of Amarin’s patents covering its cardiovascular indication. Amarin could theoretically seek an injunction against the generics’ continued sales, i.e., the same relief it sought in its unsuccessful lawsuit in Nevada. Alternatively, Amarin could also seek monetary damages in the form of lost profits or a reasonable royalty. (Amarin could not request monetary damages in the Nevada lawsuit because that suit occurred under the Hatch-Waxman Act, i.e., before either of the generics launched.) If Amarin’s suit for infringement of the cardiovascular patents has any teeth, then that alone could potentially bring the parties back to the table to negotiate a settlement. Because the generics’ exposure would include compensating for Amarin’s lost profits, that could theoretically change the calculus for the generics about whether a settlement is warranted. This factor did not exist during settlement discussions occurring within the Nevada lawsuit (to the extent that Amarin and the generics ever engaged in any settlement discussions.) Lost profits damages could be large enough to have a material impact on the business viability of either Hikma or Dr. Reddy’s. Obviously, the scope of those damages will depend upon Amarin’s success penetrating the market with its new cardiovascular indication. Exposure to lost profits damages is typically one of the reasons that hold back generics from launching at risk. This is because, in light of the steep price decreases occurring after generic entry, a generic’s potential profits are typically eclipsed by the brand’s lost profits. That means that companies such as Hikma and Dr. Reddy’s would have to seriously consider their exposure from entry to the extent that Amarin’s resulting lost profits could have a material negative impact on the bottom line of either generic company. Another significant consideration from the GSK v. Teva decision is that the Court found Teva liable for all of GSK’s lost profits, even though Teva was only one of at least eight generic drugs for Coreg® that had entered the market. Yet, Teva was the only generic that was sued by GSK. What that means is, Amarin can threaten to sue either Hikma or Dr. Reddy’s alone for all of its lost profits. *Insurance companies will be making it very clear coverage for CV patients is for brand only. My thought
España