Fed. Cir
Patent and
GSK obtained
TEVA sought to obtain approval from the FDA to market its generic version of carvedilol by filing an Abbreviated New Drug Application (ANDA) for all three indications. Under FDA rules, an ANDA filer must make a certification of how its generic would impact the innovators patent. Here, TEVA certified that it would not market carvedilol until after the '067 Patent expired ("Paragraph III" certification). TEVA also certified that the '069 Patent was "invalid, unenforceable, or not infringed" ("Paragraph IV" certification).
Patent law makes filing an ANDA an act of infringement, but GSK did not sue TEVA at this time. Instead, GSK filed a reissue application with the USPTO that resulted in surrender of the '069 Patent and issuance of RE40,000 (the '000 Patent). The '000 Patent claimed a method of decreasing mortality caused by CHF by administering carvedilol in combination with an ACE inhibitor, a diuretic, and digoxin, but added a new element in comparison to the '069 Patent: "wherein the administering comprises administering to said patient daily maintenance dosages for a maintenance period ... and said maintenance period is greater than six months."
TEVA certified to the FDA that its label for generic carvedilol would not include decreasing mortality caused by CHF. This left only the (1) hypertension and (3) post-MI LVD indications on the label - thus, it was a "skinny label": a label that seeks generic approval for some but not all of the innovator's approved indications. Through a complicated chain of events, TEVA amended its label -at the direction of the FDA- to also include "treating patients with chronic heart failure by administering carvedilol to increase survival and to reduce risk of hospitalization."
GSK later sued
TEVA's skinny label included the following: "Carvedilol is indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of ≤ 40% (with or without symptomatic heart failure)." This was intended to cover indication (3), post-MI LVD, but carve out indication (2), CHF. But there was a factual dispute over whether "have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of ≤ 40% (with or without symptomatic heart failure)" was broad enough to mean treating patients suffering CHF.
TEVA's expert testified that this description did not cover indication (2), CHF. However, GSK's expert testified that this labeling satisfied the '000 Patent limitation of "decreasing mortality caused by congestive heart failure." The jury agreed with GSK, found that TEVA induced infringement of the '000 Patent, and awarded
Significant, important, and interesting legal arguments and procedure were involved in this case - but are omitted here - this simple post is already far too complicated. The focus here is that TEVA's attempt to "carve out" CHF from its skinny label was unsuccessful.
Skinny labels were once considered as "safe harbor" from infringement, but this case shows that harbor can be invaded and overcome. Skinny labels may still work in the future, but they must be scrupulously compared to patent claims. A generic producer must insure that its "carve out" will survive an expert battle. The generic producer must be prepared with data, physician testimony, and regulatory records to establish that no physician would have used the generic in a way that would infringe the innovator's patent claims based on the skinny label. Conversely, an innovator should scrupulously review a generic producer's label versus its patent claims in order to effectively protect its intellectual property and business.
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