BRIEF—Lawyers review developments on skinny labeling

A  review of recent litigation from Sara Koblitz, a director at Hyman, Phelps & McNamara, provides reason to think that so-called skinny-labeled drugs will continue to be an option for generics manufacturers.

Skinny labeling represents an exception to the US Food and Drug Administration requirement that the label for generic medicines must be the same as for the reference medicine, with those indications still protected by patent being carved out, or excluded.

The US Congress created this novel regulatory pathway, which allows a generics drugmaker to gain approval for just the unpatented uses, in order to expedite the approval and use of copycat medicines.

Recent allegations that Hikma’s skinny-labeled generic drug, icosapent ethyl, infringed patents held by Amarin, have now been dismissed.

In her consideration of the case, Ms Koblitz notes that “Amarin’s case against Hikma could still end very differently if it is appealed to the Federal Circuit,” however.

“We still have a way to go until there’s certainty with respect to the future of the skinny label,” she concludes.

“GSK v Teva is still awaiting a decision from the Federal Circuit on Teva’s request for rehearing from the full panel, Amarin may appeal the Hikma decision, and the claims against Health Net must still be litigated.”