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When a “skinny label” results in induced patent infringement
“Skinny labels” for generic drugs are intended to help the manufacturers avoid patent infringement liability by describing only nonpatented uses. But a generic manufacturer learned the hard way that a skinny label doesn’t ensure immunity when it comes to liability for induced infringement.
The heart of the matter
Amarin Pharma sells icosapent ethyl, a drug known as Vascepa. The drug was FDA-approved for the treatment of high levels of triglycerides in 2012 and to reduce cardiovascular risks in 2019. The patents on the original indication were found invalid, though.
In 2016, Hikma Pharmaceuticals USA submitted an abbreviated new drug application (ANDA) to market a generic version of Vascepa. The ANDA was pending in 2019 when Vascepa was approved for the cardiovascular indication. Hikma then sought FDA approval only for uses not covered by the cardiovascular indication patents, what’s called a “skinny label.” The skinny label would include only the original indication. The FDA approved Hikma’s ANDA, with the proposed skinny label, in 2020.
Throughout that year, Hikma issued press releases that referred to its product as the “generic version of” or “generic equivalent to” Vascepa. Some included sales data for Vascepa, but the figures reflected sales of Vascepa for all uses, not just the original indication. Hikma also marketed its product on its website, where it indicated that the drug was “AB” rated. The rating reflects the FDA’s determination that a generic drug is therapeutically equivalent to a branded drug when used as labeled.
In November 2020, Amarin sued Hikma, alleging it had induced infringement of its valid Vascepa patents. The trial court dismissed the case before any discovery or expert testimony, finding that Amarin failed to properly plead inducement. Amarin appealed.
A bitter pill for the defendant
The U.S. Court of Appeals for the Federal Circuit initially noted that it was considering the case at a very early stage — on a motion to dismiss. As such, it was reviewing a plaintiff’s allegations, as opposed to a lower court’s findings, and it was reviewing them for plausibility, not probability.
The court then explained that a generic manufacturer can be liable for inducing infringement of a patented method — even if it has attempted to carve out the patented indications from its label — if other evidence is found regarding inducement. The question, therefore, was whether Amarin’s complaint plausibly pleaded that Hikma “actively” induced health care providers’ direct infringement. In other words, did Hikma encourage, recommend or promote infringement of the cardiovascular patents?
The Federal Circuit held that it did, despite finding that Hikma’s label didn’t encourage, recommend or promote infringement. That’s because Amarin’s inducement allegations weren’t based solely on the label; they were based on the label in combination with Hikma’s public statements and marketing materials.
Amarin alleged that Hikma’s press releases made clear that Vascepa had multiple indications and then identified its own product as a generic version of Vascepa. It also alleged that Hikma touted sales figures Hikma knew were largely attributable to the cardiovascular indication that was off-label for Hikma’s product.
According to the court, these allegations, taken together with those relating to the skinny label, at least “plausibly” stated a claim for induced infringement, which is all that is required under the motion to dismiss standard. Many of the allegations, it said, depended on what the label and public statements would communicate to physicians and the marketplace and whether they encouraged off-label use. The court said this is a question of fact, not law, and questions of fact shouldn’t be resolved through a motion to dismiss.
Notably, the court declined to hold that the single notation of the AB rating on the website — and nowhere else — insulated Hikma for induced infringement claims. After all, it said, it had previously upheld jury verdicts based in part on marketing materials with similar language.
The court’s prescription
The ruling should serve as a warning to generic manufacturers. As the court cautioned, clarity and consistency in manufacturers’ communications about a skinny label drug may be essential to avoid liability for induced infringement.
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