On June 4, Chris Loh spoke with Bloomberg Law about the U.S. Supreme Court’s recent decision addressing the “skinny label” pathway for generic drugs. An excerpt from the article, “Supreme Court Protects ‘Skinny Label’ Generic Drug Pathway,” is below.
The US Supreme Court raised the bar for branded pharmaceutical companies seeking to sue over a competitor’s generic versions of their drugs that are marketed using what’s called a skinny label.
The justices unanimously concluded that a district court judge was right to dismiss Amarin Pharma Inc.'s infringement suit over claims that Hikma Pharmaceuticals USA Inc. was encouraging doctors to prescribe its generic version of Amarin’s Vascepa heart health drug for a still-patented treatment method.
Chris Loh, a Venable partner who represents branded drug companies, said the court appeared motivated by a concern that the Federal Circuit’s approach to skinny label inducement cases was punishing companies for a few very specific types of speech—a generic company describing its product as “equivalent” or “AB"-rated—another way to say a drug is therapeutically equivalent when used according to its label.
The opinion says that form of liability “put generic manufacturers between a rock and a hard place by turning adherence to the law and industry standards into building blocks for illegal conduct.”
But “beyond that, who knows?” Loh said. The ruling was “pretty fact bound” with “no sweeping statement about immunity for skinny-label drugmakers,” and so other types of generic marketing statements could still lead to liability, he said.
For the full article, click here.