Deborah Fishman Talks Skinny-Label Lawsuit Legislation With Law360

Intellectual Property partner Deborah Fishman was recently quoted in the Law360 article, “Senate Bill Not Seen As Death Knell For Skinny Label Suits.” The article discussed a bipartisan bill aimed at ending patent lawsuits over generic-drug makers’ use of “skinny labels” to seek approval by the Food and Drug Administration for only uses of a drug that aren’t patented by the branded company.

While proponents argue the bill would curtail the “endless lawsuits” over whether generic drugs are infringing on the patented uses carved out of the label, the proposal “presupposes that the carveout is clear, [and] that’s rarely the case,” Fishman said. The legislation states that seeking skinny-label approval would be a defense to infringement, she noted, but “that doesn’t mean you can’t bring a suit.”

Even under the bill, Fishman added, patent owners could still allege that a generic drug was, in effect, being marketed for a patented use the drug maker claimed to have carved out of the label.

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