Although Professors Sean Tu and Aaron Kesselheim have advocated for legislation to respond to the Federal Circuit’s 2021 opinion in GSK v. Teva, that case did not—as they assert—“threaten[] to nullify every skinny label carveout.” Rather, the Federal Circuit applied the unremarkable principle that generic drug manufacturers are obligated to ensure that their labeling and other representations do not induce infringement of an innovator’s method-of-use patents. Consistent with this longstanding principle, generic drug manufacturers continue to pursue skinny labeling strategies. In fact, several recent court decisions have distinguished GSK and found lack of inducement by a generic applicant’s proposed labeling, showing that skinny labeling strategies have not been “nullified.” 

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