Call Off Chicken Little: The Sky is Not Falling for Skinny Labeling After GSK v. Teva

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.” More generally, the courts have emphasized the fact-specific nature of inducement analysis, which aligns with longstanding law before GSK. Moreover, protecting patented uses is critical to incentivizing innovation. Any attempt to respond to GSK by adopting a broad infringement safe harbor, such as the one that Professors Tu and Kesselheim propose, would stifle investments in new treatments.

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