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Diagnostic method patents and harms to follow-on innovation.

In a series of cases over the past decade, the Federal Circuit and Supreme Court have confronted the patent eligibility of broadly claimed diagnostic methods under § 101 of the Patent Act. These diagnostic method patents claim processes that, generally speaking, first identify a biomarker and then use correlations associated with that biomarker for diagnostic purposes. This Note argues that granting these kinds of broad claims to natural correlations creates unique harms to follow-on innovation, ones that do not occur with other types of patents. Yet these harms have not been specified in the literature or the case law. In light of both these unique harms and the lack of attendant benefits, the Federal Circuit and Supreme Court should revise their approaches to broad diagnostic method patents.