Biomarkers Unbound

The Supreme Court's Ruling on Diagnostic-Test Patents

Biomarkers are important components in the diagnosis of disease and the assessment of patients’ therapy responses. Biomarkers may prove important in medicine, but controversy about biomarker patents has increased in recent years. This brief article assesses the current state of diagnostic-test patents in the United States and their relevant controversies, pointing to several current examples.

Researchers specifically looked at the Supreme Court case Mayo Collaborative Services v. Prometheus Laboratories. The court held that “if a law of nature is not patentable, then neither is a process reciting a law of nature.” Therefore, Prometheus’ patent “amounts to nothing significantly more than an instruction to doctors to apply the applicable laws when treating their patients.” This ruling demands that patentable process must include a new use of a law of nature beyond what the field has already used and understands.

The authors note that this court case, and others involving biomarkers, attempt to resolve the issue of “whether biomarker patents hinder the practice of medicine and research by covering not just the actual test, but also the use of the biomarker generally in making diagnoses and discovering new applications.” Moving forward, further discussion will continue to focus on distinguishing patentable biomarkers from other combinable.