Patentability of diagnostics: reasons for optimism

Over the last five years, US courts have consistently declared patent claims covering diagnostics ineligible for protection. As in other fields, the vulnerability of such claims to eligibility challenges undermines confidence in the ability to protect intellectual property assets using the patent system. However, other avenues of protection (eg, trade secrets) for diagnostic tests may be limited in view of commercialisation and/or regulatory requirements. Innovative companies should glean guidance from these cases and continue to pursue patent protection for their diagnostic tests.