Modern medicine has become more tailored and personalized for patients seeking medical treatment. No longer is the “one size fits all” approach preferred by the medical community in treating various patient-types, patient groups or subgroups. Recent developments in the diagnostics field have illustrated the significant health benefits and cost savings that can be obtained by first detecting the presence or absence of an antigen or “biomarker” in a patient. This, in turn, may identify that patient as has having a particular disease state or the potential for that disease state, and the subsequent need for treatment or preventative treatment.
With the advent of personalized medicine, a slew of new diagnostic-based inventions have been developed and intellectual property protection sought in the United States. All was well for such developers and manufacturers of diagnostics until the Supreme Court’s 2012 Prometheus decision (and its resultant progeny or related cases). Unfortunately, the Supreme Court took (and the Federal Circuit continues to take) a narrow view towards the patent eligibility of diagnostics under 35 USC § 101.