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.
35 USC § 101 provides that “[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” In Prometheus, the Supreme Court held that, “without more,” process claims directed to the detection of a correlation between a metabolite and drug treatment response are not patent-eligible subject matter under § 101. Rather, the Supreme Court declared that such claims are nothing more than the mere application of a natural law that is not patent-eligible in the United States. Exactly how “without more” should be interpreted to define parameters in which diagnostics can achieve patent eligibility under § 101 has led to significant debate.
Rather than continue the debate, a more proactive approach appears to be available through careful and artful claim drafting to avoid the pitfalls presented by Prometheus and its progeny. The relevant case law clearly expresses the need to modify diagnostic claims away from the mere appreciation or recognition of a correlation between a biomarker and a natural law to an application of patent-eligible subject matter to that correlation. To illustrate, a few claim drafting examples are presented below.
Utilization of a treatment step(s)
No. A method for diagnosing a disease state A in a patient comprising the step of detecting in a patient sample the presence or absence of an antigen B (one could also use “marker B” or “biomarker B”), wherein the patient is diagnosed with disease state A if the antigen B (or “marker B” / “biomarker B”) is detected.
Yes. A method for diagnosing a disease state A in a patient comprising the steps of: (a) detecting in a patient sample the presence or absence of an antigen B, and (b) administering treatment C to the patient if antigen B is detected.
This claiming approach converts the diagnostic claim away from the mere appreciation of the natural law (i.e., “disease state”) and its correlation to the presence of the antigen to an application of a treatment method to that natural law. In doing so, the claim would be transformed or converted into patent-eligible subject matter, which is not violative of Prometheus and its progeny.
Inclusion of a novel component(s)
No. A method of diagnosing a disease state A in a patient comprising the step of obtaining and analyzing a patient sample for the presence of antigen B, wherein the patient is diagnosed with disease state A if the presence of antigen B is detected.
Yes. A method of diagnosing a disease state A in a patient comprising the steps of: (a) obtaining and analyzing a patient sample for the presence of antigen B via novel component C; and (b) diagnosing the patient with disease state A if the presence of antigen B is detected via novel component C.
In the revised claim, the inclusion of a novel component (e.g., assay, reagent, detection hardware or system and the like) converts the claim away from the mere application of a natural law via its correlation with antigen B to a claim having patent-eligible subject matter via the inclusion of component C that is applied to the natural law.
Conversion to a non-natural component(s)
No. A method of diagnosing a disease state A via the presence of an antigen B in a patient comprising the step of: acquiring and analyzing a sample from the patient for the presence of antigen B using an antibody C to detect disease state A.
Yes. A method of diagnosing a disease state A via the presence of an antigen B in a patient comprising the steps of: (a) acquiring a sample from the patient containing antigen B; (b) providing antibody C to the sample to form an antigen-antibody intermediate D; detecting the presence of antigen-antibody intermediate D in the sample to diagnose the presence of disease state A.
In the revised claim, the method is converted to patentable subject matter by the creation, determination and utilization of a refined, non-natural (i.e., “man-made”) component being the antigen-antibody intermediate or “complex”.
The Prometheus decision and its progeny have changed the landscape of personalized medicine and diagnostic-based claiming in the United States. However, that landscape has not been drastically narrowed as some commentators have suggested. Rather, through continued diligence and analysis of the case law, careful and artful claim-drafting strategies can be identified to navigate the patent eligibility obstacles presented.