Patentability of Diagnostic Testing Inventions

Summary

This practice note covers strategies for drafting patent applications for diagnostic testing inventions. Diagnostic testing patents generally claim methods for identifying a particular health condition, such as a disease, infection, or defect, based on the results of a testing process. Patents that claim a method of diagnostic testing are particularly susceptible to patent-eligibility challenges because they often involve detecting or identifying natural laws, natural phenomena, or abstract ideas—all of which are judicial exceptions that the courts have deemed to be not patent-eligible subject matter unless the claims incorporate additional element(s) that integrate the exception into a practical application or provide an inventive concept.