Molecular biomarkers, such as variations in genetic sequences, protein levels, or combinations of specific biochemical changes, are increasingly important to the emergence of personalized medicine. Biomarkers are used to detect cancers and other diseases, to predict the risk or progression of diseases, or to choose among therapeutic options. Diagnostic methods involving biomarkers have long been patentable in the U.S., and are important value drivers for companies, and a revenue source for universities.
Recent developments threaten the scope and enforcement of diagnostic method patents in the U.S., forcing innovators to plan carefully to protect their biomarker inventions.
Patent protection for diagnostic methods will fail unless the patent claims, which define the enforceable scope of the patent, are sharper than a scalpel. The claims must be focused on the key, inventive step. Extra steps in a claim permit competitors to avoid infringement while appropriating the value of the diagnostic.
For example, if a method includes multiple steps, such as (step 1) drawing blood from a patient and (step 2) detecting the presence or absence of a biomarker, no one infringes the claim unless one party performs each step of the method. Thus, if a clinician draws the blood, and a different diagnostic company detects the biomarker, there is no patent infringement.
Even properly focused diagnostic method claims forfeit their value if they are unduly narrow. Most biomarker inventions relate not to a new method of detecting a biomarker, but to the information that a detected biomarker provides about a patient’s current or future status. Claims that are limited to one method of detecting the biomarker are of little value, as competitors can select a different method, avoiding infringement.
As sequencing costs plummet, some individuals are having their complete genomes sequenced, and this trend should accelerate. Knome already provides whole genome sequencing, delivering a copy of a customer’s personal genome. Diagnostic method patents that require inspection of a sample may be of little value once a computer program can scan a personal digital file for a genetic biomarker without resorting to a biological sample. As technology evolves, patent claims that are too narrow will not effectively protect diagnostic methods.