Problems – And Solutions – For Securing Patent Protection Over Diagnostic Technologies

Drafting claims for methods of diagnosing and treating patients can be challenging since they involve the measurement of patent-ineligible subject matter and because these methods are often performed by multiple parties.

But "Test and Treat" claims are particularly desirable when connected to regulatory approval of a drug for use in patients with a positive test result. These claims must be carefully written to capture patent-eligible aspects of the diagnostic method in a manner that ensures that at least one party is held accountable in the event of infringement.

Background

In the United States, multiple parties are typically involved in a patient's diagnosis and subsequent treatment. A hospital or clinic usually does the initial examination and makes the decision to run a test. They may take samples and perform the tests themselves with in-house diagnostic equipment or contract with a third-party diagnostic laboratory facility. When the results are ready, a