Diagnostic Tests Using Standard Testing Techniques to Demonstrate Correlations Between Biological Materials and Diseases Are Ineligible for Patent Protection

The exclusive licensee alleged infringement of a patent covering methods for diagnosing a disease through the presence of particular autoantibodies. The alleged infringer moved to dismiss under Rule 12(b)(6) claiming that the asserted claims were not patent-eligible under Section 101. The district court held the claims not eligible and dismissed the case. The exclusive licensee appealed. The Federal Circuit affirmed, finding the patent claimed subject matter not eligible for patenting under Section 101.

The court analyzed whether the asserted claims were eligible for patenting using the two-step test established by the Supreme Court in Alice. On the first step, the claimed diagnostic test method was a claim directed to a natural law. The court explained that under the Supreme Court’s holdings, “correlations between the presence of a biological material and a disease are laws of nature.” Although the claims in this case had other steps, the claims were the correlation between the particular autoantibodies in the body and the specified disease, and thus a natural law. Indeed, the claim recited the steps for observing the correlation and then noted the correlation between the presence of the particular autoantibodies indicating the disease. Further, the specification emphasized that the invention was the discovery of the correlation between the autoantibodies and the disease, not the test method for determining the presence of the autoantibodies. Accordingly, the claims were directed to a natural law.

On the second step, whether the claim had transformed the natural law, the court reiterated that “applying standard techniques in a standard way to observe a natural law does not provide an inventive concept.” The patent described the other steps as “known per se in the art” or “standard techniques in the art.” Because the asserted claims merely used standard techniques, the asserted claims did not provide an inventive concept. Thus, the asserted claims were not patent-eligible.

Judge Newman dissented, arguing that diagnostic tests are patent-eligible.