Panel of U.S. Patent Court Concludes Diagnostic Methods Are Not Patentable

The U.S. Court of Appeals for the Federal Circuit, which handles all patent appeals in the United States, has held that diagnostic methods not requiring new detection techniques or resulting in new treatments are categorically ineligible for patent protection. In Athena Diagnostics v. Mayo Collaborative Servs., No. 2017-2508, 2019 U.S. App. LEXIS 3645 (Fed. Cir. Feb. 6, 2019), the Federal Circuit considered claims to diagnosing neurological disorders by detecting antibodies to a protein called muscle-specific tyrosine kinase (MuSK). The claims differed from similar diagnostics considered by the courts in that they set forth in detail the steps for mixing the synthetic protein with bodily fluid, interacting the protein with antibodies that would be indicative of the disorders, and detecting whether the disorder is indicated by the presence or absence of the antibodies after their interaction with the protein. The lower, District Court had granted a motion to dismiss early in the process of litigation on grounds that the asserted claims were directed to an unpatentable law of nature.

The Federal Circuit held that the claims were directed to the correlation between the presence of naturally-occurring MuSK autoantibodies in bodily fluid and MuSK-related neurological diseases. It found that the identified correlation was a law of nature because it existed in nature apart from any human action. Athena had argued that there was more to the claims than the bare correlation because they specifically required intermixing a synthetic molecule with a patient’s bodily fluids. The Court rejected this argument, stating that the only additional steps required by the claims relied on the application conventional techniques to detect the identified natural law. It pointed to the patent disclosure, which characterized the general techniques as being “standard” and “known in the art.”

The patentee had also tried to raise a material issue of disputed fact that would prevent resolution by motion to dismiss. Athena did so by filing an expert declaration with its opposition to Mayo’s motion to dismiss, where the expert alleged that the application of those standard techniques to the claimed diagnostic was not routine. The Court held that this was insufficient because it need only consider facts and documents that are part of, or incorporated into, the complaint. The Federal Circuit found that this was not the case with the declaration because it made allegations inconsistent with the patent specification’s characterization of the techniques as standard in the art.

One member of the panel of judges, Judge Newman, wrote a dissent in which she argued that the majority had reached the wrong conclusion. She argued that the claims could only be considered a law of nature if their specific steps, including a man-made reaction sequence employing new components in a new combination to perform a new diagnostic procedure, were excised. Judge Newman argued that the majority had improperly dissected the claims into new and old elements and ignored the way that new and old came together to produce an altogether new medical diagnostic, in contravention of the requirement that patent claims be considered as a whole. The majority acknowledged that providing patent protection to novel and nonobvious diagnostic methods would promote the progress of science and useful arts, but reasoned that it must find such claims patent-ineligible under controlling Supreme Court precedent.

Judge Newman’s point that the Federal Circuit and other courts have applied the Supreme Court’s precedents too broadly, perhaps in a way that contradicts with other relevant Supreme Court decisions, is timely and well-made. In trying to strike the correct balance between protecting the public from overbroad patents that risk tying up concepts and practices belonging in the public domain, we must also be cognizant that categorical, judge-made exclusions risk slowing down scientific and technological progress by reducing the incentives to innovate in the first place.

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