The COVID-19 pandemic has caused many pharmaceutical companies to focus R&D on both the diagnosis and treatment of infectious diseases. When it comes to patenting potentially blockbuster products, however, diagnosis and treatment inventions can have night and day results. The U.S. Patent and Trademark Office, after the case Vanda Pharmaceuticals v. West-Ward Pharmaceuticals International, issued a memo stating that "'method of treatment' claims that practically apply natural relationships should be considered patent eligible." In contrast, patent applicants seeking broad patent protection in some medical diagnosis inventions that may involve natural biological relationships may face uphill battles after the denial of rehearing en banc Athena Diagnostics v. Mayo Collaborative Services (Fed. Cir. 2019) and the Supreme Court's denial of cert. (The Supreme Court's refusal to take the case was surprising given that almost every judge on the Federal Circuit (including those who had voted against rehearing en banc), the United States Solicitor General, and many significant amici urged the Supreme Court to take case as a vehicle for clarifying its decision in Mayo.) Now, in a recent ruling in Cardionet v. Infobionic, the Federal Circuit has provided insight on potential avenues to patent eligibility for diagnostic inventions. Specifically, diagnosis techniques that involve improved devices or laboratory techniques may still be eligible for patent protection under 35 U.S.C. § 101.
Eligibility for life science patents has been in flux since the Supreme Court's Mayo and Alice line of cases, which set forth a now widely used two-step framework to determine whether a claim is directed to an ineligible concept such as an abstract idea or a law of nature. After Mayo/Alice, on the diagnosis front, in Athena, the Federal Circuit held that a diagnostic method that involved the use of a man-made molecule "may still leave the claim directed to a natural law." It is also noteworthy that diagnostic methods, other than in vivo studies, are usually patent-eligible in Europe if properly claimed.
In Cardionet, the Federal Circuit examined the patent eligibility of a diagnostic device for heart rhythm disorders claimed in U.S. Patent No. 7,941,207. The claimed device includes a logical unit to "identify a relevance of the variability in the beat-to-beat timing to at least one of atrial fibrillation and atrial flutter." A district court, in an order granting a Rule 12(b)(6) motion to dismiss, found the claims ineligible as being drawn to automating basic diagnostic processes of collecting and analyzing a patient's heartbeat, which doctors have long performed. The Federal Circuit reversed, holding that the claims are directed to an improved cardiac monitoring device. It noted that the district court erred in disregarding a statement in the specification touting the claimed invention as achieving "more accurate and clinically significant" detection of heart rhythm disorders.
The Cardionet case appears to indicate that courts continue to favor claims that involve a physical device. The independent claim in Cardionet broadly covers a device that determines variability of heartbeat for diagnosing heart rhythm disorders. Although the parties focused on the judicial exception of abstract ideas and did not appear to raise the issue of law of nature, it would have been interesting had the court also addressed the law of nature exception. (Is it not a natural law that a patient having a heart rhythm disorder will naturally exhibit variability in the beat-to-beat timing?) The difference in the outcomes in Cardionet and cases like Mayo shows that phrasing a diagnostic invention as an improvement to a machine (or a laboratory technique) remains a good avenue to eligibility.
For patent applicants, the Cardionet case demonstrates the importance of an early engagement with good patent counsel with expertise in subject matter eligibility of diagnosis inventions, particularly given the divergence of eligibility standards in the United States and Europe. To build a successful diagnosis patent portfolio under the challenging eligibility legal framework requires advanced planning and deliberate effort in phrasing the specification and claims in a favorable way. For example, a well-crafted statement in the specification could very well become critical evidence in defeating a 12(b)(6) motion to dismiss, as a district court is required to accept the statement as true and draw all reasonable inferences in favor of the patentee-as noted by the Federal Circuit in Cardionet.
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