New Developments in Patent Eligibility of Diagnostic Methods
The U.S. Courts have repeatedly invalidated patents under 35 U.S.C. § 101 as lacking patentable subject matter in areas such as business methods and computer-based inventions. However, decisions addressing inventions in the life sciences are substantially less frequent. In Cleveland Clinic Foundation v. True Health Diagnostics LLC (Fed. Cir. 2017), the Federal Circuit provided some additional guidance for patent eligibility of life sciences inventions.
Three of the patents at issue were directed to methods of detecting myeloperoxidase (MPO) (diagnostic patents), and the fourth patent was directed to methods of treating patients with heart disease based on the MPO detection methods of the other patents. The district court granted the defendant’s motion to dismiss under Fed. R. Civ. P. 12(b)(6) for failure to state a claim because the diagnostic patents lacked patentable subject matter, and the Federal Circuit affirmed that decision.
According to the Federal Circuit, the diagnostic patents were directed to a law of nature: the correlation between MPO level and heart disease. Interestingly, the opinion notes that the correlation was known in the art prior to filing the patents, however, there was no way to directly detect the MPO or correlate the levels to a risk of heart disease. The Court found that the claims did not teach a new test or laboratory technique, nor did they alter the MPO levels. Rather, the levels existed in nature without human action. Thus, the Court concluded that the claims did “not result in an inventive concept that transforms the natural phenomena of MPO being associated with cardiovascular risk into a patentable invention.”
The Court left open the question of whether the method of treatment patent contained patent-eligible subject matter because the Court held that the pleadings for that patent were deficient (this patent was only alleged to be infringed through inducement or contributorily infringed).
Unlike other decisions on patentable subject matter in the life sciences area, the holding did not turn on whether the claims broadly preempted application of a law of nature. The Patent Owner argued that the claims should be patent eligible because they were narrow and did not preempt all uses of the alleged law of nature, but the Court stated that the preemption argument was fully addressed and made moot by its determination that the claims only disclosed patent-ineligible subject matter.
In view of this decision, care should be taken when drafting claims directed to diagnostic methods to be sure to clearly claim more than the diagnostic correlation.