Quarterly International Ip Law Update
| Publication year | 2019 |
| Author | David Tseng |
David Tseng
Dorsey & Whitney LLP
Mariana Noli
Noli IP Solutions PC
In the U.S. patent system, the heightening of subject matter eligibility standards over the past decade has significantly impacted the patentability of inventions in certain disciplines. In particular, patents that relate to medical diagnosis are susceptible to subject matter eligibility challenges because claims are often directed to the analysis of natural physiological phenomena using well-known techniques. However, this perspective in not necessarily shared in other jurisdictions, where courts are not bound by the Supreme Court's framework for determining subject matter eligibility.
The Supreme Court's two-step framework under Alice/Mayo for determining subject matter eligibility requires determining "whether the claims at issue are directed to a patent-ineligible concept."1 If a patent-ineligible concept is involved, the second step requires determining whether the elements of each claim both individually and as a whole transform the nature of the claim into a patent-eligible application.
In Mayo, the Supreme Court held that patented claims directed to methods of determining the optimal dosage for autoimmune disease medication were ineligible subject matter. The adjustments required testing of the patient's blood to determine metabolic rates. The Supreme Court held that the patent claims were not eligible subject matter because the correlation between metabolic rates and dosage was effectively an unpatentable natural law—the patent lacked "additional features that provide practical assurance that the processes are genuine applications of those laws rather than drafting efforts designed to monopolize the correlations."2
In Myriad, the patents were directed to BRCA1 and BRCA2 genes that can be used in detecting cancer. The processes used by Myriad to isolate DNA at the time of Myriad's patents were well-known. The Supreme Court held that a naturally occurring DNA segment is a product of nature and is not patent eligible merely because it has been isolated.
The Supreme Court noted that there were no method claims at issue, and that the case did not involve patents on new applications directed to BRCA1 and BRCA2 genes. Further, the Supreme Court hypothesized that had Myriad created an innovative method of manipulating genes while searching for BRAC1 and BRAC2 genes, it could have sought a method patent.
Although Myriad has left open the question of whether diagnostic patents based on isolating DNA are eligible patentable subject matter, the Ariosa v. Sequenom Federal Circuit decision in 2015 answered the question with a resounding no.
In Sequenom, the patent-at-issue (U.S. Patent No. 6,258,540) recites methods for non-invasive testing of fetal DNA through amplification and detection of paternal DNA from maternal plasma that were already well-known in the art.3 The company Sequenom was the exclusive licensee of the patent and was also responsible for the commercialization of the patent. Ariosa was one of several competitors in the marketplace. Ariosa filed a declaratory judgment after Sequenom sent demand letters claiming patent infringement.
The innovative aspect of the patent was its non-invasive nature because invasive procedures such as amniocentesis may be potentially harmful to both mother and child. Moreover, the method involved analyzing cell-free fetal DNA (cffDNA) in maternal plasma or serum that researchers had previously considered to be medical waste. The patent allows for the determination of sex, blood type, and identification of genetic...
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