District court holds molecular diagnostic test unpatentable
Last week, a court in the Northern District of California used the Supreme Court’s recent landmark decision in Prometheus [ discussed here] to hold that standard molecular diagnostic method claims are ineligible for patent protection. Ariosa Diagnostics, Inc. v. Sequenom, Inc., Lexis 156554 (N.D. Cal 2013). Although the case is inevitably headed to the Federal Circuit Court of Appeals for review, the rationale applied by Sequenom represents a new interpretation of 35 U.S.C. 101 that could weaken patent protection within the biotechnology industry.
A new take on patent eligibility
The patent at issue in Sequenom, US 6,258,540 (the ‘540 patent), is drawn to noninvasive methods of determining, among other things, fetal blood type and genetic health. The inventors of the ‘540 patent discovered that fetal DNA freely circulates within maternal blood, and used this discovery to develop new noninvasive prenatal testing methods. However, relying heavily on language from Prometheus, as well as the Myriad case [ discussed here], the district court in Sequenom invalidated all of the ‘540 patent claims because, “apart from the natural phenomenon of [freely circulating fetal] DNA” they “involve no more than well-understood, routine, conventional activity, previously engaged in by those in the field.”
Prometheus and the “natural phenomenon” exception
As discussed in our previous alerts, Prometheus significantly refined the judicially crafted “natural phenomenon” exception to patent eligibility under 35 U.S.C. 101. This is especially relevant to inventions in the biotechnology industry, which generally rely on the discovery and use of natural biological processes. Though the Supreme Court in Prometheus acknowledged that “all inventions at some level…apply laws of nature,” in order to be patentable under 35 U.S.C. 101, the claimed processes must have “transformed these unpatentable natural laws into patent eligible applications of those laws.”
To make the patent eligibility determination, the Supreme Court drew its focus towards two critical inquiries: 1) whether the claimed process “too broadly preempt[s] the use of a natural law” (i.e., such that others would be foreclosed from making use of the same natural phenomenon for a different purpose), and 2) whether “a process that focuses upon the use of a natural law also contain[s] other elements or a combination of elements, sometimes referred to as an ‘inventive concept,’ sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself.”
Is this the new standard under Prometheus?
Language from Prometheus reverberated throughout the Sequenom decision, criticizing the ‘540 patent for “carr[ying] a substantial risk of preempting all practical uses of [freely circulating fetal DNA]” and failing to claim an “innovative or inventive use of a natural phenomenon.”
Some commentators have criticized the Sequenom decision, as it appears to have dissected the claimed invention into individual elements, classifying freely circulating fetal DNA as a “natural phenomenon” and detection as “no more than [a] well-understood, routine, conventional activity, previously engaged in by those in the field.” If instead, as critics contend, the invention is viewed as whole (i.e., a newly discovered method of noninvasive prenatal testing), the claims do appear to transform “unpatentable natural laws into patent eligible applications of those laws.” If such advances do not qualify as patent eligible, then the diagnostics industry specifically, and the biotechnology industry as a whole, could face a serious threat to the value of diagnostic patent portfolios and the competitive advantages that otherwise valid patents under Prometheus provide. Until the Federal Circuit determines whether Sequenom represents a proper application of the Prometheus decision, the biotechnology industry must wait to see if the jurisprudence of patent eligibility under 35 U.S.C. 101 changes once again.
Take-away points
- Next, the Federal Circuit will weigh in on the Sequenom decision and the patentability of molecular diagnostic method claims.
- Going forward, a comprehensive understanding of Prometheus, Myriad and the USPTO guidelines on patent eligibility under 35 U.S.C. 101 ( http://www.uspto.gov/patents/law/exam/2012_interim_guidance.pdf) will be critical for drafting and protecting process claims within the biotechnology industry.
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