In what appears to be another body blow to the diagnostics industry, the Federal Circuit refused on Wednesday to reconsider en banc its widely criticized decision in Ariosa v. Sequenom1 that came out earlier this summer. While conceding that “neither of the traditional preclusions of laws of nature or of abstract ideas ought to prohibit patenting of the subject matter in this case,” the Federal Circuit felt “that under Supreme Court precedent[, i.e., Mayo v. Prometheus,2] it had no option other than to affirm the district court.”
To recap, Sequenom arose from a dispute about the infringement of U.S. Patent No. 6,258,540, entitled “Non-Invasive Prenatal Diagnosis.” The ’540 patent is based on the inventors’ groundbreaking discovery that cell-free fetal DNA (cffDNA) is contained in the plasma and serum of pregnant women, which was usually discarded as medical waste. The invention of the ‘540 patent represents a revolution in prenatal care because it allows prenatal genetic testing that does not rely on invasive amniocentesis or chorionic villus sampling, which had been the predominant methods at the time.
Many stakeholders in the life science and diagnostics community felt that the ’540 patent invention should be patentable since it is directed to the practical application of the aforesaid discovery, rather than the discovery itself. The Federal Circuit, however, did not see it this way. Instead, feeling constrained by the Supreme Court’s prior decision in Mayo, the Federal Circuit affirmed the court below and decided that the claims of the ’540 patent covered nothing more than the detection of a natural phenomenon - cffDNA in maternal plasma - in combination with conventional activity, for example polymerase chain reaction (PCR). In arriving at its conclusion, the Court completely ignored the facts that distinguish Sequenom from Mayo.
Not surprisingly, Sequenom, Inc., the patent owner, filed a petition for a rehearing en banc, which was supported by numerous amicus briefs from non-profit organizations, companies and academic institutions. This support turned out to be in vain, however, since the Federal Circuit refused to lift the “dark cloud overshadowing thousands of issued and maintained biotechnology patents,” as one amicus brief characterized the Court’s Sequenom decision.
The Federal Court’s denial of a rehearing en banc and its continued refusal to clarify the Supreme Court’s analysis in Mayo are disappointing. However, there appears to be a silver lining at the horizon. All three Judges concurring in the denial felt they had no option other than to affirm the district court. However, they also seemed to be uncomfortable with the holding that the claims at issue are invalid based on section 101, and hinted that the Supreme Court should revisit the issue of patent eligibility under the Mayo framework.
For example, Judge Lourie, joined by Judge Moor, emphasized in his concurrence that “[a]ll physical steps of human ingenuity utilize natural laws or involve natural phenomena [and that t]hus, those steps cannot be patent-ineligible solely on that basis because, under that reasoning, nothing in the physical universe would be patent-eligible.” He then continued to note that “[t]he claims in this case perhaps should be in jeopardy, not because they recite natural laws or abstract ideas, but because they may be indefinite or too broad.” He even suggested that the claims might have had a better chance for survival had they been drafted in the following Jepson format:
"In a method of performing a prenatal diagnosis using techniques of fractionation and amplification, the improvement consisting of using the non-cellular fraction of a maternal blood sample."
Similarly, Judge Dyk, concurring in the denial, seemed to indicate that the claims should not fail under section 101 since “the major defect is not that the claims lack inventive concept but rather that they are overbroad.” In that regard, he further noted that the “primary concern with a patent on a law of nature is undue preemption - the fear that others’ innovative future applications of the law will be foreclosed,” and that this concern could be addressed by “limiting the scope of patents based on new discoveries to narrow claims covering applications actually reduced to practice.”
Finally, Judge Newman, dissenting, indicated that while she “agree[d] with . . . [her] colleagues that this case is wrongly decided . . . [she did] not share their view that this incorrect decision is required by Supreme Court precedent.” Instead, she took the position that “[t]he facts of this case diverge significantly from the facts and rulings in Mayo,” and that “[i]n the case at bar, the inventors are not claiming the scientific fact of the discovery of paternal DNA in the blood of a pregnant woman . . . [but] the discovery and development of a new diagnostic method of using this information.”
In view of the Federal Circuit’s own apparent dissatisfaction with the Supreme Court’s Mayo decision, or at least with its mandated application, it is not unlikely that Sequenom, Inc., will petition the Supreme Court to hear its case. It remains to be seen, of course, whether the Court will grant such a petition, and how the Court might decide if it does. Therefore, in view of this continued uncertainty stakeholders should continue to be vigilant and obtain appropriate counsel to assure that they maximize their chance of obtaining at least some protection for their diagnostic inventions.