Ariosa v. Sequenom

2015),[1] is a controversial decision of the US Federal Circuit in which the court applied the Mayo v. Prometheus test[2] to invalidate on the basis of subject matter eligibility a patent said to "solve ... a very practical problem accessing fetal DNA without creating a major health risk for the unborn child.

"[3] The rationale for denying patent-eligibility in this case allegedly stems from claims being directed toward non-eligible subject matter (Law of Nature), "if the APPLICATION [of this discovery] merely relies upon elements already known in the art.

The claim itself has two simple and conventional steps: first amplifying (by polymerase chain reaction, PCR) and then detecting the paternally inherited DNA from the plasma sample.

The district court said: "the claims at issue pose a substantial risk of preempting the natural phenomenon of paternally inherited cffDNA," which made them patent-ineligible.

The fact that once a court concludes that the claims involve only natural phenomena and "conventional" techniques, "preemption concerns are fully addressed and made moot."

This case represents the consequence – perhaps unintended – of that broad language in excluding a meritorious invention from the patent protection it deserves and should have been entitled to retain.

She criticized the Federal Circuit's position on patent-eligible subject matter (claims preempting the use of the laws of nature), following the SCOTUS decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc..

[12] Gene Quinn praised Judge Newman's position in this case, stating [her] "dissent in Ariosa would be a way forward for the Federal Circuit and would be in keeping with the admonition from the Supreme Court that 101 not be used to swallow all of patent law.

[5] However, several judges who concurred in the denial wrote separately that they disagreed with the sweep of the Supreme Court's Mayo decision that had compelled the result.

He therefore proposes a special test for natural law cases, keeping in mind the patent ineligibility of E=mc2 and based on a requirement to keep speculator trolls out: [I]f the breadth of the claim is sufficiently limited to a specific application of the new law of nature discovered by the patent applicant and [actually] reduced to practice, I think that the novelty of the discovery should be enough to supply the necessary inventive concept.

[S]o long as a claim is narrowly tailored to what the patent applicant has actually invented and reduced to practice, there is limited risk of undue preemption of the underlying idea.Dyk adds that he recognizes that the problem with the enablement and written description requirements of 35 U.S.C.

[6] Chris Holman wrote, that the Federal Circuit's opinion "is indeed very bad news for the patenting of diagnostic methods, and in the life sciences generally.

"[18] He blames the assertedly disastrous result on the Federal Circuit's failure to "consider the claim as a whole," instead of which he says it "has broken its analysis into pieces (contrary to Supreme Court's Diamond v. Diehr decision)."

[19] Noonan's point about considering the whole apparently focuses on the fact that the named inventors were the first to discover the natural phenomenon that paternally derived fetal DNA passes into the maternal bloodstream and can be detected there.

Revolutionary diagnostic testing methods that cost tens of millions of dollars to produce should be the flagship of the modern patent system.

[20]Sue Nym, a pseudonymous biotech blogger, deplores the state of patent-eligibility jurisprudence: "Seemingly every new court decision addressing subject matter eligibility under 35 U.S.C.

And patent challengers, empowered by convincing PR spin and misdirection about harm to patients, have found all too sympathetic judicial audiences.

[21]Biotech blogger Courtenay Brinckerhoff considers Judge Dyk's proposals to allow claims to what is actually reduced to practice and no more hopeful prophesies.

Patent Publius, associated in an undisclosed manner with George Mason University Law School, asserts: The overbreadth of the Federal Circuit's analysis threatens diagnostic methods across the board.

He concludes with a warning of still worse things to come: All told, the Federal Circuit's opinion in Ariosa v. Sequenom is a predictable, yet unfortunate, application of the Supreme Court's disastrous reasoning in Mayo.

The unintended consequences of the Supreme Court's opinion have been further realized in the Federal Circuit's denial of Sequenom's innovative claimed method for diagnosing fetal abnormalities.

"[24] A similar situation - a method for evaluating the patient's risk for a cardiovascular disease," which is "based on the discovery that patients with coronary artery disease (CAD) have significantly greater levels of leukocyte and blood myeloperoxidase (MPO) levels" was found to be non-patentable under Section 101 in Cleveland Clinic Foundation v. True Health Diagnostics LLC (Fed.

[25] Another highly criticized case, where Mayo/Prometheus test was used to deny patent eligibility to a commercially significant invention of identifying organ transplant rejection based on detecting the donor's DNA in the recipient's blood, was 2023 CAFC decision in CareDx and Stanford University v. Eurofins Viracor, Inc. [26] As in the previous cases, the Court cited the lack of further inventive concept beyond the newly discovered natural phenomenon.

In other words, a newly discovered law of nature can help the inventors to meet the non-obviousness requirement, but without an additional "inventive concept", that (1) limits the scope of claim, by preventing all uses of the discovered law; and (2) adds inventors' own creativity (not necessarily rising to the level of inventive step but rather at the level of substantial novelty) the requirement of Section 101 (MPEP 2106) [27] is not met.

The key to patentability, in the majority's opinion, was the resulting change in the composition of the blood plasma after separating long and short DNA fragments.