Friday, June 12, 2015

Federal Circuit Decides Ariosa, and Its Not Good News for Innovation in the Life Sciences

On November 1, 2013, I reported on the district court decision in Aria Diagnostics v. Sequenom that invalidated diagnostic method claims under the Mayo v. Prometheus test for patent eligibility.  In that post, I predicted that if “the approach used by this court is upheld by the Federal Circuit and applied generally to diagnostic claims, it would seem to severely limit the availability of patent protection for diagnostics.  

The Federal Circuit’s decision came out today, and Ariosa Diagnostics v. Sequenom (Aria has changed its name to Ariosa) is indeed very bad news for the patenting of diagnostic methods, and in the life sciences generally.  The outcome appears to have been driven by unfortunate and unnecessarily broad language used by the Supreme Court in Mayo, as noted in a thoughtful concurring opinion by Judge Linn (discussed below).

Ariosa begins by setting forth the test for patent eligibility established in Mayo:

  • Step 1 – Determine whether the claims at issue are directed to a patent ineligible concept. Id. at 1297. If the answer is yes, then proceed to Step 2.
  • Step 2 - Determine whether additional claimed elements “transform the nature of the claim” into a patent-eligible application of the concept.

The Supreme Court has described the second step of this analysis as a search for an “inventive concept”—i.e., an element or combination of elements that is “sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the [ineligible concept] itself.”

The court then proceeded to apply the Mayo test to Sequenom’s claims.  The court found that the existence of cell free fetal DNA (“cffDNA”) in maternal plasma is a natural phenomenon, that the claims are directed to methods that begin and end with cffDNA, pointing out that “Sequenom does not contend that [the inventors] created or altered any of the genetic information encoded in the cffDNA, and it is undisputed that the location of the nucleic acids existed in nature before [the inventors] found them." After concluding that the claims are directed to “matter that is naturally occurring,” thereby satisfying Step 1 of the test, the court turned to Step 2.

In applying Step 2, the court found that none of the additional elements recited in the claims provided sufficient “inventive concept” to render the claims patent eligible. In particular, the claims recite steps of preparing, amplifying and detecting DNA, but the court held that all these techniques, such as PCR or detection of a specific chromosome, were “well-understood, routine, and conventional” at the time of the invention. The court states:

[I]n this case, appending routine, conventional steps to a natural phenomenon, specified at a high level of generality, is not enough to supply an inventive concept. Where claims of a method patent are directed to an application that starts and ends with a naturally occurring phenomenon, the patent fails to disclose patent eligible subject matter if the methods themselves are conventional, routine and well understood applications in the art.

Sequenom argued that there are numerous other uses of cffDNA aside from those claimed in its patent, and thus, the patent does not preempt all uses of cffDNA. But the court rejected this argument, ruling that:
[A]lthough the Supreme Court “has made clear that the principle of preemption is the basis for the judicial exceptions to patentability, . . . the absence of complete preemption does not demonstrate patent eligibility. . . Where a patent’s claims are deemed only to disclose patent ineligible subject matter under the Mayo framework, as they are in this case, preemption concerns are fully addressed and made moot.

Sequenom and some of its supporting amici had urged the court to draw distinctions among natural phenomena based on whether or not their patenting would interfere significantly with innovation in other fields, now or in the future. The court rejected this policy argument, however, finding that the Supreme Court cases “ have not distinguished among different laws of nature or natural phenomenon according to whether or not the principles they embody are sufficiently narrow.”

In a thoughtful concurring opinion, Judge Linn states that he joined court’s opinion invalidating the claims of the Sequenom patent only because he felt “bound by the sweeping language of the test set out” by the Supreme Court in Mayo. Judge Linn expressed his view that Part 2 of the Mayo test is overly broad and was unnecessary to decide that case, and that the broad language of Mayo has had the “perhaps unintended” consequence of in this case "excluding a meritorious invention from the patent protection it deserves and should have been entitled to retain.”

Judge Linn found it “hard to deny that Sequenom’s invention is truly meritorious,” noting that prior to the invention prenatal diagnoses required invasive methods, which “present[ed] a degree of risk to the mother and to the pregnancy.” The available “techniques [we]re time consuming or require[d] expensive equipment.” He pointed out that the Royal Society had lauded the inventors’ discovery as “a paradigm shift in non-invasive prenatal diagnosis,” and that the commercial embodiment of the invention, the MaterniT21 test, was the first marketed non-invasive prenatal diagnostic test for fetal aneuploidies, such as Down’s syndrome, and presented fewer risks and a more dependable rate of abnormality detection than other tests.

According to Judge Linn, under “traditional” (pre-Mayo) standards of patentability, Sequenom’s patent would have been valid, since the inventors had “effectuate[d] a practical result and benefit not previously attained.”  His opinion concludes with the following observation: 

But for the sweeping language in the Supreme Court’s Mayo opinion, I see no reason, in policy or statute, why this breakthrough invention should be deemed patent ineligible.

I agree with Judge Linn on this point, and can only hope that the Federal Circuit can find some way to rein in the unnecessarily expansive language of Mayo.  But if the Federal Circuit is as constrained by Mayo as Judge Linn seems to believe, Congressional or Supreme Court intervention might be necessary to restore effective patent protection for important innovations as exemplified by the Sequenom test.