Sequenom’s testing is not patentable: uses conventional techniques, not innovative

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At the end of October, Judge Susan Illston of the Northern District federal court of California ruled that Sequenom’s patent for its non-invasive testing was not patentable. Here’s the surprising reasons why:

Ariosa, a competitor of Sequenom’s, filed suit asking the court to rule that its Harmony test did not violate Sequenom’s patent–referred to as the ‘540 patent, short for U.S. Patent No. 6,258,540. Sequenom filed a counterclaim, asking the court to enjoin Ariosa for violating its patent.

The court denied Sequenom’s motion for an injunction, but, in August, the Ninth Circuit Court of Appeals ordered that Judge Illston reconsider her decision. Commentators at the time thought this meant Sequenom may ultimately get the injunction and lock out Ariosa from the United States non-invasive prenatal screening (NIPS) market.

Judge Illston’s order, then, is surprising as it makes clear that Ariosa is not infringing on Sequenom’s patent. And, for those who are receiving marketing material from NIPS labs touting how revolutionary the testing is, they may be surprised at what Sequenom had to say about its own technology.

The judge’s order is informed by the caselaw on patents of naturally-occurring phenomena. In 2012, the Supreme Court issued a widely-anticipated order concerning Myriad Genetics. Myriad had held a monopoly over the testing for the BRCA1 and BRCA2 genes, the genes associated with breast cancer, because Myriad held the patent for detecting those genes. The Supreme Court invalidated that patent, ruling that because the BRCA1 and BRCA2 genes are–by being genes–products of nature, they are not patentable. As the Court said,

To be sure, [Myriad] found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.

With this rule of patent law explained, Judge Illston then applied it to Sequenom’s patent.

She began by noting that both Ariosa and Sequenom admitted that the discovery of cell free DNA in the mother’s blood was a natural phenomena and therefore not patentable. What Sequenom, instead, was claiming was that its method for detecting that cell free DNA was patentable. For Sequenom to say it’s way of identifying cfDNA was patentable, it had to meet the following rule:

[T]he claimed process–apart from natural law, natural phenomena, or abstract idea–must involve more than “well-understood, routine, conventional activity,” previously engaged in by those in the field.

Now, Sequenom markets its testing as “Clear. Convenient. Compelling.” It’s been hailed as the “holy grail” of prenatal testing. So, it must be something innovative, right? And, if so, then it would be patentable. But, look at what Sequenom’s own expert had to say about its testing:

[T]he claims of the ‘540 patent merely apply “conventional techniques” to the newly discovered natural phenomenon of cffDNA.

The inventive concept was to take a known method and to look at [it] in place where people were–where the Federal Circuit and all the experts agree were throwing waste away to look there.

They used conventional tools to make it useful to other people.

(emphasis added). Because Sequenom, itself, admitted it simply used conventional methods–methods that were already being used by others, but simply applied to locate cfDNA–then, “the only inventive concept contained in the patent is the discovery of cffDNA, which is not patentable.”

In an effort to preserve its patent, Sequenom also argued that there were alternative methods for identifying cfDNA, so others could develop NIPS testing using a method that did not infringe on Sequenom’s ‘540 patent. But, as Ariosa argued, and the court noted, none of those other methods had been shown to be commercially viable. “Indeed, Sequenom itself [] acknowledged the preemptive effect of its patent:

[M]anagement believes that the in-licensed ‘540 patent … will block all non-invasive cell-free DNA-based approaches.

The court concluded:

Thus, it appears that the effect of issuing the ‘540 patent was to wholly preempt all known methods of detecting cffDNA at that time.

Based on cfDNA being a product of nature, on Sequenom using known methods for detecting it, and for its patent having the effect of preventing all other competitors, the Court ruled that Ariosa’s Harmony test does not infringe Sequenom’s patent because Sequenom’s method was not patentable.

The ruling means several things for the new age of prenatal testing. It means that competitors will be able to offer their brand of NIPS testing without threat of an injunction for violating Sequenom’s patent (provided Judge Illston’s order is upheld on appeal). But it also means that for all of its touting, NIPS is not as ground-breaking as the labs and media reports would have the public believe, at least not in the context of being so innovative that it can be patentable. And, finally, the admission of Sequenom’s management confirms, yet again, that NIPS is not about information; it’s about selling information.

Comments

  1. Nice write up of a complex legal ruling. Appreciate you reviewing the opinions.

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