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If you've gotten a paternity test or fetal DNA test in the last twenty years, you have probably benefited from the discovery of cell-free fetal DNA, or cffDNA. This DNA is non-cellular bits of DNA floating freely in the blood stream of a pregnant woman, which can be extracted from maternal plasma and serum and tested for paternity and other genetic information.
After cffDNA was discovered, a method of detecting and interpreting it was commercialized by Sequenom and patented by Drs. Dennis Lo and James Wainscoat. Paternity and genetic tests based on cffDNA are significantly less invasive than other forms of testing. Unfortunately for Sequenom, however, those methods are also unpatentable, the Federal Circuit ruled last week.
After Sequenom accused competitor paternity and fetal DNA testing companies of infringing on its patent, those companies sought a declaratory judgment that the patent was invalid. The district court of the Northern District of California agreed, as did the Federal Circuit.
Under Section 101 of the Patent Act, an individual can patent "any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof." However, that broad definition does not extend to laws of nature, natural phenomena, or abstract ideas. But when does one's patent claim become a natural phenomena as opposed to patent-eligible applications of those?
Such patents are possible when they "transform the nature of the claim" into a patentable application by applying an "inventive concept." One can't patent solar rays, but one can patent a novel technology to harness their power.
In this case, Sequenom claimed the patents were directed at a method for detecting cffDNA, not at the cffDNA itself. Once the cffDNA was extracted, the patent prescribed ways to amplify and test it through the use of polymerase chain reactions and agarose gel stains. Those methods are widely used for amplifying and testing DNA -- PCR experiments can be, for example, performed by high school students.
Unfortunately for Sequenom, a patent claim that "simply states the law of nature while adding the words 'apply it,'" is insufficient. It's necessary to add additional, new, and useful features.
While Sequenom added additional steps to detecting and interpreting cffDNA, those were already standard when Sequenom filed its patent. Instructing doctors to apply "routine, conventional techniques" for detecting DNA is neither new or useful nor patentable. Even the inventor could not claim that techniques such as PCR were anything but routine in the late 90's.
Sequenom had argued that before its patent, "no one was using plasma or serum of pregnant mothers" to amplify and detect cffDNA. Similarly, the paper announcing the discovery has been cited over a thousand times, Sequenom claimed. That may be so, the Federal Circuit held, but the discovery of cffDNA is not an inventive concept which is patentable and it's not the patent claimed by Sequenom.
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