Court Throws Out Patent for Prenatal DNA Testing

The Federal Circuit affirmed a lower court’s ruling that a company’s method of prenatal DNA testing was not patent-eligible because it is directed to a natural phenomenon.


As stated in the court’s decision,

In 1996, Drs. Dennis Lo and James Wainscoat discovered cell-free fetal DNA (“cffDNA”) in maternal plasma and serum, the portion of maternal blood samples that other researchers had previously discarded as medical waste. cffDNA is non-cellular fetal DNA that circulates freely in the blood stream of a pregnant woman. Applying a combination of known laboratory techniques to their discovery, Drs. Lo and Wainscoat implemented a method for detecting the small fraction of paternally inherited cffDNA in maternal plasma or serum to determine fetal characteristics, such as gender. The invention, commercialized by Sequenom as its MaterniT21 test, created an alternative for prenatal diagnosis of fetal DNA that avoids the risks of widely-used techniques that took samples from the fetus or placenta. In 2001, Drs. Lo and Wainscoat obtained the ’540 patent, which relates to this discovery.

The patent claims certain methods of using cffDNA for prentatal diagnosis, but not cffDNA itself.

The Lawsuit

DNAAriosa Diagnostics makes and sells a non-invasive prenatal diagnosis test called the Harmony Test.

Natera makes a non-invasive paternity test that it licenses to Diagnostics Center, Inc.

In response to letters threatening patent infringement lawsuits, Ariosa, Natera, and Diagnostics each filed a separate declaratory judgement action alleging that they did not infringe the ‘540 patent.

A federal district court agreed with Ariosa’s argument that the claims of the patent were directed to the natural phenomenon of paternally inherited cffDNA and that the claims were thus not patent-eligible.

What can be patented?

Section 101 of the US Patent Act defines things that can be patented as follows:

Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.

Certain things cannot be patented, including:

  • Laws of nature
  • Natural phenomena
  • Abstract ideas

In the 2012 Mayo case, the US Supreme Court found that although the above things are not patentable,

an application of a law of nature . . . to a known structure or process may [deserve] patent protection. [cite] But to transform an unpatentable law of nature into a patent-eligible application of such a law, a patent must do more than simply state the law of nature while adding the words "apply it.”

Patenting Life

Living things can be patented. As reported by the New York Times, in 1988 the US Patent and Trademark Office issued to Harvard University the world’s first patent for a higher life form – a genetically engineered mouse used for cancer research.

However, in the recent Myriad case, the US Supreme Court held that a naturally occurring DNA segment is a product of nature and cannot be patented merely because it is isolated.

In the Ariosa case, the Federal Circuit agreed with the district court that

the only inventive component of the processes of the ’540 patent is to apply … well-understood, routine processes to paternally inherited cffDNA, a natural phenomenon.

Thus, held the court,

While Drs. Lo and Wainscoat’s discovery regarding cffDNA may have been a significant contribution to the medical field, that alone does not make it patentable.

If you have questions about patent law…

If you have questions about patent law, you may wish to consult a patent attorney in your area.

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