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19 July 2022AmericasStaff writer

Federal Circuit affirms US university’s patent invalidations

Kidney test patents detect “natural phenomena” | Delaware court grants Natera and Eurofins summary judgments on ineligibility.

The US Court of Appeals for the Federal Circuit has confirmed that three kidney test patents owned by Stanford University weren’t eligible for patent protection.

In a precedential decision handed down yesterday, July 18, the Federal Circuit affirmed the US District Court for the District of Delaware’s finding that the patents were directed to the detection of natural phenomena.

Each of the three patents covers diagnosing or predicting organ transplant status by using methods to detect a donor’s cell-free DNA.

When an organ transplant is rejected, the recipient’s body destroys the donor cells, releasing cfDNA from the donated organ’s dying cells into the blood. These increased levels of donor cfDNA can be detected and then used to diagnose the likelihood of an organ transplant rejection.

Stanford and California-based molecular diagnostics company CareDx, the exclusive licensee of the three patents, had sued Natera, alleging that its kidney transplant rejection test infringed the patents.

CareDx also sued Eurofins Viracor, alleging that Eurofins’ various organ transplant rejection tests infringed one of the patents.

Both disputes were dismissed by the Delaware court, which granted Natera and Eurofins’ summary judgment motions of ineligibility.

On appeal, the Federal Circuit concluded that “CareDx’s patents apply conventional measurement techniques to detect a natural phenomenon—the level of donor cfDNA and the likelihood of organ transplant rejection.”

Circuit Judge Alan Lourie, on behalf of the court, noted: “The claimed methods are indistinguishable from other diagnostic method claims the Supreme Court found ineligible in Mayo and that we found ineligible on multiple occasions.”

Turning to step two of Alice, Lourie said that the Federal Circuit has “repeatedly held” that applying standard techniques in a standard way to observe natural phenomena doesn’t provide an inventive concept.

“The practice of the asserted method claims does not result in an inventive concept that transforms the natural phenomena into a patentable invention,” he added.

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