A Major Patent Ruling in Medtech and it Doesn't Involve Axonics & Medtronic

A Federal District Court has made a decisive ruling in a patent spat between two competitors.

Omar Ford

September 29, 2021

2 Min Read
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Natera is emerging as the victor in the most recent round of a patent battle with CareDx. The Austin TX, -based company said that a Delaware Federal District Court that all three patents CareDx has asserted against it "are invalid as a matter of law under §101 for claiming patent-ineligible subject matter."

CareDx was claiming infringement on patents that cover non-invasive monitoring of organ transplant rejection through cell-free DNA analysis, the intellectual property behind the Brisbane, CA-based company’s AlloSure.

Despite the ruling, it looks as though the two companies will be dueling in the courts for a while. CareDx has already said it plans to appeal.

“While the trial court’s patent ineligibility finding for these three patents has no impact on our ability to continue providing AlloSure, we continue to believe Natera and Eurofins Viracor are infringing these patents,” the company said in a release. “We have deep respect for our partners at Stanford University, whose ground-breaking innovation enabled non-invasive organ transplant monitoring, and we are proud to defend the patents that resulted from their ingenuity. 

Natera said in a release that it expects Wednesday’s ruling will be upheld on appeal and would pursue its claims that CareDx infringes Natera's '658 and '724 patents.

The conflict between the two companies began in March of 2019. CareDx asserted that U.S. Patent Nos. 9,845,497 and 8,703,652, were exclusively licensed to it from Stanford University.

Stanford is joined in the suit as a necessary party because it is the registered owner of these patents.

Natera’s patent victory comes on the heels of a key ruling between Medtronic and Axonics. About a week ago, the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office officially upheld most claims in the Medtronic patents that Axonics challenged.

Axonics said it plans to appeal the PTAB’s decisions on the claims it declined to invalidate to the Director of the Patent & Trademark Office and to the U.S. Court of Appeals for the Federal Circuit. The PTAB’s decision only relates to the issue of invalidity or patentability of the Medtronic patents and does not mean that Axonics infringes any of the patents.

Medtronic said it plans to ask the U.S. District Court in the Central District of California to lift the stay on the IP infringement case and resume proceedings. Axonics, however, said it expects the stay on legal proceedings to continue until the appeals process is complete.

The patents are in relation to sacral neuromodulation devices.



About the Author(s)

Omar Ford

Omar Ford is MD+DI's Editor-in-Chief. You can reach him at [email protected].


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