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Court rejects Natera's patent appeal in genetic testing dispute

A landmark ruling blocks Natera from using disputed DNA amplification methods. What does this mean for cancer diagnostics and research?

The image shows a page from a book with a black and white image of a number line on it, which is a...
The image shows a page from a book with a black and white image of a number line on it, which is a patent for a method of calculating the number of people who have been diagnosed with cancer. The text and numbers on the page are likely related to the method, providing further details about the procedure.

Court rejects Natera's patent appeal in genetic testing dispute

A US appeals court has upheld a preliminary injunction against Natera, Inc. in a patent dispute over genetic testing methods. The ruling affirms an earlier decision that the company infringed on a patent covering techniques for amplifying targeted DNA while minimising unwanted genetic material. Three inventors—Richard P. Starkey, Chris D. Selinger, and Jonathan McAuliffe—hold the patent at the centre of the case.

The Federal Circuit Court reviewed Natera's appeal against a lower court's injunction in the case Natera, Inc. v. NeoGenomics Laboratories, Inc. The judges found no error in the district court's handling of claim construction or its assessment of likely infringement.

The appeals court also rejected Natera's argument that the patent was obvious. It confirmed the lower court's conclusion that the company had failed to raise a substantial question on this point.

In assessing irreparable harm, the judges supported the district court's consideration of tumor-informed testing. They noted that the original ruling had carefully weighed potential impacts on cancer patients and clinical research before issuing the injunction.

The decision leaves the preliminary injunction in place, preventing Natera from using the disputed amplification methods. The patent remains valid, and the company must comply with the court's restrictions. The ruling does not address final liability but reinforces the earlier findings on infringement and harm.

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