Recent amendments to Federal Rule of Evidence 702 did not invent the trial judge’s gatekeeping obligation, nor did they transform economic analysis. They did, however, sharpen the focus on the burden of establishing admissibility and whether an expert has reliably applied a valid methodology to the facts. Combined with the Federal Circuit’s increasingly demanding review of patent damages opinions, the practical message is unmistakable: the economic case must be engineered from the beginning, or you will surely suffer the consequences only after it is too late.

The mythology surrounding the act of invention tends to concentrate on the breakthrough moment. There is a flash of insight, a sketch is made on a cocktail napkin, the prototype is assembled in a garage to prove the brilliance of the concept. Unfortunately, commercial markets are considerably less romantic. They do not reward ideas merely because they are clever, patentable or even technically superior. They reward products that work, solve a problem customers recognize, can be manufactured at an economically sustainable price and generate an acceptable return for whoever assumes the risk of bringing them to market.

The U.S. Court of Appeals for the Federal Circuit (CAFC) issued a decision today in Dental Monitoring SAS v. Align Technology, Inc., affirming a district court ruling that found several patent claims covering deep learning based dental image analysis invalid as directed to ineligible subject matter under Section 101. Dental Monitoring SAS owns U.S. Patent 11,049,248 and U.S. Patent 10,755,409, both of which relate to dental arch image analysis. The ‘248 patent covers “a method for assessing the shape of an orthodontic aligner using a deep learning device,” while the ‘409 patent covers a method for acquiring and analyzing an image of a dental arch using the same type of device.