The Federal Circuit Limits the Reach of the FDA Exemption!

In a recent case, the Federal Circuit held that Innova’s use of a patented system and device to measure the spray characterization of inhaler devices was not protected under the FDA Exemption.  The Federal Circuit affirmed the district court’s decision based on the fact that Proveris’ ‘400 patent was not itself subject to FDA approval. 

In other words, although the sprayer device was used on products that are subject to FDA approval, since the sprayer device (Optical Sprayer Analyzer) is not subject to FDA approval it cannot be covered by the FDA exemption.  The Court reasoned that the OSA was not subject to the distortion effect of the FDA approval process, thus it cannot be covered under the FDA exemption.  

Innova was not seeking to create a product that competes with the OSA and the OSA does not require FDA approval, thus Innova’s use of the OSA cannot be protected under the FDA exemption.  The Federal Circuit relied heavily on the perfect product fit between 156 (f) and 271 (e) (1) discussed in Lilly v. Medtronic by the Supreme Court. 

The reasoning seems sound and gives new hope to owners of bio tech research tool patents, to the extent that their claimed inventions are not subject to FDA approval.  However, it may raise questions about tying products requiring FDA approval with products that are not subject to FDA approval. 

Here is the case proveris-v-innovasystems.  Enjoy!!

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