Proveris Scientific Corp. v. Innovasystems, Inc.: Federal Circuit Addresses 'Safe-Harbor' Immunity

Factual Background

The patented product is a system and apparatus characterizing aerosol sprays used to deliver drugs (e.g., nasal spray drugs). FDA approval is required for such inhaler-based drug delivery devices, and the patented product is thus used in obtaining FDA approval. Importantly, the patented product is not by itself subject to FDA approval. The infringing product is known as an optical spray analyzer (“OSA”). Like the patented product, the OSA is used as part of the FDA approval-process for nasal spray drug delivery devices, but is not by itself subject to FDA approval. The defendant, Innova, offered to sell its OSAs to pharmaceutical companies exclusively in connection with the application process for regulatory approval. Innova thus argued that its sales were immunized under the “Hatch-Waxman Act,” which states that it is not an act of infringement to sell a “patented invention ' solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.” 35 U.S.C. '271(e)(1). Innova claimed that its sale of OSAs for use solely in the FDA approval process for nasal spray drugs fell squarely within this statutory language.