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Landmark FDA Safe Harbor Case

Case Title: Landmark FDA Safe Harbor Case
Practice Area: Intellectual Property, Litigation and Dispute Resolution 
Case Desc:

There is an FDA safe harbor provision where using and testing a patented drug or device for the purpose of obtaining FDA approval does not constitute patent infringement. This case, Proveris v Innovasystems, tested the limits of the safe harbor. Proveris patented a device which itself did not need FDA approval but which could be used to obtain FDA approval for, inter alia, nasal sprays. Innovasystems sold infringing devices for use in obtaining FDA approval for sprays and argued that since the device was used for obtaining FDA approvals, it fell within the FDA no infringement safe harbor. The statute was not entirely clear and this was a case of first impression. We were able to convince the Court, based on the wording of the statute and legislative history, that the FDA safe harbor did not protect Innovasystems.

Attorney(s): Gerard F. Diebner 
Industry: Health & Life Sciences 
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