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Articles

"A Safe Harbor in a Patent Storm?"

September 10, 2008

Articles

"A Safe Harbor in a Patent Storm?"

September 10, 2008

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written by Ramon K. Tabtiang and Steven C. Carlson
Los Angeles Daily Journal
September 10, 2008

U.S. patent law includes a safe harbor from patent infringement for preparing information for submission to the U.S. Food and Drug Administration. In a recent case, Proveris Scientific Corporation v. Innovasystems, Inc., 2008 WL 2967100, the Court of Appeals of the Federal Circuit interpreted the scope of the safe harbor and placed new limits on the type of immunity it confers. The court’s opinion addressed a central issue about the scope of this safe harbor – namely what types of patents it shelters from infringement. In Proveris, a unanimous panel of the appeals court ruled that the safe harbor was only available if the infringed patent was directed to a product that itself required FDA approval, or a method of its use or manufacture. Such products include pharmaceutical drugs, protein drugs (called “biologics”), many medical devices and food additives.

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