February 15, 2017
Authored and Edited by Christopher B. McKinley; Kathleen A. Daley
In Cumberland Pharm. Inc. v. Mylan Inc., 846 F.3d 1213 (Fed. Cir. 2017), the CAFC affirmed the district court’s finding that the idea for patent on a chelating-agent-free drug formulation was not derived from FDA requests to justify the use of chelating agent EDTA. The Court held that the FDA’s request for justification differed from a suggestion to remove EDTA. Takeaway: FDA inquiries do not an inventor make. Further discussion of the decision can be found on Finnegan’s Federal Circuit IP Blog.
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