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Drug Labeling Patents: A New Line of Defense for Protecting Old Drugs?

By Thomas C. Fiala and Jon E. Wright
June 29, 2005

Pharmaceutical companies have had some success extending the lives of their patent portfolios by obtaining patents that claim the combination of a known drug, a container for holding it, and a label providing instructions for a new use of the drug. These “drug labeling patents” have given such companies a leg up in their ongoing battle with generic drug manufacturers. However, a little-noticed judicial decision handed down by the Court of Appeals for the Federal Circuit (“Federal Circuit”) has cast serious doubt over whether drug labeling claims constitute patentable subject matter.

Drug Labeling Patents

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