Obviousness Analysis Trends In Pharma Patent Cases

By Joseph Bennett-Paris and Roshan Shrestha (May 3, 2019, 2:51 PM EDT) -- Recent decisions from the U.S. Court of Appeals for the Federal Circuit highlight the uphill battle patent challengers face in seeking invalidation of pharmaceutical patents.

The Federal Circuit applies at least two different standards for determining obviousness, one for pharmaceutical patent claims directed to specific compounds or a genus of compounds, and a second when the claims are directed to a pharmaceutical formulations. Although the former standard, often called the "lead compound analysis" has been particularly weighted in favor of upholding patentability while the latter is considered to be more "relaxed," the bar appears to be shifting further in favor of...

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