What is the significance of the Enzo Biochem v. Calgene case in patent enablement?

The Enzo Biochem v. Calgene case is significant in patent enablement because it illustrates how courts assess the scope of enablement in biotechnology patents. The MPEP Section 2164.06(b) summarizes the case:

“The court held that two patents with claims directed to genetic antisense technology (which aims to control gene expression in a particular organism), were invalid because the breadth of enablement was not commensurate in scope with the claims.”

The court’s decision emphasized that:

• The limited disclosure in the specification did not support the broad claims
• The technology was highly unpredictable
• Substantial experimentation would be required to apply the invention across the claimed scope

This case underscores the importance of providing sufficient disclosure and working examples, especially in unpredictable fields like biotechnology.

To learn more:

• Enzo Biochem v. Calgene
• enablement
• biotechnology patents
• antisense technology