Is an actual reduction to practice required before filing a patent application for biological material?

No, an actual reduction to practice is not a prerequisite for filing a patent application, even for biological materials. The MPEP 2406.02 clearly states:

“[T]here is no requirement in the patent law that an actual reduction to practice occur as a condition precedent to filing a patent application.”

This means that inventors can file patent applications for biological inventions based on constructive reduction to practice, which involves providing a detailed description that would enable a person skilled in the art to make and use the invention without undue experimentation.

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Topics: MPEP 2400 - Biotechnology, MPEP 2406.02 - Deposit After Filing Date - Corroboration, Patent Law, Patent Procedure
Tags: biological material, Constructive Reduction To Practice, reduction to practice