How does the concept of ‘routine experimentation’ apply to biological material patents?

‘Routine experimentation’ is a key concept in determining whether a biological material deposit is necessary for a patent application. According to MPEP 2404.02:

“No deposit is required, however, where the required biological materials can be obtained from publicly available material with only routine experimentation and a reliable screening test.”

In the context of biological material patents:

• ‘Routine experimentation’ refers to standard procedures that are well-known and commonly practiced in the field
• It implies that a person skilled in the art can reproduce or obtain the biological material without excessive difficulty
• The concept helps distinguish between inventions that require a deposit and those that don’t
• It is closely tied to the enablement requirement of patent law

Applicants should clearly describe any experimental procedures in their patent application, demonstrating that they are indeed routine and do not constitute undue experimentation.

To learn more:

• routine experimentation
• biological material patents
• deposit requirements
• biotechnology inventions