What are the rules regarding the furnishing of samples of deposited biological material in PCT applications?

This page is an FAQ based on guidance from the Manual of Patent Examining Procedure. It is provided as guidance, with links to the ground truth sources. This is information only: it is not legal advice.

The furnishing of samples of deposited biological material in PCT applications is governed by PCT Rule 13bis.6 and national laws. Key points include:

• Furnishing of samples is generally delayed until the start of the national phase.
• This delay ends when the applicant takes steps to enter the national phase or when international publication has effects equivalent to compulsory national publication of an unexamined application.
• International Searching and Preliminary Examining Authorities generally don’t request access to samples, with the Japan Patent Office being an exception.
• If a sample is requested, the applicant is responsible for making arrangements to provide it.

The MPEP states: “The furnishing of samples of a deposit of a biological material to third persons is governed by the national laws applicable in the designated Offices.”