What restrictions apply to the furnishing of samples of biological materials?

Source: FAQ (MPEP-Based)BlueIron Update: 2024-09-30

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.

Furnishing samples of biological materials is subject to certain restrictions to prevent misuse and ensure proper access. MPEP 2410 outlines several key restrictions:

“The depositor may contract with the depository to restrict the furnishing of samples to named persons or to organizations for a specified period.”

These restrictions may include:

  • Limiting access to specific individuals or entities
  • Imposing time-based restrictions on sample availability
  • Requiring certification of the right to obtain a sample
  • Prohibiting transfer of samples to third parties

Additionally, some countries may have export restrictions on certain biological materials. Requesters and depositories must comply with all applicable national and international regulations when furnishing samples.

Topics: MPEP 2400 - Biotechnology MPEP 2410 - Furnishing Of Samples Patent Law Patent Procedure
Tags: Access Records, Deposit Access, Deposit Identification, patent grant, Ptab Contested Case