Deposit of biological material and the differing national lawsFebruary 11, 2021

For patent applications in the biotechnology area, a biological material is sometimes essential for carrying out the invention. The biological material can be any material capable of reproducing itself or being reproduced in a biological system, including bacteria, fungi, algae, eukaryotic cells, cell lines, hybridomas, plasmids, viruses, and plant seeds. If the biological material cannot otherwise be described and the material is not available to the public, making a deposit of the biological material is one option to satisfy description and enablement requirements. The deposit can be made at one of the 48 recognized international depositary authorities across the world, such as the American Type Culture Collection (ATCC), where it will be stored and available beyond the enforceable life of the patent.

Applicants in the United States may be accustomed to making the deposit after receiving a notice of allowance given that the USPTO merely requires that the deposit of the biological material be made by the time the issue fee is paid. However, the United States is relatively unique in this regard. Most foreign jurisdictions require the deposit of the biological material be made on or before the filing date of the patent application. If the application claims priority to an earlier application, the deposit must be made on or before the filing date of that earlier application. This is the case for Australia, Canada, China, the European Patent Office, Japan, New Zealand, and many others. If a required biological material is deposited after a US provisional application filing but prior to filing an international or foreign application, an applicant would be unable to benefit from the US provisional application priority date.

While requiring the deposit be made on or before the filing date is near universal, foreign jurisdictions often differ in the deadline for providing the actual details of the deposit (e.g., the name of the depositary institution, the accession number). For example, China requires a receipt of deposit and proof of viability within four months from the filing date at the latest, whereas the EPO allows for sixteen months after the date of filing of the application (or after the priority date if priority is claimed) for the information to be submitted.

Due to these complexities, it is important to begin thinking about deposit requirements early in the process, well before filing a provisional application, if an applicant intends to rely on a deposit and may seek patent protection internationally.

Brian D. Keppler, Ph.D. is a registered Patent Agent in the MVS Biotechnology & Chemical Practice Group. To learn more, visit our MVS website, or contact Brian directly via email.

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