What to know about biological materials for Canadian patents
A biological material is capable of self-replication either directly or indirectly and includes bacteria, fungi (including yeast), algae, protozoa, eukaryotic cells, cell lines, hybridomas, plasmids, viruses, plant tissue cells, lichens and seeds. Patent applicants may supplement their patent disclosure with a deposit of a biological material. Here are answers to questions about biological material we hear often at Kirby IP.
Do I need a biological deposit to support sufficiency of disclosure?
Unfortunately, the answer is it depends. If your invention cannot meet disclosure requirements without a biological material, then the deposit is needed. An exception is if the biological material is publicly known and reliably available to a person “skilled in the art”. According to Canada’s Manual of Patent Office Practice, biological material is considered to be reliably available if it can be:
- Obtained commercially
- Reproducibly prepared or isolated from available materials using established procedures and without undue experimentation.
To ensure you are meeting sufficiency of disclosure requirements, usually you should include a deposit of biological material. If you would like advice about your particular situation, please contact us.
What are Canadian requirements for depositing biological material?
Canada regulates the type of depository required and how information about the deposit is presented in the patent application. If you or your client do not comply with these regulations, the Patent Office or a court will not consider the deposit when assessing the sufficiency of your patent disclosure.
Here’s what the regulations say:
a. The sample must be deposited by the applicant at an International Depository Authority (IDA) accredited under the Budapest Treaty.
b. The description in the patent application must include the following information:
i. Name of the IDA
ii. Date of the deposit
iii. The deposit accession number.
What are the deadlines for making a deposit?
Two deadlines are important: your patent application’s filing date and its publication date.
Filing date: The deposit must be provided to a depository before either the Canadian filing date or the filing date of an international or PCT (Patent Cooperation Treaty) application.
Publication date: Information about the deposit must be supplied to the Canadian Patent Office before the patent’s publication date. Canadian applications that have already been published cannot be amended to include the deposit information. This deadline also applies to amending incorrect or incomplete information about the deposit in the application. For example, if the deposit has not been properly identified in the patent application, this must be corrected before publication.The publication date is either the Canadian publication date or, if the Canadian application arises from a PCT application, the publication of the PCT application.
For patent applications filed through the PCT route, this can present problems as the date of national entry in Canada is usually after the PCT application publishes. Thus, it is important that the above information is provided in the PCT application itself before its publication at 18 months from the priority date.
Other tips for Canadian practice
Limit access to your deposit
In Canada you can file a notice with the Patent Office limiting release of biological material to an independent expert agreed upon by the patent applicant and the Commissioner of Patents. Without this notice, samples of the biological material can be released to any third party that agrees to limited use of the deposit until the patent is issued or the application is abandoned. The notice must be filed before the Canadian patent application is published and 18 months after the filing of a previous application.
Getting this kind of notice with a PCT application is difficult because the deadline for publication has usually passed before the patent is applied in Canada; it is then too late to file the notice. However, it may be sufficient to inform the International Bureau, before completing technical preparations for publication of the international application, that you want a deposit to be issued only to a nominated expert. Form PCT/RO/134 can be used for this purpose.
We are here to help
If you have more questions about submitting biological materials, contact us at 613 237-6900.