In order to obtain patent protection in Australia, an invention must be novel, involve an inventive step and have industrial applicability. There is also a disclosure and enablement requirement that requires the applicant to describe the invention in such a manner that would allow for others in the relevant field to be able to perform the invention. Such a requirement is part of the tradeoff between the patentee and the public, wherein the patentee is granted a limited monopoly in exchange for making the knowledge publicly available.
However, for inventions involving biological material (and in particular, micro-organisms), it may be difficult, if not impossible, to describe the invention in a manner sufficient to enable a skilled person to perform the invention.
The Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure (“Budapest Treaty”)1 mitigates the burden of the applicant in describing a micro-organism.
What is the Budapest Treaty?
The Budapest Treaty regulates the deposit of any “micro-organisms” with a designated International Depositary Authority (IDA). The use of an IDA ensures that the deposit is viable and is recognised by all member states of the Budapest Treaty, thus negating the need for the applicant to make multiple deposits in all of the member states. However, the Budapest Treaty is not limited to applications of micro-organisms, and in fact can be used in relation to a wide range of biological materials, including, but not limited to, bacteria and other prokaryotes, fungi (including yeast and mushrooms), algae, protozoa, eukaryotic cells, cell lines, hybridomas, viruses, plant tissue cells, spores, seeds and hosts containing materials such as vectors, cell organelles, plasmids, DNA, RNA, genes and chromosomes.
In order to be able to validly rely on the Budapest Treaty as a mechanism for disclosure and enablement, an applicant must:
- File a sample of the biological material with an IDA on or before the filing date of the patent application;
- Make the deposit with an IDA in accordance with the provisions of the Budapest Treaty;
- Include the characteristics of the biological material in the application; and
- Reference the name of the IDA and the deposit number in the application.
Ideally, the Budapest Treaty is invoked at entry into the national phase. However, in Australia, a copy of the deposit receipt can be validly filed at any point prior to acceptance of the application.2
What happens if the application does not reference the biological deposit?
A biological deposit is considered to be part of a patent application, insofar as the deposit provides an enabling disclosure for the biological material. As such it is essential that the deposit is established before the application is filed. However, problems can arise in relying upon the Budapest Treaty if the biological deposit is not made in sufficient time to be accepted before the filing of the patent application – thus, resulting in the deposit details not being available to incorporate into the description of the patent application at the time of filing. If the deposit details are not present in the application, then the applicant is unable to rely on the Budapest Treaty which will likely lead to disclosure problems during examination.
A voluntary amendment to incorporate reference to the deposit details in the application accompanied by an extension of time3, and a declaration setting out the circumstances as to why the deposit details were not included in the patent application, are generally sufficient in order to rectify this type of situation.
Therefore, when relying on a biological deposit, the best practice is to make a deposit well in advance of filing an application (first priority application) in order to avoid any problems with incorporating the deposit details into the specification. However, in certain circumstances this may be able to be rectified by requesting an extension of time in order to incorporate the deposit details into the application.
- Ensure any sample of the biological material is deposited well before the patent application needs to be filed.
- Incorporate all the required information regarding the deposit into the patent application before filing.
- Remind foreign agents at the time of entry into the national phase that you are relying on the Budapest Treaty in order to meet disclosure and enablement requirements.
1 Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure Done at Budapest on 28 April 28, 1977, and Amended on September 26, 1980; and Regulations. WIP Publication 277(E).
2 Patents Regulations 1991 (Cth) reg 3.1(2)(c).
3 Patents Act 1990 (Cth) s223.