Micro-organism Deposits

 

A "micro-organism deposit" is a deposit of biological material with a recognised international depositary such as the American Type Culture Collection (ATCC). The term "micro-organism" is used loosely to refer to a variety of biological materials including eukaryotic cell lines, such as hybridomas, fungi, yeasts, protozoa, bacteria and viruses as well as host cells containing genetic material such as plasmids and other vectors.

 

 

A number of inventions in the area of life sciences are based on complex biological materials, such as micro-organisms and cell lines which are not easily obtainable or reproducible based on a written description of their characteristics in a patent application.  However, it is a requirement of Australian patent law that a patent application must describe fully the invention for which patent protection is sought.

 

In the case of inventions that relate to new complex biological materials, if it is not possible to describe the complex biological material in such a way that others can obtain the biological material without undue burden, then the requirement to describe fully the invention can be met by depositing a sample of the biological material in a recognised international depositary.

Where inventions require or are based on the use of previously known complex biological materials, it may not be necessary to deposit the materials providing that the materials are "reasonably available". An example would be a cell line used to propagate a new viral vector - the cell line may already be freely available from a commercial depositary.

 

 

The international depositary must a depositary for the purposes of the Budapest Treaty. A list of approved depositories can be provided on request. Not all depositories have the facilities to store all types of biological materials. For example AGAL in Australia cannot store hybridomas.

 

 

The deadline varies between different countries. Under Australian law, the deposit must be made before a complete application is filed - i.e. it is not required to be made before a provisional application is filed.

 

However, in Europe, the deposit must be made before an application is filed for which a micro-organism deposit is required, regardless of whether the application is a basic application (such as a provisional application) or a complete application. This is because for the purpose of claiming priority in Europe, the basic application(s) from which priority is claimed must also contain information identifying the micro-organism deposit.

 

Consequently, if an applicant files a basic application without first making a micro-organism deposit and then files a complete European patent application which claims priority from that earlier basic application, there is a risk that patent protection may be lost due to an invalid priority claim.

 

 

Since it can take a number of weeks to arrange for a micro-organism deposit to be made, especially if the depositary is overseas, arrangements for making a micro-organism deposit should be made as soon as possible when preparing a patent application.

 

Under Australian law, it is also necessary to include in the patent application the following details:

 

The accession number of the deposit

These details must be provided before the application is published, although extensions of time are available if the deadline is missed.

Before acceptance of the application, a copy of the deposit receipt must also be filed as well as a Notice of Entitlement which states that the applicant is entitled to rely on the deposit.

 

 

 

Deposits made in depositories under the Budapest Treaty are termed "restricted access". Prior to publication of the patent application, no third party can access the deposit. After publication but before grant, access is possible. However a number of countries, including Australia, allow the patent applicant to restrict access to the deposit to a nominated independent expert without allowing the party requesting access to actually obtain the sample of the deposit. The nominated independent expert is permitted to carry out experiments/testing with the sample and provide the results to the third party.

 

After grant but before the patent lapses or expires, a third party can access the deposit subject to conditions which may be imposed by the Australian Patent Office.  After the patent lapses or expires, the deposit is freely available to anyone.

 

 

For an international application, the deposit details must be provided by sixteen months from the earliest priority date.

This information will also satisfy Australian Patent Office requirements when the application enters the national phase in Australia.

 

It is also possible, before the same sixteen month deadline, to request that access to the deposit be restricted to a nominated independent expert, prior to grant, in those countries designated in the international application which provide for such an option. However, this option may usually also be requested on entry into the various national phases if the sixteen month deadline is missed.