Budapest Treaty on the Deposit of Microorganisms
Microorganisms that are naturally occurring cannot be the subject of patents. However, a naturally occurring microorganism that is manipulated or altered such as through gene insertion, mutation etc can be the subject of a patent.
Patent law requires that the details of an invention must be fully disclosed in order for others skilled in the relevant field to be able to replicate it. Disclosure is normally achieved by means of a written description and supplemented where necessary by drawings. In the case of inventions involving the use of microorganisms, these patentability requirements may be difficult to fulfill.
EXAMPLE: It would be almost impossible to describe an organism isolated from soil and improved by selection, e.g. mutation, so that another person could be guaranteed to isolate and improve exactly the same strain from the soil in exactly the same way.
To overcome these problems, intellectual property offices in many countries recommended that the written description of an invention involving the use of a new microorganism be supplemented by the deposit of the microorganism in a recognized culture collection. The Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure was introduced in 1980 in an effort to implement such recommendations. The Budapest Treaty recognizes 'international' depositary authorities for microorganisms, sets out the minimum standards for such collecting authorities, and also sets out the guidelines for the deposit of microorganisms. This treaty enables the deposit of the microorganism to help to satisfy the patentability requirements and also ensures that the microorganism is fully disclosed to the public.
The term "microorganism" is not defined in the Treaty. Whether a particular deposit is a microorganism or not matters less than whether the deposit is necessary for the purposes of disclosure. Tissue culture and nucleic acid molecules e.g. plasmids, can be deposited under the Treaty, even though they are not strictly microorganisms.
Under the Treaty, certain culture collections are recognized as " international depositary authorities" (IDA) and a deposit made in the IDA is recognized by all Contracting States to the Treaty. The microorganisms that are deposited with the IDA are kept for a period of at least thirty years or five years after the most recent request for a sample (whichever is longer). The Treaty does not specify at which point during the patenting process the sample must be deposited by the inventor; this is governed by national law. National laws also govern the conditions under which the samples can be accessed by other interested parties.
Currently, there are 61 Contracting States to the Budapest Treaty (as of 30 September 2005), including the United States and Australia. The European Patent Organization has also formally declared its acceptance of the Treaty.
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