Disclosure of Source of Genetic Material

Clients should be aware of a new requirement in some countries to provide a statement of the geographical origin or specific source of genetic material used in biotech inventions which are the subject of patent applications.

Although it is not possible to patent the mere discovery of a naturally occurring organism, protein or DNA sequence it is usually possible to patent an isolated DNA or amino acid sequence from an organism. Situations can arise in which an organism which is indigenous to a certain country is discovered and it, and/or its genetic material, is used in an invention by overseas scientists. Subsequently, those overseas scientists might apply for patent protection. Currently the source of the genetic material is not always disclosed in patent applications. There is a concern, particularly amongst the developing countries, that any financial benefit which may result from the exploitation of the invention should be shared with the relevant indigenous community. There are now moves to require the disclosure of the origin of genetic material in patent applications. It is believed that this may help to make it clear when a country's genetic resources have been used in this way.

The basis for requirement to disclose the geographical origin or specific source of genetic material arose through the Convention on Biological Diversity (http://www.biodiv.org/welcome.aspx). One of the Convention's aims is to promote the 'fair and equitable sharing of the benefit that can be derived from genetic resources' (see Articles 15 and 16 of the Convention). This is now reflected in the patent laws of some countries

Swedish law now requires that 'if an invention relates to material from the plant or animal kingdom or if such material is used in an invention, the patent application shall contain information about the geographical origin of the material if this is known' (emphasis added). However, lack of information on the geographical origin or on an applicant's knowledge of the origin does not affect the examination of a patent application or the rights conferred by a granted patent. Norway and Denmark have also introduced similar provisions.

In 2006, South African law was amended to require applicants for patents to make a declaration as to whether their invention is based on indigenous biological or genetic resources, traditional knowledge or traditional uses. Irrespective of the field of technology of the invention, every applicant must file a declaration within 6 months of filing the patent application. If the invention is based on such resources, knowledge or use the applicant must also file proof of title or authority to make us of this. Failure to provide the declaration is likely to slow the process of the application. Furthermore, applicants must take care when preparing the declaration as providing a false declaration is a ground for revocation.

India is an increasingly important market, especially for pharmaceuticals, and its law appears to be strict. Here, a patent can now be overturned if the source and geographical origin of biological material used in the patented invention is not disclosed or is wrongly disclosed. Also traditional knowledge can be used to render a patent application not new or not inventive in the same manner as written publications.

Some member states of the European Community consider that the disclosure of the geographical origin or, if unknown, the specific source of genetic material in patent applications should be mandatory. The opinion of the European Community is summarised in a document submitted to the World Intellectual Property Organisation (WIPO) in December 2004 (see: www.wipo.org/tk/en/genetic/proposals/european_community.pdf ). Accordingly, disclosure requirements may be incorporated into the Patent Cooperation Treaty (PCT) and regional agreements such as the European Patent Convention (EPC) and/or the national law of European countries in the future.

Where there is a possibility of seeking protection in Europe, especially in Sweden, India or South Africa it would be sensible to include a statement regarding the geographical origin or specific source of genetic material. Consequently, we encourage clients to keep a note of the record of the origin and source of materials and to notify us when preparing patent applications so that a view can be taken on whether to include details of the materials' sources.

If you require any further comments on this topic then please speak to your usual Life Sciences & Chemistry group contact.

Rachel Williams (updated September 2006)