Patent deposits and the Budapest Treaty
Biotechnology and genetic engineering are playing an increasingly important role in a broad range of industries. The enormous industrial potential of microorganisms is being investigated and large sums of money are being risked in the commercial development of new microbial processes. Patent protection may allow an organisation to regain its investments.
One requirement of patent law is that all the details of an invention must be publicly disclosed. An invention must be described in sufficient detail to permit a person skilled in the art to reproduce it.
Disclosure normally takes the form of a written description and drawings. However, inventions involving the use of microorganisms or other biological materials present problems, since repeatability often cannot be ensured by means of a written description alone. A new microbiological process cannot be tested without a culture of the organism itself. Therefore, it was agreed that the deposit of the involved biological material in an officially recognised culture collection, known as an International Depositary Authority (IDA) was to be part of the patenting procedure. This led to the need for a uniform international system, defining the minimum criteria to be met by IDAs and avoiding the need to deposit the same organism in different countries.
As such the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure was concluded in 1977 under the auspices of the World Intellectual Property Organisation (WIPO) and came into force in 1980. To date, 45 States and two Intergovernmental Industrial Property Organisations have ratified the Treaty. The main feature of the Treaty is that all countries party to it, and hence their patent offices, consider a deposit made in any one of these IDAs as being valid for the purposes of their patent procedure.
The Budapest Treaty stipulates the rights and duties of both the depositor and the IDA. The depositor has to deposit a viable organism and provide enough information to enable the IDA to handle and maintain the organism safely and correctly. The IDA for its part must process the deposit promptly and issue a receipt and a viability statement to the depositor as proof of deposit and viability. It has to keep the deposit for at least 30 years and, most importantly, furnish samples of it only to those parties entitled to receive them. The IDA must be available on the same terms to any depositor and is bound by strict rules of secrecy.
World-wide, there are at present 31 IDAs of which 21 are located in Europe. As the European IDAs take their responsibilities very seriously, patent matters occupy a prominent position on the agenda of the annual ECCO meetings. As such, in 1995, ECCO has launched an initiative to harmonise the procedures applied by the different IDAs. The result is a document called Code of Practice for IDAs that summarises the points on which a consensus exists among IDAs. It provides practical guidelines on how to deal with unclear situations in the patent deposit procedure. It aims to ensure, as far as opportune, that all IDAs apply similar principles and procedures for the handling of patent deposits. At this moment 20 IDAs have explicitly expressed their agreement with the principles described in the document.
The IDAs in ECCO cover all kinds of microorganisms – algae, animal and human cell lines including hybridomas, bacteria, bacteriophages, fungi including yeasts, plant cell cultures, plasmids and plasmid-bearing strains, protozoa and viruses. The collections are experts in state-of-the-art preservation techniques and have a generally acknowledged high scientific standard.
For IDAs in ECCO see Table 1 and the descriptions of the collections in the previous pages. For patenting purposes the collections may also accept other kinds of organisms than those maintained in their public collections.