The Budapest Treaty   Leave a comment

This is an international convention governing the recognition of deposits in officially approved culture collections for the purpose of patent applications in any country that is a party to it. Because of the difficulties and on occasion of virtual impossibility of reproducing a microorganism from a description of it in a patent specification, it is essential to deposit a strain in a culture collection centre for testing and examination by others.

The “Budapest Treaty” was signed in Budapest in 1973 and later on amended in 1980. There are 75 countries which are presently members of the Budapest Treaty. This is an international convention governing the recognition of deposits in officially approved culture collections for the purpose of patent applications in any country that is a party to this treaty. Because of the difficulties and virtual impossibility of reproducing a microorganism from a description of it in a patent specification, it is essential to deposit a strain in a culture collection centre for testing and examination by others.

An inventor is required to deposit the strain of a microorganism in a recognized depository, which assigns a registration number to the deposited microorganism. This registration number needs to be quoted in the patent application dealing with the microorganism. Obviously a strain of microorganism is required to be deposited before filing a patent application. It may be observed that this mechanism obviates the need of describing a microorganism in the patent application. Further, samples of strains can be obtained from the depository for further working on the patent. There are many international depositories in different countries such as ATCC, DSM etc. which are recognized under the Budapest Treaty. India became a member of this Treaty, with effect from December 17, 2001. The Institute of Microbial Technology (IMTEC), Chandigarh is the first Indian depository set up under the Budapest Treaty.

As in July 2011, 75 countries are signatory to the Budapest Treaty and there are 40 IDA. The total number of deposits in all the IDA stands 73,635; out of which 29925 deposits were made from 2001 onwards.  

Background

In 1974, the Director General of WIPO convened a committee of Experts to discuss the possibilities of international cooperation over the deposit of microorganisms for patent purposes. The essence of the solution prepared was that certain culture collections should be recognized as depository authorities and that a deposit made with any one of them should be recognized as valid for patent purposes by all the countries in which protection for the relevant invention was sought. At two further sessions in 1975 and 1976 the Committee of Experts examined drafts prepared by International Bureau of WIPO of a Treaty and Regulations on the International Recognition of Deposit of Microorganisms for the purpose of Patent Procedure. A third draft of this Treaty and Regulations served as a basis for the deliberations of a Diplomatic Conference, convened by the Director General of WIPO, organised by him in cooperation with the Government of Hungary, and held in Budapest form April 14 to 28, 1977. The Diplomatic Conference, which was attended by representatives of 29 states members of the Paris Union for the protection of Industrial property and observers from 2 non-member states of Paris Union, the Interim Committee of the European Patent Organisation, and 11 non-governmental international organizations, adopted a treaty with the title “Budapest Treaty on the International Recognition of the Deposit of Microorganisms’ for the purposes of patent procedure, together with Regulations under the treaty.

 The Treaty came into effect in 1980 when it had been ratified or acceded to by the requisite minimum number (five) of States, and U.S. became a contracting party in August 1980 when the treaty became effective. The Regulations under the Budapest Treaty were modified on January 20, 1981, by the Assembly of the Budapest Union in its second extraordinary session. The said modifications entered into force on January 31, 1982.

Main features of the Budapest Treaty

i) International Depositary Authorities and Recognition of single Deposit

 Under the Treaty certain culture collections are recognized as “international depositary authorities” (IDAs). Any Contracting State which allows or requires the deposit of microorganisms for the purposes of patent procedure must recognize, for those purpose, a deposit made in any IDA, wherever the IDA may be.

 Any culture collection can become an IDA provided that it has been formally nominated by the Contracting State on whose territory it is located and that contracting state has furnished assurances that the collection complies and will continue to comply with the requirements of the Treaty and Regulations. The most important of these are that the IDA will be available on the same terms to any depositor, that it will accept and store microorganisms deposited with it for the full period specified the Treaty, and that it will furnish samples of deposited microorganisms only to those entitled to receive them.

ii) Deposit and Furnishing of Samples

 The Regulations under the Treaty lay down in detail the procedure which depositors and IDA must follow, the duration of storage of deposited microorganisms (at least 30 years or five years often the most recent request for a sample, whichever is later and the mechanisms for the furnishing of samples. The Regulations do not address the timing of the deposit, However; this is left entirely to the relevant national law. Provision is made for samples to be furnished at any time to the depositor, to anyone having the depositor’s written authorization, and to any “interested” industrial property office. However, because IDA may not be familiar with the national laws of different countries, the Regulations require that a third party requesting a sample from an IDA must make his request on a form on which the relevant industrial property office certifies that he is entitled to receive a sample of that particular microorganisms. Alternatively, the industrial property office may, from time to time, notify IDAs of the accession numbers of those microorganisms referred to in patents granted and published by it, in which case such microorganisms become available without the need for certification.

iii) Safeguard of Deposits

 The Treaty and Regulations make various provisions to guard against the loss and consequent non-availability of deposited microorganisms. Thus the IDA must have the expertise and facilities necessary to keep the microorganism viable and uncontaminated throughout the storage period required by the Treaty. If for any reason an IDA is no longer able to furnish samples of microorganisms, a new deposit of the same organism can be made and can benefit from the date of deposit of the original. If for any reason an IDA ceases to function as such, The Treaty provides for the microorganisms deposited with it to be transferred to another IDA.

(iv) Meaning of the Term “Microorganism”

 The term ‘microorganism’ is not defined in the Treaty so that it may be interpreted in a broad sense as to the applicability of the Treaty to microorganisms to be deposited under it. Whether an entity technically is or is not a microorganism matters less in practice than whether deposit of that entity is necessary for the purposes of disclosure and whether an IDA will accept it. Thus, for example, tissue culture and plasmids can be deposited under the terms of the Treaty, even though they are not microorganisms in the strict sense of the word.

© R Saha

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Posted September 18, 2011 by R Saha in Learn IPR, Treaties & Agreements

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