The Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purpose of Patent Procedure, signed on April 28, 1977, was amended on September 26, 1980. The Budapest Treaty eliminates the need to deposit microorganisms in each country where patent protection is sought.
Under the treaty, the deposit of a microorganism with an “international depositary authority” satisfies the deposit requirements of treaty members’ national patent laws. An “international depositary authority” is capable of storing biological material and has established procedures that assure compliance with the Budapest Treaty. Such procedures include requirements that the deposit will remain available for the life of the patent and that samples will be furnished only to those persons or entities entitled to receive them.
The establishment of “international depositary authorities” offers several advantages to both patent applicants and contracting states. Patent applicants benefit because the need to deposit in many countries in which they seek patent protection is dramatically reduced. Since a single deposit in any “international depositary authority” will satisfy the national disclosure requirements of any member state, patent applicants’ costs are much lower. Using a single authority as a deposit increases the deposit’s security, and provides a mechanism of distribution of the deposit. Contracting states benefit because they can rely on the treaty’s uniform standards to assure effective deposit and public availability. They no longer need to independently establish a ‘recognized’ depositary to meet national patentability disclosure requirements.
As of January 1, 2009, there are 72 Contracting Parties to the Budapest Treaty and 37 “international depositary authorities” in 22 different countries.
Main features and advantages of the Budapest Treaty
The main feature of the Budapest Treaty is that member countries have to allow the deposit of microorganisms in its pure and viable form for patent purposes by the inventor and must recognize depository banks known as the “International Depository Authority” (IDA) for the same purpose. The establishment and maintenance of an IDA must be done in accordance with the rules, regulations, and guidelines to the depositor outlined in the Treaty. The member country in which an IDA is located has to assure the Director General of WIPO that the institution complies with the provisions of the Treaty. An IDA will accept deposits of microorganisms both from within the country where it is situated and from other countries.
The second advantageous feature is that the Budapest Treaty has not defined the term “microorganism,” allowing for it to be interpreted in a broad sense. This covers the deposit of biological material, which is necessary for the purpose of disclosure in the patent specification, especially in inventions relating to food and pharmaceutical industries. Presently, plasmid, cell lines, fungi, yeast, RNA, plant and animal cells, etc., can also be deposited apart from microorganisms.
The third feature is that the Budapest Treaty has removed the need to deposit the microorganism in every country where the inventor is seeking patent protection. Depositing the microorganism in any IDA is sufficient for the purposes of the patent procedure to all the national patent offices of the member countries of the Treaty. Therefore, the inventor enjoys the benefit of making the deposit only once. This feature also makes the member countries attractive to an inventor who intends to seek patent protection in several countries. The inventor will be able to save time and money under this procedure.
The Treaty also increases the security of the depositor by the establishment of a uniform system of deposit, recognition, and furnishing of samples of microorganisms. As of 1st October 2018, there are 47 IDAs.
Section 3(j) of the Patents Act, 1970 stipulates what are not considered inventions – “Plants and animals in whole or any part thereof other than microorganisms but including seeds, varieties, and species and essentially biological processes for production or propagation of plants and animals are not inventions.” Prior to the 2002 Amendment, microorganisms were not patentable in India. Pursuant to India becoming a member of the TRIPS agreement, patenting of microorganisms has been allowed.
Section 10(4)(d)(ii) establishes certain conditions to be fulfilled. If the applicant describes a biological material in the specification which does not satisfy clauses (a) and (b), and if such material is not available to the public. In this scenario, the application will have to be completed by depositing the material to an IDA under the Budapest Treaty. The first condition is that the applicant should deposit the microorganisms in the IDA prior to the date of filing in India and should make a reference to the deposit within three months of the filing of the patent application as per Rule 13(8) of the Patent Rules. Further, all the available characteristics necessary for correct identification, including the name, address of the depository institution, and date and number of the deposit must be provided.
The applicant also has to provide the geographical origin of the biological material mentioned in the specification. If the geographical origin is from India, then the applicant has to submit the permission from the National Biodiversity Authority of India before the grant of a patent over the application.
India has two IDA units; one is Microbial Culture Collection in National Centre for Cell Science Pune, India, and the second one is Microbial Type Culture Collection and Gene Bank at Institute of Microbial Technology Chandigarh, India.
Such a patent system providing recognition on the international platform, national patent offices, and regional offices is a very good step taken back then in 1977 as it reduced a lot of problems that people could have faced in the emerging and recent times according to the modernization in the society. The concept of recognition once and for all save the time and money of the people and the international depository authority being such privileged authority provides a full sense of security to the depositors as the sample of microorganisms is only deposited to the sole hands of the international authority for deposits.
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