You Might wonder weather Micro-organisms can be Patented or not?
Intellectual Property Protection in the form of a patent is granted for an invention which is novel, has an inventive step and is capable of being made or used in an industry. But when an invention is said to be novel? An invention is new if it is not in the public domain by publication in any document or used in the country or anywhere in the world before the date of filing of patent application with full specification.
As per the criteria for filing a patent- MICROORGANISMS in their NATIVE or ORIGINAL form cannot be patented as such!
With the advancement in the field of Microbiology and Biotechnology, Man has been developing tailor-made microorganisms to exploit their economic potential.
Prior to 1980, Inventions pertaining to microorganisms and other biological entities were subject to product patents in India i.e patents were granted for processes and products obtained using microorganisms but no patents were given for microbes as such.
For example- Louis Pasteur received a U.S. Patent No 141072 for process of fermenting beer but no patent was given for the living entity “yeast” per say. However, in 1980, Ananda Mohan Chakrabarty developed a “genetically modified” bacterium capable of breaking down crude oil. This property of degrading crude oil was not not found in the naturally occurring bacteria and thus this invention was thought to have significant value for cleaning up oil spills.
Ananda Mohan Chakrabarty filed a US Patent for this genetically modified bacteria but his claim on a living entity was rejected by USPTO (United States Patent and Trademark Office). But the Supreme Court decision went in the favor of Ananda Chakrabarty. The Supreme Court stated that new microorganisms not found in nature were either ‘manufactured’ or ‘composition of matter’. The ‘product of nature’ objection therefore failed and Ananda Mohan Chakrabarty was granted US Patent No. 4,259,444 in 1981.
Thus, Genetically Modified Microorganisms are PATENTABLE!
However, when an invention involves a microorganism, completely describing said invention in the description to enable a third person put the invention into practice becomes difficult. It would be virtually impossible to describe the microbial strain, its isolation, selection and modification to guarantee that the other person will obtain the same strain from the same environment. In such a situation, the microorganism itself will form an essential part of the disclosure and a sample of the microorganism must be deposited in a recognized institution for its availability to the public.
But while drafting a patent application, it has to be taken care that the description part of the patent application must enable a person skilled in the relevant area of technology to put the invention into practice.
In order to patent an invention involving microorganism in several countries, it is necessary not only to file a written description but also to deposit a sample of the microorganism with a specialized institution.
Because the handling and preservation of microorganisms require special expertise and equipments, such a process of depositing microorganism with a specialised institute for every country is complex and costly.
The “BUDAPEST TREATY” is an International Treaty administered by World Intellectual Property Organization (WIPO), signed in Budapest, Hungary in 1977 and came into force in 1980. The treaty allows or requires the Contracting States (80 Contracting Parties) to deposit a sample of microorganism for the purpose of patent with any Internationally recognized authority (IRA) irrespective of whether such authority is on or outside the territory of the said State. This means that it is no longer required to submit microorganisms to each and every national authority in which patent protection is required no longer exists.
There are 80 Contracting Parties of Budapest Treaty. For the list of Contracting States of Budapest Treaty refer to-
There are 46 on record INTERNATIONAL DEPOSITARY AUTHORITIES (IDA) under article 7 of the Budapest Treaty. For the list of INTERNATIONAL DEPOSITARY AUTHORITIES (IDA) under article 7 of the Budapest Treaty refer to-
However the depositor should, in particular, ensure that the deposit is made in the name of the applicant for the patent and a sample of the microorganism is deposited to an International Depositary Authority before filing the patent application. There should be sufficient time for delays in the mail or customs formalities (if the sample is being sent by mail). If the sample is found to be non-viable by the International Depositary Authority (IDA), a replacement sample has to be provided by the applicant for the patent.
India became a member of Budapest Treaty on 17 December 2001. In India, Microbial Type Culture Collection and Gene Bank (MTCC) at the Institute of Microbial Technology (IMTECH), Chandigarh, is a recognized International Depository Authority (IDA) of microorganisms.