Patenting of Live Microorganisms through the Budapest Treaty
Article 27(3)(b) of the TRIPS Agreement 1994 (TRIPS) specifies that patent exclusions can encompass plants and animals, with the exception of micro-organisms, as well as essentially biological methods for creating plants or animals, excluding non-biological and microbiological methods.
Microorganisms can be subject to patent protection, but it’s essential to understand that patents are granted not for discoveries but for inventions that are novel, non-obvious, and capable of industrial application. Only genetically modified inventions that provide distinct and beneficial attributes lacking from the natural organism are eligible for patents.
The Budapest Treaty
In line with TRIPS, the Budapest Treaty was established in 1977 to expedite the procedure of patenting live organisms. It permits the deposit of microorganisms for patent purposes at culture collection centres. To become International Depository Authorities (IDA), these centres must comply with the treaty’s rules. These IDA units are essential to supporting scientific research and innovation because they make sample depositions easier, provide cultures, characterize samples, and preserve biological materials.
Aim of the Treaty
The main objective of the Budapest Treaty is to grant patents worldwide recognition, saving applicants the trouble of filing in every jurisdiction. An International Depository Institution’s recognition of a microorganism is sufficient for national patent offices and regional offices, making the procedure easier for innovators around the world.
In India, thirteen approved repositories—designated by the National Biodiversity Authority—and two IDA units—one each in Pune and Chandigarh—function as ‘culture collection centres’ by storing various biological resources.
Salient features of the Treaty
- Safely preserving microorganisms for patent purposes.
- Supplying samples as needed.
- Establishing a conducive environment for sound microbiological practices.
- Identifying and characterizing samples effectively.
- Maintaining confidentiality when handling deposited microorganisms.
- Offering human resource support, including training programs on microbial techniques.
- Safeguarding the environment.
- Ensuring the proper transportation of samples.
IDA as a Single Depository: When seeking a patent for an invention, being able to replicate it is key. or non-biological inventions with stable components, this is usually simple. However, dealing with microorganisms such as bacteria can be difficult because they are dynamic in their natural environment and can change, making replications tough. To address this, inventors must adhere to the Budapest Treaty and keep these microorganisms in an IDA. IDAs’ functions include but may not be limited to:
Flexibility in interpretation of term ‘micro-organisms’: The term ‘microorganism’ is not defined in the treaty, leaving it to organizations for its flexible interpretation. This adaptability allows the deposition of various biological materials, such as plasmids, cell lines, fungi, yeast, RNA, plant and animal cells, alongside microorganisms, ensuring comprehensive protection for innovations in these fields.
The Patents (Amendment) Act of 2002 harmonized India’s patent laws with TRIPS, encompassing microorganisms within its scope. Notably, Section 3(j) of the Indian Patents Act of 1970 excludes plants, animals, seeds, and biological processes from patentability, while permitting the patenting of microorganisms. Additionally, the applicant must adhere to the criteria outlined in Section 10 of the Indian Patents Act of 1970 when disclosing the details of the contested invention’s specifications.
In conclusion, the Budapest Treaty simplified the process of patenting live microorganisms, allowing inventors to deposit them in specialized centres globally. The flexibility in defining ‘microorganisms’ within the treaty covers a wide range of biological materials, extending protection to innovations beyond bacteria. India’s alignment with these international standards through the Patents (Amendment) Act of 2002 enables microorganism patents while excluding certain biological entities, fostering innovation and biotechnological advancements with global implications for scientific research and technology.