Introduction
Microorganisms are tiny organisms that can only be seen under a microscope. Microorganisms are recognized as the earliest form of life, play a critical role in several ecological processes, and are fundamental to the biosphere. The microorganism contains biological material capable of self-replication or replication through the host organism. There are six major categories of microorganisms: viruses, fungi, bacteria, archaea, protozoa, and algae. Each of these groups exhibits unique structure, characteristics, and functions, making them irreplaceable to microbiologists and biotechnologists to utilize them for a wide range of research applications1.
Scientists employ microorganisms in processes ranging from beer brewing and bread production to the large-scale manufacturing of antibiotics, aiming to achieve specific outcomes that benefit societal health and industry. Whereas yeast is essential for fermentation processes, bacteria are harnessed for their ability to produce antibiotics and many pharmaceuticals. Genetic engineering and DNA analysis have further expanded the potential of microorganisms, leading to the development of genetically modified organisms.
The growing significance in microorganism in biotechnology and medicine has led to the need for protecting microbial innovations through patent. Patent provide legal recognition and exclusive rights to microbiologist for their novel microbial or genetically modified organism, encouraging continued research and investment.
Before 1980, patents were granted for inventions based on microbiological processes. No patent was granted for living entities per se, which were considered to be products of nature. Although patent laws were originally framed for mechanical and chemical inventions, the patenting of life forms was also included. The first patent based on microorganisms was made by Louis Pasteur on January 28, 1873, for the process of fermenting beer.
The case of Diamond v. Chakraborty in the 1980s was the key breakthrough for the patenting of microorganisms. Dr. Ananda Chakraborty filed a patent claiming a live, human-engineered bacterium capable of degrading crude oil components. The patent was upheld by the US Supreme Court. The US Patent Office initially rejected the patent application, arguing that microorganisms are natural products and, therefore, not eligible for protection under US patent law.
The United States Court of Customs and Patent Appeals overturned the US Patent Office order and recognized the innovative nature of Chakraborty's work. Following this, Sidney A. Diamond, the Commissioner of Patents and Trademarks, appealed to the US Supreme Court, which ultimately ruled in favor of Chakraborty. The court determined that the genetically engineered bacterium, which could effectively address oil spills, constituted an invention characterized by novelty, utility, non-obviousness, and industrial applicability—qualities that a naturally occurring microorganism does not possess. Prior to the Supreme Court's ruling in Diamond v. Chakraborty, patent protection was limited to process claims involving, rather than claims pertaining to the microorganisms themselves as products. This limitation hindered innovation and investment in biotechnology.2
An Overview of Patent Law and Microbiological Innovations
According to the Indian Patents Act, 1970, a Patent is defined as a monopoly and exclusive right granted to inventors for a novel and inventive product or process of manufacturing an article, which is capable of industrial application.
The Indian Patent Act of 1970 underwent substantial amendments in 2002 to comply with the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. One of the most landmark events was the inclusion of microorganisms as patentable subject matter, which marked a pivotal shift in the landscape of biotechnological innovation in India. These amendments helped to foster research and development in the fields of agriculture, biotechnology, biochemistry, pharmaceuticals, and environmental science.3
Section 3(j) of Indian Patents Act, 1970
Based on Article 27.3(b) of the TRIPS Agreement, Section 3(j) of the Indian Patent Act outlines certain exclusions of "Plants and animals in whole or in any part, including seeds, varieties, species, and essentially biological processes for their propagation and production, but excludes microorganisms. Many patents are granted for the method of producing transgenic animals or plants, as the method includes technical or human involvement and is not considered a biological process. Therefore, only the process or method for producing the transgenic plants or animals is considered a patentable entity.
However, Section 3(j) excludes microorganisms from the group of non-patentable subject matter; only microorganisms modified by human involvement fall under the patentable entities, while naturally obtained microorganisms are not patentable under Section 3(c) of the Indian Patent Act, 1970. Thus, Section 3(j) of the Indian Patent Act, 1970, provides a careful balance between encouraging innovation and protecting biodiversity and traditional knowledge. By allowing the patentability of microorganisms, the Indian legal framework recognizes the potential of these entities to contribute significantly to scientific and industrial advancements while still maintaining restrictions on biological entities.4
After the 2002 amendments to the Patent Act, 1970, the granting of patents for inventions claiming microorganisms was effective from May 20, 2003. The Budapest Treaty regulates the deposition of microorganisms with designated International Depository Authorities (IDAs), along with the availability of such microorganisms that are not fully described and not publicly accessible. If a microorganism is not fully described and not publicly accessible, then the microorganism must be deposited with a designated International Depository Authority as per the Budapest Treaty. India has been a signatory to the Budapest Treaty since 2001 for the deposition of microorganisms. India has three depositories:
- Microbial Type Culture Collection (MTCC), Chandigarh
- Microbial Culture Collection (MCC), Pune
- ICAR-National Bureau of Agriculturally Important Microorganisms (NBAIM), Mau Nath Bhanjan
According to the TRIPS agreement, the following microbiological inventions are patentable:
- The process of creating a new microorganism.
- A new microorganism produced by the specified process;
- A new microorganism in its own right; and5
- The process of cultivating or utilizing a known or new
microorganism to;
- Generate a multiplied form of the microorganism, such as a vaccine or edible biomass, and
- Produce a by-product of microbial growth, such as an antibiotic, enzyme, toxin, or another valuable industrial product.
Judicial Precedents: Dimminaco A.G. v. Controller of Patents & Designs
On January 15, 2001, a landmark decision was issued by the Calcutta High Court in the case of Dimminaco A.G. v. Controller of Patents & Designs setting a significant precedent in the realm of microbiological research and patent law. In this instance, the Assistant Controller of Patents & Designs had rejected a patent application claiming a process to develop an infectious bursitis vaccine, arguing that the claimed process involved a living virus that could not be classified as manufacture and that a vaccine consisting of a living virus could not be considered a substance or product. However, the court overturned this decision, emphasizing that the production of a marketable product containing a living entity indeed falls within the definition of manufacture.
Additionally, the court highlighted that the interpretation made by the Assistant Controller was incorrect, as the claimed vaccine involved both novelty and the capability of industrial application, which played a crucial role in safeguarding poultry against Bursitis infection. This judgment reinforced the significance of the commercial potential of biotechnological innovation and also set a precedent for microbiology patent applications in the future.6
Conclusion
The patenting of microorganisms in India presents a complex landscape with both opportunities and challenges. The Patents Act, 1970, as amended to align with the TRIPS agreement, allows for the patenting of certain microorganisms, potentially fostering innovation in biotechnology, medicine, agriculture, and environmental solutions. However, this approach also raises important considerations:
- Patenting microorganisms may incentivize research and development in biotechnology, potentially leading to advancements in various fields.
- The exclusion of naturally occurring microorganisms from patentability under Section 3(j) aims to protect biodiversity and traditional knowledge but may also limit certain areas of research.
- The patenting of life forms, even at a microbial level, continues to be a subject of ethical debate globally.
- While patent protection can stimulate investment in biotechnology, it may also raise concerns about access to and affordability of resulting products or technologies.
- India's approach to microbial patenting reflects an effort to balance domestic interests with international obligations under TRIPS.
As the field of biotechnology continues to advance, India's legal and regulatory framework for microbial patents presents opportunities for proactive development. This dynamic area offers the potential to foster innovation, address emerging challenges, and capitalize on new opportunities through strategic assessments and thoughtful adjustments to the patent system.
Footnotes
1. https://www.britannica.com/science/microbiology
2. https://supreme.justia.com/cases/federal/us/447/303/
3. https://ipindia.gov.in/writereaddata/Portal/IPOAct/1_39_1_patent-amendment-act-2002.pdf
4. https://ipindia.gov.in/writereaddata/portal/ev/sections/ps3.html
5. https://www.wipo.int/treaties/en/registration/budapest/
6. https://spicyip.com/wp-content/uploads/2013/11/Dimminaco-A.G.-v.-Controller-of-Patents-Designs.pdf
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