Patenting Biotech Invention

Biotechnology is a diverse field of science that studies and utilizes biology, biological processes and organisms to formulate new products or methods that are meant to improve human living. Biotechnology and Intellectual Property are intrinsically linked given that both fields require technology and innovation to pull them forward. What is invented through biotechnological processes must be protected through patent protection lest a third person misuses the same. It was not until the biotech industry embarked on a significant milestone with the establishment of the Department of Biotechnology in 1986 under the Ministry of Science and Technology that important research was executed in the field.

Initially, laws relating to patents in India did not cover inventions related to biotechnology until an amendment in 2002 acknowledged biotechnological, biochemical and microbiological processes as having the potential to be patented. This came after careful observation of rising international trends with respect to innovations and inventions concerning biotechnology.

SCOPE FOR PATENT PROTECTION:

The growth of patents in biotechnology has been remarkable in recent decades, driven by several key factors that reflect the increasing importance and complexity of this field. Biotechnology has witnessed significant scientific breakthroughs, including advancements in genomics, proteomics, and molecular biology. The development of gene sequencing technologies like CRISPR-Cas9 has revolutionized biotechnology. Advances in genomics have paved the way for personalized medicine, where treatments are tailored to an individual’s genetic makeup.

The biotechnology industry has attracted substantial investments from both private and public sectors. Investors are more inclined to support biotech startups and research projects when they can see the potential for patent protection, which can provide a return on their investments. The commercialization of biotechnological innovations has become a major driver of patent activity. Biotech companies recognize the value of securing intellectual property rights to bring their products and therapies to market, resulting in a surge in patent applications.

The growth of patents in biotechnology can be attributed to a combination of scientific progress, commercial opportunities, global competition, interdisciplinary research, and the need to protect investments and innovations. As biotechnology continues to evolve, patent activity is expected to remain a vital component of the industry, facilitating innovation, commercialization, and the development of life-changing technologies and therapies. The interdisciplinary nature of biotech innovations frequently results in patent filings that cover a broad range of technologies. Biotechnology is a global industry, with companies and researchers competing on an international scale. Patents offer a competitive advantage by providing exclusivity in various markets, encouraging entities to secure patents in multiple countries.

LAWS RELATED TO PATENT IN INDIA:

The Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, which came into effect in 1995, was a notable turning point in global intellectual property rights (IPR) regimes. India as a prominent member of the World Trade Organization (WTO) is obligated under the Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement and mandates its member countries to provide patent protection for inventions in all fields of technology including biotechnology. This aligned Indian patent laws with international standards starting with the introduction of product patents in sectors like pharmaceuticals and agrochemicals allowing the country to produce affordable generic versions of patented medicines.

To obtain patentability an invention must fulfil criteria of novelty, inventiveness and industrial application. Legislation regarding patents in India has strict provisions as to what can and cannot be patented. Section 3 of the Patents Act, 1970 and its subsequent amendments lists down some of these exceptions:

1. If the invention is against public order, morality, or harmful to plant, animal, humans or the environment in general.
2. If the invention is a discovery of any living or non-living thing which already exists in nature
3. The discovery of any scientific principle or abstract theory
4. An agricultural or horticultural method
5. Anything that is traditional knowledge.
6. While microorganisms are excluded from patent protection, those which are modified or genetically engineered may fall under the ambit of being patented.

However, the rapidness of development in scientific innovation has left behind gaping moral and ethical dilemmas given development in statutes are not nearly as rapid as development in biotechnology.

LIMITATIONS FOR PROTECTION:

Various contentions have arisen with respect to biotechnological inventions. One of the most significant controversies involves access to essential medication. Pharmaceutical companies often secure patents on inventions relating to drugs allowing them to charge high prices for research and development processes. Several arguments have been that this practice can limit access to life-saving treatments, particularly in low-income countries where patients may not afford the exorbitant prices. This debate has led to calls for reforms in patent law to balance the need for innovation with the importance of global healthcare.

Concerns have also been raised with the aspects of patenting of living organisms, such microorganisms, plants, animals or constituents of genes, cells, RNA, DNA etc., whether or not these are part of the subject matter of a patentable innovation. It further tends to raise ethical concerns related to unintended ecological consequences particularly in areas of genetic modification in living organisms.

While India’s generic pharmaceutical industry has been instrumental in providing affordable medicine worldwide, strict patent enforcement for biotech drugs can potentially limit access to essential life-saving medicines.

Biotechnology patents serve as a critical catalyst for innovation and economic growth in the biotech industry. By offering inventors exclusive rights to their creations, patents incentivize research and development, attract investment, and ensure the disclosure of valuable knowledge. Additionally, patents play a pivotal role in regulating product quality and safety, while also providing legal protections against unauthorized use or replication of inventions. Ultimately, these patents are indispensable for advancing biotechnology, driving the creation of new therapies, technologies, and products, and contributing to the betterment of society.