All you Need to Know About Biotechnology Patents in India
The diversity of biotechnological inventions and discoveries is unique. From the science of genetics to tissue culture, the field is expanding and changing quickly. Numerous biotechnology innovations promise better medicines, healthcare, and innovative industrial processes. The development of products can cost a biotechnology company millions of dollars, so it stands to reason that these businesses seek patents that will secure their investment while also ensuring a return.
How it all began
The story of biotechnology patents started in the United States with the case of Diamond vs. Anand Chakrabarty (1980) – a biochemist at General Electric (GE) who developed a genetically modified organism that had the capability to decompose crude oil . The inventor’s initial patent application was turned down. Later, after further appeal, the patent was granted by the court stating that, “the claim of the inventor is not to a hitherto unknown natural phenomenon, but a non-naturally occurring composition or manufacture of matter — a product of human inventiveness.”
In India, the Patent Act was enacted in the year 1856. In 1970, a significant amendment was introduced that satisfied the worldwide standards of patentability of an invention covering novelty, industrial applicability, and inventive step. However, this did not include any specific provision for the biotechnology sector. In 2002, an amendment to the patent laws was made to specifically include biochemical, microbiological, and biotechnological processes in the definition of potentially patentable methods.
Prerequisites for obtaining a biotech patent
To register and receive a biotechnology patent, there are a few conditions that the invention must fulfill.
- Patentable Subject Matter:
According to the Patents Act 1970, there are certain inventions that cannot be filed for patenting. These include:
- Discovery of living things occurring in nature;
- The whole plant or animal, or any component of it, including seeds; species, varieties, and primarily biological processes used in the reproduction or propagation of the plant or animal;
- Human beings and embryonic stem cells;
- Genetically modified multicellular organisms including plants, human beings, animals, and their parts;
- The methods of medical treatment
However, the processes involving microbiology and microorganisms are a patentable subject matter. DNA and Gene sequences with known functions are also regarded as patentable under Biotechnology Patents in India.
- Industrial Applicability:
In India, for an invention to be used industrially, it must be demonstrated that it can be produced, used in at least one field of work, and developed as many times as necessary with the exact same properties. The guidelines also state that if the functions of DNA and Gene sequences are not disclosed, they do not qualify for the Industrial Applicability requirement for Biotechnology Patent in India.
Since there are no established cases in India dealing with this issue, the novelty of any biotechnology innovations is evaluated using the Manual of Patent Office Practice and Procedure. It states that certain biological products, such as plasmids and recombinant DNA, as well as the manufacturing procedures for these products, are eligible for patentability in India, provided that such products are developed with the substantial involvement of humans.
- Inventive Step:
According to the law, an invention has an inventive step if it is technically advanced as compared to an existing knowledge, or has economic significance, or both. For instance, isolated protein and gene sequences will be considered to involve an inventive step considering their naturally existing counterparts. Furthermore, because biotechnology-related ideas have so many applications in the diagnostics and pharmaceutical industries, it is relatively simple to demonstrate that they have economic relevance.
The law includes provisions for the deposition of biological materials or substances at an authorised depository in India for biotechnology inventions in India. According to the Manual of Patent Practice and Procedure, the inventor must fully describe the innovation in the specification.
The use of any biological material or substance that could seriously harm human, animal, or plant health or the environment, as well as any technique of creating it, will not be permitted in India. Additionally, as these inventions violate public morality and order, they are not allowed to be patented in India. Examples include the cloning of people or animals, altering the germline, using human or animal embryos, and altering the genetic makeup of people or animals.specification.
The Need for Biotechnology Patents
Biotechnology is perhaps one of the most research-intensive industries. Companies in this sector typically invest between 40 and 50 percent of their revenues in research and development, as opposed to 13 percent for the pharmaceutical business and 5 percent for the chemical industry. Research findings must be protected, and obtaining patents is the best way to do this. The risk of copied products entering the market is decreased by having sufficient patent protection for breakthroughs and the research that led to them.
Patents enable competing businesses to discover what other businesses are doing and be motivated to develop their own innovations, in a manner similar to how publications in scientific journals motivate fresh research concepts and discovery initiatives. Simply put, the biotechnology business is advanced through patents.
Growth in Biotech Patenting in India
Over the past three decades, the Indian biotechnology business has experienced sustained expansion. The current industry players comprise a number of privately-held Indian businesses that have gained a sizeable share of the domestic pharmaceutical market as a result of favorable government regulations and limited competition from outside. The Indian pharmaceutical industry, which is mostly renowned for its generic medications, has begun to move up the value chain as a result of increased investments in research to create new medications and reformulate those already on the market.
According to a Clarivate Analytics research, the pharmaceutical industry comprised almost 15% of the 1.3 lakh patents that were submitted in India overall between 2013 and 2015. The largest Indian private company to submit healthcare and pharmaceutical patents in India between 2015 and 2020 is the diversified conglomerate ITC Limited. ITC’s Life Sciences and Technology Centre (LSTC), one of the biggest innovation hubs in the nation with a focus on nutrition, health, and wellbeing, received 453 files between 2015 and 2020. The top 15 companies in 2020 to apply for biotechnology patents comprise nearly 11 percent of the patents filed in the pharma and healthcare sector.
Bharat Biotech is another Indian pharmaceutical giant that has produced an impressive succession of innovative vaccines and bio-therapeutics. They own over 145 global patents. Companies such as these are driving the Indian biotechnology sector forward with vigour. Interest in the sector is evident from the new government as well as the private sector initiatives that focus on the development of more biotechnology parks in the nation.
Biotechnology solutions should be patented, as the value of patented biotech products is highest close to the expiration date of the patent. For instance, if a company has a 10-year patent for a medication, by the 7th year, this medication will have received regulatory approval, made market entry, and ideally, gained consumer acceptance and trust – all without any rivals. They will also have undergone clinical trials. This, consequently, acts as a first-mover advantage for the parent company even after the patent expires. Patented commodities can generate a sizable income, which can subsequently be used to fund additional biotechnology research for new products – helping in moving the industry forward