Concept of Biotechnology

For human development, it is important to invent products in the field of biotechnology. The biotechnological field has resolved several problems. The inventions of biotechnology have branched out of several fields. Geoffrey Carr said, "biotechnology can transform humanity provided humanity wishes to be transformed.

"Biotechnology is an area that involves living organisms in order to develop or make products. It also includes any technological application that uses biologica'systems or living organisms to modify a product or process for a specific purpose. Biotechnology includes DNA techniques and analysis of genetic information.

In India, the patent office has issued guidelines related to biotechnology and the intention behind this is to establish uniform practices for the examination of the application of biotechnology patents. The guidelines can be revised by the office of patents. The revision can be based on interpretations by the court of law, legal amendments, and valuable ideas from the inventor.

Biotechnology Patent in India

In India, the patent act was enacted in 1856. The act has been modified and amended several times. One of the major amendments came into being in 1970 which has satisfied the international norms of the patentability of an invention and covers novelty, inventive steps, and industrial application. Patent act 1970, has not covered inventions related to biotechnology and the protection of such inventions.

The high court demanded to amend the patent act 1970, in order to include biotechnology inventions in India because, at the same time, the US patent office and European patent office have been observing an increase in the number of biotechnology inventions. In 2002, an amendment related to biotechnology patents came into being, which explicitly included biochemical, biotechnological processes, and microbiology.

In Diamond v. Anand Chakrabarty[1], A genetically modified organism was developed by a biochemist and that organism has the capability to decompose crude oil. His application was rejected initially but after the appeal, the patent was granted by the court to the inventor. The order states that the claim of the inventor is for a non-naturally occurring composition of a matter a product of human inventiveness. This was a well-known case in the field of biotechnology.

In Dimminaco A.G. v. Controller of Patents and Designs[2], Dimminaco applied for a patent as he has invented a process of preparing a live vaccine to combat Bursitis which is an infectious poultry disease. The patent office refuses to grant a patent. He filed an appeal in the High Court of Calcutta, the court held that there is no statutory bar in accepting a manner of manufacturing a product that contains a living organism. It can be patented.

Basic requisites for obtaining a Patent in biotechnology in India

In order to get a patent in India, an invention must be novel. There must be an inventive step and there must be an industrial application of the invention. There are some inventions that are excluded from patentability under section 3 of the patent act.

Section 2(1) (j), this section talks about novelty, inventive steps, and industrial applicability of products or processes.

Section 10(4) and rule 13 (8) of the Patent act talk about the deposition of biological material if that material is not available to the public or it cannot be described adequately. The material must be deposited according to the Budapest treaty. It must be deposited with an international depository authority. Microbial culture collection Pune, Microbial type culture collection, and Gene bank Chandigarh are the international depository authorities located in India.

Inventions that are non-patentable in India
Section 3 and 4 of the Patent Act 1970, explains inventions that are non-patentable in India. These are the inventions that are non-patentable under biotechnology Patents in India.

1. Section 3 (b) focuses on Inventions contrary to morality or which can cause serious prejudice to human, animal, or plant life.
2. Section 3(c) talks about the inventions related to the discovery of any living thing or non-living substance offered in nature.
3. Section 3(d) talks about the invention which is related to the mere discovery of a new form of a known substance and it does not result in any kind of enhancement of known efficacy or which is a mere discovery of a new property or new use for a known substance.
4. Section 3(e) focuses on the invention which is related to mere admixture.
5. Section 3(h) is related to the methods of agriculture.
6. Section 3(i) talks about the method of treatment and diagnosis.
7. As per section 3(p), invention which includes traditional knowledge is non-patentable.

TRIPS Agreement on Patentability of inventions related to biotechnology

Article 27 of the TRIPS Agreement prevails in every member country. This article explains that an invention must have novelty, inventive steps, and industrial application. Article 27(2) of the TRIPS Agreement states that the country may not grant a patent to any invention which are against public order or may prejudice plant animal, and human life. According to Article 27(3), countries may exclude from patentability those inventions which involve diagnostic, therapeutic, and surgical methods along with animals and plants except microorganisms.

There is a lack of clarity in the TRIPS agreement in relation to microorganisms and microbiological processes. TRIPS Agreement fails to explain whether a product that is produced by a known microorganism is entitled to be patented or not. Countries have to create a distinction between the product of human intervention and products that are freely occurring in nature.

Issues related to the patentability of biotechnology inventions

An Invention must be no one and non-obvious in nature in order to get a patent but in the case of biotechnology inventions, the product already exists in nature. It is also considered unethical to convert this naturally occurring subject matter into private property.

In biotechnology, it is very difficult to fulfill the criteria of patentability. Identifying Novelty in living beings is a tough task. As scientists apply similar techniques in order to isolate individual gene sequences, it becomes tricky to identify non-obviousness in the field of biotechnology.

In the case of biological materials, there is controversy. Some people state that biological materials are mere discoveries, so therefore they are not patentable, others argue that certain biological materials are man-made inventions, so patents should be granted.

If there is a lack of utility the patent application has been refused. For biotechnology innovations, utility standards have been raised. It is very difficult to get patents for human genomes since human genes occur naturally so they are not invented but discovered.

Another issue with biotechnological inventions is that biological materials are capable of reproducing. It means that it is capable of changing forms. This lead to the question of whether the patent includes the shift or stops at the original state.

Currently, patent law has failed in providing sufficient protection for biotechnology inventions. It is very difficult to accurately describe, genetically engineered inventions. It is possible that a patent can be granted to a patentee who does not deserve it in the case of biotechnology innovations.

Conclusion
It is evident that the field of biotechnology needs to be explored in India. It is needed that the interest of inventors must be protected. The inventions of the people who are working in the field of biotechnology and inventing products must get protection under patent law. There is a need to enable inventors and inventions to compete globally. There is a lack of guidelines for patents in biotechnology.

In recent cases, it has been clarified that biological materials which are prepared in labs and not present in the natural environment have earned some rights of patentability. Biotechnology patterns were introduced in India in order to protect the rights and interests of inventors.

End-Notes:

1. 447 U.S. 303, 100 S. Ct. 2204 (1980)
2. (2002) I.P.L.R. 255 (Cal)