"Biotechnology can transform humanity provided humanity
wishes to be transformed"
Biotechnology inventions are important for human development. It is the broad area of biology involving living systems and organisms to develop or make products, or any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific uses.
Thomas Jefferson the man behind the first Patent Act did not have even slightest idea that the life forms can ever become a subject of Patent protection. The most famous case of Diamond v Anand Chakrabarty where a biochemist at GE developed a genetically modified organism that had the ability to decompose crude oil. At first his patent application was rejected which on further appeal was granted by the court with order stating "His claim is not to a hitherto unknown natural phenomenon, but to a non-naturally occurring manufacture or composition of matter-a product of human ingenuity".
Biotechnology Patent and India
Patent Act in India was enacted in 1856. It has been modified several times since then; one major amendment being in 1970 which satisfied the international norms of patentability covering novelty, inventive step and industrial application. But this version had nothing specific concerning Biotechnology invention and protection. At the same time, since the patent offices and courts in US and EU were seeing increasing number of biotech inventions and patent application, the demand for amendment of Indian Patent Act to introduce biotech patentability gained voice in India. The amendment came in 2002 to explicitly include biochemical, biotechnological and microbiological processes within the definition of potentially patentable process.
Statutory obstacles to patentability
The criteria for fulfilling patentability requirements are novelty, inventiveness, and industrial application. Apart from this, some inventions are also excluded from patentability under section 3 of the Patent Act, 1970.
What Is Not Patentable In India:
- Section 3 (b) - . As per the section an invention would not be patentable if it is immoral or against public order, harmful to human, animal or plant life or harmful to environment
- Discovery of living things or non- living substances in nature - Section 3 (c)
- Plants and animals in whole or any parts thereof other than micro-organisms but including seeds, varieties and species - Section 3 (j)
- Essentially biological processes for the production or propagation of plants and animals– Section 3 (j)
- Any Process for the medicinal, surgical, curative, prophylactic, diagnostic or therapeutic or other treatment of human beings or animals to render them free of disease or to increase their economic value or that of their products – Section 3(i)
- Methods of agriculture or horticulture – Section 3(h)
- Traditional knowledge – Section 3(p)
Deposition of biological material
Under Section 10(4) and rule 13 (8)of the Patent Act, an applicant must deposit the biological material mentioned in the specification if it is unavailable to the public and cannot be described adequately as per the provisions of the act. The material must be deposited with an international depository authority under the Budapest Treaty.
The international depository authorities in India are the Microbial Culture Collection, Pune and Microbial Type Culture Collection and Gene Bank, Chandigarh. It is the duty of the applicant to give information w.r.t biological material used in specification.
Time period - The deposit must be made no later than the filing date of the patent application in India. Mentioning of the deposit must be made in the specification within the prescribed period (i.e. three months from the filing date).
Sequence listing is the most important part of any bilological invention. It pertains to the listing of nucleotides and amino acids. The details of nucleotides and/or amino acids shall be filed in electronic form. However, the fee with respect to the equivalent number of pages shall be payable. In the case of Biotechnology related inventions, relevant numbers of the sequence listing shall be mentioned at appropriate place in the specification. Sequence listing should also be given in electronic form.
It is true that necessity propels any invention. In this new era our necessities are increasing fuelling inventions but again it is our responsibility to protect our rights too.
- Organ Transplantation - Organ transplantation is a big moral issue for biological based invention. It possess a big moral issues. The biological invention facilitate the organ transplantation is opposed by numerous intellectual based on religious faith. Also it is anticipated by some that it may give rise to illegal Human trafficking.
- Biological Weapons - Biological weapons are the most dreaded ones today, far more dangerous than nuclear, chemical or conventional weapons. Discussion on this issue is most crucial.
- Bioinformatics- It is a methology of biological studies implemented with the help of computer programme. It is generally used for gene identification and prediction of upcoming diseases. Many believe that this could bring legal turmoil in the society. Also it may hamper the natural living of humans.
It can be seen that the Biotechnology and life form patentability is a subject of exploration in India. With more and more research and innovation going on in this field and keeping in view the rich bio-diversity that India enjoys, there is a real need to protect the interest of inventors. India needs to enable its inventors and inventions to compete in the global scenario, although few claims are considered but they are more on case-to-case basis and there is a lack of tidy guidelines.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.