Biotechnology is the transformation of natural things by way of human inventions. Biotechnology creation is important for the development of humans. It is not a very new concept, it exists since ancient times and many centuries witness its progress. The term ‘biotechnology’ not only includes the old biotechnology such as the traditional way of producing fermented products but also includes the new biotechnology presented by genetic engineering and recombinant technology.
In old day, the technology fermentation was used to manufacture and conserve goods for a long period of time. But biotechnology proved itself a wonder when it make genetically modified or we can say non-natural organism. Genetic engineering is able to control living organism and make such organisms to work and function, a way different from natural ones.
Ultimately who thought that biotechnology could operate either plants or animals or human being and for that we will need a comprehensive law on biotechnology for its regulation. Although, as biotechnology has progressed from various generations in times and with the development there was the need of legal framework with proper regulations, for that TRIPS agreement was enacted. This TRIPS agreement gives protection to the regulation done in the field of biotechnology inventions as well. The biotech inventions can be patented under the following patentability criteria, although there exists complexity of manipulating the living forms, need special attention.
Evolution of Indian Patents act
The first patent law in India was enacted by the British ruler “the act VI of 1856” on protection of inventions based on British patent law of 1852. After several changes we made, the consolidation Indian Patents and Designs Act 1911 was enacted which gives protection to inventions. By the passage of time and the changing socio-politico scenarios in India there were many changes were made by the new legislation and the result of those changes and amendment is the enactment of Patents Act, 1970. The patents act 1970 calls attention to the inventions that satisfies the universally accepted requirement of patentability like novelty, inventive and industrial application. The patents act 1970 also undergone through several amendments and after that the final patents (amendment) act 2005 (referred as patents act) was introduced and also introduce the product patents on substances capable to be used as medicine, drugs or food could be obtained when India completed implementation of TRIPS required amendments to its act. Further important changes were made in patenting procedure through the introduction of patent rights 2003 which was amended and resulting to a new practice and procedure.
The patent act 1970 does not say anything about biotechnology inventions however judicial pronouncement in some countries are suitable interventions by the judiciary which leads to the amendments in patent law and grand permission to biotech inventions. The same approach was followed by India and India’s patent law was amended in the year 2002 and in include biochemical, biotechnology and microbiological processes, in the definition of potentially patentable chemical processes. As with the development, the formal bio-guidance becomes the need of hour as biotechnology is getting momentum in India. The requirement of submission of working of patents in India is another feature of the Indian Patents Act.
Biotechnology patenting activity in India
Although the inventions in this category, are most likely of the foreign religion but still there is a recommendable growth in Indian application. Indian inventions are mostly in recombinant DNA, molecule, recombinant vaccine, monoclonal antibodies, etc.
As the subject, the claim made for invention should be new, non obvious, industrially acceptable and requires sufficient disclosure. When there is a new element in the existing one in the nature is discovered, than one cannot get patent on that because that form already exists in nature that is not any new. Furthermore to translate the discovery as patentable subject, the compound that is discovered should be change by the human invention and change it into a new form which does not exist in nature or the outcome as a result of the process resulting as the technical advancement and/or economic significance.
Some examples Inventions which can be patentable:-
Treatment for plants.
Cleaning of environment with the help of biological materials
Enzyme purification method.
Artificial origin’s living entities like vaccines or micro-organism are patentable.
Plasmids, DNA types of biological materials are patentable
Some examples of non-patentable inventions:-
Section 3(b) under this section an invention will not be patentable if it is immortal or if it is against public order or harm to human.
Section 3(c) under this section the discovery of living thing or non- living substances in nature will not me patentable.
Section 3(d) this section talks about new use or new property of know substance will not claim patent.
Section 3(h) under this section method of agriculture or horticulture will not be patentable.
As per section 3(p) you cannot claim patent no traditional knowledge.
Patent of organic material:
The patent application of the source and geographic origin of the organic material used in the invention requires mandatory disclosure – Sec.10 (4) (d) of the Indian Patent Act, 2005. In the case of patent applications, biological materials such as DNA, a recombinant vector, or gene-related cells or inventions that cannot be described in such a way as to meet competence and best mode requirements and if such material is available to the public Submission and / or submission of organic material to an International Depository Authority. Under the Budapest Treaty (IDA) is required if adequate disclosure is not possible – Sec.10 (4) (ii). Disclosure is mandatory if the invention requires any specific material providing specific assets to work.
If a substance such as protein / peptides / amino acids is prepared artificially, inventors can opt for live submissions to make suitable submissions work to help overcome invention. The law also provides for pre-conflict and revocation of patents on the basis of non-disclosure or mis-disclosure of the source or geographic origin of biological resources and conventional knowledge – Sec. 25 (1) and Sec. 64.
Prior permission is required by national biodiversity authorities to access biological material by foreigners / NRIs as per sec. 3, as before seeking patent formed on biological material and vaccines obtained from India 6 (1) of the Biodiversity Act 2002.
Patentability of Micro-organism (s)
Guidelines were formulated to investigate patent applications involving microbes with a view to adequate human intervention and utility.
Microbiological inventions include new products, processes, uses, and compositions incorporating biological products. These inventions cover methods for isolating and acquiring new organisms, improving their character, modifying them and finding new and better uses of them.
The patent for new microbes is based on the characteristics of microbes available in prior art and their differences with use. Known microbes are restricted to new uses, even where patent law allows such protection. The same is true of genetically modified microbes. Genes and gene products are thought to be similar to chemical compositions.
In 2002, Calcutta High Court's Diminko AG v. Controller of Patents stated that the patent on microbe is valid. The court ruled that the act did not prevent a living product from being patented. As a result, a large number of patents have been granted to microorganisms since then.
As a university, practiced by most patent offices, new microbes isolated for the first time from natural microorganisms can only be patented if they differ in character from known microbes and a new or Get better use or function. Microbial claims have been allowed on the basis that they are the products of microbial processes.
Patent law and Conservation of Biological Diversity (CBD):
India enacted the Biological Diversity Act to address issues of informed consent, disclosure and access and profit sharing in advance. The Act is primarily aimed at regulating access to biological resources and allied traditional knowledge to ensure equitable sharing of benefits arising from their use.
All matters relating to access to foreign persons, a non-resident Indian, institutions or companies (not incorporated or registered in India; or with foreign participation in their share capital or management in India), and all matters. The transfer of research results to any foreigner is dealt with by the NBA. Section 3 provides that all foreign nationals require approval from the NBA to obtain biological resources or related knowledge, and Section 4 provides that Indian individuals / institutions have knowledge / research related to any biological resources and Get approval or get out of it before transferring content. India) foreign individuals, non-resident Indians, institutions or companies (who are not incorporated or registered in India; or are incorporated or registered with foreign participation in their share capital or management in India). The NBA may consult the Biodiversity Management Committees (BMC) or any other expert committee for this purpose and subsequently grant approval under Section 19 under such terms and conditions as may be appropriate for the same.
In the case of collaborative projects (covered by Section 5 of the Biological Diversity Act), which are either approved by the government or are in line with government-made policy guidelines, no further approval from the NBA is required.
The Biological Diversity Act prohibits an application for any IPR in or outside India without the prior approval of the NBA. For this, the placing of the gate is envisaged in several stages:
Section 6 (1) provides that prior approval of NBA is requir