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 required before applying for any type of IPR (or outside India) based on any research or information on biological resource obtained from India. However, such approval is not required where IPR rights related to the conservation of plant varieties apply to [Section 6 (3)]. This is because in such cases, it is the Plant Diversity and Farmers ‘Rights Authority, established under the Plant Diversity and Farmers’ Rights Act, 2001, which confers rights and prescribes the sharing of benefits. This authority, in turn, supports the NBA’s grant of authority;
In the case of a patent, one can obtain such approval after publication of the patent application and before granting the patent.
In the case of the assignment of IP rights to third persons, individuals who have been granted access to biological resources and related knowledge can transfer the same with approval from the NBA.
While allowing such, NBA is likely to enforce profit sharing conditions such as monetary benefits such as royalties, joint ventures, technology transfer product development. The parameters involved for the payment of such compensation are extent of use, aspect of stability, impact and expected outcome level, short term and long term benefits etc.
The NBA drafted new guidelines on access and benefit sharing, especially on international governance, access and profit sharing; The Sui Genies system was developed for the protection of traditional knowledge and amendments to the Biological Diversity Act, 2002 and the Biological Diversity Rules, 2004 and opened to public hearing. But till today the final draft has not been released.
Patent law and Traditional Knowledge
The TRIPS Agreement contains some provisions with limited application to protect traditional knowledge. The obligation to protect geographical signs can be used to protect traditional knowledge, if associated with the sign used for the production and sale of goods. It is clarified that other characteristics of a given quality, reputation, or goods are essentially attributed to its geographic origin so that geographic signals can be identified for safety.
. The India’s current Patents Act contains a number of provisions aimed at traditional knowledge beyond the scope of patenting. Section 3 (p) excludes an invention from a patent that is, in fact, conventional knowledge or that is an aggregation or duplication of a traditionally known component or known properties of components. This exclusion is but one of several provisions inserted in the new Act in an effort to prevent the exercise of proprietary rights in India’s genetic resources and indigenous knowledge. As noted above, the disclosure requirements of the Acts include an order incorporating the source and geographic origin of the organic material used in the claimed invention, and the interested party opposing or petitioning to revoke the Indian patent on this basis the invention can be claimed. Knowledge, oral or otherwise, is available within any local or indigenous community in India or anywhere.
Biotech Patent Jurisprudence in India
Dimminaco A.G. v. Controller There is no adequate case law development in relation to biotechnology inventions in India as the industry is in an infancy stage. Decision of leading biotech patent law of Indian courts a. Yes. Patents, Designs and Trade Marks (in 2002), where for the first time and demonstrated the usefulness of a biotech invention. A process related invention for the preparation of infectious bursitis vaccine. The vaccine was useful to protect poultry against infectious bursitis infection. The Patent Office initially rejected the patent application on the grounds that the claim was not an invention. But the effectiveness of the invention should not dispute. This decision, however, Diamond v. More than twenty years after Chakraborty’s US Supreme Court ruling was released, but Indian commentators consider it to be a longstanding decision, the court overturned the Indian Patent Office’s longstanding policy to refuse the process.
Thus, it opens the door for biotechnology patents in India, as Chakraborty’s decision did in the United States. Reversing the decision of the subsidiary controllers, the court considered that there was evidence that the Indian Patent Office had already granted a biotechnology process patent that was producing a living end product. The assistant controller did not act on the correct principles, rejecting Dimkinkos' application on the grounds that it could not be called a method of manufacture because it contained a live virus in the final product. The Indian Patent Office observed Diminkos teaching that the fact that an invention is alive (or makes a living product) does not automatically exclude it from the patent. MPPP states that a living entity of artificial origin, such as germs, or vaccines, is considered patentable, although higher life forms such as plants or multi-cellular animals, whether natural or artificial origin. In addition, biological materials such as recombinant DNA, plasmids and its manufacturing processes are patentable, provided that they are manufactured by original human intervention. In addition, processes related to germs or chemical substances that use such microbes are patentable.
As stated here, issues related to patents for organic materials are relatively new to India. Standardized practice regarding patenting or non-patenting of biological inventions has not yet been satisfactorily established. However, if an invention's claim relates to a novel and inventive and modified genetic material, in which such genetic material is identified by its protein or amino acid sequences, at least in detail and in claims, such genetic material Is industrial. When enabled, the Patent Office generally accepts such invention as a patent. Therefore, inventions are subject to the fulfilment of relatively broad criteria. It is worth mentioning that in India, the patent of organic material is still decided more often on a case-by-case basis.
India's post-trips patent laws include a number of provisions that make biotechnology patenting more attractive as a basis for competitive advantage. The Diminco decision likewise gives more judicial and administrative appreciation of the importance of biotechnology patenting. It is clear from the accepted claims described herein that biotech patents can be obtained in various fields provided the details / competence requirements are complied with and artfully prosecuted. Also, India is one of the biodiversity countries, thus, it would be prudent. Protect biotechnology related inventions as it will help Indian biotechnology research to compete globally. India needs to profitably derive appropriate benefits from its rich bio resources Provision for patent protection in biotechnological innovations and inventions.
By Ashi Agarwal