Recently Prime Minister Mr Narendra Modi unveiled the "Make in India" campaign, with an aim to turn the country into a global manufacturing hub. Biotechnogy Sector is one of the sectors which has identified by Government among 25 sectors that will be covered under the Make In India plan. The Make in India campaign aims at turning the country into a global manufacturing hub by smoothening business processes and attracting foreign companies to set up factories in India and invest in the country's infrastructure.1
The Indian biotechnology sector is divided into five major segments; bio-pharma, bio-services, bio-agri, bio-industrial and bio-informatics. The biopharmaceutical sector accounts for the largest share of the biotech industry with a share of 64% in total revenues in 2013, followed by bio-services (18%), bioagri (14%), bio-industrial (3%) and bio-informatics (1%). The revenue from bio-pharma exports reached USD 2.2 Billion in 2013, accounting for 51% of total revenues of the biotech industry. 2
The sector has seen high growth with a CAGR in excess of 20 percent and the key drivers for growth in the biotech sector are increasing investments, outsourcing activities, exports and the government's focus on the sector. The Department of Biotechnology has established biotech parks in various parts of the country to facilitate product development, research and innovation, and the development of biotechnology industrial clusters. The parks offer investors incubator facilities, pilot plant facilities for solvent extraction and laboratory and office spaces. 3
LEGISLATIVE FRAME WORK AND POLICIES IN BIOTECHNOLOGY SECTOR
BY PATENT PROTECTION
Apart from Pharmaceutical sectors, biotechnology innovations and research are instrumental in health care systems, agricultural industry, polymers & materials sectors, etc. Research & development in this area is relatively time consuming and involves huge investment with risk involved with the outcome. To promote such results much more importance is affixed with respect to patenting the inventions in said field, and enabling the growing research sector to monetarily sustain itself.
A) Indian Patent Office issued draft guidelines on Examination of Biotech Applications
The Indian Patent Office (IPO) has issued draft guidelines on examination of biotechnology patent applications. The guidelines detail illustrative examples on various facets of patentability of biotechnology related inventions, including novelty, inventive step, industrial application, sufficiency of disclosure, clarity of claims and biodiversity related issues. 4
The patentability of biotechnology related inventions particularly genetic engineering has also been discussed. The details of wording of claims, clarity, support and sufficiency of the disclosure are provided. However, for better understanding of the issues related to novelty and inventive step, a preliminary discussion of claims of biotechnology related inventions are covered. These include the polynucleotides or gene sequences, polypeptides or protein sequences, vectors, gene libraries, host cells, micro-organisms and stem cells plants and animals tissue culture, pharmaceutical or vaccine compositions comprising micro-organisms, proteins, polynucleotides and antibodies or antigen binding fragments thereof monoclonal or polyclonal. 5
B) Biotechnology Patent Facilitation Cell (BPFC):
In order to help the patent seekers, a Biotechnology Patent Facilitation Cell (BPFC) 6 has been catering to the need of promotion of biotech research by:
1. creating awareness and understanding among biologists and biotechnologists, relating to patents and the challenges and opportunities in this area
2. providing patenting facilities to biologists and biotechnologists in the country for filing Indian and foreign patents on a sustained basis.
3. keeping a watch on development in the area of IPR and make important issues known to policy makers, bio-scientists, biotech industry, etc.
C) Technology Transfer and Intellectual Property Rights :
The Government Policies in Patenting Ministry of Science and Technology has issued the guidelines "Instructions for Technology Transfer and Intellectual Property Rights" 7, which would help in enhancing the motivation of scientists, research institutions and universities in projects funded by the Department of Science and Technology, Department of Biotechnology, Department of Scientific and Industrial Research and Department of Ocean Development. The salient features of the guidelines are reproduced below from the official website:
1. Ownership of Intellectual Property: Institutions shall be encouraged to seek protection of intellectual property rights in respect of the results of R&D. They may retain the ownership of such IPR. 'Institutions' would mean any technical, scientific or academic establishment where research is carried out through funding by the central/ stategovernment.
2. Transfer of Technology: The institutions shall take the necessary steps to commercially exploit patents on exclusive or non-exclusive basis.
3. Royalty to Inventors: The owner institution is permitted to retain the benefits and earnings generated out of the IPR. The institution may determine the share of inventor(s) and other persons from such actual earnings. However, such share(s) shall be limited to one third of the actual earnings.
4. Norms for Private Industry: IPR generated through joint research by institution(s) and industrial concern(s) through joint efforts can be owned jointly by them as may be mutually agreed to by them through a written agreement. The institution and industrial concern may transfer the technology to a third party for commercialization on exclusive/non-exclusive basis. The third party, exclusively licensed to market the innovation inIndia, must manufacture the product in India. The joint owners may share the benefits and earnings arising out of commercial exploitation of the IPR. The institution may determine the share of the inventor(s) and other persons from such actual earnings. Such share(s) shall not exceed 1/3rd of the actual earnings.
5. Patent Facilitating Fund: The owner institution(s) shall set apart no less than 25% of the revenue generated from IPR, to create a Patent Facilitating Fund. The fund shall be utilized by the owner for updating inventions, filing new patent applications and protecting the IP rights against infringement and for building competency in the area of IPR and related issues.
6. Information: The institutions shall submit information relating to the details of the patent obtained the benefits and earnings arising out of IPR and the turnover of the products periodically to the department/Ministry which had provided funds.
D) Council of Scientific and Industrial research (CSIR)
Another government authority working for the same cause is the Council of Scientific and Industrial research (CSIR) which has moved from their earlier mantra of "publish or perish" to "patent or perish". The Indian Government has under its "Science and Technology Policy" also highlighted that Innovative fiscal measures are planned and strategies for attracting higher levels of investments both public and private in science and technological development and Development of technologies that add value to India's indigenous resources would be Supported and the Indian share in the global herbal product market would be increased.
2. Regulatory Framework in India: Biotechnology Sector
Department of Biotechnology [DBT] constituted under the Ministry of Science and Technology is the nodal agency for policy, promotion of R&D, international cooperation and manufacturing activities. Together with DBT, Genetic Engineering and Approval Committee [GEAC] constituted under Ministry of Environment and Forests [MoEF] is the leading regulatory body in the area of Biotechnology in India. Several committees have also been constituted under the said ministries to regulate the activities involving handling, manufacture, storage, testing, and release of genetic modified materials in India. These committees have statutory authority. Most of the committee members are from the scientific community and staff of DBT and MoEF. DBT appoints the members to the committees. The GEAC is supposed to be assisted by the State Biotechnology Coordination Committees (SBCC) and District Level Committees (DLC). 8
The most important committees are:
- The Institutional Biosafety Committees (IBSC), responsible for the local implementation of guidelines,
- Review Committee on Genetic Manipulations (RCGM) responsible for issuing permits;
- GEAC responsible for monitoring the large scale and commercial use of transgenic materials.
National Guidelines for Stem Cell Research 2O13:9
- The guidelines have been laid down to ensure that research with human stem cells is conducted in a responsible and ethical manner and complies with all regulatory requirements pertaining to biomedical research in general and of stem cell research in particular.
- These guidelines apply to all stakeholders including individual researchers, organizations, sponsors, oversight/regulatory committees and any other associated with both basic and clinical research on all types of human stem cells and their derivatives.
Guidelines on Similar Biologics-Regulatory Requirements for Marketing Authorization in India 2O12:10
The Guidelines on Similar Biologics prepared by the Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology (DBT) lay down the regulatory pathway for a biologic claiming to be similar to an already authorized reference biologic.
- The guidelines address the regulatory pathway regarding the manufacturing process and quality aspects for similar biologics.
- These guidelines also address the premarket regulatory requirements including a comparability exercise for quality, preclinical and clinical studies and post-market regulatory requirements for similar biologics.
INDIAN GOVERNMENT INITIATIVES FOR MAKE IN INDIA CAMPEIGN IN BIOTECHNOLOGY SECTOR:
PROVISIONS OF THE 2O14-2O15 UNION BUDGET:11 Service tax exemption for services provided by operators of common biomedical waste treatment facilities to a clinical establishment by way of treatment or disposal of bio-medical waste or processes incidental thereto.
- Refund of customs duty paid at the time of import of scientific and technical instruments, apparatus, etc. by public funded and other research institutions, subject to submission of a certificate of registration from the Department of Scientific & Industrial Research.
- Depreciation allowance on plant and machinery has been raised to 40% from 25%.
- Customs duty exemption on goods imported in certain cases for R&D.
- Customs and excise duty exemption to recognised Scientific & Industrial Research Organisations (SIRO).
- 150% weighted tax deduction on R&D expenditure.
- A 3-year excise duty waiver on patented products.
- 100% rebate on own R&D expenditure.
- 125% rebate if research is contracted in publicly-funded R&D institutions.
- Joint R&D projects are provided with special fiscal benefits.
- The setting up of a venture capital fund to support small and medium enterprises.
- Promoting innovations through BIPP, SBIRI, BIRAC and biotech
- Import Duty Exemption : Promotion of Import Duties on key R&D, contract manufacturing / clinical trial equipment and duty credit
- Priority Sector Lending: Enable lending by Indian banks to biotech companies as priority sector lending.
- Customs Duty Removal: Remove customs duty on raw materials imported into India, that go into making the finished product is imported duty free.
- Simplification of Procedures: Simplification and streamlining of procedures for import, clearance and storage of biological, land acquisition, obtaining environmental and pollution control approvals would be simplified and streamlined within shorter time frame lines through consultations with various central and state government departments.
- Fostering Inter-Company Relationships: The Indian Government further intends to make efforts to remove hurdles for contract research especially for input output norms and tax on revenue generated through contract research / R&D.
- Developing Communication Systems: One significant feature of the biotech industry is the fluidity and variety of its inter-company relationships, traditionally much greater than in other industries. 13
- The Department of Biotechnology has established biotech parks in various parts of the country to facilitate product development, research and innovation, and the development of biotechnology industrial clusters.
- Operational biotech parks are located at Lucknow in Uttar Pradesh, Bangalore in Karnataka, Kalamassery and Kochi in Kerala, Guwahati in Assam and Chindwara in Madhya Pradesh.
- The parks offer investors incubator facilities, pilot plant facilities for solvent extraction and laboratory and office spaces.
- India constitutes around 8% of the total global generics market, by volume, indicating a huge untapped opportunity in the sector.
- Outsourcing to India is projected to spike up after the discovery and manufacture of formulations.
- Hybrid seeds, including GM seeds, represent new business opportunities in India based on yield improvement.
As per the report published in Make in India initiative; Indian biotech industry will grow at an average growth rate of around 30% a year and reach USD 100 Billion by 2025. The market size of the sector is expected to rise up to USD 11.6 Billion by 2017 due to a range of factors such as growing demand for healthcare services, intensive R&D activities and strong government initiatives.
The Indian government has taken several initiatives to create a conducive environment for the protection of intellectual property rights of innovators and creators by bringing about changes at legislative and policy level. In addition, specific focus has been placed on improved service delivery by upgrading infrastructure, building capacity and using state-of-the-art technology in the functioning of intellectual property offices in the country. This measure has resulted in sweeping changes in IP administration within the country.
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