A revolution: biotech patents in India
In May 2011, Glenmark Pharmaceuticals entered into a licence agreement with Sanofi Aventis in one of the first-ever deals for a novel biologic molecule in India for the treatment of autoimmune diseases. Bharat Biotech, an Indian Biotech company, developed a diarrhoea vaccine to be supplied to the UN and other markets at $1 each, making it the cheapest vaccine available in the market.
In 2006, India, despite having excellent technical manpower, did not have any novel biotechnology product to its credit. In 2009, Biocon developed the first and only novel humanised monoclonal antibody for the treatment of rheumatoid arthritis and psoriasis in Class 1, and in 2011, Glenmark developed a novel biopharmaceutical for the treatment of auto-immune diseases.
A recent survey shows that there are around 400 biotechnology companies in India that contribute approximately 30 percent of the total revenue of the sector. There are around 50 research and development labs in the public sector providing high-quality R&D services at a low cost.
Some of the primary reasons for the impetus in India’s biotech sector include excellent technical manpower, low cost and genetic diversity. Besides the above, several worldrenowned institutes such as the Indian Institute of Science (IISc), the National Centre for Biological Sciences (NCBS), the Jawaharlal Nehru Centre for Advance Scientific Research and the BARC Central Direct Research Institute provide high-quality R&D services to India and other countries.
Having said this, the two critical factors conducive to both investment and growth in the biotech sector are government policy on biotechnology and a robust intellectual property protection and enforcement mechanism.
The Department of Biotechnology issued a vision statement to provide a broad framework and outline the progress in this sector, including agriculture and food biotechnology industries, industrial biotechnology therapeutic and medicinal biotechnology, regenerative and genomic medicine.
"Whether or not a micro-biological process is considered as being essentially biological is judged by the patent office on the basis of essence of the invention, taking into account the extent of human intervention and its impact on the result."
Intellectual property, and particularly patents, become the central focus of research and development in this area of technology. As biotech business requires huge front-end investment at a very high risk, an obvious expectation of such investments is to provide market exclusivity with robust judicial enforcement, so as to provide a platform for the high-risk investment to flourish and prosper. Against this backdrop, the number of patent applications filed under the biotechnology category seems to have dropped from 1,950 in 2007-2008 to 1,303 in 2009-2010. Let us now examine why there has been a drop in patent filings despite the boom in the biotech sector.
The patent office recently finalised the Patent Office Manual, which is intended to provide directions to the examiner on examining patent applications and bring uniformity in practice between the four patent offices. However, in the absence of significant case law, several of these provisions are open to different interpretations.
Under the Indian Patents Act, once the subject matter has been scrutinised for novelty and innovativeness, a second level of scrutiny is undertaken by the Indian Patent Office under Section 3. Some of the important provisions of Section 3 that have an impact on the grant of patents to biotechnology inventions include:
