Patenting in biotechnology – the Indian scenario

India is among the top 12 biotechnology destinations in the world and has the third-biggest biotechnology industry in Asia-Pacific. India’s biotechnology industry is evolving rapidly and growing at a compound annual growth rate of 20%. As per Biospectrum’s 11th annual Indian biotechnology industry survey, the Indian biotechnology industry grew by 15.1% from 2012 to 2013, increasing its revenues to $3.81 billion. Further, the market size of the sector is expected to increase to $11.6 billion by 2017. This rapid growth is attributed to a range of factors, including heightened demand for healthcare services, intensive R&D activities and strong government initiatives. India is a huge market for biotechnology products and services due to its billion-plus population and increasing economic prosperity.

The domestic industry is now moving into innovation, with companies focusing on strengthening their R&D development capabilities. In its 12th five-year plan, the Indian government aims to spend $3.7 billion on the biotechnology sector, compared to $1.1 billion in the 11th five-year plan. The Indian biotechnology industry can be divided into five key segments: bio-pharmaceuticals, bio-services, bio-agriculture, bio-industrial and bioinformatics. Bio-pharmaceuticals accounts for the largest market share, with over 60% of the total revenues (see Figure 1).

Patent filing trends

The 2014 Indian Patent Office (IPO) annual report stated that approximately 43,000 patent applications were filed between April 2013 and March 2014. Over 2,300 of these related to biotechnology and other related fields (eg, biochemistry, microbiology, biomedical devices and chemical or biological inventions related to traditional knowledge – see Figure 2).

Although the report indicates no criteria for patent selection in these fields, it gives a preliminary indication of biotechnology patenting activity in India.

Although patent filing in India in general has increased in the last few years, biotechnology patent filing has decreased (see Figures 3 and 4). This is consistent with the global trend. Among other things, it could be attributed to more stringent criteria for patentability and grant of patents in this domain.

Patentable subject matter

Under the Patent Act 1970, every invention must pass a two-step test in order to be patentable – namely, it must:

not fall in any of the categories specifically excluded under Section 3 of the Patent Act; and

pass the well-known three-pronged test of novelty, inventive step and industrial applicability.

The following are the excluded biotechnology-related inventions.

Section 3(b) – inventions contrary to public morality

Inventions for which the primary or intended use or commercial exploitation is contrary to public order or morality or which cause serious prejudice to human, animal or plant life or health or to the environment are unpatentable. Examples include genetic modification of animals which results in suffering of the modified animal without any substantial medical or other benefit, and inventions causing adverse environmental impact.