The Indian Biotechnology sector is poised for a tremendous growth and IP (Intellectual Property) protection is necesary for India to make it to the top as a global competitor. Neesha Patel finds out

In India, the pharma industry is one of the first to reap the benefits of biotechnology. Human health biotechnology products account for about 60 percent of the domestic market, while bio-drugs, vaccines and diagnostics have significant market shares as well. Consequently, Indian pharma is beginning to benefit from enhanced IP protection of their products.

IP is central to the biotechnology industry, and brings with it a dimension, facilitating collaborative activity, whether it is a drug discovery or clinical or market-related trials. Affordability and accessibility to the products of biotechnology are the two key factors central to the advancement of this sector. Policies that foster a balance between sustaining innovation and facilitating technology diffusion has been addressed with substantial progress in terms of support for R&D, human resource generation and infrastructure development.

A streamlined and efficient patent protection, in addition to the industry’s maturing relationship with capital markets is the hallmark of America's global leadership in biotechnology. In contrast, most developing countries do not have strong IPR (Intellectual Property Rights) regimes and suffer negative effects of "brain drain". The reason being, lack of effective copyright laws, which force scientists and technicians to immigrate to countries, where their research is protected from unfair exploitation by competitors.

Even though, the WTO TRIPS agreement provides a foundation for IPR protection, enforcement is lacking in many parts of the world. The basic obligation in the area of patents is that inventions in all fields of technology, whether products or processes, shall be patentable if they meet three criteria - being novel, involving an inventive step and being capable of industrial application.

Biotechnology patent applications experience numerous restrictions, primarily, due to the undefined scope and complex nature of the technology. Deciding the scope of patent protection for inventions is a difficult task, as it raises a number of technical and ethical issues. To begin with, biotechnology is an intimidating amalgamation of biology and chemistry and claim interpretations. They force a judge or patent examiner to grapple with rather fundamental issues, such as the significance of the term 'human' when describing a protein. Next, it raises important policy questions, such as, the degree to which a legal monopoly should be granted to an innovator, whose significant contribution could be diminished by the consequent development of a competitor product or technique.

Currently, The United States Patent and Trademark Office is struggling to interpret biotechnology patent claims, and efforts are being made to reform the restriction practice that, in turn, would improve patent quality, efficiency and will be necessary for international harmonisation of rules.

India needs to implement strong patent legislation, data exclusivity, and improve IPR infrastructure and enforcement in order to achieve its potential as an R&D powerhouse. The much-delayed second amendment to India's 1970 patent law was passed in May 2002, welcoming the extension of pharmaceutical patent protection from seven to twenty years. With this change, India fulfilled part of its commitment to the international community by protecting intellectual property. The Bill, however, makes broad ambiguous allowance for compulsory licensing, and is unclear about patent protection for imports.

Indian pharmaceutical companies and researchers, especially in the biotechnological sector, would benefit from increased diffusion of knowledge that results from international partnerships and increased integration. Fortunately, data exclusivity is an administrative protection, which can be easily implemented without passage of legislation. Requiring the government to treat test data as the exclusive property of the firm that generated it, (for a fixed period of time), is an effective method of providing protection, while legislators draft laws to complete the legal IP framework. The National Biotech Policy provides a framework and strategic direction to different sectors in order to accelerate the pace of development of biotechnology in India over the next ten years.

(www.expresspharmapulse.com)