India, Intellectual Property and Biotechnology Industry
This is a guest post from BiotechBlog reader Viren Konde. Do you have a response to Viren’s post? If so, you may respond in the comments section below.
The recent editorial on “Intellectual property and biotechnology innovation: To protect or not protect” by Dr Yali Friedman, Managing Editor of the Journal of Commercial Biotechnology was thought provoking and led to this write-up. The editorial emphasized on the intellectual property protection differences between the developing and developed countries, and their drug manufacturers on the issues of patents, price controls, and research & development investments in the biotechnology sector. The remarks indicate that, the developed countries, being the ‘technology producer’ have favored strong intellectual property protection to motive the innovation and apparently the trade; while the developing countries being the ‘technology consumers’ have exploited the benefits of it at much lower cost by building a weaker intellectual property protection system.
Although it is logical that all countries, whether, developing and developed, should offer the strongest intellectual property protection possible, it is believed that, there are no legal definitions of “developed” and “developing” countries. The WTO members have announced for themselves whether they are “developed” or “developing” countries, with an open option to challenge the decision of a member to make use of provisions available to the developing countries. It was also believed in the agreement that the developed countries need maximalist IP regimes, as they are highly innovative and strong IP regimes provide the requisite incentives in this regard. On the other hand, developing countries require minimalist IP regimes, as they are hardly innovative and are often net importers of technology. These norms have also formed the basis for the 1970’s Indian Patents Act for the ‘developing India’. The amendments to Indian Patent Act in a timely fashion [Indian Patent (Amendment) Acts of 1999, 2002, and 2005] have driven India to ‘innovative (Product Patents) regime’ in its intellectual property policy.
Today, although, India continues to remain a “developing” country; it is also considered a ‘technologically proficient’, and therefore as an innovative developing country. Therefore, in the present times, the older definitions of intellectual property based on the differences between developed versus developing countries can not relate to India. Some developing countries like India are more scientifically advanced than others as a result of decades of investments in education, medical infrastructure, and manufacturing capacity. India hosts more drug manufacturing facilities that have been approved by U.S Food and Drug Administration than any country other than the United States. India’s biotechnology industry is managing to position itself on the strength of contract research, clinical research and contract manufacturing services together with the sales of off-patent biologics in the local as well as lightly regulated markets in the Middle East, Africa and Asia.
Unfortunately, India’s patent regime does not appear to be satisfying to the developed world given that India, though “technologically competent” in certain technology sectors like software and pharmaceuticals have not yet witnessed any significant levels of “innovation” in the biomedical utility sectors like biotechnological products and processes. Recently, the US-based Biotechnology Industry Organization (BIO) criticized India’s patent law and the Office of the US Trade Representatives kept India (and some other countries) on the USTR’s “Priority Watch List” in order to bring India’s patent law more in line with Western IP protections. Clearly, there are some issues and concerns that need clarification and that will be discussed here, such as the patentability criteria under section 3(d), and the provision of compulsory licensing in the Indian Patent Act; the price control and the cost difference of the innovator verses generic biotechnology drugs; the TRIPS mandate on clinical data protection and exclusivity; and also the pre- and post-grant patent opposition provisions used by Indian biogeneric manufacturers.
– Viren Konde