The Indian pharmaceutical industry is ranked as the fastest growing pharma industry in the world. This growth was aided by the Patents (Amendment) Act 2005, India''s final step towards achieving complete TRIPs compliance. The flip side of it is the threat posed to a generic industry that has, so far, ensured the availability of affordable drugs.
The Amendment Act aimed to balance the competing interests of various stakeholders, including domestic generic medicine producers, domestic researchers, multinational pharmaceutical companies and humanitarian groups concerned with access to medicines. However, the amendment to section 3(d) relating to patenting of derivatives of pharma products that differ significantly in property from the basic molecule have narrowed down the ambit of pharma patenting. And this has provided excellent subject matter for litigation.
In countries where Novartis has obtained a patent on Gleevec, the drug is sold at $2,600 per patient per month while generic versions in India are available for less than $200 per patient per month. Campaign groups protesting this move are worried that the downtrodden population in the developing world could lose access to vital drugs if Novartis'' challenge succeeds. In defence, Novartis claims that tightening of IP laws would boost investment in developing more medicines.
Following its patent application rejection, Novartis has gone to the courts. In response, the Madras High Court on April 2007 reserved its verdict and the two-judge court also ordered that another challenge by Novartis to a decision rejecting its patent application be referred to an appellate board consisting of IP specialists and headed by a former judge. This ongoing tussle has now acquired a symbolic value.
The BIO white paper found that the biotechnology industry is actively engaged in inventing innovative therapies and synthesis of generic versions of various drugs is a step towards such biotech innovations. According to recent observation , biotech companies and university scientists agree that patents are a key force behind biotech innovations, and they rely on patents to attract funding for conducting years of research necessary to develop a new product and ultimately making them available to patients. So, if we look at the bigger picture patenting is like taking a medicine, unpalatable to the tongue but nevertheless essential for the well being of the whole body and it is imperative that India consumes this medicine to remain ahead in the race as the nation with the fastest growing pharmaceutical industry.