It takes at least ten years for a new medicine to complete its journey from initial discovery to marketplace in treating patients. The screening process for a potential drug candidate starts with 10,000 drug candidates and ends up with only one approved drug. The cost involved in taking a prescribed medicine to a market place is estimated to cost the drug makers $2.871 billion according to a recent study by Tufts Center for the Study of Drug Development and published in the Journal of Health Economics. This being the process of drug development, India's position characterized as a strong generic nation and a low R&D investment towards drug development till pre-2005 took certain gestational time in becoming an innovator country from just an imitator country. India's Patents Act 1970 Amendment in 2005 to become TRIPS compliant in granting pharmaceutical product patents paved the way for a formidable increase in filing of pharmaceutical patent applications in India and in abroad. The dramatic improvements in the number of patents filed were aimed to save lives and improve health through break-through innovations as well as incremental innovations.
Breakthrough inventions usually include development of first-in-class medicine, with a new mechanism of action whereas incremental inventions include improvements in therapeutic quality, safety, and efficacy over existing medicines. The following article discuss in detail the role of incremental inventions in the pharmaceutical industry, impact of Section 3(d)2 1970 and the prospective impact in the Indian market.
Improving the properties of existing medicines involves various types such as a process for expanding therapeutic classes of drug; increase the number of available dosing options, discovering new physiological interactions of known medicines, improving properties of existing medicines such as metabolism, reduced adverse effects and other delivery systems. Incremental inventions can also include reformulating an existing medicine to adapt children compliance with treatment regimes, to increase the shelf-life of a medicine, to improve the heat stability of a medicine so that it remains effective under diverse environments.
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