Namrata Sahu, LLM at IIT Kharagpur
ABSTRACT
The expansion of the pharmaceutical industry has been accompanied by the development and application of secondary patents. The use of secondary patents to extend periods of exclusivity has become a common practice among pharmaceutical firms. The Indian regime of pharmaceutical patents in India has been particularly controversial with its unique provisions related to the secondary patent system contained in Section 3(d) of the Indian Patent Act 1970, which restricts the ever-greening of patents. That means to qualify for the patent test of a known substance, it has to additionally pass the enhanced efficacy round. This led to the growth of the generic market in India. But it caught attention when Novartis was denied a patent for its product Glivec. This paper will highlight the evergreen debate and controversy concerning section 3(d) of the Patent Act concerning its use for rejection trends in pharmaceutical patents, the judicial interpretation as well as highlighting the EU Directive 2001/83/EC, which contains the definition of "generic substances" which in line with an explanation attached to section 3(d) to provide better legal protection to legitimate Indian Innovations and to remove the controversy and uncertainty surrounding the scope and effect of section 3(d) of the Patents Act, 1970.
Keywords: Pharmaceuticals, ever-greening, patents, innovation, generic
