The 2005 Amendment to the Patents Act, witnessed the introduction of the “Product-Patent” regime into the Indian Patent Scheme. The amendment has expanded the dimensions of patent grant vide this inclusion, but the prospect of patentees acquiring the same has narrowed. The amendment has particularly affected the food, chemical and pharmaceutical sector.

The quest to obtain a patent on Nevirapine Hemihydrate is one such instance. While the Patent Office found the composition to be novel, a lack of inventive step was slated, along with non-fulfillment of the efficacy ground (as regards derivatives, polymorphs, isomers etc.) suggested under Section 3(d) of the Patents Act. The authorities noted that having failed to depict as to how a change in particle size translated itself to improved therapeutic effect, nullified the enhancement proposition. Further, Section 3(e), (claimed substances obtained by mere admixture) was also found to further the case of the opposition.

While top brands continue to rule the market, most of the drugs launched today are not new molecules in themselves, but new forms of existing molecules. The anti-diabetic segment echoes this trend, with the launch of only four new molecules over the last four years. With a total of about 4,830 drugs being launched in the two-year period 2003-05, the same has fallen to 4,700 in 2006-2008. The maximum number of brands were launched in the anti-infective segment (646 drugs) while a minimum was experienced in the anti-diabetes segment (108 drugs). It is evident that the product patent regime has heightened the dilemma of patentees, in their pursuit to obtain patents, leading to a consequent decrease in the number of drugs launched.