Indian Generics Maker Renews Criticism of Patent Law
The chairman of Indian generics maker Cipla has reiterated his concerns over India's new Word Trade Organization-compliant patent law, approved last month. Dr. Y.K. Hamied has called for a series of changes to the law, such as allowing generics makers to pay a clearly defined "reasonable" royalty of roughly 2% on generic formulations of patented drugs. Hamied has also condemned the legislation on the basis that some provisions overstep the basic scope of the country's TRIPS obligations.
Measures singled out for criticism include the retrospective patent protection granted for drugs registered after 1995. Further, the generics-based domestic industry's concerns are now likely also to focus on so-called "evergreening" of patents, as well as the fact that most imported drugs will be subject to intellectual property provisions even if patented outside India. In addition to labelling the law as "genocide," Hamied has also urged that the practice of compulsory licensing be expanded in view of the growing threat of HIV/AIDS in India.
Nevertheless, the government will be keen to point out that the new law does allow India to continue exporting essential drugs to 49 low-income countries using compulsory licensing, although it does not enable such products to be sold on the domestic market. Further, authorities should recognise that as this latest criticism comes from a leading generics maker, it should not be taken at face value.
Indeed, as 97% of drugs sold in India are currently off patent, and this figure
is expected to remain around the 40% mark even by 2015, it is expected that
the patent law's impact on the fast-evolving Indian sector should be gradual.
The government is also likely to ensure that the introduction of the law does
not take essential medicines out of the reach of ordinary Indians, as existing
price controls are already widely seen as harsh.