The pharmaceutical industry received a lift Wednesday when the Indian Patent Office rejected an application from a domestic company that sought a compulsory license to make a generic version of a brand-name medicine. In this case, Lee Pharma hoped to sell a lower-cost version of Onglyza, a diabetes pill sold by AstraZeneca.
The decision was being closely watched as global drug makers look for signs that the Indian government will alter its approach toward protecting patent rights. Countries can issue compulsory licenses to a generic drug maker allowing it to copy a patented medicine without the consent of the pharmaceutical company that owns the patent. This right was spelled out in a World Trade Organization agreement.
One argument for pursuing — and issuing — a compulsory license is affordability. Thailand took this step several years ago to lower costs for different medicines and, more recently, India issued a license as well. But the pharmaceutical industry worries that the Indian government is willing to consider issuing licenses as a way to bolster its own generic drug makers as much as widen access to medicines.