The global pharmaceutical industry would be tracking the landmark patent case between Novartis and India’s patent office. At the root of the dispute is Novartis’ drug Glivec, which combats a rare type of cancer and stomach tumours. In November 2003, Novartis was granted exclusive marketing right (EMR) to sell the drug for five years, which prevented Cipla, Ranbaxy and Sun Pharma from marketing the medicine when it was launched in January 2005. After the EMR was enforced, the price of the drug soared from Rs 10,000 for a month’s requirement to about Rs 1.2 lakh.
Indian companies argued Glivec was merely an alteration of an old drug and, therefore, did not satisfy the novelty criterion under the Patents Act, nor did it introduce any improvement in the efficacy of the drug. In January 2006, the Chennai patent office rejected Novartis’ patent application, stating the drug was “only a new form of a known substance”.
After losing two challenges in the Madras High Court, Novartis approached the Supreme Court, challenging section 3(d) of the Patents Act. The case is significant because unlike countries that simply follow whatever is patented by the US Food and Drug Administration, India examines each patent on its own merit.
According to Unni Karunakara, international president, Medecins Sans Frontieres, if Novartis wins the case, patents in India would be granted as broadly as these are in wealthy countries, and on new formulations of known medicines already in use. This would impact the domestic pharmaceutical industry only mildly, as the contribution of low-cost reverse engineered patented drugs is relatively small. However, the impact on patients would be severe, as treatment costs would rise significantly, as seen in the Glivec case. India’s status of being the ‘pharmacy of the world’ would also be impacted by the judgment, as domestic companies have played an important role in providing cheap life-saving drugs.
Currently, India’s patent law does not prohibit patented products. However, it doesn’t allow ‘me-too’ versions of drugs, which is what the Novartis case is all about. With few blockbuster drugs being discovered by big pharma companies, global firms have been extending their patent period by tweaking existing molecules. A British medical journal published a study rating barely five per cent of all newly patented drugs as breakthrough. As India is a huge market and the primary source for generic drugs worldwide, big pharma companies have more to lose from this case than domestic companies.