India Supreme Court: Novartis's Glivec patent not novel

Domestic generic manufacturers Ranbaxy and Cipla brought the opposition, with both represented by Singh & Singh. Anand & Anand acted for Novartis. You can read the Court's ruling here.

The comptroller of patents rejected the Glivec application for lack of novelty. Specifically at issue was section 3(d) of the Patents Act, which states that new formulations of existing drugs are not novel unless they “differ significantly in properties with regard to efficacy”. The act specifically refers to alternative forms such as salts and ethers. Glivec is a salt formulation of the known molecule imatinib.

The IPAB agreed with the patent controller, finding that Glivec was not patentable.

Novartis claims that Glivec is a major improvement over the original molecule, stating that “without further development, [imatinib] could not safely be administered to patients and represented only the first step in the process to develop Glivec as a viable treatment for cancer” (emphasis in original).

The Glivec saga has been ongoing for over six years, with Novartis going so far as challenging the constitutionality of section 3(d). On the other side of the dispute, generics and activists claimed that the application was an attempt at evergreening, where a rights holder patents a minor variation of a drug to extend the protection period.

The Glivec case is just the latest development raising concerns among international pharmaceutical companies about IP protection in India. India has denied patent protection to a number of drugs developed by multinationals, including Pfizer’s sutent and Roche’s Pegasys. Observers around the world have also been discussing the country’s increasingly aggressive compulsory licensing programme, whether it improves access to medicines as intended and whether it is in violation of TRIPs.