On April 1, the Indian Supreme Court denied Novartis’ appeal challenging the rejection of a patent for its cancer drug Glivec (imatinib mesylate), which has been patented in almost 40 countries including China, Russia, and Taiwan. This landmark ruling ends a seven-year legal battle by Novartis, which never has been granted an original patent for Glivec in India. The ruling will hinder medical progress and innovation, the manufacturer said.
“We brought this case because we strongly believe patents safeguard innovation and encourage medical progress, particularly for unmet medical needs. This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options,” said Ranjit Shahani, vice chairman and managing director, Novartis India Limited.
In 2009, Novartis had filed a petition with the Indian Supreme Court, challenging the denial of the Glivec beta crystal form patent on two grounds, based on sections 3b and 3d of the Indian patent law. Section 3b will not allow patents for products that are not in the public interest and have not been shown to have greater efficacy compared with existing products. Section 3d will not allow patents for existing drugs unless the new claims demonstrate superiority.
The lawyer representing Cipla, an Indian generic drug manufacturer, said that the court ruling showed that only new drugs would be eligible for a patent, not an existing drug that had been slightly altered, according to a Washington Post report. “Patents will be given only for genuine inventions, and repetitive patents will not be given for minor tweaks to an existing drug,” according to Pratibha Singh, Cipla’s lawyer, reported the Washington Post.
Several groups, such as the Cancer Patients Aid Association and Medicins San Frontieres, opposed Novartis’ case, fearing that many poor patients around the world would no longer have access to Glivec, which is indicated for the treatment of chronic myeloid leukemia and other cancers, due to cost. The monthly cost of Glivec is about $2,600, and its generic equivalent is available in India for $175, according to the Washington Post.
Novartis said that it planned to continue to provide the drug free of charge to 95% of the patients who are prescribed the drug, which covers more than 16,000 patients in India. The 5% of the population are able to obtain the drug through insurance, reimbursement, or through a generous co-pay program.
“The primary concern of this case was with India’s growing non-recognition of intellectual property rights that sustain research and development for innovative medicines,” Novartis said in a statement. “As a leader in both innovative and generic medicines, Novartis strongly supports the contribution of generics to improving public health once drug patents expire.”