Novartis Suffers Setback in Indian Patent Case for Glivec

The Indian Supreme Court has ruled against Novartis in the company’s appeal to grant a patent for the company’s anticancer drug, Glivec/Gleevec (imatinib mesylate) in India.

In a statement on the ruling, Novartis said that it had never been granted an original patent for Glivec in India. Novartis filed a Special Leave Petition with the Indian Supreme Court in 2009 challenging the denial of the Glivec beta-crystal form patent on two grounds, based on Sections 3(d) and 3(b) of the Indian patent law. In addition to seeking a patent for Glivec, the company filed the case to help clarify these unique aspects of the patent law.

"Novartis has never been granted an original patent for Glivec in India,” said Ranjit Shahani, vice-chairman and managing director, Novartis India Limited, in the company’s statement. “We strongly believe that original innovation should be recognized in patents to encourage investment in medical innovation especially for unmet medical needs. 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."

At issue in the case was whether Glivec was considered an innovative product and, therefore, afforded protection under Indian patent law. Novartis had argued that the beta-crystal form of imatinib mesylate was novel and that it should be given patent protection under India law. India, which is part of the World Trade Organization, had amended its patent law in 2005 to assert that pharmaceutical companies had to prove enhanced clinical efficacy of their drugs over already patented compounds. In its ruling against Novartis, the Indian Supreme Court cited a 1996 patent (US Patent No. 5,521,184), which included several derivatives of N-phenyl-2-pyrimidine-amine, including imatinib, in a free-base form (1). Novartis asserted that it had first developed the methanesulfonic acid addition salt, imatinib mesylate, and later the beta-crystalline form of the salt, which had improved properties, such as flow, thermodynamic stability, and lower hygroscopicity compared with the alpha-crystal form. The India Supreme  Court, however, ruled that the beta-crystalline form of imatinib failed to meet the tests of “invention” and “patentability” under Indian law.

“PhRMA is very disappointed with the Indian Supreme Court’s decision to deny a patent on Glivec,” said Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO John Castellani, in an Apr. 1, 2013 statement. “This decision marks yet another example of the deteriorating innovation environment in India....In order to solve the real health challenges of India’s patients, it is critically important that India promote a policy environment that supports continued research and development of new medicines for the health of patients in India and worldwide. Protecting intellectual property is fundamental to the discovery of new medicines. The research-based pharmaceutical industry is committed to working closely with the Indian Government and other stakeholders to find appropriate solutions to this challenge.”

Reference

• 1. J. Zimmerman, “Pyrimidine Derivatives and Processes for the Preparation Thereof (US Patent No,521,184), May 28, 1996.