Novartis has lost a landmark case in the Supreme Court of India in which it sought patent protection for its cancer drug Gleevec. Applauded by nongovernmental organizations that source generic drugs from India, the ruling is a setback for multinational drug companies that have been lobbying India to strengthen its patent protection regime.
In its 112-page ruling, the Supreme Court essentially judged that the active ingredient in Gleevec, imatinib mesylate in β-crystalline form, is a close derivative of imatinib. Imatinib is not patentable because it was invented before 1995, the year after which India recognizes patents on pharmaceutical substances. The court ruled that imatinib mesylate in β-crystalline form is also not patentable because it is a somewhat obvious improvement on imatinib.
Novartis says it is concerned with India’s “growing nonrecognition of intellectual property rights that sustain research and development for innovative medicines.” It notes that Gleevec, a treatment for leukemia and other forms of cancers, is patented in nearly 40 countries. Novartis says it supplies the drug in India at no cost to 95% of patients with a prescription.
Doctors Without Borders, a charitable organization that provides emergency medical assistance in developing countries, calls the ruling “a huge relief for the millions of patients and doctors in developing countries who depend on affordable medicines from India.”
In its decision, the Supreme Court observed that Indian legislators working on a tight schedule in late 2004 had used vague terminology to draft a new patent law that complies with India’s obligations as a new member of the World Trade Organization. By researching the transcripts of the country’s parliamentary proceedings, the court discovered that legislators at the time intended to protect Indian patients against attempts by drug companies to patent relatively obvious discoveries.
In recent years, multinational drug companies have failed repeatedly in their efforts to protect patents on products they sell in India. Last September, a court in Chennai allowed the compulsory licensing of the Bayer cancer drug Nexavar, and a court in Delhi declared that Roche could not obtain a patent for its lung cancer drug Tarceva (C&EN, Sept. 17, 2012, page 9).