Novartis Loses India Patent Fight

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 buy generic drugs from India, the ruling is another setback for multinational drug companies that were hoping for stricter patent protection.

In its 112-page ruling, the Supreme Court decided that Gleevec’s active ingredient, imatinib mesylate in β-crystalline form, is a close derivative of imatinib. Imatinib itself 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 too closely related to 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 is patented in nearly 40 countries.

Doctors Without Borders, a charitable organization that provides medical assistance in developing nations, calls the ruling “a huge relief for the millions of patients and doctors in developing countries who depend on affordable medicines from India.”

If Novartis had won the case, the group contends, drug firms would have sought patents in India for their latest AIDS drugs, which are often more effective than generics even though they might be only slightly different. Reasonably priced next-generation AIDS treatments are crucial to fighting drug resistance, the group says.

From a legal point of view, the Supreme Court judgment is both a landmark and a nonevent, says N. S. Gopalakrishnan, a professor at the Inter University Centre for Intellectual Property Rights Studies at India’s Cochin University of Science & Technology. On the one hand, it’s as much a landmark as KSR International Co. v. Teleflex, Inc., a case about obviousness in inventions that the U.S. Supreme Court heard in 2007. On the other hand, he says, the ruling merely confirms that India’s patent law must be read with the intent of the legislators who wrote it in mind.

India passed the law in 2004 to comply with its new obligations as a member of the World Trade Organization. Although the law itself is vague, by reviewing parliamentary proceedings from the time, the Supreme Court determined that legislators intended to protect Indian citizens against the patenting of relatively obvious discoveries. WTO has not challenged the law, Gopalakrishnan notes.

In recent years, multinational drug companies have failed repeatedly in their efforts to obtain patent protection for certain products 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).

India does recognize drug patents, Gopalakrishnan argues. “You will get a 20-year patent for a genuine innovation,” he says. “And as for the incremental improvements that happen later on, this case presents an occasion for looking at mechanisms other than a 20-year monopoly to reward the innovators.”