A boon for cancer patients

Historic SC ruling victory for local makers of cheap generic drugs

• Swiss pharma giant Novartis loses cancer drug Glivec patent caseA
• A blow to Western firms targeting India to drive salesA
• Govt and medical aid organisations hail Supreme Court verdict

New Delhi/Mumbai (Agencies): In a landmark judgment with global implications, the Supreme Court has dismissed Swiss pharmaceutical giant Novartis AG's petition seeking patent protection for its anti-cancer drug, Glivec (Imatinib mesylate). The apex court bench of Justices Aftab Alam and Ranjana Prakash Desai dismissed on Monday with cost Novartis' plea challenging the Intellectual Property Appellate Board's decision declining the plea for patent of the drug that is used in the treatment of chronic myeloid leukaemia and malignant gastrointestinal stromal tumours. Novartis had claimed that it is the inventor of the beta crystalline form of Imatinib mesylate, but Justice Alam said that the claim was beyond the realm of patents. "In whatever way Section 3(d) of the Indian Patent Act is interpreted, Novartis cannot claim that it is a patent. It fails the test of patentability," he said. Upholding Section 3 (d), the court held that the amended portion of this section is only for genuine inventions. Novartis can file a review petition within 90 days. The judgment came after a prolonged legal battle. Novartis first applied for a patent in 2006 for its new version of the drug, arguing that it was easier to absorb and therefore qualified for a fresh patent. However, the Chennai-based Intellectual Property Appellate Board rejected the application based on a law aimed at preventing companies from getting fresh patents by making only minor changes to existing drugs, a practice known as "evergreening". Officials also turned down a subsequent appeal by the company three years later. Since then the legal battle for the patent of the blood cancer drug had been going on with international pharmaceutical firms closely watching it. Winning such a patent by Novartis would have barred Indian firms from manufacturing generic drugs. The ruling's effect will be felt well beyond the limited number of patients in India who need Glivec, because it will help maintain India's role as the world's most important provider of inexpensive medicines, which is critical in the global fight against HIV/AIDS and other diseases. The apex court's verdict can pave the way for cancer patients getting cheaper drugs as a one-month dose of Glivec costs around Rs 1.2 lakh, while generic drugs, manufactured by Indian companies, for the same period, are priced at Rs 8,000. Healthcare campaigners have welcomed the decision, saying, "The ruling will save a lot of lives across the developing world." However, Novartis said the Supreme Court's ruling "discourages future innovation" which Indian authorities denied on the grounds that the updated version was only slightly different from the previous one. Patents usually protect the companies for 20 years of exclusive sales. After that, it is open to other firms who can make cheaper copies of the original drug. Once the protection expires, the first company to challenge the patent gets an exclusive right to sell the copy for 180 days. After 180 days, more companies can sell the generic versions, potentially resulting in a further price drop. India's generic drug makers are among the biggest in the world and many expect them to benefit from patents expiring in the coming years. However, there have been concerns that if firms are granted patents for updated versions of their drugs, it may not only deny access to cheaper medicines to poor people, but also hurt the makers of generic drugs. The decision sets a benchmark for intellectual property cases in India, where many patented drugs are unaffordable for most of its 1.2 billion people, and does not bode well for foreign firms engaged in ongoing disputes in India, including Pfizer Inc and Roche Holding AG, analysts said. Among the chief beneficiaries of Monday's Supreme Court ruling will be India's Cipla Ltd and Natco Pharma Ltd, which already sell 'generic' Glivec in India at around one-tenth of the price of the branded drug. "The multinational companies will have to find new ways of doing business in India," analysts say, suggesting they may consider licensing agreements with local firms to offer cheap versions of branded drugs like Glivec. Ranjit Shahani, managing director of Novartis India Ltd, said it would still file patents and carry on investing in the country, but with caution, and would continue to refrain from research and development activities there. "The intellectual property ecosystem in India is not very encouraging," Shahani told reporters in Mumbai after the ruling. Pfizer's cancer drug Sutent and Roche's hepatitis C treatment Pegasys lost their patented status in India last year, decisions the companies are fighting to have reversed. The Supreme Court's latest ruling will make it tougher for them to win back patent protection. The Union government hailed the ruling as "historic." Commerce and Industry Minister Anand Sharma said the ruling reaffirmed provisions in Indian law that mandate the need for substantial innovation before new patents are issued on medicines. Anand Grover, a lawyer representing Cancer Patients Aid Association, said he was "ecstatic with the ruling. This will go a long way in providing affordable medicine for the poor," he said.