Landmark verdict, say pharma bodies

The Indian pharmaceutical industry and health aid agencies have welcomed the judgment of the Supreme Court which has upheld the refusal by the Patent Office to grant multi-national pharma giant Novartis a patent for the beta-polymorphic form of imatinib mesylate sold as Glivec and used in the treatment of cancer.

“This is a landmark judgment that will serve to set at rest the controversy that was raised regarding the scope of Section 3(d) in the Patents Act, which is a crucial safeguard against the extension of patent monopolies of known drugs and the consequent delay in the availability of affordable generic versions,” said D. G. Shah, Secretary-General, Indian Pharmaceutical Alliance (IPA).

The judgment in the Novartis case is a victory for patients in India and around the world, according to Yusuf Hamied, Chairman, Cipla. “We are pleased with the judgment which prevents the use of frivolous patents to deny access to medicines for patients,’’ Dr. Hamied said in a statement.

In its initial reaction, international body Medecins Sans Frontieres (Doctors without Borders) has welcomed the verdict saying “it appears to be the best outcome for patients in developing countries as fewer patents will be granted on existing medicines,” Leena Menghaney, Medecins Sans Frontieres Access Campaign Manager India said in a statement. “Novartis’ attacks on the elements of India’s patent law that protect public health have failed. The Supreme Court’s decision prevents companies from abusing the patent system to get unwarranted patents on existing medicines, to block price-busting generic competition on HIV and other essential medicines. This confirms that all patent offices in India have to use this interpretation and the law is now clear and must be strictly applied.”

The verdict has provided clarity regarding ‘evergreening’ of products and it would now be difficult for multi-national companies to establish that a product is a genuine invention, according to Ranvir Singh, a pharmaceutical analyst with Sharekhan.

“It is a big positive for generic manufacturers, patients and consumers and certainly a negative for multi-national pharma companies,” Mr. Singh told The Hindu. “However, the positive is that with the clarity in law, companies can better evolve a country-specific strategy. For MNCs, now branded generics are more lucrative than patented products.”