New Delhi, April 1
Today’s Supreme Court judgment rejecting Novartis’ patent protection claim over imantinib mesylate, a critical blood cancer drug, is a huge victory for patients’ access to affordable generic medicines in India and abroad.

The court rejected the Swiss pharma major’s claim on grounds that the drug it was seeking to patent was a mere modification (salt form) of an older medicine called imatinib and didn’t offer improved therapeutic efficacy. Under the 2005 Indian Patents Act, improved efficacy of newer forms of known drugs is a requirement for grant of patents to such medicines.

The development means Novartis can’t monopolise the said cancer drug market by selling it at higher prices and preventing Indian drug makers from producing its generic versions which are available at one twentieth the cost of the branded version.

It was in 2003 that Novartis launched imatinib mesylate under the brand name Gleevec in the US for $2,600 per patient per month. Its generic versions became available in India for a mere $200 per patient per month ensuring patient access to life saving medicines which are known to prolong lives.

Today’s judgment is trendsetting as it means drug MNCs can be refused patent protection on improved versions of existing medicines unless they prove enhanced efficacy. The court rejected Novartis’ definition of efficacy as “improved bioavailability” for the said drug and held that therapeutic efficacy was a must.

“The development is a very welcome for patients as cancer drugs will remain affordable to them but on the flip side prevent global drug makers may stop launching newer, better drugs in India. It’s time India started investing in R&D and improved its health spending to invent new drugs,” Dr Ashok Vaid, chairman, Oncology, Medanta Medicity, told The Tribune.

While overseas drug makers would now be wary of launching new medicines in India given its weak patent laws, domestic pharma industry can expand its business and further improve availability of life saving generic drugs. India is called the world’s pharmacy as it supplies bulk medicines to the developing world. Lack of patent protections in India enabled our generic medicine industry to produce cheap drugs.

“Today over 80 per cent antiretroviral medicines (ARVs) used by UNAIDS for HIV treatment come from generics in India and 80 per cent ARVs purchased with donor funds globally come from India. Indian generics also supply cheap malaria and tuberculosis treatments to the world. That has been possible because we didn’t have patents until 2005,” says senior SC lawyer Anand Grover who represented the Cancer Patients Association in the Novartis suit.

Until 2005, India didn’t grant patents on medicines. This enabled generic manufacturers to compete and reduce the prices of critical drugs. Thanks to India’s generic drug makers, the price of ARVs for HIV treatment came down from one person per year cost of $10,000 in 2000 to less than 1 per cent of that figure today.

India started granting medicine patents from 2005 to comply with WTO under which the life of a patent is 20 years. India, however, ensured safeguards in its law. “Section 3(d) of the Indian Patent Act prevents companies from gaining patents on modifications to existing drugs in order to ever extend monopolies.

The SC judgment is a huge relief for millions of patients and doctors in developing countries who depend on affordable Indian medicines,” said Unni Karunakara, International President, Doctors without Borders.

The CASE: WHAT IT MEANS FOR YOU

* SC's refusal to grant patent to Novartis on a blood cancer drug on grounds that it is not new and innovative and is merely a modified version of an old drug means Indian generic drug makers can continue to manufacture cheap versions of the super costly Gleevec

* The interpretation of Indian Patents Law by the SC means drug MNCs will have to prove enhanced therapeutic efficacy of improved drugs if they want such drugs patented.

* In the absence of patents of critical life saving drugs, Indian generic drug makers can continue producing cheap versions and supplying to the developing world