India’s Supreme Court on Monday rejected a Swiss pharmaceutical company’s effort to patent an updated version of its cancer drug, a decision aimed at boosting a domestic generic drug manufacturing industry that supplies cheap versions of lifesaving cancer and HIV medicines for much the developing world.
In a case closely watched by global drug makers, Switzerland’s Novartis AG has been fighting since 2006 to patent its leukemia-treating drug Gleevec in India on the grounds that it is a newer version. India passed its first patent protection law in 2005.
Novartis AG lost a seven-year long legal battle for getting its blood cancer drug Glivec patented in India and to restrain Indian companies from manufacturing generic drugs, with the Supreme Court rejecting the multinational company’s plea.
In a landmark judgment that is likely to set a legal precedent for similar patent claims in the future, the Supreme Court said that the beta crystalline form of the salt called imatinib mesylate in the drug fails the test of “invention and patentability.”
“The Supreme Court has said that product was known prior to 1995, and a new patent cannot be granted because it is just a little modification on the old one.
Novartis’ claim was opposed by Indian pharma companies, which claimed that the MNC is not entitled for patent and it is indulging in “ever-greening” of patent by simply changing the composition of the ingredients of the drug.
Ever-greening of patent right is a strategy allegedly adopted by the innovators having patent rights over products to renew them by bringing in some minor changes such as adding new mixtures or formulations. It is done when their patent is about to expire.
Drug companies in India can now manufacture a generic version of the drug, which can cost about Rs 10,000 a month – slashing the price by almost 92 per cent. India’s domestic drugs market is the 14th largest globally, but with annual growth of 13-14 per cent and the world’s second biggest population, it has massive potential at a time when traditional developed markets have slowed down.
A one-month dose of Glivec costs around Rs 1.2 lakh generic drugs, manufactured by Indian companies, for the same period are priced at Rs 8,000.
Glivec is a major advance in treating chronic myeloid leukaemia, which kills 80-90 per cent of sufferers, and some gastrointestinal cancers. The ruling is a boost for healthcare activists who want the government to make medicines cheaper in a country where patented drugs constitute under 10 per cent of total drug sales.
But in 2005, India became compliant with World Trade Organisation rules on intellectual property and now grants patents on innovative new drugs. Patents usually run for 20 years or more from the date they are taken out.
Glivec was already on the market, however, so Novartis decided to seek a patent on a slightly altered version, potentially giving it a longer period of market exclusivity.
At stake in the legal battle was not just the right of generic companies to make cheap drugs for India once original patents expire but also access to newer drugs for poorer countries in much of Africa and Asia. India has long been known as the pharmacy of the developing world.
The judgement, which was keenly watched by pharma companies across the world, will clear hurdles coming in the way for the manufacture of generic drugs in India for cancer patients.
A patent on the new form would have given Novartis a 20-year monopoly on the drug. Earlier, the Comptroller General of Patent and Design had denied patent to Glivec on several grounds including its alleged failure to meet stipulations under sections 3(d) and 3(b) of the Indian Patent Law. Section 3(d) restricts patents for already known drugs unless the new claims are superior in terms of efficacy while
The ruling is thought likely to affect drugs belonging to several other companies. Pfizer’s cancer drug Sutent and Roche’s hepatitis C treatment Pegasys lost their patented status in India last year. They may now find it harder to obtain a patent on new versions.