Inside Novartis' patent gambit

As the Supreme Court ruled against granting the pharma major a patent on its anti-cancer drug Glivec, HT takes a look at what this means for Indian pharma and patients, reports Gaurav Choudhury.

As the Supreme Court ruled against granting the pharma major a patent on its anti-cancer drug Glivec, HT takes a look at what this means for Indian pharma and patients.

What is the case regarding Novartis AG’s anti-cancer drug Glivec?
Swiss drug maker Norvatis AG’s Glivec (chemical name: imatinib mesylate) is a blockbuster anti-cancer drug. India had granted the company the approval to market Glivec in 2001.

In 2005, India enacted the Indian Patents Amendment Act. The company challenged section 3(d) of the Indian Patent Act.

In 2009, the Patent Appellate Board refused to grant a patent to Glivec. The company moved the Supreme Court in 2009.

What has the Supreme Court ruled?
On Monday, the Supreme Court ruled against Novartis rejecting its request to grant patent for Glivec. The apex court ruled that the tweaked form of the drug was not a truly new product.

What was the core issue of the case?
Section 3(d) of the Indian Patent Act was at the centre of the dispute. The section addresses “evergreening” and whether a new form of a known substance can and should be granted patents.

The case has relevance in other drug patent disputes as it involves interpretation of section 3(d), a public health safeguard introduced by Parliament in 2005 to prevent 'evergreening', describing manufacturers getting several patents on a single medicine.

Apart from the new molecule (active medical ingredient), manufacturers seek patents for formulations, combinations, new delivery devices, new use, isomers, polymorphs, manufacturing process at different points of time, which allows them to extend the monopoly beyond the 20 years of the first patent.

Section 3(d) disallows patenting of new forms of already known molecules unless the patent applicant shows significant enhancement in product efficacy.

What is evergreening?
The SC verdict will likely set a precedent over the debate on so-called “evergreening” of drugs by pharma companies.

Evergreening refers to a ploy pharma companies adopt to extend the patented period of a drug by marginally altering a patented formulation that may not necessarily have a major impact on its therapeutic value.

What does the SC ruling mean for consumers?
The ruling will ensure the anticancer drug is affordable for millions of Indians.

What does the ruling mean for Indian pharma companies?
The ruling is poised to give a boost to domestic generic drug manufacturers. Indian drugmakers can continue to sell copies of the drug at a lower price. It provides clarity on the extent of innovation required to retain patents in India

What does it mean for global pharma?
The ruling is a big blow to some MNCs banking on easy patent power. However, Innovator MNCs may hold back planned drug launches, fearing weak intellectual property protection.

Are there any similar cases in focus?
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.

This ruling will make it tougher for them to win back patent protection. Last year, the patent office overruled German major Bayer’s objections to allowing Natco Pharma to produce a generic of cancer drug Nexavar.

What is the relevance of TRIPS?
Trade Related Intellectual Property Rights agreement, to which India is a signatory, makes it mandatory for member countries to guarantee a 20-year patent protection to firms producing “new drugs.” India enacted the legislation in 2005.

What has been India’s drug patent record in recent times?
Drug-patent related decisions have generally gone in favour of domestic, generic drug companies.

Last year, the patent office overruled German major Bayer AG’s objections to allowing Natco Pharma to produce a generic version of cancer medicine Nexavar.

Under, TRIPS countries can grant compulsory licences for producing generic versions if it is felt that most people cannot afford the patented drug.