Of Patents & Patients....

In a landmark ruling, the Supreme Court has rejected a patent bid by Swiss drug giant Novartis for a cancer drug, thus paving the way for access to cheap generic drugs and affordable healthcare.
Novartis fought a seven-year legal battle to gain patent protection for an updated version of its blockbuster cancer drug Glivec, arguing that the compound was a significant improvement because it is more easily absorbed by the body.
But in a ruling that went to the heart of patent law in India, known as the ‘pharmacy to the world’, the apex court said the compound ‘did not satisfy the test of novelty or inventiveness’ required by Indian legislation.
Indian patent laws restrict pharmaceutical companies from seeking fresh patents for making only small modifications – an industry practice known as ‘evergreening’ – and the ruling enables generic drug makers to continue copying Glivec.
Medecins Sans Frontieres (MSF) says Glivec – often hailed as a “silver bullet” for its breakthrough in treating a deadly form of leukaemia – costs over Rs.1.2 lakh a month in its branded form while the generic version is available in India for around Rs.8,000.
 Novartis, which reported net profit of $9.6 billion in 2012 on sales of $56.7 billion, condemned the judgment, saying in a statement it “discourages innovative drug discovery essential to advancing medical science for patients”.
“This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options,” said Ranjit Shahani, managing director of Novartis India.
The Supreme Court upheld the view of India's Intellectual Property Appellate Board, which refused to grant Novartis protection in 2009 on the grounds that the amended form of Glivec was not vastly different from the earlier version.
The Madras High Court had also rejected Novartis’s arguments in 2007.
Global drug makers say India's generics industry reduces commercial incentives to produce cutting-edge medicines and Novartis has warned it might stop introducing new drugs in India.
At the same time,the market is difficult to ignore and is set to touch $74 billion in sales by 2020 from $11 billion in 2011,according to industry estimates.
THE CASE
In 1997, Novartis filed a patent application to have exclusive rights to manufacture Glivec and to restrain Indian firms from making generic variants. It claimed that the drug was more stable and more soluble. While the Patent Controller in Chennai denied Novartis a patent, the case reached finally reached the SC in 2009.
THE RULING
A bench of justices Aftab Alam and Ranjana Prakash Desai refused to give credence to Novartis’s claim that 'Imatinib Mesylate', a substance used in the cancer drug, is a new product and the outcome of an invention. The court held that a repetitive patent was not permissible.
GLOBAL SIGNIFICANCE
The apex court judgment can pave the way for access to cheaper drugs as a one-month dose of Glivec costs around Rs.1.2 lakh. Generic drugs manufactured by Indian companies, will cost around Rs.8,000 per month. If Indian law allowed global drug firms to extend the lifespan of patents by making minor changes to medicines, it would have adversely affected the country’s $26-billion generic drug industry, which supplies much of the cheap medicine used in the developing world.
ADVANTAGE GENERIC
Nearly 10 years ago, Mumbai-based Cipla began selling generic anti-retro viral drugs (to suppress HIV virus) at one tenth of the price MNCs charged. The firm took advantage of Indian laws that allowed local companies to make such drugs as long as they used a process that differed from the original patented process.
Cipla sold the medicne to international aid agency MSF at $350 per patient a year, which was between $10,000 and 15,000 in the market, on the condition that they gave it to patients for free.