NEW DELHI In a landmark ruling, the Supreme Court on Monday 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 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.
“The ruling has come as a big relief,” Leena Menghaney, a lawyer with medical charity Medecins Sans Frontieres (MSF), said outside the courtroom. “It will save a lot of lives – not only in India but across the developing world.” “The ruling doesn’t mean no patents will be granted in India, but the abusive practice of seeking many patents for one drug will be curbed,” she added. 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.
Lawyer Anand Grover, representing the Cancer Patients Aid Association in the case,said he was ‘ecstatic’, adding that the ruling will ‘go a long way in providing affordable medicine for the poor’.
Pratibha Singh, a lawyer acting on behalf of generics drug giant Cipla, said the judgment ‘makes it clear you cannot patent a drug by just making some minor modifications – the key Section 3(d) of the patent law has been upheld by the court’. 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 billionin2011,accordingtoindustryestimates.
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.
Abench 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.
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.
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.
GLIVEC ISSUE, IN THE EYES OF NOVARTIS, SC AND OTHERS
We certainly do not wish the law of patent in this country to develop on the lines where the scope of the patent is determined not on the intrinsic worth of the invention but by the artful drafting of its claims by skillful lawyers
– JUSTICES AFTAB ALAM, RANJANA DESAI, SC
Patents will continue to be granted by India, but definitely the abusive practice of getting many patents on one drug will be stopped
– LEENA MENGHANEY, MSF
This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options. Novartis will introduce products in India, but will not invest in R&D. Novartis India will also continue to invest here, but with caution
– RANJIT SHAHANI, MD, NOVARTIS INDIANDIA