In a milestone judgment that will be regarded as the gold standard to deal with patent bids by multinational pharmaceutical companies in India, the Supreme Court on Monday rejected Swiss drug maker Novartis AG’s plea to patent an expensive anticancer drug Glivec.
The verdict allows Indian manufacturers to continue making inexpensive replicas of the drug at a fraction of the cost of Glivec, which like many patented foreign drugs, is out of reach for a majority of the country’s population. It also delivers a blow to international drug firms, which may have to rework their formula of marketing costly brands in the country.
Glivec is effective in treating chronic myeloid leukemia (CML), a type of blood cancer. Its major component is imatanib mesylate, which is used by local firms to make generic anticancer drugs. The apex court’s ruling has been hailed by domestic manufactures as well as health activists, who say poor Indians will now be able to afford the cancer treatment.
Y K Sapru (70), founder chairman and CEO of the Cancer Patients Aid Association (CPAA), the petitioner in the patent case, said “Today’s landmark judgment will make life-saving anti-cancer drugs affordable so that no lives will be lost to cancer just because the drug available for treatment is unaffordable. The judgment will totally change the cancer scene in India as well as over 75 other countries where India exports cancer drugs.”
Novartis stocks plunged following the judgment, while the local pharma stocks soared.
It has been learnt that Novartis will rationalise the price of its drug to stay competitive with domestic manufacturers. It is likely to slash the price to an amount costing less than the Indian variants cost. “I always had a fear in the back of my mind of losing the case as the legal battle was against a pharma MNC, which is very strong in all aspects including monetarily. But the judgment has only strengthened my trust and faith in Indian judiciary.”
His wife Rekha (70), who has always stood by Sapru, said, “I always had faith in him and our work for a cause to reach those in need.” The CPAA helps 3,000 patients avail of the drug either for free or at a very nominal price.
The patent war
In 2001, Novartis introduced its wonder drug Glivec, effective in treating chronic myeloid leukemia (CML), a form of blood cancer, Sapru said. The launch came after the firm had applied in India for a patent for Glivec in 1998 and was granted exclusive marketing rights (EMR) in January 2003. As a result Indian courts forbade 6 out of 9 generic producers to market imatanib mesylate (IM), the main component of Glivec.
Sapru said, “The CPAA went to the Supreme Court against granting of EMR to Novartis. In March 2005, Parliament passed the Indian Patent Act. In January 2006, the Patent Controller of India rejected the application of Novartis for Glivec after evaluating all the points raised by CPAA.
As a result once again generic versions of Glivec were available in the Indian market at affordable prices. And in May 2006, Novartis appealed against this judgment and filed a case against the Indian Patent Act. The CPAA, MSF, Oxfam and other NGOs launched a global agitation against Novartis.”
The court's decision has global significance since India’s $26 billion generic drug industry, which supplies much of the cheap medicine used in the developing world, could be stunted if Indian law allowed global drug companies to extend the lifespan of patents by making minor changes to medicines. Once a drug’s patent expires, generic manufacturers can legally produce it. They are able to make drugs at a fraction of the original manufacturer's cost because they don’t carry out the expensive research and development.
Verdict a setback: Novartis India
In a press statement, Ranjit Shahani, vice-chairman and managing director of Novartis India Limited, a unit of Swiss drug maker Novartis AG, said, “Novartis has never been granted an original patent for Glivec in India... We brought this case because we strongly believe patents safeguard innovation and encourage medical progress, particularly for unmet medical needs. This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options.”
Hope for patients
Manish Sarviya (41), a resident of Dahisar, was detected with CML in 2006 and since then was prescribed by his treating doctors to have IM tablets. Sarviya said, “I earn a mere Rs 3,000-4,000 a month selling incense sticks. I have been asked to take this medicine lifelong and cannot afford it. I hope the SC judgment would make expensive drugs affordable for common man.”
Mohit Gupta (6), a resident of Goregaon, was detected with CML five months ago and put on IM tablets, which is being given for free. His father Manoj finds it difficult to provide treatment to his son. Thankfully, the CPAA is giving him free medicines, he said.
Abed Shaikh (8), a resident of Jogeshwari also detected with CML five months ago, has been put on IM tablets, given for free. Efforts made to contact his parents did not yield result. However, it is learnt that Shaikh is responding to the treatment and is presently being treated at Sion hospital.
Rs 1.2 lakh for month-long course
Doctors usually recommend CML patients to have three tablets of imatanib mesylate per day, which means the patients had to pay almost over Rs 1.2 lakh for a month-long course of Glivec an amount unaffordable for most Indians. Indian pharma companies make a similar drug priced at roughly Rs 11,000 for the same course. A chemist at Parel said Glivec 400 mg tablets usually costs around Rs 40,000 for 30 tablets and the entire course of 90 tablets costs Rs 1,20,000, which may be discounted to cost up to Rs 1.05 lakh. He added that Glivec 100 mg tablets would cost around Rs 65,000 for 120 tablets.