People gather at Novartis India headquarters in Mumbai yesterday.
NEW DELHI: The Supreme Court rejected yesterday a patent bid by Swiss drug giant Novartis in a landmark ruling activists and experts say will allow continued supply of cheap generic drugs and save lives in poorer nations.
Novartis fought a seven-year legal battle to gain patent protection for an updated version of its blockbuster leukaemia drug Glivec, arguing the compound was a significant improvement because it is more easily absorbed by the body.
Justice Aftab Alam said the claim was “beyond the realm of patents”.
“We firmly reject the appellant’s (Novartis) case that Imatinib Mesylate is a new product and the outcome of an invention... We hold and find that Imatinib Mesylate is a known substance...” and its pharmacological properties are also known, the court said, in a judgment running into 36,089 words.
“In whatever way Section 3(d) of the Indian Patents Act is interpreted, Novartis cannot claim that it is a patent. It fails the test of patentability,” he said.
But in a judgement that went to the heart of patent law in a country known as the “pharmacy to the world”, the top court said the compound “did not satisfy the test of novelty or inventiveness” required by Indian legislation.
India’s law restricts pharmaceutical companies from seeking fresh patents for making minor modifications — an industry practice known as “evergreening” —and the ruling enables generic drug makers to continue copying Glivec.
Health experts welcomed the ruling, saying it would ensure that patients get access to cheaper life-saving drugs.
“This is a landmark judgment. This will have a long-term and wide impact, as the generic version makes it more affordable for the poor,” Y K Sapru of the Mumbai-based Cancer Patients Aid Association said.
“Now the prices of life-saving drugs will be reduced from Rs160,000 per month to just Rs6,000,” Sapru added.
Sameer Kaul, a senior surgical oncologist at the Indraprastha Apollo Hospitals, also hailed the ruling. “The government should have stepped in much earlier to negotiate the prices with the company,” Kaul said.
“The government should encourage the local pharmaceutical industry to spend more on research, so that we can develop own molecules. Also, the patent time-period of 20-30 years is absurd. It should not be more than two or three years,” he said.
Leena Menghaney, a lawyer with medical charity Medecins Sans Frontieres (MSF), said yesterday’s ruling was “a big relief” that would save lives in India and elsewhere in the developing world and set a legal precedent.
“Breakthrough, innovative medicines will still get patents in India but the judgement means drug companies cannot keep seeking patents for small changes to one drug,” such as introducing paediatric dosages, she told a news conference.
The legal case was the highest-profile of several being pursued by multinationals in the vast Indian market, set to touch $74bn in sales by 2020 from $11bn in 2011 according to a study by financial services firm PwC.
Global drugmakers say India’s powerhouse generics industry and strict patent filtering reduce commercial incentives to produce cutting-edge medicines.
Novartis, which reported a net profit of $9.6bn in 2012 on sales of $56.7bn, condemned the judgement, saying it “discourages innovative drug discovery essential to advancing medical science”.
“The ecosystem in India to encourage investment is not there. We have been boxed in from all sides,” Novartis India Managing Director Ranjit Shahani said in Mumbai. He said the company would continue to invest “cautiously” in India.
Shares of Novartis India, the local unit of the Basel-headquartered group, slid nearly seven percent before paring losses to end down 1.81 percent at Rs587.95.
AIIMS’ P K Julka said: “The ruling is good for poor patients. It will ensure continued access to cheap drugs.”
Unni Karunakara, international president of medical humanitarian aid organisation Medecins Sans Frontieres, said: “This is a huge relief for the millions of patients and doctors in developing countries.”
“The Supreme Court’s decision now makes patents on the medicines that we desperately need less likely,” Karunakara said.
Indian generic medicines are exported abroad to other developing countries also.
Anand Grover, the lawyer representing Indian companies, said: “We are very happy that the court has rejected attempts by Novartis to water down our patent laws.”Mark Elliot, executive vice president of the US Chamber of Commerce’s Global Intellectual Property Center, also criticised the ruling as damaging prospects for “future innovation”.
But shares of Indian generics giant Cipla gained 1.2 percent to 384.30 rupees and its chairman, Yusuf Hamied, who revolutionised Aids treatment over a decade ago by supplying cut-price drugs to the world’s poor, praised the ruling.
It “prevents use of frivolous patents to deny access to medicines” and “is a victory for patients both in India and around the world,” Hamied said.
It “prevents use of frivolous patents to deny access to medicines” and “is a victory for patients both in India and around the world,” Hamied said.
The Supreme Court upheld the view of India’s Intellectual Property Appellate Board, which refused to grant Novartis protection in 2009.
India’s huge generic drug industry has been a major supplier of vastly cheaper copycat medicines to treat diseases such as cancer, TB and Aids for those who cannot afford expensive branded versions across the developing world.
The copycat drugs sector grew because India did not issue drug patents until 2005 when it began complying with World Trade Organisation rules.
Just two other nations, Argentina and the Philippines, have similar legislation but their laws are not as strict at filtering patents, Grover told reporters.
“Only 25 percent of patents in the West are awarded for breakthrough drugs. This judgement should encourage companies to look for genuine innovations” rather than claiming ever longer patent protection on older drugs, MSF’s Menghaney said.
The ruling might only be a “breather” as patient rights campaigners fear a new India-European Union free trade deal expected soon could contain intellectual property clauses seeking to restrict generic drugmakers, she said.
“But today we are celebrating,” she added.
Agencies
