Science has nothing to do with business, says Indian pharmaceutical firm chief.
By Neethu M.
NEW DELHI: The global pharmaceutical industry was dealt a heavy blow after the Supreme Court in India dismissed the Swiss drug maker Novartis’ attempt to win patent protection for its cancer drug Glivec. Indian pharmaceuticals can rejoice, especially Cipla and Natco Pharma, as they already sell the generic cancer drug Glivec in India at around one-tenth of the price of the branded drug.
The ruling has been largely welcomed by Indian pharmaceutical company executives, doctors, lawyers and analysts. Most say that in the wake of the landmark ruling the drug will now be available at affordable prices for the common people in India.
Novartis, however, lashed out at the verdict.
Ranjit Shahani, the managing director of Novartis India Ltd said the intellectual property ecosystem in the country is not encouraging. He pointed out that over 16,000 patients in India use Glivec and they get it free of charge.
“We will continue with our investments in India even though cautiously,” said Shahani.
Meanwhile, the US Trade Representative spokesperson Andrea Mead said that they are “reviewing” the Indian top court’s order.
However, most analysts and experts interviewed by The American Bazaar supported the ruling.
Speaking to The American Bazaar on condition of anonymity, the chairman of a major Indian pharmaceutical company said that “it is a total fallacy since science has nothing to do with business.” He said, “people will always innovate. What have the western countries done in India. Nothing…not one multi-national company has done any fundamental research in India. None of them bother about the health needs of the country. It’s the indigenous companies in our country which has provided the medicines. In 1972 they all packed up their bags and left when the patent laws were changed. In 2005, India reversed their 1972 pattern and they want to come back and explore the business proposal. They are not in India for the health needs of the country.”
The pharmaceutical company chairman also debunked the notion that India is not protecting international patents. He pointed out that “in the last couple of years 5,000 patents have been granted in India. We have only challenged half a dozen patents.”
Raj Latha Kotni, IT lawyer and a legal consultant in Lexport, disputed the claim that the ruling is a setback to the medical innovations, as the Western companies might now turn back on investing in new technologies and innovations in India.
“I don’t agree with the fact that this judgment will be a setback to medical innovations. If a drug does have inherent efficacy over a known form, it will be obviously allowed in India. It may not discourage any global investor. The judgment is delivered based on the provisions of a particular section of the Act. No court in any country allows a patent application if it does not qualify the test of Act and is non-patentable under respective patent Act,” she said.
Kotni adds: “Glivec has become a bitter pill as it does not have any enhanced efficacy as per SC’s judgment and a patent cannot be granted to new forms of known substances without any efficacy as per the Indian Patent Act. If the Supreme Court has allowed the Novartis [argument], India should be ready for ever-greening of more patents and expensive drugs.”
India’s Commerce Minister Anand Sharma justified the Supreme Court verdict, saying that the Indian patent law is entirely in conformity with the multilateral agreement TRIPS (Trade-Related Intellectual Property Rights). “We have fully met and we assured our partners and investors that India is never going to be in breach of its international obligation… We reaffirm government’s commitment to ensure availability of life-saving medicines at affordable costs and we will never accept this concept of ever greening.”
Chinu Srinivasan, Karnataka Drug Action Forum President, said, “decisions on siting research facilities for future innovation are taken on the basis of other considerations. And that decision is hardly related to a country having a patent regime according to their satisfaction. Any MNC will site its research where it gets the best tax benefits (Novartis has therefore one in Singapore) and where there is easy availability of top class scientists. It could make innovations in India using its Indian R and D center if it were to have one, but still market the innovation in USA and at a price they think fit.”
He added: “In any case most of the current Pharma R and D is done in the West. And this patent decision no way discourages innovation in India — anybody can and will continue to innovate and may get a product patent on it for 20 years as per Indian laws. Our patent laws are strictly compliant with TRIPS since 2005. Global firms not wanting to invest seems therefore illogical.”
Srinivasan also said investment decisions will be made if the costs of manufacture here are low and advantageous to the companies concerned. “They can manufacture here and take the entire produce to USA and market it — nobody can stop them in India as per Indian laws. And the Indian market is very low in comparison. The US, EU and Japan market is about 75 percent of the world market in dollar terms (in 2011). And even this is not all newly patented medicines,” he said.
While the Indian law do not permit patent for an amended version of a drug, the US law permits the same. But Chinu Srinivasan is of the opinion that “The US law is the weaker law in the interests of US patients and is not ideal. In fact it has led to a lot of frivolous patenting in the US much to the detriment of its own populace. The Supreme Court ruling is as per our patents law which is fully in compliance with the requirements of an international agreement like TRIPS which includes the US as a signatory. It is unfortunate for them Section 3 d does not allow a lenient patenting system in India.”
Srinivasan also had strong words for the U.S. Chamber of Commerce’s Global Intellectual Property Center Executive Vice President Mark Elliot who said in a statement that the court decision is a symptom of a much larger problem in inadequate protection of intellectual property rights in India.
“Mr. Elliot should read the order and he will realize what the the Supreme Court has done is perfectly legal within the ambit of Indian patent laws — last amended in 2005 as part of our TRIPS/WTO obligations,” he said. “India has the needed IP laws perfectly in place. It is unfortunate our laws are not made to suit the US Chamber of Commerce but the people of India in mind. The rest of his statement is empty rhetoric and grandstanding and a symptom of hubris and bad homework — what he says cannot be gospel about the adequacy/inadequacy of IP protection in India.”