Patients over patents

The Supreme Court of India passed a landmark judgement on 1 April, leaving global pharmaceutical majors in the hope that the court’s decision was a hoax in keeping with the spirit of April Fools’ Day. But it was not to be.  

Global drug companies may think the apex court’s decision to deny Novartis a patent in India for a new version of a cancer drug unwelcome, but it is the view of this column that the Supreme Court made the right call.  

Novartis called the refusal to grant a patent a threat to innovation in the country. However, Indian  regulators seem to have a very clear priority – to do what is within their means to ensure drugs are made available to Indians at affordable prices. Indians are relatively poor and if the regulators can ensure that at least drugs are being provided to them at affordable prices, then that must be the case. 

Novartis has been in a long legal battle seeking a patent for a new version of its blockbuster cancer drug Glivec, and the company had its hopes of a favourable outcome quashed as the Supreme Court determined that the new version of Novartis’ drug was not substantially different from the old one to warrant a patent.  

The company has been critical of the Supreme Court’s decision, saying it will encumber medical progress for diseases that do not already have effective treatment options. The argument is that the refusal to grant patent protection in a market as big as India hits profits to the extent that the company cannot spend as much on research and the development of new drugs as it otherwise would.  

The truth is developing countries are seeing a rapidly growing demand for drugs and drug manufacturers need to tap into growing demand in these countries to make up for the scarce growth in the West. India is one such important market with a large and growing demand for drugs, but now Novartis cannot hope to make any money from the sale of its drug in the country due to the availability of locally manufactured generics in the market.  

India may be a huge market for the global pharma companies, but is also the world’s largest manufacturer of generic drugs. As such, the tussle between the drug companies and groups backing patient rights constantly comes to the fore. There is much at stake for large drug companies with the passing of the patent cliff in 2012, which saw an estimated $52 billion of branded drugs losing their patents. It is a potentially difficult time for pharma companies as they seek avenues to boost their revenues or to prolong their patents.  

Big pharma has also been quick to call into question India’s commitment to the sanctity of intellectual property rights. Some others have made pronouncements that this decision of the Supreme Court will deter foreign direct investment inflow into India. Proclamations to this effect have also been made in the past, but money has continued to pour into the country.  

Most importantly, however, it can be argued that the Supreme Court, by refusing to permit a patent for what it thinks is just a tweaked version of an already existing drug, is in fact driving the likes of Novartis towards real innovation, contrary to what the company itself may say.