| Leena Menghaney |
Critical legal battles between multinational pharma companies and India—whether it’s Indian companies, the Indian government or Indian patient groups – are now taking centre stage in an ongoing struggle over the interpretation of India’s medicines patent law. The country is testing its new patent law which has re-introduced patent protection for drugs and other health technologies after a gap of more than three decades. Under the amended law, product patents on new pharma compounds are allowed; patents on new forms of existing medicines are strongly discouraged.
What is adding to the multinationals’ heartburn is India’s legal approach to examining pending patent applications. Companies file separate patent applications relating to different aspects of the same medicine as a strategy to obtain and extend monopolies in India. This strategy – popularly known as evergreening – is designed to block Indian generic companies from offering competition to their highly priced medicines. But to counter this practice, generic competitors and patient groups in India are entitled to file ‘patent oppositions’— a legal challenge to prevent or overturn the granting of unwarranted patents. This is starting to show results, with a number of patent applications on cancer and HIV medicines failing the tough standards of patentability set under Indian law. This has opened up generic competition leading to major price reductions on these drugs; for example, the price of a first line HIV medicine has fallen from over $ 5000 in 2005 to less than $100 in 2012.
Unsurprisingly, rumbles of discontent are being heard from multinational pharma companies, claiming that Indian patent law stifles innovation. That predictable claim is untrue. India grants patent protection to new compounds but also recognises that generic competition drives incremental innovations – such as putting two or three separate medicines into one pill, or using known industry practices to formulate paediatric versions of a drug. These incremental innovations that come without a new 20-year patent monopoly are in fact vital to treatment providers such as Médecins Sans Frontières (MSF) who work in resource poor settings. However, this legal approach is not something that pharma companies like Novartis appear to agree with; and the patent law is being challenged through a court case in the Supreme Court of India.
But this response from industry also gives us the opportunity to debate the innovation system for pharma itself. At the heart of the debate is the intellectual property-driven research and development (R&D) system itself. Evidence is mounting that governments are saddled with a R&D system that suffers from declining rates of innovation; a mismatch between research investments and the medical needs of society; and dramatically high drug prices as patents block the introduction of low-cost generic versions.
Under a patent system such as the one India has implemented as part of its obligations under international trade rules, innovation by definition is a market driven model and requires private monopoly for any medicines or technologies that are in fact developed for rich markets. R&D for domestic public health needs such as malaria, tuberculosis and kala azar suffer neglect and are mostly left to private foundations such as Drugs for Neglected Diseases Initiative (DNDi). And access to newer medicines which are increasingly being patented locally depends purely on the will and charity of a few US, EU and Swiss-based pharma companies.
What is needed in India is an innovation policy that is much wider than simply a Patent Act and system; it needs to incentivise new innovative models of drug development and health technologies research, targeted to public health needs. Such models will involve serious public investment in research, as well as mechanisms through which such investments can lead to treatments that are non-proprietary, making them available for generic production. India would be better served not by blindly implementing the patent system, but by a policy which encourages research labs, pharma companies and governments to share resources, the risks, and rewards of R&D.