Back to old ways
Drug multinationals are lobbying for a devious patent linkage system to block the entry of competitive generics
Drug firms are campaigning for a new system to prevent generics from gaining foothold
THE ORGANISATION of Pharmaceutical Producers of India (oppi) wants “a streamlined, transparent, fair and equitable regulatory process” for drug marketing and manufacturing approvals. The government believes it has such a system in place. So believe (by and large) all those with a stake in the matter. There is the Central Drugs Standard Control Organisation (cdsco), which is the national regulatory body for pharmaceuticals. Within the cdsco is the Drug Controller General of India (dgci), who regulates medicines and medical devices under the aegis of the Ministry of Health and Family Welfare.
What then is oppi’s grouse? oppi is the lobbying group of innovator drug multinationals, and it wants a system that provides them with all information on entities seeking to import, register, market or manufacture drugs in the country. To this end, they have suggested an initiative, which will provide information on all such applications. The sugam portal, according to the proposal made by oppi to the Department of Pharmaceuticals (dop), should not only list such applications but also carry “essential documents” and provide real-time information on how such applications are proceeding.
To the uninitiated, this might seem a good idea. But what oppi is seeking to do is usher in patent linkage through the backdoor. Patent linkage is a process through which marketing approvals for a drug are linked to the status of the patent corresponding to the originator’s product. This means dgci and the patent office act in concert to prevent the marketing approval of generic drugs until after the expiration of
patents covering the drug product. It also means that applicants, invariably generic companies, seeking marketing approval show that the pharma product for which they are applying is not protected by a valid patent.
Under World Trade Organization rules, patent linkage is not mandatory, and as such Indian laws do not recognise this practice. The patent system and the drug regulatory system are separate and independent mechanisms created under different laws as envisaged by India’s policy makers. In 2008, an attempt by the then dgci to introduce patent linkage was thwarted by public health advocates. Later, moves by drug giants to do so were quashed by the courts. Not deterred, oppi is now floating sugam, which it frankly admits, will put innovator companies on notice about the potential competition from generic makers and alleviate some of their concerns even while conceding that Indian laws do not permit patent linkage.
Malini Aisola of the All India Drug Action Network explains what exactly is afoot. oppi, she says, is seeking to outsource its task of finding potential patent infringers to cdsco, although its mandate is to work towards safe medicines and not to be a tool in the hands of innovator pharma firms. oppi is asking cdsco to create a registry of all pending registrations in order to arm itself with information that will be used to block the entry of generics. “It is simply trying to use public resources towards the protection of patents which are private rights.”
Why then is the dop secretary pushing this proposal despite the opposition of the health ministry?