Compulsory licensing of Tamiflu & Relenza on the cards

Made-in-India low-cost generics to gain most in case of copulsory licensing of Tamiflu and Relenza.

As swine flu (H1N1 Influenza A) threteans to assume epidemic proportions, there is a possibility of compulsory licensing being introduced for Tamiflu and Relenza.

Producers of low-cost generic versions of Tamiflu and Relenza including Cipla, Hetero, Ranbaxy, Natco would be the greatest beneficiaries, once compulsory licensing of the patented drugs Tamiflu and Relenza come into force. 

Compulsory licensing of Roche’s Tamiflu (oseltamivir) and GSK’s Relenza (zanamivir) may well be a possibility as more and more nations across the world start stockpiling these medicines – the only  available treatments against the deadly flu virus – which threatens to assume epidemic proportions.

Industry analysts say that the compulsory licencing provision can be invoked anytime now since the world is currently facing a grave emergency of swine flu epidemic which can be a threat to the entire humanity.

Compulsory licensing in the time of health emergencies

In a compulsory license, a government can force a patent holder who has an exclusive right to grant a licence to be used by the state. 

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) agreed by member countries under World Trade Organisation (WTO) also allow the grant of compulsory licenses.

TRIPS allows those third world countries which often lack the technology to be able to manufacture the drugs, in case of emergencies and pandemic outbreaks.

In such situations, compulsory licensing is seen as a balancing act between exclusive rights and public health concerns.

Apparently, TRIPS handles compulsory licenses as an exception to the agreement’s minimum requirement that all WTO Member States afford a patentee a right of exclusivity during the complete patent term.

The Doha declaration recognized the need for compulsory licensing in emergency situations. Following this, Canada implemented it in 2005. On 17 May 2006 the European Union also legalised compulsory licensing provision.

Doha declaration allows compulsory licences to be issued in developed countries for the manufacture of patented drugs, provided they are exported to those on the least-developed countries and other countries having per-capita incomes of less than US$745 a year as per UN list.

So public interest one of the major considerations for allowing compulsory licencing. With a great public health emergency underway, it is almost certain that the compulsory licensing provision will come into play as the World Trade Organization allows various countries to buy from low-cost suppliers or generics firms.

Oseltamivir & zanamivir:India’s generic edge

Several countries have already developed capabilities and capacities to produce oseltamivir and zanamivir. Indian generic companies say that they could also swiftly boost the output of antiviral drugs to tackle swine flu in case of demand.

Hyderabad-based Hetero Drugs, for instance, claims to be the world’s largest licensed producer of the generic version of Swiss drugmaker Roche Holding’s Tamiflu (oseltamivir).

“We’ve created a capacity to produce 80 million doses a month,” Hetero director of marketing Srinivas Reddy said.Hetero supplied 200 million doses of the drug in the last three years to India and other countries Hetero is negotiating with many nations around the world for supplies, Mr Reddy said.

Same for Cipla, which has been recently allowed by an Indian High Court for selling its own version Roche’s Tamiflu in India. “We have received some inquiries from Mexico, Israel, New Zealand and Latin America, but nothing has been finalized in terms of exports,” stated joint managing director Amar Lulla.

Cipla has the capability to supply 1.5 million doses of oseltamivir in four to six weeks, Lulla said.

Cipla’s cheaper version of Tamiflu costs about Rs 50 ($1) a capsule for export markets, slightly more than Hetero’s 10 doses for about Rs 300 ($6.0).

Ramesh Adige, president of Ranbaxy Laboratories, the third supplier in India, said his company was also prepared to begin supplying a generic version of the drug if needed.

Already India government is planning to buy nine million doses of oseltamivir (Tamiflu) within a week, to boost its reserve.

The government has already received price bids from Cipla, Ranbaxy Hetero and the local unit of Switzerland-based Roche Holding AG, Vineet Chawdhry, joint secretary in the ministry of health and family welfare said.

Clearly, with needing countries and growing demands, Indian generic makers stand to gain, once the compulsory licensing provision come into play.