The Indian government has given the go-ahead for production of a generic version of the antiviral drug, the Times of India reported on October 25, 2005. Thailand and Argentina are said to be considering a similar move.
The Indian newspaper report said firms in the country could start production straight away without Roche's approval because the Basel-based pharmaceutical company had not applied for a patent in India.
The announcement prompted a swift and unambiguous response from Roche. "We have applied for a patent," a spokeswoman said.
The World Health Organization has warned of a possible pandemic of the fatal H5N1 bird-flu virus. Since the disease first emerged in 2003, occasional outbreaks among humans have killed more than 60 people in southeast Asia.
Tamiflu is considered one of the few drugs likely to be effective against the spread of the disease among humans. Since the latest outbreak, countries around the world have rushed to stockpile the antiviral drug prompting concerns that Roche will be unable to keep up with demand.
Roche said last week it was ready to share production of Tamiflu with rival firms but ruled out relinquishing the patent for the drug.
The Indian generic drugs maker, Cipla, was among the first companies to announce it wanted permission to produce a version of Tamiflu. According to the Times of India, both Cipla and another manufacturer, Ranbaxy, wrote to Roche requesting permission to make the drug under a licence agreement but received no response.
"For us, the problem is not the patent but the capacity for Tamiflu production," the Roche spokeswoman said in comments reported on Thursday. "We have ten years' experience and we would like to be consulted as this is a long, complex process."
When it comes to India, Swiss pharma giant Roche does not have a ‘‘product patent’’ for Tamiflu, its highly prized anti-influenza drug, the only one known to be effective against bird flu. Roche has a patent in most countries [?] valid until 2016 but has been a bit slow tapping the Indian market.
This means Indian companies can now manufacture generic versions of the drug for Indian markets but cannot export these products.
Confirming this to The Indian Express, Dr Ashwani Kumar, Drug Controller General of India, said: ‘‘Roche does not have a product patent in India and international patent is not enough according to Indian patent laws. The companies can manufacture generic versions of the drug medicine by filing a licensing application with the government.’’
But the government hasn’t received any applications from Indian companies yet.
Speaking to The Indian Express from Basel, Switzerland, spokesperson for Roche Martina Rupp said the firm had a patent pending in India. ‘‘This is not about patents but it is about manufacturing capacity. Our doors are open for companies to come and have a fact-based discussion with us,’’ she said. ‘‘The manufacturing of Tamiflu is lengthy and expensive and we have a lot of experience in it.’’
Ranbaxy, which is talking to Roche, says it’s not just looking at the Indian market.
‘‘We have approached Roche for a non-exclusive license for all countries. The issue cannot be looked at country wise,’’ said Ramesh L. Adige, ED for Corporate Affairs.
According to him, however, drugs for India should not be a problem.
‘‘We are willing to manufacture the drugs with cooperation with the government of India,’’ he added.
Speaking to The Indian Express, Amar Lulla, Joint Managing Director of Cipla—which said it would be ready with a generic version by early next year—agreed that manufacturing in India should not be a problem under the new scenario.
Last week Ranbaxy and Cipla both wrote to Roche expressing their desire to manufacture Tamiflu’s generic version. Roche had earlier said it wants to remain the drug’s lone manufacturer but has shown flexibility following international pressure.
In a statement last week, it said it’s ready to license the drug to generic companies across the world.
From Yaron Brook:
Instead of threatening Roche, we should be praising it for having the foresight to license and manufacture Tamiflu, the drug that appears to be the most effective treatment for the current strand of avian flu.
Alec Van Gelder in Patent Nonsense And Avian Flu repeats many of the mistakes of past writers.
So far only one medicine has proved effective in treating human cases of H5N1. That medicine, Tamiflu, was developed by pharmaceutical company Roche, which owns the patent. Because of the pressure to "do something", politicians are considering breaking Roche's patent on the populist premise that this will increase the availability of Tamiflu. Tamiflu was developed by Gilead, who owns the patent. No one is talking about breaking "Roche's patent."
First, the raw ingredients for Tamiflu come from a Chinese herb which is in short supply. Unless production of the herb is increased, it will be impossible to increase production of Tamiflu. In this case, breaking the patent would have no impact on availability of the drug. Tamiflu can be made without the use of star anise.
Second, Tamiflu is difficult to manufacture. Since Roche has developed the manufacturing expertise, it seems sensible to encourage Roche to increase production and/or to help other companies produce the drug under a voluntary licence. Breaking the patent through a compulsory license would actively discourage Roche from either producing the drug or lending its expertise, which would be directly counterproductive. There is more than one way to make Tamiflu, and Indian companies have already developed expertise and are ready to go.
It would be helpful if Alec Van Gelder got his facts straight. Van Gelder does conclude:
But the most important role for government is to uphold private property rights and ensure that the rule of law applies - which means protecting rather than breaking patents. The alternative - the rule of the mob - would truly be devastating.