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Taiwan Breaks Patent Law to 
Produce Generic Tamiflu 

MICHAEL VINCENT The World Today / ABC (Australia) 24oct2005 (including other articles)

[Several related articles below]

 

ELEANOR HALL: With governments around the world concerned about a possible influenza pandemic, Taiwan has become the first country to break patent laws and produce its own generic flu drug.

Avian-Flu Outbreak
Map of areas affected6 by avian flu.

source: WHO (Wall Street Journal article below)

Taipei had been in talks with drug company Roche to secure more supplies of the anti-viral drug Tamiflu, but it now says it will not wait for the company's consent any longer and is beginning work on its own version.

This puts the Asian nation in breach of international copyright laws, and strategic analysts say unless world supplies increase, other countries may follow, as Michael Vincent reports.

MICHAEL VINCENT: Winter is closing in on the northern hemisphere, and there are concerns amongst scientists bird flu could mix with human influenza, causing a pandemic.

Britain is the latest country to be spooked.

Quarantine authorities have found a parrot from South America had been infected by the deadly strain of bird flu H5N1 after contact with birds from Taiwan. Other birds in the facility are now being tested.

Taiwan has not recorded any cases of H5N1, but authorities are concerned the island could be hit by birds migrating from China. This fear was enough for the Taiwanese Government to begin producing its own antiviral drug before getting permission from drug giant Roche.

Brendan McRandle is Program Director at the Australian Strategic Policy Institute.

BRENDAN MCRANDLE: Well I think it's an indication of just how serious the Taiwan Government views the potential outbreak of a human influenza pandemic. My understanding is that Taiwan has a very limited stockpile of Tamiflu at the moment, perhaps around 160,000 doses. That's much fewer than Australia's three and a half million doses of Tamiflu, and I can understand that they'd be quite anxious to try to build up their stocks fairly quickly.

MICHAEL VINCENT: They're obviously in breach of patent regulations, but potentially as well in trouble with the World Trade Organisation. But why do you think they've taken this step?

BRENDAN MCRANDLE: Well I'm not a patent law expert, but I do understand that there are some occasions when an emergency or crisis may mean that the patent can be overlooked. That's not a usual situation and I don't think that's happened before.

I think really it's an indication of just how seriously Taipei is viewing the potential of an influenza outbreak, and they're seeing this as probably the only opportunity they have to build up the stocks for their own population, because it's been well publicised that the production of Tamiflu is a difficult process and there's a lot of bottlenecks in that production of world supply is actually quite limited.

MICHAEL VINCENT: There is no international public health emergency as yet, which could allow for a breach of copyright laws.

Free trade advocate, Alan Oxley, of ITS Global consultants, said Roche is unlikely to sue Taiwan.

ALAN OXLEY: Even if there were some issue with the rules, also typically you find in these circumstances the drug companies don't hold out and sit behind their legal positions, they recognise that they're far too exposed if they try to do that.

MICHAEL VINCENT: But if Roche let Taiwan get away with this without exacting some money from them, they could potentially have other countries do this as well?

ALAN OXLEY: Yeah, well Roche is currently being sued by the company which developed, apparently, the product that it's wanting to hold on to. It's indicated it's willing to allow others to manufacture it, and I think it's seeking a condition that it only be done for the purposes of public emergencies.

MICHAEL VINCENT: So you think Roche will be able to survive without taking some sort of legal action?

ALAN OXLEY: I would think they would not do so in these circumstances. If you look back at when we had previous debates like this, the drug companies have generally been careful about their public image, and have not been as hard-hearted as is generally kind of claimed.

MICHAEL VINCENT: Taiwan is not part of the World Health Organisation and despite a lack of world Tamiflu supply, Taipei's desperate actions are being discouraged.

Peter Cordingley is WHO Spokesman for the Western Pacific Region.

PETER CORDINGLEY: Everybody knows that there isn't enough Tamiflu and there's not going to be enough Tamiflu in the next year. In fact, even in the worst-case scenario, there will never be enough Tamiflu.

So, you know, we are anxious to see as much Tamiflu come on the market as possible but there is momentum in this area. Roche, the people who have the manufacturing licence for Tamiflu, have already said they will allow subcontractors to produce certain elements of the production. They're now talking to governments and other manufacturers about even bigger contribution to the output problem.

And I think we should, from a WHO point of view, we should let this momentum continue for a while to see how much more we can put on the market.

MICHAEL VINCENT: You'd like to see countries respect the international licence agreements?

PETER CORDINGLEY: We'd like to see a lot more Tamiflu on the market, but we're not anxious to see Tamiflu go on the market in breach of international regulations. We're not comfortable with that at all.

MICHAEL VINCENT: Would you accept in the future if countries did want to produce it without licence, if there is a pandemic?

PETER CORDINGLEY: This would be none of our business at WHO. We don't have to accept or not to accept. But our position is that, you know, there are international laws, which have to be respected, or at least negotiated, and we hope that all member countries of WHO will follow those rules.

MICHAEL VINCENT: So you hope none of them follow the lead of at least one country?

PETER CORDINGLEY: We've seen media reports that Taiwan is thinking of doing it independently of Roche's approval. That's a matter for Taiwan. WHO is not, we're not the international police. We can't do anything about this kind of thing.

ELEANOR HALL: The Spokesman for the World Health Authority in the Western Pacific Region, Peter Cordingley, speaking there to Michael Vincent.

source: http://www.abc.net.au/worldtoday/content/2005/s1489213.htm 25oct2005

 

China Department of Health Requests License
from Roche to Manufacture Drug Tamiflu

STEPHEN CHE / The China Post 25oct2005

 

Health authorities have requested that the Swiss drug company Roche Holding AG, maker of the only known drug to effectively fight bird flu, engage in negotiations with the Taiwan government over releasing the right to manufacture the drug Tamiflu.

Department of Health (DOH) minister Hou Sheng-mou said that he has written to the CEO of Roche Holding AG Dr. Franz B. Humer to invite him to negotiate the matter of allowing Taiwan drug manufactures to produce Tamiflu, of which Roche holds the patent.

As it takes twelve months to make Tamiflu, there has been a worldwide shortage of the drug as the World Health Organization recommends governments to keep in reserve enough Tamiflu to accommodate 10 percent of their population in case of an outbreak among humans.

Taiwan has already ordered Tamiflu from Roche Holding AG to provide for only 4 percent of the population by the middle of next year, according to Hou.

Director of Center for Disease Control Steve Kuo has said that the nation's National Health Research Institutes has already made small portions of the drug and he is confident local manufacturers could mass-produce Tamiflu within a few months, according to the Financial Times.

Hou said that current laws allow for the nullification of drug patents in case of a disease outbreak, and that the Taiwan government will not hesitate to start local manufacturing of Tamiflu if the worst does occur.

But Hou said that he hopes to negotiate with Roche Holding AG before the disease does spread between humans in order to increase Taiwan's reserve of Tamiflu as quick as possible.

In related news, the Bureau of Animal and Plant Health Inspection and Quarantine has announced that it is working with customs agencies to stop the influx of smuggled animals in order to prevent animal-carrying diseases from spreading to Taiwan.

The bureau said that it has stepped up quarantine efforts in ports and international airports and has coordinated with customs agencies to stop smuggled animals along coastal areas.

This follows a bust made by the bureau and the Coast Guard on Friday of 1,500 smuggled birds, mice, and turtles found on a ship from mainland China. All the animals were destroyed to prevent the spread of diseases.

The bureau will also hold an exercise on Wednesday to simulate the situation of a bird flu outbreak among humans and practice methods against the disease.

source: http://www.chinapost.com.tw/i_latestdetail.asp?id=31703 25oct2005

 

Indian Company to Make Generic Version of Flu Drug Tamiflu

DONALD G. McNEIL Jr. / New York Times 14oct2005

 

A major Indian drug company announced yesterday that it would start making a generic version of Tamiflu, the anti-influenza drug that is in critically short supply in the face of a possible epidemic of avian flu.

"Right or wrong, we're going to commercialize and make oseltamivir," said Dr. Yusuf K. Hamied, chairman of Cipla of Bombay, using the drug's generic name and acknowledging that he might face a fight in the Indian courts with Roche, the Swiss pharmaceutical giant that holds the patent.

Although generic manufacturers cannot legally sell the patented drug in the West, all national patent laws, including those of the United States, allow governments to cancel patents during emergencies and either buy generics or force patent holders to license their formulas to rivals.

A spokeswoman for the Department of Health and Human Services, which has recently ordered 12.3 million doses of Tamiflu from Roche, said she could not comment on the effect of Cipla's announcement. "Preparing the world for a pandemic flu outbreak is a top priority, and we're looking at various options in stockpiling drugs and vaccine," said the spokeswoman, Christina Pearson. "But there are a lot of issues, and it's too early to speculate about this right now."

Roche has been under growing pressure from several countries and the United Nations secretary general, Kofi Annan, to license generic versions of the drug, which eases flu's worst symptoms.

The company, which sells Tamiflu for $60 per treatment in the United States, has repeatedly refused to license the generic version, or even to disclose how much it makes, other than saying it plans to increase production "eightfold." A Roche spokesman, Terry Hurley, said yesterday that the company "fully intends to remain the sole manufacturer of Tamiflu."

Making the drug involves 10 complex steps, he said, and the company believes that it will take another company "two to three years, starting from scratch," to produce it.

Dr. Hamied dismissed that claim, saying that he initially thought it would be too hard but that his scientists had finished reverse-engineering the drug in his laboratories two weeks ago. He said he could have small commercial quantities available as early as January.

Asked if he thought Dr. Hamied was making an idle boast, Mr. Hurley declined to comment.

Cipla, India's third-largest drug maker, has copied dozens of Western drugs, including Lipitor and Viagra, and produces raw ingredients for Western drug companies. Its inexpensive H.I.V. drugs, approved by the World Health Organization, are used by 400,000 people worldwide.

Dr. Hamied said he would sell generic Tamiflu "at a humanitarian price" in developing nations and not aim at the American or European market. "God forbid the avian flu should strike India," he said. "There is no line of defense."

Under Indian patent laws, which were tightened in March, he believes that he can sell the drug in India and in 49 other countries rated "least developed" by the United Nations.

The new law recognizes patents filed by Western companies after Jan. 1, 1995, and the Tamiflu patent in India was filed with a "priority date" of Feb. 26, 1995. Dr. Hamied said he thought the Indian government would be unlikely to fight over a 10-year-old difference of two months, especially if the lives of millions of Indians were at stake.

Scientists in Taiwan and other countries have said they, too, can produce generic Tamiflu, if patent issues are resolved.

Mr. Hurley declined to say whether Roche would fight Cipla in court, but said, "If we determine that there has been an infringement, we'd move to protect our rights and interests."

source: http://www.nytimes.com/2005/10/14/health/14virus.html 25oct2005

Thailand Government Pharmaceutical Organisation to Make Thai Version of Tamiflu

APINYA WIPATAYOTIN PIYARAT JONGCHAROEN / Bangkok Post 18oct2005

 

The first Thai-made generic version of the anti-viral drug Oseltamivir, better known as Tamiflu, will be manufactured by the Government Pharmaceutical Organisation and be available to the public from October of next year, chief of the Disease Control Department Thawat Sundarachan said yesterday. Thailand plans to start production of Oseltamivir, and expects to have up to 50,000 capsules by next October. It is now in the laboratory testing stage.

"We have ordered the active pharmaceutical ingredient of Oseltamivir from India.

"We expect clinical tests to be completed before October. But in case of a [bird flu] epidemic spreading [among humans], we will speed up production of the medicine.

"There is no need to wait for the clinical trials," he said.

Thailand has so far stocked up 660,000 capsules of imported Oseltamivir, or Tamiflu, which is one of the few medicines known to be effective in combating bird flu in humans, and ordered another 340,000 capsules from Switzerland.

The medicine's shelf-life is about five years.

Pharmaceutical giant Roche, which is based in Switzerland, has the sole patent to produce Oseltamivir under the Tamiflu brand name.

Dr Thawat downplayed concerns over intellectual property rights, saying that the government would introduce a compulsory license allowing the country to produce the drug on the grounds of urgent public health needs.

Meanwhile in Kanchanaburi, public health and livestock officials have destroyed 364 free-range chickens raised by villagers in Phanom Thuan district after many were found to have died of bird flu.

The action was taken after samples of dead chickens were collected from 14 areas in tambon Phang Tru and sent to the research and animal health development centre in Ratchaburi for testing. The centre confirmed the chickens died of the lethal H5N1 avian flu virus.

More than 10 officials were dispatched to the area to spray disinfectant and they declared the area an outbreak zone.

Ratchaburi governor Wongsawat Sawasdipanich and public health and livestock office chiefs also went to Ban Khao Ngaem in Muang district where sparrows have succumbed to bird flu.

Samples of fowl were taken at random from about 18,000 chickens being raised in 26 villages within a 5km radius from where the outbreak was detected and sent to Mahidol University for laboratory testing.

Disinfectants were sprayed in a wide area to prevent any possible spread of the disease.

source: http://www.bangkokpost.com/News/18Oct2005_news12.php 25oct2005

 

Taiwan Says It Copied Flu Drug Made by Roche

JASON DEAN in Taipei, Taiwan, RASUL BAILAY in New Delhi and NICHOLAS ZAMISKA in Hong Kong
Wall Street Journal 25oct2005

Taiwanese health officials worried about the spread of bird flu said they created a homegrown version of Tamiflu in 18 days, despite assertions by the drug's Swiss producer that the antiflu medicine is prohibitively difficult for others to make.

Officials at Taiwan's National Health Research Institutes began looking into Tamiflu production this year. But it wasn't until late August, amid rising concerns about the possibility of a large-scale outbreak of avian influenza in people, that a team of researchers began working to synthesize the Roche Holding AG drug in the institute's lab. The researchers said they haven't conducted clinical trials using their version of the drug.

Meanwhile, the European Union looked set to ban all imports of exotic birds, after a parrot died of the H5N1 strain of bird flu while in quarantine in the United Kingdom. The parrot, from South America, had been held with other breeds from Taiwan, although it isn't certain whether the parrot contracted the disease while in quarantine or before. The European Commission yesterday proposed a ban on all imports of live pets and captured birds to the EU and was set to put the idea to a meeting of veterinary experts today. (See related article9.)

Also yesterday, China reported a fresh outbreak of avian influenza that began last Thursday and killed 550 chickens and geese in Tianchang city of Anhui province, according to a report filed by the country's Ministry of Agriculture to the World Organization for Animal Health in Paris. Local health officials responded by culling 44,736 birds, according to the report.

Tamiflu, which is used to treat other types of flu, is thought by health experts to be the most effective drug in fighting avian flu, but public-health officials around the world have raised concerns that not enough of it would be available should the disease mutate and cause an outbreak among humans.

Amid pressure from countries seeking to stockpile Tamiflu in preparation for such a scenario, Roche said this month that it would consider licensing other companies to make the drug. But it also has said it believes no other companies are capable of producing it. A Roche executive recently told The Wall Street Journal that it probably would take three years for another company to produce the drug.

A Roche spokeswoman said she didn't know if it were possible that Taiwan had figured out how to make Tamiflu, but that it wouldn't be an issue if the island were to start making the drug. "We've said we are open to others helping in pandemic production," she said. She said Taiwan officials and Roche, of Basel, Switzerland, had agreed to meet but didn't provide further details.

The National Health Research Institutes is working with a private company, ScinoPharm Taiwan Ltd., to prepare for large-scale production, which could be ready within three to five months, said an institute official. Taiwan's government has asked Roche to work out a licensing agreement, but Taiwan officials have said they will produce their version of Tamiflu without permission if it is necessary to avoid a public-health crisis.

The Taiwan researchers aren't the only ones to have produced generic Tamiflu. Mumbai-based Cipla Ltd. announced Oct. 14 that it had synthesized a generic version of the drug.

Taiwan officials said they would prefer to license Tamiflu from Roche, but that they can't wait indefinitely for a deal. "We cannot wait until the outbreak occurs," said Su Ih-jen, director of the National Health Research Institutes' clinical-research department. "That's too late for Taiwan."

---- James Hookway in Bangkok, Thailand, and Jeanne Whalen in London contributed to this article.

THE REPLICA

A glimpse of the companies or stats agencies planning to make or provide ingredients for oseltamir phosphate, the generci name for Roche's Tamiflu;

Page A18

 

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