Roche refuses to allow generic Tamiflu

Facing a potential pandemic, the Pharma company Roche has refused a request to relax patent rules to allow for a generic version of the antiviral Tamiflu. The drug is pricey at 60 dollars for ten pills and experts doubt that the company could meet deman in a full outbreak. According to the article it would take 10 years and 16 billion dollars to supply 20 percent of the worlds population. Countires will simply sidestep the patent if the situation gets any worse.

Tamiflu, a pricey antiviral pill invented in a Bay Area lab and made in part from a spice used in Chinese cookery, has emerged as the world's first line of defense against bird flu should the deadly strain begin its feared spread among human beings.

As nations begin to stockpile the drug in anticipation of a flu pandemic, calls are mounting for countries to sidestep patents on the drug -- as Brazil first did for AIDS medications -- and make their own generic versions.

But Swiss pharmaceuticals giant Roche, which acquired rights to the drug from Gilead Sciences Inc. of Foster City in 1996, said Wednesday it had no intention of letting others make it.
We wont share

What are the rammificiations of the US breaking patent laws and manufacturing generic tamiflu?

Roche is pretty big, but there's no way they'd punish the US by not doing business with it no? Be like shooting itself in the foot no? Then again perhaps they'd just increase the cost of everything else that they sell?

You know, I can understand wanting to keep a hold on intellectual property rights, but that's a little in poor taste. I would imagine they could set something up--perhaps releasing the patent in a pandemic situation, when lives are depending on it, and then re-establishing their control of the licensing when the coast is clear. Maybe even do it like they do with music and books, cut a royalty contract, where for every pill you sell, my company gets $5 or whatever.

Gotta love business mentality...

FredT,

I just found this:

Cipla to produce Tamiflu version
www.newsnow.co.uk...

Web posted at: 10/16/2005 6:33:43
Source ::: AFP
LONDON: Indian pharmaceutical manufacturer Cipla plans to produce a generic version of the anti-viral drug Tamiflu to counter a feared bird flu pandemic, the Financial Times reported yesterday quoting a company official. “The whole world needs it and there is a tremendous shortage,” Cipla’s joint managing director Amar Lulla told the paper, brushing off the potential threat of legal action from Tamiflu’s maker Roche.

Can they legally do this? How do we know it will be an exact replica? They must have some Roche spies.

This is going to get pretty messy!

Its no unheard of. Several South American governments have manufactured AIDS drugs even though they were not off patent. Roche has dropped the ball badly IMHO. I doubt they will or can do anything about it. The government of India is looking out for its people and if it deems it "In the national interest" it will do what it has too.

They really don't need spies. Just a good chemical analysis of the drug and a good lab and they are set.

Gilead, the ones who actually own the patent to Tamiflu, sent a termnination letter to Roche a few months ago. They are charging that Roche is not paying them the royalties they are due, and not working in the best interest of the public or the product.

"Despite our repeated communication of concerns over the last several years, Roche has not adequately demonstrated the requisite commitment to Tamiflu since its launch in the United States nearly six years ago, nor has it allocated the necessary resources to realize the potential of the product as a treatment and preventive for influenza," said John C. Martin, PhD, President and Chief Executive Officer, Gilead Sciences. "Gilead is taking this action in the interest of our shareholders and, importantly, because it is essential for public health that healthcare professionals and consumers have improved access to information about Tamiflu, as well as to the product itself."

Gilead's notice of termination describes material breaches of obligations by Roche under the 1996 Agreement in the following areas: (1) Roche's failure to use best efforts to commercialize Tamiflu by adequately and sustainably promoting and marketing the product in all significant markets, including the failure to launch in a number of markets where the product has been approved; (2) Roche's failure to use best efforts to commercialize Tamiflu as evidenced by past problems with the manufacturing process that led to shortages in product supply; and (3) Roche's failure to properly calculate and pay the royalties fairly owed to Gilead.

Gilead Delivers Termination Notice to Roche for Tamiflu Development and Licensing Agreement

So does this company realize the virus could kill 30-40% or more of the worlds population? (according to Springer) I tshould be given free to every citizen! Like those potasium iodate tablets that came in the mail!....In Ireland that is...

In the Toronto Star this morning is a story about the main ingredient in Tamiflu.
It's a herb which is plentiful in China and is harvested yearly in large quantity.
Star Anise is a common herb which helps the gastro-intestinal system, and comes in a sugar cube from a Dutch manufaturer. It's something that I put in my coffee after a large meal. The licorice flavour is very pleasant as well.

If the herb is that plentiful, and the recipe obviously not all that difficult to produce, why is it so expensive? It certainly isn't because of the country of origin, because China exports as much to the U.S. as Canada...even surpassing Canada at one point this year.

[edit on 30-10-2005 by masqua]

[edit on 30-10-2005 by masqua]

OK, I think I must step in here.

One thing that has to be considered is that the road from the mentioned herb to the product Tamiflu is a very long one. It consists of ten (including some VERY sophisticated) main steps that all in all take 6-8 months!

If another company wants to start it from scratch, it would take them 2-3 years to be able to produce a Tamiflu generic.

Roche wants to make sure that Tamiflu is only produced in accordance with appropriate quality specifications, safety and regulatory guidelines.

Besides, for the last 3 years, Roche has urged governments to stockpile Tamiflu in advance (because once there is an outbreak, you can´t produce it at short notice). It´s not Roche´s fault that it wasn´t done.

Now, Roche IS interested in third parties helping producing Tamiflu. But, as mentioned before, it has to be veryfied that all the standards can be met. This is an ongoing process.

I hope I could help clarify some things....

I am watching (for the second time today) a meeting between HHS and House Reps. Commitee on the issues surrounding Tamiflu and H5N1. What cm23 said is correct.

Roche is not refusing to permit other companies to manufacture Tamiflu. The manufacturing process, however, is extremely complex, and not every pharm company can meet the standards necessary to cook it effectively. Roche has expressed a willingness to allow other, qualified companies to manufacture it.

And it's important to point out that, after all of the emphasis being put on Tamiflu, it is very possible that it will not be effective on the mutated H5N1 when it reaches human-killer status. But it is the best we have at the moment.