Friday, May 15, 2009

A(H1N1) virus, Tamiflu and CL

Here's one case of possible issuance of compulsory licensing (CL) in Mexico. Import from India the drug Antiflu, a copycat of Tamiflu, still on patent in Mexico. Tamiflu is the only existing effective anti-influenza A(H1N1) medication. But the real "killer" of said virus, a vaccine, has not been invented yet. WHO announced on May 2 that it will take 5 to 6 months for such vaccine to hit the drug stores worldwide. So Tamiflu and its copycat, Antiflu, are more of stop-gap measures and not the real cure to the virus.

The same drama and debate repeated over and over: Patients need a good medicine to cure a particular dreaded disease. But an existing medicine is still on patent and is sold expensively. Pharma company A, the medicine inventor, says they need to sell at a high price to recover the huge costs in researching, developing and marketing the medicine (industry average cost is around $1 billion per effective and successful medicine) . Comes pharma company T, did not spend a single centavo in innovation R&D, only in copycat R&D and announces to sell the copycat at a much lower price. The government and the public side with company T and go ahead with CL issuance.

Other innovator companies, pharma companies B, C, D, E, etc. now afraid to develop a new medicine to potential diseases like goat flu, horse flu, carabao flu, dog flu, cat flu, etc. Because once you become successful in developing an effective medicine against those potential diseases, your invention will be confiscated through issuance of a CL. And some copycat pharma companies U, V, W, X, AA, etc. are unhappy too, there is no more new and innovator drugs to copy.

Societies will have to grapple with those contradictions, both present and future.
Here's the news story.

Indian group to sell copy of Tamiflu

By Andrew Jack in London

Published: May 14 2009 03:00

An Indian pharmaceutical company is gearing up to sell a cheap version of Tamiflu , the leading patented antiviral flu drug, to emerging economies in a move that will pit intellectual property rights against affordable access to drugs.

Cipla, based in Mumbai, said yesterday it had agreed to sell significant quantities of its Antiflu preparation to Mexico, the country at the centre of the outbreak.

The move came only hours after the World Health Organisation said the drug was as effective as Tamiflu.

Yusuf Hamied , the head of Cipla, confirmed that Mexico had already agreed in principle to purchase stocks of Antiflu, and talks were under way with a number of other governments in Latin America, the Middle East and Africa.

The launch risks provoking a clash with Gilead and Roche, the companies that developed and distribute Tamiflu, the drug known generically as oseltamivir, which Antiflu replicates.

Cipla recently won a case within India against Gilead, which holds the patents on Tamiflu, paving the way for the manufacture of its version. If Mexico now issues a compulsory licence to waive the patent on the drug, existing international trade rules would allow purchases of Antiflu, although intense lobbying by drug companies has severely limited such practices until now.

Amar Lulla, Cipla's managing director, stressed he would sell stocks of Antiflu to Mexico and other countries only on condition that they indemnified the company against any legal action over patents.

He said his company would offer Antiflu for sale at about $10 (£6.60) per course of treatment. Roche sells Tamiflu for government pandemic stockpiles at €15 (£13.50) for richer countries and €12 for poorer ones....

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