[Ip-health] India's WSJ: Sanofi reiterates threat to sue Indian co. planning to export clopidogrel to Thais; is "optimistic" it will reach deal with Thailand in price negotiations

[Sarah Rimmington]

Sanofi in talks with Thai govt to protect its patent right
The new health minister of Thailand has supported the previous
government's decision to override patents to increase patient access to
medicines

by C.H. Unnikrishnan
Published at Mint (national busines newspaper owned by Hindustan Times
that has exclusive agreement with WSJ to publish journal-branded news
and info).
http://www.livemint.com/2008/03/13164842/Sanofi-in-talks-with-Thai-govt.htm=
l


Mumbai: Denying a legitimate call for cheaper drugs by the Thailand
government, French drug-multinational Sanofi-Aventis has reiterated that
it will resort to legal options if Indian generic company, Cadila
Healthcare Ltd pursues export orders for the cheap generic version of
its patented heart drug clopidogrel to that country.

Sanofi, which sells the drug under the brand name Plavix there, said it
is =93in negotiations with the Thai government and optimistic of
protecting its patent right unaffected in the market.=94

Sanofi=92s continued threat to the Indian generic company is important
while the new health minister of Thailand has supported the previous
government=92s decision to override patents to increase patient access to
medicines. Though multinational companies such as Sanofi, F Hoffman La
Roche Ltd, Novartis AG were expecting a roll back of the previous
government=92s decision after the new prime minister Samak Sundaravej
launched a review of the same, the health ministry=92s present view of
allowing cheap copy versions to cut the medicines cost had renewed hope
of generic companies to pursue the orders.

Sanofi=92s international media relations vice president, Jean-Marc Podvin,
told Mint on Tuesday his =93company believes that the compulsory licence
for Plavix is still not in effect in Thailand and we remain optimistic
that it will not, as we are negotiating with the Thai government.=94

The Ahmedabad-based Cadila had secured an export order from the
Government Pharmaceutical Organisation of Thailand for at least two
million tablets of this popular blood-thinning drug. This export order
was granted to the Indian generic company after the previous Thai
government issued a compulsory license for importing it to the country
to cut the medicine cost.

Sanofi has been granted patent for Clopidogrel in Thailand. A compulsory
license is a trade flexibility provided by the World Trade Organisation
to its member countries to override an exclusive protection granted to
patent holder if there is a medical emergency due to limited access of
the drug caused by short supply, cost affordability etc.

Plavix is currently priced at $247 to $370 per tablet in Thailand. When
asked whether the company will be forced to reduce prices after the
negotiation with the government (if affordability is the problem that
led to issuing a compulsory license), Podvin said: =93I cannot comment at
this point in time as the talks are in progress.=94 However, he
emphasized: =93The company is optimistic that its intellectual property
right will be protected.=94

A senior official from Zydus, who did not wished to be names, said, =93The
company is producing the drug for export to Thailand, but in the current
scenario it will delay the delivery to evaluate the legal environment
there.=94

Sanofi had sent a letter to Zydus in January, stating that it will be
forced to take legal action if the company executes the export order for
generic version of Plavix.

An Independent Online report had quoted Thailand=92s consumer activists
claiming that at least 34,000 heart patients could lose access to cheap
drugs for this important treatment if the generic supply is halted.

Although Thailand=92s new health minister has decided to support the
previous governments stand to override patents for essential drugs, the
ministry has mentioned only cancer drugs, excluding HIV/AIDS and heart
drugs, in its recommendation. This has disappointed patient groups there
and they are afraid Sanofi=92s negotiations may lead to cancellation of
compulsory license for clopidogrel.

This is the first instance of a global patent holder warning an Indian
generic company before starting exports of copy drugs to another country
despite a compulsory licence issued by the government there. Since India
also has the product patent regime in place from 2005 onwards, the
country is now hearing its first case of compulsory license sought by a
local generic company --Natco Pharma Ltd to export two cancer drugs
--erlotinib and sunitinib, patented by F Hoffman La Roche Ltd and Pfizer
Inc, to export them to Nepal.
=93Though the context in the Indian case is different, these all will set
the trend in the global healthcare market, especially in the developing
countries where the patent regime would affect drug access to the
needy,=94 says Gopakumar Nair, a patent consultant in Mumbai.

It may be recalled that the World Health Organisation had recently
announced its support to all developing nations to utilise WTO=92s trade
flexibilities such as compulsory licenses for highly priced drugs if the
patent protection blocks the patient access.

--
Sarah Rimmington
Attorney
Essential Action, Access to Medicines Project
Washington, DC
Tel: (202) 387-8030
Cell: (202) 422-2687
www.essentialaction.org/access/