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 “in negotiations with the Thai government and optimistic of protecting its patent right unaffected in the market.”
Sanofi’s continued threat to the Indian generic company is important while the new health minister of Thailand has supported the previous government’s 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’s decision after the new prime minister Samak Sundaravej launched a review of the same, the health ministry’s present view of allowing cheap copy versions to cut the medicines cost had renewed hope of generic companies to pursue the orders.
Sanofi’s international media relations vice president, Jean-Marc Podvin, told Mint on Tuesday his “company 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.”
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: “I cannot comment at this point in time as the talks are in progress.” However, he emphasized: “The company is optimistic that its intellectual property right will be protected.”
A senior official from Zydus, who did not wished to be names, said, “The 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.”
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’s 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’s 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’s 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.
“Though 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,” 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’s trade flexibilities such as compulsory licenses for highly priced drugs if the patent protection blocks the patient access.