A recent US court decision introduces entirely new questions about the balance between a transformative work and a copyright infringement. It also places the responsibility of balancing the public interest in freedom of expression against the interests of rights holders squarely in the hands of the court, writes Leslee Friedman.
Brazil is actively engaged in a cutting-edge debate over reform of its copyright law, involving issues such as the abuse of copyright holders and constructive exceptions in the law (like copying for education and/or transformative purposes and authorisation to copy by libraries and museums to preserve their works). But the government needs to hear from all interested parties – especially the artists – and avoid letting the debate transform into a political-ideological discussion, writes Brazilian lawyer Manuela Correia Botelho Colombo.Intellectual Property Watch
2 November 2007
Thailand: 20 More Drugs In Pipeline For Possible Compulsory Licences
By Sinfah Tunsarawuth for Intellectual Property Watch
BANGKOK – Thailand has in its pipeline about 20 more items of various patented drugs that could be candidates for compulsory licences, allowing the government to exercise its right over the patent owners to cut prices and make the medicines more available to the public, a senior Thai government official said.
The items include drugs for treating hypertension, diabetes and hyperlipidaemia, said Sorachai Jamniandamrongkarn, a pharmaceutical expert of the National Health Security Office, in an interview with Intellectual Property Watch. He is the secretary of a National Health Security Board’s subcommittee that studies and names drugs for possible compulsory licensing by the government.
“They are drugs that are expensive but vital to the cure or treatment of patients, Sorachai said. “These are drugs essential for saving life.” However, he said that in the end, the action might be imposed on no more than 10 items.
These 20 drugs are in addition to three drugs the government has already issued compulsory licences for and another four cancer-treatment medicines whose patent owners are likely to be subject to same kind of enforcement by the Public Health Ministry, unless a price cut is agreed soon.
Late last year, the Thai government first announced its use of compulsory licensing on two patented anti-retroviral drugs for HIV/AIDS patients (efavirenz, manufactured and marketed by Merck Sharp and Dohme as Stocrin, and lopinavir/ritonavir, manufactured and marketed by Abbott Laboratories as Kaletra) and another anti-coagulant for treating heart disease (clopidogrel, manufactured and marketed by Sanofi-Aventis as Plavix) (IPW, Public Health, 12 March 2007).
But only efavirenz has so far been imported by the Government Pharmaceutical Organization from India for use with AIDS patients. The Thai government has identified suppliers, also in India, of lopinavir/ritonavir and clopidogrel and is working through the process to import them.
That was the first time that the Thai government has resorted to compulsory licensing to reduce prices of patented drugs, an action permitted by section 51 of Thailand’s Patent Act, without having to seek consent from the patent owners. The law reflects the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).
The government negotiated for price cuts with the three companies before issuing the compulsory licences, a measure that allows the government to buy or produce drugs that are patented from other cheaper sources.
The efavirenz produced by Merck Sharp and Dohme used to cost 1,400 baht (US$41) per a bottle of 30 pills, while the non-patented version imported from India costs 550 baht ($16). The price of the patented version has then come down to 770 baht ($22).
Sorachai said: “Before we announced compulsory licensing, the companies always said the price they offered us was already a ‘no-profit price’. But after our enforcement, they cut their price further.”
For the anti-coagulant, Sorachai said the patented one costs 72 Thai baht ($2) per pill while the one that the Thai government is going to import from India will cost only 1.10 baht (3 cents) per pill.
Apart from the three drugs, the government has singled out four more medicines for treating various kinds of cancer for possibly issuing of compulsory licences. The government plans to have another round of negotiation with the patent owners soon before its official announcement of the licences.
The four include docetaxel for treating lung and breast cancer, manufactured and marketed by Sanofi-Aventis as Taxotere; erlotinib for treating lung cancer, manufactured and marketed by Roche as Tarceva; and imatinib for treating leukemia and gastrointestinal tumors and letrozole for breast cancer, both manufactured and marketed by Novartis as Glivec and Femara respectively.
These drugs are among a list of about 900 items of so-called national essential medicines that will be available to Thai people for their treatment and cure at reasonable price under government-sponsored health insurance schemes. Thai government officials have insisted that compulsory licensing would be enforced on patented drugs used under these insurance programs only, and not for any commercial sale.
Sorachai said Thailand had tried to impose the measure on patented drugs before. “But we failed since we lacked a strong political will. It was only under this government and this current public health minister that we are able to do it.”
The current government was appointed by a military junta after last year’s September bloodless coup. Thailand is set to have a general election on 23 December 2007.
Sinfah Tunsarawuth may be reached at info@ip-watch.ch.
Categories: Biodiversity/Genetic Resources/Biotech, Developing Country Policy, Enforcement, English, Human Rights, News, Patent Policy, Public Health, Technical Cooperation/ Technology Transfer, WHO
