Compulsory license of docetaxel drug dispute

The Council of State will today consider the legitimacy of the compulsory licensing (CL) policy on cancer drugs implemented by the Public Health Ministry. The Commerce Ministry asked the government's legal advisory body to consider the policy's legality in June after the France-based pharmaceutical company Sanofi Aventis sent a letter to the chief of the Intellectual Property (IP) Department, Puangrat Asavapisit, asking for a review of the CL policy. The letter claimed the Public Health Ministry did not have the right to use CL to bypass the patent of its breast cancer drug Docetaxel.

The company cited articles 50 and 51 of the Patent Act, which stipulate that the Commerce Ministry had sole authority to announce the policy. Also, the company could take legal action against the Government Pharmaceutical Organisation (GPO) if its copycat version from India was imported to Thailand without permission.

The NGO also condemned the drug company for not respecting Thailand's rights under the World Trade Organisation's Agreement on Trade-Related Aspects of Intellectual Property Rights, which allows a government to use CL. The group also lashed out at the Commerce Ministry for failing to protect public benefits through access to affordable life-saving drugs.

''Even the World Bank applauds the efficacy of the Thai policy on Aids drugs distribution,'' the group said in its statement released yesterday. ''Without compulsory licensing the government cannot afford to buy expensive drugs for HIV-positive people. Therefore it is the responsibility of every state agency to consciously protect public benefits.''

GPO board chairman Vichai Chokewiwat said he and officials from the National Health Security Office would testify to the Council of State today. He insisted the policy was legitimate under article 51 (2) of the Patent Act, which allows governmental bodies to exercise a compulsory licensing policy. The GPO's legal department and an IP law expert agreed, he said.

''Such a request is nonsense,'' Dr Vichai said. ''The IP Department has the authority only to finalise the royalty fee which the government has to pay to the drug patent owner only.''

Sanofi's Docetaxel is one of the four drugs named under the CL policy announced by former public health minister Mongkol Na Songkhla in January. The others are the breast cancer drug Letrozole and the leukaemia and gastrointestinal stromal tumour drug Imatinib, both produced by Novartis; and lung cancer drug Erlotinib, made by Roche.

 

Brajilian Patent office rejects patentof Gilead on HIV drug

The Brazilian Patent Office has rejected a patent application filed by Gilead Sciences for its Viread medication (Generic name tenofovir disoproxil fumarate [TDF]). This is the first time that a patent related to an antiretroviral (ARV) medicine has been rejected as a result of a pre-grant opposition in Brazil And Doctors Without Borders (DWB) is saying the move could increase access to a key AIDS drug across the developing world.

Tido von Schoen-Angier, executive director of DWB’s Access Campaign, says in a statement that Viread “is a cornerstone drug, recommended by the World Health Organization both for patients starting treatment and for those whose medications aren’t working anymore. In the past, Brazil’s production of anti-retroviral drugs has helped to bring down prices of ARVs globally. We hope this will happen again.”

According to the non-profit, Viread can now be made by Brazilian generic companies or imported from abroad. Around 31,000 people currently receive Viread through Brazil’s universal AIDS treatment program, and an estimated 37,000 by the end of 2008, which would translate into considerable savings. Companies in India make a WHO-approved version for $158 for one patient’s yearly treatment, compared to the $1,387 charged by Gilead in Brazil.

A Gilead spokeswoman says that this patent has been issued in countries around the world, including most recently in China, and has been reissued in the United States following a thorough evaluation during the re-examination process that the U.S. Patent and Trademark Office concluded earlier this year. We remain confident in the strength of our intellectual property for Viread and plan to vigorously defend the patent and the scientific innovation on which it is based. If necessary, appealing a final decision will remain an option in Brazil.

The patent application filed by Gilead Sciences was opposed by a coalition of Brazilian NGOs and a government pharmaceutical laboratory. The patent office in Brazil rejected it on the grounds that it lacks inventiveness – one of the key requirements for a patent in Brazilian and international patent law.