Brazil's HIV drug compulsory license

Brazil overrides Merck patent on HIV drug

The interaction between public health, innovation and intellectual property rights is of serious concern to governments, business and the general public. The Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH) established by the World Health Assembly in 2003 has already completed a compelling report on this complex issue with focuses on the intersections between intellectual property rights, innovation and public health.

In my presentation titled "TREND OF THE THIRD REVISION OF CHINA'S PATENT LAW AND ITS IMPACT ON CHINA’S PHARMACEUTICAL INDUSTRY" at the First International China Biopharmaceutical Symposium (ICBPS) - development, regulatory approval, production, distribution - China and Worldwide held in December 2006, Beijing, I talked about the proposed changes in the draft third amendment of China's Patent Law (now handed to the State Council for further deliberation) on drug compulsory license. These revisions include, inter alia,

Article 49.

Where a national emergency or any extraordinary state of affairs occurs, or where the public interest so requires, the Patent Administration Department Under the State Council may, as suggested by a competent department under the State Council, grant the entity designated by the department a compulsory license to exploit the patent for invention or utility model.

In order to prevent, treat and control an epidemic disease, the Patent Administration Department Under the State Council may grant a compulsory license to exploit the patent for invention or utility model according to the provisions of the preceding paragraph.

and Article 50.

Where a drug for treating an epidemic disease has been granted a patent in China, and a developing country or a least developed country who have no or insufficient capability to manufacture the said drug, hopes to import the drug from China, the Patent Administrative department Under the State Council may grant an entity which is qualified for exploitation, a compulsory license to manufacture the said drug and to export it to the said country.

Where the Patent Administrative department Under the State Council grants a compulsory license in accordance with the provisions of the preceding paragraph, the said department shall clearly set forth relevant requirements in the decision on compulsory license.

不过，国家知识产权局条法司司长尹新天在最近会见美国礼来公司全球总裁约翰·勒奇莱特博士时表示，中国政府已注意到巴西和泰国政府开始采取强制许可措施来确保本国公众的卫生利益，但中国会慎重行使这类权利，决不会贸然行事。