On January 18, the State Council website announced the "Decision of the State Council on Amending the Implementing Rules for the Patent Law of the People's Republic of China" (hereinafter referred to as the "Decision"). Since February 1 this year Effective from today.
The revised Patent Law came into effect on October 1, 2009, which added the types of compulsory licenses and clarified the scope of application of compulsory licenses. Therefore, the relevant implementation rules must also be revised.
"The addition of a compulsory licensing system to the patent law is mainly to implement the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights and to balance the interests of patents and patent users. Rights and interests, such as patients who need drug treatment and patent holders." said Zhang Yuncai, secretary-general of the China Intellectual Property Research Association.
Be careful when using compulsory licenses
The "Decision" will implement compulsory licensing of "not fully implemented patents" The conditions are defined as the situation where the method or scale of the patentee and its licensee's implementation of the patent cannot meet the domestic demand for patented products or patented methods.
"Simply put, the compulsory licensing system is mainly implemented in situations where the contradiction between demand and supply is very obvious or in emergencies. Typical cases in the past were implemented in the poorest countries in Africa. "Zhang Yuncai said.
When answering questions on the revision of the Patent Law Implementing Rules, the person in charge of the Legislative Affairs Office of the State Council also said that the revision of the compulsory licensing system is to meet the needs of responding to the public health crisis.
"The United States has used it before, but only in individual cases, and it will be used in situations such as endangering public health and national emergencies. This is consistent with the provisions of the World Trade Organization. Consistent." Li Mingde said.
According to the provisions of the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights and Public Health Declaration, the “Decision” defines “drugs that have obtained patent rights” "Any patented product in the field of medicine that is needed to solve a public health problem or in accordance with a patented"Products directly obtained by law", including patented active ingredients required to manufacture the product and diagnostic supplies required to use the product.
According to Beijing Jijia Li Yongbo, a lawyer at the law firm, said that overseas, pharmaceutical companies are more concerned about this issue, but the domestic industry has not paid much attention to it.
So far, there is no One patent was enforced.
"In 2009, a company applied for a compulsory license to produce influenza A vaccine, but there is no conclusion yet. Li Yongbo told reporters that apart from this, there are no other cases.
"After all, unlike poor African countries, my country's drug demand and supply have not yet reached a contradiction. The situation is too acute. There has been no incident so urgent that compulsory licensing is required, even in situations like SARS. "Zhang Yuncai said.
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