On February 16, 2006, the Beijing No.2 Intermediate People's Court made a non-infringement judgment on the patent infringement case of San * * v. Wansheng Pharmaceutical, known as the first case of China bolar exception, according to the provisions of Article 1 1 of the Patent Law. In the judgment, the court held that although the defendant Wansheng Company used the patented method to manufacture the drugs involved for the purpose of conducting clinical trials and applying for production licenses, its manufacturing behavior was to meet the needs of administrative examination and approval of drug registration by relevant state departments to test the safety and effectiveness of the drugs involved. In view of the fact that the defendant Wansheng Company did not manufacture the drugs involved directly for the purpose of sales, and it did not belong to the act of implementing patents for the purpose of production and operation as stipulated in Article 1 1 of the Patent Law of People's Republic of China (PRC), the court found that the defendant Wansheng Company's actions involved in the case did not constitute infringement of the patents involved.
In the subsequent patent infringement case of Lilly Company v. Li Gan, the court once again reiterated that conducting clinical trials of new drugs and applying for production licenses are not acts aimed at production and operation.
However, these judgments have caused controversy in academic circles. Some people think that the court's application of the Bolar exception is suspected of lacking legal basis. On February 27th, 2008, the National People's Congress Standing Committee (NPCSC) adopted the Proposal of the NPC Standing Committee on Amending the Constitution of People's Republic of China (PRC).
Attachment: Item (5) of Article 69 of the Patent Law (revised in 2008)
(5) manufacturing, using or importing patented drugs or patented medical devices for the purpose of providing information required for administrative examination and approval, or manufacturing or importing patented drugs or patented medical devices exclusively for them. "