A Study Of The "Bolar Exception" Principle In China's Patent Law

The 69th article in "the Patent Law" (2008 Amendments), those not being considered patent infringement cases, has just adopted a subsection (e), which provides "To provide the information needed for administrative approvals, manufacturing, using, importing patented drugs or medical devices patent, as well as specifically for the manufacturing, importing patented drugs or patented medical devices." This is the internationally accepted"Bolar exception" principle. The establishment of "Bolar exception"principle in China's legislation, in light of the pharmaceutical and medical device companies, in particular, generic drug manufacturers, is of great significance. It not only solved the problems concerning the applicable statutes in the former pharmaceutical patent infringement cases, but also further improved the patent law and provided a clear legal basis for patent protection in the pharmaceutical industry.Although China has adopted the "Bolar exception" principle in the new patent law, but its application is still in a trial stage. This provision itself and its supporting patent links systems still have some shortcomings, such as the provision's geographical restrictions, absence of the the extension system of drug patents protection, and the defective process of drug application-approval registration. Since the Bolar exception and the drugs patent links systems need to be linked closely in practice, there is an inseparable close contact between the two, so to discuss them together is of certain practical significance.This article is divided into four chapters. Key elements as follows:The first part is an overview of the Bolar exception principle, introducing the definition, evolution and rationality of the Bolar exception principle. The Bolar exception principle has provided a reliable legal basis for generic pharmaceuticals business to obtain the required data before the the expiration of the patent, providing a way for the generic drugs entering the market earlier, abating the monopoly of the former patent drugs after the expiry of the patent. This section is to explore the Bolar exception principle and its matching background involved in the system.The second part introduces the patent link system, associated with the Bolar exception principle, including the extension system of drugs patent protection and different approval procedures for patent and generic drug applications. This provides a reference for analyzing China's Bolar exception regulation and its matching drugs patent link system.The third section describes the problems existed in China's Bolar exception system. After introducing the necessity of establishing the Bolar exception principle, this paper analyzed the problem in this principle. On the one hand by analyzing the Bolar exception to prove the geographical restrictions, on the other hand the shortcomings of the associated drugs patent link system were illustrated in the paper, primarily focusing on extending patent protection and drug application approval process deficiencies. Through the analysis of the both to prove the importance of the combination and cooperation of the Bolar exception and its matching drugs patent link system.The fourth section provides some proposal of improvement of the Bolar exception system. Firstly, the elimination of the inherent geographical restrictions concerning the Bolar exception was suggested. Secondly, the suggestions for improving the related drugs patent link system were proposed.The last section is the conclusion of the whole article.