On The Protection Of Our Intellectual Property Rights To The Drug

The pioneering application of biotechnology by pharmaceutical companies has been a driving force for the high-tech industries in a Knowledge Economy Era. However, high-tech industries are by nature vulnerable not only to financial constraint, market pressure, but also easy exposure to infringement. Henceforth the protection of intellectual property rights has become an increasing concern over the survival and sustainable growth of pharmaceutical companies.Since the opening and reform policy was adopted, China's economy has been developing continuously for more than twenty years and the growth achieved has been highly recognized by the rest of the world. In 1999, in spite of the size of the population, the GDP per capita of China reached US$ 800, still low-level, but finally passed the poverty line as set by the World Bank. In the meantime, the pharmaceutical industry of China has leaped forward in both manufacturing capacity and market performances attributable to the accomplishments by state-owned, private, FIE, and foreign pharmaceutical companies. For the year 2000, the total sales of Pharmaceuticals in China were US$ 15 billion. This number is anticipated to grow at an annual rate of 12%, compared to 7% of the whole world, for the next 10 years and to reach US$ 45 billion in the year 2010.Almost simultaneously, we have witnessed the remarkable steps taken by China in protecting pharmaceutical intellectual property rights: First Amendment to PRC Patent Law, effective January 1, 1993, that embraces Pharmaceuticals; execution of bilateral agreements with 19 countries to endorse administrative protection measures; and other alternatives available to proprietors, including registration of innovative Pharmaceuticals, anti-unfair competition policies, and trademark registration. It is worth mentioning that the intellectual property protection scheme of China has been well developed to meet the demand of the potentially largest Pharmaceuticals market within a comparatively short period of time.For numerous reasons, primarily difficulties in construing the prevailing rules, companies do have problems, in particular, with patent application, conviction of infringement, the relationship between administrative protection and registration of innovative Pharmaceuticals, and adjustment to marketing strategies. The dissertation analyzes the problems and recommends solutions ranging from extension of patent lives through new formulations to competent IP attorneys.The dissertation aims to provide a coverage of the relevant regulations that pharmaceutical companies could refer to to best protect their intellectual property rights in China. However, inevitable omissions and errors are anticipated. Reader's comments arewelcome.I wish to express my sincere appreciation to Professor Li, Shunde, Director of Intellectual Property Rights Section, CASS Law School, who has taken his precious time providing precious advice on the dissertation. I have been exposed to the dedication and strength of CASS' scholastic atmosphere.I am also very appreciative of the enlightening opinions of the scholars and experts, whose names and works are proudly mentioned in the bibliography.