Study Of The Bolar Exception System And Its Use

The Bolar Exception，also known as the Bolar Exemption，is a regulation thatallows pharmaceutical companies to use the patent solely for providing information tothe administration to get the approval and submission of the generic drugs, such use ofthe patent would not be seen as an infringement. The Bolar Exception System wasapplied first by the United States, and then it adopted by other countries quickly.Canada, Germany, Italy and other countries have introduced similar amendments totheir Patent Law to bring in the Bolar Exception System. China has brought in thethird amendment to the Patent Law on December27,2008, adding the BolarException System to the Patent Law.Practice in foreign countries confirmed that the Bolar Exception System couldhelp to develop the generic drug industry effectively, as well as lowering the drugprices and cutting off public health expenditure. The Bolar Exception Systemalleviates public health crisis successfully. But patent drug companies adopted avariety of methods to deal with the challenges of generic drugs, causing accessobstruction to the public of low-price drugs. China introduced the Bolar ExceptionSystem in2008, and set up patent linkage system, but China is lack of specificregulations, applying the Bolar Exception System is difficult. This thesis attempts toexplore the impact of the Bolar Exception System by analyzing the practical effects ofthis regulation, and how to improve the Bolar Exception System further.United States, Canada, Germany, Japan and other countries have all introducedthe Bolar Exception System. They provided different Data Exclusivity Period topatented drugs. United States, Germany and other countries which are moredeveloped in pharmaceutical industry have set up the Patent Term Extension System,while China, Japan and other countries did not introduce this system considering theirown level of development of the pharmaceutical industry. Countries applied the BolarException System differently according to their different levels of development of thepharmaceutical industry.Practice has proved that Bolar Exception system has played an important role inpromoting the development of generic drug industry. Market growth rate of genericdrug is higher than the overall level of the pharmaceutical market, and the number ofgeneric drug applications received by the United States and the European Union increased rapidly. Patent litigation filed by generic drug companies increased muchyear by year. The proportion of generic drug in prescription increased, and saved a lotof health care costs.Patent drug companies using authorized generic drugs, pay-for-delay agreementand other means to participate in the competition, postponing the low-cost genericdrugs to appear in the market, thus brought up new challenges to the Bolar ExceptionSystem, and some states have launched antitrust investigations. To deal with newissues, the Bolar Exception System need to be improved, through the establishment ofthe counterclaim system, and the normalization of the antitrust investigations toregulate patent drug companies for promoting generic drug industry and lowing thedrug price.The pharmaceutical market in China has great potential, but China facesdifficulties such as repeated low-level drug development, faulty patent informationsystem and other issues. In this regard, China’s Bolar Exception System needs to bemodified, such as canceling two-year constraints to the ANDAs, and setting upgeneric drug approval suspension system, improving the patent linkage system, andwe can consider setting up generic drug exclusivity system, etc., to motivate Chinesegenerics industry.