A Study on Patent Litigation Strategies of Generic Drug Company

• Main Authors: WENG, SHENG-CHIEH, 翁聖杰
• Other Authors: 謝銘洋
• Format: Others
• Language: zh-TW
• Published: 2014
• Online Access: http://ndltd.ncl.edu.tw/handle/80622061114950821229

碩士 === 東吳大學 === 法律學系 === 102 === The pharmaceutical expenditures have been increasing due to the use of patented new drugs and have caused heavy financial burdens for worldwide governments. Therefore, in recent years, to support the low-cost generics for saving health care expenditures has become the direction of pharmaceutical policies for worldwide governments. In 2009 the patented drugs market facing the competition from generics already reaches 24 billion US dollars. These generics competitors developed price war in each therapeutic category and diminished the profits of pharmaceutical companies of patented drug products. Each government endeavors in increasing the use of generics to lower the health care expenditure. There are 80 patent-protected pharmaceutical products become off-patented during 2008 and 2010. The market of these boosters, with a market value of 50 billion US dollars, has become the target of generics pharmaceutical companies. It is expected that the period within future will be declared as the golden age of generics. The maximum public benefit of generics is providing the publics with the right to choose cheaper pharmaceutical products through the free mechanism of price competition in the market. Therefore each government encourages the prescription of generics, the correspondent regulations, and the complementary measures for generics. This is quite important for the vigorous development of pharmaceutical industry, and more influential on the public right on the use of pharmaceutical products and public health welfare. The performance and potential of generics in prescription drug market demonstrates the threat of the sharp reduction in the profit of patented drugs manufacturers. Hence the patented drugs manufacturers have been continuously planned to utilize the intellectual property management strategies for those products which are going to be off-patented and threat by generics competition and tried to obstruct the launch of generics. This damages the right and benefit of consumers to purchase the medicines they need with reasonable pricing. In view of this, the generics regulations, correspondent policies of intellectual property right, and the reasonable regulations about complementary measures are quite important for the development of generics industries in each country, and also the public right on the use of pharmaceutical products and public health welfare. In recent years the lawsuits charged against domestic generics manufacturers for infringement of the intellectual property rights of patented drug manufacturers are increasing. the correspondent domestic and international regulations and practical legislations of intellectual property are referenced and compared. The reference information of correspondent domestic/international cases and case studies about pharmaceutical related intellectual property lawsuits are provided. The intellectual property related topics which impact the development of generics industry are also studied. The necessity of legislation of generics law or specific chapter in the law of pharmaceutical affairs is also studied. This report also investigates the way to strengthen the developing circumstances of our pharmaceutical industry. On the circumstances that many domestic pharmaceutical manufacturers are charged of infringement lawsuits, it’s essential to study the legislation of the law of generics products as the reference of strategic planning for the development of future generics market in our country. And to solve the problems in our domestic pharmaceutical industry, it is recommended to revise the correspondent regulations which may be improper in practical before the legislation of generics law.