降脂药阿托伐他汀的美国专利保护策略

The strategy of U.S. patent protection about lipid-lowering drug atorvastatin

阿托伐他汀的美国专利保护时间已超过20年期限,通过调查其在药物研究的不同阶段,提交化合物专利、药物专利和晶体专利等的申请时间和授权情况,以及所依据的美国专利保护相关的法律和政策,分析专利药物的保护策略。立普妥的系列专利申请正好在美国专利新法(1995年6月8日)修订前后,可充分利用美国专利新法延长专利保护时间,包括哈奇-维克斯曼法案、临时专利申请、继续专利申请、首先仿制权、儿科独占期和私下协议等。

U, S. patent protection for atorvastatin （Lipitor） has expired for more than 20 years. The applications and authorization of U. S. Patent of Lipitor at different stages such as compounds patents, drug patents and crystals patent, as well as the relevant laws and policies, are investigated in this article, and the drug patent protection strategy is researched. A series of patent applications of Lipitor were submitted just before and after the revise of the U.S. Patent new law （June 8, 1995） , which took full advantage of the new law to extend the patent protection, incl imitation right, uding Hatch-Waxman Act, a provisional pediatric exclusivity and private agreeme patent application, patent applications continuation, first nts.