如何在仿制药开发过程中规避专利侵权--Xipptyltd执行经理amp;LeightonHoward先生.ppt

专利更新工具 3.了解应该何时获得专利信息 摘自： GenericsWeb Pipeline Selector 报告:阿托伐他汀 4.理解专利的地位 未来专利的影响 在下述基础上增强对品牌产品的保护: 1. 法规要求: 本质上相似(保护商业原料药) 生物等效性(保护商业制剂) 2. 经济上/商业上的要求: 保护受成本控制的原料药生产厂商 增加研发费用以绕开专利 4.理解专利的地位 重要性的程度 壁垒 防止仿制药的竞争,如行不通可以提起诉讼 不能绕开专利 ? 栅栏 允许仿制药在增加的成本上竞争 可以通过事先的研发绕开专利 ? 绊脚石 如果早期确定的话，允许仿制药的竞争 可以非常容易的绕开专利 4.理解专利的地位 * group/selection or racemate/enantiomer patents Disclosed processes, formulations and use may not be commercially viable * A question we are commonly asked is “when does THE patent on DRUG expire” – these days there is almost never one single patent covering the active ingredient – the old days of generics are gone. * It is no longer acceptable to assume that the molecule patent is the only patent of interest * Need to work hard to find out when active ingredient patents expire. These variations are due to different adoption and transition and will hopefully become closer over time. * I attended a conference this month on Patent Searching, one of many held every year in this field The Basic message here is that an inexperienced searcher has next to no chance of finding all of the relevant * Pravastatin Filing Trends since active ingredient patent. * Nowadays generics companies are no longer satisfied with launching amongst many competitors, they want to minimise competition wherever necessary and file there own patents to block other generic competition. TOO Complex??? * Brick Walls e.g. active ingredient patents, Some use Hurdles e.g. Omeprazole formulation, Amlodipine salts Stumbling Blocks e.g. many process formulation patents * Theory that if it is made outside of the country of use then it won’t infringe patents is wrong Claims should be used to interpret the invention, but often broad and need to rely on the preamble Legal Status can be obtained reliably, but results of litigation may not show up for some time due to appeals, however, once the patent information has been obtained a legal interpretation of its meaning is essential. * It is im