生物制药

最近开始接手这个项目，有关专利问题还不是很确定：现在欧盟那边有一篇制剂专利，国内也有一篇。我对于这两篇专利具体保护的内容有些拿不准，求高手帮忙。

这几篇专利在第一条主权利要求中都列举了处方中用到的一些辅料并且全部对其使用量进行了限制，我想问下我是不是就不可以使用该专利里列举的辅料？还是我可以使用但是不能完全按照专利里面的辅料种类和用量来使用？有一点差别就可以了？

以下为欧盟专利的前几条：

Summary of the Invention

[0007] One general aspect, relates to a tablet of a clopidogrel salt comprising a therapeutically effective amount of a

clopidogrel salt; lactose; stearic acid; and one or more of other pharmaceutically acceptable excipients; wherein clopidogrel

salt is hydrobromide or hydrochloride.

[0008] Another aspect, relates to a tablet of a clopidogrel salt comprising a therapeutically effective amount of a

clopidogrel salt; lactose and microcrystalline cellulose; stearic acid; and one or more of other pharmaceutically acceptable

excipients wherein clopidogrel salt is hydrobromide or hydrochloride.

[0009] Yet another aspect, relates to a tablet of a clopidogrel salt comprising a therapeutically effective amount of a

clopidogrel salt; lactose; stearic acid and hydrogenated castor oil; and one or more of other pharmaceutically acceptable

excipients; wherein clopidogrel salt is hydrobromide or hydrochloride.

[0010] Another aspect, relates to a tablet of a clopidogrel salt comprising a therapeutically effective amount of a

clopidogrel salt; lactose and microcrystalline cellulose; stearic acid and hydrogenated castor oil; and one or more of

other pharmaceutically acceptable excipients; wherein clopidogrel salt is hydrobromide or hydrochloride.

[0011] Another aspect, relates to a tablet of a clopidogrel salt comprising a therapeutically effective amount of a

clopidogrel salt, prepared by process comprising the steps of

(a) blending the clopidogrel salt with the one or more of the diluents and other pharmaceutically acceptable excipients;

(b) mixing one or more of the lubricants with the blend of step (a); and

(c) compressing the final blend of step (b) into tablet;

wherein the clopidogrel salt is hydrobromide or hydrochloride.

[0012] A further aspect, relates to a tablet of a clopidogrel salt comprising a therapeutically effective amount of a

clopidogrel salt, prepared by process comprising the steps of

(a) blending the clopidogrel salt with lactose and other pharmaceutically acceptable excipients;

(b) mixing stearic acid with the blend of step (a); and

(c) compressing the final blend of step (b) into tablet;

wherein the clopidogrel salt is hydrobromide or hydrochloride.

[0013] Another aspect, relates to a tablet of a clopidogrel salt comprising a therapeutically effective amount of a

clopidogrel salt, prepared by process comprising the steps of

(a) blending the clopidogrel salt with lactose and microcrystalline cellulose and optionally other pharmaceutically

acceptable excipients;

(b) mixing stearic acid with the blend of step (a); and

(c) compressing the final blend of step (b) into tablet;



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