Thursday, April 21, 2011

【China AIDS:6458】 雅培放弃几种药物在印度的专利申请

 

雅培放弃几种药物在印度的专利申请

由于印度专利局(India Patent Office)已经驳回雅培公司关于洛匹那韦/利托那韦(克立芝)耐热剂型的专利申请, 近日雅培公司主动放弃了对该药物的几个相关专利的申请行动。

2011413 印度专利局根据印度专利法的第15条,拒绝了雅培公司申请号为IN/PCT/2001/0018/MUM(`00018)关于利托那韦结晶体的专利申请。 作为印度社区组织的代表, I-MAK进行了充分的准备并向印度专利部门提出反对向00018授予专利的请求。 印度几大国内药厂如Banbxy, Matrix Cipla也参加了此反对行动。

显然,印度的专利法和印度社区组织的反对, 使雅培放弃了克立芝在印度的专利申请。

00018专利的放弃是与雅培印度律师团在早些时候达成一致的。 双方同意对申请号为767/MUMNP/2007677/MUMNP/2007 (均为00018的分案申请)以及726/MUMN/2009 (339/MUMNP/2009(339)的分案申请),拒绝耐热克立芝剂型的专利申请不再采取进一步的行动。我们正在等待印度专利局就雅培放弃专利申请的官方确认。去年,雅培也放弃了339的另一个分案申请(申请号:2474/DELNP/2009)。

       根据我们对印度专利局数据库的检索,目前还没有新的分案申请的出现。由于从申请到公开需要一些时间, 所以我们将持续观察。与此同时, 雅培也可能会改变对专利号为1638?MUMNP/2007 (同时也是00018的分案申请)的专利诉求, 重新回到对利托那韦结晶体的权利诉求。现在的分案申请仅仅对利托那韦纯晶体的生产备制提出专利请求。

雅培可以就此向印度专利上诉委员会(Intellectual Property Appellate Board)提出控告, 截至日期为2011331 但目前没有相关的上诉信息。



 

 

Abbott Abandons Several Patents Application in India

On the back of the Indian Patent Office's (IPO) decision to reject Abbott's patent application for the heat stable form of lopinavir/ritonavir, Abbott has procceeded to voluntarily abandon a number of  key applications relating to the drug.

On 13 April 2011, the IPO issued a decision under s15 of the Patents Act refusing Abbott's application number IN/PCT/2001/00018/MUM ('00018), which claimed a polymorph of ritonavir. I-MAK had prepared and filed a pre-grant opposition to 00018 on behalf of Indian patient groups. The application was also opposed by Ranbaxy, Matrix and Cipla.

It appears that in light of the IPO maintaining its objections through the first examination report and pending pre-grant oppositions, Abbott abandoned the application.

The abandoning of 00018 follows an earlier correspondence from Abbott's Indian attorneys requesting that no further action be taken in relation application numbers 676/MUMNP/2007, 677/MUMNP/2007 (both divisional applications of 00018) and 726/MUMNP/2009 (a divisional of 339/MUMNP/2007 ('339), the refused heat stable form of lopinavir/ritonavir). We are still awaiting official correspondence from the IPO confirming the abandoning of the applications. Abbott had abandoned another divisional application of '339 (Application No. 2474/DELNP/2009) last year (see here).

According to our initial checks on the IPO database, no new divisional applications for the abandoned ones have surfaced as yet. However, it can take some time before such applications are published, so we wait to see. It is also possible Abbott may change the claims of its application 1638/MUMNP/2007 (also a divisional of '00018) back to the original claims covering the polymorph of ritonavir. The current divisional claims only cover a process for preparing a substantially pure ritonavir crystalline form.

With respect to the refused application for '339 relating to the heat stable form, the deadline for Abbott to appeal to the Intellectual Property Appellate Board (IPAB) was 31 March 2011. To date we have not received any notice of an appeal, but this can take time to be processed by the IPAB.

 
 



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