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印度部分撤销罗氏赫赛汀(Herceptin)专利

来源:生物谷 2013-08-05 11:21

2013年8月5日讯 /生物谷BIOON/ --罗氏(Roche)发言人8月4日证实,印度已部分撤销该公司乳腺癌重磅药物赫赛汀(Herceptin)的专利。

瑞士报纸《Schweiz am Sonntag》报道称,印度加尔各答专利局已于7月17日撤销了赫赛汀的分案专利(divisional patents),理由是这些分案专利未正确提交。

罗氏发言人称:“现在可以证实,加尔各答专利局已撤消了赫赛汀的分案专利,目前我们正在考虑进一步的行动。”

该决定是印度在知识产权和药品定价方面一系列裁决中的最新行动。

上周五,印度也撤销了葛兰素史克(GSK)乳腺癌药物泰立沙(Tykerb,通用名:二甲苯磺酸拉帕替尼片,简称:拉帕替尼,lapatinib)专利,但维持了Tykerb初始化合物或活性药物成分lapatinib(拉帕替尼)的专利。

印度知识产权上诉委员会(IPAB)称,盐形式的lapatinib缺乏创新,不能授予专利。该项裁决遵循了印度法院此前不允许渐进式创新的一项具有里程碑意义的裁决。

目前,罗氏已适应了其在印度的业务模式,增加可负担得起的药物,并尽量避开印度专利局的麻烦。

2012年8月,罗氏与印度仿制药公司Emcure Pharmaceutics达成联盟,在印度推出了廉价版的赫赛汀和美罗华(MabThera)。

去年,印度撤销了辉瑞(Pfizer)抗癌药Sutent、罗氏(Roche)丙型肝炎药物派罗欣(Pegasys)、默沙东(Merck & Co)哮喘药气雾剂悬浮剂配方的专利。所有这些被撤销的理由中,均包括缺乏创新。

备注:专利分案申请(Divisional Patent Application)

所谓专利分案申请,是指申请人申请的专利包括两项以上的发明、实用新型或者外观设计时,申请人在原申请提出之后,收到专利行政部门批准授予专利通知之日之前或者收到国务院专利行政部门批准授予专利通知之日起两个月内可以行使向国务院专利行政部门提出将专利申请分立成两项以上的专利申请。(生物谷Bioon.com)

英文原文:India partly revokes Roche cancer drug patent

By Reuters | 4 Aug, 2013, 04.04PM IST - India has partly revoked patents granted to Roche Holding AG for its breast cancer drug Herceptin, a spokesman for the drugmaker confirmed on Sunday.

Swiss newspaper Schweiz am Sonntag reported that the Kolkata Patent Office had lifted divisional patents for Herceptin on July 17 on the grounds they had not been properly submitted.

"I can confirm that the Assistant Controller of Patents at the Kolkata Patent Office has revoked divisional patents of Herceptin and that we are now considering the further course of action," a spokesman for Roche said.

The decision is the latest in a series of rulings on intellectual property and pricing in India that have frustrated attempts by Western drugmakers to sell their medicines in India's fast-growing drugs market.

On Friday, India revoked a patent granted to GlaxoSmithKline's for breast cancer drug Tykerb, following on from a landmark court ruling in April disallowing patents for incremental innovations.

Roche has already adapted its business model in India to increase affordable access to drugs and try to stave off trouble from India's patent authorities.

In August 2012, it introduced cut-price versions of Herceptin and another cancer drug MabThera, under an alliance with Indian generics firm Emcure Pharmaceutics.

Last year, India revoked patents granted to Roche's hepatitis C drug Pegasys, Pfizer Inc's cancer drug Sutent, and Merck & Co's asthma treatment aerosol suspension formulation. All were revoked on grounds that included lack of innovation.

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