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首页 » Roche » 罗氏放弃赫赛汀(Herceptin)印度专利

罗氏放弃赫赛汀(Herceptin)印度专利

来源:生物谷 2013-08-16 18:16

2013年8月16日讯 /生物谷BIOON/ --罗氏(Roche)今日宣布,已决定不再寻求乳腺癌药物赫赛汀(Herceptin)在印度的专利申请。

本月早些时候,印度加尔各答专利局驳回了罗氏提交的专利,理由是罗氏未能正确提交赫赛汀的专利申请。

罗氏发言人在一份电子邮件声明中称,罗氏已经决定,不在寻求印度专利第205534号(次级专利,secondary patent)及相关的分案专利申请(divisional applications),这一决定,是出于对印度特定权利的强度和知识产权(IP)环境总体的考虑。

西方制药公司热切进军印度130亿美元药物市场,但同时也对该国知识产权的保护水平产生担忧。在印度,仿制药销售占药品销售的90%以上。

赫赛汀是罗氏第三大重磅产品,2013年上半年的全球销售达到了33亿美元,该药用于一种极具侵略性(HER2阳性)的乳腺癌的治疗。

印度政府已经在考虑,针对赫赛汀发布一份强制许可(compulsory license),这一强制许可将允许印度本土制药商生产及销售便宜得多的赫赛汀仿制药。但至今,印度政府还未作出最后决定。

在2012年,印度颁布了该国有史以来首个强制许可,允许印度本土制药商Natco制药公司生产拜耳(Bayer)肾脏和肝脏抗癌药多吉美(Nexavar)的仿制药。

此次,罗氏不再寻求赫赛汀专利的决定,可能为仿制药商生产便宜赫赛汀生物仿制药铺平了道路,因为这些生物仿制药与原药并非完全相同。

然而,罗氏称,目前在印度还没有赫赛汀生物仿制药获批,该公司将继续强制实施涵盖其他药物在印度的专利。(生物谷Bioon.com)

英文原文:Roche gives up on India patent for breast cancer drug

ZURICH | Fri Aug 16, 2013 5:00am EDT (Reuters) - Roche Holding AG has decided not to pursue a patent application for its breast cancer drug Herceptin in India, the Swiss company said on Friday, as Western drugmakers come under pressure over high prices in the fast-growing market.

The Kolkata Patent Office said earlier this month that it had dismissed certain patent applications filed by Roche, because the company had failed to submit the applications for Herceptin correctly.

"Roche has come to the conclusion not to pursue Indian Patent No. 205534 (the secondary patent) and the related divisional applications," a Roche spokesman said in an emailed statement. "This decision takes into account the strength of the particular rights and the IP (intellectual property) environment in India in general."

Western pharmaceutical companies are keen to tap into India's $13 billion drug market, but there are concerns about the level of protection for intellectual property in the country, where generic medicines account for more than 90 percent of drug sales.

Herceptin, a treatment for a particularly aggressive form of breast cancer, is Roche's third-biggest seller and notched up global revenues of 3.08 billion Swiss francs ($3.30 billion) in the first half of the year.

India's government has considered issuing a compulsory license on Herceptin, which would allow local drugmakers to sell far cheaper, generic copies. The government has so far held off from a decision.

In 2012, India issued the first ever compulsory license to domestic drugmaker Natco Pharma on a kidney and liver cancer drug, Nexavar, patented by Germany's Bayer.

Roche's decision not to pursue a patent for Herceptin could pave the way for generic drugmakers to produce cheaper copies, known as biosimilars, because they are not identical replicas of the original drug.

However, Roche said there are no approved versions in India of a biosimilar version of Herceptin, also known as Trastuzumab.

Roche said it would continue to enforce other patents covering its drugs in India. ($1 = 0.9346 Swiss francs)

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