中国拒绝吉利德丙肝药物专利

StephenW

China rejects Gilead hepatitis C drug patent: advocacy group                    By Brendan Pierson            
           

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<span class="articleLocation">China has rejected Gilead Sciences Inc's application for a new patent related to its costly hepatitis C drug Sovaldi, removing a potential barrier to generic versions of the drug there, a U.S. legal group announced on Friday.

The New York-based group, Initiative for Medicines, Access & Knowledge, or I-MAK, challenged Gilead's patent application this year as part of its campaign to make generic Sovaldi available in several countries. The group said on Friday it had received notice of the patent application rejection from officials in the China State Intellectual Property Office.

I-MAK said it challenged the Gilead patent applications in China and other countries so hepatitis C patients could get cheaper generic versions of the drug. Tahir Amin, I-MAK's director of intellectual property, said the latest decision makes it more likely that advocates may challenge another Gilead drug patent in China that currently prevents the introduction of generic treatments for hepatitis C.

The application China has rejected was on a so-called prodrug, a chemical used to activate Sovaldi's active chemical once it is in the body, according to I-MAK.

               
Gilead still has a patent in China on sofosbuvir, the main ingredient of Sovaldi, a highly effective treatment for hepatitis C which costs $1,000 per pill in the United States. That adds up to $84,000 for a typical 12-week course.

California-based Gilead agreed last year to make the drug available for lower prices in 91 developing countries, although I-MAK has said that more than 59 million low-income hepatitis C patients worldwide are still without access to the drug.

In May I-MAK said it had brought legal challenges against Gilead's patents or patent applications in five countries not covered by the agreement: China, Argentina, Brazil, Russia and Ukraine.

               
Amin said he believed the decision by China's patent office to reject the prodrug patent application would encourage challenges to the sofosbuvir patent as well.

If that patent were invalidated, he said, it would open the door for Chinese companies to sell generic Sovaldi, as well as to supply raw materials for the drug to manufacturers in other countries.

               
In January, India's patent office refused to grant Gilead a patent on Sovaldi, finding it was not inventive enough. Gilead is appealing the ruling.

Last month, the United Nations' World Health Organization added Sovaldi to its essential medicines list and urged lower prices, especially in middle income countries.


(Editing by Ted Botha and David Gregorio)

StephenW

中国拒绝吉利德丙肝药物专利：宣传组
由布伦丹·皮尔森

中国已经拒绝吉利德科学公司申请了新的专利涉及​​到其昂贵的丙型肝炎药物Sovaldi，消除潜在的障碍药物有，上周五公布了美国的法律一批仿制版本。

纽约基群，倡议药品，访问和知识，或I-MAK，挑战吉利德公司的专利申请，今年作为其运动，使一些国家的通用Sovaldi可用的一部分。该集团上周五表示，它已收到了来自官员在中国国家知识产权局的专利申请拒绝通知。

I-MAK表示，挑战和吉利德专利申请在中国和其他国家因此丙肝患者能得到药物的廉价仿制版本。塔希尔·阿明，知识产权的I-MAK的导演说，最新的决定使得它更可能是倡导者可能挑战在中国的另一个吉利德药品专利，目前防止引进仿制治疗丙型肝炎。

中国已经拒绝该应用程序是在一个所谓的前药，用于激活Sovaldi的活性化学品，一旦它在体内的化学，根据I-MAK。

Gilead公司仍对索非布韦在中国的专利，Sovaldi，一个非常有效的治疗丙肝的费用，每丸千美元在美国的主要成分。这增加了高达$ 84,000一个典型的12周的课程。

总部位于加州的Gilead公司去年同意使药物提供更低的价格在91发展中国家，虽然我-MAK曾表示，超过59万低收入丙型肝炎患者世界范围内仍然没有获得该药品。

在五月I-MAK表示，已起诉吉利德公司的专利，或在五个国家的专利申请不属于协议的法律挑战：中国，阿根廷，巴西，俄罗斯和乌克兰。

阿明说，他认为该决定由中国专利局驳回药的专利申请将鼓励挑战，索非布韦专利为好。

如果该专利无效了，他说，这将打开大门，为中国企业卖仿制Sovaldi，以及供应原料药制造商在其他国家。

今年一月，印度专利局拒绝授予Gilead公司在Sovaldi的专利，发现它不是创造性不够。 Gilead公司是有吸引力的裁决。

上个月，联合国世界卫生组织添加Sovaldi其基本药物目录，并敦促更低的价格，尤其是在中等收入国家。

（编辑特德·博塔和大卫·格雷戈里奥）

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