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Herbert Smith Freehills LLP | China | 25 May 2022

China’s first decision in a case initiated under its patent linkage system

China has recently seen the first decision in a case initiated under its patent linkage system. Under this system, when a generic drug company files…
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Zhong Lun Law Firm | China | 19 May 2022

我国现行药品专利链接制度存在的问题及完善建议(下)

2021年6月1日实施的《专利法》第76条正式规定了药品专利链接制度,随后国家药品监督管理局、国家知识产权局、最高人民法院陆续出台…
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Zhong Lun Law Firm | China | 18 May 2022

我国现行药品专利链接制度存在的问题及完善建议(上)

2021年6月1日实施的《专利法》第76条正式规定了药品专利链接制度,随后国家药品监督管理局、国家知识产权局、最高人民法院陆续出台…
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Saint Island International Patent & Law Offices | Taiwan | 24 Apr 2022

Medical Use Claims and Indications Specified on Generic Drug Approvals

In an attempt to resolve disputes on patent invalidity and infringement among brand drug companies and generic drug companies, a patent linkage…
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Lexology PRO | Asia-Pacific, Australia | 23 Mar 2022

ACCC refuses to approve pharma agreement in rare patent settlement request

Australia’s antitrust authority has voiced its concerns about a proposed patent dispute settlement and licensing agreement between Celgene and two drugmakers, warning that it could distort competition between generic manufacturers.
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Pearl Cohen Zedek Latzer Baratz | Israel | 25 Oct 2021

Loophole to enhance generics' ability to launch at risk during patent term extension protection period

The Israeli Ministry of Justice has proposed changes to Israel's patent term extension laws that significantly enhance generics' ability to launch at risk. Although the proposal ostensibly offers Israeli generics the same benefits afforded to European generics, the proposal does not include the safeguards found in the European regulations. If the proposal is ratified, innovators will need to......
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Lexology PRO | United Kingdom | 29 Jul 2021

CMA doles out £100 million in fines for excessive pricing of thyroid drug

The UK’s Competition and Markets Authority has hit Advanz Pharma and its two former owners with more than £100 million in fines for overcharging the country’s national health service for thyroid medication liothyronine over an eight-year period.
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Wanhuida Intellectual Property | China | 26 Jul 2021

China issues implementation measures on pharmaceutical patent linkage system

The National Medical Products Administration and the China National Intellectual Property Administration recently jointly released the Measures for the Implementation of Early Resolution Mechanism for Pharmaceutical Patent Disputes (for Trial Implementation) (the measures), ironing out the operational details of the pharmaceutical patent linkage system. This article provides a brief......
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Herbert Smith Freehills LLP | Australia | 29 Apr 2020

Commonwealth fails in its claim for compensation for PBS expenditure

Justice Nicholas’ long-awaited decision in Commonwealth v Sanofi is an Australian first. Of the 4 cases in Australia in which the Commonwealth has…
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Peksung Intellectual Property Ltd | China | 20 Apr 2020

中国仿制药的发展现状分析

仿制药是指与原研药在剂量、安全性、效力、质量、药效以及适应症上均相同的一种仿制药品。现代仿制药起源于1984…
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