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Hatch-Waxman China

Rothwell, Figg, Ernst & Manbeck, P.C.

China’s Hatch-Waxman Act: Patent Linkage System Implemented in the 4th Amendment to the Chinese Patent Law

The Standing Committee of the 13th National People’s Congress, China’s top legislature, adopted the Fourth Amendment to the 1984 Chinese Patent Law on October 17, 2020. The Fourth Amendment follows a series of amendments that...more

Hogan Lovells

China adopts revised patent law with Hatch-Waxman-like incentives for innovative drugs

Hogan Lovells on

On October 17, the National People’s Congress (NPC) formally adopted a revised patent law, which will take effect on June 1, 2021. The new law includes significant changes in the intellectual property legal framework with...more

Hogan Lovells

China’s NMPA releases proposal for modified “Hatch Waxman” following patent law reform

Hogan Lovells on

On 11 September 2020, China’s National Medical Products Administration (NMPA, formerly “China Food and Drug Administration”) published its proposed regulation on patent linkage, “Measures for the Implementation of the Early...more

Hogan Lovells

Proposed changes to draft patent law further strengthen incentives to bring new drugs to China

Hogan Lovells on

On 6 July, China’s National People’s Congress (NPC) published additional amendments to its draft patent law, which was first released in January 2019. As we reported at that time here, the proposed Chinese Patent Law...more

Eversheds Sutherland (US) LLP

US-China Trade Agreement - Pharma impacts

President Trump has signed Phase I of a much anticipated multi-part trade agreement between the United States and China with provisions that will aid the branded pharmaceutical industry. One of the main goals of the agreement...more

Wilson Sonsini Goodrich & Rosati

China FDA Proposes Hatch-Waxman-Like Regulatory Framework Linking Drug Approval to Patent Rights

Recently, the China Food and Drug Administration (CFDA) issued a policy proposal linking drug approval to patent rights.1 The proposal is intended to promote innovation in the development of both drugs and medical devices and...more

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