INTERPRETATION

Comparing China and US Drug Patent Linkage Regulations

by Grace Wang
Aug 20, 2021

China Rolls Out Measures for Resolving Drug Patent Disputes

China's two government agencies—National Medical Products Administration (NMPA) and China National Intellectual Property Administration (CNIPA)—recently issued the Measures for Implementing the Early Resolution Mechanism for Drug Patent Disputes (Trial) (hereinafter referred to as the Measures) with immediate effect.1

Before the Measures' promulgation, China has implemented some policies and regulation on drug patents (see in previous report China Rolls Out Measures to Establish Drug Patent Linkage System). But there was still a vacuum of detailed regulations for settling patent disputes.

Luckily, the new Measures outlines the process for resolving patent disputes early before the generics get approval. As the Measures and other patent-related policies and regulations are put into action, China has built up a skeleton of the drug patent linkage system. Though not yet fully-fledged, the system can operate with the newly enacted Measures and improve itself in the future.

The Measures, according to NMPA and CNIPA, draws upon the experience of the international practices. That's probably why the Measures highly resembles the US Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act2.

From setting a stay period to hold off the approval of the disputable generic application to rewarding the first successful generic challenger with 12-month market exclusivity, the Measures in China is largely modeled after some regulations in the US Hatch-Waxman Act. But the Measures still feature some details that are tailored to China's conditions.

 

Similar Goals of China and the US

China's new-born Measures on drug patents was conceived in response to the domestic pharmaceutical industrial trends. There is a surge of new drug applications (NDAs), and the number of drug patent registration applications has grown to the highest in the world. In 2020, China saw 68,720 patent registration applications, 6.6 percent of which are for health technologies.3

Besides, China needs to tackle the existing and potential drug patent disputes as it is incentivizing the development of high-quality and inexpensive generics (see in the Catalog of Encouraged Generic Drugs in China) and encouraging the import of Overseas New Drugs Urgently Needed in China's Clinical Settings.

As the US has a comparatively developed drug patent linkage system, China is building up a system by learning from the US, especially from the Hatch-Waxman Act. The Measures and the Hatch-Waxman Act share some similar aims:

  • To balance the patent protection of brand-name drugs and the development and registration of generics;

  • To encourage the innovation in the pharmaceutical industry;

  • To prevent market monopoly resulting from undue exploitation of patent barriers;

  • To help people access to safe, effective, and reasonably priced drugs.

 

Measures Differ with Chinese Characteristics

Below is a generalized comparison between the drug patent linkage regulations in China and the US. If you need detailed contents of China's Measures, please refer to BaiPharm's previous report How Does China's Drug Patent Linkage System Work.

Grace Wang
ChemLinked Regulatory Analyst
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