{"id":15264,"date":"2025-02-07T06:30:00","date_gmt":"2025-02-07T06:30:00","guid":{"rendered":"https:\/\/focus.cbbc.org\/?p=15264"},"modified":"2025-02-05T19:06:34","modified_gmt":"2025-02-05T19:06:34","slug":"2024-a-stellar-year-for-intellectual-property-in-china","status":"publish","type":"post","link":"https:\/\/focus.cbbc.org\/2024-a-stellar-year-for-intellectual-property-in-china\/","title":{"rendered":"2024: A Stellar Year for Intellectual Property in China"},"content":{"rendered":"\n

2024 was a standout year for intellectual property (IP) in China and around the world. In this article, Lydia Topping<\/strong> and Peter Mumford<\/strong> from Potter Clarkson LLP<\/a><\/strong> spotlight some of the most exciting IP developments from the Chinese market in 2024<\/h2>\n\n\n
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China\u2019s new patent extensions: A game-changer for innovators<\/strong><\/h4>\n\n\n\n

Exclusivity for pharmaceuticals in China has taken a giant leap forward with the introduction of new patent term extension (PTE), a concept that originated in the US with the Hatch-Waxman Act of 1984. This move, part of an economic agreement with the US in January 2020, became effective with the new Chinese Patent Law and detailed guidelines published in January 2024.<\/p>\n\n\n\n

The law allows for up to five years additional term for patents covering new drugs, with the total effective term not exceeding 14 years from the drug’s marketing approval date. The new PTE provisions apply to product patents, preparation method patents, and medical use patents of an active pharmaceutical ingredient in a \u201cnew drug\u201d.<\/p>\n\n\n\n

To qualify for PTE, the patent must be valid, not previously extended, and include drug-related technical solutions. Only one patent term can be extended per drug. The China National Intellectual Property Administration (CNIPA) examines PTE requests, allowing for observations or amendments before making a decision, which can be challenged.<\/p>\n\n\n\n

The protection scope of PTE is narrower than the original patent, limited to the new drug for an approved indication. A new indication can support a new PTE but will only cover the new indication underlying the PTE.<\/p>\n\n\n\n