China has strengthened protection for pharmaceutical intellectual property through its handling of cases involving the drug patent linkage system, according to a Beijing court.

The patent linkage system connects the regulatory approval of pharmaceuticals with the status of their patents. It helps address potential patent infringement disputes before generic drugs enter the market and allows generic drug companies to challenge patents they believe are invalid or irrelevant.

China introduced the drug patent linkage system in June 2021 following an amendment to the Patent Law. The Beijing Intellectual Property Court was granted centralized jurisdiction over first-instance cases related to the drug patent linkage system nationwide.

Data released by the court on Wednesday shows that between June 2021 and June 2026, it accepted 382 cases related to the system, more than 90 of which involved foreign parties. The litigants have included major international pharmaceutical companies such as Abb-Vie, Merck, Roche and AstraZeneca.

To handle these cases more efficiently, the court has formed a specialized judicial team to reduce processing times, protect the legal rights of the parties involved and take into account the time-sensitive nature of drug approvals.

The court has also stepped up efforts to address technical challenges in pharmaceutical cases by involving technical investigation officers, forensic appraisers and experts in the fact-finding process.

Song Yushui, vice-president of the court, said the pharmaceutical industry is highly technology-intensive, with research and development requiring substantial investment, lengthy development periods and considerable risk.

She noted that progress in the sector depends on continuous research and breakthroughs by original drug companies, as well as the timely development of generic drugs. This dual approach improves access to medicines and reduces costs, allowing patients to benefit from affordable and effective drugs sooner, she said.

China has become an increasingly important market for patent planning and competition among domestic and international pharmaceutical companies, Song said. This reflects the growing global significance of China's pharmaceutical market, the expansion of domestic research and development capabilities and the introduction of supportive policies.

She emphasized the importance of the linkage system, saying its core value lies in connecting the review and approval of generic drug applications with the protection of patents held by original drug developers.

"By addressing potential patent infringement disputes before a generic drug enters the market, the system aims to ensure that innovators receive their due returns, generic developers have clear guidelines, and patients gain more benefits," she said.

The system also offers global-origin drug companies an important opportunity to develop localized strategies in China and helps the Chinese pharmaceutical industry align more closely with international practices, she added.

Song stressed that the system can function effectively only when its boundaries are clearly defined. Through a series of cases, the court has clarified procedural issues, including requirements for accepting cases, who is eligible to bring an action and filing deadlines, helping ensure that the system operates as intended.

On Wednesday, the court also released details of nine notable pharmaceutical patent cases to provide clearer guidance to companies in the sector, promote the effective implementation of the system, support high-quality industry development and regulate the conduct of pharmaceutical companies.

Contact the writers at caoyin@chinadaily.com.cn