Patent Amendments ©(Part II of II)

The Greater China IP Updates

By Lyndon

Measures for Administrative Adjudication of Early Settlement Mechanism on Drug Patent Disputes Issued by the China National Intellectual Property Administration

The above mentioned provisions issued by CNIPA are to handle administrative adjudication proceedings involving patent disputes in the process of marketing review and approval of drug patents. Key points are as follows:

1. Administrative adjudication is allowed only if the petitioning party has not filed a lawsuit with the people’s court over the issue previously. However, if a party is dissatisfied with the administrative adjudication, they may file a lawsuit with the people’s court within 15 days of the administrative ruling.
2. Where the party petitioning for an administrative adjudication of a drug patent dispute is an applicant of drug marketing approval, the party shall submit a technical solution for the relevant drugs. If the technical solution involves confidential information, the technical solution and a declaration can be submitted separately.
3. CNIPA may choose to conduct a written examination or an oral hearing. If the petitioner does not participate, or decides to suspend participation midway, the case shall be subject to default hearing.

These provisions are for Article 76 of the Patent Law which took effect on June 1, 2021.

CNIPA and EPO Agree to Simplify Patent Application Process

The China National Intellectual Property Administration (CNIPA) and the European Patent Office (EPO) have decided that from July 1, 2021, there will be no need to submit a copy of the prior application search report made by the CNIPA when a European patent application or a Patent Cooperation Treaty application claiming priority from an earlier application in China filed with the EPO enters the European phase. Such a decision is the result of increased efficiency in data exchange leading to an important technical guarantee for the implementation of this policy. It will further simplify the process and improve the process of patent application in Europe. It is also the latest example of cooperation which was initiated by a pilot project two years ago. The project enabled nationals and residents of the PRC to select the EPO as their International Searching Authority (ISA) for applications filed in English under the Patent Cooperation Treaty.

Patent Linkage Implemented in China

The patent linkage system refers to the linkage between the regulatory approval of generic drugs and the patent protection of the relevant innovative drugs. When the owner of a generic drug applies for marketing authorization, the drug regulatory department will work together with the patent administration on the patent issue. One aspect of the linkage system is the Bolar exemption whereby clinical trials for generics and bio-similars are exempt from infringement which means the manufacturer is allowed to use data previously submitted by the original applicant. In the recent revision of the Patent Law, the establishment of a patent linkage system has been codified in Article 76. The National Medical Products Administration (NMPA) and the China National Intellectual Property Administration (CNIPA) issued the Implementing Measures for Pharmaceutical Patent Dispute Early Resolution Mechanism on July 4, 2021. Patents eligible for listing include compound patents of pharmaceutical active ingredients, patents of pharmaceutical compositions comprising active ingredients and patents of pharmaceutical use. Listed biological products include patents of structures of active ingredients and patents of pharmaceutical use. In the patent linkage system, the NMPA will establish a patent registration form for marketed drugs. Generic drug companies will have to submit a statement on the patent issues along with their marketing authorization application.

Hong Kong Intellectual Property Office Announces New Course

The Hong Kong Intellectual Property Office has announced a new IP Training Program for late August 2021. Mediation of IP Disputes will be held online on August 25^th and is intended to enhance the participants’ understanding of the advantages of using mediation in resolving intellectual property related disputes. The class will be broken up into various sections held by different speakers:

1. Introduction to the Mediate First Pledge.
2. IP Disputes and Mediation.
3. IP Mediation in China.
4. Practical Tips for Mediation.

The class is likely to contribute to understanding the various matters to consider when choosing mediation, case preparation and interim measures for protecting IP, and enforcement of mediation settlement agreements.