China's fourth amendment of the Patent Law will come into effect on June 1, 2021. The Implementing Rules of the Patent Law and the Guidelines for Patent Examination have been revised compatibly. Here are some changes you may find particularly relevant:
Drug patent term extension
Patents relating to a new drug approved for marketing in China may be granted a maximum five-year patent term extension by the patent administration department as a compensation for the time taken by regulatory review and approval; and the total effective patent term shall not exceed 14 years. While their scope, in particular the definition of "new drugs" remains to be clarified, these provisions embodies enhanced protection for original drugs, whose regulatory review and approval can take far longer time than generic drugs.
Pharmaceutical patent linkage system
The amendment has introduced a new article to provide legal basis for pharmaceutical patent linkage system and early dispute resolution for pharmaceutical patent-related disputes. If a dispute arises during the drug review and approval procedures, the relevant parties may bring a lawsuit, requesting the court to adjudge whether the alleged infringing technical scheme applied for patent falls within the scope of patent protection of others and it does not consider to be a patent infringement litigation. After the court issues a decision, the National Medical Products Administration (NMPA) may, within the prescribed time limit, make a decision on whether to suspend the approval of the drug.
In addition, the relevant parties may also request the National Intellectual Property Administration (CNIPA) to make an administrative ruling on such disputes.
It remains to be seen how these principles will be implemented in practice. At present, the NMPA and Supreme People's Court are drafting and revising the Implementation Rules of Early Resolution Mechanism for Drug Patent Disputes (Trial) and the Judicial Interpretations on Several Issues Concerning the Application of Laws in the Trial of Patent Civil Cases Involving the Review and Approval of Drug Marketing, respectively. More information will be provided to you once available.
Examination on pharmaceutical patent applications
The CNIPA announced in January 2021 that it has adjusted some criteria for examining pharmaceutical patent applications. The adjustments are related to post-filing experimental data supplement, limitations of composition claims, determination of novelty and inventiveness of compounds, determination of inventiveness of genes, recombinant vectors, transformants, monoclonal antibodies, and polypeptides and proteins. We will watch the relevant changes in practice and provide guidance and comments in due course.
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