CHINA Law and Practice Contributed by: Binxin Li, Guangzhen Shang, Yue He and Lesley Wang, LeanWill Law Firm
including co-ordination between drug registration and patent prosecution, and divisional application filings. The term of PTE is calculated based on the following two criteria: • the number of interval days between the patent filing date and the drug approval date minus five years shall not exceed five years; and • the remaining patent term after the drug approval date shall not exceed 14 years. In addition, if applicable, both the PTE and the PTA could be available for one specific patent. 4.2 Paediatric Extensions Paediatric extension is currently not available in China. 4.3 Paediatric-Use Marketing Authorisations Currently, there is no provision for paediatric-use MAs in China. 4.4 Orphan Medicines Extensions There is currently no special rule for orphan medicines in China. However, the patentee can apply for PTA and/or PTE if the related patent meets the require ‑ ments for PTE and/or PTA (see 4.1 Supplementary Protection Certificates ).
For a PI application, the court would require the appli ‑ cant to provide a bond or case security, the amount of which would be determined by the court based on the consideration of the potential losses the respondent may suffer as a result of the enforcement of the PI. If the application proves erroneous and the respondent suffers damage, the respondent may claim compen ‑ sation from the applicant. If, during enforcement of the measure, the respondent’s probable losses exceed the security furnished by the applicant, the court may order the applicant to post additional security. If the applicant refuses to do so, the court may lift or par ‑ tially lift the PI measures. A third party of interest who believes the PI is erroneous could also seek relief dur ‑ ing enforcement by filing an execution objection, or they may bring a separate action for damages. A PI order takes effect immediately upon issuance and remains in force until the final judgment takes legal effect. The court serves the ruling on the parties. Sev ‑ eral procedural deadlines run from the date of service – eg, the five-day period to apply for reconsideration of the PI. The enforcement of the PI will not be stayed during the reconsideration procedure initiated by the respondent. For an urgent PI application, the court shall rule within 48 hours after acceptance of such application. For pre-suit PI, if the applicant fails to file suit or apply for arbitration within 30 days after the court granted the PI, the court shall dissolve the PI. A granted PI is generally not lifted merely because the respondent offers counter-security, unless the appli ‑ cant consents. 5.2 Final Injunctive Relief Final injunctive relief (ie, permanent injunction) is available in both civil and administrative enforcement proceedings. It can be awarded upon the plaintiff’s request in a patent infringement case once infringe ‑ ment is established, unless the permanent injunction would harm national or public interests. The perma ‑ nent injunction will be enforceable after the court judg ‑ ment or an administrative decision becomes effective. In civil proceedings, if the defendant fails to obey the injunction, the plaintiff may apply for compulsory enforcement before the court. Normally, the compul ‑ sory enforcement will be completed within six months after the application thereof is accepted by the court.
5. Relief Available for Patent Infringement 5.1 Preliminary Injunctive Relief
Preliminary injunctions are available for the plaintiff in civil enforcement proceedings. Under the PRC Patent Law, the court may grant a PI in a patent infringement case after considering: • the likelihood for the patentee to prevail on merits; • the possibility of irreparable harm to the plaintiff;
• hardship on both sides; and • any impacts on public interest.
However, in practice, it is generally quite challenging to obtain a PI in a patent infringement case, consider ‑ ing the difficulty in meeting the irreparable harm and public interest requirements.
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