On 9 February 2021, the China National IP Administration (CNIPA) published draft Administrative Adjudication Measures for Early Resolution Mechanism for Drug Patent Disputes (https://www.cnipa.gov.cn/art/2021/2/9/art_75_156702.html, hereinafter drug patent linkage measures) for comments by 27 March 2021.
In less than one month, on 2 March 2021, CNIPA published draft Measures for Administrative Adjudication of Major Patent Infringement Disputes (https://www.cnipa.gov.cn/art/2021/3/2/art_75_157045.html, hereinafter major case measures) for comments by 2 April 2021.
These drafts relate to the 4th Amendment to China's Patent
Law that will come into force on June 1, 2021, which empowers the
CNIPA to adjudicate drug patent disputes, and major patent
infringement disputes, respectively (see my article
https://www.linkedin.com/pulse/4th-amendments-chinese-patent-law-toby-mak/?lipi=urn%3
Ali%3Apage%3Ad_flagship3_profile_view_base_post_details%3B7E2MSZiKQvWw5NIjj%2Bo2%2Fw%3D%3D).
The major texts of these drafts appear to be a set of rules from those of the Chinese courts, detailing the mechanism for accepting and the downstream handling of an infringement complaint.
According to the experiences in the 3rd Revision to the Chinese Patent Law in 2008, the above measures would be applicable to adjudication cases filed after 1 June 2021, the day when the 4th revision of the Chinese Patent Law comes into force.
For the drug patent linkage measures, the following points are noted:
- These drug patent linkage measures work in conjunction with the
Patent Linkage Implementation Method from the China's National
Medical Products Administration (NMPA) and the CNIPA, which is
still in the drafting stage (hereinafter NMPA/CNIPA draft
implementation method. Please refer to my article at
https://www.linkedin.com/pulse/chinas-draft-patent-linkage-implementation-method-public-toby-mak/?lipi=urn%3
Ali%3Apage%3Ad_flagship3_profile_view_base_post_details%3BP3zJHVugR6OMCnF0UEfrPg%3D%3D) - No deadline has been specified for the CNIPA to accept or adjudicate the case, putting drug patentees in adverse position. Specifically, drug patentees may not be able to stop the NMPA from granting drug marketing approval as stipulated in the NMPA/CNIPA draft implementation method within the necessary time frame (45 days for accepting the case, and 9 months for providing the adjudication results to the NMPA).
- Impractically short notice period for oral hearing is provided, particularly for foreign entities involved. Specifically, only 3 days notice is given for an oral hearing to be held.
- Very short appeal period is provided, again putting foreign entities involved in adverse position. Specifically, the adjudication decision could be appealed within only 15 days to a court. By contrast, the time limit to file an appeal to a CNIPA's re-examination or invalidation decision is 3 months.
For the major case measures, these are directed only to those cases involving major public interests, having a significant impact on the development of the industry, or major cases across different provinces or municipal cities (i.e., big and important cases).
It will be interesting to see whether patentees would try the CNIPA, rather than at courts, for such important cases, notwithstanding that the CNIPA could only determine the following:
- For the drug patent linkage measures, whether the generic drug falls within the scope of the drug patent.
- For the major case measures, whether infringement has occurred when adjudicating major patent infringement cases, but not offering any compensation, while cease order may be awarded.
On the other hand, this may be an effort to diverge caseloads from the courts, particularly the Beijing IP Court. Many cases were rejected by Chinese courts purely on formalities, in particularly failure to present notarized and legalized Powers of Attorney, while Chinese courts are accepting an astonishing number of cases every year (for example, the Beijing IP Court accepts over 14000 cases per year on average (from 2014 to 2019). If their cases were not accepted by a Chinese court, patentees may have no other choice but to turn to the CNIPA.
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