Newsletter
Patent Term Extension and Patent Linkage Implemented in China from 1 June 2021
Patent Term Extension and Patent Linkage Implemented
in China from 1 June 2021
in China from 1 June 2021
Patent Term Extension (PTE)
According to the Chinese Patent Law, Article 42, Paragraph 3, effective as of 1 June 2021, to compensate for the time required for regulatory review of new drugs, the China National Intellectual Property Administration ("CNIPA") shall grant patent term compensation (equivalent to a PTE) for invention patents relating to new drugs for which market approval is obtained in China. The compensated patent term shall not exceed 5 years, and the total patent term from the approval date of the new drug shall not exceed 14 years.
The CNIPA has announced draft Articles 85-4 to 85-7 of the Enforcement Rules of the Patent Law ("Rules") regarding patent term compensation for collecting public comments, but the draft has not yet been finalized. Therefore, there is still uncertainty as to how a PTE application will be examined.
According to draft Article 85-4 of the Rules, pharmaceutical PTEs can be granted for product, preparation process or medical use patents relating to new chemical, biological and traditional Chinese medicine ("TCM") drugs that meet the requirements for a PTE. The new drug related patents refer to those patents relating to the active ingredient of a new drug first approved by the National Medical Products Administration ("NMPA"). New TCM drug related patents refer to those patents relating to new innovative TCM drugs and optimized TCM drugs with improved efficacy.
Draft Article 85-5 of the Rules stipulates that the compensated patent term for a patent based on a new drug is the period from the approval date of the new drug to the filing date of the patent minus 5 years.
Draft Article 85-6 of the Rules stipulates that the scope of the patent during the compensated patent term is limited to the new drug approved by the NMPA in China and the approved indication.
According to Article 85-7 of the Rules, a PTE application should be filed with the CNIPA within 3 months from the approval date of a new drug, and the new drug and patent should meet all of the following conditions:
(1) if a drug is covered by multiple patents, compensated patent term can be granted for only one of the patents;
(2) if a patent covers multiple drugs, compensated patent term can only be granted based on one of the drugs;
(3) the patent has not been subjected to a PTE; and
(4) the remaining patent term should not be less than 6 months.
However, according to Article 6 of the "Interim Measures for the Processing of Related Examination Businesses Regarding the Enforcement Rules of the Patent Law" issued by the CNIPA on 25 May 2021," as of 1 June 2021, patentees can, based on Article 42.3 of the amended Patent Law, file a request in writing for a PTE within 3 months from a drug marketing approval (MA), and then pay the relevant fees according to the notification to be issued by the CNIPA. The CNIPA will examine the request after the amended Rules are released. In addition, according to a further explanation about Article 6 of the "Interim Measures" issued by the CNIPA, the PTE set forth in Article 42.3 of the amended Patent Law does NOT retroactively apply to new drug related patents where the MA for said new drug was obtained on or before 31 May 2021.
Patent Linkage
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 (Trial for Implementation) on 4 July 2021.
A. Subject Matter Eligible for Listing
Patents eligible for listing are shown below.
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Patent types that may be listed
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Chemical drugs
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Traditional Chinese medicines
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Biological products
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Compound Patents of pharmaceutical active ingredients;
Patents of pharmaceutical compositions comprising active ingredients;
Patents of pharmaceutical use
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Patents of TCM compositions;
Patents of TCM extracts;
Patents of pharmaceutical use
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Patents of sequential structures of active ingredients
Patents of pharmaceutical use
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B. Deadlines for Patent Listing
An MA holder can list patent information for its new drug product in the Chinese Marketing Drug Patent Information Record Platform ("the Platform") within 30 days after obtaining a drug marketing approval for the new drug.
If the applicant of the subject application is interested in knowing about the possibility of applying for a patent listing, please let us know and provide us with the relevant background information as soon as possible so that we can evaluate the matter and provide you with further detailed comments.
Lee and Li, Attorneys-at-Law
Lee and Li - Leaven IPR Agency Ltd.