China’s National Intellectual Property Administration (CNIPA) and the National Medical Products Administration (NMPA) published draft measures entitled ‘Implementing measures for drug patent dispute early resolution mechanism (trial for implementation)’ on 11 September 2020. These outline further aspects of the patent linkage system that were presented in July’s proposed amendments to China’s patent law . Public comments on these measures are due by 25 October 2020.
China’s draft measures for patent linkage system
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The patent linkage system and patent database
The draft measures outline that, under the patent linkage system, the NMPA’s Center for Drug Evaluation (CDE) is to create a public database of innovator patents on pharmaceutical active ingredients, formulations and methods of use. In addition, the draft measures set time limits and outline procedures for submitting and updating patent listing information in the database.
The measures also state that, if a drug is not being processed as a new drug application (NDA) or if it has not yet received marketing authorization in China, it will not be eligible for patent listing in the database. If not included in the database, the drug will not be eligible for patent linkage protection. In addition, NDA applicants or those that hold the marketing authorization of a product are responsible for the truthfulness, accuracy and completeness of information in the patent database. Penalties will be imposed upon those who intentionally list unrelated patents.
Certifications for generics
When it comes to generics products, drug applicants filing for marketing authorization will be required to make certifications regarding the related innovator drug patents that are listed on the database. The certification system has four categories and is similar to the US’s Hatch-Waxman framework.
For Category I (no innovator drug patent information on the platform) and Category II (the innovator drug patent information on the platform has expired or been invalidated) certifications, generic drug application can be approved immediately. For Category III certifications (there is innovator drug patent information, but the generic drug applicant certifies that the generic drug will not go on the market before the expiration of the patent) the generic drug application can be approved immediately, but the generic drug applicant can only launch the product after the patent expiration. And for Category IV certifications (there is innovator drug patent information, but the generic drug applicant believes the patent should be invalidated or the generic does not fall within the scope of the patent protection) innovator producers to challenge applications via a court through the CNIPA within 45 days of publication.
The CDE will also publicize generic drug applications and patent certification, plus any declarations regarding the invalidity or termination of patents for innovator products.
Biosimilar applications and patent challenge incentives
Under the draft measures, the marketing authorization for biosimilar applications can be approved immediately, as long as they are not found to infringe on a biological innovator patent.
In addition, one of the key incentives for generics manufacturers to challenge innovator drug patents is that the first generic drug to be approved is now eligible for up to one year of market exclusivity.
Inter partes review and the generic drug industry
1. GaBI Online - Generics and Biosimilars Initiative. China publishes new patent law amendment [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Oct 23]. Available from: www.gabionline.net/Policies-Legislation/China-publishes-new-patent-law-amendment
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