In what has been a much anticipated announcement, the National People's Congress in China released for public opinion on 03 July 2020 its second draft amendments to the "Patent Law of the PRC" ("Patent Law") – ("draft amendments to the Patent Law"). Significant changes include the introduction of a Patent Linkage system and a Supplemental Protection Period. These issues have long been discussed but there had been no further information released since the Supplemental Protection Period had been included in the previous draft of 4 January 2019. The draft amendments to the Patent Law are open for public opinion until 16 August 2020 and the text of the amendments and methods for comment can be found here.
The provision for Patent Linkage is included in Article 75 of the draft. It is an addition to the provisions found in Article 69 of the current Patent Law and is included after the exemptions to non-infringement.
Under the proposed Patent Linkage provisions, a patentee/interested party can commence legal proceedings against the party seeking marketing authorisation ("MA") for a drug which falls within the scope of a patent recorded in the "Chinese Marketed Drug Patent Information Record Platform" ("Record Platform"). However, the term "interested party" has not been specifically defined in the draft, but it should include an exclusive licensee who has the right to sue. In addition, it is not immediately evident whether the Record Platform refers to the current "Orange Book", the National Medical Products Administration ("NMPA") website or a new platform. The "Orange Book" is officially called the "Marketed Drugs Catalogue of China” and was introduced in December 2017. It contains information on active pharmaceutical ingredient, dosage form, specification, MA holder, and patent information for drug products approved in China. Patent information on a new drug can be uploaded on MA application, or within 30 days from the grant of the MA. For already listed drugs, the MA holder should provide the relevant information within 30 days from the patent being granted or on relevant patent information changes. The types of patents that may be listed in the Orange Book are compound patents (specifically excluding crystal forms), product patents (preparation and composition), and use patents (indication). As the exact mechanisms for the Record Platform are not yet clear, it will require further monitoring to confirm exactly what provisions are implemented.
To utilise the proposed Patent Linkage provision, the patentee/interested party must commence proceedings before the court (the exact court remains undefined at this time) or the China National Intellectual Property Administration ("CNIPA") within 30 days of the MA application being published by the NMPA. The forum within which to commence an action is at the discretion of the patentee/interested party. If the patentee/interested party does not file an action against the new drug MA applicant within the statutory 30 day time period, the MA applicant may file for a declaration of non-infringement with the court or CNIPA.
However, the filing of legal proceedings does not appear to stay the review of an MA application. What is stipulated in the draft amendments is that if the court or CNIPA makes a judgment/ruling within nine months of accepting the complaint, the NMPA may grant the MA approval once a chemical drug has passed its technical review. The specific use of the term "chemical" and the wording in the section makes it unclear as to whether these provisions relate to biologics.
While the draft has outlined the general provisions for Patent Linkage, more detail on the procedure will be formulated by the NMPA and the CNIPA for the State Council's authorisation. The one clear mechanism stated is that for appeal from the CNIPA route, which requires that the party unsatisfied with the ruling has 15 days within which to appeal the