CNIPA "First" Drug Patent Linkage Decision

Written by Mr. Toby Mak, IP Expert and collaborator of the China IP SME Helpdesk

Thanks for the heads up from Aaron Wininger of Schwegman Lundberg & Woessner, shortly after the first drug patent linkage decision from the Beijing IP Court, the CNIPA also announced that they have issued their "first" drug patent linkage decision. It is interesting to feel the heat of the competition.

The CNIPA's announcement is at the link below:

https://www.cnipa.gov.cn/art/2022/4/25/art_53_175126.html

The drug at issue is oxycodone hydrochloride sustained-release tablets to relieve severe pain (like those from cancer) of Purdue Pharma under the brand OxyContin (basically, an opioid painkiller). The generic applicant is Yichang Renfu Pharmaceutical Industry Limited Liability Company (Renfu, 宜昌人福药业有限责任公司).

The patents at issue are 201210135209.X, 201510599477.0, and 201010151552.4.

201210135209.X and 201510599477.0 belong to the same family of WO/2008/023261A1 with priority from US60/840,244, and therefore also have the same filing date of 24 August 2007 and full term expiry of 24 August 2027.

201010151552.4 belongs to a different family of WO/2005/097801A1, with full term expiry on 30 March 2025.

The CNIPA ruled that the generic drug from Renfu does not fall with the scope of the patents at issue.

Renfu also challenged that the recordal of 201010151552.4 (in the drug patent database at NMPA) is incorrect, but this challenge was not recognized by the CNIPA, while the reason is not specified in the CNIPA's announcement above.

The main claims of 201210135209.X, 201510599477.0, and 201010151552.4 could be summarized as below, in addition to the active ingredient oxycodone hydrochloride:

As with the first drug patent linkage decision from the BJ IP Court (see my previous reports), it may not be that difficult for the generic of Renfu to get around the claims of the above 3 three patents. For example, this could be achieved by not using polyethylene oxide at all, and showing that the undesirable precursor 14-hydroxycodeinone presents in an amount of more than 15ppm in the composition.

Another point to note is that the CNIPA's announcement also mentioned that 39 drug patent linkage complaints have been accepted out of 59 filed thus far, a significant increase from the previous CNIPA's announcement in October 2021 (12 accepted out of 23 filed).

It is interesting to see that the challenges from the generics in China thus far (the above challenge from Renfu, the challenge from Haihe in the BJ IP Court decision, and the first type 4.2 declaration from Hansoh (see my CN Orange Book User Guide)) all refer to generics having seemingly properties inferior to the respective original drugs, while it appears that the purpose of the CN drug patent linkage system is to provide better and cheaper drugs for people in China according to the BJ IP Court decision.

The first drug patent linkage decision with the generic drug decided to fall within the scope of the patent(s) at issue still awaits to be seen

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