First judicial judgment and first administrative decision for
pharmaceutical patent linkage released in April

The new 2021 Patent Law of China provides a system connecting the patent and the pharmaceutical regulatory authorities in order to clear potential infringement disputes over a patented drug at an earlier stage before issuing market approval to a generic copy. To this end, the patentee or an interested party—the exclusive licensee, for example—has two ways of resolving such a dispute. Firstly, they may choose to file a lawsuit with the court for a judicial judgment, where the Beijing IP Court possesses the exclusive jurisdiction over the subject matter. Alternatively, they may file a complaint with the China National IP Administration (CNIPA) in pursuance of an administrative decision. Recently, in April 2022, both forums made decisions regarding the first cases they docketed at the end of 2021.

The Beijing IP Court made the nation's first-ever judgment for a patent linkage lawsuit on April 15th.[1]

Chugai Pharmaceutical Co., Ltd. from Japan (Chugai) is the owner of the patent no. 200580009877.6, which is associated with the drug Eldecalcitol (traded as Edirol) for the treatment of osteoporosis. Chugai listed the information of this patent and Eldecalcitol on the Patent Information Registration Platform (PIRP). The domestic company Wenzhou Haihe Pharmaceutical Industry (Haihe) attempted to apply for marketing approval for a generic version of Eldecalcitol and also certified that its generic copy did not infringe the registered patent. However, Chugai sued Haihe for patent infringement.

The court found that Haihe’s generic drug did not fall within the literal scope defined by the patent claims, nor did it match the patent's claimed elements by equivalence. Therefore, the court ruled in favor of the defendant Haihe. It is reported that Chugai has appealed the judgment to the Beijing High People’s Court.

In giving its reasoning for this judgment, the court highlighted the legislative background of the patent linkage system introduced in the new Patent Law effective from mid-2021. Firstly, patent linkage stimulates investments in the innovation and development of new drugs, and secondly, it encourages the creation of cheaper generic versions available in the market. With this mechanism in place, patients as consumers will benefit by having more affordable access to high-quality medicines.

Only a few days later, on April 25th, the CNIPA announced the first batch of administrative decisions on the pharmaceutical patent linkage disputes.[2]  

Purdue Pharma L.P. (Purdue) from the USA listed on the PIRP three patents—nos. 201210135209.X, 201510599477.0 and 201010151552.4—related to its three different dosages of a sustained-release tablet of oxycodone hydrochloride, which is an opiate analgesic. Purdue requested the CNIPA to determine whether the technical features of a generic copy manufactured by a competitor, Yichang Renfu Pharmaceutical Co., Ltd. (Renfu), were read on by its three listed patents.

In order to examine this case, CNIPA formed a review panel consisting of five examiners with backgrounds specialized in pharmaceutical and chemical science. The panel coordinated with the National Medical Products Administration (NMPA) to retrieve critical documents and organized several rounds of evidence exchange with both parties. Following an oral hearing, the panel found that Renfu’s generic copy did not fall within the scope of the patents.

Looking at the results of both the judgment and the administrative decision, the generic drug manufacturers have been victorious in both cases. A winning patentee or original drug manufacturer is yet to be seen. Furthermore, following a review, it was decided that both the judicial judgment and the administrative decision had been issued efficiently. The Beijing IP Court took approximately five months (from November to April) to reach a decision, while the CNIPA spent around six months (from October to April) to reach one. They correctly observed the 9-month halting period, in which the NMPA cannot issue approval to the generic copy until a decision for a patent infringement dispute has been reached, either by CNIPA or by Beijing IP Court.

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