CHINA: NEW DEVELOPMENTS FOR PHARMACEUTICAL PATENTS
Ticagrelor (trade name Brilinta, Brilique, and Possia) is a blockbuster drug produced by AstraZeneca with total sales of $1,079m in 2017.
is a platelet aggregation inhibitor and is used for the prevention of thrombotic events (for example stroke or heart attack) in people with acute coronary syndrome or myocardial infarction with ST elevation.
In China, this drug is protected by the Chinese Patent No. 99815926.3 owned by AstraZeneca AB [SE], which is directed to the compound itself, pharmaceutical composition comprising the same and use thereof among others.
The patent was challenged by Shenzhen Salubris Pharmaceuticals Co., Ltd. on April 27, 2017 and was declared invalid totally by the Patent Reexamination Board (PRB) on October 10, 2017. Upon appeal, Beijing IP Court upheld the PRB’s decision. However, the second instance court, Beijing High People’s Court, reversed the Beijing IP Court’s judgement and the PRB’s decision and remanded this case to PRB on December 26, 2018.
According to the Beijing High Court, when identifying a distinguishing technical feature in assessment of inventiveness of a patent, a technical feature should be identified in light of its role in the whole technical solution in which it is located. For a Markush claim directed to a compound of a general formula, the immutable skeleton of the general formula shall as a whole be identified as a technical feature, which a person skilled in the art would not be motivated to change, because the immutable skeleton is a moiety that produces pharmacological activity and it is thus unpredictable whether a change of a part of the immutable skeleton would maintain the pharmacological activity.
This case shows that the Court is attempting to correct the PRB’s currently rigid and stringent standard of patent validity, which is very important to encouragement of innovation in the pharmaceutical industry. This is one of the recent indications that China is striving to strengthen patent protection in this industry, including efforts to establish patent linkage system, patent term extension, and punitive damage.
In addition, it is noteworthy that in this case, Beijing High Court repeatedly affirmed the PRB’s finding that the post-filing data cannot be accepted if the specification of a patent neither mentions nor demonstrates with experimental data the technical effects to be proved by the post-filing data. Accordingly, when drafting a pharmaceutical or biotech patent application, it is critical to include in the application experimental data that at least preliminarily prove an effect of the invention that could confer inventive step.
This information was provided by our partners CCPIT Patent & Trademark Law Office. In particularly we thank Mr. Chuanhong Long (Vice President).