【China IP Latest Report】Patent Invalid Decision of Ticagrelor Tablets Revoked by Beijing Higher People's Court

【China IP Latest Report】Patent Invalid Decision of Ticagrelor Tablets Revoked by Beijing Higher People's Court

2018/12/29

On December 24, 2018, Beijing Higher People's Court made a verdict on patent invalid administrative proceedings of compound invention patent (No. 99815926.3) of Ticagrelor Tablets of AstraZeneca, revoking administrative judgement of Beijing #IP court [Jing 73 XingChu No.753 (2018)]Beijing, revoking No.33591 patent invalid administrative decision of Patent Reexamination Board, and asking the Patent Reexamination Board to review decision of the original request for invalidation.

On July 2011, Ticagrelor Tablets was approved to list through US the Food and Drug Administration (FDA). The important compound invention patent (No. 99815926.3) of Ticagrelor Tablets will be expired on Dec 2, 2019

on April 27, 2017, Shenzhen Salubris Pharmaceutical Co., Ltd. (Salubris) firstly launched patent battle appealing Patent Reexamination Board of CNIPA to judge the compound invention patent (No. 99815926.3) of Ticagrelor Tablets is invalid.

On October 17, 2017, issued by Patent Reexamination Board, the patent invalid examination decision (No. 33591) announced that the patent is invalid because of no equipment with creativeness.

On January 16, 2018, AstraZeneca officially filed a litigation to Beijing IP Court against the patent invalid announcement decision (No. 33591) of Ticagrelor Tablets made by Patent Reexamination Board of CNIPA and asked it to revoke the invalid decision.

On July 30, 2018, Beijing IP Court held that, compared with evidence 1 and the combination of public knowledge and common sense, this patent right claim 1 does not have prominent substantive features and significant progress, and therefore does not have creativity. It dismissed the claim of AstraZeneca.

On August 30, 2018, AstraZeneca brought an appeal to Beijing Higher People’s Court.

On December 24, 2018, Beijing Higher People’s Court held that part of the facts of the original judgment and the decision to be sued were not clearly ascertained, and should be revoked according to law. The Patent Reexamination Board should make a new examination decision on the request for invalidation of the patent.

In the sensitive period of the reform of China's pharmaceutical patent system, this case once attracted attention and heated discussion. According to statistics, in 2018, the patent reexamination board accepted a total of 40 patent invalidation request cases in the pharmaceutical field (9 of which were compound patents), among which 25 had made the examination decision of invalidation request and 15 cases were still in the oral trial stage. Of the 25 invalidation decisions made, 11 (3 being compound patents) were declared invalid, accounting for 44%. 8 patents were partially invalid (2 were compound patents), accounting for 32%. Six patents (one for a compound) maintained patent validity, accounting for 24%. This could mean that patents in China's pharmaceutical sector are 76% inefficient in 2018. Of course, some people think that some invalid cases should not be included in the statistics of all invalid cases, the inefficiency is 44%. To this, the personage inside course of study expresses, no matter be 76% or 44%, this proportion still is far higher than euramerican country.

This case is now temporarily over after more that one year. In 2018, China's pharmaceutical industry faced a series of patent challenges. The reversal of this case may lead to a new understanding and reflection of the whole industry on the status of domestic pharmaceutical patent protection.




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