Xinlitai-Strategy to Invalidate AstraZeneca Patents

Ticagrelor, the leader of anti-platelet aggregation drugs, has once again become the focus of attention in the industry because of the patent dispute between Xinlitai and AstraZeneca. The China Patent Reexamination Board declared AstraZeneca's Chinese Patent No. 200610002509.5 (crystal patent) invalid. Whether it is an innovative drug or a generic drug company, patents are one of the core assets and important barriers, and patents on drug molecules and patents on crystal forms of drug molecules are two very critical items in patents. Patent protection and breakthrough is a system that includes the application of technology, the understanding of regulations, and the implementation of patent policies.

On November 22, 2017, the Patent Reexamination Board made decision No. 33975 invalidation, declaring AstraZeneca's Chinese patent No. 200610002509.5 invalid. After the compound patent protecting the anti-platelet drug ticagrelor was declared invalid in October 17, AstraZeneca lost the crystal form patent.

AstraZeneca loses another round-the crystal form patent of ticagrelor is declared invalid.

On November 22, 2017, the Patent Reexamination Board made decision No. 33975 invalidation, declaring AstraZeneca's Chinese patent No. 200610002509.5 invalid. After the compound patent ZL 99815926.3 protecting the antiplatelet drug ticagrelor was declared invalid in October 17, AstraZeneca lost another round in the battle to defend the crystal form patent of ticagrelor.

A strong challenger.

AstraZeneca's ticagrelor is the first triazolo [4,5-D] pyrimidine anti-platelet aggregation drug. It was approved by the US FDA in July 2011 and obtained my country's Food and Drug Administration in November 2012. The import drug license issued by the bureau officially entered the Chinese market. Compared to its main competitor, clopidogrel, ticagrelor does not require hepatic metabolic activation and is characterized by more rapid and potent platelet inhibition. Since its launch, ticagrelor has been recommend as the first-line or preferred antiplatelet drug for ACS patients by many European and American guidelines, and its sales are also rising. In 2016, global sales have reached $0.839 billion, which is expected to enter the "blockbuster" club. What's more, ticagrelor was included in the Medicare drug list this year, with huge room for future growth.

Among the many generic drug filers for ticagrelor, Shenzhen Xinlitai took the lead. After taking the lead in completing the bioequivalence experiment, Xinlitai was the first to submit a listing application on March 9, 17. In the list published by CDE on November 22, 17, Xinlitai's ticagrelor tablets were included in the priority review procedure. It can be seen that Xinlitai has basically cleared the obstacles on the road to drug registration, waiting to become the first imitation manufacturer of ticagrelor.

However, whether Xinlitai's ticagrelor generic drug can be sold smoothly depends not only on whether it has obtained the drug marketing license, but also on other limiting factors, the most important of which includes whether there are "patent barriers". If you go on sale at the risk of patent infringement in order to take the lead in seizing the market, you may face large compensation or even a ban in the future.

AstraZeneca has obtained several patents for the protection of ticagrelor in China, the most important of which are the patent ZL 99815926.3 for the protection of the compound structure (expiring on December 2, 2019) and the patent ZL 01810582.3 for the protection of crystal forms (mainly protecting crystal forms I, III and IV, expiring on May 31, 2021) and its divisional ZL 200610002509.5 (protecting crystal form II, expiring on May 31, 2021).

If Xinlitai's generic drug listing application can be approved by priority review in 2018, it will take about 3 years to wait until the relevant patents expire without the risk of infringement. At that time, the companies in the back line will all catch up and start from the same starting line. This is certainly what Xinlitai does not want to see, so it is only through patent challenges to remove obstacles early. As a result, Xinlitai first filed a request for invalidation of the compound patent on April 27, 2017, and then filed a request for invalidation of the crystal II patent on June 22, 2017. Both cases are currently concluded with the declaration of invalidation of all the patents involved.

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