As a well-known targeted drug for the treatment of cancer, sorafenib tosylate tablets (the product name is NEXAVAR) encountered a patent invalidation dispute. Recently, the National Intellectual Property Administration, PRC made the review decision No. 46292, the patent for sorafenib tosylate preparations held by Bayer, Germany (patent number CN200680007187 .1) The declared patent rights are all invalid.
The requester for the invalidation of this case was Chongqing Yaoyou Pharmaceutical Co., Ltd., and the invalidation request date was November 27, 2019.
The above-mentioned decision is based on Article 22, paragraph 3 of the Patent Law. This clause stipulates that inventive step means that the invention has outstanding substantive features and a significant improvement compared with the technology existing before the filing date. The collegiate panel believes that the sorafenib tosylate preparation patent held by Bayer in Germany does not comply with the provisions on creativity in the above clause and should be completely invalidated.
However, according to Article 46, paragraph 2 of the Patent Law, if Bayer AG is not satisfied with the decision, it can file a lawsuit with the Beijing Intellectual Property Court within three months from the date of receiving the decision.
According to investigations, sorafenib tosylate tablets are an oral multi-kinase inhibitor developed by Bayer in Germany. Its mechanism of action is to inhibit tumor cell proliferation and angiogenesis from multiple targets. According to the company's annual report, sales of sorafenib products were 712 million euros in 2018 and 706 million euros in 2019. According to the data of Yaozhi.com, the sales of sorafenib domestic sample hospitals reached 730 million yuan, which was monopolized by the original research company, Bayer. According to the data from Ask Doctor website, the current domestic price of a box of 200mg*60 sorafenib tosylate tablets is more than RMB 25,192.
It is reported that for new and innovative drugs, pharmaceutical companies generally submit a series of patent applications to lay out drug patents, and gradually form patent chains or patent pools by forming compound patents, crystalline patents, preparation patents, preparation method patents, compound use patents, etc., so as to form layers of protection and extend the patent period of the product. Among them, compound patents are the most important. The German Bayer company has laid out patents for compounds, crystal forms, formulations, preparation methods, etc. for sorafenib tosylate formulations in China, but the rights of these patents are not stable at present.
In response to Bayer's patent for sorafenib tosylate formulations, Yaoyou Pharmaceutical has submitted two invalidation requests. On September 6, 2018, Yaoyou Pharmaceutical filed its first request for invalidation. Based on the amended claims of Bayer, the State Intellectual Property Office maintained the sorafenib tosylate formulation on March 14, 2019. The patent right is valid. On November 27, 2019, Yaoyou Pharmaceutical filed a second request for invalidation, and the patent for sorafenib tosylate was finally declared invalid.
In addition, the patent for sorafenib tosylate (patent number CN00802685.8) of Bayer in Germany has expired in January 2020 in China.
