A pharmaceutical company has the patent right of apatini, a heavyweight drug, which was completely exploded by Hengrui!

The result of patent infringement case against apatinib, Hengrui's heavyweight new drug, came out: on August 31, 2017, the Patent Reexamination Board decided that the patent right zl201510398190.1 of Shanghai xuanchuangbio, the plaintiff, was all invalid, which means Hengrui won the patent dispute case Today (September 11) Hengrui pharmaceutical announced that the company filed a request for invalidation of the above patent right of xuanchuang bio with the Patent Reexamination Board of the State Intellectual Property Office on March 28, 2017 The Patent Reexamination Board decided on August 31, 2017 that the patent right zl201510398190.1 of xuanchuang bio was all invalid Earlier, Shanghai xuanchuang Biotechnology Co., Ltd (hereinafter referred to as "xuanchuang biology") sued Hengrui pharmaceutical for infringing its patent right of zl201510398190.1 "crystal form of methanesulphonate a of nicotinamide derivatives and its preparation method and application", and demanded Hengrui to stop infringing and compensate 1 million yuan, and stop producing and selling apatinib Apatinib is a national class 1.1 small molecule targeted new drug independently developed by Hengrui pharmaceutical It was approved by CFDA in October 2014 and used in the clinical treatment of advanced gastric cancer At the same time, many indications such as lung cancer and liver cancer are also expanding The worry of the industry earlier was that once Hengrui was convicted of patent infringement, the plaintiff's requirement to "immediately stop infringement" meant that apatinib, a heavy new drug with an expected annual revenue of more than 2 billion yuan, could no longer be produced and sold by Hengrui, which was undoubtedly a huge blow to Hengrui Now that the case is settled, the result is undoubtedly good news for Hengrui Hengrui also said in the announcement that apatini's sales revenue in 2016 did not reach 10% of the absolute value of the company's latest audited net assets If there is an adverse judgment in the patent infringement case of xuanchuang biology, it will not affect the company's daily operation and development According to the analysis of patent lawyers, the lawsuit once again reflects that domestic pharmaceutical enterprises still lack long-term development plans in terms of pharmaceutical intellectual property, and the awareness of intellectual property protection still needs to be strengthened 1 Crystal type dispute: according to the litigation information, Shanghai xuanchuang Biotechnology Co., Ltd initiated the lawsuit on the ground that Hengrui pharmaceutical infringed its invention patent right of "formanesulphonate a crystal type of nicotinamide derivative and its preparation method and application" (Patent No.: zl201510398190.1) Shanghai xuanchuang biology is a technology company engaged in biological, chemical technology, product testing technology, etc it was founded in Shanghai in December 2013 It can be seen from the search that Shanghai xuanchuang biology currently has 46 patents, of which 23 patents were applied for in 2015 alone The patent involved in this case was applied by Shanghai xuanchuang biology as the applicant (patentee) on July 8, 2015, which was made public on October 7, 2016, and obtained patent authorization on April 27, 2016 The patent content is mainly to prove that the formanesulfonate a crystal form of nicotinamide derivatives provided by the invention has good high temperature stability, high humidity stability and light stability, can be used in the treatment of advanced non-small cell lung cancer, gastric cancer, liver cancer or breast cancer drugs, and has good bioavailability On October 27, 2016, xuanchuang biology notarized the purchase of apatinib produced by Hengrui pharmaceutical and entrusted Shanghai Pharmaceutical Industry Research Institute to conduct crystal analysis On November 17, 2016, Shanghai Pharmaceutical Industry Research Institute issued a crystal analysis report, and reached the conclusion that the crystal form of apatinib produced by Hengrui pharmaceutical is consistent with that of apatinib mesylate API provided by xuanchuang biology Since then, the litigation has also started But in fact, apatinib of Hengrui medicine was listed far earlier than the application time of related patents As early as August 2011, Hengrui pharmaceutical began to apply to the drug review center of the State Food and Drug Administration for listing of the drug In December 2014, apatinib was approved to be listed as a major special scientific and technological achievement of major new drug creation, and was rated as a new drug of category 1.1 As one of the earliest drugs developed by Hengrui, apatinib is of great importance to Hengrui On the one hand, apatinib's ten-year R & D process is the witness of Hengrui pharmaceutical's independent innovation path, and its successful listing is the strength of Hengrui pharmaceutical as a "R & D elder brother" in China: apatinib is the first small molecule anti angiogenic targeted drug proved safe and effective in the world for advanced gastric cancer, and it is also the one that significantly prolongs the survival period after the failure of standard chemotherapy for advanced gastric cancer Single drug At the same time, the drug is the only oral preparation of gastric cancer targeting drug, which can effectively improve the compliance of patients with treatment, and significantly reduce the cost of treatment On the other hand, it is also based on the significance of apatini, which quickly brings market returns to Hengrui after its listing As the first anti-tumor innovative drug of Hengrui, apatinib achieved a sales performance of more than 300 million yuan when it was listed Now, liver cancer, lung cancer and other indications are also in clinical trials With the continuous expansion of new indications, apatinib is considered to be a heavyweight product with more than 2 billion yuan in the future After being sued by xuanchuang biology, Hengrui pharmaceutical actively responded to the case and quickly made a response, claiming that the patent involved is invalid, which is also a common practice when facing patent infringement litigation It is understood that the Beijing Intellectual Property Court also received the "Notice of review status of invalidation case" in March 2017 Six months later, the patent infringement lawsuit was finally settled 2 The patent layout of pharmaceutical enterprises will highlight the judgment that "patent zl201510398190.1 of xuanchuang bio is all invalid", so it can be said that Hengrui pharmaceutical is perfect But the patent infringement cases also give some warning to pharmaceutical companies, especially innovative pharmaceutical companies Industry insiders pointed out that the patent litigation reflects that the awareness of domestic pharmaceutical enterprises in the protection of pharmaceutical intellectual property rights remains to be strengthened In fact, Hengrui pharmaceutical does not neglect patent work According to the 2016 annual report of Hengrui medicine, in recent years, Hengrui has applied for more than 400 invention patents, including 149 international patent applications Specific to apatinib, according to the information of DDN, apatinib's compound patent was first applied in China in 2002, then submitted to PCT for publication, and successively obtained authorization in China, the United States, Japan and Europe, thus providing absolute patent protection for the follow-up research and development and marketing of drugs In the process of research and development, Hengrui has successively applied for related peripheral patents after compound patents, among which, due to the problems of stability and bioavailability in the use of the compound, it is found that the preparation of corresponding salt can solve this problem, so Hengrui has focused on the protection of its salt patents, including organic salt, inorganic salt and salt forming method 。 In order to further consolidate the scope of protection, Jiangsu Hengrui also carried out a comprehensive layout of indications and combination of drugs In the indications, the word "proliferative diseases" was used to expand the scope of indications, laying the groundwork for the development of multiple indications But even so, apatini is still challenged by patents from the outside world According to industry analysis, this may also be because pharmaceutical companies will not apply for patents for some key technologies to avoid the disclosure of key information in order to protect trade secrets Most of the decisions made by enterprises are based on the information of their own core technologies, and they believe that competitors are difficult to replicate success But the risk is that, generally, patent lawsuits between enterprises often last for a long time Behind the marathon litigation, there are a lot of extra human, material and energy paid by both enterprises Therefore, once competitors take the lead in obtaining patents, they will be involved in patent infringement litigation similar to this time, so they have to deal with it and increase the operation cost of enterprises Of course, patent infringement case is not a problem of Hengrui From a global perspective, almost every large pharmaceutical enterprise has patent disputes Similar cases abound in China Such as the infringement lawsuit between Qilu pharmaceutical and Sihuan pharmaceutical, the invention patent case of Shandong Hanlin bio and Shanghai Kaisai bio, etc In recent years, with the increasing innovation capacity of our country, enterprises pay more and more attention to the importance of intellectual property Still take Hengrui as an example It is well known that Hengrui has invested heavily in R & D in recent years, and the annual R & D investment accounts for about 10% of the total sales In direct proportion to the growth of R & D investment, Hengrui's fast-growing patent application rate has increased from single digit to 44 applications per year in the past 15 years However, the industry insiders pointed out that most pharmaceutical enterprises are still weak in the awareness of intellectual property rights, and many enterprises' passive practice of post remediation is not conducive to the innovation and R & D of enterprises In particular, with the rise of innovative drug research and development, patents representing innovation power have become a major factor to measure the innovation ability of enterprises In this case, it is particularly important to complete the patent layout in advance Just in the past may, the general office of the State Council specially printed and distributed the 2017 national key points of fighting against intellectual property infringement and the manufacture and sale of fake and shoddy goods, which put forward that we should increase the efforts to fight against intellectual property infringement, and raise the protection of intellectual property to a new high, reflecting the national focus on this work In this case, pharmaceutical enterprises should improve the awareness of intellectual property protection to avoid problems.