Betta Pharmaceuticals Anticancer Drug Star Product Patent Litigation

in aShares of listed companies, known as the "first shares of anti-cancer drugs," Beida Pharmaceutical got into a marathon lawsuit.

Beida Pharmaceutical is a national high-tech enterprise founded by the team of returnees with independent intellectual property rights and innovative drug research and development as the core, integrating pharmaceutical research and development, production and marketing. the areas targeted are malignant tumors, diabetes, cardiovascular diseases and other diseases that seriously affect people's health and life. 2011In 2002, the company's independent research and development of the national class 1 new drug icotinib (commodity name: kemena) received the new drug certificate and production approval issued by the state food and drug administration and began to go on sale, bringing rapid growth to the company's revenue and profits and becoming the main source of the company's revenue and profits. according to the 2018 semi-annual report, kemena generated revenue of 0.581 billion yuan in the first half of 2018, accounting for 100 of the total revenue, the gross margin of the product was 95.51 per cent, with sales up 28.54 per cent year-on-year and operating income up 16.70 per cent year-on-year.

Beida Pharmaceutical is a national high-tech enterprise founded by the team of returnees with independent intellectual property rights and innovative drug research and development as the core, integrating pharmaceutical research and development, production and marketing. the areas targeted are malignant tumors, diabetes, cardiovascular diseases and other diseases that seriously affect people's health and life. 2011In 2002, the company's independent research and development of the national class 1 new drug icotinib (commodity name: kemena) received the new drug certificate and production approval issued by the state food and drug administration and began to go on sale, bringing rapid growth to the company's revenue and profits and becoming the main source of the company's revenue and profits. according to the 2018 semi-annual report, kemena generated revenue of 0.581 billion yuan in the first half of 2018, accounting for 100 of the total revenue, the gross margin of the product was 95.51 per cent, with sales up 28.54 per cent year-on-year and operating income up 16.70 per cent year-on-year.

At present, the Company is involved in three pending litigation matters outside China and two pending litigation matters within China.

The whole story of the patent dispute over ecotinib

Ø 2000

Xie Guojian told reporters that he 2000Appointment of Beida Chemical Company in April.

Ø 2001

Xie Guojian said that it "led the development of a targeted kinase inhibitor for the treatment of advanced lung cancer".

Ø 2003

Wang Yinxiang and Ding Lieming returned to China to start their own businesses. Beida Limited (the predecessor of Beida Pharmaceuticals) was established, and Beida in the United States was established with "EGFR".Tyrosine Kinase Inhibitor "Technology became a shareholder of Betta Limited.

Ø 2006-2015Year

In 2006, icotinib entered clinical trials. Company 8.More than a year of research and development, in 2011 Beida Pharmaceuticals Class 1 new drug Ectinib (Kemena) was approved and achieved product launch. From 2011 to 2015, the annual compound growth rate of sales revenue of this product reached 97.4.

Ø 2014

Betta Pharmaceuticals and its shareholder, American Betta, were sued by Xie Guojian, a former employee of American Betta. 2017The annual report disclosed that it is still in trial.

Ø 2016

Beida Pharmaceuticals began to move into the capital market, and finally in 11month successfully listed.

Ø 2017 7Month 31

The Hangzhou Intermediate People's Court accepted the GUOJIAN.XIE (Chinese name: Xie Guojian) v. Beida Pharmaceuticals, a dispute over the transfer of equity.

Ø September 2018Month 25

A pretrial meeting was held in Hangzhou Intermediate People's Court in a lawsuit against Bayda Pharmaceuticals and Bayda Pharmaceuticals shareholders of the United States.

Back in 2014In, Betta Pharmaceuticals and its shareholder, Betta USA, were sued by Xie Guojian, a former employee of Betta USA. Since then, the case has made no substantial progress. On July 31, 2017 after listing, Hangzhou Intermediate People's Court accepted the case of GUOJIAN XIE (Chinese name: Xie Guojian) v. Beida Pharmaceutical over equity transfer dispute.

Plaintiff Xie Guojian in 2017In August, 1993, a lawsuit was filed against Beida Pharmaceutical, Beta Pharma Scientific, Inc. (US Beida) and Zhang Xiaodong, claiming that as one of the inventors and applicants of the 2002 US provisional patent "EGFR Tyrosine Kinase Inhibitor" (provisional patent number: 60/368.852), he and the other four applicants enjoyed the ownership of the provisional patent, the establishment of Zhejiang Beida Pharmaceutical Co., Ltd. (the predecessor of Beida Pharmaceuticals) by the provisional patent as an intangible asset violated the plaintiff's rights.

Disclosure pursuant to the prospectus (2003On March 28, 1993), Beida Co., Ltd. carried out further transformation and research and development on the basis of "EGFR tyrosine kinase inhibitor". After completing the writing of the patent application documents, it formally submitted a patent application to the China Intellectual Property Office. It successfully applied for and obtained the invention patent "Novel Fused Quinazoline Derivative as Tyrosine Kinase Inhibitor" corresponding to the compound structure of Icotinib ". On the basis of this patent, Bayda Co., Ltd. further independently developed core technologies such as crystal structure, drug combination and preparation method of icotinib, and obtained the invention patent "icotinib hydrochloride and its preparation method, crystal form, drug composition and use" on July 7, 2009. The icotinib hydrochloride developed here is the star product of Bayda Pharmaceutical, Kemena.

Xie Guojian's lawyer told the Beijing News reporter that Xie Guojian's current claim is to obtain compensation, and its corresponding patent should have obtained the U.S. Beida equity.

Whose patent?

Xie Guojian said that he was in 2000.In April, 2002, Zhang Xiaodong was hired to set up Beta Chemical Company in the United States (the predecessor of Beta Chemical Company in the United States, which now holds part of the equity of Beta Pharmaceutical through Beta in the United States), and led the research and development of a kinase inhibitor for targeted treatment of advanced lung cancer. The research and development results were tested in the laboratory of Wang Yinxiang, a postdoctoral fellow at Yale University Medical School, and found special anti-cancer activity, wang Yinxiang revealed to his graduate student classmate, Ding Lieming, who is currently the chairman of Beida Pharmaceuticals, that after the test map was released, Zhang Xiaodong discussed with Wang Yinxiang and Ding Lieming to develop a market for the technological achievements in China.

1 of 2003In January, Wang Yinxiang and Ding Lieming returned home immediately. On the one hand, they declared the clinical trials and project funds of kinase inhibitors, and on the other hand, they established and registered Zhejiang Beida Pharmaceutical Co., Ltd.

1 of 2003In January, Beda Limited was established, and Beda USA became a shareholder of Beda Limited with the technology of "EGFR tyrosine kinase inhibitor" (according to Beda Pharmaceuticals' prospectus, at that time Beda USA had a shareholding structure of only Zhang Xiaodong, who held 100 per cent of Beda USA).

Xie Guojian believes that as a member of the core research and development team of Beida Limited, he has made great contributions to the research and development of Ectinib Hydrochloride. Beida Limited shall grant part of its shares in Beida Limited in accordance with the aforementioned joint venture investment agreement, but Beida Limited has not issued any shares of Beida Limited to it except for paying its salary.

According to the announcement of Beda Pharmaceuticals, Beda has already worked with DON ZHANG.(Zhang Xiaodong),GUOJIAN XIE (Xie Guojian) and other 5 employees to sign the Confidentiality Agreement, "The above-mentioned employees confirm that all the intellectual property rights and commercial interests of discovery, invention, improvement and technological innovation belong to Beta Pharma Inc. (hereinafter referred to as" BETA "), and all relevant patent application rights in the United States and abroad belong to BETA", this claim has also repeatedly appeared in the cross-examination opinions put forward by the lawyers representing Betta Pharmaceuticals. The lawyer representing Beida Pharmaceuticals has repeatedly mentioned that Xie Guojian is an employee of Beida in the United States and does not belong to the right holder of the patent. Xie Guojian's lawyer responded that "American law is different from Chinese law. American law emphasizes that the inventor holds a patent right".

At present, the case is still under trial, and the focus of the dispute between the two parties has extended from the ownership of the patent to multiple issues. 2018On October 10, 1993, Beida Pharmaceutical issued a morning announcement saying that the dispute over the patent right of "EGFR tyrosine kinase inhibitor" had been clearly stated in the listing prospectus. Xie Guojian was an employee of BETA. According to the agreement between the two parties, the ownership of intellectual property rights produced by all job activities during the employment period belonged to BETA, and the plaintiff did not own the patents or technological achievements involved, BETA enjoys all the rights to the patent and has changed the description in the United States Patent and Trademark Office, and in accordance with the laws and regulations of the time, BETA has the right to enter into a stake in Beida Pharmaceuticals at the price of the patented technology through an agreement. In the process of establishing the company, Betta Pharmaceuticals has passed the corresponding statutory approval and approval in accordance with the law, and the procedure is completely legal.