Zhejiang Huahai Pharmaceutical Co., Ltd. was sued by Japan's second largest pharmaceutical company for generic drug patent infringement.

A few days ago, Zhejiang Huahai Pharmaceutical Co., Ltd. (Zhejiang Huahai Pharmaceutical Co., Ltd., hereinafter referred to as "Huahai Pharmaceutical") and a series of its branches in the United States were recently sued by Japanese drug manufacturer Astellas Pharmaceutical Co., Ltd. (Astellas Pharma Inc., hereinafter referred to as Astellas) for patent infringement.

In recent years, the low-cost and high-efficacy characteristics of generic drug products (Genetic Pharmaceutical Products) have catered to the purpose of pharmaceutical cost control by governments of various countries, and have also made it a key development area for pharmaceutical companies in various countries today and in the future. However, with the strong development momentum, the patent war in related fields has also entered a white-hot stage, and many overseas enterprises in China have been continuously harassed by competition subjects and patent hooligans from various countries.

The defendant's Huahai Pharmaceutical is one of them. According to the information available on the RPX, Huahai Pharmaceutical has been a defendant in the US Federal District Court seven times, while the plaintiffs are counterparts from Germany, Japan, Israel and the United States. Huahai Pharmaceutical's first lawsuit can be traced back to June 22, 2007. At that time, the plaintiff was Israel Teva Pharmaceutical Industry Co., Ltd. (Teva Pharmaceutical Industrial), a world-renowned multinational pharmaceutical company. In addition, several other plaintiffs also have giants in the pharmaceutical field, as shown in the following table:

Founded in 1989, Huahai is a pharmaceutical company integrating pharmaceutical preparations and raw materials in China. It was listed on the Shanghai Stock Exchange in 2003. At present, the company has 15 branches (or subsidiaries) in Shanghai, Jiangsu, Hangzhou and the United States, with more than 4000 employees. In addition, Huahai's preparations have passed FDA(Food and Drug Administration, U.S. Food and Drug Administration) and have ANDA (Brief New Drug Application for Generic Drugs) preparation document number. It is currently one of the most officially certified pharmaceutical enterprises in China through FDA, WHO (World Health Organization), European Union, Mexico and other international mainstream markets. In addition, Huahai Pharmaceutical has a fast pace in the field of preparation export and international development. It is currently one of the few pharmaceutical companies in China that can carry out large-scale and commercial preparation production and export to European and American markets. The company has core technology in the field of cardiovascular pully and sartan drugs, and is the world's largest supplier of pully and sartan drugs.

This time, there are also three branches of Huahai located in the United States:

Huahai US Inc. was established in 2004 to prepare, manufacture, promote, and distribute pharmaceutical products, including products Prinston by another defendant. Huahai USA provides API (Active Pharmaceutical Ingredients, API) to Huahai, the head office, and also promotes general dose finished products through Prinston.

Founded in 2009, Princeton Pharmaceuticals (Prinston Pharmaceutical Inc.) is a New Jersey-based pharmaceutical company. Like Huahai America, Prinston is also a U.S. subsidiary of Zhejiang Huahai Pharmaceutical, which is mainly engaged in the research and development, registered production, promotion and distribution of generic drug products.

Soclco Healthcare USA, LLC (Solco Healthcare U.S. LLC) is a wholly owned subsidiary of Prinston, primarily engaged in the sale and marketing of Prinston products, and related matters in the pharmaceutical field.

Anstellas

The plaintiff, Astellas Pharmaceutical Group, is the second largest pharmaceutical company in Japan. It is mainly engaged in five key research and development areas of urology, transplantation immunity/infectious diseases, oncology, neuroscience and diabetic complications/nephropathy, and has expanded muscle diseases., Ophthalmology two new treatment areas. In 2014, the Astellas Group's global sales totaled $10.394 billion billion.

The predecessor of Astellas "Fujisawa Store" was established in 1894, specializing in pesticides, and was transformed into a pharmaceutical manufacturing enterprise in 1943, and was renamed "Fujisawa Pharmaceutical Industry". In 1971, Fujisawa officially expanded its antibiotic "cefazolin" to the global market, and established an American company six years later. Since then, Fujisawa has undergone a series of restructurings and name changes, culminating in the formation of the Astellas Pharmaceutical Group on 1 April 2005.

brief analysis of the case

Plaintiff Astellas, together with its US subsidiary and Irish branch, claimed in the indictment that Zhejiang Huahai, Huahai USA, Princeton Pharmaceuticals and Soclco were cooperating and assisting Princeton in submitting the new drug application approval brief (Abbreviated New Drug Application, ANDA) No.209475 to FDA, it includes an application for the right to manufacture, import, market and distribute a pharmaceutical product containing a mirabegron (Mirabegron) compound as an ingredient for the treatment of overactive bladder (Overactive Bladder)[4]. However, the plaintiff's products and actions infringed the following four patents held by the plaintiff:

The plaintiff also stated that a Notice of Letter (notification letter) was sent to Princeton on September 8. Therefore, the above-mentioned defendants should know the identity of the plaintiff and that the plaintiff will initiate infringement complaints against the defendant within 45 days after receiving the notification letter.

In addition, in the application for relief, the plaintiff, in addition to routinely requesting the court to determine the defendant's infringement, issue an injunction, and a series of cost compensation applications, also requested the court to order the defendant not to continue its application No.209475 during the validity of the plaintiff's patent.

The Court issued a summons to the accused on the day the indictment was received. However, the plaintiff asked the court to withdraw the summons to the defendant on the 17th. Under normal circumstances, there are two possibilities for the plaintiff to move. One is that an out-of-court settlement has been reached with the defendant, and the other is that the plaintiff needs to make further adjustments to the defendant or patent in this case. Seven Star Day will also continue to pay attention to the development of this case.