Recently, Anhui and Shanghai provinces and cities have announced that due to issues such as intellectual property protection, the procurement qualification of Zoornidazole tablets produced by Warner Pharmaceutical has been suspended.

Warner Pharmaceuticals' "Zoornidazole Tablets" have been suspended from purchasing in Anhui and Shanghai

On April 24th, Shanghai Sunshine Pharmaceutical Procurement Network issued a notice on suspending the procurement qualification of Hunan Warner Pharmaceutical Co., Ltd. for producing levononidazole tablets, stating that it is necessary to protect intellectual property rights in the field of pharmaceutical bidding and procurement, and to suspend the production of levononidazole tablets (specification packaging: 0.25g) by Hunan Warner Pharmaceutical Co., Ltd × 6 pieces/board × 1 board/box, 0.25g × 6 pieces/board × 2 boards/boxes) procurement qualification.

On April 17 a week ago, the Anhui Provincial Medicine Price and Centralized Procurement Center issued the Notice on Suspension of Relevant Drug Trading Qualifications. According to the Letter on Intellectual Property Protection in the Process of Drug Online issued by the National Health Insurance Bureau, if patent infringement is involved in the products that have been sold online on the medical procurement platform, it should be based on the administrative ruling of the patent administration department or the judicial judgment of the people's court, The corresponding drugs were suspended from the Internet. The product was Zoornidazole Tablets of Hunan Warner Pharmaceutical Co., Ltd., and the basis for withdrawal was the Supreme People's Court's Civil Judgment (2020) No. 1158, and the Shanghai Intellectual Property Court's Civil Judgment (2019) No. 607, Hu 73, Zhi Min Chu.

The news has once again sparked industry attention to the patent dispute over levononidazole tablets.

On May 4, the staff of Hunan Warner Pharmaceutical Co., Ltd. responded that the application for suspension of levonidazole tablets from the provincial and municipal pharmaceutical centralized bidding and procurement platforms was an initiative of the Supreme People's Court in the second trial of the company's patent dispute over levonidazole tablets, and the company no longer produced and sold levonidazole tablets.

More than 30 million yuan was claimed for patent infringement

In fact, Warner Pharmaceuticals has been deeply involved in litigation for a long time due to this levononidazole tablet. The object of the lawsuit is the only company in China that has obtained the approval document for levonidazole tablets. The main competitor, Shenghe Pharmaceutical, claimed 30.76 million yuan from Warner Pharmaceutical and Dalian CITIC Pharmaceutical on the grounds of patent infringement.

According to the official website of the National Drug Administration, Shenghe Pharmaceutical and Warner Pharmaceutical were approved as Class 1.3 chemical drugs in December 2017 and Class 2.1 chemical drugs in March 2020, respectively.

According to the China Judgment Document Network, Shenghe Pharmaceutical, Dalian CITIC Pharmaceutical Co., Ltd. (hereinafter referred to as Dalian CITIC), and Warner Pharmaceutical have had multiple lawsuits related to intellectual property rights since 2019.

The core points of controversy, namely the two patents of Shenghe Pharmaceutical regarding levoonidazole tablets, are "Application of levoonidazole in the preparation of anti parasitic infection drugs" (patent number: ZL200510083517.2) and "Application of levoonidazole in the preparation of anti anaerobic infection drugs" (patent number: ZL200510068478.9).

In August 2019, Shenghe Pharmaceutical filed a lawsuit accusing Warner Pharmaceuticals and Dalian CITIC of violating the aforementioned two patents by manufacturing, selling, and promising to sell levononidazole tablets. This case has gone through the first instance of Shanghai Intellectual Property Court and the second instance of the Supreme People's Court. At the end of 2021, the Supreme Court ruled that Warner Pharmaceutical and Dalian CITIC lost the case, and paid a total of 800000 yuan and litigation costs.

Regarding the outcome of the second instance judgment, Warner Pharmaceuticals and Dalian CITIC filed a retrial application, but the Supreme People's Court rejected the retrial application on November 10, 2022.

According to Warner Pharmaceuticals' announcement, after losing the lawsuit, Warner Pharmaceuticals has stopped the production and sales of the products involved in the lawsuit. On December 30, 2021, Warner Pharmaceuticals issued a "Drug Recall Notice", initiating a three-level recall process and recalling all levononidazole tablets in the market.

Pharmaceutical field: Without patents, there are no new drugs

With the continuous deepening of market economy development, mastering independent intellectual property rights means possessing reliable core competitiveness, which can occupy a favorable position in the increasingly fierce market competition. The pharmaceutical industry, as a knowledge-based organization with outstanding professionalism, is a concentrated output of high-tech, and should pay more attention to the protection of intellectual property rights to achieve sustainable and healthy development of the pharmaceutical industry.

There is a saying in the field of medicine, 'Without patents, there is no new drug'. So what patents can drugs apply for?

Drug patents can be divided into invention patents, utility model patents, and design patents.

Drug invention patents usually best reflect technological value and research and development level, including product patents, method patents, and usage patents. The protected objects of product patents can involve pharmaceutical compounds and compositions, biological products, raw materials and excipients, intermediates, metabolites, pharmaceutical precursors, pharmaceutical preparations, isomers, crystal forms, etc; The protected objects of method patents can include processes, formulas, processing and production methods, as well as extraction and processing methods of traditional Chinese medicine; The protected objects of utility patents can include the first discovered medical value and the second discovered medical use.

Utility model refers to a new technical solution proposed for the shape, structure, or combination of a product that is suitable for practical use. In the case of a drug, if its drug dosage form, shape, structure, etc. meet the conditions for granting patent rights, a utility model patent can be applied for.

Appearance design refers to a new design that is aesthetically pleasing and suitable for industrial applications, including the shape, pattern, or combination of colors, shapes, and patterns of a product. It mainly involves the appearance of drugs and packaging containers.

Not only that, pharmaceutical enterprises should also strengthen intellectual property management. Intellectual property management of pharmaceutical enterprises runs through the entire process of research and development and enterprise operation. From project screening, drug discovery, structural optimization to clinical development, drug registration, and market competition, intellectual property issues involved in various links need to be taken seriously. It is also necessary to establish a standardized system for the full lifecycle management of intellectual property rights within the enterprise, in order to safeguard the development and growth of the enterprise. As more and more pharmaceutical companies become bigger and stronger, the pharmaceutical industry will naturally become more prosperous and prosperous.

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