Drugdu.com expert's response:

The legal provisions related to pharmaceutical patents mainly include the following laws and regulations:

I. Patent Law of the People's Republic of China

Scope of Patent Protection: According to the Patent Law, the scope of patent protection for pharmaceuticals encompasses patents for new drugs, new preparation methods, and new uses. This includes but is not limited to new compounds, pharmaceutical compositions, new microbial and genetic engineering products, new isomers, new effective crystalline forms, etc. Utility model patents also involve improvements in shape and structure related to the function of pharmaceuticals, while design patents pertain to the appearance and packaging of pharmaceuticals.

Patent Term and Compensation: The term of invention patents is twenty years. For invention patents related to new drugs that obtain marketing authorization in China, the patent term may be compensated for the time taken up by review and approval, but the total effective patent term after compensation shall not exceed fourteen years.

Patent Infringement: The act of implementing a patent without the permission of the patentee constitutes infringement. The patentee or interested parties may resolve infringement disputes through negotiation, litigation, or by requesting the department in charge of patent administration to handle them.

II. Pharmaceutical Administration Law of the People's Republic of China

Principles of Pharmaceutical Administration: Pharmaceutical administration centers on people's health, adhering to the principles of risk management and full-process control.

Requirements for Pharmaceutical Research, Production, Operation, and Use Activities: Engaging in pharmaceutical research, production, operation, and use activities shall comply with relevant laws and regulations, ensuring the authenticity, accuracy, completeness, and traceability of information throughout the entire process.

III. Other Relevant Laws and Regulations

In addition to the Patent Law and Pharmaceutical Administration Law, laws and regulations related to pharmaceutical patents also include the Implementing Regulations of the Patent Law of the People's Republic of China, Measures for Administrative Adjudication and Mediation of Patent Disputes, and others. These regulations provide detailed provisions on patent application, examination, authorization, protection, and the handling of patent disputes.

IV. Specific Cases and Judicial Interpretations

In practical operations, disputes related to pharmaceutical patents may involve specific cases and judicial interpretations. These cases and interpretations help further clarify the legal boundaries and scope of protection for pharmaceutical patents, providing specific guidance for the exercise of patent rights and the resolution of disputes.

In summary, the legal provisions related to pharmaceutical patents cover multiple aspects such as the scope of patent protection, term and compensation, and handling of patent infringement disputes, providing a legal basis for pharmaceutical innovation, protection, and management. At the same time, other relevant laws and regulations, as well as specific cases and judicial interpretations, also provide strong support for the protection and implementation of pharmaceutical patents.