How long is the patent protection period of drugs? General drugs apply for invention patents in China, and the protection period of invention patents in China, the United States and Japan is 20 years. At the same time, it is necessary to pay annual fees in accordance with relevant regulations, which is true in all countries. Failure to pay the annual fee is regarded as giving up the patent protection period of drugs, but different countries pay the annual fee in different ways. For the process of drug patent application, click "Drug Patent Application Process and Fees" to see the details.
There is no special regulation on the term of patent protection for new drugs in China, that is, the invention patent is 20 years, and the utility model and design are 10 years. The patent protection period of the United States, Japan and other countries is also 20 years, but the United States and Japan implement the patent compensation period system.
The United States is the first country to implement the patent compensation period system. 1984, the US Congress promulgated the Drug Price Competition and Patent Term Compensation Act. Article 2 of the law stipulates that the patentee of inventions made of drugs, medical devices, food additives and pigment additives for human use may compensate for part of the patent protection time lost because his patented products are awaiting federal pre-sale approval. The extension period in the United States is equal to 1/2 (clinical trial stage time) plus the application stage time, and the extension period generally does not exceed 5 years. However, due to FDA approval, the actual protection period cannot exceed 14 years.
The patent compensation period in Japan starts from the later date of patent registration and the start date of clinical trial, and ends on the date of obtaining administrative license. The total compensation period shall not exceed 5 years. The patent application must be submitted within three months after receiving the above administrative license, but the above application shall not be submitted after the expiration of the original patent protection period.
Patent compensation is applicable to human or veterinary drugs, human or veterinary diagnostic reagents or materials and medical purposes, but not to medical devices or devices. It is expected that China can also set up a compensation system for patent drug protection period as soon as possible to promote drug research and development into a virtuous circle.
The above is about whether a drug can apply for a patent and the duration of patent protection. It should be noted that the patent authorization is only made according to the relevant provisions of the patent law, which does not mean that the drug has the conditions for market access. Before implementing the patent, the patentee needs to go through the examination and approval procedures with relevant functional departments in accordance with relevant laws and regulations.