Can pharmaceuticals be patented? The answer is yes, the pharmaceutical industry is not only an important pillar of industrial industry in the vast majority of countries, but also a major area of concentration of intangible assets. Therefore, countries all over the world pay great attention to the protection of intellectual property rights in the pharmaceutical field.
How long is the patent protection period for pharmaceuticals? Generally pharmaceuticals in China are applying for invention patents, China, the United States, Japan's invention patent protection period is 20 years, and at the same time need to pay the annual fee in accordance with the relevant provisions of the countries are so, the annual fee is not paid, deemed to automatically give up the patent protection period of the drug just each country to pay the annual patent fee in a different way. As for the process of applying for a patent on a drug, click on "Drug Patent Application Process and Fees" to view the details.
New drug patent protection period, China has no special provisions, that is, the invention patent protection for 20 years, utility model and design protection for 10 years. The United States, Japan and other countries, the duration of patent protection are also 20 years, but the United States and Japan have the implementation of the patent compensation term system.
The United States is the first country to implement the patent compensation term system. The U.S. Congress enacted the Drug Price Competition and Patent Term Compensation Act in 1984, which stipulates in Article 2 that patentees of inventions of human drugs, medical devices, food additives, and color additives may be compensated for a portion of the time lost in patent protection due to the fact that their patented products are awaiting federal pre-sale approval. The extension period in the U.S. is equal to 1/2 (clinical trial phase time) plus the filing phase time, and the extension period generally does not exceed five years. However, the actual period of protection cannot exceed 14 years from the time of FDA approval.
The compensation period for Japanese patents begins on the later of the date of patent registration, the date of commencement of clinical trials, and ends on the date of receipt of the administrative license, and the total compensation period may not exceed 5 years. The patent application must be filed within three months after the receipt of the said administrative authorization, but the said application may not be filed after the expiration of the original patent protection period.
The patent term compensation applies to drugs for human or veterinary use, diagnostic reagents or materials for human or veterinary use, medical use, and does not apply to medical devices or apparatus. It is expected that China will also set up a compensation system for the term of protection of patented drugs as soon as possible, so as to promote the research and development of drugs into a benign cycle.
The above is about whether the drug can apply for a patent, as well as the content of the patent protection period of the drug, it should be noted that the patent authorization is only made in accordance with the relevant provisions of the Patent Law, does not mean that the drug has the conditions of market access, the patentee in the implementation of the patent before the need to the relevant regulations to the relevant functional departments for approval procedures.