First, according to different laws and regulations.
Patent application is based on the Patent Law and its implementing rules, as well as the review guidelines formulated and issued by the patent authorities, while new drug registration is based on the Drug Administration Law and its implementing regulations and the Measures for the Administration of Drug Registration formulated and issued by the drug supervision and administration department.
Second, the purpose and function of the system are different.
The main function of the patent system is to stimulate the development of new drugs, which can not only recover the investment in research and development, but also obtain certain benefits, thus improving its enthusiasm for developing new drugs.
The purpose of implementing the system of drug clinical trial approval and production registration is to standardize the development of new drugs, ensure the safety of human drug use and safeguard people's health. By keeping the clinical trial data of registered new drugs confidential for 6 years
Period, you can ensure that the huge investment in clinical trials will not be used by others for free; Giving new drugs a safety trial period of no more than 5 years can ensure the safety of human medication and safeguard the interests of consumers.
Third, the objects and conditions of protection are different.
The protection objects of medical patents are mainly new inventions in the medical field, that is, technological innovation, including newly developed raw materials, that is, active ingredients, new pharmaceutical preparations or compounds, new preparation processes or their improvements. Among them, the most important authorization conditions are novelty, creativity and practicality. The object of new drug registration protection is drugs that are not listed and sold in China.
Fourth, the duration and means of protection are different.
According to the current patent law, the term of invention patent right is 20 years.
The US Food and Drug Administration continues to monitor the safety of this new drug. The monitoring period of new drugs is determined according to the existing safety research data and the research situation at home and abroad, and the longest period shall not exceed 5 years from the date when the new drugs are approved for production.
Five, the competent institutions and personnel are different.
The competent authority of patent application is China National Intellectual Property Administration Patent Office.
The competent authority for registration of new drugs is the US Food and Drug Administration.
Sixth, the terms and concepts used are different.
First of all, patent application requires technical terms, while drug registration uses the generic name and trade name of the drug.
In addition, the novelty of patent application refers to the concept that has never been published at home and abroad before the filing date, that is, it is the first in the world and belongs to absolute novelty; The newly registered new drug means that it has not been sold in China, that is, it is the first one in China, which is a relatively novel concept.
Furthermore, a new product for which a patent is applied means that the product itself is different from the known product in the prior art. Article 8 of the Measures for the Administration of Drug Registration clearly stipulates that if the route of administration is changed and new indications are added, it shall be managed according to the application for new drugs.
Seven, the classification system and method are different.
There are only two types of patent applications: products and methods. According to the specific content of new drug development, traditional Chinese medicine and natural medicine can be divided into nine categories.
Eight, the scope and timing of application are different.
The claims in the patent application can appropriately summarize the invention. The registration of new drugs is usually a specific product with a very specific chemical structure or composition and content. It may become another new drug with a little change, and its protection scope is relatively narrow.
Judging from the timing of application, patent application only needs innovation in technical scheme, and does not need many clinical trials in pharmacology, toxicology and stability, so its application timing is earlier than the registration of new drugs, and it can generally be applied after the pre-clinical research is completed. In addition, because patent examination is based on the first application system, only one patent right can be granted for the same invention.
Nine, the approval procedures and restrictions are different.
The examination and approval procedures for patent applications must follow the principle of hearing and implement the first application system, and only one patent right can be granted for the same invention-creation.
New drug registration has less strict restrictions on modification. After receiving the application materials, the State Food and Drug Administration of the United States shall organize technicians from pharmacy, medicine and other disciplines to conduct technical evaluation on new drugs, and may require the applicant to supplement the materials and provide drug samples when necessary.