First, the relationship and difference between the two kinds of protection
The purpose of patent protection and variety protection of traditional Chinese medicine is to protect the legality of technological achievements of traditional Chinese medicine and promote the development of traditional Chinese medicine. At this point, they are unified. The differences between them are as follows:
1. The legal effects of the two kinds of protection are different: the legal basis of patent protection is the Patent Law of People's Republic of China (PRC), which belongs to the national law formally adopted by the National People's Congress Standing Committee (NPCSC). The protection mode is that the patent office grants the scope of patent protection, the court judges whether there is infringement through litigation procedures, and the court enforces sanctions against the infringer; The basis for the protection of traditional Chinese medicine varieties is the Regulations on the Protection of Traditional Chinese Medicine Varieties formulated by the State Council, which belongs to national laws and regulations. The way of protection shall be supervised and managed by the state health administrative department (now changed from the State Administration of Pharmaceutical Products, the same below) and administrative protection measures shall be taken. The former is more effective in law than the latter. In other words, according to the contradiction between laws and regulations, regulations are subject to the principle of law. For the same variety of traditional Chinese medicine, if the rights and interests protected by the two are different, the latter shall prevail in legal effect. For this reason, the second paragraph of Article 2 of the Regulations on the Protection of Traditional Chinese Medicine Varieties stipulates: "The varieties of traditional Chinese medicine that apply for patents shall be handled in accordance with the provisions of the Patent Law, and these Regulations shall not apply."
2. The nature of the rights of the protected person is different: the patent right belongs to the category of intellectual property. The so-called intellectual property right is a special intangible property right generally recognized internationally, including industrial property right and copyright, and industrial property right includes patent right and trademark ownership. Intellectual property has the characteristics of exclusive right and property right in legal concept. Patent protection is to protect the patent applicant by granting the patent right, and the patentee enjoys the exclusive right of the patented technology, that is, the patentee enjoys the right to exclusively use his patent right and restrict it or allow others to use his patent right. In other words, the patentee has the right to decide whether to exclusively produce his patented drug or license other manufacturers to produce it. If the use of the patented technology without the permission of the patentee constitutes infringement, the patentee has the right to stop the infringement and demand the infringer to compensate for its economic losses; Traditional Chinese medicine variety protection belongs to the administrative protection measures for the varieties of traditional Chinese medicine produced by specific production enterprises, and does not have the characteristics of legal exclusive rights and property rights. That is, for the protection of traditional Chinese medicine varieties, there is not only one beneficiary of the same protected variety, but also more than two production enterprises, and the right holder who decides to protect several production enterprises from producing the same product at the same time is not the holder of the certificate of traditional Chinese medicine protection varieties, that is, the right of the holder of the certificate of traditional Chinese medicine protection varieties is non-exclusive, and the right to punish the unauthorized imitation of traditional Chinese medicine protection varieties belongs to the health administrative department, and the holder of the certificate of traditional Chinese Because of the property right, the patentee, like the ordinary property owner, has the right to decide the fate of his own patent, such as transfer, gift, abandonment, etc. This is the right of disposition of the property owner in the legal concept. Therefore, the patent right can be freely traded in the field of commodity circulation, and the patentee has the right to decide whether to obtain economic benefits through partial or total transfer; However, the rights of holders of certificates of protected varieties of traditional Chinese medicine cannot freely enter the field of commodity circulation for trading and transfer. Only for the protected varieties of traditional Chinese medicine that are in short supply in clinic, the holder of the certificate of protected varieties of traditional Chinese medicine can charge a reasonable use fee according to the imitation suggestion put forward by the competent department of traditional Chinese medicine production and operation and approved by the administrative department of health of the State Council. If the two sides fail to reach an agreement through consultation, the administrative department of health will make a ruling. In other words, it is conditional and involuntary for the holder of the certificate of protected varieties of traditional Chinese medicine to collect such royalties.
3. The object scope of patent protection is different: the object of patent protection includes compound traditional Chinese medicine, single preparation, traditional Chinese medicine extract and its preparation, preparation method or processing technology of traditional Chinese medicine, and new use of traditional Chinese medicine. Moreover, the drugs protected by patents can be officially approved drugs or unlisted drugs under research; The object of protection of varieties of traditional Chinese medicine is only drugs listed in the national drug standards and the drug standards of provinces, autonomous regions and municipalities directly under the central government recognized by the health administrative department of the State Council (Article 2 of the Regulations on Varieties of Traditional Chinese Medicine stipulates that "these Regulations shall apply to varieties of traditional Chinese medicine produced and manufactured in China, including proprietary Chinese medicines, natural drug extracts and their preparations and artificial products of traditional Chinese medicine." —Editor's Note)
4. Different protection periods: the protection period of drug patents is 20 years; The duration of drug protection in China is not uniform. The first-class protected varieties of traditional Chinese medicine are 30 years, 20 years, 10 years respectively, and the second-class protected varieties of traditional Chinese medicine are 7 years.
/ws 01/cl0366/25226.htmlprotected varieties of traditional Chinese medicine.
/sipo/zlsq/zlsqzn/200507/t20050728 _ 78177.htm Patent Application Guide