| Objective:This work was trying to make the inner features of Chinese herbal extract combination patents more explicit, by studied the patent development history, the patentee distribution, and the treating disease categories of the patents. To provide reference for facilitating the scientific research innovation of the Chinese herbal extract combinations, and promoting the development and protection of the Chinese herbal extract combination patents.Methods:The patent documents in this work were retrieved from the official website of the State Intellectual Property Office of China, China Patent Information Center and China Intellectual Property Rights. To acquire an objective perspective on patent analysis of the TCM extract combination field, patents in force granted in the period 1995-2014 were selected for this work. Microsoft Access (MS Access 2010), Statistical Program for Social Sciences, software (version 20.0; SPSS, Inc., Chicago, IL, USA) and Microsoft Excel (2010) were applied to all the analysis in this work. The simple statistics combined with the higher-order statistics, and the theoretical analysis combined with the examples was used as the method. And each step was studied in different specific methods.1. Simple analysis was combined with cluster analysis, as which a method to study the patent development history, the patentee distribution, and the treating disease categories of the patents.2. The patents in force for Chinese herbal extract combinations were regarded as the objects, and frequency analysis, cluster analysis, factor analysis and correlation analysis were used together as the methods in the study of compatibility regularity of Chinese herbal extract combinations, which can treating the important disease categories.3. The Chinese herbs belong to the Araliaceae, Leguminosae, Umbelliferae, Labiatae and Compositae respectively were regarded as the objects, and the property, flavor and the meridian tropism of Chinese herbs were used as the parameters, fuzzy cluster analysis and information from literatures were utilized for analysis the interrelation of the Chinese herbs.4. On the basis of the patentee distribution analysis, the patents in force of the high-frequency patentee were regarded as the objects. The simple statistical method was applied to analysis the construction mode of the patent portfolio. The analysis research content mainly included the dosage form, activity structure and purpose, and the classification methods were according to International Patent Classification.5. On the basis of the study of the inner features of Chinese herbal extract combination patents, theoretical study was combined with case study to explore the patentability judgment of the invention of Chinese herbal extract combination, and then standing on the different positions, some rational suggestions were proposed.Results:1. The development of the patent protection of Chinese herbal extract combination started from 20 years ago. The service inventions in the patents in force of Chinese herbal extract combinations were 78.11 percent. The high-frequency patentees are TCM enterprises, colleges and universities, or technical enterprises. The Chinese herbal extract combinations recorded in the patents in force were used to prevent and treat the diseases of heart system or liver system.2. For preventing and treating heart system disease, a high number of patents in force included high-frequency Chinese herbs such as Salvia miltiorrhiza, Panax ginseng, and Panax notoginseng, as well as high-frequency Chinese herbal families such as Araliaceae, Leguminosae, Labiatae and Umbelliferae. Chinese herbal pairs such as Panax ginseng+Ophiopogon japonicus, Salvia miltiorrhiza+Dalbergia odorifera, and Panax ginseng+Schisandra chinensis are also commonly used, as well as Chinese herbal family pairs such as Araliaceae+Liliaceae, Lauraceae+Leguminosae and Araliaceae+Schisandraceae. 3. For preventing and treating liver system disease, a high number of patents in force included high-frequency Chinese herbs such as Salvia miltiorrhiza, Astragalus membranaceus, and Ligusticum chuanxiong, as well as high-frequency Chinese herbal families such as Labiatae, Leguminosae, and Umbelliferae. Chinese herbal pairs such as Gardenia jasminoides+Scutellaria baicalensis, Bupleurum chinese+Glycyrrhiza uralensis, and Paeonia lactiflora+Angelica sinensis are also commonly used, as well as Chinese herbal family pairs such as Rubiaceae+Labiatae, Umbelliferae+Leguminosae, and Ranunculaceae+Umbelliferae. 4. There are some Chinese herbs in the same herbal family show some similarities in active ingredients and pharmacological effects. Then according to the fuzzy cluster analysis, the Chinese herbs in the same category show more similarities in active ingredients and pharmacological effects.5. The patent portfolio of Chinese herbal extract combinations containing Salvia miltiorrhiza have been full built basically by Tasly. The patent portfolio is based upon the granted patent right of combination of Salvia miltiorrhiza extract+Panax notoginseng extract+Borneolum syntheticum, and around the innovation in the core patent increased the technologies by the methods such as replaced the extract in the core patent or detailed the ratio range. Therefore, the patent portfolio is a defense system with more stability and strength of patent protection.Conclusion:1. The development of the patent protection of Chinese herbal extract combination in recent twenty years was distributed into four stages, while trends show the number of patent applications and patents granted to be on the rise. And the development was owed to four main factors:the relevant laws, regulations and the major strategies formulated by government, the industrialization trend of the Chinese herbal extracts, the abundant scientific achievements, and the status of scientific and technological advancement. The service invention was the main type of the Chinese herbal exact combination patents in force, and the proportion of service invention is relatively large in the field of the TCM patent. Most of the high-frequency patentees of the patents in force were modern Chinese medicine enterprise, which have set some interrelated intellectual property strategies. Most of the Chinese herbal extract combinations recorded in the patents in force was used to prevent and treat the diseases of heart system or liver system.2. In the Chinese herbal extract combinations recorded in the patents in force, for preventing and treating the heart system or liver system diseases, most of the high-frequency Chinese herbs belonged to the high-frequency Chinese herbal families, and the herbal pairs were common used coincide with the herbal family pairs. The analysis of combination law of the Chinese herbal extract combinations showed of applicable value in independent research and development and application for patents.3. In the same herbal family, the Chinese herbs have the similar drug properties were more similar in pharmacological effect and medicinal ingredients. The abundant Chinese herbs in the high-frequency Chinese herbal family were uncommonly used, and need to be further studied. On the basis of differing usage of the foregoing characteristic, the researcher in the field of TCM can replace the high-frequency in the combination with the low-frequency Chinese herbs to research the new combination further. The high-frequency Chinese herbs should not be overdevelopment. Then, the start of the research can be improved, a reference can be provided for promoting the output of the innovation and completing the patent portfolio, and further promoting the development of the Chinese herbal extract combination patent.4. The patent portfolio of the traditional Chinese medicine enterprises should built combine with the inner features of Chinese herbal extract combinations. On the basis of the patent of supporting technology (such as preparation method of extract unit, the active ingredient and the purpose of the combinations) was granted, periphery research should be processed surrounding a kind of production with the junction in respect of purpose. The research and developing direction should be diversification, to increase the technology developing route. Then, apply for the patents in accordance with the technology developing route, to enhance the completeness of the patent portfolio. For increase the possibility of success of the patent portfolio, the quality and occasion should be paid more attention in the patent application.5. The patentability of Chinese herbal extract combination should be judged by a combination of the TCM theory and Patent Law. The verification data of typical units or authoritative experts in the field of TCM should be noted. And the specific standards to examination and patent infringement determination should add the special chapter on the invention of TCM.Suggestions:1. In the aspect of policy-making:The main task should mainly about to improve the policies of patent protection about Chinese herbal extract combination. Standard to patent examination is supposed to established, which would be appropriate for the patent of Chinese herbal extract combination inventions, to improve the objectivity and accuracy of patent examination and patent infringement determination. The diversified reward policy should be proposed, to increase the innovative results.2. In the aspect of company operations: The main task should mainly about to improve and perfect the patent strategy of Chinese herbal extract combination. The TCM enterprises should attach more importance to the research and development strategy of patent documents, to assist the formulation of patent strategy. To achieve the sustainable development of core patent, and strengthen the defensive patent strategy, the core patent should be surrounded by independent innovation, and the patent application should be accelerated when the innovation have the possibility of industrialization. The multiply forms of innovation should be advocated in the conditions of economic and innovation ability allow.3. In the aspect of scientific research:The main task should mainly about to improve the patentability of innovative results and to take the innovation into a product. On the basis of various scientific research fields, the research institutions should improve the rational use of patent documents information, and increase basic research, to improve the patentability of innovative results. And the collaborative innovation and development center should be built in all colleges and universities of traditional Chinese medicine, to strengthen the university-industry cooperation. And a system should be established to follow up the scientific research progress and the patent filings, and improve the industrialization of the innovative achievements. |
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