Influencing factors, evolution, and strategies for improving the quality of traditional Chinese medicine patents: an empirical study based on patent invalidation cases

Abstract

This study analyzes 134 invalidated traditional Chinese medicine (TCM) patents from 1984 to 2021 to explore common weaknesses and track quality progression. The findings highlight that TCM patents applied for between 2001 and 2005 face higher invalidation rates, with disputes often arising 4–7 years post-application. Disputes are concentrated in patents related to cardiovascular and cerebrovascular diseases, exacerbated by widespread geographical distribution and technology saturation. Combination patents are more prone to invalidation than single-component ones, and patents using preparation methods to describe products carry hidden risks. Additionally, citing more references positively impacts patent stability. Despite progress, TCM patents still encounter significant challenges in quality and consistency.

1. Introduction

Despite being the source of medical relief for 80% of the global population, traditional medicine (TM) and its associated knowledge are generally perceived as a form of local knowledge, in contrast to Western medicine [1]. Patent rights serve to prohibit others from selling, manufacturing, producing, advertising, or otherwise utilizing an invention or idea for which an individual holds a patent. A patent, however, does not confer an automatic right to use the invention. Rather, it represents a national authorization granting exclusive rights for a limited duration over a novel and practical invention. Typically, these rights are territorially bound, necessitating inventors seeking protection across multiple jurisdictions to obtain corresponding patents [2]. Such calls appear to resonate within intellectual property (IP) systems and are informed by the commercial and trade value of TM [3]. There are no simple and uncontroversial answers when dealing with the question of how to legally protect TM. IP rights can be used to protect traditional knowledge in general, and TM in particular. Patents emerge as a powerful tool to protect TM, particularly when the alternatives are explored. The case is even clearer when public perception is considered. In China patents are a popular method of protecting traditional Chinese medicine (TCM) [4].

The report of the 20th National Congress of the Communist Party of China emphasized the need to ‘promote the inheritance, innovation and development of traditional Chinese medicine (TCM)’. In recent years, the Chinese government has progressively introduced multiple policies on TCM innovation to facilitate the development of new drugs based on TCM, establish a unique evaluation and approval system suitable for TCM laws, and liberate TCM from the constraints of Western medicine. The patent system is a crucial mechanism for promoting innovation and development in the TCM industry, with the quality of patents being a key factor for the market to contribute to technological innovation. Since the implementation of the Patent Law in 1985, the overall number of patent applications and authorizations for TCM has consistently increased. Yet, there have been constant disagreements in the TCM and intellectual property communities concerning the quantity and quality of TCM patents. Through an analysis of the maintenance period of TCM patents in China, Xuefei and Hongmei [5] have demonstrated that most authorized TCM patents are maintained for more than 12 years, indicating optimism about TCM patent quality. Shengyan et al. [6] have posited that the increase in the number of authorized patents and market share for TCM has not kept pace with the rapidly growing number of patent applications, suggesting that many of the applications are of low quality. Based on the perspective of research and development investment, Yadi et al. [7] have determined that the number of patent applications by listed TCM companies in China from 2012 to 2016 was within a reasonable range. However, abnormal patent applications were observed, and the quality of patents needed improvement. Therefore, TCM patent quality and the existing problems are worthy of further exploration.

Invalidating a patent is an action taken by a third party who discovers that an authorized patent does not meet the requirements for patent authorization and requests a declaration of invalidity of the patent. If the patent grant does not meet the legal authorization conditions, the Patent Reexamination Board corrects the improper authorization through a declaration of invalidity or partial invalidity of the patent. From the perspective of the public and potential stakeholders, the patent invalidation system helps identify and eliminate problematic patents. It serves as a control mechanism for patent quality after authorization [8]. From the perspective of the patent examination authorities, the invalidation system helps correct errors or improper authorization and serves as a post-authorization remedy for patent authorization examinations. The invalidation review procedure is a retrospective verification of patent quality.

In general, the quality of patents involves three aspects: the quality of the patent itself, of the patent right, and of the patent system’s operation. Evaluating patent quality comprehensively involves considering technical, legal, and economic aspects [9]. The request for invalidation of a patent is usually initiated by a third party, which naturally proves that the patent in question has economic value. Invalid patent cases are controversial cases in which the granting standard is disputed. From the perspective of invalid cases, analyzing TCM patent quality can more fully reflect TCM patents’ technical and legal quality issues. Therefore, this paper identified invalid TCM patents since the implementation of China’s Patent Law as the research object and conducted empirical analysis of the disputed technical and legal characteristics of these patents. It also combined relevant policies on Chinese medicine and intellectual property rights to reveal the evolution of TCM patent quality. Furthermore, it identified existing problems in the protection and examination of TCM patents and provided targeted policy suggestions to enhance the quality of examination and protection.

2. Data resource and research method

2.1. Data resource

This study utilized the official website of the Patent Reexamination Board of the National Intellectual Property Administration as a data source. It collected 134 invalidated decision documents for publicly disclosed TCM invention patents spanning from 1984 to 2021. The researcher categorized and reviewed the trial information of each decision document. Furthermore, the researcher employed the National Intellectual Property Administration’s patent search and analysis platform to gather relevant publicly disclosed documents for each disputed patent to further analyze each patent’s technical features. Through this method, the researcher aimed to analyze technical and legal quality issues associated with TCM patents. The ultimate goal was to propose policy recommendations that could contribute to the enhancement of the quality of patent examination and protection.

2.2. Research method

The study selected appropriate legal and technical feature indicators from the review process and disputed patent technical documents of invalid TCM patent cases. These indicators included invalid decision time, disputed patent application time, patent age, scope of disease treatment, number of medicinal ingredients, protection object, protection strategy, number of claims, and citation count. Subsequently, the research conducted a statistical analysis, examining the number of invalid requests and decision outcomes for each feature indicator. The study calculated the proportion of invalid requests and assessed the success rate of invalidation to gain insights into the quality issues associated with TCM patents. Through this approach, the study aimed to identify the weaknesses in TCM patent quality.

In exploring low-quality patents, when evaluating the invalid success rate, a score of 1 was assigned to all invalid decision results, 0.5 was assigned to partial invalid decision results, and a score of 0 was assigned to upheld valid decision results. The invalid success rate score I can be represented as follows:

$$I=\frac{W_i+0.5P_i}{M}$$

Where Wi denotes the number of all invalid decisions, Pi denotes the number of partial invalid decisions, and M denotes the total number of the three types of decisions [10].

In theory, a higher proportion of invalid requests among the selected indicators suggests greater controversy over the rights and technology associated with the corresponding type of TCM patent. The reasons for heightened controversy over industrial patents with different characteristics can vary. In industries involving discrete products, such as the chemical and pharmaceutical fields, patents are often utilized to prevent competitors from developing alternatives. Invalid requests are frequently employed to safeguard new developments. The existence of numerous similar or imitative technologies with weak heterogeneity, which cannot serve as a ‘special resource’ to enhance competitiveness [11], leads to disputes over patent rights. This points to extensive homogenization of patents in this field, a low level of innovation, and poor quality of writing as fundamental reasons for initiating disputes.

Furthermore, a higher score in the invalid success rate among the selected indicators indicates a greater likelihood that the corresponding type of TCM patent technology scheme will face rejection, highlighting lower stability and consistency in patent examination. The primary reason behind this is the influence of ‘pro-patent policy’ and the impact of ‘rational neglect’ [12] in the authorization examination process, leading to a lower quality of examination [13]. Categories with high invalid success rates in indicator analysis can be identified as weak points that are easily ignored in authorization examinations. This suggests that examinations in these areas lack uniform standards and are highly influenced by examiners’ subjectivity. Therefore, further consideration of the applicability of examination standards is essential.

3. Analysis of factors affecting TCM patent quality

3.1. Patent application time: TCM patents applied for between 2001 and 2005 are more likely to be invalidated

Based on the analysis of the number of invalid requests and the success rate of invalid patents concerning the application time of disputed patents, it was observed that before 1990, the earliest applied TCM patents exhibited a low proportion of invalid requests and a correspondingly low success rate, constituting only 3.0% of requests. Between 1990 and 2000, the proportion of invalid requests and the success rate of TCM patents increased slightly, with request proportions rising to approximately 7–8%, accompanied by an increase in the success rate. However, between 2000 and 2010, the proportion of invalid requests and the success rate of TCM patents increased substantially. In particular, the patents applied for between 2001 and 2005 were most frequently subject to invalid requests, with a request proportion of 61.2% and the highest success rate of invalid requests. However, after 2011, the proportion of invalid requests and the success rate of patents applied for decreased to historically low levels (Figure 1). The analysis indicated a stage-specific clustering phenomenon in the application time of disputed patents. TCM patent applications between 2001 and 2005 were most likely invalid, while patent applications after 2011 demonstrated greater stability.

Figure 1.

The proportion of invalid requests and the success rate of invalidity change with the patent application time.

3.2. Patent age: patent disputes frequently occur 4–7 years after application

The age of disputed patents refers to the time elapsed from the date of application to the date the invalidity request was filed. The analysis revealed that, for TCM patents over 10 years, an extended maintenance time was associated with a lower proportion of invalidity requests and a decreased success rate for disputed patents. Conversely, for TCM patents less than 10 years old, the frequency of invalidity requests was highest between 4 and 7 years of age, with the highest success rate observed for patents between 4 and 6 years old (Figure 2). The analysis indicated that a substantial number of invalidity requests for TCM patents were filed within two to three years after patent authorization, and during this period, the success rate of invalidity was high. Data highlighted that the age at which TCM invention patents become invalid aligned with the general trend observed in Chinese patents [14].

Figure 2.

Invalid request proportion and invalid success rate scores across different age groups.

In the pharmaceutical industry, the value of inventions generally increases over time, especially as they gain approval from regulatory authorities and gain recognition from medical professionals. Therefore, competitors frequently challenge these inventions after they are granted patents and receive regulatory approvals [15]. Such decisions are more often made in accordance with the economic value of patent rights. The refinement of patent technology occurs two to three years after authorization, coinciding with the maturation of market cultivation. During this period, patentees may begin to enforce their patent rights, and the existence of these rights may restrict market competition, thereby increasing the risk of patent litigation. In cases of patent infringement, accused infringers often counter-sue using claims of invalidity. As the maintenance time of a patent increases, the risk of it being threatened by invalidity decreases. A patent right that has withstood the test of market competition tends to exhibit higher stability.

3.3. The treatment (application) field: patent technology related to three types of diseases, including cardiovascular and cerebrovascular diseases, are the hot spots for disputes

As indicated in Table 1, invalid cases involve 11 disease areas, with the top three treatment areas being cardiovascular and cerebrovascular, gynecological, and bone and joint diseases. Over 50% of invalid cases pertain to these top three disease areas, and their invalid success rate values are also the highest. This suggests that TCM patents in these disease areas are contested and exhibit the lowest stability of rights. Innovation is driven by harmful competition within a low-level innovation environment.

Table 1.

Proportion of invalid requests and the success rate of invalidity scores for different disease types.

Disease types	Proportion of invalid requests (%)	Success rate of invalidity scores
Cardiovascular and cerebrovascular diseases	23.1	0.082
Gynecological diseases	16.4	0.056
Bone and joint diseases	15.7	0.060
Tonics	10.4	0.041
Tumor diseases	7.5	0.026
Liver and gallbladder diseases	6.0	0.052
Heat-clearing and detoxifying	5.2	0.022
Ophthalmic diseases	4.5	0.015
Respiratory diseases such as cough and asthma	4.5	0.007
Skin diseases	3.7	0.026
Spleen and stomach diseases	3.0	0.019

3.4. Widespread geographical distribution of disputed enterprises: homogenization issues and technology saturation in patent applications

The analysis of invalidation cases shows that patent disputes are most common in the fields of cardiovascular and cerebrovascular diseases, gynecology, and osteoarticular diseases, where patent stability is also the weakest. The invalidation request rates and success rates vary across these disease categories, with 36, 34 and 35 patents involved in disputes related to cardiovascular and cerebrovascular, gynecological, and osteoarticular diseases, respectively. Compared with disease fields with fewer disputes, companies involved in disputes in these areas are more widely distributed geographically (Figure 3), encompassing all regions where TCM companies are located in China, with minimal variation in distribution across regions. There are numerous varieties of TCM in these three disease fields with a high degree of innovation based on ‘secondary innovation’, involving improvements and inventions on classic formulas with five or fewer flavors [16]. This implies that the number of existing technologies and the saturation of technology are relatively high in these disease fields, resulting in a small difference in distinguishing features between technologies. Furthermore, according to the World Traditional Medicine Patent Database, the types of finished medicinal materials involved in patent applications are primarily concentrated in more than 10 common plant-based medicinal materials such as Angelica sinensis, Glycyrrhiza uralensis, Astragalus membranaceus, Carthamus tinctorius, Rheum palmatum, Paeonia lactiflora, and Panax notoginseng [17]. Despite the existence of 13,000 Chinese medicinal materials in China, the variety of Chinese medicinal materials in the field of applying for TCM patents is minimal. This indicates that exploring innovative resources for Chinese medicinal materials is far from sufficient, and there is a serious homogenization problem in developing classic formulas.

Figure 3.

The distribution of TCM companies in the disease fields with the most patent disputes.

3.5. Protecting the object: combination patents are more likely to be invalidated than single-component patents

The protection object of TCM patents is divided into two categories: combination and single-component patents. Combination patents involve prescriptions comprising two or more organically combined drugs based on TCM theory to target specific conditions, contrasting with single-component (single herb) patents [18]. Both combination and single-component patents are further divided into three categories based on the exact composition of the components: raw materials, extracts, and active ingredients or effective components. Raw materials are direct preparations of Chinese medicinal materials through simple processes such as cleaning and grinding. Extracts involve using solvents to extract and separate medicinal materials, with the composition of the product being unclear, such as paste, clear paste, and thick paste. Active ingredients or effective components are more refined extracts and separations. These can be characterized by secondary metabolites of natural medicinal materials, including alkaloids, flavonoids, anthraquinones, coumarins, terpenes, saponins, cardiac glycosides, volatile oils, and other substances [19]. An analysis of the percentage of invalid requests and invalid success rate values based on the degree of characterization of disputed patent components revealed that the overall probability of combination patents being invalidated was higher than that of single-component patents. The percentage of invalid requests for combination patents was 80.6%, significantly higher than that of invalid requests for single-component patents at 19.4%. Moreover, the invalid success rate values for all three types of combination patents were higher than those for their respective single-component counterparts, with the highest being combination extracts (see Table 2).

Table 2.

Proportion of invalid requests and invalid success rate score of different component characterization levels.

Protection object(component characterization levels)	Proportion of invalid requests (%)	Success rate of invalidity scores
Active ingredients or effective components of single-component	14.2	0.030
Extracts of single-component	2.2	0.007
Raw material of single-component	3.0	0.004
Active ingredients or effective components of combination	9.7	0.056
Extracts of combination	59.7	0.254
Raw materials of combination	11.2	0.063

3.6. Protection method: writing patent claims using preparation methods to characterize the product’s hidden risks

Explaining the specific composition of most TCM products, legally considered mixtures, is challenging. In patent protection practice, describing TCM technical solutions only through structure and/or composition can be difficult. Therefore, preparation methods are often employed to characterize product claims, ultimately achieving the goal of jointly protecting products and methods. Four protection methods have been developed for TCM patents: composition and quantity characterization, preparation method characterization, simple protection of preparation methods, and product combination methods and usage. TCM patents characterized by preparation methods are most frequently challenged and have the highest invalidity rate. According to Article 11 of the Patent Law, the scope of protection for method claims extends to the method and the products directly obtained by the method. Thus, most challenged and invalidated TCM patents relate to the preparation method. Although widely used, this protection method may pose certain risks to the stability of TCM patents (Table 3).

Table 3.

Invalid request ratio and invalid success rate value for different protection methods.

Protection method	Proportion of invalid requests (%)	Success rate of invalidity scores
Preparation method characterization	66.4	0.269
Simple protection of preparation methods	16.4	0.071
Product combination methods and usage	9.0	0.030
Composition and quantity characterization	8.2	0.045

3.7. Citation of references: quantity positively affects the stability of the patent

There are two types of citations for TCM patents: patent literature and non-patent literature. From the perspective of the proportion of invalid requests, disputed patents with cited patent literature constitute approximately 70%, and disputed patents without cited patent literature constitute 29.9% (Table 4). Disputed patents with cited non-patent literature constitute 49.3%, roughly the same as the number of disputed patents without cited non-patent literature (Table 5). Although the citation rate of patent literature for disputed TCM patents is higher than that of non-patent literature, the citation quantity for patent literature is not high, averaging only 1–2 citations. From the perspective of the invalid success rate for both patent and non-patent literature, the invalid success rate of disputed patents without citations is the highest, decreasing as the number of cited literature increases. This indicates that the number of citations positively affects the stability of TCM patents.

Table 4.

The invalid request proportion and invalid success rate scores for cited patent literature.

Citation quantity for patent literature	Proportion of invalid requests (%)	Success rate of invalidity scores
No citation	29.9	0.138
1	27.6	0.101
2	27.6	0.116
3	8.2	0.019
Above 4	6.7	0.014

Table 5.

The invalid request proportion and invalid success rate scores for cited non-patent literature.

Citation quantity for non-patent literature	Proportion of invalid requests (%)	Success rate of invalidity scores
No citation	49.3	0.235
1	7.5	0.026
2	6.0	0.026
3	8.2	0.030
4	8.2	0.034
5	6.7	0.015
6	3.7	0.011
7	1.5	0.007
8	3.0	0.004
9	0.7	0.007
10	0.7	0.000
12	1.5	0.000
13	0.7	0.007
23	2.2	0.004

4. Evolution of TCM patent quality

Combined with the corresponding year’s Chinese patent grant rate, each year’s number and success rate of patent invalidation were compared and analyzed. From the perspective of the change in right stability, TCM patent quality can be divided into three stages: the weak period from 1997 to 2005, exploration period from 2006 to 2011, and the improvement period after 2011 (Figure 4).

Figure 4.

Variations in the number and success rate of invalid decisions for Chinese invention patents in TCM.

4.1. The weak period (1997–2005)

In July 1996, the original China National Science and Technology Commission proposed the ‘Action Plan for the Modernization of Traditional Chinese Medicine Science and Technology Industry’. After more than a year of specialized research and extensive discussions at multiple levels, a special report was submitted to the State Council in December 1997, receiving affirmation from the central leadership as well as leaders of 18 relevant ministries and units in attendance [20]. Since then, the strategy for the modernization of traditional Chinese medicine has been officially launched, marking a significant shift in the concept and methodology of research and production within the entire traditional Chinese medicine industry. Efforts have been made to break away from the traditional mode of production relying solely on conventional experience, and instead, move towards an industrialized and modernized production model.

The earliest invalidation decision of TCM patents occurred in 1997, coinciding with promulgation of the first amendment of the China Patent Law. This amendment expanded the scope of patent protection for pharmaceuticals and extended the patent protection period. Although the invalidation system was established in the first patent law in 1984, the overall number of patent applications for TCM was low during that time, with an average annual application of only 17 patents in the first five years of implementing the Patent Law. In contrast, the average number of yearly applications for chemical drug patents by domestic applicants during the same period was 64, and the average number of yearly applications for pharmaceuticals by foreign applicants in China had reached 538 [21]. This indicated that despite the existence of the Patent Law, the application of the patent system was still dominated by foreign pharmaceutical companies. Most TCM enterprises, at that time, had a deep-rooted understanding of protecting core competitiveness through trade secrets. Indigenous communities often lacked the necessary resources to effectively navigate the complexities of patent application procedures. This process extends beyond mere administrative tasks, requiring access to legal expertise for application preparation. Moreover, in the context of TCM, identifying the inventor could pose significant challenges in that time. Multiple groups may hold similar information, raising concerns of unfairness if one group were to monopolize patent rights. Consequently, reluctance to disclose proprietary information may deter groups from pursuing patent protection. Furthermore, upon expiration of the patent term, the previously protected information becomes part of the public domain [22]. A complete system of patent protection for Chinese medicine had not yet been established, and the public disclosure model in exchange for patent protection was generally less accepted.

While trade secret protection may initially seem advantageous, it presents several notable challenges. Secrecy does not necessarily have to be absolute; information can be disclosed on a need-to-know basis or under a confidentiality agreement. However, this approach seems more suitable for controlled business environments rather than broader subjects. One advantage is that trade secret protection does not require government involvement or registration. However, without sufficient evidence of efforts to maintain secrecy, courts may not recognize a trade secret in infringement litigation. Moreover, trade secret protection is generally considered weaker than patent protection as it does not safeguard against reverse engineering or independent development [4]. Furthermore, trade secret protection can impede the flow of information, particularly in industries like pharmaceuticals. From a moral standpoint, arguments may be raised against keeping potentially beneficial information secret from the public [23].

In 1992, the State Council issued the National Medium- and Long-Term Science and Technology Development Plan, which, for the first time, identified independent TCM innovation as a long-term development strategy and a key development priority for the country [24]. Since affirming the core position of independent TCM innovation from a top-level design perspective, the number of patent applications for TCM has increased yearly, with an average of more than 200 annual applications. The first invalidation request case for a TCM patent marked an awareness of using patent protection for TCM innovation. The second amendment of the Patent Law in 2000 established China’s current patent invalidation system, and a complete patent protection system was finally established [25]. In December 2001, China formally joined the World Trade Organization (WTO). To join the WTO, China had promised to adjust its patent judicial and administrative enforcement as the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) required. The TRIPS Agreement, overseen by the World Trade Organization (WTO), sets essential global standards for protecting intellectual property rights. Recognizing its importance is crucial, as it establishes fundamental guidelines for safeguarding inventions, trademarks, copyrights, and other forms of intellectual property. All WTO member countries are required to adhere to these standards, ensuring a basic level of protection. Compliance is vital for driving innovation, fostering fair competition, and enhancing international trade relations. China simplified its drug patent approval process, strived to align its drug patent protection framework with European and American conventions and requirements, and opened up the drug market further. A series of accession decisions significantly impacted China’s economic and social development. The changes made in intellectual property rights were more favorable for European and American pharmaceutical companies to skillfully use the patent system to impact and occupy the Chinese pharmaceutical market, posing a significant threat to national pharmaceutical enterprises.

In November 2002, the State Council issued the Outline for the Modernization of Traditional Chinese Medicine Development. This affirmed basic principles of modernization, including combining inheritance with innovation, developing innovative TCM products with independent intellectual property rights, and comprehensively improving TCM research and development capabilities and production levels [26]. Simultaneously, during the amendment of the Drug Administration Law in the same period, local drug standards were abolished and replaced with unified national drug standards. Furthermore, the compilation of the varieties of Chinese patent medicine that were upgraded from local to national standards was completed. With the advancement of TCM modernization and the improvement of Chinese medicine standards, some TCM enterprises, aware of patent protection, submitted patent applications for their local standard varieties in advance. This period coincided with the period before and after China’s accession to the WTO. To protect local Chinese medicine enterprises and reduce the impact on the TCM industry after joining the WTO, the TCM patent authorization rate during this period was significantly higher than those in other periods. The number of authorized patents even exceeded the number of applications that year. According to this research statistics, from 2000 to 2005, the number of patent applications for Chinese medicine was 8,489, and the number of authorized patents was as high as 8,920, with an authorization rate of over 70% in 2000, the highest in history.

However, this practice of concentrated authorizations during special periods resulted in some domestic TCM companies receiving infringement warnings or being the subject of lawsuits from patent holders who applied for patents ahead of time, when they lawfully imitated the varieties that became national standards. Most imitating companies chose to file invalidity requests against the patents, increasing the number of TCM invalid cases from 2005 until 2011, along with the success rate of invalidity requests. This fully exposes the chaos in the management and examination system of TCM patents during the process of joining the WTO and drug management reform. Under the influence of protective strategies, the examination of TCM patent authorization was quite lax. Furthermore, no clear examination norms or standards existed, resulting in serious mistakes in understanding basic issues such as publishing drug standards and recognizing existing technology.

4.2. Exploratory period (2006–2011)

In this period, the development of TCM entered a new stage. In January 2007, the State Council issued the Outline of the Development Plan for Traditional Chinese Medicine Innovation (2006–2020), which expanded the basic principle of combining inheritance and innovation to four aspects: inheritance, innovation, modernization, and internationalization. It proposed the principle of promoting modernization and internationalization together, using internationalization to promote TCM modernization. The scientific aspects of TCM theory expressed by traditional concepts are challenging to be universally understood and accepted by modern society. Thus, using modern technology to support the inheritance and innovation of TCM was encouraged. The aim of promoting TCM innovation was to fully utilize the three forces of TCM, Western medicine, and integrated Chinese and Western medicine to develop together.

Since entering the WTO, the Chinese government had continued implementing patent application policies. The State Intellectual Property Office carried out policies to reduce patent fees, and local financial institutions provided patent fee subsidies to patent applicants or patent holders free of charge. The entire society had gradually shown a patent competition and contest with the main goal of obtaining and possessing patent rights [27]. Against the backdrop of patent competition, the number of TCM patents also multiplied. From 2006 to 2013, TCM patent applications reached 40,715, with an authorization rate between 38 and 46%. The annual average application volume was 4.8 times that of the previous five years. Even if the authorization rate had declined compared with the rate in the previous period, the authorization volume was still more than double. However, many of the authorized patents for TCM were based on the excavation and revival of classical TCM prescriptions and folk prescriptions, and the stability of their patent rights was at risk. The number of ineffective TCM cases during this period continued to increase. In addition, many TCM patents authorized in China had not been truly industrialized. By contrast, Europe, America, and Japan had significant momentum in the international patent regime of herbal medicine and TCM and had already gained enormous economic benefits, putting pressure on China’s share of the international and domestic TCM markets [28].

Simultaneously, the intellectual property community was increasingly concerned about the issue of ‘junk patents’, believing that the source of ‘junk patents’ lay in enterprises using funding policies to make inappropriate applications [29,30]. In October 2007, the State Intellectual Property Office issued ‘Several Provisions on Regulating Patent Application Behavior’, prohibiting abnormal patent application behavior. In June 2008, the State Council issued and began implementing the ‘National Intellectual Property Strategy’, further emphasizing the need to continuously improve the level of patent administrative law enforcement. Furthermore, it increased talent training in patent examination, improved patent examination procedures according to the conditions for granting patent rights, and enhanced the quality of the examination. These policies and regulations marked the awakening of quality consciousness in the Chinese patent system. During the same period, the number of invalid requests and success rates for invalidation of TCM patents applied for and authorized were significantly lower than those before 2005. This suggests that the awareness of patent quality impacted the field of TCM patents, with administration entering an exploration stage for improving TCM patent quality. During this period, the national Twelfth Five-Year Major New Drug Creation’s major scientific and technological project supported the clinical research on a range of innovative compound Chinese medicines with market prospects. Simultaneously, it involved screening large varieties of drugs with high market demand and added value, utilizing technological innovation and upgrading to enhance the quality of large varieties of drugs. Innovative TCM varieties with independent intellectual property rights, such as Di’ao Xin Xue Kang and Danshen Capsules, were cultivated and obtained EU market approval [31].

4.3. Period of enhancement (after 2011)

During this period, the government gradually realized that a quantitative patent strategy could no longer provide sufficient innovation for economic development. In 2014, the State Council issued the Action Plan for Implementation of the National Intellectual Property Strategy (2014–2020) and prioritized improving intellectual property creation quality. Patent creation began to seek a transition from the previous quantity scale to a quality-benefit model, in which increasing quantity while enhancing quality became the watchword in the deployment of intellectual property creation work. The same year, the State Intellectual Property Office issued ‘Several Opinions on Further Improving the Quality of Patent Applications’, highlighting the quality-oriented regional patent evaluation approach. In 2015, the ‘Several Opinions of the State Council on Accelerating the Building of a Strong Intellectual Property Country under New Circumstances’ proposed launching a patent quality improvement project to enhance intellectual property’s added value and international influence. The work orientation of ‘high-level creation, high-quality application, efficient examination, and high-standard granting’ was established, emphasizing improving patent examination quality as the key to improving patent quality [32]. To enhance the quality of patent examinations, the State Intellectual Property Office established a patent examination quality evaluation group and a non-normal patent application monitoring group. Moreover, it hired patent examination quality supervisors, strengthened the evaluation and feedback of patent examination quality, formed a dual supervision mechanism of internal and external examination quality, and strengthened the monitoring of non-normal patent applications [33].

In February 2016, the State Council issued the ‘Outline of the Development Plan for Traditional Chinese Medicine (2016–2030)’, which gave strategic attention and expectations to the development of TCM [34]. The plan proposed relying on the development of TCM to promote economic transformation and upgrading, cultivate new economic growth drivers, further stimulate the original advantages of TCM, and promote the high-quality and efficient development of the TCM industry. At the end of the same year, the first ‘Law of Traditional Chinese Medicine’ was promulgated [35]. This law was aimed at establishing and improving a scientific and technological innovation system, evaluation system, and management system in line with the characteristics of TCM, thereby promoting the progress and innovation of TCM science and technology. Since then, the TCM field has formed a complete regulatory system of ‘one law and one outline’ to provide guarantees.

With the implementation of various policies and measures for the patent quality improvement project, according to this research statistics, the average authorization rate of TCM patents has further decreased to approximately 20.0%. At the same time, the number of invalid requests and the success rate of invalid cases for TCM patents have further decreased, indicating that the authorization standards for TCM patents and post-authorization stability have improved. Under the new situation, the development strategy of TCM and the project to improve patent quality facilitate the development and improvement of TCM patent quality.

5. Conclusion: analysis of problems in the protection and examination of TCM patents

5.1. The existing patent protection model cannot reflect the technological innovation of TCM compound formulations

Through the statistical analysis of disputed patent subjects in invalidation cases, it is found that for TCM patents, combination patents are the most common type of technical solution that triggers disputes, and the success rate of invalidating compound patents is relatively high, especially for issues related to combination extracts. The core issue stems from the mismatch between the current protection models and the specific needs of patent protection for combination TCM in China. In practice, compromises are often made between technical features and patent protection, resulting in a higher frequency and rate of invalidation for compound invention patents.

The combination of using multiple medicinal herbs is one of the most prevalent medication modalities in TCM. Each combination of herbs utilized for treatment in TCM is referred to as a preparation. Efforts to extract and characterize active compounds from TCM preparations, as well as to elucidate their mechanisms of action, hold great promise for the development of novel drugs [36]. However, this innovative approach of extracting active ingredients from combination TCM formulations is better suited for modern patent protection models, as it fundamentally constitutes pharmaceutical innovation. China’s patent protection system was largely transplanted from western countries and was naturally more tailored to protect innovations involving the extraction of single components. It has not adequately addressed how to protect the innovative modes inherent to TCM combination.

Currently, there are two paths for TCM patent protection: one is to adopt Western medicine standards in research and development and preparation of patented TCM, making it easier to obtain patents internationally. This trend can be called ‘the westernization of TCM’. [37] The other path is to expand and modify the existing patent examination rules compatible with Western medicine to apply them to TCM inventions [38]. For example, in the China Patent Examination Guidelines framework, TCM inventions with unknown components have obtained patents in the form of compound and use inventions. Therefore, the characterization of ‘Product by Process’ is commonly used in TCM patent applications.

Overall, the existing patent protection mode for TCM analogizes technical solutions to chemical combination formulations, converting the allocation of components into factors and parameterizing the preparation conditions and method parameters. The technical scheme differences formed under this protection mode also fall into two categories: one involves altering the composition and ratio of the components and applying them as new formulations after expanding or replacing ancient formulas [39]. The other entails changing the dosage form or preparation method, transforming traditional decoctions, pills, powders, wines, etc., into modern dosage forms such as tablets, capsules, granules, injections, etc., or changing the original preparation method while adjusting the ratio of excipients and raw materials [40]. These types of patents constitute 89% of the invalid TCM patent cases. However, in practice, changing the composition and ratio of the components are often considered as additions, reductions, or substitutions under the guidance of the principle of traditional technical compatibility and represents a transformation of traditional technology. Changing the dosage form or preparation method is often considered as applying conventional means in chemical pharmaceutical technology to the less commonly used field of TCM, representing the transplantation of technology from an adjacent industry. These transformations or transplantations are considered to be completed through a limited number of experiments or knowledge-based judgments, invalidating many TCM patents.

In the field of TCM technology, many ancient prescriptions and folk remedies only have simple component records, and the specific effects are unclear or lack scientific data for verification. Resurrecting roughly recorded TCM into modern Chinese medicine with exact efficacy data is difficult for professionals in this field. It requires innovation in formula efficacy screening, pharmacological and toxicological experiments, drug preparation research, pilot scale-up, and other aspects, entailing significant innovation difficulty. However, under the existing standard framework, it is easily judged as lacking novelty or creativity, which is not conducive to the inheritance and innovation of TCM.

5.2. The legal representation of the technical characteristics of TCM is single and flawed

The examination of TCM patents has long followed the method used for chemical drugs. Therefore, the writing of TCM patents has also attempted to imitate the writing of patents for chemical compositions, mainly using the peripheral limitation method to draft the claims. First, the overall concept of the technical solution is recorded, and then the existing technology and distinguishing features are divided into independent claims through connecting language. Then, dependent claims are formed by limiting the combination of distinguishing technical features, and the number of dependent claims can be stacked with different limited features, thus forming multiple claims [41].

The guidelines for examining chemical drug patents are also used as a reference for writing TCM patents [42]. The provisions regarding the use of preparation methods to characterize products are employed as distinguishing technical features, encompassing changes in steps, raw materials, excipients, devices, environment, and other aspects, to pursue the widest possible protection scope. Many TCM patents use the peripheral limitation method to draft the claims, presenting routinized and formulaic features on the surface to comprehensively protect the formulation. However, from the perspective of invalidity examination results, using preparation methods to protect products has a relatively high invalidity rate.

In fact, the technical scheme characterized by the preparation method to produce the product’s writing requirements originates from the central limitation: generalizing multiple specific implementation methods and forming functional limitation technical features. This generalization requires a large amount of experimental data basis, and the scale and results of the experiments must be reflected in the specification. However, many TCM invention patent specifications are simple in content, have a relatively short length, and lack experimental data support. According to statistics, TCM patent applications in China are, on average, 8 pages, whereas foreign invention patent applications in China average 25 pages [6]. Due to the lack of sufficient data support in patent writing, it is difficult for the examination to reveal a technical scheme with beneficial technical effects or significant progress.

5.3. The ability to apply existing technology in the process of innovation and transformation in TCM urgently needs improvement

Shortcomings exist in the TCM patent applications for existing technologies with regard to literature citation awareness, citation initiative, and citation ability. The proportion of TCM patents without citation is relatively high, indicating that the awareness of utilizing existing literature is relatively weak. Several TCM patents are based on traditional techniques or technical secrets. Applicants usually believe that a unilateral technical scheme that has never been disclosed naturally meets the patent’s novelty and creativity requirements, without searching for similar technologies that have been used or disclosed. At the same time, they also lack the professional conditions for retrieval [43]. Most TCM companies have not yet adopted professional database systems to retrieve literature on their relevant technology research and development.

Furthermore, numerous TCM patents are improvements based on ancient formulas, folk prescriptions, and folk remedies. To prevent the novelty from being destroyed, the applicant intentionally conceals key basic technologies, or due to limitations in the level of retrieval ability, the scope of retrieval analysis is not comprehensive enough. They only use a familiar database for querying without reasonably utilizing other databases, leading to incomplete retrieval and possibly repetitive research and development and ultimately the wastage of scientific research resources.

From this research, it could be found TCM patents provide few references, averaging only 1–2, and non-patent literature is seriously neglected. Patent literature discloses applied existing technologies, and non-patent literature discloses scientific research results, including many cutting-edge achievements and key technologies that can promote significant progress in the industry. They provide important content on the patent background technology and are essential for understanding and reproducing the invention points. Emphasizing only patent literature and overlooking non-patent literature can affect the completeness of the patent, leading to unstable rights and a failure to analyze the technical meaning and extension. This may result in a loss of opportunity to prove breakthrough technologies.

6. Expert opinion: suggestions for improving the examination and protection policies for enhancing TCM patent quality

6.1. Establish a special patent examination mechanism that emphasizes the innovation of TCM technology

No specific standard exists for the examination of TCM patents in the Patent Examination Guidelines. Instead, they are examined according to the standards for chemical drugs, which are unsuitable for TCM. The categorization of knowledge systems into Western and non-Western paradigms, along with their interaction within cosmopolitan and local contexts, is emblematically illustrated by the dichotomy commonly drawn between Western orthodox medicine and traditional medicine [44]. In general, TCM encompasses a spectrum of medical traditions grounded in distinct and often interconnected theories and philosophies, markedly divergent from those of Western orthodox medicine. TCM differs fundamentally from Western medicine in its orientation, theories of physiology, etiology, diagnostic methodologies, therapeutic modalities, and pharmacological approaches. The primary disparity between TCM and Western medicine lies in their foundational medical theories. While Western medicine adopts a Cartesian reductionist approach, emphasizing the separation of mind and body, TCM adopts a holistic perspective. TCM is considered both an art and a science, viewing humanity as an integrated whole, where the mind, body, and spirit are interconnected. This interconnectedness extends to the broader unity between individuals and their communities, which serves as a central objective of traditional therapy. Treatment in TCM is approached holistically, taking into account the entirety of the individual [45,46].

Therefore, establishing examination standards that align with the characteristics of TCM is crucial to guide the development of TCM innovation. The specific standards can be conceived from the following points: (1) incorporating the theories and principles of TCM into the requirements for ‘creativity, novelty, and utility’ in patent judgment so that TCM theories and the medicines can benefit from the patent system for innovation and development; (2) considering the overall treatment characteristics of TCM, strengthening the verification requirements in pharmacology and pharmacodynamics such as ‘improving efficacy, reducing adverse reactions, and changing the main disease and symptoms’ when evaluating the innovative level of TCM technical solutions, and appropriately weakening the analysis of the relation between similar compound elements and judgments on whether parameter changes provide teaching inspiration; (3) appropriately increasing the creative standards for technology solutions that already have commercial benefits and industry preparation and encouraging applicants to disclose commercial data so that examiners can make overall judgments based on the existing benefits; and (4) clarifying the specific forms of technology innovation in the field of TCM, emphasizing the ‘inventive points’ in the overall formulation design and technical route of TCM compound prescriptions, and strengthening the requirements and adoption of clinical efficacy evidence for TCM inventions.

6.2. Designing a technical feature characterization method applicable to patents for TCM compound formulations

Reasonable patent creative authorization standards can guide the direction of innovation activities and optimize the quality of patent applications. Based on the special examination standards for patents in the field of TCM, the strategies and protection modes for applying for TCM patents are discussed, aiming to develop a ‘Guideline for Writing Patent Applications in the Field of TCM’ to achieve a unified standard for examining and protecting and comprehensively improving TCM patent quality.

This could break through the widely used method of characterizing products through preparation methods and overcome the limitations of peripheral writing methods by establishing a characterization and writing method specifically applicable to TCM patents. First, the difference between TCM patents and compound patents and the use of secondary metabolites as a basis for classification are distinguished. If the technical scheme is characterized by secondary metabolites, it will be classified into the compound field, and if the names of component TCM flavors still characterize the technical scheme, it will be classified as a TCM patent.

Regarding the distinguishing features of TCM patents, it is necessary to characterize them through feature analysis, with detailed implementation examples and efficacy data. Writing is no longer the main method for constructing necessary technical features. The emphasis is on using the overarching concept of the technical scheme and distinguishing features. Instead, TCM patent applications should be grounded in citing existing literature as the foundation for the invention. Similarly, it is crucial to incorporate background basic knowledge, including TCM theory and medicinal material-producing areas, in TCM patent applications. Additionally, the verification of distinguishing features should be conducted through comparative data in pharmacology and pharmacodynamics experiments, focusing on aspects such as improving efficacy, reducing adverse reactions, and changing the main symptoms of the disease.

6.3. Using intellectual property policy tools to actively guide the industry and prevent simple and repetitive research and development

The TCM industry association should focus more on research and development trends, regularly release industry research updates and analyses, and guide TCM inventors on increasing their focus on technology research and development gaps and areas with little controversy. For example, they could focus on innovations in Chinese patent medicine for treating spleen and stomach, dermatological, and ophthalmological diseases, as well as some other rare diseases. Biodiversity conservation should also be integrated into the development of Chinese medicinal resources. Agricultural knowledge property protections should be established as a prerequisite to build agricultural science and technology parks, purposefully absorbing potential invention patents to form a patent pool. Integrated management and operations can be adopted to promote technological innovation in areas such as Chinese medicinal plant germplasm resources, cultivation technology, and inspection and identification. TCM companies should be encouraged to develop single herbs and simple compound classic Chinese medicine prescriptions and break through the extract level in the secondary development of existing varieties. New formulations and other therapeutic uses could be developed at the level of practical components, focusing on their pharmacological mechanisms and patent layout around their effective sites or components. Simultaneously, a supervisory and evaluative organization for compound patent quality should be established to assist patent examination departments in evaluating TCM innovation, tracking, and recording the development, technology transfer, and operation of already authorized patents for actively guiding TCM patent innovation toward promoting industry development.

Funding Statement

This work was supported by Shanghai Philosophy and Social Science Planning Research Project under [Grant No. 2021ZFX003].

Ethical approval

It is a research on medicine patent without involving laboratory or clinic study, there is no need to obtain ethical approval or other relevant permissions for this research.

Author contributions

The author Xin LI conceived of the presented idea, acquired the funding, verified the analytical methods, collected data and developed patent analysis, writing – review & editing. The author agreed to be accountable for all aspects of the work.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Data availability statement

Raw data were generated at Patent Reexamination and Invalidation Examination Department of China National Intellectual Property Administration. Derived data supporting the findings of this study are available from the corresponding author X LI on request.