Protect traditional Chinese medicine products in the United States and China
“In theory, product claims offer the strongest patent protection because they are not limited to the use or preparation of the traditional Chinese medicine (TCM) product. In reality, however, the assessment of counterfeiting often involves examining the methods used to prepare the TCM product.
Traditional Chinese Medicine, or TCM, is a subset of herbal medicine. MTC patent applications generally fall into four categories.
- A compound formula is the predominant type of Chinese medicine patent application. This is not surprising because most TCMs combine two or more medicinal substances to be effective.
- Medicinal craftsmanship refers to the active ingredients extracted from medicinal materials using a specialized process, or the specialized process itself.
- Medicinal materials refer to the original medicinal materials used in the preparation of Chinese medicines. Some of these original medicinal materials are the whole plant or a certain part of the plant, and some have to be processed.
- Related products refer to non-medicinal products containing Chinese medicines, including medicated foods, namely functional foods, health products and cosmetics containing Chinese medicines.
These categories reflect the main objectives of TCM patent protection: namely, to protect the formula, craftsmanship, original materials, and commercial products.
Complaint Forms and Scope
Method claims are useful when the process for preparing, purifying or extracting the TCM product is innovative, but the final composition is unclear. It is important to define the complaint form according to the characteristics of the raw materials, the process and the dosage. The raw materials must include all the components and proportions used to prepare the TCM product. The process should include all stages and conditions, such as temperature, pressure, time, etc. The dosage can be broadly described as “drug”, if one skilled in the art can understand what this means in light of the patent; otherwise, the dosage must be specific. Below is an example of TCM method claim:
A process for the production of a medicament for postpartum treatment, prepared from: 20 to 30 parts by weight of motherwort, 3 to 9 parts by weight of angelica, 1 to 6 parts by weight of ginseng, 6 to 12 parts by weight of astragalus, and 5-13 parts by weight of Polygonum multiflorum, peach stones 4-7 parts by weight, Cyperus rotundus 6-9 parts by weight, mixed with water and decocted twice, the amount of water added each time is 10 times the amount of raw material, and the decoction is 1 to 3 hours each time. The decoction is combined, filtered and the filtrate is concentrated to a clear paste with a relative density of 1.25 to 1.28, 40 to 70 parts by weight of brown sugar and 5 to 10 parts by weight of dextrin are added to make granules, which are dried into granules.
The scope of a method claim extends to the product obtained by the method. Article 11 of the Chinese Patent Law provides that “after the granting of the patent right of invention, except as otherwise provided in this Law, no entity or individual may exploit the invention without permission. of the patent owner, i.e. without use, promise to sell, sell or import products directly obtained by the patented method.
Use claims are useful when the application of the TCM product is innovative. The “Review Guidelines” provide this basic formula: “The application of substance X in the preparation of therapeutic drug Y.” Additionally, if effective ingredients are known, the claim may be written as “[t]The application of substance X in the preparation of therapeutic drug Y, where the effective ingredients are Z.
The scope of a use claim, however, is limited to the claimed use. Therefore, obtaining a corresponding method claim is advantageous when it is applicable to protect the preparation, packaging and promotion of TCM products.
Finally, product claims are useful when the final composition of TCM is known. In theory, they offer the strongest patent protection because they are not limited to the use or preparation of the TCM product. In reality, however, the assessment of counterfeiting often involves examining the methods used to prepare the TCM product. The bottom line is that there must be sufficient evidence that a product prepared by a different method is the same product prepared by the inventor.
Special features of TCM patents in Chinese patent infringement lawsuits
As previously stated, the method claims are useful when the process for preparing, purifying or extracting the TCM product is innovative, but the final composition is unclear. Most MTC patents fall into this category and these patents present unique litigation challenges.
For example, Beijing Yadong Biopharmaceutical Co., Ltd. (“Yadong”) and Guizhou Kangna Shengfang Pharmaceutical Co., Ltd. (“Kangna”) have been involved in litigation over a patent for MTC. in Beijing No. 1 Intermediate People’s Court. [(2006)??????8603?.] The court concluded that claim 3 of patent No. ZL02134148.6 was different from Yadong’s TCM capsules. Specifically, the Court found that in claim 3, “Fructus corni is decocted three times with water… a drug residue plus 5 times the amount of 90% ethanol for the reflux extraction twice, 1 hour each time ”, where Yadong’s capsule was“ Cornus fruit plus ethanol refluxed for the second time… drug residue to be used ”, which was a significant difference. Therefore, the method of prescribing and preparing Yadong capsules did not fall within the scope of protection of claim 3.
Another example includes the appeal of a patent infringement dispute between Guizhou Baixiang Pharmaceutical Co., Ltd. (“Baixiang”) and patent holder Zhao Shusheng. [(2011)???????6?.] Baixiang, the defendant, obtained approval to register the drug and disclosed its method of preparation on the drug’s label. The most important difference is that the claimed patent uses two ethanol refluxes and the respondent adopted the three ethanol reflux technique, and the timing of each reflux was also different.
The Applicant argued that three reflux and two reflux are technologically equivalent. The Court disagreed for two reasons. First, although three reflux and two reflux both extract the active ingredients from Yantuo, the applicant has not provided sufficient evidence that they achieve the same extraction results. Second, the defendant has shown that the triple reflux has much better extraction results than the double reflux. Applicant’s witnesses also conceded that increasing the number of refluxes was more effective.
These are typical examples of TCM patent litigation where the active ingredients are primarily characterized by extraction and preparation methods, making it difficult to enforce patent rights.
TCM, as a subset of herbal medicine, has similar patent protection principles and challenges in the United States. Composition claims are useful where the active ingredients are known and can be limited to a specific use. For example, Frisun, Inc. (Wuhan, China) obtained U.S. Patent No. 7,575,772 on “Process and Composition of Luo Han Guo Fruit Syrup and Jam” which “brings together all the advantages of Luo Han Guo to meet the current market demand for a natural and sugar-free sweetener.” In TCM research, Luo Han Guo (or monk fruit) is known to have the potential to be a low glycemic index natural sweetener and therefore may be an alternative to sugar for diabetic populations. See, for example, Ying. Z., Yan. Z., Jeff. E., Chi-Fu. H., Insulin Secretion Stimulating Effects of Mogroside V and Luo Han Kuo Fruit Extract (Siraitia grosvenori Swingle) Fruit Extract., Acta Pharmaceutica Sinica., 44 (11): 1252-1257 (2009) .
The number of patent acquisitions for herbal medicines has increased dramatically. From 1976 to 2003, the United States Patent and Trademark Office (USPTO) granted a total of 1,968 herbal patents. [Surge in US patents on botanicals, NATURE BIOTECHNOLOGY VOLUME 22 NUMBER 6 JUNE 2004.] As of 2019, the USPTO has received over 4,000 herbal patent applications since 2019. This number is quite conservative, as many new application forms have yet to be released to the public. Below are a few:
The challenge will increase
Patent protection for TCM can present many challenges due to the various types of TCM products and the uncertainty of the active ingredients. As herbal medicine patents become more popular, we can expect to see similar challenges in the enforcement of patent rights in herbal medicine technology.
Shui Li is an intellectual property lawyer at Robins Kaplan. Her background is in cross-border litigation, and she has worked with a variety of technology industries, including medicinal chemistry, biotechnology, video streaming, telecommunications, and semiconductors.
Yongfeng Zheng is legal advisor to Tasly Holding Group Co. Ltd. He holds a doctorate in law, a master’s degree in medicine, and is vice-president of the China Patent Protection Association.
Chunxuan Li is a partner and patent attorney of Beijing Lifang law firm.