Protecting Traditional Chinese Medicine Products in the United States and China

“In theory, product claims provide the strongest patent protection because they are not limited to the use or preparation of the Traditional Chinese Medicine (TCM) product. In reality, however, assessing infringements often involves examining the methods used to prepare the TCM product. »

Traditional Chinese Medicine, or TCM, is a subset of herbal medicine. TCM patent applications generally fall into four categories.

  • A compound formula is the predominant type of patent application in Chinese medicine. This is not surprising since most TCMs combine two or more medicinal substances to be effective.
  • Medicinal craft 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 purposes of TCM patent protection: namely, to protect the formula, craftsmanship, source materials and commercial products.

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Claim Forms and Scope

Method claims

Method claims are useful when the process for preparing, purifying or extracting the MCT product is novel, 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. Raw materials should include all components and proportions used to prepare the TCM product. The process should include all steps and conditions, such as temperature, pressure, time, etc. otherwise, the dosage must be specific. Below is an example of a TCM method claim:

A process for producing 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 Astragalus 12 parts by weight, and Polygonum multiflorum 5-13 parts by weight, Peach pits 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 materials, and the decoction lasts 1-3 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 China’s patent law states that “After the patent right of invention has been granted, except as otherwise provided by this law, no entity or person shall exploit the invention without the permission of the owner of the patent, i.e. use, promise to sell, sell or import products directly obtained by the patented method”.

Use Claims

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 worded as follows: “[t]the application of substance X in the preparation of therapeutic drug Y, where the effective ingredients are Z.

However, the scope of a use claim is limited to the claimed use. Therefore, obtaining a corresponding method claim is advantageous, where appropriate, to protect the preparation, packaging and promotion of TCM products.

Product claims

Finally, product claims are useful when the final composition of the 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, assessing the infringement 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 noted above, method claims are useful when the process for preparing, purifying or extracting the MCT product is novel, but the final composition is unclear. Most TCM 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”) were involved in a patent dispute of MTC before the Beijing No. 1 Intermediate People’s Court. [(2006)??????8603?.] The Court found 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…drug residue plus 5 times the amount of 90% ethanol for reflux extraction two times, 1 hour each time”, where the Yadong capsule was “Fruit Cornus plus ethanol refluxed a second time…drug residue to use”, which was a significant difference. Therefore, the method of prescription and preparation of Yadong capsules did not fall within the scope of claim 3.

Another example is the appeal of a patent infringement dispute between Guizhou Baixiang Pharmaceutical Co., Ltd. (“Baixiang”) and patentee Zhao Shusheng. [(2011)???????6?.] Baixiang, the defendant, obtained permission to register the medicine and disclosed its method of preparation on the medicine’s label. The most significant difference is that the claimed patent states the use of two refluxes of ethanol and the defendant adopted the technique of three refluxes of ethanol, and the duration of each reflux was also different.

Applicant has argued that three refluxes and two refluxes are technologically equivalent. The Court disagreed for two reasons. First, although three reflux and two reflux both extract the active ingredients of yantuo, the applicant has not provided sufficient evidence that they achieve the same extraction results. Second, the defendant showed that the three refluxes had much better extraction results than the two refluxes. Applicant’s witnesses also agreed 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.

US patent protection for TCM

TCM, as a subset of herbal medicine, has similar principles and challenges for patent protection in the United States. Composition claims are useful when the active ingredients are known and can be limited to a specific use. For example, Frisun, Inc. (Wuhan, China) was granted U.S. Patent No. 7,575,772 on “Process and Composition for Luo Han Guo Fruit Syrup and Jam” which “combines all the advantages of Luo Han Guo to meet current market demand for a natural 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, Yin. Z., Yan. Z., Jeff. E., Chi-Fu. H., Insulin-stimulating effects of mogroside V and fruit extract of Luo Han Kuo (Siraitia grosvenori Swingle) fruit extract., Acta Pharmaceutica Sinica., 44 (11): 1252-1257 (2009 ).

The number of patent acquisitions for herbal medicines has increased significantly. 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 made public. Here are a few:

The challenge will increase

Patent protection for TCM can present many challenges due to the different types of TCM products and uncertainty of active ingredients. As patents on medicinal plants become more popular, we can expect to see similar challenges in enforcing patent rights on medicinal plant technology.