First patenting guidelines for traditional Chinese medicine

Background
Patenting Chinese medicine
Draft guidelines
Comment

The Taiwan Intellectual Property Office (TIPO) has issued draft patent examination guidelines for Chinese medicine products. It has convened several public hearings in order to gather comments from interested groups, such as non-profit professional organisations and private experts. The guidelines, which are the first of their kind in this field, aim to clarify the examination procedure for both TIPO and patent applicants. 

Background
With its extensive use of natural ingredients, such as herbs and insects, Chinese medicine has played an influential role in traditional Asian culture, including in many industrialised countries including Taiwan, China, Korea and Japan. In some parts of Asia, Chinese medicine is used in everyday life in the form of health supplements, and its efficacy is believed to surpass that of Western medicine. In China and Taiwan, traditional Chinese medicine is even considered to be an integral part of the healthcare system. For example, traditional Chinese medicine treatments may be prescribed to: 

• counter side effects of chemotherapy; 
• fight the cravings and withdrawal symptoms experienced by drug addicts; and 
• relieve a variety of chronic conditions.

As such, the Chinese medicine industry has played an important role in Taiwan’s economy and many patent applications for Chinese medicine products are filed every year. 

Patenting Chinese medicine
The patenting of Chinese medicine products has been the subject of intense discussion in Taiwan. The medical theories underlying Chinese medicine have been developed over thousands of years and differ vastly from Western medical theories. In contrast to Western medical practices (in which the search for a single lead compound forms the basis of pharmaceutical developments), traditional Chinese medicine is based on the overall effect of a range of compounds acting simultaneously. Due to the fundamental differences between Chinese and Western medicine, the patenting guidelines needed to be reviewed in order to accommodate issues relating specifically to Chinese medicine, as these were not addressed appropriately under the current guidelines. 

Draft guidelines
TIPO has thus released pioneering draft guidelines, which are specifically designed for Chinese medicine products. The guidelines contain refined definitions with regard to various aspects of patenting. Despite the particularities of Chinese medicine, the definition of a ‘patentable object’ is the same as for chemicals. However, the guidelines provide new definitions for ‘TCM diagnostic’, ‘TCM therapeutic methods’ and ‘surgical methods applied directly to human and animals’, which cannot be patented based on the principles of public interest. In addition, patents will not be issued for practices involving living tissues due to ethical concerns.

The guidelines also address the drafting of specification and claims. As is the case for contemporary Western medicine, applicants must submit information on the method of extraction, the composition and the method of preparation of the active formula. Because the different parts of a plant may produce different therapeutic effects, such information must be specified in order to satisfy the enablement requirement. The applicant must also indicate the origin of the plant, as well as the season of harvest.

The most notable feature of the guidelines is the acceptable form of efficacy assessment, which is based on the traditional Chinese diagnostic methods (ie, observe, hear and smell, patient’s background and pulse reading). TIPO will determine whether a product is efficient and satisfies the inventive step requirement based on these traditional methods.

Further, the guidelines address the controversy surrounding the subjective nature of Chinese medicine. According to the guidelines, traditional Chinese medical assessments may be accepted if they are accompanied by objective evidence. For example, in order to patent a compound for the treatment of poor blood circulation, an applicant must provide supporting evidence such as: 

• descriptive evidence of the improvement of the symptoms (eg, redness of the skin); and 
• numerical proof (eg, blood flow rate).

Comment
It is expected that, due to the particular nature of Chinese medicine, the guidelines will raise new issues and require further interpretation. During the public hearing stage, the main features of the guidelines were well received by government officials, attorneys and the industry. It is anticipated that the guidelines could be applied in the near future following further refinement and amendment.