Qin Chuan

How to best protect the intellectual property rights (IPR) of TCM has long been a challenge for its practitioners in China.

For Dong Zhenhua, applying for patents is definitely not the answer.

A TCM practitioner, Dong owns an ancient prescription for the treatment of rheumatoid arthritis, which is reportedly very effective.

But she is not willing to apply for a patent for her prescription. "If the prescription gets out, everything is gone," she argues, referring to the fact that the prescription will be publicized once the application is filed.

Details of a prescription, including specifics of herbs and how to use them, have to be made public in the course of a patent application, explains Gu Xiaoli, deputy director of the co-ordination and administration department under the State Intellectual Property Office.

But this runs contrary to the traditions and practice of most TCM practitioners who are accustomed to jealously guarding remedies very often passed down by family members or apprentices, generation after generation.

Consequently, there is a conflict between the modern idea of patent protection and age-old practices.

The rationale behind patenting is to ultimately allow greater, and ultimately free accessibility to the product concerned. In China, the lifespan of a patent is 20 years.

But TCM doctors regard their remedies as personal belongings and something upon which they depend for a living.

But, Liu Tonghua, a professor with the Beijing University of Chinese Medicine, who has been studying TCM intellectual property rights for years, suggests TCM practitioners should apply for patents if they want to protect their prescriptions.

If the patents are applied for and granted, they will have access to protection in the event of their concoction being infringed upon. But if they do not apply, it will be impossible for them to do anything once a prescription is taken up by others, said Liu.

He recommends practitioners conduct a thorough and in-depth study of all the prescriptions they own. Many, however, depend on years of experience when it comes to treating patients and do not really know which kinds of herbs are indispensable to their prescriptions, said Liu.

This is the biggest problem for TCM patent application in China, he added. "Patent requires scientific research, not just experience."

In addition, the Chinese have much to learn about patent application.

For example, when applying for a patent for a set of forceps, overseas applicants are likely to submit more than 20 drawings, demonstrating detailed aspects of the product. But, said Liu, Chinese applicants would tend to hand in a few.

"Just as China is in the process of industrialization, people are still learning how to apply for patents appropriately," he added.

A guide on how to apply for a TCM patent is soon to be published and will help people understand the application process, said Liu, one of its authors.

To gain more experience of TCM intellectual property protection, last October Gu's office designated Ankang in Shaanxi Province as a national pilot base for the industrialization of patented TCM techniques.

It is anticipated experience gained there could be promoted across the country.

Ankang was chosen because of the local TCM industry's existing network, ranging from herb growing, research and medicine production.

The base is the only one of its kind in the country, she said.

Herbs in Ankang, which lies in mountainous southern Shaanxi, are considered good in quality and rich in variety.

The State Administration of Traditional Chinese Medicine has also launched a research programme to better protect TCM knowledge, the China News Service reported.

Liu Changhua with the Chinese Academy of Traditional Chinese Medicine, told the agency the existing system affords insufficient protection.

It is pressing that a new and practical one be developed, he was quoted as saying.

The programme will conduct research on the classification of TCM resources, who should own and benefit from TCM knowledge and how to share the benefits once intellectual property rights are granted, said Liu.

A database for TCM patents is also to be set up, the report quoted him as saying.

Modernization guidelines

In addition, the protection of TCM resources and their intellectual property rights is included in a national guideline for the modernization of the TCM industry between 2002 and 2010. This was compiled in 2002 by seven government bodies working in conjunction with the Chinese Academy of Sciences.

According to the guideline, regulations on the protection and management of TCM resources will be drafted.

A strategy on the protection of TCM intellectual property rights will be designed, in response to fierce international competition for patents, the guideline states.

But whether or not genetic resources, traditional knowledge and folk arts should fall under the remit of IPR protection remains a disputed topic worldwide.

The conflict lies mainly between developing countries and developed ones, with the former accusing the latter of exploiting their traditional resources without making adequate compensation, said Gu.

"The concept of intellectual property rights in themselves has been developing," she adds.

The World Intellectual Property Organization (WIPO) has already focused on the need for protection of traditional knowledge.

Last March, the WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC) decided on concrete steps to accelerate international work on protecting traditional knowledge and folklore.

Its discussions resulted in an agreement on the development of the necessary building blocks for their protection.

This was the first meeting of the IGC since its mandate was renewed by the WIPO General Assembly in October 2003, with instructions speeding up its work and focusing on the international dimension of the subject area.

One of the major issues the committee will address is strengthening the defensive protection of traditional knowledge and genetic resources against illegitimate patenting.

Traditional knowledge should include traditional medicine, said Shen Zhixiang, director of the Department of International Co-operation under the State Administration of Traditional Chinese Medicine.

Greater protection

China can learn much from the experience of other countries to protect traditional medicine.

Thailand protects its traditional medicine through an effective legal framework, which classifies prescriptions into three categories, said Shen.

Those included at national level are strictly protected and anyone wanting to make use of them needs to get approval.

The second level refers to those owned by individuals, who register prescriptions at the department for protection, and the third refers to those made public and freely available.

Other means of protection are continually being explored.

Shen said his administration and the State Council's Legislative Affairs Office are working together on drafting regulations to protect the intellectual property rights of TCM.

He said it is highly likely a number of TCM prescriptions will be listed under State-level IPR protection.

It is like the use of a natural resource, he said. "If you want to use it, you pay for it."

Other experts have called for the protection of the original habitat of herbs.

Xu Jintang, a professor with the Institute of Medicinal Plants under the Chinese Academy of Medical Sciences, says such protection should be a priority.

"We should promote the idea that herbs should be planted at suitable places. Herbs just cannot be planted everywhere," a reference to the fact that herb growing is becoming popular across the country as a more profitable alternative to normal crops.

The planting of different herbs requires different natural conditions, including local climate and altitude, said Xu. But only suitable places can produce good-quality herbs, he added.

Specific standards need also to be set for herb growing to preserve the original habitat of various types.

Training of qualified professionals, such as herb gatherers, should also strengthened, said Xu.

In the past, experienced gatherers could tell the good from the bad at a glance, but now such levels of skill are diminishing.

"Medicines are different from other produce. They are meant to save lives," added Xu.

Wider recognition

In recent years interest and recognition of TCM has flourished all over the world.

Shen's administration and the Ministry of Health have, to date, signed co-operative agreements on TCM with counterpart departments of 67 countries.

These agreements make it possible for TCM to become legally accepted, in the countries concerned, in the future.

For example, under an agreement with Italy signed last November, TCM experts will go there to teach and clinics will be set up, said Shen.

"But it will take time for foreign countries, especially those outside Asia, to understand TCM fully and accept it," he said.

The natural herbs industry, already a multi-billion one, is forecast to grow enormously in the next few years. The World Bank estimates globally it will generate a revenue of US$200 billion by 2008, from the US$80 billion of 2000, the People's Daily recently reported.

In the past five years, China's export of TCM products has been on the rise. It reached US$720 million in 2003 and has been experiencing an annual growth of 5.5 per cent, the report said.

In particular, the market in Europe has witnessed 26 per cent annual growth.

Currently there are more than 50,000 TCM institutions in more than 130 countries, according to the report.

Acupuncture, a notable part of TCM, is widely accepted in many countries and has over 20,000 practitioners in Germany, France and the United Kingdom. And in the United States alone the number is around 10,000.

The number of overseas students learning TCM in China comprises the largest group among those studying the natural sciences.

But TCM still has a long way to go.

Currently the output value of the TCM industry in China is less than 100 billion yuan (US$12 billion), says Shen.

And TCM accounts for less than one-fifth of China's pharmaceutical market.

(China Daily 02/21/2005 page5)