In 1994, the Chinese PLA Academy of Military Medical Science signed patent license agreement with Swiss pharma house Novartis, which accquired the rights to market the therapy outside China. As an R&D institution of Chinese PLA, the Academy of Military Medical Science at that time has neither capability nor right to commercialise the coartem, while China has no pharma company whose preparation manufacturing level can meet the international requirement. So the two sides filed a group overseas patent applications including that PCT application, and carried out patent layout in Europe.

Novartis sticked to its promise. The coartem patent entered Europe, Japan, South Korea through PCT path very quickly, and such drug with materials provided by China and produced by Novartis, opened the international market rapidly. In 1999, Novartis became the first pharma company which sold fix-does artemisinin-based combination therapy (ACT) in the world.

In 2002, coartem was added to the World Health Organization's list of essential medicines. The reserch of artemisinin is an area of great concern for WHO after China made public molecular structure of artemisinin. According to international practice, the new medicine must be checked by GMP before it was registered in foreign countries. Because China has no pharma company can meet the GMP standard, the cooperation between WHO and China was stopped. The cooperation with Novartis makes Chinese anti-malarial durg added to the WHO's list of essential medicines. The dream came true, but the way to achieve the dream is so embarrassed.

"Artemisinin was a native anti-malarial durg in China, but some standards were made by foreign countries. This is a China's whole pharmaceutical industry issue more than a matter of anti-malarial drug industry ," said Lu Chunming, the former prisident of Chongqing Huali Pharmaceutical Company. "The history of artemisinin reflects the basic situation of Chinese pharmaceutical industry, that is, most exported durgs are active pharmaceutical ingredients (APIs). Because APIs were bought by foreign companies, and processed into commercial drug, they have made a huge profit out of APIs. The reasons for that is not only China has weak R&D base, but also has difficulties in commercialization of drugs. Besides, China hasn't seen any magnification in its voice in the international market, " said Li Shunde, director general of Legal and IP Department of Chinese Academy of Science.

In 2007, Guilin Pharmaceutical Company, the subsidiary of Shanghai Fosun Pharmaceutical Company, have officially passed the WHO-PQ certification, to supply drugs directly to WHO programs, the only domestic supplier that is on the list. Although some Chinese pharma houses are capable of competing with Novartis, the latecomers still have a long way to go if they want to compete with them.

The sore of artemisinin is a lesson in Chinese traditional medicine industry. Due to the speical history, it is quite difficult to protect innovative results, while the lack of commercialization capability needs ungently to be improved. "Under current conditions, great efforts should be made to strengthen management of artemisinin resources and ensure quality and a sustainable supply, " said Yue Xuelian from SIPO. "The invention of artemisinin finds inspiration in Chinese ancient documents, which embodies the important role of traditional knowledge in inovation. We shall attach great importance to use and protection of traditional knowledge in a bid to arouse an innovative spirit throughout society," adds Yue.

Artemisinin, which is recognized by the international community as the first new medicine in China, just like the country where it was born, is increasingly involved in the world. We believe that China's pharmaceuticals industry can do well enough in international market competition in the future.

(China IP News)