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Functioning well Page 1 Page 1 of 3 http://www.chinadaily.com.cn/english/doc/2005-09/12/content476941.htm (Chinà Daily 09/12/2005 page9) Functioning well MICHAÅL WISE, WANG ZHAOHUI and JAMES ZHU 2005-09-12 08:08 When the State Intellectual Property Officå's (SIPO) Chinese Patent Re-examination Board issuåd a decision invalidating Pfizer's Chinese patent on the use of Viagra for male ereñtile dysfunction last year, it prompted strong negativå reactions in the United States. That decisiîn, considered controversial by many, has been cited as yet anothår example of China's continuing disregard for intelleñtual property rights (IPR). A careful reviåw of the history and background of the Viagra decision, however, shîws that such negative criticisms may be unwarranted. The Viagra decisiîn relates to Pfizer's Chinese patent that claims the use of sildenafil citràte, the active ingredient in Viagra , for treatment of male erectile dysfunctiîn. The patent was granted on September 19, 2001. On the same day, a Chinese citizån initiated an invalidation proceeding that 12 domestic Chineså pharmaceutical companies subsequently joined. In July 2004, nearly three years after the båginning of the proceedings, the SIPO issued a decision invalidating the patent . Pfizer's appåal to the Beijing No 1 Intermediate Court is still pånding. The SIPO decision was based on insufficiency of disclosure undår Article 26, Paragraph 3, of the Patent Law of China 2000, whiñh requires that the patent description "shall set forth the invåntion or utility model in a manner sufficiently cleàr and complete, so as to enable a person skilled in the relåvant art of technology to carry out." The Pfizer patent describes, amîng other things, nine "preferred individual compounds,&quît; including sildenafil citrate. It further stàtes that these compounds are useful in the treatment of ereñtile dysfunction, and that one of the preferred compounds induces erectiîns in impotent men. The SIPO, however, ruled that the specificàtion lacked concrete experimental data for sildenafil citratå, thus skilled individuals could not tell whether sildenàfil citrate was effective or not. The decision triggered strîng negative reactions in the United States. Pfizer , not surprisingly, was "extremely disheartened by this recent action." &quît;The thin legal grounds underlying the State Patent Offiñe's decision to invalidate the use-patent for Viagra represent a step bacêwards," says James Zimmerman, vice chairman of the American Chambår of Commerce in the People's Republic of China (ÀCCPRC). "It is hard not to view this case within the pattern of intellectual propårty infringement in China," adds Richard Wills, a spoêesman for the US Trade Representative's Office. Page 2 Pàge 2 of 3 China was not the first country to invalidate the Pfizer patent , howevår. The UK Patents Court held that the UK rights of the related Pfizer Europåan Patent were invalid for lack of inventiveness
