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European drug maker gives up patent
By Qin Jize (China Daily)
Updated: 2004-08-19 00:45

Europe's largest drug maker GlaxoSmithKline (GSK) has abandoned its defence of a patent in China for rosiglitazone, a major chemical component of its leading anti-diabetes drug Avandia.

The move was announced during a preliminary hearing over the patent challenge held by State Intellectual and Patent Office (SIPO) Wednesday.

"After careful assessment of the situation, GSK is voluntarily abandoning the rosiglitazone formulation patent and withdrawing from the hearing," said Lillian Xiao, spokeswoman of the Beijing-based office.

She emphasized that the patent that GSK is abandoning is not the Avandia compound patent covering rosiglitazone maleate.

In China, patents covering the active ingredient of Avandia and its manufacturing process were granted to GSK in 2000 and 1998 respectively.

However, starting from the early 1990s, more than a dozen Chinese drug makers began to copy rosiglitazone.

GSK filed the third patent application to SIPO in 1998 for pharmaceutical formulations containing 2 to 8 mg rosiglitazone or its pharmaceutically acceptable salts or solvates, which extends the protection for the product to the other salts of rosiglitzone.

The patent was granted in July 2003 and GSK immediately requested its Chinese rivals to stop copying rosiglitazone, otherwise they would face legal actions.

Early this year, four Chinese pharmaceuticals makers, including Shanghai Sunve Pharmaceutical Company and Chongqing-based Taiji Group filed invalidation requests against the rosiglitazone formulation patent granted to GSK.

A hearing had been scheduled Wednesday by the Patent Re-examination Board to consider these invalidity requests. But GSK quit the action.

Xiao said GSK's decision will not let Chinese competitors sell copies of Avandia, because the company still holds two other Chinese patents covering the drug.

"We're very pleased that the rosiglitazone formulation patent is no longer exist and GSK has made a reasonable decision," said Chen, official of the patent department with Taiji Group.

"It provides access to Chinese pharmaceutical makers," said Hou Dakun, a consultant for the pharmaceutical industry in China. "They now can produce a local variant Avandia after GSK waived its patent protection.

But he didn't think there would be an obvious increase of patent lawsuit challenging the international pharmaceutical giants because the "domestic enterprises are still weak in terms of research and development."

Few Chinese drug makers know how to produce the most advanced medicine even though the formulation patent is invalid, he said.

However, he added, any patent earning a huge profit in the market would spark heated disputes not only in China but all over the world. Drugmakers are becoming increasingly aware of breaking the monopoly of international pharmaceutical giants on compounds they are copying, he said.

The Chinese Government withdrew the patent last month for Viagra, the male-impotence treatment made by Pfizer Inc, the world's biggest drug maker.

Although the two parties to the lawsuit deny any links between Viagra and Avandia, the public still held the opinion that the Viagra ruling would no doubt influence the Avandia result.

"As an arbitration agency, we will always be just and fair," said Bai Guangqing, deputy director of the Patent Re-examination Board, under the SIPO.

He assured that the revoking of Viagra would not play any role if the Avandia case is investigated. "It's only evidence and investigation can tell the final result," he said.

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