Drug company pulls out of Chinese lawsuit over diabetes drug
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《英国医生杂志》
In a move that highlights the struggle between multinational drug companies and manufacturers of generic drugs, GlaxoSmithKline has withdrawn from legal action in China to defend the formulation patent on rosiglitazone, the major component of its antidiabetes drug Avandia.
The large multinational companies, such as GlaxoSmithKline, are trying to get a foothold in the Chinese market while preventing competition from local copies of their products. Rather than just continue to breach copyright the Chinese companies are trying to secure the right to make the drugs legally.
Chris Hunter-Ward, the UK spokesman for GlaxoSmithKline, said: "There had been previous disclosures of some of the elements we tried to patent. We saw that our case was not that robust and decided it was sensible to withdraw."
The formulation patent covered rosiglitazone maleate and its pharmaceutically equivalent salts and was granted to GlaxoSmithKline by China抯 State Intellectual Patent Office in July 2003. The company subsequently informed the Chinese manufacturers of generic copies of its existing patent.
Earlier this year four manufacturers, including Chinese pharmaceutical giants the Taiji Group and Shanghai Sunve, challenged the validity of the rosiglitazone formulation patent in the courts. On 18 August, the day of the preliminary hearing, GlaxoSmithKline abandoned the suit.
The decision will not affect GlaxoSmithKline抯 exclusive right to manufacture Avandia, as the manufacturing process and compound patents were granted in 1998 and 2000, respectively. Both were successfully defended against challenges by Chinese manufacturers two years ago. But it will allow Chinese manufacturers to make their own rosiglitazone salts legally and start the process of developing their own antidiabetes drugs.
The fact that Chinese manufacturers have challenged GlaxoSmithKline through the courts is a positive development, said Mr Hunter-Ward. "It is encouraging that instead of just copying drugs, Chinese manufacturers are using the legal system . We have no issue with the legal system in China. Our concern is that the authorities continue to enforce the law," he said.
Last month Pfizer抯 domestic Chinese patent for sildenafil citrate, the main chemical component of Viagra, was overturned. The two decisions reflect a shift in China that is positive for the industry, said Dr Eric Noehrenberg, director of international trade and market policy at the International Federation of Pharmaceuticals Manufacturers Associations.
"It is clear that drug companies now need to be more prepared for further challenges, and I抦 certain companies are getting themselves ready for that. It will encourage other Chinese manufacturers to challenge patents, but if enough cases come up they may see that they can抰 win them all," he said.
Foreign drug companies will need to tighten up their Chinese patent applications in future, warned Douglas Clark, a Shanghai based partner of the law firm Lovells and an expert on intellectual property law. "The tendency is to apply for broad claims, and there have been cases where the patent examiner has let through claims that would not have been allowed in other countries. This only leaves companies open to having their patents cancelled later, with all the costs and adverse publicity that can generate. They should try and get stronger patents in place in the first place," he said.(Hong Kong Jane Parry)
The large multinational companies, such as GlaxoSmithKline, are trying to get a foothold in the Chinese market while preventing competition from local copies of their products. Rather than just continue to breach copyright the Chinese companies are trying to secure the right to make the drugs legally.
Chris Hunter-Ward, the UK spokesman for GlaxoSmithKline, said: "There had been previous disclosures of some of the elements we tried to patent. We saw that our case was not that robust and decided it was sensible to withdraw."
The formulation patent covered rosiglitazone maleate and its pharmaceutically equivalent salts and was granted to GlaxoSmithKline by China抯 State Intellectual Patent Office in July 2003. The company subsequently informed the Chinese manufacturers of generic copies of its existing patent.
Earlier this year four manufacturers, including Chinese pharmaceutical giants the Taiji Group and Shanghai Sunve, challenged the validity of the rosiglitazone formulation patent in the courts. On 18 August, the day of the preliminary hearing, GlaxoSmithKline abandoned the suit.
The decision will not affect GlaxoSmithKline抯 exclusive right to manufacture Avandia, as the manufacturing process and compound patents were granted in 1998 and 2000, respectively. Both were successfully defended against challenges by Chinese manufacturers two years ago. But it will allow Chinese manufacturers to make their own rosiglitazone salts legally and start the process of developing their own antidiabetes drugs.
The fact that Chinese manufacturers have challenged GlaxoSmithKline through the courts is a positive development, said Mr Hunter-Ward. "It is encouraging that instead of just copying drugs, Chinese manufacturers are using the legal system . We have no issue with the legal system in China. Our concern is that the authorities continue to enforce the law," he said.
Last month Pfizer抯 domestic Chinese patent for sildenafil citrate, the main chemical component of Viagra, was overturned. The two decisions reflect a shift in China that is positive for the industry, said Dr Eric Noehrenberg, director of international trade and market policy at the International Federation of Pharmaceuticals Manufacturers Associations.
"It is clear that drug companies now need to be more prepared for further challenges, and I抦 certain companies are getting themselves ready for that. It will encourage other Chinese manufacturers to challenge patents, but if enough cases come up they may see that they can抰 win them all," he said.
Foreign drug companies will need to tighten up their Chinese patent applications in future, warned Douglas Clark, a Shanghai based partner of the law firm Lovells and an expert on intellectual property law. "The tendency is to apply for broad claims, and there have been cases where the patent examiner has let through claims that would not have been allowed in other countries. This only leaves companies open to having their patents cancelled later, with all the costs and adverse publicity that can generate. They should try and get stronger patents in place in the first place," he said.(Hong Kong Jane Parry)