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AIDS Drug Imports to Be Exempt from Customs TaxesThe chances of survival for Chinese AIDS patients and HIV carriers are climbing as the central government's efforts to provide cheap and effective medicines begin to yield results. Official sources said that imported anti-AIDS drugs are expected to become exempt from customs taxes in the near future in order to lessen the financial burden on AIDS patients. Though the report did not reveal any details about the tax exemption, it said the policies are expected to greatly reduce the price of the drugs. Reports said that major international AIDS drug manufacturers are also expected to lower their drug prices in China following negotiations with related governmental departments. Potent patentEver since its launch in 1994, Viagra, a medicine developed by Pfizer Pharmaceutical Company, the largest medical company in the world, for the treatment of male impotence, has seen more than its fair share of drama being marred by counterfeits and court battles. A Chinese version of the drug was available for sale in 1994, notwithstanding approval for the sale of the drug by Chinese medical authorities was granted only 2 years ago. While a patent battle - launched by Chinese pharmaceutical companies - is also currently underway with a patent-review panel of the State Intellectual Property Office (SIPO) considering an objection to the patent granted to Pfizer, which claims exclusive rights for the use of the active ingredient in Viagra, namely sildenafil, noted for its patent claims to be able to treat the disease known in medical parlance as Erectile Dysfunction (ED). According to the patent granted to Pfizer by SIPO last September, no other company can use the patented ingredients to manufacture medicine for ED in China until 2014, and would allow Pfizer to monopolize the lucrative Chinese market for ED medicine, estimated to be worth US$ 20 billion. On the very day the patent was granted, a man named Pan Huaping - of whom no other details are available - applied to SIPO asking the patent be declared invalid. Twelve Chinese pharmaceutical companies have subsequently submitted similar applications. SIPO officials described the patent dispute as the largest ever they have had to handle since the Patent Law of China was promulgated in 1984. "It is the first such case in which so many companies and people are collectively challenging a single patent," said Sun Zejian, an SIPO official who sits on the review panel. "We are being very cautious in dealing with the case because it involves many stakeholders and concerns very complicated legal issues." Earlier last month, a two-day oral hearing was held at SIPO's Beijing headquarters after more than a year of documentary procedures to determine the validity of the patent. The outcome of the case is so important that it may influence future strategies of both Pfizer and its Chinese competitors in the market. Pfizer is said to be considering closing down its Chinese plants making Viagra if the patent were declared invalid. But Pfizer denied any such move. Theoretically, there is no time limit for the panel to render the decision. Sun from SIPO denied the panel will give a decision anytime soon, saying the panel is still in discussing the case. "Given its significance, the case will set a precedent for future handling of similar patent disputes," he said. "We'll take into account not only China's patent laws, but also international practices in deciding the case." He ruled out the possibility of a second oral hearing before the final decision, saying both the claimants and the respondents have presented their full arguments and there is little dispute over the factual aspects. But experts said that the legal aspects of the case might be one of the major reasons that would make it hard for a decision to be reached, as the patent has been granted for the use of sildenafil - among other compounds - to treat impotence, but not to sildenafil itself, because China's Patent Law does not recognize patents on chemical compounds. This is described as a "use patent", a concept adopted by some other countries but not clearly defined in China's Patent Law. However, such patents have been granted by SIPO for quite a long time. "In practice, you may apply for a use patent on a type of tooth paste if you find it can be used to kill bugs," said Jin from SIPO. One of the claimants' major arguments is that Pfizer's patent is invalid because there had been publications of similar findings prior to Pfizer's filing of the patent application. The publication renders Pfizer's finding "unobvious", thus failing to meet the requirements of China's Patent Law that a patent must be novel and demonstrates an inventive step to be valid. The Chinese side also cited a case in the United Kingdom last June in which the House of Lords, the country's highest judicial authority, rejected Pfizer's appeal against a ruling that invalidated Viagra's UK mechanism of action patent on the grounds of obviousness. The patent invalidation effectively opened the door for other companies to market ED medicine using PDE-5 inhibitors other than sildenafil as treatment for impotence in the UK - something which had been prohibited under Pfizer's broad patent claims. However, even with a decision, according to China's Patent Law, any side which is dissatisfied with the decision of the review panel may file a lawsuit at the No1 Intermediate People's Court of Beijing within three months of receiving the decision. Lehman Lee & XuA Licensed Chinese Law Partnership
The China Health Sciences Newsletter is intended to be used for news purposes only. It should not be taken as comprehensive legal advice, and Lehman, Lee & Xu will not be held responsible for any such reliance on its contents. |
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