China’s counterfeit commitment to patents
Crafting an appropriate response to China’s emergence as a major international economic player has generated intense debate around the world. In the US, an issue in campaign debates between the rival presidential candidates is China’s treatment of intellectual property rights. Beijing’s struggle to rationalise its World Trade Organisation commitments on intellectual property with the rising commercial pressures of an expanding domestic industry, however, are not merely an “American” problem. China’s treatment of IPR presents a considerable threat to important sources of enduring value for the knowledge-based economies of North America, the European Union and Asia. New developments in the pharmaceutical sector should give pause to both governments and investors regarding China’s reliability as an economic partner. ADVERTISEMENT At the request of 12 Chinese pharmaceutical companies, China’s State Intellectual Property Office last month overturned the patent for Viagra held in China by Pfizer Pharmaceuticals. Details of the move have been slow to surface and Pfizer is appealing against the decision, but the ruling appears to be based on a rather curious Chinese interpretation of international standards pertaining to patent protection. For the time being, China appears to have ruled that Viagra is not a new product, nor innovative, nor useful. Therefore it is not worthy of patent protection. Fast on the heels of the Viagra decision, another group of Chinese companies has launched a similar challenge to the popular diabetes drug Avandia, patented by GlaxoSmithKline. A hearing on the Avandia case is set for August 18, but Chinese manufacturers have already embraced the “precedent” of the Viagra decision as a harbinger of their imminent success. A ruling in this case will provide a clear indication of Beijing’s priorities.These precedents should not go unnoticed. Faced with rising global pressure to crack down on patent infringement, Beijing may be in the process of redefining patent criteria effectively to safeguard Chinese drug-makers from accusations of illegal infringements. The removal of patents on Viagra or Avandia would offer Chinese companies free rein to manufacture homegrown copycat drugs without fear of prosecution. If these cases continue in their current direction, China may in the process violate its obligations to the WTO. For the global research pharmaceutical industry, the ruling carries the significant threat of a Chinese government tacitly supporting the production of counterfeit drugs by domestic Chinese companies. For China’s trading partners worldwide, the ruling demonstrates China’s somewhat cautious embrace of the WTO’s rules-based system, which it joined in 2002.The effect of several such patent decisions by the Chinese authorities could stifle revenue and therefore funding by international pharmaceutical companies for important research and development efforts on any number of valuable therapeutic drugs. The costs in the US, for example, of bringing even one new drug to market approach $800m; the loss of substantial profits from a popular drug such as Viagra will most certainly influence new R&D spending and priorities. Over the long term, such decisions will affect consumers as well as governments that subsidise national healthcare programmes which include drug benefits.China’s actions on patent infringement require action from a significant number of WTO member states. Whether or not Beijing’s decisions on Viagra and Avandia represent merely the growing pains of WTO accession or the application of a wilful new policy of IPR mercantilism is academic. These decisions will mark China’s first significant actions on patent matters since the country joined the rules-based system of international trade. WTO members that have invested in the future of knowledge-based industries should use the successful conclusion last weekend of framework negotiations in the Doha round of trade talks to remind Beijing of the importance of the principles at stake in these cases. Inaction risks undermining global legal protections for the world’s most valuable knowledge-based industries. The Viagra decision, if upheld, would mean Beijing has walked away from the world’s efforts over the past decade to enforce intellectual property rights in China.Understandably, few countries wish to confront China on trade without the cover afforded by leadership from Brussels or Washington. Deciding to take China to task on its infringement of patent protection should not be imperiled by presidential politics in the US or the imminent change of leadership in the European Commission. Leaders in both capitals should move immediately on China to preserve the kind of international economic rules from which companies, workers and consumers around the world benefit.
中国对专利保护真有承诺吗
中国作为国际上一个重要的经济强国，如何正确应对中国的崛起已在全球上引发大量的讨论。在美国总统候选人的竞选辩论中，中国在知识产权方面的做法是讨论议题之一。中国国内产业不断增长在商业上带来越来越多的压力，中国力图以此为由，为它对世界贸易组织的承诺进行辩护，这种努力所带来的并不仅仅是“美国的”问题。对于北美、欧盟和亚洲等地区的知识型经济来说，知识产权是创造持久价值的重要来源；中国在知识产权方面的做法对此构成了严重的威胁。最近医药领域形势的发展，将会使有关国家政府和投资者都对中国作为经济合作伙伴的可靠程度进行反思。
在中国12家医药公司的申请下，中国国家知识产权局在上个月撤销了辉瑞制药有限公司(Pfizer Pharmaceuticals)所持有的伟哥(Viagra)的在华专利。这一举措的详情迟迟未能获得披露，辉瑞公司正对此裁决提出上诉。但是看起来，这项裁决所依据的是中国对有关专利保护的国际标准的一种奇怪的解释。到目前为止，中国似乎已经裁定，不论是从新颖性还是从实用性看，伟哥都不是一种新药。因此，该药不能得到专利保护。
在有关的裁决之后，另一批中国公司紧接着发起一项类似的挑战，目标是颇受欢迎的糖尿病药物文迪雅(Avandia)，该项专利为葛兰素史克(GlaxoSmithKline)公司所有。有关文迪雅的听证会定于8月18日举行，但先前有关伟哥的裁决受到中国厂家的欢迎，他们认为这是胜利在望的好兆头。这一案件的裁决，将表明中国政府心目中的优先顺序。
这些事件应当得到重视。面对全球日益高涨的要求打击侵权行为的压力，中国政府可能正在有效地重新界定专利的标准，以保护中国制药商免于因非法侵权而受到起诉。撤销伟哥和文迪雅的专利，将使中国公司放手在国内生产仿制药品，且无受讼之虞。如果此类案件继续层出不穷，中国可能会在此过程中违反它的世贸义务。
对于世界上开展研发的制药行业来说，这项裁决标志着一个严重的威胁，即中国政府暗中支持国内公司生产仿冒药品。对于中国在世界上的贸易伙伴来说，这项裁决反映了中国2002年入世后虽然接受了世贸组织建立在法律基础上的体系，但多少有些勉强。
中国政府在专利方面几项类似决定产生了严重的后果，这使国际制药公司在研发任何治疗药物的时候，都无法获得利润，甚而无法筹集资金。以美国为例，仅将一种新药推向市场所需花费的成本就高达近8亿美元；而”伟哥”等受欢迎的药物如果失去其丰富的利润，必定会使新药研发的经费和优先顺序受到限制。长此以往，这种裁决将既不利于消费者，也会影响到政府对包括药品补助的国家医疗保健项目进行扶持。
针对中国在专利侵权方面的举动，众多世贸组织成员国必须采取行动。无论中国政府对伟哥和文迪雅的裁决所反映的现象是中国入世所经历的阵痛，还是为了商业利益在实行任性的知识产权政策，都是无关紧要的。自从中国加入建立在法律基础上的国际贸易体系之后，这几项裁决将是中国首次在专利方面所采取的重要举措。那些致力于知识产业的未来的世贸组织成员，应当借助上周末“多哈回合”贸易谈判所达成的框架协议共识，提醒中国政府认识那些受到上述案例威胁的原则的重要性。听之任之将破坏世界上最有价值的知识产业的全球性法律保护。有关”伟哥”的裁决如果不推翻的话，这就意味着中国政府背离了过去10年全世界增进中国知识产权的努力。
可以理解的是，没有欧盟或美国的领导所提供的保护，没有几个国家愿意在贸易问题上与中国对抗。虽然美国正在举行总统选举，欧洲委员会也即将进行换届，这些都不应当影响使中国承担起打击违反专利保护的责任的努力。布鲁塞尔和华盛顿的领导人应当立即对中国采取行动，保护造福于全世界企业、员工和消费者的国际经济规则。
Naotaka Matsukata，何威法律事务所(Hunton Williams)国际业务策略部门主管。
