The Economic Theory of Patent Protection and Pandemic Influenza Vaccines: Do Patents Really Incentivize Innovation in the Field?
The Economic Theory of Patent Protection and Pandemic Influenza Vaccines: Do Patents Really Incentivize Innovation in the Field?
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DOI：
10.1177/0098858816658280
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发表时间：
2016-05-01
影响因子：
0.6
通讯作者：
Eccleston-Turner, Mark
中科院分区：
文献类型：
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作者：
Eccleston-Turner, Mark
研制新疫苗是抗击全球传染病的关键挑战之一。因此，为疫苗创新创造最佳条件是法律在这场战斗中可能发挥的最重要作用之一。在药品方面，工业界和学术文献通常援引专利保护的经济理论，为救生药品和疫苗的专利申请辩护。专利保护的经济理论认为，创新是由于专利保护了创新者的研究和开发投资而发生的。这一理论的支持者声称，如果没有专利，药物和疫苗的创新速度将大大降低。本文探讨了专利保护的经济理论对大流行性流感疫苗的适用性。本文探讨了与专利法、理论和创新相关的一些因素，包括：大流行性流感疫苗的专利格局;制造商享有的市场支配地位;如果专利保护不到位，仿制者制造仿制疫苗所带来的实际风险;以及，创造仿制疫苗的许可和监管规定。根据专利保护的经济理论，专利通过为创新者提供对其创新的暂时垄断，并保护他们免受希望制造廉价复制品的模仿者的威胁，来激励创新。然而，即使没有专利，大流行性流感疫苗制造商也处于这种地位。由于大流行性流感疫苗上市的规模经济和复杂的监管和许可框架，制造商几乎没有仿制药的风险。此外，由于大流行性流感疫苗制造商向各国和各组织垄断的市场出售的产品供不应求，因此创新的动机非常强烈，而各国和各组织都希望获得尽可能多的疫苗。与大流行性流感疫苗相关的独特条件似乎比创新可以申请专利这一事实更能激励这一领域的创新和研究。
The creation of new vaccines is one of the key challenges in the battle against global infectious diseases. Therefore, creating the optimal conditions for innovation in vaccines is one of the most important roles law may undertake in this battle. In relation to pharmaceuticals, the economic theory of patent protection is commonly cited by industry and in the academic literature to justify the patenting of life-saving medicines and vaccines. The economic theory of patent protection holds that innovation occurs due to patents protecting the research and development investment made by the innovator. Proponents of this theory claim that without patents such innovation in medicines and vaccines would occur at a significantly reduced rate. This Article considers the applicability of the economic theory of patent protection to pandemic influenza vaccines. This Article examines a number of factors relevant to patent law, theory, and innovation including: the patent landscape for pandemic influenza vaccines; the market dominance enjoyed by manufacturers; the actual risk posed by imitators making generic vaccines if patent protection were not in place; and, the licensing and regulatory provisions for creating generic vaccines. According to the economic theory of patent protection, a patent incentivizes innovation by providing an innovator with a temporary monopoly regarding their innovation, and by protecting them from the threat posed by imitators who wish to make a cheap replica of the product. However, even without a patent, pandemic influenza vaccine manufacturers are in this position. Due to economies of scale and the complicated regulatory and licensing frameworks relevant to bringing a pandemic influenza vaccine to market, manufacturers are at little to no risk from generic imitators. Moreover, there is a very strong incentive to innovate because pandemic influenza vaccine manufacturers are selling a product for which demand exceeds supply to a captive market of nations and organizations, each of which is hoping to secure as much vaccine as possible. The unique conditions associated with pandemic influenza vaccines appear to provide more of an incentive to innovate and research in this field than the fact that the innovations can be patented.