Kaplan Warren A, Beall Reed F
Department of Global Health, Boston University School of Public Health, Boston, MA 02118 USA.
Population Health Program, Faculties of Medicine and of Law, University of Ottawa, One Stewart St, Ottawa, ON K1N 6N5 Canada.
J Pharm Policy Pract. 2016 Jul 19;10:3. doi: 10.1186/s40545-016-0072-8. eCollection 2017.
BACKGROUND: Lack of access to insulin and poor health outcomes are issues for both low and high income countries. This has been accompanied by a shift from relatively inexpensive human insulin to its more expensive analogs, marketed by three to four main global players. Nonetheless, patent-based market exclusivities are beginning to expire there for the first generation insulin analogs. This paper adds a global dimension to information on the U.S. patent landscape for insulin by reviewing the patent status of insulins with emphasis on the situation outside the US and Europe. METHODS: Using the term "insulin", we searched for patents listed on the United States Food and Drug Administration's (USFDA) Orange Book and the Canadian Online Drug Product Database Online Query and its Patent Register. With this information, we expanded the search globally using the World Intellectual Property Organization (WIPO) PatentScope database, the European Patent Office's INPADOC database and various country-specific Patent Offices. RESULTS: Patent protected insulins marketed in the U.S. and other countries are facing an imminent patent-expiration "cliff' yet the three companies that dominate the global insulin market are continuing to file for patents in and outside the U.S, but very rarely in Africa. Only a few local producers in the so-called "pharmerging" markets (e.g., Brazil, India, China) are filing for global patent protection on their own insulins. There is moderate, but statistically significant association between patent filings and diabetes disease burden. CONCLUSIONS: The global market dominance by a few companies of analog over human insulin will likely continue even though patents on the current portfolio of insulin analogs will expire very soon. Multinationals are continuing to file for more insulin patents in the bigger markets with large disease burdens and a rapidly emerging middle class. Off-patent human insulins can effectively manage diabetes. A practical way forward would be find (potential) generic manufacturers globally and nudge them towards opportunities to diversify their national insulin markets with acceptable off-patent products for export.
背景:胰岛素获取困难和健康结果不佳是低收入和高收入国家都面临的问题。与此同时,胰岛素市场已从相对便宜的人胰岛素转向由三到四家全球主要企业销售的更昂贵的类似物。尽管如此,第一代胰岛素类似物基于专利的市场独占期已开始在美国到期。本文通过回顾胰岛素的专利状况,重点关注美国和欧洲以外的情况,为胰岛素在美国专利格局方面的信息增添了全球维度。 方法:使用“胰岛素”一词,我们检索了美国食品药品监督管理局(USFDA)的橙皮书、加拿大在线药品产品数据库在线查询及其专利登记册上列出的专利。利用这些信息,我们通过世界知识产权组织(WIPO)专利数据库、欧洲专利局的INPADOC数据库以及各国的专利局在全球范围内进行了扩展搜索。 结果:在美国和其他国家销售的受专利保护的胰岛素正面临着迫在眉睫的专利到期“悬崖”,然而,主导全球胰岛素市场的三家公司仍在继续在美国国内外申请专利,但在非洲申请的很少。在所谓的“新兴制药”市场(如巴西、印度、中国),只有少数本地生产商为其自己的胰岛素申请全球专利保护。专利申请与糖尿病疾病负担之间存在适度但具有统计学意义的关联。 结论:尽管目前胰岛素类似物系列的专利很快将到期,但少数公司在全球市场上对胰岛素类似物的主导地位可能仍将持续。跨国公司继续在疾病负担大且中产阶级迅速崛起的更大市场申请更多胰岛素专利。非专利人胰岛素可以有效控制糖尿病。一条切实可行的前进道路是在全球范围内寻找(潜在的)仿制药制造商,并推动他们利用可接受的非专利出口产品实现本国胰岛素市场多样化的机会。
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