Manheim Bruce S, Granahan Patricia, Dow Kenneth J
Life Sciences Group at the law firm Ropes and Gray LLP in Washington, DC, USA.
Health Aff (Millwood). 2006 Mar-Apr;25(2):394-404. doi: 10.1377/hlthaff.25.2.394.
Congress adopted legislation in 1984 to encourage pharmaceutical companies to develop new drugs, while simultaneously allowing competitors to bring cheaper generic versions to market. More than twenty years later, Congress may be faced with a similar balancing act for biologics. When Congress takes up this issue, it must focus on the substantial differences that exist between biologics and drugs. It should also evaluate the patent law, which is yielding increasingly narrow patents. If additional measures are not adopted in light of the intersection of these factors, then any legislation allowing for "follow-on" biologics could stifle development of new medicines from biotechnology.
1984年，国会通过立法鼓励制药公司研发新药，同时允许竞争对手将更便宜的仿制药推向市场。二十多年后，国会在生物制品问题上可能面临类似的权衡之举。当国会着手处理这个问题时，必须关注生物制品与药品之间存在的重大差异。它还应评估专利法，该法律所授予的专利范围越来越窄。如果不根据这些因素的交叉影响采取额外措施，那么任何允许“后续”生物制品的立法都可能抑制生物技术新药的研发。
