一项发表在《JAMA》上的美国研究揭示了制药公司的专利策略。1自1990年以来，小分子药物的平均专利数量大幅增长，从1990年的每种药物2.1项专利增至2019年的6.9项，增长幅度超过两倍。1
这些新增专利的主要特点是与药物的活性成分无关。1相反，它们多数针对非活性成分的微调、用法方式的更新或特殊给药装置等周边方面。1通过这种方式，制药企业建立起一个密集的专利网络，有效延缓了廉价仿制药的上市时间。1研究表明，这种专利堆积策略使药物价格保持在较高水平，尽管从临床角度看并无实质性进展。1
A study published in JAMA reveals that pharmaceutical manufacturers have substantially increased patent filings on small-molecule drugs as a strategy to delay generic competition and sustain elevated prices.1 Between 1990 and 2019, the average number of patents per small-molecule drug more than tripled, rising from 2.1 patents in 1990 to 6.9 patents by 2019.1
The majority of this patent growth stems from what researchers term "non-core patents," which are not directly related to the active pharmaceutical ingredient itself.1 Instead, these patents cover modifications to inactive ingredients, updated administration methods, or specialized delivery devices.1 By constructing what amounts to a patent thicket around each drug, manufacturers effectively create legal barriers that prevent cheaper generic alternatives from reaching the market, thereby preserving higher drug prices without delivering meaningful clinical advances.1
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