● Covered by 1 source · 1 reportMedium impact1 negative
Study finds pharmaceutical companies triple drug patents, delaying generic competition
Key points
- Average patents per drug increased from 2.1 (1990) to 6.9 (2019).
- Growth is mainly in 'nonprimary' patents, not active ingredients.
- Patent thickets delay generic drug availability.
- Patent protection extended from 2 years (1990) to 6.1 years (2019).
Patent Growth in Pharmaceutical Industry
A study published in JAMA found a significant increase in the number of patents associated with small-molecule drugs. Researchers observed that the average number of patents per drug approved by the FDA rose from 2.1 in 1990 to 6.9 in 2019.
Rise of Nonprimary Patents
The majority of this patent growth stems from 'nonprimary' patents. These patents cover aspects such as minor modifications to nonactive ingredients, updates to drug usage methods, or designs for specialized delivery devices like auto-injectors, rather than the drug's core active ingredient.
Impact on Generic Drug Availability and Pricing
These numerous additional patents create 'patent thickets,' which delay the introduction of affordable generic versions of drugs to the market. This practice allows brand-name drugs to maintain higher prices for longer periods, without necessarily introducing new clinical advancements.
The study, led by S. Sean Tu, an expert in drug and patent law, indicated that the duration a drug remained under patent protection extended from an average of two years in 1990 to 6.1 years in 2019 due to this increase in patents.
Methodology and Implications
Researchers utilized publicly available data on FDA-approved small-molecule drugs and their associated patents from 1990 to 2019. They categorized patent types and analyzed their effect on patent terms. The study suggests that this 'patent overgrowth' contributes to limited price competition, impacting patients and the healthcare system by increasing spending.
✨ This summary was generated by AI from the outlets' reporting listed below. It is not independently verified and may contain errors — check the original sources. How BrevFeed works →
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Reporting from
A JAMA study revealed that the average number of patents per small-molecule drug tripled between 1990 and 2019, primarily due to nonprimary patents. This increase in patent thickets extends the period drugs are under patent protection, delaying the market entry of affordable generics and contributing to higher drug prices.