To keep drug prices high, pharma has been piling up the patents

Your prescription drug costs are higher because of added patents on minor drug changes.

A study published in JAMA reveals that pharmaceutical companies have significantly increased the number of patents on small-molecule drugs, extending exclusivity periods and contributing to higher drug prices. Between 1990 and 2019, the average number of patents per drug rose from 2.1 to 6.9. This growth is primarily driven by "nonprimary" patents, which cover minor modifications or delivery devices rather than active ingredients. These "patent thickets" can extend a drug's patent protection by an average of 6.1 years, delaying the market entry of more affordable generic alternatives. Researchers found that nonprimary patents constituted 84% of the total 10,940 patents filed on 1,981 small-molecule drugs approved during the study period. The study's lead author, S. Sean Tu, suggests reforms to the patent system, including increased scrutiny by the USPTO and potential legal remedies for patent abuse, to address this trend.

The proliferation of "patent thickets" on small-molecule drugs signifies a strategic shift by pharmaceutical companies to leverage the US patent system for extended market exclusivity, rather than relying solely on innovation of active ingredients. This practice, which has more than tripled the average number of patents per drug since 1990, effectively creates barriers to generic competition, keeping drug prices elevated for longer periods. The study highlights that these nonprimary patents, which are increasingly common, may not correlate with significant clinical advancements, suggesting a system that prioritizes sustained revenue streams over prompt access to affordable treatments.

This trend directly impacts the healthcare landscape by diminishing price competition and potentially leading to significant overspending by patients and the healthcare system. The extended exclusivity periods, driven by secondary patents, complicate and delay the entry of generics, a critical pathway for reducing medication costs. The call for reforms, including stricter patent office oversight and legal accountability for patent abuse, indicates a growing recognition of the need to rebalance patent protections to encourage genuine innovation while ensuring timely access to affordable medicines.