Patents Undermine Drug Innovation and Access by Gabby Couture

The U.S. patent system hinders genuine biomedical innovation by rewarding pharmaceutical companies for manipulating the patent process, rather than for developing legitimate treatments that benefit many. Policy reform is necessary to boost true innovation and lower drug prices.

Pharmaceutical companies argue that high drug prices are necessary to support innovation. However, many firms today are spending less on developing new drugs and more on protecting their profits through legal tactics. They utilize practices like “evergreening” and “product hopping” to dominate the market without providing medical improvements. These strategies prevent generic drugs from competing in the market, which makes the initial drug price extremely high. It is time to change this system to reward real innovation and make drugs affordable for patients. 

Patents are designed to give drug developers a temporary monopoly to help boost innovation. However, in recent years, companies have used the patent system to block competition rather than to protect their discoveries. A 2018 report from the Initiative for Medicines, Access & Knowledge found that the top 12 best-selling drugs in the U.S. had an average of 125 patent applications filed per drug. Many of these drugs received more than 100 years of patent protection. This type of use of the patent system is known as “evergreening.” It involves filing patents on changes like new dosages rather than actual innovative improvements.

This forms a “patent thicket,” which makes it very difficult for generic manufacturers to work through the legal system and bring affordable versions of drugs to the public. One had over 130 patent applications and managed to delay similar competition in the U.S. until 2023, which is two decades after its initial approval. In contrast, similar drugs have been available in Europe for years at a much lower cost.  

Generic drugs reduce the price of the original drug by up to 90% once they enter the market. However, companies can prevent this process through “product hopping.” Product hopping is introducing altered versions of a drug and taking out the older one to force doctors to prescribe the newer, patent-protected version. This strategy harms patients by keeping the lower-cost alternatives out of the market. 

According to a 2021 article published in JAMA by Kesselheim and colleagues, anti-competitive tactics such as these harm any inspiration for true innovations. The authors argue that while patents are meant to encourage groundbreaking research, “the current system rewards companies for small, low-risk modifications” that serve to block competition.

To ensure new medicines and affordable prices are implemented, a few important changes are needed:

1. Limit Patent Thickets: Congress should limit the number of patents that can be filed per drug. This would reduce evergreening and allow generic drugs to enter the market faster.
2. Ban Product Hopping: Regulatory agencies should punish companies that withdraw older drug versions to prevent generic drugs from entering the market.
3. Promote Breakthroughs: Give extra patent protection only to drugs that clearly work better than current ones.
4. Increase Transparency: Ensure pharmaceutical companies release development costs and the extent of taxpayer funding when setting prices.

The current patent system does not serve its purpose of encouraging innovation. Instead, it regards legal tactics that protect profits and diminish competition. Patients struggle to afford medications, which is why we must reform the system to prioritize meaningful innovation and patient access. Progress in biomedical research should not be measured by the number of patents filed, but by the widespread accessibility and improved lives.