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From Patents to Patients: Rethinking Drug Patent Rights for a More Accessible Future Cuauhtemoc Ulises Gonzalez, PhD Candidate University of Texas MD Anderson Cancer Center at the UTHealth Houston
Mission ■ Reduce drug prices in the United States ■ Major Policy Recommendations to Congress 1. Remove the sole production rights obtained from a drug patent and allow generics to go through FDA approval sooner. 2. Ownership rights are maintained from a drug patent and generics must pay royalties to the drug patent owner for an extended duration longer than the current 20 years.
Introduction: Pharmaceutical patents The Patent Act of 1952 was signed into law by President Harry S. Truman to establish the provisions and principles surrounding patent rights in the United States. Since its establishment it has been amended to adopt a 20-year patent term from the initial 17-year patent term. In addition, to address concerns regarding access to affordable drugs and to continue fostering the innovation of drugs, the Drug Price Competition and Patent Term restoration Act of 1984 was enacted, also known as the Hatch-Waxman Act. While the 20-year term derives from the Patent Act, the Hatch-Waxman Act set up a pathway for generic drugs to be developed and introduced before the expiration of patents if they can prove the patents are invalid, unenforceable, or that the generic will not infringe on the patent. Lastly, the U.S. Food and Drug administration is the regulatory agency in charge of maintaining the safety, efficacy, and quality of drugs marketed in the United States.
has negatively impacted the people of United States as it limits access to healthcare for those in lower socioeconomic status. While high drug prices in the United States compared to other countries can be attributed to multiple complex factors, one factor that is rarely discussed is the large investment required to produce drugs. Pharmaceutical companies are invested in multiple drugs at a time as it is estimated that 0.1% of these drugs reach the counter, and it can take 10+ years for one drug to reach the counter due to the required FDA regulations that keep our drugs safe, effective, and high-quality. This leaves pharmaceutical companies with less than 10 years to recover their investment and profit to continue drug research and development, forcing companies to inflate their prices during their patent lifespan. This is in addition to the returns expected of investors. Pharmaceutical companies have also found ways to circumvent the 20-year lifespan of a drug by including patents surrounding the drug formulation, delivery, and equipment. This allows them to extend their patent and prevent generics from being produced and competing. Because competition allows drugs to be cheaper to the public due to cost and demand, action must be taken to tackle the issue of pharmaceutical companies needing to recoup their investments within a 10-year timeframe.
Proposal: Win-win for the public and drug companies. While the Hatch-Waxman Act aimed to address drug accessibility and promote the free market, it does not do this sufficiently. Therefore, I propose congress make policy changes on the patent system set for new drug development. To benefit U.S. citizens and pharmaceutical companies, the following aim must be met.
Current Challenges: Drug patents promote drug Reduce the cost of drugs while continuing to price hikes and obstruction of competition. incentivize drug development. Based on 2017 statistics, the United States sits at the top in pharmaceutical expenditure with $1220 price per capita when compared with the next four countries’ price per capita of $963, $838, $823, $806 which is 21%, 31%, 32%, 34% cheaper than that of U.S., respectively. This
The Pharmacologist • September 2023
To reduce the cost of drugs, generics must be allowed to initiate production earlier than allowed by the current patent system; therefore, the sole production rights generated by a patent must be removed, but rights to ownership should
