October 1st kicked off the start to Breast Cancer Awareness Month. One Cleveland- based doctor is doing his share of “thinking pink” with the development of a vaccine that could prevent breast cancer. Vincent Tuohy, an immunologist in the Cleveland area, developed the vaccine about three years ago, although the vaccine’s recent success in trials has brought more media attention.
The fact that a breast cancer prevention vaccine was developed years ago seems odd, since an average of 39,620 deaths still occur from breast cancer each year. It almost goes without saying that there is a catch to this vaccine: it has only been tested in mice. However, the vaccine was safe and effective in preventing breast cancer in mice, including those that were bred to have a predisposition for breast cancer. With only success in mice and also the need to pass the FDA approval process, it’s likely that the vaccine will not be available for humans for at least 10 years.
It might seem strange to some that late stage cancer treatments are readily available, while preventive measures are still lacking. Some researchers suggest that the likely culprit for this disparity is the U.S. patent system.
For a preventive vaccine such as Dr. Tuohy’s, the clinical stage of the process can take a long time, considering the FDA’s rigorous process. Here, the vaccine was invented three years ago and has only made its way through animal testing. Since Dr. Tuohy estimates at least 10 years until completion, the vaccine, at best, will have only 7 years left of patent protection when it is finally ready for human use.
To understand why this process takes so long, it is worth noting the FDA’s requirements in approving a new vaccine. To get approval for a vaccine, the FDA needs to see that it actually extends patients’ lifespan. If a patient has late stage cancer, it is easy to see if the vaccine works. However, it could take decades to see if a preventive vaccine, such as Dr. Tuohy’s, actually has any effect. If this is the case, the timeline for the FDA’s approval process could far surpass the time of patent protection.
But why does this legal issue interfere with the work of researchers so much? The answer is simple: money. For each and every tick of the patent clock, investors lose exclusive financial rights to the vaccine. Many investors are instead choosing to invest in vaccines that have quicker approval processes because they are afforded more time within the 20-year period to benefit financially.
As for the breast cancer vaccine, Dr. Tuohy thankfully found an investor last month that has agreed to cover the cost of the first phase of FDA testing, which includes the first clinical trials to test the drugs on humans.
* Caitlin S. Hale is a second year law student at Wake Forest University School of Law. She holds a Bachelor of Arts in English, with a minor in Communication Studies, and received a certificate of technical and professional writing and communication from East Carolina University. Upon graduation, she intends to practice labor and employment law.