The United States has gone back and forth over whether its citizens have a moral right to access potentially life sustaining or lifesaving treatment when they are terminally ill. Currently, forty-one states and the US Senate have passed "right to try" laws that permit terminally ill patients to have access to experimental treatments that have not yet received FDA approval. The United States has had a difficult time determining whether a patient has the right to refuse life-sustaining or lifesaving treatment because of fear that the patient is suicidal. The Supreme Court has addressed this problem and determined that the State does have an interest in preserving the healthy lives of its citizens.
This dilemma is complicated further by the prospect of personalized medicine, i.e. the use of medicine specifically created for one particular individual. With this narrow application, there would likely be no commercial viability for the treatments elsewhere. Further, due to the complicated nature of these medications, the Supreme Court has allowed "biosimilar" patents, which allow non-exact copies of a drug to be made. This is unlike, and potentially less rigorous than, the standard FDA approval requirements.
This Note addresses the problems that arise when the patent protectors of the personalized product interfere with the patient's right to receive treatment and the state's interest in protecting its citizens by making medical treatment available. If the patient cannot afford the personalized medication, and it is the only treatment, is there a right to the treatment? If the patient consented to the creation of the personalized and lifesaving treatment (not just experimental), is there a right to refuse the treatment at a later date? First, this Note will explain what personalized medicine is, and give an overview of how treatment can be so precisely designed for each individual's genomic makeup. Second, this Note will examine the property rights of one's genetic information, especially when that information is obtained without the patient's consent. Third, this note will summarize the process for patenting these biologic products a. Fourth, this Note will provide a description of the Abigail Alliance case and the idea of medical self-defense. Finaly, this Note will argue why patents of this nature will interfere with the idea of the moral "right to try" and how that interference will require incentive structuring for medical innovation to change.
Johnson T. Laney,
The Shifting Landscape of Medicine: Patents of Personalized Biologic Treatments and Their Potential Conflicts with Right-to-Try Laws,
J. Intell. Prop. L.
Available at: https://digitalcommons.law.uga.edu/jipl/vol26/iss1/6