Date of Award

Spring 2019

Thesis Type

Open Access

Degree Name

Honors Bachelor of Arts

Department

Chemistry

Sponsor

Dr. Laurel Habgood

Committee Member

Dr. James Patrone

Committee Member

Dr. Eric Smaw

Abstract

The development of a therapeutic to treat a particular disease is a complicated process that incorporates numerous components such as drug discovery, clinical trials, FDA approval and patentability. In the last two decades, cancer research and development has shifted from identifying small molecule therapeutic agents to focusing research on a novel approach designated as immunotherapy. Today, immunotherapy has progressed from a twentieth century scientific theory into an innovative treatment to cancer. In particular, CAR T cells have demonstrated therapeutic properties for certain types of cancers, but these living cells are not compatible with the traditional therapeutic model. First, the drug development process and the historical path of therapeutics in the FDA is introduced to provide a foundation of knowledge concerning drug discovery. Second, the biological and medicinal elements of CAR T cells are outlined and compared to the traditional small molecule Taxol. The third chapter presents CAR T cell patent trends and relevant historical patent debates that focus on evaluating the patentability of biological subject matter. The fourth chapter discloses current CAR T cell patent debates and the potential implications of CAR T cells on patent law and the pharmaceutical industry. It is established that although CAR T cell therapy does not fit into the traditional therapeutic patentability model, CAR T cell therapy should be patentable based on previous biological subject matter patentability decisions made in the court of law. The patentability of CAR T cells continues to be debated in present-day CAR T cell patent disputes which will have significant effects on future patent law and drug development.

Rights Holder

McKenzie List

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