Clinical Trials and Intellectual Property Rights
The areas that are affected by intellectual property rights when conducting clinical trials are the molecular structure of the drug, how it works in the human body, and outcomes of the clinical trial. The invention has to prove its uniqueness by disclosing technical information on the subject to attain a patent. The molecular structure should not be similar to other existing products covered by the patent law (Gregg & Tzanidis, 2021). Based on the available research and expectations of the products, a patent can be applied at the initial stages of a clinical trial. In addition, the product in development may have a similar action mechanism to existing products, but the chemical structure should be different. This allows the patent holder to have exclusive rights to a product’s molecular composition. However, the trials are time-consuming, and the set objectives may not be attained. Therefore, the patent provides a grace period for the patent holder to continue developing their product.
Another area affected by patents in clinical trials is the action mechanism of a product. New products enlisted in a similar therapeutic category should have a distinct working mechanism in the human body (Gregg & Tzanidis, 2021). During the first phase of the clinical trial, the product under development is administered to healthy people to establish its effects; however, during the second phase, it is administered to actual patients. As a result, a patent may be applied based on how the product reacts to the body. Moreover, a patent can be applied based on the administration methods. After conducting a clinical trial, the study results may lead to alternative techniques for administering care, which can be patent. Hence, patents provide marketing rights reducing the risks in investing on innovation.
Reference
Gregg, C., & Tzanidis, A. (2021). Australia: The nexus between intellectual property and clinical trials: An Australian perspective. Mondaq.