Due to the intrinsic link between public health and patent law in the context of access to pharmaceuticals, the necessity of striking a reasonable balance between the intellectual property rights of patent holders and the interests of public health has given rise to the need for specific regulatory provisions within pharmaceutical patents.
Accordingly, while patent rights grant the holder broad exclusive rights over the drug, certain acts are exempt from the scope of patent protection. In particular, considering the direct impact of drug prices on access to medicine and the correlation between the market availability of generic drugs and the reduction of drug prices, an exemption has been introduced. This exemption allows generic drug manufacturers to conduct tests and trials for regulatory approval purposes without constituting an infringement on the patent rights of the original drug manufacturer, emphasizing the public’s right to health. This exception was first recognized in the United States through a Federal Court ruling and has subsequently been codified into law within European Union member states and Turkey.
