Navigating Intellectual Property Rights: Patentability and Market Exclusivity for Orphan Drugs in The Evolving Landscape

Abstract

Intellectual property is an intangible property created with the endeavor of human intellect. This concept is formulated for the recognition and value for the inventions, creation of mind, literary or artistic work, designs, and traditional knowledge can be given recognition by providing Intellectual Property Rights. Intellectual property is necessary for the progress and well-being of the humanity so that new inventions and creations, further innovations are encouraged. Patent gives exclusive rights for product and process whereby without the permission of the patent owner invention cannot be commercialized. Patent Law is developed as per the standards prescribed in the TRIPS agreement globally. Patent rights are also granted for drugs as pharmaceutical research is expensive and unpredictable. Pharmaceutical sector protects their inventions by product or process patent rights. Nowadays rare diseases or orphan’s diseases caused by genetic alterations have become a threat for human life. It has become a necessity to develop new drugs or orphan drugs to treat these rare disorders even though it is fewer in numbers. In US and EU once a drug receives the status of orphan is attained the protection is limited to 10 to 12 years of protection from commercialization. In such scenario the companies who have spent millions for their Research and Development will not be in a situation to take back the investment. High revenue or capital investment is hindering the development of orphan drugs. Orphan drug exclusivity with the patent protection will definitely help in encouraging more inventions for rare diseases thereby generating a world without disease. This paper surmises upon the importance of patent to orphan drugs and exclusivity to the manufactures which can be achieved only by appropriate policy decisions and regulatory framework.