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The development of patent law reflects a continuous attempt to strike a balance between encouraging innovation and ensuring public access to essential products. Within this framework, certain exceptions and doctrines have been evolved to prevent the abuse of patent rights and to promote competition and public welfare. Two such important concepts are the Bolar provision and parallel import, both of which play a crucial role in the pharmaceutical sector and other industries where patent protection intersects with public interest concerns. The Bolar provision, sometimes referred to as the “early working” exception, is a statutory exception to patent infringement. It allows third parties, typically generic drug manufacturers, to use a patented invention without the consent of the patent holder for the limited purpose of obtaining regulatory approval before the patent expires. The rationale behind this provision lies in the need to avoid delays in the entry of generic products into the market. Without such a provision, generic manufacturers would have to wait until the patent expires before beginning the process of testing and regulatory approval, which can take several years. This would effectively extend the monopoly of the patent holder beyond the legally granted term, thereby delaying access to more affordable alternatives. The origin of the Bolar provision can be traced to a judicial decision in the United States, where a generic manufacturer was held liable for patent infringement for conducting tests necessary for regulatory approval before patent expiry. In response, legislation was enacted to allow such activities, recognizing that they were necessary for ensuring timely market entry of generics. Many countries, including India, have incorporated similar provisions in their _________ __________ ____ _________ ______ _______ _______.
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