Abstract
AbstractThe main objective of this review is to highlight and explore the inter-relationship and the functioning of the intellectual property right in the pharmaceutical and biotechnology industry. The rising tide of patent applications can be witnessed globally in this industry as the need for such protection and licensing has become imperative so as to safeguard the rights of the inventor and also to encourage and promote new talents, inventions and innovations which can be a boon for the economy. The field of biotechnology is an upcoming science which is still at the initial stage of establishing a foundation but it promises a revolution in the fields of medicine, agriculture, pharmaceuticals and industrial sector amongst other sectors of the economy along with contribution to the GDP growth.
Highlights
Intellectual property refers to the exclusive rights granted by the State over creations of the human mind, in particular, inventions, literary and artistic works, distinctive signs and designs used in commerce
SMEs in the pharmaceutical industry may use the wealth of information contained in patent documents as a crucial input to their Research and Development (R&D) work, to get ideas for further innovation, to ensure their "freedom to operate" or to find out when a patent is due to expire opening the door for the introduction of generics
In addition to the general security exception, which applies to the entire Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, specific exclusions are permissible from the scope of patentability
Summary
Intellectual property refers to the exclusive rights granted by the State over creations of the human mind, in particular, inventions, literary and artistic works, distinctive signs and designs used in commerce. Industrial designs, plant variety protection and copyright and related rights are generally less relevant to most SMEs in the pharmaceutical sector but this could vary depending on the product line and strategy of each company. Where a country does not make available patent protection for pharmaceutical and agricultural chemical products as on 1.1.1995, they have to provide a means for accepting applications for such inventions (mailbox), apply applicable priority rights and provide exclusive marketing rights (EMRs) for such products. In addition to the general security exception, which applies to the entire TRIPS Agreement, specific exclusions are permissible from the scope of patentability These are available in the areas of inventions whose commercial exploitation is to be prevented to protect public order or morality, human, animal plant life or health or to avoid serious prejudice to the environment. The list is by no means exhaustive and not all of the above are patentable in all countries
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