“Undue difficulty in gaining patent protection will deter investment by reducing the prospect of a reasonable return. This is not in the interests of patients, or of industry. On the other hand, too free availability and excessive breadth of protection will give undue reward for prosaic contribution and may inhibit the speed of exchange of basic knowledge and the likelihood of development of useful products.”1
Genes are the physical units of heredity that parents automatically transfers to children. They are composed of a molecule termed deoxyribonucleic acid (DNA). DNA is composed of sequences of components known as nucleotides.3 Genes are cardinal as they consist of blueprints for the body engaged in formulating proteins. It is proteins that are responsible for growth of our bodies.4 Genes are chemical compounds qualified as compositions of subject matter to meet patent standards. Amongst the parameters of patentability determined by the US Patent Act, there are various exceptions as scrutinized by the courts. A naturally occurring or a preexisting substance of nature is not patentable, per se. However, the courts have ascertained that a product of nature may be patentable if significant artificial alterations are made. By isolating, purifying or otherwise altering a naturally occurring product, an inventor may obtain a patent on the product in its altered form.5 Thus, one cannot patent a naturally occurring gene or protein as it exists in the body, but one can patent a gene or protein that has been isolated from the body and is useful in that form as a pharmaceutical drug, screening assay or other application.6
The practice of granting patents on genes, although upheld by the courts, has come under criticism and scrutiny by some legal scholars, scientists and politicians. The subject of gene patenting includes several ethical, legal, and economic constituents. Although not mutually exclusive, brief understandings of several issues are as follows.