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The above stand on patenting genes is simply stated, however, the problem becomes more complicated when one looks at the historical developments of the patent doctrines that come to justify ‘gene patents’. Genes and gene sequences (alsocalled ‘Expressed Sequence Tags’) pose peculiar legal problems due to their characteristic of being ‘products of nature’. Because genes are a part of the natural human body and exist prior to any human activity, they are legally considered to be a natural product.

Furthermore, under intellectual property norms, natural products have an added mandate against their patentability. Thus, the notion of a ‘human gene patent’ highlights an area of doctrinal confusion underlying patent law – one that has been identified in the cases of several earlier biochemical inventions. Given this similarity between biotechnology and biochemistry, it is appropriate at this juncture to provide a historical overview of various legal landmarks that have been sparked by innovations in both fields.

These legal landmarks stretch back to the beginning of the first half of the 20th century beginning with the Plant Patent Act of 1930. The Plant Patent Act was enacted to provide the incentive to plant breeders, through the grant of monopoly rights, to asexually reproduced plants. The act read that “[w]hoever invents or discovers and asexually reproduces[a] new & distinct,” variety of plant would be entitled to a plant patent over such a plant.

This was the first-ever legislative measure in theUnited States allowing monopoly rights over naturally existing beings with the condition of those beings having the capability to reproduce asexually.

Another important landmark in the doctrinal history of biotechnology patents is US Supreme Court’s judgment in Diamond v. Chakrabarty, 447 U.S. 303 (1980) (known popularly and cited hereafter as Chakrabarty case). In this lawsuit, the plaintiff sough patent rights to a genetically modified bacterium that was capable of clearing oil spills over water. This bacterium was created by Anand Chakrabarty, a biochemical engineer at the GE & Co. The Commissioner of the United States Patent and Trademark Examination office, Sidney A. Diamond, opposed the patent up until the Supreme Court on the grounds that patents cannot be granted over a product of nature or a living object.

Chakrabarty was an important case before the Supreme Court and the biotechnology industry closely watched the result of the case. The lawsuit and its hearing before the Supreme Court occurred in 1980, a time when the industry was beginning to bloom into its most active phase. In the decision for Chakrabarty the Court upheld the plaintiff’s patent over the genetically manufactured bacteria by a wafer thin majority of 5:4 with Chief Justice Burger writing the majority opinion.

The majority judgment held that ‘anything under the Sun made by man’ was patentable and compared the decision in Chakrabarty with a previous decision in the lawsuit Funk Bros. Seed Co. v. Kalo Inoculant Co, 333 U.S. 127 (1948). In Funk Bros. the claimant discovered a certain naturally existing bacteria to be useful in agriculture. The Supreme Court, in Funk Bros., held that claimant has merely discovered the handiwork of nature.

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