Patenting Genetically Engineered Microorganisms: Legal and Scientific Implications

For a long time, scientists in the petrochemical industry were aware of certain bacteria that could break down hydrocarbons in crude oil into simpler and less harmful substances. However, since no single strain of bacteria could metabolize all hydrocarbons present in crude oil, multiple strains were used during oil spills. Unfortunately, not all of these strains could survive in varying environmental conditions, and they sometimes competed with each other, leading to reduced effectiveness.

In 2013, the Supreme Court made a significant decision that prevented the patenting of human genes. The case involved a breast cancer test that relied on the detection of a faulty BRCA1 gene. The impact of this ruling could extend to other naturally occurring substances, such as proteins from animal or human sources, microorganisms sourced from soil or sea, and compounds extracted from plants.

In 1971, Ananda Chakrabarty, an Indian American microbiologist working at General Electric, discovered plasmids that could degrade crude oil. These plasmids could be transferred to the bacterium Pseudomonas to create a genetically engineered species that did not exist in nature. This newly created "oil-eating" bacterium was capable of consuming oil several times faster than the earlier four strains combined, breaking down two-thirds of the hydrocarbons present in a typical oil spill. But, the question arose whether a living organism could be patented.

The US Constitution's Article I, Section 8 granted the right to grant patents to promote the progress of science and useful arts. It granted a fixed-term monopoly to the inventor in exchange for publicly sharing knowledge of the invention. In 1873, Louis Pasteur was granted a US patent for a purified yeast cell. The Plant Patent Act of 1930 allowed plants to be patented, as they were an exception and could foster agricultural innovation. However, in 1980, Sidney Diamond, the Commissioner of the Patent and Trademark Office, challenged the patentability of the "oil-eating" Pseudomonas on the basis that, as bacteria, they were products of nature.

In Diamond v. Chakrabarty, the US Supreme Court, in a 5-4 decision, held that "the fact that micro-organisms are alive is without legal significance for the purposes of patent law" and that "anything under the sun made by man" is patentable. This landmark decision led to an avalanche of biotechnology patent applications and approvals, including the first transgenic animal, the "Harvard Mouse," in 1988, and genetically engineered crops in 1990. Only Canada prohibited patents on higher life forms, such as mice. However, in 2013, the US Supreme Court held that naturally occurring DNA sequences were ineligible for patents.