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.

The Controversy Surrounding Genetically Modified Crops (GMC)

The use of genetically modified crops (GMC) has sparked intense debate, blending scientific advancements with societal, health, and economic concerns. The United States, as the largest producer of GMC, supports their safety, with many reputable scientific organizations asserting that GMC are "substantially equivalent" to conventional foods and do not require special labeling. In contrast, several European Union member states question their safety and have opposed the importation and cultivation of GMC.

Genetic Modification Techniques

Genetic modification (GM) builds on the concept of genetic recombination, first observed in 1947, which involves the natural transfer of DNA between organisms. GMC are created by inserting specific genes into plants to enhance desirable traits, often using a biolistic device (gene gun) or agrobacteria. One common example is Bacillus thuringiensis (Bt toxin), a natural pesticide used to reduce chemical use. The first GMC was tobacco, engineered for herbicide resistance in 1982. The first commercially available GMC, the Flavr Savr tomato, debuted in the U.S. in 1994, offering a longer shelf life.

Benefits and Criticisms of GMC

Supporters of GMC highlight their potential to improve food security, increase crop resilience, and enhance nutritional content, particularly in resource-poor areas. However, critics raise concerns about the safety of GMC, including potential allergic reactions, the risk of contaminating non-GM crops, and the creation of "superweeds." Additionally, there are concerns regarding corporate control over GMC patents, with companies like Monsanto holding 90% of the world's GM seed patents.

A conceptual image of a genetically modified organism (GMO): corn growing in a pea pod.

The Evolution of Insulin: From Discovery to Biotechnology Innovation

In the early 1920s, groundbreaking research by Frederick Banting and Charles Best led to a pivotal discovery in the treatment of diabetes mellitus. They demonstrated that a pancreatic extract could effectively manage diabetes, revolutionizing the way the disease was treated. By 1923, this pancreatic extract—derived from pig and beef organs, with insulin as its active ingredient—was commercialized by Eli Lilly. Just three years later, the extract was crystallized, marking a significant milestone in medical science.

Frederick Sanger’s Breakthrough in Protein Sequencing

The 1940s and 1950s marked a new era in biochemistry with the pioneering work of English chemist Frederick Sanger. In 1943, Sanger began investigating the amino acid sequence of insulin at Cambridge University. At that time, insulin was one of the few proteins available in pure form, readily obtainable from the British pharmacy chain Boots. After years of dedicated research, Sanger succeeded in determining the precise amino acid sequence of insulin. In 1951 and 1952, he discovered that insulin consists of two peptide chains: an A chain containing 21 amino acids and a B chain with 30 amino acids.

This groundbreaking discovery made insulin the first protein to have its complete amino acid sequence determined. Sanger's work proved that all human proteins possess a unique chemical sequence composed of the 20 standard amino acids. For his monumental contributions to the understanding of protein chemistry, Sanger was awarded the Nobel Prize in Chemistry in 1958. In 1977, he became the only individual to win the Nobel Prize in Chemistry twice, a testament to his enduring legacy in the field.

The Synthesis of Insulin: Advancements in Biotechnology

With the chemical structure of insulin now fully understood, scientists were able to begin synthesizing this vital hormone in the laboratory. By 1963, researchers succeeded in synthesizing insulin, paving the way for greater precision in treatment. However, the insulin derived from animals, although effective, had slight differences from human insulin. Pig insulin differs by one amino acid, while beef insulin differs by three. These small variations, while seemingly insignificant, were responsible for allergic reactions in some diabetic patients.

The Dawn of Genetically Engineered Human Insulin

In 1978, a groundbreaking achievement in biotechnology took place. Researchers at the City of Hope National Medical Center, in collaboration with Genentech, a biotech company led by biochemist Herbert Boyer, succeeded in synthesizing human insulin using recombinant DNA technology. This process involved inserting the human insulin gene into bacterial DNA, creating genetically modified bacteria that acted as biological factories. These bacteria multiplied rapidly, producing virtually limitless supplies of human insulin.

This innovation marked a turning point in diabetes treatment. In 1982, Eli Lilly introduced Humulin, the first commercially available human insulin, replacing animal-derived insulin. Humulin was a game-changer in the management of diabetes, offering a safer and more reliable alternative to animal insulin.

The Legacy of Insulin Innovation

The journey of insulin—from its initial discovery to the development of synthetic and genetically engineered forms—has been a testament to the power of scientific collaboration and innovation. The work of Banting, Best, Sanger, Boyer, and countless others has not only revolutionized diabetes treatment but also paved the way for advancements in biotechnology and genetic engineering. Today, the ability to produce insulin through biotechnology has transformed the lives of millions of people worldwide, offering a more effective and accessible treatment for diabetes than ever before.

A three-dimensional model of the insulin molecule. By convention, the following colors represent specific elements: white = hydrogen; black (shown here as dark gray) = carbon; blue = nitrogen; red = oxygen; yellow = sulfur.