Gene Patents is History

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Genes are a large part in the academic field of biology. Genetics, the study of genes and genomes has been greatly expanded and has led to many discoveries that have helped our understanding of a variety of life functions. However, with such great discoveries comes the controversy that follows them.

For many generations now there have been a great number of patents that have been filed on biological products, including the first human biological product of a purified version of adrenaline on March 20, 1906. This patent was challenged and question whether it was legal to patent a biological product. The case challenging the patent was Parke-Davis v. Mulford. The patent was upheld on the argument that the purified version of the patent was more useful than the naturally occurring substance. With this ruling it was possible for organic substances to patent as long as they are not the exact substance in question.

In 1980 in another case, Diamond v. Chakrabarty, regarding the first patent of a newly-created living organism, the U.S. Supreme Court upheld the patent of a bacterium for digesting crude oil in oil spills. The patent was originally rejected by the United States Patent and Trademark Office (USPTO), however, Chakrabarty appealed. The USPTO rejected the patent because raw natural materials are not subjected to patents. The ruling from this case stated that as long as the organism is truly “man-made” then it is patentable. Because Chakrabarty’s organism was “man-made” through genetic engineering and its DNA was modified it was patentable.

Through the cases mentioned, the successive patents regarding a number of biological products, substances or live organisms, have given rises to a trend to patent much of genetic science. From this trend arises the large controversy of “gene patent”. A gene patent is a patent on a specific isolated gene sequence, its chemical composition, the processes for obtaining or using it, or a combination of these claims. With a gene patent, a person or a corporation has the legal ownership of the said gene and related genetic information and as such, has control of the gene. The fact that a person or thing may have ownership of a gene creates an “anticommon” that goes against an ideal scientific commons, argues Law professor Rebecca S. Eisenberg. Science is about the sharing of knowledge, with that knowledge as the commons. By patenting genes the scientific community is limiting the amount of research possible, an end opposite to the goal of science. However, regardless whether this “anticommons” exist or not, it does not change the fact that it does limit the amount of work that scientist can do. Professional societies of pathologists have criticized patents on disease genes and exclusive licenses to perform DNA diagnostic tests. With specific genes patented these pathologist are required to obtain permission to use the genes in question in their duties.

On March 26th 2012, the U.S. Supreme Court overruled a lower court ruling allowing human genes to be patented. The court overturned patents belonging to Myriad Genetics Inc. Myriad was the owner of two genes linked to increased risk of breast and ovarian cancer. Mutations on the BRCA1 and BRCA2 genes are associated with greater risk of breast and ovarian cancer. With the patent on these genes, doctors were unable to perform the tests necessary to help patients look for anomalies in their health.

Patents on genes have been ongoing for 30 years but in the controversial case with Myriad Genetics Inc. with the Supreme Court’s new ruling, gene patents are a part the past.

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