July 23, 2024

The Ethics of Gene Patenting

The first question discussed in last Wednesday’s class had to do with the ethics of patenting in science. Professor Jiang asked, “Should genes be patented?”. To contextualize this question, it is imperative to know that the U.S. Supreme Court ruled, in the 2013 court case Association for Molecular Pathology v. Myriad Genetics, Inc., that “a naturally occurring DNA segment is a product of nature and not patent eligible” (Sherkow & Greely, 2015). As of 2013, the patenting of all naturally-occurring genetic material is illegal. Genetic material that does not occurred naturally or has been modified in some way can be patented. However, it was not always like this.

Before 2013, the patenting of genetic material that has only been isolated or purified was allowed, even if it was naturally-occurring (Sherkow & Greely, 2015). The most famous example of this was the Parke-Davis decision in the year 1900 where Judge Learned Hand ruled that it was valid to patent adrenaline because it was “isolated and purified from its natural surroundings” and that somehow changed adrenaline’s identity as a product of nature (Sherkow & Greely, 2015). This decision governed patenting in biology for the rest of the century and it also justified the series of patents on nucleotides that occurred throughout the mid-20th century. The patents changed as biology advanced, as a field, and this all led to “the first human gene patent … in 1982” (Sherkow & Greely, 2015).

Up until the start of the Human Genome Project in 1990, over 1,000 patents claimed genes or genetic sequences (Sherkow & Greely, 2015). Despite the Human Genome Project’s overt opposition towards the patenting of genes, gene patenting would not become illegal until the Supreme Court ruling in 2013 (Sherkow & Greely, 2015). The patent company had continued to threat litigation or actually carry out litigation for sixteen years (Sherkow & Greely, 2015). Despite their incessant efforts, all of their claims were deemed invalid (Sherkow & Greely, 2015). To validate their claims as valid meant that Myriad Genetics, Inc. was to be given “the exclusive right to isolate an individual’s … genes” (Sherkow & Greely, 2015). When it is seen in this light, it should be obvious as to why gene patenting is unethical.

Not only was the ruling difficult for Myriad Genetics, Inc. to accept, but the biotech industry struggled at first to adapt to the new landscape, in regards to patenting in science (Servick, 2014). The patent proposals of the scientific and biological communities were approximately likely to be rejected 40% of the time (Servick, 2014). The system had been a certain way for so long. Thus, it is totally understandable that the Supreme Court’s decision may have been difficult to get used to at first. Ultimately, however, this decision would allow science to progress the most in the long run. This topic became relevant again just three years later, in 2016, in regards to the topic of genetically modified plants (Porter, Durand, & Elmayan, 2016). It is in the best interest of all parties that knowledge about the biotechnologies allowing for the genetic modification of crops and plants be non-patented public information (Porter, Durand, & Elmayan, 2016). Genetically modified plants are still plants. Plants have native genes and sequences (Porter, Durand, & Elmayan, 2016). The discovery or manipulation of such genes and sequences cannot be considered an invention and, therefore, should not be patented (Porter, Durand, & Elmayan, 2016).

So long as science continues to progress, the issue of patenting will continue to arise because people want to profit any way that they can. To further encourage the advancement of the scientific community, it is important to refer back to the rulings of the past and to prevent the patenting of naturally occurring genetic materials.

 

References

Porter, J. R., Durand, J., & Elmayan, T. (2016). Edited plants should not be patented. Nature, 530(7588), 33-33. doi:10.1038/530033b

Servick, K. (2014). Biotech feels a chill from changing U.S. patent rules. Science, 345(6192), 14-15. doi:10.1126/science.345.6192.14

Sherkow, J. S., & Greely, H. T. (2015). The History of Patenting Genetic Material. Annual Review of Genetics, 49(1), 161-182. doi:10.1146/annurev-genet-112414-054731

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