Can Human DNA Be Patented?

The question of whether human DNA can be patented has been a complex and controversial issue for decades. While scientific breakthroughs have brought significant advancements in genetic research, the legal landscape surrounding human DNA patents remains fluid and subject to numerous court cases and regulatory changes.

Legal Framework in Europe and the US

Europe: In Europe, at least, it is perfectly legal to patent DNA as a purified chemical compound. The legal precedent can be traced back to the patenting of aspirin, which was initially recognized as a new chemical compound. The same logic applies to DNA: if it is a previously unknown compound, it can be patented. However, with the sequencing of the human genome, the availability of DNA sequences has become much more widespread, making it increasingly difficult for companies to obtain patents on DNA sequences alone.

United States: In the United States, a different legal framework has developed. In 2013, the Supreme Court ruled that naturally occurring DNA sequences cannot be patented. This ruling was a significant step in addressing the ethical and scientific concerns around patenting human genes. However, the Court allowed for the patenting of synthetic DNA or DNA sequences created through human intervention. This means that while naturally occurring human DNA cannot be patented, treatments and processes derived from such sequences can be, provided that they demonstrate significant innovation and contribute to a substantial new technological advance.

Substantive Value and Originality

A key element in obtaining a patent is the requirement for an "element of human ingenuity." Simply finding a naturally occurring sequence in nature is insufficient to warrant a patent. Innovators need to demonstrate that they have created something new and novel, such as a new method for using the DNA sequence or a new synthetic variant. For example, genetically engineered plants and animals can often be patented because these products are the result of human intervention and innovation.

Historical Context and Controversy

The heyday of DNA sequencing and associated controversy was likely the 1990s. At that time, the technology was rapidly advancing, and there were many ethical concerns about patenting human genes. For instance, companies were aggressively attempting to purchase the rights to specific human genomes from various populations.

One contentious case involved companies soliciting individuals or groups to sequence and patent the genomes of various populations, including Icelanders, Native American tribes, Native Hawaiians, and Australian Aborigines. While these efforts raised significant ethical concerns, they also highlighted the complexity of the issue and the need for a more nuanced understanding of the legal and ethical boundaries.

Recent Developments and Future Prospects

While the legal landscape has evolved, the ability to patent human DNA through its derived processes remains an evolving area. In recent years, there have been some strange and controversial court decisions in the US. These decisions have further complicated the legal framework and added a layer of unpredictability to patent law.

As technology continues to advance, it is likely that the legal and regulatory frameworks will also evolve. Innovators and companies will need to navigate these complex legal issues carefully to ensure that they are adhering to the evolving standards and regulations.

Conclusion

Whether human DNA can be patented is a multifaceted question that requires a deep understanding of both legal and ethical considerations. While naturally occurring DNA sequences cannot be patented, treatments and processes derived from these sequences can be, provided they demonstrate significant innovation. As the field of genetic research continues to evolve, the legal landscape will undoubtedly continue to adapt to the changing landscape of scientific discovery.