Why Did the U.S. Government Decide That DNA Cannot Be Patented?

Artificially created DNA is patentable and naturally occurring DNA present in cells is not. That has not changed. However, a few years ago, there was a dispute over whether naturally occurring DNA that has been artificially isolated can be patented.

The Patentability of DNA: A Brief Overview

The debate surrounding the patentability of DNA is rooted in a fundamental question: Can a discovery of nature, which is inherently non-patentable, be patented through the act of isolation? Until 2013, artificially created DNA was considered patentable, while naturally occurring DNA found in cells was not. This balance was disrupted when the U.S. Supreme Court weighed in, resulting in a significant shift in how genetic material can be patented.

The U.S. Supreme Court Ruling of 2013

In 2013, the U.S. Supreme Court rendered a decision that fundamentally altered the landscape of DNA patenting. In a landmark case, the Court ruled that naturally occurring DNA, even when artificially isolated from cells, is not patentable. The rationale behind this decision was clear: the act of isolating naturally occurring DNA does not alter its natural state, thus it remains a product of nature and cannot be patented. This decision was a response to long-standing disputes and contained significant implications for the biotech industry and scientific research.

Key Considerations and Rationale

The Supreme Court's ruling was based on a critical understanding of patent law. The core principle is that inventions, which result from human ingenuity and innovation, are patentable, whereas purely natural phenomena are not. For example, a method to process DNA to extract specific sequences could be patented, but not the DNA itself.

From a legal standpoint, the decision emphasized the importance of ensuring that the patent system does not grant exclusive rights over discoveries from nature, such as genes, which are fundamental building blocks of life and critical for scientific advancements. This decision was not just about isolating DNA but had broader implications for genetic research, medical advancements, and the overall utility of the patent system.

Implications and Controversies

The implications of the Supreme Court's decision extended beyond legal frameworks and impacted the broader scientific community. It led to debates about the future of genetic research and how patents should be handled in biotechnology. Some argued that this decision could stifle innovation, as the exclusive rights to patents in genetic material could now be more difficult to obtain. Others saw it as a necessary step to ensure that genetic discoveries remain a common resource for the advancement of medical and scientific knowledge.

The decision also highlighted the tension between commercial interests and public good. While private companies could still patent synthetic DNA or methods for working with DNA, the inability to patent naturally occurring DNA provided a safeguard to ensure that such discoveries were not monopolized, preventing broader access to genetic information and treatments.

Conclusion

Artificially created DNA remains patentable, but naturally occurring DNA, when isolated, cannot be patented. This decision by the U.S. Supreme Court balances the interests of innovation and public welfare. It ensures that while scientific advancements continue through the patenting of new methods and synthetic products, the fundamental elements of nature remain accessible for the common good of humanity. The ongoing debate and future legal challenges will continue to shape the landscape of DNA patenting and the ethical considerations inherent in biotechnology.

Keywords: patent, DNA, naturally occurring, isolated DNA, Supreme Court