Genetic Editing for Healthcare Advances in Disease Management First Edition by Unknown

Author:Unknown
Language: eng
Format: epub
Published: 2026-06-15T00:00:00+00:00

Forming the foundations of patent law are three basic criteria for invention: utility, novelty, and non-obviousness; all inventions, including those based on genetic material, are required to meet these test criteria. Instead, the application of these principles to genes and genetic technologies has been particularly difficult and controversial, leading to distinct challenges and interpretations in law.

6.2.2 What Are “Inventions” in Genetics: Products of Nature or Man-Made?

One of the bedrock principles of patent law in most jurisdictions is the nonpatentability of “products of nature.” Intuitively, this principle is based on the fact that natural laws, natural phenomena, and abstract ideas are the basis of science and technology development and should be in the public domain for everyone. Nevertheless, a clear distinction between a “product of nature” and a patentable “invention” is particularly nuanced and difficult to draw in the field of genetics. The human being has genes, and genes are indeed products of nature. They are naturally occurring sequences of DNA which evolved over millennia. Finders, after all, have long been considered basic discoveries of nature and patent-ineligible: just because you found a opened a new gene or its function, the scientific world has long considered all that a patent-less scientific achievement in itself. But patent law acknowledges that human intervention and genius can take a product of nature and elevate it into a patentable invention. Such transformation generally involves some type of human modification or change that produces an item that is “new” and “useful,” and not found in nature in that unique form [9]. The key question in gene patenting then is 120the amount of human intervention that is necessary to convert a naturally occurring gene into a patentable invention. Patent offices and courts have struggled with this question in the past, leading to shifting interpretations and legal precedents. The early gene patents were typically directed to “isolated and purified” DNA sequences. The argument was that isolating a gene from its natural environment and purifying it and characterizing its sequence and function involved sufficient human ingenuity to make it patentable, even though the underlying genetic information itself was naturally occurring. It built on the notion that this isolated and purified form of the gene was not found in nature in that very form and had been given a novel utility through the agency of human beings.

But this “isolation and purification” rationale has been increasingly criticized and challenged in the courts, particularly in landmark cases like Association for Molecular Pathology v. Myriad Genetics in the United States. In Myriad, the Supreme Court ruled that isolated natural gene sequences are not per se patentable, even though they have been isolated. The Court reasoned that when a gene is isolated, it does not form anything new; rather, it simply reveals something that already exists in nature. The court explained that methods for isolating genes and (newly-discovered) applications of genetic information may be patentable, but the gene sequences themselves in their natural state are not patentable subject matter. The outcome of this and

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