August 20, 2018

On the Legal Importance of Viewing Genes as Code

The Supreme Court yesterday issued its opinion in the much–awaited Myriad case, which challenged the validity of patents on isolated human genes. The Court held that the isolated genetic sequences claimed in Myriad’s patents did not satisfy the inventive threshold for patentability, although the complementary DNA (cDNA) claimed in the patents did. One of the more interesting elements of the case for me is the extent to which the outcome turned on a single conceptual choice: When assessing patentability, should the legal analysis focus on the isolated DNA’s chemical structure or its information-coding function? The Court decided that the information-coding function was the proper focus. That choice led the justices to the inevitable conclusion that the isolated sequences were not patentable. The Court of Appeals for the Federal Circuit, by contrast, had focused on the sequences’ chemical structure and had reached the opposite conclusion.

Why did this conceptual choice turn out to be so consequential? To be patentable, an invention must be the product of human ingenuity. Products of nature and natural phenomena are excluded from the scope of patent protection. The leading case in the domain of patents on living organisms is Diamond v. Chakrabarty, in which the Court said that patent protection could extend to “anything under the sun that is made by man.” The scope is very broad (i.e., “anything under the sun), but it isn’t unlimited (i.e., it has to be “made by man”).  The question courts must ask to separate products of nature from products of human ingenuity is whether the claimed invention is “markedly different” from something that is found in nature.
[Read more…]