6 Pages Posted: 21 Jan 2010 Last revised: 26 Jan 2010
Date Written: January 16, 2010
The United States Patent and Trademark Office (PTO) is presently being sued for its practice of issuing patents on isolated but otherwise-natural genes. In this essay I challenge such patents on two distinct but related grounds: obviousness and naturalness.
The Supreme Court has held all “human-made inventions” - biological or otherwise - to be patentable, in contrast to “products of nature” which are not. Hence, patentability is well-settled for truly modified genes or engineered organisms, but it is less clear when a substance exists in nature - albeit encumbered by other commingled matter obstructing its access or use. The PTO contends that “isolated and purified” genes are patentable subject matter (not just the means of isolation, or subsequent uses). However, genes do become isolated and purified in the natural course of cells synthesizing proteins via transient structures which are readily extractable and substantially identical to their artificially-reconstituted (and patented) counterparts. Although precedent on the product-of-nature doctrine admittedly makes it an easy barrier to overcome, such precedent uses an inadequate test for naturalness.
Additionally, in general when courts have regarded mere isolation as invention, they seem to have implicitly misattributed the ingenuity of certain methods and processes to the underlying objects thereof. I submit that an isolated gene is an obvious variation of - and a distinct element within - a product of nature.
Keywords: gene, patent, DNA, isolate, obvious, nature
Suggested Citation: Suggested Citation
Alfano, Kenneth M., Revisiting Isolation as Invention: The Obviousness of Isolated Natural Genes and a New Test for Naturalness (January 16, 2010). Mississippi Law Journal, MISSing Sources, Vol. 79, No. 76, 2010. Available at SSRN: https://ssrn.com/abstract=1537690