April 5, 2010

The recent decision by the U.S. District Court for the Southern District of New York to the effect that isolated and purified DNA lacking “markedly different characteristics” from native DNA does not constitute patentable subject matter under Section 101 of the Patent Act, marks a dramatic break with over 150 years of legal precedent. ( Association for Molecular Pathology v. U.S. Patent and Trademark Office, S.D.N.Y., No. 09 Civ. 4515, 3/29/10.)

Many of the most important advances in medical science have been based on the isolation and purification of naturally occurring chemicals, and identifying important medical uses for them.

Aspirin is an example of such a discovery. The isolation, purification and analgesic use of this naturally occurring compound was patented many years ago. Such discoveries should be held patentable, provided they would not have been obvious to one of ordinary skill in the art. The isolation of a known gene with a known function and use would be an example of an isolated gene not patentable for reasons of obviousness. However, the isolation and purification of a gene for which there was no prior motivation to do so should be patentable. While the isolated gene in this case may not be patentable for obviousness under 35 USC section 103, it is possible that the holding that it is not patentable subject matter under 35 USC section 101 will be reversed by the Court of Appeals for the Federal Circuit.