The U.S. Supreme Court has handed down its unanimous decision today in relation to the patentability of naturally occurring DNA sequences. It has determined that merely isolating and determining the functions of a naturally occurring DNA sequence does not entitle the discoverer to a patent on that sequence. However, application and derivatives of that sequence, for example cDNA, are patentable subject matter.
In my humble opinion, the court has got this completely right. Merely isolating something from nature is not invention, although there is a level of case law which suggests that it is, in relation to pharmaceuticals. This case has significant implications in other areas of technology, for example for patents on any naturally occurring but isolated substances. Unless a ‘non-naturally occurring manufacture or composition of matter’ is brought into existence, there is no patentable subject matter.
This case was specifically concerned with patents around, inter alia, the BRCA1 and BRCA2 genes which indicate an increased risk of breast and ovarian cancer.
The court went to some lengths to be clear that they has no decided anything about non-naturally occurring DNA sequences, nor about methods for sequencing, nor about applications of the newly discovered knowledge. This case concerned the patents directed to the cDNA and DNA per se.
For those interested, the full decision is available here:
The equivalent Australian case found for Myriad at first instance, and is currently on appeal to the Full Court of the Federal Court.
by Peter Franke