The Federal Circuit’s decision in Ariad v. Lilly, in which Ariad has filed a petition for rehearing, also affects the viability of these types of patent claims. The court examined the level of detail required to satisfy the written description requirement. In invalidating claims to methods for suppressing the level of activity for a transcription factor, the court held that the specification failed to provide an adequate description of the molecules that are capable of reducing the activity. The discussion in the specification of three classes of molecules, a method of reducing activity from molecules in one class, and a few examples of molecules from one class was not sufficient to support broad claims to methods for reducing activity. One has to wonder, in light of Ariad, to what extent Myriad’s claims to methods of screening for the BRCA genes are adequately described in its patents. This may also touch on the patents for the compositions of matter as well. Should Myriad’s composition of matter patents be upheld to cover all methods that can be associated with a particular gene, particularly when the patent holder was only in possession of a small number of methods at the time of invention?

In addition, the the Federal Circuit’s decision in In re Kubin will decrease the likelihood that these types of composition of matter claims will be granted. In Kubin, the court determined that claims to cDNA encoding a known protein were obvious where there was some motivation to clone the cDNA and a reasonable expectation of success in view of enabling instructions in the prior art. While Myriad’s composition of matter claims would probably not be obvious in light of Kubin, given the level of skill in the art at the time of invention, more recent composition of matter claims could be called into question.