Federal Circuit panel concludes isolated DNA molecules are patent eligible subject matter because they do not exist in the same form in nature.

The plaintiffs brought a declaratory judgment action against an owner of patents for isolated gene sequences and methods of comparing and analyzing specific gene sequences for the presence of cancer-predisposing mutations, arguing that the claims all addressed non-patentable subject matter.  The district court held that all of the patentee’s claims for isolated DNA molecules, for comparing and analyzing gene sequences, and for methods of screening DNA sequences were invalid, because the claims did not cover patent eligible subject matter.   

The Federal Circuit reversed the district court’s decision that isolated DNA molecules are not patentable because they are not the same products found in nature but instead are modified and isolated from naturally-existing material attached to the sequences.  The Federal Circuit affirmed that the method claims for comparing and analyzing gene sequences were not patentable, because these claims only covered abstract mental processes.  Lastly, the Federal Circuit concluded that one method claim for screening potential cancer therapeutics was patent eligible, because this claim included transformative steps for growing cells transformed with an altered gene,  and thus involves “functional and palpable applications,” and is not so “manifestly abstract” as to claim only a scientific principle.     

The law does not allow patents on products of nature.  However, this rule does not extend to compositions where human intervention has given the composition “markedly different” characteristics from naturally occurring compositions.  According to the Federal Circuit, isolated DNA sequences are patent eligible subject matter, because isolated DNA molecules are distinct from DNA in its native form.  This is true irrespective of whether the isolated DNA molecules were synthesized in a laboratory or chemically cleaved from their native DNA structures.  With respect to the method claims for comparing and analyzing gene sequences, claims that only involve inspection and abstract mental processes, without physical manipulation, are not patentable.  However, processes that involve one or more abstract mental steps can, in some cases, be patentable if they also include other “transformative steps.”  Here, the one patent eligible method claim included two transformative steps, or physical manipulations, that were central to its purpose.  The patent eligible method claim was also limited to an extent where it presented concrete applications. 

This decision is expected to be further appealed, either to the Federal Circuit en banc or to the Supreme Court.

A copy of the opinion can be found here.