Isolated and purified genetic material, including DNA, has long been protectable by patent in the US, and the USPTO has consistently applied the view that the process of isolation and purification produced a new composition of matter that differs from the naturally occurring material. This position emerged from a line of case law establishing patent eligibility of engineered bacteria and nucleic acids encoding human proteins.
The Myriad decision
The US Supreme Court has decided in Association of Molecular Pathology v. Myriad Genetics Inc. that isolation of genes does not alter them sufficiently. The isolated genes remain products of nature, and despite the breaking of chemical bonds they are not eligible for patent protection under 35 USC §101.
In denying patent protection to isolated genes the court made it clear that cDNAs can be patent eligible where they lack introns and represent chemical entities that are not found in the natural environment. It is likely that patent eligibility of DNA sequences will depend in the future in large part on whether they differ significantly from corresponding sequences in nature. Additionally, the court noted explicitly that the decision on DNA sequences does not reach to methods of manipulating naturally occurring DNA or using information stored in such material. Myriad is already asserting its remaining claims against competitors Ambry Genetics and Gene by Gene.
The court’s decision will likely cause concern to patentees whose claims are directed to isolated nucleic acids that do not differ from those found in nature, but claims to uses of these nucleic acids will be unaffected. We do not feel that other naturally occurring products will be covered by this decision. In fact, we see this as a very positive development for those patentees relying on cDNA-based claims, for example those developing recombinant therapeutic proteins and antibodies.
The USPTO has already acted to ensure that this decision is to be followed during prosecution of pending US applications. Please let us know if you are concerned about the impact of these developments on your granted US patents. Note that the patenting of biological materials including nucleic acids in Europe is governed by the ‘Biotech directive’ and will not be impacted by the US court’s decision.