It is clear from the directive that the purpose of the DNA sequence must be disclosed in the patent. This requirement was generally understood to be for industrial application and not, as the ECJ has decided, to limit the protection. Some countries, notably Germany and France, provided purpose-bound protection to DNA claims when implementing the directive. Most, however, did not, so the decision will lead to a change in the law in many countries.
The decision also confirms DNA’s special status. No other molecule’s protection is limited to its function (except for second medical uses of known compounds). There was a suggestion in the Advocate General’s opinion, which was not reproduced in the ECJ’s judgment, that mere discoveries were not patentable. This is not the case.
Naturally occurring chemicals that are found to have beneficial properties are patentable. Their inventiveness is judged on the ordinary principles of patent law. There is no barrier simply because they are a discovery, and protection extends to the molecule as such. The ECJ did not address why DNA should be treated differently.
It is, of course, true that DNA is not the effector molecule. Its value comes from the information it carries, and in this respect it is unique. In the majority of cases, the DNA will be performing its function within viable cells and as such will be protected.
The effects of the decision will be felt most keenly in the agricultural biotechnology sector. Claims to DNA sequences will not protect derivative or processed products, even if the DNA sequence is still present. The challenge for patentees in this area will be to find alternative ways to protect these products.