In order to qualify for a patent, an invention has to comply, at least, with the 3 most commonly known criteria: it has to be novel, inventive and susceptible of industrial application. In everyday practice the latter criterion is generally no more than a formality, except in the case of Life Sciences.
The European Patent Office (EPO) stipulates that an invention must be susceptible of industrial application in order to qualify for a patent. This criterion is adequately met if there are convincing arguments that the invention can be made or used in any industry. The industrial applicability criterion is never really an issue when it comes to patenting an invention, for the simple reason that most inventions solve a technical problem that has been around for some time, such as a car that is not fast enough yet. The industrial applicability of the invention is obvious in that case.
Life Sciences form an exception to this. That is because technical inventions generally involve tangible products, as a result of which their application can be clearly seen or felt. The industrial applicability of the invention is obvious in that case. The same cannot always be said of inventions in the field of Life Sciences. These are often abstract and therefore intangible. It is not always immediately apparent what their application is, let alone that you can instantly see how the invention is susceptible of industrial application. DNA or protein sequences are a good example of this.
Development of drugs
Industrial applicability acquired an entirely new meaning as biotechnology started to develop. Knowledge about DNA and protein sequences and their role in curing diseases appeared to be valuable for the development of drugs. These sequences were patented on a grand scale, despite the discoverers not yet knowing what their precise function was. The idea behind this was that it was best to file a patent application as soon as possible and decide exactly what you are going to do with it at a later stage. This working method was acceptable in the patent system because it generally takes ten to twelve years to bring an invention to the market.
Lots of irritation
For years it was common practice for pharmaceutical and biotechnology companies to patent sequences in advance, without knowing exactly what their effect was. This led to problems, however, as it meant that companies were monopolising a lot of genetic information. Researchers from other companies, or from the public domain, then ran the risk of infringing patents simply by conducting research. This caused a lot of irritation and led to the idea of having patents like this nullified at national courts on the grounds that they did not meet the industrial applicability requirement. After all, if you do not know what the application of certain sequences is going to be, you will also be unable to explain how you can make them susceptible of industrial application. This was a successful approach.
List of applications
The lesson to be learned from this is that patent attorneys have to be very careful when drafting a patent application for an invention in the field of Life Sciences. The function and intended effect of the sequences have to be accurately described. A plausible case for the invention being susceptible to industrial application also has to be made to ensure complete clarity on this criterion, at least as far as the EPO is concerned. Once the patent has been granted, the criterion can still be used as a smart instrument in national courts. For example in cases where the function has not been made very clear or where the patent contains an over-extensive list without specific functions or applications.