Are genes patentable and what does that mean?
Hannes: In order to patent something, several patentability criteria have to be met, i.e. the invention you want to protect (as defined by the claims) should be novel, inventive (non-obvious) and applicable in some kind of industry. These conditions also apply to DNA sequences, including genes. An important consideration is that you can only obtain protection for a human gene isolated from its natural environment. Parts of the human body, including genes, cannot be patented – these are considered discoveries. Moreover, a sequence cannot be patented as such because you need to show a useful function in the patent application, meaning that you need wet lab data, not mere in silico predictions. Examples of patentable sequences include the DNA sequence of probes used in diagnostic tests, in viral vectors for gene therapy or to confer resistance to pests in plants.
What are the consequences of gene patenting by third parties for our research?
Hannes: It is important to recognize that gene patent holders do not actually own the genes that are the subjects of their patents – in this regard, the term gene patent is a bit unfortunate. The only right conferred by a patent is the right to exclude others from making, using, selling or importing a non-naturally occurring, manmade product or process, as defined by the patent’s claims.
Jan: Moreover, in Belgium there is a broad research exemption, which allows academic researchers to carry out scientific work on any gene as long it is not for direct commercial purposes.
Of course, businesses that offer commercial use of genes (e.g. diagnostic assays) need to ensure they are not blocked by third-party IP – this is exactly the same as for other patented products.
Are we heading towards a very expensive healthcare system because of patented genes?
Floor: Yes and no. Patents offer a limited monopoly, which allows companies to recuperate their R&D and market approval costs as well as make a profit. This obviously adds to the cost of the more advanced genetic tests. At the same time, though, it is also in the interest of those companies to enable broad access to their products and increase their market share and net gains.
Importantly, in the long run, a more accurate diagnosis will improve the quality of life of patients, while the personalized medicine model will likely reduce therapy costs thanks to the use of (patented) ‘companion diagnostics’ that can predict which drug will work for which patient. In other words, it is quite possible that the increase in the cost of diagnosis will be outweighed by a decrease in therapy costs.
Can we still create added value for patients?
Jan: Since it is VIB’s primary mission to create benefits for society on the basis of research results, VIB is highly committed to protect its scientists’ gene-based findings just as it does any other findings. And let’s not forget that patent applications and patents are the sine qua non incentive for finding a suitable commercial partner and developing a product.
Accordingly, VIB will continue to file for patent protection on the use of specific human genes and gene variants. We are carefully monitoring the legal situation in several jurisdictions. In the meantime, we encourage VIB researchers to submit any gene-based applications to the Tech Transfer Team.