Abstract
Gene therapies hold great promise for treatment of diseases but so far their market authorisation has been limited. This paper describes the development of patented gene therapies in the sector of life sciences and health. It was found that the annual number of patented gene therapies increased significantly till the year 2005. A cluster analysis of gene therapies patented in 1995 shows that: a) more than eighty percent has been renewed for more than fifteen years (fifty three per cent till the maximum patent term) and b) fifty per cent of the patents have been licensed. There is a statistically significant correlation between the numbers of citations in future patent applications by third parties and the number of years of patent renewals. A case study of the patent EP 0833934 of biotechnology start- up Crucell demonstrates that the number of citations by third companies to this patent even predicts the companies’ market capitalization. This research yielded evidence that the number of patent citations can be used as indicator to determine the value of gene therapies. Such information is of relevance for both the patentee and investors.
| Original language | English |
|---|---|
| Pages (from-to) | 61-73 |
| Number of pages | 13 |
| Journal | Journal of Commercial Biotechnology |
| Volume | 23 |
| Issue number | 2 |
| Publication status | Published - Apr 2017 |
Funding
Nowadays, the European Medicines Agency receives less than five applications(4) for gene therapy medical products (http://www.ema.europa.eu/GTMP) per year and so far only Glybera® and Strimvelis® have received market authorisation. On the other hand, the outlook and consequences of patenting DNA and genes for therapies and research are well documented(5–7) and the number of gene patents(8) was on the rise. With the wake of biotechnology companies (e.g. Genentech, Amgen, Chiron) discussions about ownership of knowledge funded by governmental financial research organisations (e.g. National Institutes of Health (NIH) started. The role and implications of intellectual property rights (IPR) for innovations and the development of the biotechnology sector became apparent(9). Since the eighties the potential cures for patients with genetic malfunctioning organs, numerous technologies have been patented in domains like cancer, immunology and vaccines. In this sector in particular the commercialisation of academic patents both in the USA and the EU is evident(10,11). On a global scale both pharma and biotechnology companies that manage their IPR well can become very successful(12,13).
| Funders | Funder number |
|---|---|
| National Institutes of Health |
Keywords
- Biotechnology
- Citations
- Gene therapies
- Market capitalization
- Patents
- Value
