Intellectual Property: the key to innovation and survival for small and medium-sized biopharma companies
Small and medium-sized enterprises, SMEs, are key drivers of innovation, economic growth and job creation. They are the backbone of the EU economy, representing 99.8% of EU enterprises and generating 85% of new jobs in the private sector. They employ close to 90 million people across Europe (1).
In the healthcare biotech sector, SMEs are an innovation powerhouse: 27% of all new medicines authorised between 2010-2012 by the EMA originate from SMEs. This figure rises to 61% for new medicines for orphan indications and rare diseases (2).
For these companies, intellectual property is fundamental: both their chances to turn a promising molecule into an innovative medicine successfully and their very survival often depend upon it.
Medicines take many years to research and develop and can only be made available to patients once a marketing authorisation has been granted – often up to 10 years. Among many other things, this process requires extensive clinical trials to demonstrate the safety and efficacy of the new medicine. Many candidate medicines will fail along the way.
Understanding how medicines are researched and developed is critical to understanding why the pharmaceutical industry and, in particular, biopharmaceutical SMEs, need intellectual property rights protection. Patents are essential assets for SMEs to secure the funds necessary to further develop their ideas into innovative medicines for the patients who need them. Without patents and the certainty they provide, no investor would invest (3) and thereby allow these SMEs to continue their work – innovation would come to a standstill.
“For SMEs, a patent is the key to securing investment, which enables us to continue researching into solutions for patients. For SMEs, patents, and the returns they help provide, are the key element in creating a virtuous circle for innovation, benefitting patients and society as a whole,” says Barbara Freischem, Executive Director of EBE
2. Linker H., Ziogas C., Carr M., Porta N., Eichler H.-G.: Regulatory watch: Where do new medicines originate from in the EU?, Nature Reviews Drug Discovery 13, 92–93 (2014), doi:10.1038/nrd4232, http://www.nature.com/nrd/journal/v13/n2/full/nrd4232.html
European Biopharmaceutical Enterprises (EBE) represents the voice of biopharmaceutical companies of all sizes in Europe and is a specialised group within the European Federation of Pharmaceutical Industries and Associations (EFPIA). Established in 2000, EBE is recognised as the leading biopharmaceutical association in Europe.
Barbara Freischem, Executive Director
European Biopharmaceutical Enterprises – EBE
Tel: +32 2 62 62 564