In 1998, the EU harmonised patent law relating to biotechnological inventions. This clarifies which inventions are patentable or not on ethical grounds, giving the legal certainty to organisations in the sector that is required to attract the considerable investment that is needed for innovation.
Directive on the legal protection of biotechnological inventions
Directive 98/44/EC, the so-called ‘Biotech Directive’ on the legal protection of biotechnological inventions was adopted in 1998 and implemented by all EU countries.
- Text of Directive 98/44/EC
- Frequently Asked questions, 30 July 2000
- State of play, 15 January 2007 (98 kB)
- EU legislation summary: Legal protection of biotechnological inventions
NGT patent study
The Commission launched a study on the impact of patents on plants, focusing in particular on plants obtained through new genomic techniques (NGTs), as announced in the 2023 Communication on ‘Ensuring resilient and sustainable use of the EU's natural resources.’ The study, led by the Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW), is currently underway and will conclude in the second half of 2025.
The study covers the following key elements
- mapping the EU and selected non-EU countries’ plant breeding and plant reproductive material markets, as well as the patent landscape on NGTs and NGT plants
- assessing possible IP issues related to NGT plant patents and techniques, along with intellectual property (IP) awareness in this context
- identifying and assessing the effectiveness of existing regulatory mechanisms relevant to NGT plant patents, as well as voluntary measures designed to avoid or mitigate negative impacts
- highlighting key takeaways on potential impacts and preliminary considerations for possible new measures.
The outcome of the study will serve as an evidence base for policy considerations on possible future IP measures in relation to NGT plants.
Expert group on the development and implications of patent law in the field of biotechnology and genetic engineering
The Biotech Directive requires regular reporting on particular issues in the field of biotechnology and genetic engineering. To provide information on recent scientific developments and their implications on patent law, the Commission set up an expert group with the mission to provide expertise, analysis and comments on the rapid evolutions in the biotechnological field.
- Commission Decision on setting up a Commission expert group on development and implications of patent law in the field of biotechnology and genetic engineering (including call for applications), 7 November 2012 (197 kB)
- Expert Group members, meeting agendas and minutes from the Register of Commission Expert Groups
Final report of the expert group
The report of the expert group provides expert analysis, views and recommendations on three main subjects directly linked to Directive 98/44/EC on the legal protection of biotechnological inventions. The report consists of three chapters dedicated to the patentability of human stem cells, the patentability of patent-related inventions and the scope of protection for DNA-related inventions. The issues surrounding these subjects were identified by experts as deserving of immediate discussion at the beginning of their work. Please note that this report does not necessarily represent the position of the Commission.
Commission notice on certain articles of Directive 98/44
On 3 November the Commission adopted a notice clarifying certain articles of Directive 98/44 on the protection of biotechnological inventions. The Directive focuses on patenting in the biotech industry. The notice states that products created through essential biological processes should be excluded from patentability. Furthermore, it calls for more analysis of compulsory cross licensing between plant variety rights and patenting. The Commission also expands on how the Directive ensures that there is enough fair access to patented material of biological origin. Although a Commission Notice is not legally binding, its aim is to provide more clarity on the issue for the biotech, plant and animal breeding sectors.
- Full document: Commission notice on certain articles of Directive 98/44
Reports
Second report on the development and implications of patent law in the field of biotechnology and genetic engineering (2005)
This report covers developments and implications of patent law in the field of biotechnology and genetic engineering. It focuses on issues in the area of patents relating to gene sequences and the patentability of inventions relating to stem cells. It also reports on the implementation of the Directive.
- Report (COM(2005) 312 final), Annex 1 and Annex 2
- Press release: Commission adopts a second report on biotechnological inventions, covering gene patents and stem cells, 18 July 2005
First report on the development and implications of patent law in the field of biotechnology and genetic engineering (2002)
This report called for the swift implementation of the 1998 Directive on the legal protection of biotechnological inventions to stop Europe falling behind its competitors in this sector, damaging its overall efforts to become the most competitive economy in the world. The report also addresses key provisions of the Directive, such as the potential patenting of plants and animals and the patenting of elements isolated from the human body or otherwise produced, including stem cells.
- Report (COM(2002) 545 final)
- Press release: Biotechnology sector needs proper application of EU patent law, 10 October 2002