Position papers

EuropaBio position on the recent Biotech Patent Directive EC Notice

Patents for products obtained by means of essentially biological processes should be granted when meeting stringent criteria applied across technology sectors.

1. On 8 November, the European Commission issued a Commission Notice on the interpretation of certain articles of Directive 98/44 on the legal protection of biotechnological inventions. The Commission took the view that the legislator’s intent when adopting Directive 98/44/EC was to exclude products obtained by means of essentially biological processes from patentability.

2. Directive 98/44/EC defines a stable and predictable patent framework which ensures an efficient and harmonized set of rules to protect biotechnological inventions. EuropaBio welcomes the Commission’s recommendation that a revision of the Directive is unnecessary. The changing technological landscape is best addressed through case law.

In addition, EuropaBio also welcomes the Commission’s recognition that rather than a revision, there are more reliable ways of ensuring increased access for plant breeders to patented plant-related inventions, such as improved transparency (through the PINTO database), access to genetic resources (through the International Licensing Platform), and strengthened cooperation between the Community Plant Variety Office and the European Patent Office.

3. EuropaBio notes that with regard to the question as to whether plants obtained by essentially biological processes are excluded from patentability, the conclusion of the European Commission, is opposite to the one set forth in the decision by the Enlarged Board of Appeal (EBA) of the European Patent Office (EPO) in the Tomato II/Broccoli II cases. In addition, there is a significant difference in the definition given by both instances to the term of “essentially biological processes” which appears to be due to different interpretations of the underlying legislation.

4. EuropaBio is of the opinion that patents for products obtained by means of essentially biological processes should be granted when the claimed inventions meet the stringent criteria for patentability applied across the various sectors of technology and that no change in the examination and granting practice of the EPO is needed pursuant to the Commission Notice.

However, the interpretations by both the EBA and European Commission should be brought together with the aim to restore the legal certainty business operators from the plant breeding sector need to continue their European plant R&D activities.

Therefore, EuropaBio calls upon the Member States of the European Union to actively work towards aligning the interpretations of the applicable law.

5. EuropaBio, many of whose members are involved in plant breeding, recognizes the concerns that exist in part of the breeding community with respect to patenting products obtained by breeding. However, we acknowledge that patent protection is the only way for legal protection to be obtained for plant-based innovation that is applicable to multiple plant varieties and crops. In the absence of patent protection for an invention obtained by means of essentially biological processes, plant breeders will be discouraged from research, development and investment to foster innovation and, therefore, there will be fewer innovative features for plant breeders to access and for farmers to use.

The interests of all stakeholders should be properly safeguarded and balanced. EuropaBio believes that this can be obtained through ensuring the high-quality of patents, transparency on which commercial varieties are patented, the ability to breed with material containing patented traits and the willingness to grant licenses remain the cornerstones in the balancing of interests.

Indeed, ensuring high quality of patent examination and granting of patents is of fundamental importance for reconciling the interests of all plant breeders. Therefore, EuropaBio welcomes the strengthening of cooperation between the EPO and the Community Plant Variety Office (CPVO).

In addition, the PINTO database established by the European Seed Association enables plant breeders to verify which commercial plant varieties are subject to patents when considering their breeding programs.

Furthermore, a breeder’s exemption can already be found in many national patent laws. Likewise, a breeder’s exemption is included in the Unified Patent Court Agreement which is currently being implemented in the EU, and which will become effective for all European patents and patents with unitary effect in the near future.

Finally, licensing practices are well established in the plant breeding industry and in vegetables the licensing process was facilitated through the International Licensing Platform Vegetables.

6. The right conferred by a patent covering products obtained by essentially biological processes and plant variety rights can coexist. They both provide a useful tool in the progress and sustainability of the sector of plant breeding.

EuropaBio encourages further discussions in this area and would welcome the opportunity to work with all stakeholders towards securing a balanced and flexible patent protection approach for plant-related inventions.