REPONSE Question n°E-002350-16 de Elisabeth Köstinger (PPE) - Brevetabilité du vivant et application de la directive 98-44

Niveau juridique : Union européenne

  • texte de la question posée le 21-03-2016 (en anglais/allemand uniquement)

In accordance with Article 4 of the EU Directive on the legal protection of biotechnological inventions (98/44/EC), biological processes for the production of plants or animals are essentially not patentable.

This exception is needed to protect consumers, farmers and plant breeders and avoid exclusive rights to food. However, the latest judicial practice by the European Patent Office (G 2/12 — ‘Tomatoes II’ and G 2/13 ‘Broccoli II’) undermines not only European legislation, but also the rules of the European Patent Convention itself.

In order to end this alarming process, the European Commission must urgently examine the interpretation and the scope of the exception on the legal protection of biotechnological inventions. No patents on life should be issued.

1. What are the Commission’s plans to ensure free access to and use of breeding material?

2. If the European Patent Office does not stop this practice of granting patents, the patent laws must be tightened. Does the Commission share this call and what other measures does the Commission identify with regard to this?

  • REPONSE du 28 juin de la part Ms BieĊ„kowska au nom de la Commission

1. Directive 98/44/EC on the legal protection of biotechnological inventions, which harmonises national patent laws regarding biotechnological inventions(1), states that plant varieties are not patentable. This principle also applies to essentially biological processes for the production of plants consisting entirely of crossing and selection.

The Enlarged Board of Appeal of the European Patent Office (EPO) has decided that plants and plant parts obtained by essentially biological processes are eligible for patent protection if the formal requirements for patentability are fulfilled(2). The Commission is aware of breeders’ concerns raised by these decisions.

2. The Commission has tasked the Biotech expert group(3) to provide it with legal and technical expertise on issues pertinent to the application of the directive(4) and it would be appropriate to await the group’s findings on this sensitive matter.


(1) The directive clarifies which inventions are patentable duly taking account of ethical or moral principles.

(2) An invention has to be novel, involve an inventive step and have industrial applicability. In addition, the subject-matter must be regarded as patentable.

(3) C(2012)7686 final of 7.11.2012.

(4) A large number of the issues examined relate to plant inventions, including the relationship between patent law and plant variety rights.