Niveau juridique : Union européenne
Texte de la question :
« Under the Commission’s legislative proposal [1] on new genomic techniques (NGTs), category 1 NGT plants are any plants that meet the criteria to be considered equivalent to conventional plants, with modifications that could have been produced through conventional breeding. The proposal would exempt category 1 NGT plants from traceability requirements.
The European Patent Office has confirmed that NGT plant innovators will continue to apply for patents under the system used for genetically modified organisms. This creates a situation whereby a breeder could produce, through conventional breeding, a plant similar to a category 1 NGT plant patented by another actor. With no traceability requirements, it would not be possible to prove that the material of the patent holder had not been used in the conventional breeding of the similar plant.
1.Does the NGT proposal contain any provisions that would prevent a patent holder from accusing conventional breeders of violating their intellectual property rights in relation to a category 1 NGT plant ?
2.If not, what measures will the Commission take to prevent this from happening ?
3.What steps is it taking to ensure that the NGT proposal does not create legal uncertainty for breeders using conventional breeding and thereby threaten innovation in the breeding sector ?
[1] Commission proposal of 5 July 2023 for a regulation of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625 (COM(2023)0411). »
Réponse donnée par Ms Kyriakides au nom de la Commission européenne le 17 octobre 2023
« The Commission proposal on plants obtained by certain new genomic techniques (NGTs) concerns the release and placing on the market of plants obtained by these techniques but does not regulate intellectual property issues.
Patent protection of such plants is governed in a separate piece of EU law [1], the provisions of which are reflected in the European Patent Convention (EPC).
As clarified in the Commission Notice from 2016 [2], under the provisions of Directive 98/44/EC plants obtained by essentially biological processes are excluded from patentability.
This has been included in the implementing rules of the EPC and confirmed in opinion G 3/19 (‘Pepper case’) [3] of the Enlarged Board of Appeal of the European Patent Office (EPO).
Applying the exclusion, patents on plants produced by technical processes, including on NGT plants, cannot cover similar plants obtained by conventional breeding. This is reflected in the examination practice of EPO and can be relied upon in proceedings before competent courts.
To address possible disagreements, plant breeders can be expected to keep records on breeding material and technique used to produce the conventionally bred plant.
The Commission recognises that the legal framework needs to be balanced, safeguarding inter alia breeding and cultivation of unpatented conventional and organic crops.
Thus, the Commission will assess, as part of a broader market analysis, the impact that the patenting of plants and related licensing and transparency practices may have on innovation in plant breeding and on breeders’ access to genetic material and techniques [4], and report on its findings in 2026, which will identify possible challenges in the sector and serve as basis to decide on any possible follow-up actions. »
[1] Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions. OJ L 213, 30.7.1998, p. 13-21.
[2] Commission Notice on certain articles of Directive 98/44/EC of the European Parliament and of the Council on the legal protection of biotechnological inventions. C/2016/6997, OJ C 411, 8.11.2016, p. 3-14.
[3] link.epo.org/web/G_3-19_opinion_EBoA_20200514_en.pdf
[4] COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Ensuring resilient and sustainable use of EU’s natural resources (COM(2023) 410 final).
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