The Polish Presidency has put forth a proposal to amend existing legislation, specifically eliminating the proposed patent ban on new genetic technologies (NGT) related to plants, their materials, and products. In an effort to streamline the regulatory framework for marketing NGT plants, the European Parliament had previously suggested an amendment that would effectively render NGT plants, their components, genetic information, and associated processes unpatentable. This initiative aimed to mitigate legal ambiguities, reduce costs, and decrease reliance on major agritech corporations for farmers and breeders, aligning with the EU Commission's goals of promoting sustainable agriculture and enhancing food security in the region. However, discussions surrounding the exclusion's extent raised concerns, particularly regarding its potential implications for the genetic tools utilized in targeted mutagenesis. Additionally, there was hesitance to amend established legislation such as the EU Biotech Directive, the UPCA, and the TRIPS agreement, alongside considerations regarding necessary revisions to the European Patent Convention. Although the Belgian Presidency attempted to narrow the proposal to encompass only lower-risk NGT1 plants, they failed to achieve a majority vote. Recognizing the need to resolve the impasse among EU member states to advance regulatory legislation, the Polish Presidency has introduced a framework aimed at fostering innovation and ensuring breeders have free access to plant varieties. This framework distinguishes between patents protecting fundamental technologies and those pertaining to specific plant traits. Under this proposal, reproductive material from NGT1 plants can be marketed without additional constraints unless it is covered by a product or process patent. If patents do exist, member states may impose restrictions, including limitations on cultivation and labeling requirements, to safeguard local farmers and breeders. The proposal also includes a verification process to ascertain relevant patents, placing the responsibility on parties marketing the reproductive material. Importantly, these provisions apply solely to reproductive material and are limited to NGT1 plants, with broader reproductive materials exempt from verification. The removal of the patent ban has garnered support, and acceptance of the Polish proposal could facilitate legislative advancement, although numerous non-IP related challenges remain.
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