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The breeding exemption limits the right of patent holders by allowing plant breeders to use freely patented biological material for creating new plant variety types. Three European countries, France, Germany, and Switzerland, have already adopted this type of exemption into their patent laws, and the Netherlands is expected to amend its patent law by 2013. The debate in the Netherlands included the introduction of a “comprehensive breeding exemption” as well, that is an exemption that allows the commercialization of plant varieties containing patented elements. The proposal for amendments to patent law did not go unnoticed. The industry itself raised concerns with respect to the compliance of patent exceptions with the European directive on the legal protection of biological inventions (98/44/EC) and the TRIPS Agreement. Being all European Union (EU) countries signatories of the TRIPS Agreement, the EU directive provisions reflect the ratio and voluntas legis of TRIPS. Thus this paper focuses on article 30 of the TRIPS Agreement, the only provision that explicitly provides for exceptions to patent rights at international level. In this context, the analysis aims at proffering a solution to the high legal uncertainty characterizing the debate on patent exceptions for the plant‐breeding sector.

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Inventions involving human embryonic stem cells (hESC) have unprecedented potential to improve human life through discovery of new drugs and treatment of incurable neurodegenerative diseases, but at the same time, the use of human embryos in research gives rise to contrasting ethical, moral and religious views on the patentability of such inventions. Whether and to what extent patent offices should take these views into account is an open question. The “ordre public” and “morality” clause in patent law may help us find an answer, but neither the legislator nor courts have clarified the meaning of these vague terms. Judicial interpretation has sometimes increased their ambiguity and raised legal uncertainty for the patentability of hESC inventions. This situation may be desirable in some cases, but not in others where the principles of the legal system as a whole come into play. This paper will shed light on the meaning of “ordre public” and “morality” for hESC inventions by examining patent law in the broader legal framework and emphasizing the interconnectedness of national legal systems in a global market as well as the common interest in healthcare innovations.