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3.3b
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Biotechnological inventions
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In the area of biotechnological inventions, the following list of exceptions to patentability under Art. 53(a) is laid down in Rule 23d. The list is illustrative and non-exhaustive and is to be seen as giving concrete form to the concept of "ordre public" and "morality" in this technical field.
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Under Art. 53(a), European patents are not to be granted in respect of biotechnological inventions which concern:
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Rule 23d
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For the purpose of this exclusion a process for the cloning of human beings may be defined as any process, including techniques of embryo splitting, designed to create a human being with the same nuclear genetic information as another living or deceased human being (EU Dir. 98/44/EC, rec. 41).
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(ii)
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processes for modifying the germ line genetic identity of human beings;
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Rule 23d(b)
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(iii)
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uses of human embryos for industrial or commercial purposes;
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Rule 23d(c)
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The exclusion of the uses of human embryos for industrial or commercial purposes does not affect inventions for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it (EU Dir. 98/44/EC, rec. 42).
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(iv)
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processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.
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Rule 23d(d)
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The substantial medical benefit referred to above includes any benefit in terms of research, prevention, diagnosis or therapy (EU Dir. 98/44/EC, rec. 45).
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In addition, the human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions (see, however, IV, 2a.2). Such stages in the formation or development of the human body include germ cells (EU Dir. 98/44/EC, rec. 16).
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Rule 23e(1)
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Also excluded from patentability are processes to produce chimeras from germ cells or totipotent cells of humans and animals (EU Dir. 98/44/EC, rec. 38).
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CHAPTER IV PATENTABILITY
3.3a Economic effects
3.4 Plant and animal varieties, processes for the production of plants or animals
