Biopatenting: “Angst” v. European Harmonization – The ECJ Decision on Stem Cell Patents

Case C-34/10 Brüstle v. Greenpeace1.Article 6(2)(c) of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions must be interpreted as meaning that:–any human ovum after fertilisation, any non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted, and any non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis constitute a ‘human embryo’;–it is for the referring court to ascertain, in the light of scientific developments, whether a stem cell obtained from a human embryo at the blastocyst stage constitutes a ‘human embryo’ within the meaning of Article 6(2)(c) of Directive 98/44.2.The exclusion from patentability concerning the use of human embryos for industrial or commercial purposes set out in Article 6(2)(c) of Directive 98/44 also covers the use of human embryos for purposes of scientific research, only use for therapeutic or diagnostic purposes which is applied to the human embryo and is useful to it being patentable.3.Article 6(2)(c) of Directive 98/44 excludes an invention from patentability where the technical teaching which is the subject-matter of the patent application requires the prior destruction of human embryos or their use as base material, whatever the stage at which that takes place and even if the description of the technical teaching claimed does not refer to the use of human embryos.

La sentenza della Corte di giustizia dell’Unione europea del 18 ottobre 2011 e la nozione di embrione in senso ampio

L’articolo esamina la sentenza n° C-34/10 (caso Oliver Brüstle vs Greenpeace e V) del 18 ottobre 2011, emanata dalla Corte Europea di Giustizia, evidenziandone l’importanza, i limiti e le auspicabili implicazioni. Oggetto della sentenza sono tre questioni interpretative relative all’art. 6 della Direttiva sulla protezione giuridica delle invenzioni biotecnologiche. Tra queste, la principale riguarda la nozione di embrione umano. “Costituisce un embrione umano – affermano i giudici – qualunque ovulo umano fin dalla fecondazione, qualunque ovulo umano non fecondato in cui sia impiantato il nucleo di una cellula umana matura e qualunque ovulo umano non fecondato che, attraverso partenogenesi, sia indotto a dividersi e a svilupparsi”. Di conseguenza non possono essere concessi brevetti a procedure che utilizzino embrioni umani o che, comunque, ne presuppongano la preventiva distruzione. Il contesto della sentenza riguarda, appunto, la materia dei brevetti e come si legge al punto 31 della sentenza “la portata dei termini per i quali il diritto dell’Unione non fornisce alcuna definizione va operata tenendo conto del contesto in cui essi sono utilizzati e degli scopi perseguiti dalla normativa di cui fanno parte”. Nonostante il chiaro limite, la sentenza ha una sua positività che va oltre l’ambito brevettuale. I motivi della non brevettabilità consistono in un giudizio etico che non può essere ignorato anche al di fuori del campo brevettuale. La riflessione si estende anche all’ambito dei programmi di ricerca europei, dove coerenza vorrebbe che gli incentivi economici non fossero assegnati per la ricerca che implica la distruzione di embrioni umani e investe anche la comunità scientifica spingendo verso le ben più promettenti ricerche su cellule staminali adulte. Non dimentichiamo, infine, dopo l’entrata in vigore del Trattato di Lisbona, l’influenza che la giurisprudenza della Corte di giustizia europea di Lussemburgo potrebbe avere sulla giurisprudenza della Corte europea dei diritti dell’uomo di Strasburgo, meno incline – al momento – a riconoscere un concetto di embrione in senso ampio. ---------- The article deals with the European Court of Justice’s decision on October 18th 2011 (C-34/10, Brüstle vs Greepeace e. V.) and it shows importance, limits and desirable consequences of it. Three explanatory issues regarding the article no. 6 of the directive on the legal protection of biothecnological inventions are object of this decision. The most important among them concerns with the notion of human embryo. The Court states that: “any human ovum after fertilization, any non-fertilized human ovum into which the cell has been transplanted and any non-fertilized human ovum whose division and further development have been stimulated by parthenogenesis, constitute a human embryo”. Therefore, procedures using human embryos or which implies the destruction of human embryos are not patentable. The contest of the decision concerns exactly patent field and the point no. 31 states: “It must be borne in mind, further, that the meaning and scope of terms for which European Union law provides no definition must be determined by considering, inter alia, the contest in which they occur and the purposes of the rules of which they form part”. Despite of this clear limit, the decision is positive beyond patent matter. The ethical judgment could not be ignored outside patent field, involving the European research programs too: economic incentives should not be allocated for those researches that destroy human embryos. On the other hand, research on adult human stem cells should be implemented. Finally, after the Treaty of Lisbon, we should consider the possible influence on the European Court of Human Rights.

Fetal Pain, Abortion, Viability, and the Constitution

On April 13, 2010, Nebraska enacted a new state ban on abortion in the Pain-Capable Unborn Child Protection Act that ha caught the attention of many on both sides of the abortion debate, and has inspired other states to attempt similar measures. The statute requires the referring or abortion-providing physician to make a “determination of the probable postfertilization age of the unborn child” (defined as, “the age of the unborn child as calculated from the fertilization of the human ovum”) and makes it illegal to induce or attempt to perform or induce an abortion upon a woman when the “probable postfertilization age” of the fetus is “twenty or more weeks” unless the doctor determines in “reasonable medical judgment (1) she has a condition which so complicates her medical condition as to necessitate the abortion of her pregnancy to avert her death or to avert serious risk of substantial and irreversible physical impairment of a major bodily function or (2) it is necessary to preserve the life of an unborn child.”