title: Commentary: is totipotency of a human cell a sufficient reason to exclude its patentability under the European law?
abstract: This article argues that totipotent character of human totipotent cells--defined as the capacity of a cell "to differentiate into all somatic lineages (ectoderm, mesoderm, endoderm), the germ line and extra-embryonic tissues such as the placenta"--is not a sufficient reason to exclude their patentability on the basis of Article 5(1) of the Directive 98/44/EC on the Legal Protection of Biotechnological Inventions (Biopatent Directive), which maintains that "the human body, at the various stages of its formation and development, [...] cannot constitute patentable inventions." Since human totipotent cells have both the potential to generate an entire new organism or to generate only different tissues or organs of an organism, they simultaneously fit the definition of the unpatentable human body at the earliest stage of its formation as well as of an element of the human body, which "may constitute a patentable invention" pursuant to Article 5(2) of the Biopatent Directive, whether that element is isolated from the human body or otherwise produced by means of a technical process. Therefore, this article suggests that, when evaluating patentability of human totipotent cells, they should be further evaluated according to their location and their method of derivation (i.e., whether human totipotent cells are located in the human body, whether they are isolated from the human body, or whether they are produced otherwise by means of a technical process). Disclosure of potential conflicts of interest is found at the end of this article.
authors.affiliation: Max Planck Institute for Intellectual Property, Competition and Tax Law, München, Germany. katja.triller@gmail.com
authors.forename: Katja Triller
authors.initials: KT
authors.lastname: Vrtovec
authors.forename: Bojan
authors.initials: B
authors.lastname: Vrtovec
mesh_terms: D001709:Biotechnology / Q000941:ethics / Q000331:legislation & jurisprudence; D019976:Cloning, Organism / Q000941:ethics / Q000331:legislation & jurisprudence; D005060:Europe; D005818:Genetic Engineering / Q000941:ethics / Q000331:legislation & jurisprudence; D006801:Humans; D010330:Patents as Topic / Q000941:ethics / Q000331:legislation & jurisprudence*; D039901:Totipotent Stem Cells / Q000502:physiology