A method that makes use of human embryos is – in general – excluded from patentability even if the embryos are not destroyed during their use; Article 53 (a), R. 28 (c) EPC. Moreover, an (originally undisclosed) disclaimer meant to exclude a future use of human embryos in line with Article 53 (a), R. 28 (c) EPC does not restrict the subject-matter of the claim and is thus not allowable under Articles 123 (2) and 84 EPC.
The patent holder lodged an appeal against the negative decision of the Examining Division regarding European patent application 05028411.6. Claim 1 of the rejected application is directed to a method for obtaining pluripotent embryonic stem cells in an embryo preserving manner from blastocysts. After an initial positive Communication from the Examining Division, the application was rejected since the claims contravened R. 28 (c) EPC which stipulates that patents shall not be granted for biotechnological inventions concerning the use of human embryos for industrial or commercial purposes. The Examining Division outlined that the claim comprised the use of embryos that are needed as a “starting material” to perform the claimed method for industrial and commercial purposes. Referring to decision G 2/06 (the “WARF” decision) the Examining Division also indicated that the non-destruction of the embryo in the claimed method was of no importance and, moreover, the claimed method was of no benefit to the embryo itself. Consequently, the invention was found to be excluded from patentability; Article 53 (a) in combination with R. 28 (c) EPC.
In the appeal instance, the Applicant argued that there would be an exemption regarding the exclusion from patentability, namely if the invention aims at diagnostic or therapeutic purposes, which would both be possible in the case at hand. The obtained cells could be used for means of pre-implantation diagnosis, i.e. for diagnostic purposes and the cells could equally be used at a later stage for therapeutic purposes for the human that developed from the embryo. The Appeal Board responded that it concurred with the opinion of the Examining Division regarding the exclusion from patentability and that the purposes as outlined by the Applicant were not derivable as such from the claims. In turn, the Applicant filed a new claim-set with a disclaimer excluding the use of the obtained stem cells for industrial and commercial purposes.
Consequently, the question at stake was finally whether the introduction of such a disclaimer was permissible under Article 123 (2) EPC. In the case at hand, the negative feature cannot be derived from the application as originally filed. Based on the decisions G 1/03 and G 2/03, the Applicant argued that the disclaimer was allowable as it excluded subject-matter which, under Articles 52 to 57 EPC, is excluded from patentability for non-technical reasons. The Board of Appeal rejected this argument based on the following approach: The disclaimer would only be allowable if it indeed excluded subject-matter which was otherwise claimed. In the case at hand, the claim without the disclaimer is directed to a method for obtaining embryonic stem cells, which are the “direct product” of the claim. However, the disclaimer excluded merely the future use of the obtained stem cells. Thus, the Board of Appeals found that, by means of the disclaimer, the patent holder, tried to exclude something that was not even covered by the claims and the subject-matter would therefore not be limited by the disclaimer. Hence, such a disclaimer was not in line with Article 123 (2) and 84 EPC and, therefore, found to be unallowable. In consequence, the appeal was rejected.
Both the well-known EPO “WARF” decision and the equally well-known decision of the German Federal Supreme Court in the “Brüstle” case (Case no. X ZR 58/07) likely caused a general misperception regarding the exclusion of patentability concerning inventions relating to the use of human embryos for industrial or commercial purposes. As outlined by the present decision, the issue of exclusion from patentability is independent of the fact whether the embryo is actually destroyed during its use or not. As a result, the only exception from the exclusion of patentability pursuant to Article 53 (a) in combination with R. 28 (c) EPC is that the embryo benefits from its own use, i.e. when it is used for own diagnostic or therapeutic purposes (cf. Directive 98/44/EC, rec. 42). This use, however, needs to be claimed. A mere indication of a diagnostic and/or therapeutic (future) use in a method or product claim that is not further delimiting in terms of a technical feature is at least not allowable under Article 84 EPC. Thus, the allowable frame for patentable inventions relating directly or indirectly to human embryos is very limited. As a consequence, due care has to be taken to consider the current legal background when drafting and prosecuting applications in this technical field.