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26 Biotechnology L. Rep. 1 (2007)

handle is hein.journals/bothnl26 and id is 1 raw text is: 26 Biotechnology Law Report 1 Number 1 (February 2007) © Mary Ann Liebert, Inc. DOI: 10.1089/bir.2006.9994 Recent Developments in European Patent Law Stem Cell Patents: Does T 0866/01 (Euthanasia Compositions) of an Appeal Board of the EPO Provide the Answers for the Enlarged Board of Appeal Case G 2/06 (Primate Embryonic Stem Cells)? Dr. FRANZ-JOSEF ZIMMER and Dr. GEORGE SEISENBERGER* T HIS REPORT DEALS with decision T 1374/04 of a Technical Board of Appeal of the European Patent Office (EPO), which forwarded several questions con- cerning the patentability of claims directed to embry- onic stem cells to the Enlarged Board of Appeal (EBA). The case before the EBA is still pending as G2/06. Moral aspects of stem cell technology are the sub- ject of great controversy among the European public. Whereas a detailed consideration of all moral aspects of stem cell technology may turn out to be fairly complex, the EBA will have to make its decision solely on the ba- sis of the EPC and the relevant articles and rules laid down therein, in particular, Article 53(a) EPC and Rule * Dr. Franz-Josef Zimmer and Dr. George Seisenberger prac- tice patent law with the firm of GrUnecker, Kinkeldey, Stock- mair & Schwanhausser in Munich, Germany. Article 53(a) EPC stipulates that European patents shall not be granted in respect of in- ventions the publication or exploitation of which would be contrary to ordre public or morality, provided that the exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States. Rule 23d(c) EPC stipulates that under Article 53(a), European patents shall not be granted in respect of biotechnological inventions which, in partic- ular, concern the following: (c) uses of human embryos for industrial or commercial purposes; All the decisions of the EPO cited in this article are avail- able from the EPO's homepage under the key word Boards of Appeal. 23d(c) EPC.1 Here, I show how, within the legal frame- work of the EPC, the Technical Board in charge dealt with issues of morality in the recent Decision T 0866/01 (Euthanasia compositions). This case might provide some hints as to how the EBA might find a way to pro- vide the answers in the case G 2/06 pending before it. THE QUESTIONS REFERRED TO THE EBA IN PENDING G 2/06 In the case underlying decision T 1374/04, the Ex- amining Division refused European patent application No. 96 903 521.1 (Primate embryonic stem cells) comprising ten claims. Claim 1 reads: 1. A cell culture comprising primate embryonic stem cells which (i) are capable of proliferation in vitro culture for over one year, (ii) maintain a karyotype in which all chromo- somes normally characteristic of the primate species are present and are not noticeably al- tered through culture for over one year, (iii) maintain the potential to differentiate to de- rivatives of endoderm, mesoderm, and ecto- derm tissues throughout the culture, and (iv) are prevented from differentiating when cul- tured on a fibroblast feeder layer. The Patentee lodged an appeal against this decision. The Board of Appeal considered the question of patentability of human embryonic stem cells as being an exceptionally important point of law in the mean- ing of Article 112(a) EPC, for which a decision by the EBA is required. According to the Appeal Board's rea- soning, the patentability of human embryonic stem 1

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