Another Blow To Human Embryonic Stem Cell Patents In Europe: The TBA’s Decision In Culturing Stem Cells/TECHNION (T-2221/10)
February 8, 2014
In a decision rendered on 4th February 2014 in Culturing Stem Cells/TECHNION (T-2221/10), the EPO’s Technical Board of Appeal 3.3.08 (TBA) refused the patentability of an invention related to maintenance of human embryonic stem cells (hESCs) in an undifferentiated state by the addition of human foreskin cells and to the culture of such hESCs.
The TBA found such an invention unpatentable under the provisions of Article 53(a) of the European Patent Convention (EPC) in conjunction with Rule 28(c) of the Implementing Regulations to the EPC. In reaching such a conclusion, the TBA applied the findings of the Court of Justice of the European Union (CJEU) from the controversial Oliver Brüstle case (C-24/10), and stated that „the inventions which make use of publicly available hESC lines which were initially derived by a process resulting in the destruction of the human embryos are excluded from patentability“, in accordance with the afore-mentioned provisions.
THE FACTS
The case relates to the European patent application 03751238.1 filed with the EPO on 7th October 2003, claiming priority from US applications 60/416.242 (filed on 7th October 2002) and 10/368,045 (filed on 19th February 2003) and having the title „Human foreskin cells suitable for culturing stem cells“. Claims 1-4 of the Application, as amended, concerned methods of maintaining hESCs in an undifferentiated state, while claims 5-8 of the Application, as amended, concerned cell cultures comprising hESCs.
During the patent examination proceedings, the Enlarged Board of Appeal of the EPO (EBA) rendered its decision in Stem Cells/WARF (G-02/06). The EBA held that inventions concerning products which can only be obtained by destruction of human embryos are unpatentable. Following such decision, the ED considered product claims comprising hESCs allowable only if the cells are not obtained from human embryos.
The outstanding question before the ED was, therefore, whether some established hESC lines were available to the public at the relevant day of the patent application, so that the invention could be put into practice from such established cell lines, without it being necessary to destroy a human embryo. The ED, upon analyzing the evidence submitted by the applicant, concluded that neither the specific hESC lines referred to in the application nor any other hESC lines were publicly available before the priority (7th October 2002) and the filing date (7th October 2003), in accordance with the requirements for public availability of biological material as set in G-2/93, T-923/092 and T-576/91. The ED found the applicant’s evidence to the contrary unpersuasive and refused the application on the grounds of the ordre public and morality exclusion to patentability, since the only possibility to put the claimed invention into practice was, in the ED’s opinion, based on destroying human embryos.
The ED’s decision was appealed by the applicant, which submitted further evidence of public availability of stem cell lines at the relevant date, with the grounds of appeal and later during the proceedings.
In the meantime, the CJEU issued its decision in the Oliver Brüstle case (C-24/10) in which it interpreted Article 6 (2) (c) of the Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions (the Biotech Directive), stating inter alia that the provision „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.“
THE DECISION OF THE TBA
Much like the ED in the examination proceedings, the TBA concluded that there wasn’t sufficient evidence on file to prove that the lines of hESCs were publicly available before the relevant dates. It also considered evidence newly submitted by the applicant to be insufficient for drawing a conclusion to the contrary.
But more importantly, the TBA raised another, more fundamental question that has to be considered when examining the requirements of Art. 53 (a) EPC in combination with Rule 28 (c) EPC: “whether or not the accomplishment of the invention by relying on the use of an established [hESC] cell line, thus without de novo production of [hESCs] by destroying human embryos, would nevertheless be in conflict with the requirements of Article 53(a) EPC if said [hESC] line has been originally produced by a method involving the destruction of a human embryo”.
In trying to resolve that issue, the TBA once again analyzed all evidence and the EBA’s decision in G-02/10. The TBA found that all cell lines mentioned by the applicant in the appeal proceedings as being publicly available at the relevant date of the application were initially derived from the inner cell mass of blastocyst stage human embryos resulting in the destruction of the human embryos. Furthermore, the TBA interpreted the EBA’s statement that „where the teaching to obtain the [hESCs] claimed is confined to the use (involving their destruction) of human embryos, the argument raised by the Appellant, namely that the exclusion from patentability would go much too far if one would consider all the steps preceding an invention for the purposes of Rule 28(c) (formerly 23d(c)) EPC, is not relevant” to mean that „for the purpose of Rule 28(c) EPC, all steps preceding the claimed use of [hESCs] which are a necessary precondition for carrying out the claimed invention, have to be considered“.
By applying such an interpretation of G-02/10 to the present case, the TBA concluded that the claimed invention fails to pass the test of Article 53(a) EPC in conjunction with rule 28(c) EPC and is, thus, unpatentable. In other words, even if it would be considered that hESC lines were publicly available at the priority and filing dates, respectively, these hESC lines were results of human embryo destruction bringing the claimed invention in conflict with the ordre public and morality exclusion to patentability.
Finally, the TBA noted that the EPO was not obliged to follow the CJEU ruling in C-24/10, but that the judgments of the CJEU should be considered as persuasive. The TBA also observed that its decision in the present case was in line with the CJEU’s decision in C-24/10.
COMMENT
This decision is obviously another nail in the coffin of hESCs patents in Europe. The decision is not surprising though, since the EBA’s decision in G-02/10 left too much space open for different interpretations, albeit, in my opinion, the intention of the members of the EBA was to allow hESC patents which relied on the established and commercially available stem cell lines as base material and not the contrary – the latter being claimed in the CJEU’s judgment. However, since this ruling is binding to 28 of its 38 contracting states and since the EPO’s practice is not to consider the ordre public and morality issue separately for each state designated in the patent application, but rather for all designated states as a whole, it would be really impractical if the EPO did not follow the CJEU’s ruling, because that might lead to invalidation of the patents granted in the 28 EU member states.
It is doubtful, however, that such a situation in which the research and commercialization of products based on hESCs technologies, including the ones obviously involving the destruction of human embryos, are allowed in many European countries, while at the same time it is not possible to patent such products, bears any legal or even moral logic.
Be it as it may, until a source of hESCs is demonstrated not to involve the destruction of human embryos, inventions utilizing hESCs are going to be refused under Article 53(a) EPC and Rule 28(c) EPC. That being said, it is going to be interesting to see whether patent applications for inventions involving the hESC filed after February 2008 are going to share the destiny of hESC patent applications thus far or is that date going to be the turning-point for hESCs patents in Europe. This is when a scientific article was published claiming that hESC lines were developed from single blastomeres extracted from embryos by using a technique similar to preimplantation genetic diagnosis, not destroying the embryos involved in the process. 1
The full text of the TBA’s decision can be found here.
- CHUNG, Young, et.al., “Human Embryonic Stem Cell Lines Generated without Embryo Destruction”, Cell Stem Cell, Volume 2, Issue 2, p. 113–117, 7 February 2008 ↩
Jasmina Mutabžija
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