Recently, the German Federal Supreme Court decided on a nullity action on the patentability of progenitor cells extracted from human embryonic stem cells under s 2 (2) sentence 1 no 3 of the German Patent Act.
S 2 (2) sentence 1 no 3 of the German Patent Act (PatG) implements Article 6 (2) (c) of the European Directive 98/44 and reads:
“In particular, patents shall not be awarded for: uses of human embryos for industrial or commercial purposes;”
The nullity defendant is the proprietor of the German Patent number 197 56 864 directed at isolated and purified neural progenitor cells (including but not limited to human cells), methods for its manufacturing from embryonic stem cells and the use of the neural progenitor cells for the therapy of neural defects.
The nullity plaintiff had applied for the patent to be declared null and void in as far as progenitor cells are comprised which are derived from human embryonic stem cells for lack of patentability under s 2 (2) sentence 1 no 3 PatG.
At first instance, the German Federal Patent Court had declared the patent to be null and void in as far as it relates to progenitor cells and the manufacturing thereof from embryonic stem cells from human embryos. The patent proprietor appealed against this decision and motioned for the patent to be upheld as granted or, by way of auxiliary request, to uphold the patent with the claims phrased such as to exclude progenitor cells which have been derived from human embryonic stem cells, the production of which included the destruction of human embryos.
The Federal Supreme Court in a decision of 17 December 2009 (docket no Xa ZR 58/07) decided to refer some questions to the CJEU regarding the interpretation of Article 6 of Directive 98/44 on which the latter issued a widely noted judgment on 18 October 2011 (docket no C-34/10 – Brüstle). Briefly summarized, the CJEU inter alia defined the term “human embryo”. It found that Article 6 (2)(c) of Directive (EC) 98/44 also covered the use of human embryos for scientific research and held that it “excludes an invention from patentability where the technical teaching […] requires the prior destruction of human embryos or their use as base material […] even if the technical teaching claimed does not refer to the use of human embryos.” Following this decision, the German Federal Supreme Court recently issued its decision in the case at hand.
The German Federal Supreme Court found that the patent was not patentable as granted under s 2 (2) (c) PatG but was patentable as applied for in the aforementioned auxiliary request. The Court explicitly differentiated between progenitor cells derived from stem cells which were obtained in a way involving the destruction of a human embryo and progenitor cells derived from stem cells which were obtained in a way which did not involve the destruction of human embryos. On the basis of the above mentioned CJEU decision, the German Court found that the patent as granted violated human dignity because although it did not expressly relate to the destruction of human embryos, the patent claims also included a technical teaching presupposing the destruction of human embryos. At the priority date, according to the understanding of the skilled person, the obtaining of stem cells typically involved the destruction of embryos. In light of s 2 (2) sentence 1 no 3 PatG this aspect was found to lack patentability and that it had to be excluded from the claims.
The patent as upheld by the Federal Supreme Court has a broader scope compared to the version as previously upheld by the Federal Patent Court. This was because the latter generally excluded from the patent progenitor cells derived from embryonic stem cells from human embryos without limiting these to the destruction of the human embryos. The Federal Supreme Court therefore found the aforementioned auxiliary request to be admissible and further to be disclosed such that a skilled person was able to implement the invention. In addition, it pointed out that it did not find it necessary that a specific way of obtaining progenitor cells without involving the destruction of human embryos was disclosed in the patent specification. Also, publications had been presented to the Court describing the obtaining of stem cells without requiring the destruction of human embryos. Moreover, the Court stated that human stem cells as such which have been obtained without involving the destruction of a human embryo did not classify as embryos. The Court found that it was not sufficient that these could – in combination with other, namely tetraploid, cells – potentially lead to a viable embryo for the stem cell in itself was not an organism having the capability of initiating the process of the development of a human being.
The Federal Supreme Court finally rejected a further reference to the CJEU on the question of the interpretation of the CJEU of Article 6 (2) (c) of Directive 98/44 contradicted Article 27 TRIPS since there was no indication that the CJEU had ignored Article 27 (2) TRIPS. The Court pointed out that the CJEU had cited this provision in the Brüstle-decision and applied the principles of the dignity and integrity of human beings set out therein.
After all, the Federal Supreme Court has drawn an interesting line regarding the applicability of s 2 (2) sentence 1 no 3 PatG which at the same time acknowledges and respects the findings of the CJEU and takes into account scientific developments which allow for obtaining stem cells without involving the destruction of human embryos.
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