Dipl. Biotechnol. Vanessa Bockhorni
The 10th Civil Senate of the Federal Court of Justice decided on November 27, 2012 that
a) unlimited patenting of precursor cells extracted from human embryonic stem cells is excluded according to § 2 (2) no. 3 Patents Act, in case stem cell lines and stem cells which have been extracted from human embryos come into consideration as starting material;
b) patenting of precursor cells is possible, when the patent claim is limited to the extent that precursor cells from human embryonic stem cells are not comprised, for the isolation of which embryos were destroyed;
c) human stem cells which were obtained without destroying embryos are not to be considered as embryos in terms of § 2 (2) no. 3 Patents Act for the reason that by combining them with other cells, a viable embryo can be obtained.
Briefly worded, patent protection on human embryonic stem cells is possible in case the cells are obtained by a method in which the human embryo is not destroyed.
This decision is based on a patent which relates to isolated precursor cells with neuronal or glial characteristics from embryonic stem cells (ES cells) and their use for the therapy of neural defects in animals and humans. Patent owner is Professor Dr. Brüstle who has probably become well-known through the media in the meantime. Greenpeace e.V. as plaintiff filed an invalidity action against the patent as far as cells are concerned which are obtained from human embryonic stem cells. The first instance, the Federal Patent Court, agreed with Greenpeace based on § 2 (2) Patents Act and revoked the patent to the extent applied for.
The defendant filed an appeal against this decision and defended the patent to the full extent or in the alternative to a limited extent. In the auxiliary request I, patent claim 1 was limited to the extent that “ES cells” was amended to “ES cells from cell lines” and the claim ended with the following wording “…, whereas no isolated purified precursor cells from human embryonic stem cells are comprised during the extraction of which embryos were destroyed”. The same formulation was also added to the process claims.
Following that, the Court of Appeal (the Federal Court of Justice) asked for a preliminary ruling by the European Court of Justice (ECJ) which was answered by the ECJ with its decision of October 18, 2011 to the effect that the prohibition on patenting also refers to the use of human embryos for the purpose of scientific research.
Upon clarification of the above and further questions by the ECJ, the Federal Court of Justice could take a decision in this matter itself and allowed the auxiliary request I. According to the view of the Federal Court of Justice, human embryonic stem cells as such are no embryos as they do not have the ability to activate the development process of a human. This ability would not belong to stem cells that are extracted from embryos at the blastocyst stage. Therefore, the patent protection of embryonic stem cells remains when these have been obtained with methods with which human embryos are not destroyed.
In the view of the Federal Court of Justice, the question whether there are practicable ways for the expert to obtain stem cells from embryos without destroying them, can remain open. These practicable methods are included in patent protection even if they are not disclosed in the patent specification.
This decision gives hope to biotechnology companies to still receive a significantly positive return on-invest for their extremely costly research investments.
§ 2 (2) no. 3 Patents act stipulates that no patents are granted for the use of human embryos for industrial or commercial purposes. Here, the regulation of the German Embryo Protection Act must be considered as well.
Author: Dipl. Biotechnol. Vanessa Bockhorni (Patent Attorney), Update 1/2013
Patent Attorneys and Lawyers Bockhorni & Kollegen
Munich/ Germany
www.patguard.de
