Stem cell patents: legal aspects

18 Jun 2012


*New 18 June 2012*: The EU ban on embryonic stem cell patents is legally flawed, argues a paper and public lecture by Aurora Plomer, Chair of Law and Bioethics at the University of Sheffield, UK. Find out more.

June 2011: Lately there have been several cases on the patentability of inventions related to human embryonic stem cells (hESC) in Europe. Now the first case has reached the European Court of Justice (ECJ), the highest European court, whose decision will be binding for all EU member states.

The judgement of the ECJ is still outstanding. However, the Advocate General Yves Bot offered his opinion on the case, which points towards a complete prohibition of patents for inventions relating to hESC. While the court does not have to follow the opinion, it does so in a majority of the cases.

The case history
The current case arose in Germany from a patent of belonging to Prof. Oliver Brüstle. The patent covers neural progenitor cells (precursors of nerve cells), neuronal cells derived from these progenitors, and a method for producing them from hESC lines. hESC lines are typically derived from surplus fertilized egg cells, which are produced in large numbers during in vitro fertilization (IVF) and otherwise discarded. Once established, hESC lines can be permanently maintained and proliferated and thus serve as a source of tissue-specific cells, such as neuronal precursors.

Brüstle’s patent was originally filed in 1997 and granted by the German Patent Office in 1999. In 2004 Greenpeace filed a nullity action against the patent based on reasons of ordre public and morality. A decision of the German Federal Patent Court in 2006 rendered the patent partially invalid, eliminating all claims relating to cells derived from hESC lines. Following Brüstle’s appeal against this decision, the German Federal Court of Justice referred the dispute to the ECJ, arguing that its decision in the case depends on the interpretation of Article 6 of the European Biopatent Directive (Art. 6).

The legal situation
The EU Biopatent Directive (Directive on the Legal Protection of Biotechnological Inventions 98/44/EC) was meant to assure harmonized patent protection for biotechnological inventions in the EU. The directive also contains exemptions from patentability including Art. 6(1), which states that patents contrary to ordre public and morality are excluded from patentability. To provide national courts and patent offices with guidance on how to interpret this clause, an illustrative list of examples was incorporated in Art. 6(2) of the Biopatent Directive.

"The EU Biopatent Directive was meant to assure harmonized patent protection for biotechnological inventions in the EU"

One of these examples has now proven to be key for the patentability of stem-cell-based inventions: Art. 6 (2) (c), which states that in particular “uses of human embryos for industrial or commercial purposes” shall be excluded from patentability. However, there is no definition of any of the terms used in this provision found within the Directive, neither of the term human embryo nor of what is to be understood by “uses for industrial or commercial purposes”.

Consequently and contrary to the aim of the European legislator to achieve harmonisation, there are significant differences in how the Directive has been implemented in the EU member states, and even more variation in how the corresponding provisions of national patent law have been applied in the member states. As a result, some countries have adopted a rather liberal approach to patenting. For example, in the UK about 100 patents on hESC-based inventions had already been granted by 2009 [1]. Others, such as Germany – at least with the first instance ruling of the German Federal Patent Court - have so far opted for a much more restrictive interpretation of the Directive.

The opinion of the Advocate General Yves Bot
European Court of Justice: Image by SsolbergjEuropean Court of Justice: Image by SsolbergjIn his opinion the Advocate General made a suggestion on how Art. 6 (2) (c) of the Biopatent Directive and its terms should be understood. Bot rightly argues that the concept of a human embryo must be subject to a common understanding in all EU member states. Furthermore, he states clearly that hESC are not included in that concept, because they do not in themselves have the capacity to develop into a human being. Nevertheless, he surprisingly took a restrictive approach on patenting of hESC-based inventions: even inventions based on legally established hESC lines are excluded from patentability due to the fact that hESC lines are originally derived from fertilized human eggs.

Should the court follow Bot’s opinion, all national patents on inventions based on hESC that have been granted in EU member states could become subject to nullity suits for the same reasons of ordre public and morality as have been used to challenge Brüstle’s patent.

Consequences beyond patent law
Besides the immediate destruction of all current intellectual property on hESC-based inventions in Europe, a decision in line with Bot’s opinion would significantly impact other areas of legal decision-making, including in particular decisions on EU research funding or market authorisation:

"A decision in line with Bot's opinion would significantly impact other areas of legal decision-making, including EU research funding or market authorisation"

Within its Seventh Framework Programme for Research and Technological Development (FP7), the European Commission has been supporting a number of European research projects dealing with established hESC lines. These projects typically include industrial partners, with the aim to move stem cell technology swiftly towards biomedical application. Following the notion of the Advocate General that the preceding step of hESC derivation from fertilized eggs renders such applications illegal, funding of research on established hESC lines might have to be discontinued in the EC’s next funding programme FP8, due to start in 2014.

There has also been EU regulation on admission of medicinal products to the European market. The European Tissue and Cells Directive sets standards of quality and safety for tissues and cells intended for human application, including hESC. If the step of deriving the cells has to be included in moral considerations on medicinal products, then hESC and tissue-specific cells obtained from hESC cannot be admissible for treatment.

In addition, EU member states’ national practice in hESC research, as well as regulations affecting related fields such as preimplantation genetic diagnosis (PGD), would have to be reconsidered.

The situation at the European Patent Office
European Patent Office: Image by M.MinderhoudEuropean Patent Office: Image by M.MinderhoudAlthough most European Patent Convention (EPC) member states are also member states of the EU, the EPC is an independent international treaty for the protection of inventions in Europe. The European Patent Organisation, with the European Patent Office (EPO), is the intergovernmental organisation based on the EPC. By providing a centralised application and examination procedure in all of the adhering states, the EPC allows significant simplification and economisation of patenting. However, after a European Patent is granted under the EPC, it falls into a bundle of national patents. The assessment of validity and infringement of the patent is consequently governed by each national regulatory system.

While not being bound to do so, the European Patent Organisation implemented the wording of the EU Biopatent Directive in its Implementing Regulations, in particular the here relevant Art. 6(2) (c) in Rule 28 of the Implementing Regulations of the EPC. Although using the same wording as the Biopatent Directive, the European Patent Organisation is an independent international intergovernmental body and has been interpreting the corresponding provision independently.

So far, the most relevant decision regarding patentability of hESC-based inventions at the EPO has been the so-called WARF decision (case G 02/06) issued by the EPO’s Enlarged Board of Appeal. It concerns the European patent application EP0770125 filed by the Wisconsin Alumni Research Foundation (WARF), which relates to “primate ES cells”. While emphasising that the judgement is not applicable to all stem cell inventions, the Enlarged Board of Appeal held that all inventions are excluded from patentability if their exploitation involves destruction of a human embryo. Following this ruling, the EPO’s current practice is to allow patenting of stem cell inventions based on hESC lines as long as at the time of filing the application existing hESC lines were already available.

Although the EPO is not obliged to follow a ruling of the ECJ, it is expected that there would be mutual consideration to avoid severe disharmony within the European patent system.

Related links

New related material June 2012:

General background:

Legal documents:

Plomer, Towards Systemic Legal Conflict: Art. 6 (2) (c) of the EU Directive on biotechnological Inventions, in Plomer, A./ Torremans, P. (Ed.), Embryonic Stem Cell Patents – European Law and Ethics, Oxford/New York 2009, p. 173 ff., 196.