After more than four years the Enlarged Board of Appeal, the highest instance of the European Patent Office (EPO), has reached a decision in a case relating to the patenting of human embryonic stem cells. While the decision is by no means clear-cut, it does at least move us one small step closer towards a distinction between what can and what cannot be protected by patent. Patentability is a decisive factor as far as the future in this area of research is concerned, writes Maria Stenbäck, a European Patent Attorney and Senior Patent Attorney with Awapatent.
What is commonly known as the “WARF case” relates to an application(1) filed by the Wisconsin Alumni Research Foundation (WARF) in 1996 that describes a method for obtaining embryonic cell cultures from primates. The application includes no examples of specific human embryonic stem cells, but in view of the fact that it refers to human embryonic stem cells that are available from the US National Institutes of Health (NIH) and includes in its patent claims the use of human embryos as a starting material, this fact has acquired great significance in the case.
Patents on stem cells in Europe
The central question in this issue is whether patenting human stems cells is acceptable from an ethical point of view. This is by no means an easy question to answer. More specifically, the matter concerns a number of paragraphs in the European Patent Convention (EPC) that are wide open to totally different interpretations.
Most controversial among these is the general provision that prohibits the patenting of inventions whose commercial exploitation would be contrary to public order (“ordre public”) or morality.(2)
However, the fact that something is forbidden in national legislation in some or even all of the EPO’s 35 contracting states does not mean that it automatically falls into the category of patents precluded by this paragraph. On the contrary, it is a prerequisite for ensuring that the law can be applied in practice, as attitudes to stem cell research vary greatly from country to country. At the same time, the absence of any clearly established practice in this regard does make it extremely difficult to determine exactly what may be deemed to be contrary to public order and morality. It was the interpretation of this paragraph in particular that the industry had hoped would be clarified with the resolution of the WARF case.
There are, however, more regulations in European patent law that are relevant to the case. An attempt made to harmonise patent legislation within the European Union (EU) with regard to, for example, stem cell related inventions resulted on 6 July 1998 in directive 98/44/EC of the European Parliament and of the Council on the legal protection of biotechnical inventions. Although the EPO has no formal links with the EU and is not obliged to implement EC directives, this directive has subsequently been incorporated into European patent law. In fact, the EPC even goes as far as to state that the EC directive is to be used as an extra point of reference for interpreting the law.(3)
It is for this reason that the EPC includes a number of exceptions with regard to biotechnology(4) that have their origin in the EC directive. For example, it says that Community patents shall not be granted for biotechnical inventions that involve the use of human embryos for industrial or commercial purposes. This rule has acquired great significance in assessments of the patentability of inventions that include the use of embryonic stem cells.
The human body at the various stages of its formation and development is similarly excluded from patentability(5), and this regulation has also been quoted in discussions about the feasibility of seeking patent protection for embryonic stem cells.
For many years biotech companies and we in the patent industry have been uncertain about how these rules are to be applied to patents relating to human stem cells in general and to human embryonic stem cells in particular. That is why, for four long years, we had pinned so much hope on a resolution of the WARF application. Unfortunately, we are still waiting for more than half of our questions to be answered.
WARF case provided no answers
In July 2004 an EPO Examining Division refused to grant a patent for the WARF application on the grounds that it was disqualified by the exception pertaining to inventions that are contrary to public order or morality, and that, as the application proposed the use of human embryos for industrial and commercial purposes, it was not patentable.
In September 2004 WARF appealed against this rejection(6) and in November 2005 the Technical Board of Appeal that was dealing with the appeal decided to refer the question of the patentability of embryonic stem cells to a higher instance, the Enlarged Board of Appeal (EBoA), as the points at issue were considered to be highly significant from a legal point of view.(7)
Four questions were raised
The first question was whether the exception concerning patents for “biotechnical inventions that involve the use of human embryos for industrial or commercial purposes” could be applied retrospectively to an application that had been filed before the rule entered into force.
This question is important because the WARF application was filed three years before the EC directive was implemented in 1999: had the answer to this question been “no”, this would have meant that the EBoA’s further comments would not have applied to other applications filed after the EC directive had been implemented in the European Patent Convention.
Not surprisingly, the answer was “yes” – a decision that even WARF supported. The reason for this was that there is nothing that suggests that commercial exploitation has ever been considered patentable and the introduction of this rule did not therefore deprive WARF of the opportunity to patent something that would previously have been possible.
The second question was based on the fact that, at the time when WARF’s application was filed, it was only possible to prepare the products described in the application with the help of a method that necessarily involved the destruction of human embryos. The actual method did not figure as part of the patent claims, but the question was whether this fact would per se preclude the granting of a patent in view of the rule that forbids the patenting of biotechnical inventions that involve the use of human embryos for industrial or commercial purposes.
The EBoA’s answer to this question was “yes”. Certain industry observers claim that this answer will have a negative effect on the development of human embryonic stem cell research. I believe, however, that it is too early to reach such a conclusion, particularly in view of the considerable advances in technology that have been made since WARF filed its application and which mean that, in many cases, it is no longer necessary to destroy human embryos.
The EBoA set forth in its answer the explanation that it considers that “biotechnical inventions that involve the use of human embryos for industrial or commercial purposes” constitute a form of “inventions whose commercial exploitation would be contrary to public order or morality”. By taking this line, the EBoA linked two regulations that hitherto have not been directly related in the EPC.
Unfortunately this affirmative answer relieves the EBoA of the obligation to respond to the third question, which was the one that the industry had most of all hoped to have resolved.
Question number three, to which an answer was required only if the answer to question one or two was “no”, asked whether WARF’s patent application would be rejected with reference to the EPC article that bars the patentability of inventions whose commercial exploitation would be contrary to public order or morality.
It was the answer to this question – in other words, what is considered to be contrary to public order and morality – that we had waited for four years. The EBoA’s decision not to answer the question, with the motivation that the answers to both question one and question two were “yes”, meant that it sidestepped this controversial issue. The EBoA was able to point out that its decision was not about the patentability in general of inventions related to human stem cell cultures, but confined itself solely to the fact that it is not possible to patent inventions concerning products that can only be produced by destroying human embryos.
In conclusion the EBoA replied to the fourth and final question by making clear that the fact that technical developments after the filing date have subsequently made it possible to obtain the products by means other than the destruction of human embryos is of no significance. This outcome was expected and, as such, is unlikely to have any great impact on current stem cell research activities.
Status still unclear
There have been more than 40 patent applications pending with the EPO that have been directly dependent on the WARF decision, and there are in all likelihood many more related innovations waiting in the wings, for which patents have not yet been filed. In view of the fact that the EBoA, in effect, avoided the need to clarify a situation that the industry has been waiting to have clarified since 2004 – the question of whether it is possible at all to use patents to protect human stem cell research – hopes are now pinned on decisions relating to certain of these applications that may provide answers to the questions still outstanding.
Interestingly, one of these issues is the WARF application itself. Its fate has not yet been finally sealed, since the EPO has given WARF until 2 April to specify how it wishes to proceed with the matter. More interesting still is an application(8) filed by Professor Brüstle of the Institute of Reconstructive Neurobiology at the University of Bonn.
Professor Brüstle’s patent was granted in February 2006. Part of the application referred to a specified, non-tumorigenic cell composition obtainable from mammalian embryonic stem cells by using a special method, which was given special dispensation because the method does not involve the destruction of human embryos. A notice of opposition to this patent has been lodged, but proceedings have been delayed pending the outcome of the WARF case.
It will now be very interesting indeed to see what will happen to this application.
Maria Stenbäck
Senior Patent Attorney and European Patent Attorney
Footnotes
1. Patent application no. EP 0 770 125
2. Article 53(a) in the European Patent Convention (EPC)
3. Rule 26 in the EPC
4. Rule 28 in the EPC
5. Rule 29 in the EPC
6. The appeal was filed as number T 1374/04
7. The case was filed under the reference G 2/06
8. Patent application no. EP 1 040 185
9. Patent application no. EP 0 695 351