Pharmalicensing brings you advice, commentary and analysis from industry experts.
Dr Phillip M. Webber
Frank B. Dehn & Co, Patent and Trademark Attorneys, London
Introduction
In the past few years, a number of decisions have issued from the Examining and Opposition Divisions of the European Patent Office (‘EPO’) regarding the patentability of human embryonic cells. Appeals against three of these decisions have recently been filed and a ruling on this matter must now be made by the EPO’s Boards of Appeal.
This article looks at the background to these three appeals and at the factors which might influence the Boards of Appeal in arriving at their ruling. (For details of the science behind the use of human embryonic cells and some of the background to these appeals, reference may be made to the author's previous article.) 1
The Legal Framework in Europe
With regard to the patenting of biotechnological inventions in Europe, the main legislative framework is that provided by Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 (‘the Biotech Directive’). 2 The Member States of the European Union were obliged to bring the provisions of the Biotech Directive into force in each of their countries before 30 July 2000. However, as of November 2004, there are still a number of countries that have failed to do this.
The main patent-granting body in Europe is the EPO. Although the EPO was not bound by the provisions of the Biotech Directive (since it is not a member of the European Union), in June 1999 the Administrative Council of the EPO amended the Rules of the European Patent Convention (‘EPC’) to include a new chapter on Biotechnological Inventions (Rules 23b-23e EPC). Through the addition of these new Rules, a number of the Articles of the Biotech Directive were explicitly incorporated into the EPC. The Recitals of the Biotech Directive were also deemed to be ‘supplementary means of interpretation’ by Rule 23b EPC which states:
For European patent applications and patents concerning biotechnological inventions, the relevant provisions of the Convention shall be applied and interpreted in accordance with the provisions of this chapter. Directive 98/44/EC of 6 July 1998 on the legal protection for biotechnological inventions shall be used as supplementary means of interpretation.
Consequently, the provisions of the EPC are now in line with those of the Biotech Directive.
The Morality Provisions of the EPC
In contrast to the patent laws of countries such as the United States, the EPC includes a provision that relates specifically to the morality of the claimed invention. Article 53(a) EPC states:
European patents shall not be granted in respect of: (a) inventions the publication or exploitation of which would be contrary to ‘ordre public’ or morality, provided that the exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States.
The classic example of an invention which would not be patentable under this provision is a letter bomb. Until the incorporation of the provisions of the Biotech Directive into the EPC, there was no specific guidance in the EPC on what inventions fell within Article 53(a) EPC. However, new Rule 23d EPC states:
Under Article 53(a), European patents shall not be granted in respect of biotechnological inventions which, in particular, concern the following:
(a) processes for cloning human beings;
(b) processes for modifying the germ line genetic identity of human beings;
(c) uses of human embryos for industrial or commercial purposes;
(d) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.
Thus inventions which concern the above are now deemed to be immoral and hence unpatentable under the EPC. Rule 23d(c) EPC is of particular relevance to the patenting of human embryonic cells. Also of relevance is Rule 23e EPC which states:
The Patentability of Human Embryonic Cells
As far as the patentability of human embryonic cells is concerned, these cells can be subdivided into two main groups according to the legal provisions that are currently deemed to apply to them:
| Human cell type | Biotech directive | EPC | |
| Group 1 | Pluripotent stem cells | Art.6(2) | Rule 23d(c) |
| multipotent stem cells | |||
| Embryonic (non stem) stem cells | |||
| Group 2 | Totipotent stem cells | Art.5(1) | Rule 23e(1) |
| Art.6(2) | Rule 23d(c) |
A key distinction between the above two groups of cells is that the cells of Group 2 have the capability of forming a whole human being, whilst the cells of Group 1 do not.
Decisions Issued by the EPO
At least three decisions have now been issued by the EPO regarding the patentability of human embryonic cells. One of them was from the Opposition Division, the other two were from the Examining Division. Appeals have now been filed against each of these decisions by the applicants or proprietors. Thus there are now at least three appeals before the Boards of Appeal, as follows:
| Appeal no | Application no | Proprietor/applicant |
| T1079/03–338 | OD EP 94913174.2 | University of Edinburgh |
| T1374/04–338 | ED EP 96903521.1 | Wisconsin Alumni Research Foundation |
| T522/04–338 | ED EP 93921175.1 | California Institute of Technology |
The decisions of the Opposition Division (OD) and the Examining Division (ED) on each of the above cases will be discussed briefly below.
The ‘Edinburgh’ Patent (T1079/03)
Claim 1 of the main request under appeal reads:
The first reasoned decision on how the EPO was interpreting Rule 23d(c) EPC came in the Opposition Proceedings on the ‘Edinburgh’ patent (EP 94913174.2). After grant, 14 opponents filed oppositions to the patent. Oral proceedings were held at the EPO in July 2002, after which the patent was maintained in amended form. The decision of the Opposition Division was given in July 2003.
With regard to the morality of the invention, the Opposition Division referred to the provisions of Article 53(a) EPC (inventions contrary to morality), Rule 23b EPC (in which the provisions of the Biotech Directive were to be taken into account), Rule 23d(c) EPC (‘uses of embryos for industrial or commercial purposes’) and Rule 23e(1) EPC (patentability of the human body).
The Opposition Division compared the provisions of Rules 23d(c) and 23e(1) EPC:
... European patents shall not be granted in respect of biotechnological inventions which, in particular, concern the following: ...
(c) uses of human embryos for industrial or commercial purposes.
Rule 23e(1) EPC:
The human body, at the various stages of its formation and development ... cannot constitute patentable inventions.
They reasoned that Rule 23e(1) EPC covered human embryos since such embryos fell within the scope of ‘the human body’ at an early stage of development. Furthermore, they asserted that Rule 23e(1) EPC should be interpreted as excluding from patentability not only the human body (and embryos) per se, but also all uses of the human body (and embryos) since they asserted that if a product was unethical, all uses of that product should also be deemed to be unethical. Therefore Rule 23e(1) EPC was interpreted as excluding from patentability all uses of human embryos.
The Opposition Division further reasoned that if Rule 23d(c) EPC was interpreted narrowly, then it would be redundant since it would fall within the scope of Rule 23e(1) EPC. Consequently, in order to ascribe a meaning to Rule 23d(c) EPC over and above that of Rule 23e(1) EPC, the Opposition Division asserted that it was appropriate to interpret Rule 23d(c) EPC broadly, that is, that all inventions relating to uses of human embryos for industrial or commercial purposes should not be patentable, and also that any embryonic cells derived from those embryos should also not be patentable.
Since most of the claims of the Edinburgh patent were interpreted as relating to the use of human embryos for the production of embryonic cells and that human embryos would be destroyed in the process, the Opposition Division ruled that the invention was contrary to Article 53a and Rule 23d(c) EPC. The majority of the claims of the patent were also deemed to be non-enabled (Article 83 EPC).
The WARF Patent Application
Claim 1 of the Wisconsin Alumni Research Foundation patent application reads:
The patent application describes the removal of embryonic stem cells from the inner cell mass of monkey blastocysts and the culturing of those stem cells on feeder cells. The application discloses that the same procedures and growth conditions will allow the isolation and growth of human embryonic stem cells and such cells have been deposited with the NIH. The cells are described as being pluripotent.
Despite a valiant defence of the above claim by the applicant, the WARF patent application was refused by the Examining Division in oral proceedings which were held in Munich on 17 June 2004. The provisions of Article 53(a) EPC and Rule 23d(c) EPC were cited.
In particular, the Examining Division stated (emphasis added):
10. Considering that the claimed subject matter is directed to cell cultures rather than to a method for the generation of these cultures, the relation of the product to the generating method was examined. The application, as originally filed, does not disclose any other way of obtaining the claimed ES cell cultures, such that the skilled person who wishes to perform the invention ... may not arrive at this end unless he follows the steps of the specific methods disclosed in the application. Since no alternative starting material is given but preimplantation embryos, the disclosed cultures of embryonic stem cells are inseparable from the methods that generate them and from the use of embryo as starting material.
In the opinion of the Examining Division, it was important whether or not the claimed material could only be derived from a human embryo. The Examining Division also stressed that it was important to look at the invention as a whole, rather than what was specifically claimed:
On the subject of whether downstream products, such as growth factors derived from cell cultures, were also excluded from patentability, the Examining Division stated:
This leaves open the question, however, of how direct the link must be between the use of the human embryo and the claimed ‘potentially useful substance’.
In summary, the key issue as far as the Examining Division in this case was concerned appears to be whether or not the invention involved the ‘direct and unavoidable use of a human embryo’. In their opinion, other issues such as the role of the EPO as an arbiter on ethical issues and the correct approach to be taken with regard to ethical issues were considered not to be relevant.
The CIT Patent Application (T522/04)
Claim 1 of the main request under appeal reads:
Neural crest stem cells are pluripotent stem cells.
The CIT patent application was refused by the Examining Division in a decision dated 17 October 2003. In the decision, the Examining Division stated:
2.3.3. ... The relevant question is whether the claimed cells comprise human embryonic cells since then the invention involves the use of a human embryo.
From the comments reproduced above, it appears that both the Opposition Division and Examining Division are taking a broad interpretation of the term ‘uses of human embryos for industrial or commercial purposes’. Applications are currently being refused if the invention inevitably involves the use of a human embryo, even if such uses are not specifically claimed.
In the above-mentioned decisions, the question of the patentability of totipotent cells was not considered.
What factors might influence the Boards of Appeal?
The key question is whether the Boards of Appeal will uphold the decisions of the Opposition and Examining Divisions or come to another conclusion.
It is useful to note in this regard that all these of the appeals have been assigned to Board 3.3.8 and so one of the decisions will accord with one other.
There are a number of criteria which might influence the Boards in their decisions. Some of these criteria are listed below:
Each of these will be discussed below.
Interpretation of Exclusions from Patentability
The reference to ‘uses of human embryos for industrial and commercial purposes’ in Rule 23d(c) EPC is a derogation from the general principle that:
One does not have to look far into the case law of the EPO Boards of Appeal to find references to how the Boards have traditionally interpreted exclusions from patentability:
6. Like any exception to a general rule of this kind the exclusion of ‘essentially biological’ processes for the production of plants (or animals) has to be narrowly construed.
T19/90 (Oncomouse/Harvard)
... Article 53(b) EPC is an exception, for certain kinds of inventions, to the general rule under Article 52(1) EPC that European patents ‘shall be’ granted for all inventions which are susceptible of industrial application, which are new and which involve an inventive step. Any such exception must, as repeatedly pointed out by the Boards of Appeal, be narrowly construed ... The Examining Division has given no convincing reasons for deviating in this particular case from this principle of interpretation, nor are any such reasons apparent to the Board.
T356/93 (Plant Cells/Plant Genetic Systems)
8. … exceptions to patentability have been narrowly construed, in particular in respect of plant and animal varieties … In the Board’s view, this approach applies equally with respect to the provisions of Article 53(a) EPC.
Furthermore, the Enlarged Board of the EPO’s decision on the interpretation of the exclusion from patentability of plant varieties (G1/98 Transgenic plant/Novartis II) was in line with the above-quoted case law in that a narrow interpretation of the term ‘plant variety’ was taken.
In the light of the above, it appears that taking a broad interpretation of Rules 23d(c) and 23e(1) EPC can only be justified if exceptional circumstances are found. With regard to Rule 23d EPC, such circumstances might arguably be present by virtue of the words:
Rule 23d EPC European patents shall not be granted in respect of biotechnological inventions which, in particular, concern the following ...
and Recital 38 which states: ... whereas this list [of unpatentable inventions] obviously cannot presume to be exhaustive ...
Both of the above passages imply that the list of inventions to be excluded from patentability should not be limited just to those specified in Rule 23d EPC. The above passages do not, however, imply that a broad interpretation should be taken of the inventions which are listed, just that other inventions (in other non-specified areas) might be deemed to be unpatentable in the future.
If one took the traditional, narrow interpretation of Rule 23e(1) EPC, only ‘the human body [per se], at the various stages of its formation and development’ would be excluded from patentability. Under this interpretation, there would not be any overlap between Rules 23e(1) and 23d(c) EPC since the former would relate to products and the latter to uses. There would then be no grounds for interpreting Rule 23d(c) EPC broadly to exclude human embryonic cells per se.
Non-patentable Inventions
It is also worth considering how the EPO treats other inventions which are deemed to be non-patentable.
(2) The following in particular shall not be regarded as inventions within the meaning of paragraph 1:
(a) discoveries, scientific theories and mathematical methods;
(b) aesthetic creations;
(c) schemes, rules and methods for performing mental acts, playing games or doing business, and programs for computers;
(d) presentation of information.
(3) The provisions of paragraph 2 shall exclude patentability of the subject matter or activities referred to in that provision only to the extent to which a European patent application or European patent relates to such subject matter or activities as such.
In the Pensions Benefit case (T931/95, Pension Benefit Systems Partnership), the invention related to a method for controlling a pension benefits program, and corresponding apparatus. The question arose as to whether or not the invention should be deemed to be an unpatentable method of doing business (Article 52(2)c EPC). In this case, the Board of Appeal overlooked the substance of the invention and just looked at the form of the claims. In doing this, they found the method claims to be unpatentable under Article 52(2)c EPC but the apparatus claims to be patentable. (The apparatus claims were subsequently found to lack inventive step.)
Thus in this case, whilst the invention per se might have been deemed to relate to an unpatentable method of doing business, the exclusion from patentability that applied to methods of doing business was not extended to associated products. It is accepted, however, that this example is perhaps not directly relevant to the issues at hand (namely, the interpretation of Rule 23d(c) EPC) since Article 52(3) EPC limits the exclusion from patentability to the specified ‘subject matter or activities as such.’
However, there is no ‘as such’ in Article 52(4) EPC:
(Article 52(1) EPC states that patents shall only be granted for inventions which are ‘susceptible of industrial application’.)
It is often the case that the specification of a European patent application is based on a US-derived application in which the invention is completely described in terms of a method of treatment. Even under such circumstances, it is the common practice of the EPO to allow claims in European-style second medical use format (that is, use of product X in the manufacture of a medicament for the treatment of disease Y).
Thus, even though the invention is deemed to be nonpatentable (as a ‘method of treatment of the human or animal body’), the EPO will allow associated second medical use claims (G5/83, Second medical indication/Eisai). This is, therefore, another example of where the EPO looks only at the form of the claim and not its substance. On this basis, it is arguable that the EPO should not expand the scope of Rule 23d(c) EPC to cover products (for example, human embryonic cells), since the Rule only refers to uses.
Decisions of Opposition and Examining Divisions
The decision of the Opposition Division in the Edinburgh patent has been discussed above. In summary, the Opposition Division took broad interpretations of both Rule 23(e)1 EPC and Rule 23d(c) EPC, and arrived at the conclusion that all uses of human embryos and also the products derived therefrom should be deemed to be unpatentable.
The decision of the Opposition Division was fully reasoned and one can readily follow the logic that was used in coming to the conclusions. The Boards of Appeal can be expected, therefore, to give serious consideration to following the Opposition Division's findings.
It is, however, also possible to criticise the logic that was used by the Opposition Division. The interpretation that is usually given to exclusions from patentability has been discussed above. Furthermore, one of the reasons that the Opposition Division gave for interpreting Rule 23d(c) EPC broadly was their assertion that the exclusion of the human body from patentability (Rule 23e(1) EPC) should extend to all uses of the human body. The reason that they gave for this assertion was that if a product is deemed to be unethical then all uses of that product should also be deemed to be unethical. This reasoning can be questioned. The classic examples that are often cited of unethical inventions are items such as letter bombs and antipersonnel mines. Whilst such products may be seen to be intrinsically unethical, it is primarily the manner in which they might be used that is unethical (that is, to take human life). It is possible to envisage ethical uses of such products, for example, the use of anti-personnel mines in the demolition of an unstable building. Thus the assertion that all uses of an unethical product are also unethical does not always hold true.
Similarly, it is possible to criticize the conclusion of the Examining Division on the WARF patent application that the morality of the invention as a whole had to be considered, not just the form of the claims. This goes against the teachings of the Boards of Appeal and Enlarged Board, as discussed above in the comments given under ‘Non-patentable inventions’.
The interpretation of Article 53(a) EPC was also considered in the Leland Opposition (opposition to EP 88312222.8).3 This patent related to immunocompromised chimeric mice which had been produced using tissues and cells which had been taken from aborted foetuses or children under the age of three. Although the Opposition Division did not have cause to interpret the provisions of Rule 23d(c) EPC, the following comments were made:
Given that a number of European states allow research on human embryos, it is not difficult to see how the above comments could apply equally to the patentability of human embryonic cells.
However, a significant distinction between the Leland opposition and the Edinburgh opposition must be kept in mind. In the Leland opposition, the invention did not fall squarely within one of the key exclusions from patentability which are specified in Rule 23d EPC (although Rule 23d(d) EPC was considered, namely processes for modifying the genetic identity of animals); the morality of the invention was therefore judged under the general provisions of Article 53(a) EPC. In the Edinburgh opposition, the provisions of Rule 23d(c) EPC were deemed specifically to be applicable; hence the morality of the invention was judged under the more proscriptive provisions of Rule 23d(c) EPC.
It must be remembered that even if society were to deem inventions involving the use of human embryos morally acceptable, the EPO would still be bound by the provisions of Rule 23d(c) EPC to exclude such inventions from patentability (at least on a narrow interpretation of this Rule). It is arguable, therefore, that there is little to be gained by the appellants in arguing that the attitude of society to human embryo research has changed since the introduction of Rule 23d EPC into the EPC. It is possible, however, that this might have a subtle influence on how the Boards interpret Rule 23d(c) EPC.
‘Article 16c Reports’
Article 16 of the Biotech Directive states:
The Commission shall send the European Parliament and the Council: ...
(c) annually as from the date specified in Article 15(1), a report on the development and implications of patent law in the field of biotechnology and genetic engineering.
One possible inference from the above statement is that the ‘16c reports’ should be taken into consideration when the provisions of the Biotech Directive are being interpreted.
Despite the fact that ‘the date specified in Article 15(1)’ was 30 July 2000, the first (and so far only) such report was issued in October 2002.4 It contained a summary of the provisions of the Biotech Directive and the extent to which the directive had (or rather had not) been implemented in the Member States. Very few comments were given on the patenting of human embryonic cells and cells lines obtained from them. This issue was, however, identified as a key area on which the European Commission would have to investigate further.
This issue has, therefore, been investigated by a group of independent experts (patent experts, scientists, lawyers, economists) who met in May 2003. Their views have been presented to the European Commission, but it is not clear when the actual report will finally be made public. It is understood that the report is likely to be in the form of a review of the nature of stem cells and patent applications on them, the EPO's patenting practice, possible interpretations of the ethical exceptions from patentability and the effect that these might have, rather than drawing firm conclusions.
Consequently, at the present time, the ‘16c reports’ do not provide any useful guidance on the patentability of human embryonic cells.
Since the Boards of Appeal know that a second ‘16c report’ is on its way, it would seem that arguably they should await its publication and consider its findings before coming to a conclusion on the interpretation of Rules 23d(c) and 23e(1) EPC.
Opinions of the European Group on Ethics
Article 53(a) EPC states:
(a) inventions the publication or exploitation of which would be contrary to ‘ordre public’ or morality, provided that the exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States.
Whilst Article 53(a) EPC requires the EPO to take into consideration the morality of the invention for which a patent is requested, this Article provides no guidance on how the EPO must judge which inventions are ‘contrary to "ordre public" or morality’. Furthermore, this Article specifically states that ‘ordre public’ and ‘morality’ cannot be judged on what is not allowed by the laws of the Contracting States.
In Decision T356/93 (Plant cells/Plant Genetic Systems), the EPO Board of Appeal stated:
With regard to ‘European institutions’, Article 7 of the Biotech Directive states that:
Furthermore, Recital 44 of the Biotech Directive states:
What is the EGE?
The European Group on Ethics in Science and New Technologies (‘EGE’) is an independent, pluralist and multidisciplinary body which advises the European Commission on ethical aspects of science and new technologies in connection with the preparation and implementation of Community legislation or policies. It succeeded, in 1997, the Group of Advisers on the Ethical Implications of Biotechnology (GAEIB 1991–1997). During its first mandate (1998–2000), the EGE provided opinions on subjects as diverse as human tissue banking, human embryo research, personal health data in the information society, doping in sport and human stem cell research. Its 12 current members include, among others, professors of law, ethics and theology.
How might the opinions be relevant?
The opinions of the EGE might be relevant to the interpretation of the Articles of the Biotech Directive for two reasons.
First, some of the opinions of the EGE appear to have been influential during the drafting of the Biotech Directive; this matter is discussed further below under the heading ‘Travaux préparatoires’. Second, the opinions that have been given since the adoption of the Biotech Directive in 2000 might be considered to be relevant to how the provisions of the Biotech Directive should be interpreted in areas that are not specifically covered by the Biotech Directive (such as the patenting of human embryonic cells). This matter will be discussed below.
Is the EPO obliged to consider the opinions of the EGE?
Before considering the more recent opinions of the EGE, it is worth considering whether or not the EPO is obliged in any way to take the opinions of the EGE into account when considering ethical or moral matters. This question arises in the light of the criticism that was directed towards Opinion No 16 of the EGE (on the ‘Ethical aspects of patenting inventions involving human stem cells’)5 by the EPO's Opposition Division in their decision on the Edinburgh patent. In that decision, the Opposition Division dismissed the EGE’s opinion with the words:
As mentioned above, Article 7 of the Biotech Directive states that the EGE ‘evaluates all ethical aspects of biotechnology’ and Recital 44 states that ‘the Group may be consulted’. In an early draft of Article 7, it was stated that the EGE ‘shall assess all ethical aspects of biotechnology’ but there was still no requirement for its conclusions to be taken into account. None of these statements can be considered to be a positive instruction to follow the advice given in these opinions.
Furthermore, in the Statement of the Council's Reasons which accompanied the Common Position adopted by the Council on 26 February 19986 during the drafting of the Biotech Directive, the Council referred to the EGE and stated:
Hence it would appear that the EPO is not obliged to follow these opinions. Notwithstanding this, the eminent status of the members of the EGE cannot be disregarded lightly.
EGE Opinion No 16
In formulating the above opinion, the EGE clearly looked in depth at the ethical issues surrounding the use of human stem cells and at the patenting process in general. In their general conclusions, they stated that it would be contrary to public and patients’ interests to ban all patenting of stem cells or stem cells lines since such a ban would result in a major slowing of this field of research. They also felt that this would be ‘contrary to the EU choices as expressed by the 1998 EU Directive on patenting’ (that is, the Biotech Directive).
However, rather than give their opinion on which areas they felt should be patentable on ethical grounds, they tried to justify excluding certain areas from patentability on grounds of lack of industrial application and breadth of claims. This seems to go beyond their remit, as defined in Recital 44 (see above). Furthermore, at least some of their conclusions betray a basic lack of understanding of the patent system:
As mentioned above, Article 5(2) of the Biotech Directive and Rule 23e(2) EPC specifically allow patents on elements which has been isolated from the human body. Furthermore, the above quotation does not distinguish between the patenting of embryonic stem cells and adult stems cells; the ethical issues relating to these two types of cells are significantly different.
The second main point made by the EGE is that:
The general standard for industrial application which is applied by the EPO is relatively low. In the event that a patent application directed to a specific stem cell or cell line did not disclose any specific use and no use could readily be envisaged, it is possible that the EPO would reject such a patent application. However, in most cases it is difficult to see that no reasonable use for the claimed stem cell line could be envisaged. With regard to the breadth of stem cell patents, the fact that the claims of a patent application are broad is not in itself a valid reason to prevent the patent application being granted. The breadth of the claims should, however, be commensurate with the disclosure of the invention (Article 84 EPC).
The EGE concluded:
As to the patentability of processes involving human stem cells, whatever their source, there is no specific ethical obstacle, in so far as they fulfil the requirements of patentability (novelty, inventive step and industrial application).
Thus it is clearly the opinion of the EGE that patents should be granted only to modified stem cell lines and processes that involve human stem cells. (This last conclusion supports the patentability of the cells claimed in the Edinburgh patent since those cells are modified by the inclusion of a selectable marker.)
Regrettably, the EGE's reasoning in Opinion No 16 must be seen as being out of line with the EPC. This greatly undermines its value to the extent that it is difficult to ascribe any weight to its findings.
Laws of the EPC member states on embryo research
Some of the appellants before the Boards of Appeal have referred to the fact that at least some of the Member States of the EPC allow research to be carried out on embryos (notably the United Kingdom), whilst accepting that such research is prohibited in other Member States. They have used this point to argue that all uses of human embryos should not be deemed to be unpatentable by the EPO.
The question arises as to whether this line of argument is likely to have any influence on the Boards of Appeal. The second half-sentence of Article 53(a) EPC appears to be relevant here:
European patents shall not be granted in respect of:
(a) inventions the publication or exploitation of which would be contrary to ‘ordre public’ or morality, provided that the exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States.
In T356/93 (Plant cells/Plant Genetic Systems), the Board stated that:
It seems, therefore, that the Boards are unlikely to be influenced by whether or not research on human embryos is allowed in the Member States of the EPC.
EU funding for embryo research
A further issue that might have an influence on how the Boards of Appeal interpret Rule 23d(c) EPC is the current proposal for an EU Council Decision which relates to the use of EU funding for research into stem cells. The latest draft of the Decision7 specifically allows EU funding for spare human embryos to be used for research purposes to create new human embryonic stem cell lines.
The proposal has the following restrictions (amongst others):
In order to be funded by the Community, research projects involving the procurement of stem cells from human embryos must also meet the following conditions: ...
(b) the human embryos used for the procurement of stem cells must have been created before 27 June 2002 as a result of medically-assisted in vitro fertilisation designed to induce pregnancy, and were no longer to be used for that purpose …
The proposal has not, however, yet been passed; progress appears to have stalled in December 2003.
It appears, therefore, that the European Parliament no longer considers that it is unethical to use human embryos for the procurement of stem cells. This is perhaps a reflection of how society’s attitude to the use of human embryos has changed in the last few years.
The effect that this might have on the Boards of Appeal is questionable for the reasons given above under the heading ‘Laws of the EPC Member States on Embryo Research’.
Opinion of the President of the EPO
On 21 September 2004, the German newspaper Frankfurter Allgemeine Zeitung published an article entitled ‘Ich wäre so gerne Nanobiotechnologe’ (‘I would love to be a nanobiotechnologist’) about Alain Pompidou, who took over the Presidency of the EPO in July 2004. This article provides an insight into the thoughts of M. Pompidou on the subject of the patenting of stem cells.
Thirty years ago, M. Pompidou was a professor of histology, embryology and cell genetics at the University of Paris. Since then he has been engaged in ethical and bioethical questions and he has stamped his mark on biopolitics as a cabinet advisor in France, a European Commissioner and a representative in organisations such as UNESCO and the Human Genome Project. Consequently, he has a specific and well-informed interest in questions relating to the patentability of human embryonic cells.
The newspaper article states that he is undecided on questions relating to the use of embryos. On the one hand, he states that he has no problems with the use of spare embryos from IVF clinics for medical research. He feels that this is now generally accepted by most of society. On the other hand, he feels that the rules regarding the exclusion relating to ‘uses of human embryos’ are firmly in place and that the decision of the Boards of Appeal will finally resolve this matter.
Whilst M. Pompidou appears to state that he will leave the Boards to come to their own conclusions, given his background, it is difficult to believe that he will not wish to have at least some say in this matter.
Travaux préparatoires
It is interesting to look back at the drafting of the Biotech Directive and to try to establish the reasons why Articles 5(1) and Article 6(2) (that is, Rules 23e(1) and 23d(c) EPC) were included in the Biotech Directive. In this way, some insight into the intention of the legislators may be gained.
In Board of Appeal decision T19/90 (Oncomouse/Harvard), the Board stated that:
The history of Article 5(1) (Rule 23e(1) EPC) and then Article 6(2) (Rule 23d(c) EPC) will therefore now be considered.
Article 5(1) Biotech Directive (Rule 23e(1) EPC)
The wording of Article 5(1) and the corresponding Recital 16 appeared for the first time in the amendments made by the European Parliament as tabled on 25 June 1997. 8 The amendment to add this wording appears to have been prompted by Opinion No. 8 of the EGE9 dated 25 September 1996. In Item 2.3 of that opinion, it is stated that:
It appears, therefore, that the legislator wished to make it entirely clear that all of the various or different stages of human development cannot be patented, even though such stages might lack novelty or not satisfy one of the other criteria for patentability.
The ‘various/different stages of … formation and development’ of the human body are given below:
Stages of early human development
Consequently, any claim to one of the above would be deemed to be unpatentable under Article 5(1) of the Biotech Directive (Rule 23e(1) EPC).
Article 6(2)c Biotech Directive (Rule 23d(c) EPC)
The first draft of the Biotech Directive which was rejected by the European Parliament in 1995 contained no mention of the uses of human embryos or of human cloning issues. The second draft began life in February 1996 and it also contained no mention of such issues. However, in September 1996 and May 1997, the European Group on Ethics in Science and New Technologies (EGE) issued their eighth10 and ninth11 opinions. These appear to have been particularly influential on the amendments that were made by the European Parliament in the Report which was issued on 25 June 1997.12 Whilst EGE Opinion No 8 is specifically mentioned in the amended Proposal (as new citation 3a), it seems reasonable to conclude that Opinion No 9 was also taken into consideration, given that it was published nearly one month before the tabling of the Report.
The Report of 25 June 199713 makes reference to an amended draft Article 9(2) which states:
2. On the basis of paragraph 1, the following shall be considered unpatentable:
(a) procedures for human reproductive cloning;
(b) processes for modifying the germ line genetic identity of human beings;
(c) processes for modifying the genetic identity of animals …
(d) Methods in which human embryos are used;
(e) Methods for the artificial production of human embryos containing the same genetic information as another human being or a dead person (human cloning).
Some insight as to why the above provisions were inserted may be obtained from Opinion No 9 of the EGE, in particular the following:
This comment appears to have inspired the introduction of the above draft Article 9(2)a. The provisions of draft Article 9(2)e were later deleted, presumably due to the overlap in scope between draft Articles 9(2)a and 9(2)e. These provisions refer specifically to the (reproductive) cloning of humans.
With regard to draft Article 9(2)d, Opinion No 9 continues:
2.10 The European Community should clearly express its condemnation of human reproductive cloning and should take this into account in the relevant texts and regulations in preparation as the ... and the proposed [Biotech] Directive …
Point 2.7 is not referring directly to the cloning of humans, but to methods of cloning embryos using existing embryos (that is, ‘by embryo splitting or by nuclear transfer from an existing embryo’). This arguably provided a basis for the introduction of the proposed prohibition on ‘methods in which human embryos are used’ (the above draft Article 9(2)d) in order to ensure that all other reproductive cloning-related uses of human embryos were excluded. Furthermore, at that time in the drafting of the directive, there were uncertainties as to whether or not the term ‘human body’ or ‘human being’ would encompass embryos.
Consequently, it might have been deemed to be desirable to include a prohibition which specifically referred to methods of using human embryos in addition to the ban on patenting the ‘human body’ and the reference to a ‘human being or dead person’ in draft Article 9(2)e
It is clear that draft Article 9(2)e was not directed to ‘embryo splitting or by nuclear transfer from an existing embryo’ since this Article refers to ‘embryos containing the same genetic information as another human being’, whereas the embryo splitting and nuclear transfer techniques referred to above were aimed simply at multiplying the number of available embryos having the same genetic information.
If the above conclusions are correct, Article 6(2)c of the Biotech Directive (that is, Rule 23d(c) EPC) only specifically envisaged covering ‘embryo splitting’ (to produce a number of viable embryos) and ‘nuclear transfer’(of nuclei from one embryo to a number of individual enucleated eggs). Both these techniques appear to be intended to increase the number of viable embryos and hence to increase the chance of successful implantation in assisted reproduction techniques.
The reference to ‘embryo splitting’ was eventually incorporated into Recital 41, as part of the definition of cloning. The wording ‘methods in which human embryos are used’ was changed to ‘uses of human embryos for industrial or commercial purposes’ in the Common Position which was adopted by the Council on 26 February 199814 in order to ensure that only such purposes were to be excluded (and not therapeutic or diagnostic purposes which might be useful to the embryo, as mentioned in Recital 42).
Thus from the travaux préparatoires mentioned above, it seems arguable that the original intention of Rule 23d(c) EPC was merely to exclude from patentability techniques such as ‘embryo splitting’ and ‘nuclear transfer’ from one embryo to a plurality of enucleated eggs in order to increase the chance of successful implantation in assisted reproduction techniques.
Conclusions on the patentability of totipotent human stem cells
One of the main provisions that applies to the patentability of human totipotent stem cells is Article 5(1) of the Biotech Directive (Rule 23e(1) EPC).
This is elaborated upon in Recital 16 of the Biotech Directive which states:
This provision appears to have been based on a statement in Opinion No 8 of the EGE which referred to ‘the human body, at the different stages of its constitution and development’. There appears to be no dispute that this provision covers the early stages of human development, such as the morula, blastocyst and embryo.
Although human totipotent stem cells are capable of forming a complete human being, such cells are not a ‘stage’ of development of the human body – they are a constituent part of the morula or the blastocyst. To be of any use, they must first be isolated from the morula or from the blastocyst, that is, they must be isolated through the intervention of man from one of ‘stages’ of human development.
With regard to isolated elements, Article 5(2) of the Biotech Directive and Rule 23e(2) EPC state that:
This is further clarified by Recital 21 of the Biotech Directive which states:
Thus the exclusion from patentability does not apply to elements which have been isolated from the human body or produced in a technical manner. Human totipotent stem cells would appear to fall squarely within the provisions of the above Article 5(2) and Recital 21; and hence, on this basis, there must be a reasonable argument that such cells should not be excluded from patentability.
However, it cannot be forgotten that one of the defining characteristics of totipotent human stem cells is their ability to form an entire human being. It must, therefore, be accepted that significant moral issues remain regarding the patentability of cells with such properties.
Since the issue of the patentability of totipotent human embryonic stem cells is not specifically before the Boards of Appeal, it seems that we are unlikely to get a decision from them on this matter under Rule 23e(1) EPC. Such cells also fall within the provisions of Rule 23d(c) EPC and hence the Boards’ decisions on that matter will be relevant.
Conclusions on the patentability of pluripotent and multipotent human stem cells and human embryonic cells
The provision which is key to determining the patentability of pluripotent and multipotent human stem cells, and human embryonic cells is clearly Rule 23d(c) EPC.
Rule 23d(c) EPC
... European patents shall not be granted in respect of biotechnological inventions which, in particular, concern the following: ...
(c) uses of human embryos for industrial or commercial purposes.
It is currently the view of the Opposition and Examining Divisions that this provision excludes from patentability all claims to the industrial or commercial use of human embryos and also all claims to associated products which ‘necessitate the direct and unavoidable use of a human embryo’, for example, embryonic cells.
The justification for taking a broad interpretation of Rule 23d(c) EPC was the broad interpretation which was taken in the Edinburgh patent opposition of Rule 23e(1) EPC.
The above provision was interpreted as covering the human body as a product and also all uses of the human body, thus making a narrow interpretation of Rule 23d(c) EPC untenable.
These broad interpretations are open to criticism on the grounds that exclusions from patentability have traditionally been interpreted narrowly by the Boards of Appeal and the Enlarged Board. As has been shown above, the Boards have generally looked at the form of a particular claim and not at its substance. In doing this, they have taken a literal interpretation of the wording of exclusions from patentability. Reference may be made in this regard to the patentability of apparatus involved in business methods but not methods of doing business, and to the patentability of second medical use claims but not methods of treatment. In both the latter examples, there will be a ‘direct and unavoidable’ link between the patentable products/uses and the unpatentable methods; this has not, however, prevented the former from being patented.
Arguments for allowing patenting of human embryonic cells can readily be found in considering of the change in society’s attitude to the use of human embryonic stem cells. This is exemplified by the votes in the European Parliament to allow funding for limited uses of human embryos to obtain stem cells, and the allowing of embryo research in some Member States of the EPC. Such examples prove that all uses of human embryos are not now considered to be ‘so abhorrent that the grant of a patent would be inconceivable’. It appears, therefore, that uses of human embryos would not now fall foul of the general provisions of Article 53(a) EPC, when taken alone.
However, we cannot ignore the provisions of Rule 23d(c) EPC. Although Article 164(2) EPC states the provisions given in the Articles of the EPC ‘shall prevail’ over the provisions of the Rules in cases where there is a conflict between the Articles and the Rules, arguably there is no conflict in this case: the language of Rule 23d EPC is clear (even if its scope is not).
From the travaux préparatoires, it appears arguable that the wording of Rule 23d(c) EPC was intended to cover only techniques of embryo multiplication, such as embryo splitting and inter-embryo nuclear transfer. It is difficult to reconcile this with the broad interpretation which has been taken by the Opposition and Examining Boards.
The Boards will now have to construe the wording of Rule 23d(c) EPC themselves and form their own conclusions on what falls within its scope. In the author’s opinion, the comments given above provide reasonable grounds for coming to a different conclusion from that given by the Opposition and Examining Divisions. The Boards' decisions are expected within the next one to two years. 15
References
1)P .M. W ebber, ‘Embryonic cell patenting’, [2003/2004] 3 BLSR 87–98.
2)Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998
3)Decision of the EPO Opposition Division of 16 August 2001 against EP 88312222.8 in the name of The Board and Trustee of the Leland Stanfor Junior University.
4)Report from the Commission to the European Parliament and the CouncilCOM(2002) 545 final.
5)Opinion of the European Group on Ethics 2002 Opinion No. 16 of 7 May 2002: ‘Ethical aspects of patenting inventions involving human stem cells’
6)Common Position (EC) No. 19/98 adopted by the Council on 26 February 1998 with a view to adopting Directive 98/.../EC of the European Parliament and of the Council on the legal protection of biotechnological inventions: C 110/17 published 8 April 1998.
7)EuroParl Briefing of 17–11–2003(s) ;European Parliament – Final A5-0369/2003 of 4 November 2003; Amended Proposal for a Council Decision amending decision 2002/834/EC on the specific proposal for research, technological development and demonstration: ‘Integrating and strengthening the European research area’(2002-2006) COM/2003/0749 final – CNS 2003/0151
8)Report on the proposal for a European Parliament and Council Directive on the legal protection of biotechnological inventions (COM (95)0661–C4–0063/96–95/0350(COD)) Committee on Legal Affairs and Citizens' Rights. 25 June 1997. A4–0222/97.
9)Opinion of the Group of Advisers on the Ethical Implications of Biotechnology to the European Commission. No 8 ‘Ethical aspects of patenting inventions involving elements of the human body’.
10)Ibid.
11)Opinion of the Group of Advisors on the Ethical Implications of Biotechnology to the European Commission: Opinion No.9, ‘Ethical aspects of cloning techniques’.
12)Note 8 above.
13)Note 8 above.
14)Note 6 above.
15)The information given here is necessarily of a general nature and is given by way of guidance only. Specific legal advice should be sought on any particular matter. Frank B Dehn & Co. cannot accept any responsibility whatsoever for any action taken or not taken on the basis of the information contained herein.
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