Patentability of human embryonic stem cells

The European Patent Convention and the (Non)Patentability of Human Embryonic Stem Cells—the Warf Case∗ Sigrid Sterckx† [Keywords to Follow] THE ‘‘MORALITY CLAUSE’’ IN EUROPEAN PATENT LAW A patent for an invention confers on the owner (the patentee) the right to prevent others from using the invention. Having a patent does not per se give the patentee the right to use or exploit the invention herself, as such use may be subject to regulation. However, since patents are granted by or on behalf of the state this carries the implication that performance of the invention is approved of by the state. As British patent barrister Daniel Alexander has put it: granting a patent implies that the patent office, and hence the state, is ‘‘putting its imprimatur’’ on the invention at issue.1 Accordingly, the patent law governing the issue of patents by the European Patent Office (EPO), the Convention on the Grant of European Patents (EPC), explicitly forbids the granting of patents for ‘‘immoral’’ inventions. This ban is set out in Art.53(a) EPC as follows: ‘‘European patents shall not be granted in respect of . . . inventions the commercial exploitation of which would be contrary to ‘ordre public’ or morality, provided that * This article is based on an amicus curiae brief submitted to the Enlarged Board of Appeal of the European Patent Office on June 18, 2008 in connection with case G02/06. It reflects the views of the author and the amicus brief was submitted by the author on her own behalf and not at the request of any other party. † Professor of Ethics at the Vrije Universiteit Brussel and Universiteit Gent, Belgium and Senior Research Fellow, Fund for Scientific Research Flanders, Belgium. The author wishes to thank her husband, Julian Cockbain, a European patent attorney, for his assistance and inspiring suggestions regarding this article. She would also like to express her gratitude to Professor Paul Schotsmans of Leuven University for his helpful comments on the ethical arguments. 1 D. Alexander, ‘‘The case for and against the patenting of biotechnological inventions’’ in S. Sterckx (ed.), Biotechnology, Patents and Morality, 2nd reworked edn (Aldershot: Ashgate, 2000), p.310. [2008] I.P.Q.: No. 4  2008 Thomson Reuters (Legal) Ltd. and Contributors Sigrid Sterckx 479 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.’’2 This exclusion from patentability is permissible under the terms of the Agreement on Trade Related aspects of Intellectual Property rights (TRIPS),3 a convention to which all member states of the World Trade Organization are party. It has no exact counterpart in the patent law of the United States. US patent law does require inventions to have ‘‘utility’’ to be patentable, and for a long time utility was deemed to include morality, but that requirement seems to have faded over the past half century or so.4 The second half-sentence of Art.53(a) EPC, quoted above, to the effect that legality and morality are not co-terminous, implies not only that the fact that the exploitation of an invention is forbidden in some or all the Member States does not imply that such exploitation is contrary to morality, but also that if the commercial exploitation of an invention is not forbidden by law or regulation we cannot conclude from this that such exploitation is morally permissible. Apart from this clarification, the meanings of the concepts of ‘‘morality’’ and ‘‘ordre public’’ and what might or might not be contrary to ‘‘ordre public’’ or morality were not made clear in the original version of the EPC. An EPO Board of Appeal Decision5 regarding the patentability of transgenic plants has attempted to throw some light on the meaning of these concepts. Another EPO Board of Appeal Decision6 has recommended a particular approach as to how to assess morality in the case of a patent application relating to transgenic animals, namely that there should be a ‘‘balancing act’’ between the benefits and the disadvantages, an approach which, in the field of ethics, is known as ‘‘utilitarian’’ (see below). In practice, in the examination of European patent applications, the individual examiners follow a set of guidelines,7 which have no force of law. According to these guidelines, the criterion to be applied to assess morality is whether or not the general public Convention on the grant of European Patents (European Patent Convention), 13th edn (Munich: European Patent Office, 2007), p.80. 3 Annex 1C, Agreement on Trade-RelatedAspects of Intellectual Property Rights, to the Marrakesh Agreement establishing the World Trade Organization (Geneva: World Trade Organization, 1994), available at http://www.wto.org/english/tratop e/trips e/t agm0 e.html [Accessed August 18, 2008]. 4 R.P. Merges and J.F. Duffy, Patent law and policy: cases and materials, 3rd edn (Newark: Lexis-Nexis, 2002), pp.216–228. 5 Decision T-356/93 of the European Patent Office Technical Board of Appeal, Official Journal of the European Patent Office (1995), p.545, ss.5 and 6. The concept of ‘‘ordre public’’, according to this Board, relates to the protection of the security and the physical integrity of individuals as part of society and also encompasses the protection of the environment (para.5). The concept of ‘‘morality’’ is defined as: ‘‘[R]elated to the belief that some behaviour is right and acceptable whereas other behaviour is wrong, this belief being founded on the totality of the accepted norms which are deeply rooted in a particular culture. For the purposes of the EPC, the culture in question is the culture inherent in European society and civilisation, Accordingly, under Article 53(a) EPC, inventions the exploitation of which is not in conformity with the conventionally-accepted standards of conduct pertaining to this culture are to be excluded from patentability as being contrary to morality.’’ (para.6) 6 Decision T-19/90, Official Journal of the European Patent Office (1990), p.476: ‘‘The decision as to whether or not Article 53(a) EPC is a bar to patenting the present invention would seem to depend mainly on a careful weighing up of the suffering of animals and possible risks to the environment on the one hand, and the invention’s usefulness to mankind on the other.’’ 7 Guidelines for examination in the European Patent Office, December 2007 edn (Munich: European Patent Office, 2007). 2 [2008] I.P.Q.: No. 4  2008 Thomson Reuters (Legal) Ltd. and Contributors 480 Human Embryonic Cells—the WARF Case would find the invention abhorrent.8 Obviously, with such a threshold, the inclusion by the legislator of a morality clause which is rarely (if ever) to be considered, would be turned into a meaningless act. Fortunately, the guidelines have no force of law. Following the adoption of Directive 98/449 on the legal protection of biotechnological inventions by the European Union, the Member States of which overlap considerably with the states which are party to the EPC, in 1999 the European Patent Office introduced rules which reflected the prohibitions on patenting set out in that Directive. Of the new rules that were introduced into the EPC, for present purposes only rr.28(c) and 29(1) EPC are relevant. They read as follows: ‘‘ Under Article 53(a), European patents shall not be granted in respect of biotechnological inventions which, in particular, concern . . . uses of human embryos for industrial or commercial purposes.10 The human body, at the various stages of its formation and development, and the simple discovery of one of its elements. . . cannot constitute patentable inventions.’’11 WARF’S PATENT APPLICATION Before the abovementioned rules were introduced, the Wisconsin Alumni Research Foundation (WARF—the technology transfer office for the University of Wisconsin in Madison) had filed a European patent application12 for an ‘‘invention’’13 by James Thomson which encompassed within the monopoly it claimed compositions (cultures) of human embryonic stem cells (hES cells).14 8 In s.C.IV-4.1 of these Guidelines it is stated that: ‘‘Any invention the commercial exploitation of which would be contrary to ‘ordre public’ or morality is specifically excluded from patentability. The purpose of this is to deny protection to inventions likely to induce riot or public disorder, or to lead to criminal or other generally offensive behaviour. . . Anti-personnel mines are an obvious example. This provision is likely to be invoked only in rare and extreme cases. A fair test to apply is to consider whether it is probable that the public in general would regard the invention as so abhorrent that the grant of patent rights would be inconceivable.’’ 9 Directive 98/44 on the legal protection of biotechnological inventions [1998] O.J. L213/13. 10 Conventionon the grant of EuropeanPatents (EuropeanPatent Convention),13th edn (Munich: European Patent Office, 2007), pp.256–258. 11 Convention on the grant of European Patents, p.258. 12 J. Thomson, Primate embryonic stem cells (1996), International patent application publication number WO96/22362, WIPO, Geneva. 13 Although the morality issue is the main issue in this case, there is also doubt as to whether hES cells qualify as an invention or whether they are a discovery and hence not patentable pursuant to Art.52(2) EPC, although the EPO has not raised this question. We cannot elaborate on this issue here. 14 Patents and patent applications are required to define the scope of the invention for which a monopoly is granted or sought in a series of numbered sentences referred to as ‘‘claims’’. These claims must not encompass subject matter that is not new but are usually in as generic as possible language so as to cover all possible products or processes that might utilise the invention. One of the relevant claims of the WARF European patent application, App. No.96903521, thus reads as follows: ‘‘A cell culture comprising primate embryonic stem cells which (i) are capable of proliferation in vitro culture for over [2008] I.P.Q.: No. 4  2008 Thomson Reuters (Legal) Ltd. and Contributors Sigrid Sterckx 481 After fertilisation, the human egg divides and divides again to form a cluster of cells, each of which has the potential to form placental or foetal tissue. These cells are referred to as being ‘‘totipotent’’—they can ‘‘do anything’’. After a while, the cells in the cluster develop into two different types—one type can form placental tissue, while the second type can develop into any form of foetal tissue but not into placental tissue. This second type of cells are referred to as being ‘‘pluripotent’’—they can ‘‘do a lot of things’’. At a later stage, this second type of cells develop into the precursors for specific tissues. hES cells are collected by taking pluripotent cells from a cell cluster—generally a cluster produced for in vitro fertilisation purposes—before this later stage. This procedure destroys the cell cluster, the ‘‘embryo’’, from which the pluripotent cells are collected. While some purists might argue that the cell cluster that is destroyed in this procedure does not yet qualify to be called an ‘‘embryo’’, but is merely a so-called ‘‘pre-embryo’’, even WARF has accepted that for present purposes the cell cluster is indeed an ‘‘embryo’’.15 The pluripotent hES cells of a hES cell culture of the type WARF is seeking to patent in Europe do not themselves have the potential to develop into a human being. Nonetheless, the production of these cells requires destruction of an embryo, and the grant of a patent would allow WARF to collect royalties on commercial use of these cell cultures, e.g. in the development of therapies. The deliberate destruction of embryos is of course repugnant to many people, and hES cell research is tightly controlled, or even forbidden, in many countries. In the United States, for example, President G.W. Bush has forbidden the use of Federal funding for hES cell research except on cell lines in existence before August 2001.16 In a limited number of EU countries, including the United Kingdom, hES cell research is permitted. However, as noted earlier, the assessment of the patentability of an invention is not determined by whether its exploitation is legally permitted or not. REFUSAL OF WARF’S APPLICATION, APPEAL AND REFERRAL TO THE EPO’S HIGHEST ARBITER The WARF patent application was refused by the EPO examiners for claiming subject matter excluded from patentability by r.28(c) EPC, which, as mentioned earlier, prohibits the patenting of biotechnological inventions which concern uses of human embryos one year, (ii) maintain a karyotype in which all chromosomes normally characteristic of the primate species are present and are not noticeably altered through culture for over one year, (iii) maintain the potential to differentiate to derivatives of endoderm, mesoderm, and ectoderm tissues throughout the culture, and (iv) are prevented from differentiating when cultured on a fibroblast feeder layer.’’ 15 Letter of May 22, 2008 from J A Kemp & Co, the European Patent Attorneys for WARF submitted to the European Patent Office in connection with case G-02/06, s.3, available at http://www.epoline.org/ portal/public/registerplus/ [Accessed August 18, 2008] by entering the publication number as EP0770125. 16 G.W. Bush, Fact sheet: embryonic stem cell research (Washington: White House, 2001), available at http:www.whitehouse.gov/news/releases/2001/08/20010809-1.html [Accessed August 18, 2008]. [2008] I.P.Q.: No. 4  2008 Thomson Reuters (Legal) Ltd. and Contributors 482 Human Embryonic Cells—the WARF Case for industrial or commercial purposes. WARF appealed that refusal, and the Technical Board of Appeal (TBA) that heard the appeal referred the question of the patentability of hES cell cultures to the EPO’s Enlarged Board of Appeal (EBA),17 a body which, like the US Supreme Court or the United Kingdom’s House of Lords, is the final arbiter for deciding how particular passages of a law should be interpreted.18 More specifically, the Technical Board of Appeal referred the following questions to the Enlarged Board of Appeal (the numbering of the Rules was changed in 2007 and the new numbering is used throughout herein and is inserted below): 1. Does r.[28(c)] EPC apply to an application filed before the entry into force of the rule? 2. If the answer to question 1 is yes, does r.[28(c)] EPC forbid the patenting of claims directed to products (here: human embryonic stem cell cultures) which—as described in the application—at the filing date could be prepared exclusively by a method which necessarily involved the destruction of the human embryos from which the said products are derived, if the said method is not part of the claims? 3. If the answer to question 1 or 2 is no, does Art.53(a) EPC forbid patenting such claims? 4. In the context of questions 2 and 3, is it of relevance that after the filing date the same products could be obtained without having to recur to a method necessarily involving the destruction of human embryos (here: e.g. derivation from available human embryonic cell lines)?19 The Enlarged Board of Appeal responded, initially by inviting submissions (amicus curiae briefs) from interested parties, and, after receiving hundreds of such submissions, in March 2008 issued a summons20 to WARF to attend a hearing in June 2008 to present 17 Interlocutory decision T-1374/04 of the European Patent Office Technical Board of Appeal, (European Patent Office, Munich, 2006), available at http://legal.european-patent-office.org/dg3/pdf/ t041374ex1.pdf [Accessed August 18, 2008]. 18 Documents on the EPO file for the WARF case may be accessed at http://www.epoline.org/portal/ public/registerplus/ [Accessed August 18, 2008] by entering the ‘‘publication number’’ as EP0770125. EPO decisions by a Board of Appeal may likewise be accessed at http://www.epo.org/patents/appeals/searchdecisions.html by entering the case number in the format x yyyy/zz where x is G or T for decisions of the Enlarged or Technical Boards of Appeal respectively, yyyy is a four digit number corresponding to the first part of the case number (i.e. 11 becomes 0011), and zz are the last two digits in the year component of the case number. Thus for the opinion of the Enlarged Board of Appeal in Case G-01/04 (EPO 2005) mentioned below, enter G0001/04. 19 Interlocutory decision T-1374/04 of the European Patent Office Technical Board of Appeal, (Munich: European Patent Office, 2006), pp.34–35, available at http://legal.european-patent-office.org/dg3/ pdf/t041374ex1.pdf [Accessed August 18, 2008]. 20 Summons to Oral Proceedings dated March 20, 2008 by the European Patent Office in case G-02/06, available at http://www.epoline.org/portal/public/registerplus/ [Accessed August 18, 2008] by entering the publication number as EP0770125. [2008] I.P.Q.: No. 4  2008 Thomson Reuters (Legal) Ltd. and Contributors Sigrid Sterckx 483 its arguments.21 The summons set out the points the Enlarged Board considered to be relevant and, in May 2008, WARF filed comments addressing those points.22 ANALYSIS OF THE ISSUES REFERRED TO THE ENLARGED BOARD OF APPEAL The questions put to the Enlarged Board may, on the surface, look simple and straightforward. Paraphrased, they seem to be: (1) (2) (3) (4) Does the rule apply to the WARF application? If applied, does the rule exclude Thomson’s invention from being patented? If not applied, then is Thomson’s invention excluded by the Article? Would matters change if there are relevant scientific developments? In fact, however, the questions are not so straightforward. Question 1: Does the rule apply? The communications between WARF and the EPO show that there may be controversy as to the applicability of r.28(c) for a number of reasons. The rule was brought into force by the EPO without being ratified by all the EPC Member States. It reflects the terms of an EU Directive and not all EPC Member States are part of the European Union. The rule was brought into force after the TRIPS Agreement and would not be TRIPS-compliant if it would exclude from patentability things that are not excluded by Art.53(a) EPC. Finally, it would have to be overruled by Art.53(a) EPC if it would exclude things not excluded by that Article, since Art.164(2) EPC provides that, in the case of conflict between Articles and rules, the Articles must prevail. The answer the Enlarged Board will give to the question as to whether r.28(c) applies seems very likely to be ‘‘yes’’. In the summons to WARF, the rapporteur for the Enlarged Board summarised as follows: ‘‘In the submission of . . . [WARF] it was submitted that Rules 23b to 23e EPC (now Rules 26 to 29 EPC) were intended to clarify the interpretation of Article 53 EPC and accordingly they applied to applications filed before 1 September 1999, their date of entry into force. This is also the view taken by the president of the EPO, and in the majority of submissions in amicus curiae briefs, supported in some cases by fully developed arguments. By comparison, for the views expressed in some amicus curiae briefs that these Rules should only apply to applications filed after 1 September 1999, or should not be applied at all, the argumentation seems less developed.’’23 21 The state of play up to the summons is discussed in S. Sterckx and J. Cockbain, ‘‘Patenting human embryonic stem cells’’, PropEur Newsletter (2006), Supplement to Vol.3, available at http://www.propeur.bham.ac.uk/Newsletter%20Vol%203%20Supplement.pdf [Accessed August 18, 2008]. 22 Letter of May 22, 2008 from J A Kemp & Co, the European Patent Attorneys for WARF submitted to the European Patent Office in connection with case G-02/06, available at http://www.epoline.org/portal/ public/registerplus/ [Accessed August 18, 2008] by entering the publication number as EP0770125. 23 Summons to Oral Proceedings dated March 20, 2008 by the European Patent Office in case G-02/06, s.3, available at http://www.epoline.org/portal/public/registerplus/[Accessed August 18, 2008] by entering the publication number as EP0770125. [2008] I.P.Q.: No. 4  2008 Thomson Reuters (Legal) Ltd. and Contributors 484 Human Embryonic Cells—the WARF Case In its response, WARF took the slightly different position that the rule could be applied, but only if it didn’t extend to exclude subject matter not excluded by the Article, as it would then be contrary to TRIPS. Clearly, in WARF’s view the answer to question 1 would only be ‘‘yes’’ if the answers to questions 2 and 3 were ‘‘no’’. Question 2: Does the rule exclude Thomson’s invention? The precise wording of r.28(c) excludes from patentability inventions ‘‘that concern . . . uses of human embryos for industrial or commercial purposes’’. The claims in WARF’s application do not actually recite any uses of embryos, e.g. process steps involving their destruction, but instead define the invention as ‘‘a cell culture’’ rather than for example as ‘‘a cell culture made by using embryos’’. Under normal practice, the ‘‘invention’’ referred to in the Article and the Rule would be taken by the EPO to mean the invention as defined in the claims. However, two points need to be borne in mind here. First, since embryos must be destroyed to derive the claimed hES cell cultures in the first place, and since clearly destroying embryos is an example of using embryos, the invention cannot reasonably be said not to concern a use of human embryos, regardless of the wording of the claims. Secondly, the question arises as to whether or not the use is for industrial or commercial purposes. Here it must be borne in mind that, since we are talking about a patent application, and since, as noted by EPO Board of Appeal member Rainer Moufang, ‘‘the intention of commercialization . . . is necessarily linked to a patent application’’,24 the answer to this second question would clearly have to be affirmative. The Enlarged Board’s summons to WARF sets out three possible interpretations of the rule: restrictive; intermediate; and extensive. This wording was probably chosen to avoid the terms ‘‘narrow’’ and ‘‘broad’’ used in earlier EPO case law. These interpretations (again with the numbering brought into line with the current text of the EPC) were set out as follows: ‘‘ Restrictive—Rule [28(c)] EPC merely forbids use of the phrase ‘‘use of human embryos’’ in the claim without any need further to consider what the claim is directed to, or the description says. Intermediate—The words of Rule [28(c)] EPC should be given their ordinary meaning in the light of the object and purpose of the EPC in conformity with Directive 98/44/EC of 6 July 1998 (Rule [26(1)] EPC). Since a patent gives the right to forbid others to make or use the subject matter claimed for industrial or commercial purposes, the way in which the patent describes how to make or use the claimed subject matter needs to be considered when considering whether the exception to patentability arises, irrespective of the wording of the claim. Extensive—Since Rule [28] EPC gives only examples of exceptions to patentability under Article 53(b) EPC [sic], there is no case for a ‘‘narrow’’ interpretation of Rule 24 R. Moufang, ‘‘Patenting of human genes, cells and parts of the body—the ethical dimensions of patent law’’ (1994) 25 I.I.C. 487, 504. [2008] I.P.Q.: No. 4  2008 Thomson Reuters (Legal) Ltd. and Contributors Sigrid Sterckx 485 [28(c)] EPC even if there might be one for Article 53(a) EPC. Rather uses analogous to those forbidden by the examples provided in Rule [28] also fall under Article 53(a) EPC.’’25 Under the ‘‘restrictive’’ interpretation, the answer to question 2 would of course be ‘‘no’’. Unsurprisingly, WARF’s position in its response to the Enlarged Board was that the intermediate and extensive interpretations were incorrect.26 However, in the period between the appeal hearing in WARF’s case and the written referral of the questions to the Enlarged Board, the Enlarged Board commented in another opinion—G01/0427—that exclusions from patentability need not always be interpreted narrowly. The Enlarged Board in this context, somewhat redundantly unless the existence of the WARF case was on the minds of its members, commented as follows: ‘‘It is true that there are exclusion clauses from patentability provided for in the EPC. It is also true that the frequently cited principle, according to which exclusion clauses from patentability laid down in the EPC are to be construed in a restrictive manner, does not apply without exception.’’28 The Enlarged Board members for Case G-01/04 and the present WARF case, Case G-02/06, overlap. Accordingly, the Board can clearly be expected to favour either the intermediate or the extensive, but not the restrictive, interpretation. The restrictive interpretation would, after all, allow almost any exclusion from patentability to be sidestepped merely by careful claim drafting. This surely was not the intention of the legislator. The Enlarged Board’s summons warns that, if WARF’s claims can be read to cover compositions containing cells with the potential to develop into embryos, in particular totipotent cells, even a narrow reading of r.28(c) EPC—or r.29(1) EPC, for that matter—would seem to exclude such claims. WARF responded by pointing out that the claimed cells are not totipotent and have no potential to develop into embryos. The President of the EPO accepted this in the Oral Proceedings in June 2008. Potentiality of the hES cells would thus appear to be a red herring in this context—any ethical basis for considering commercial exploitation of hES cell cultures to be ‘‘contrary to morality’’ must therefore lie elsewhere. 25 Summons to Oral Proceedings dated March 20, 2008 by the European Patent Office in case G-02/06, available at http://www.epoline.org/portal/public/registerplus/ [Accessed August 18, 2008] by entering the publication number as EP0770125, s.5 (emphasis added). 26 Strangely enough, WARF also submits that the restrictive interpretation is incorrect because it is too narrow. No further argumentation is given apart from the following vague statement: ‘‘The Appellant contends it is the scope of the claim which has to be considered. In considering the scope of the claim it is not sufficient to focus on the particular form of words used but necessary to consider the substance of the claim.’’ Letter of May 22, 2008 from J A Kemp & Co, the European Patent Attorneys for WARF submitted to the European Patent Office in connection with case G-02/06, s.43, available at http://www.epoline.org/portal/public/registerplus/ [Accessed August 18, 2008] by entering the publication number as EP0770125. 27 Opinion G-01/04 of the Enlarged Board of Appeal of the European Patent Office, available at http://legal.european-patent-office.org/dg3/biblio/g040001ex1.htm [Accessed August 18, 2008]. 28 Opinion G-01/04 of the Enlarged Board of Appeal of the European Patent Office s.20. [2008] I.P.Q.: No. 4  2008 Thomson Reuters (Legal) Ltd. and Contributors 486 Human Embryonic Cells—the WARF Case For the Enlarged Board to conclude that the rule applies and excludes Thomson’s invention, i.e. to reply ‘‘yes’’ to questions 1 and 2, seemingly has two advantages: (1) this would not criticise the implementation of the rule; and (2) the criticism of at least some aspect of hES cell work as immoral would then derive from the European Union, as authors of the abovementioned EU Directive on biotechnology patents on which the rule is based, rather than from the EPO. However, such a conclusion cannot validly be taken without also confirming that Thomson’s invention is excluded by the morality clause (Art.53(a) EPC), since, as noted above, Art.164(2) EPC states that where rules and Articles conflict the Articles prevail. In order to decide whether r.28(c) conflicts with Art.53(a), by excluding more than the article, WARF’s invention must be assessed under Art.53(a). QUESTION 3: DOES THE ARTICLE EXCLUDE THOMSON’S INVENTION? The way the Technical Board of Appeal has phrased question 3 is, to our mind, highly regrettable as, according to the Board, if the answers to questions 1 and 2 are ‘‘yes’’, then question 3 need not be answered. However, WARF’s application cannot validly be rejected unless the answer to question 3 would be ‘‘yes’’, whatever the answers are to questions 1 and 2. The Enlarged Board cannot and should not escape question 3, which is the crux of the matter as was acknowledged at the Oral Proceedings in June 2008. Demonstrating that the subject matter of WARF’s application concerns a use of human embryos for industrial or commercial purposes, as we have done above, is certainly important, but it is not enough. It is also necessary to demonstrate that the commercial exploitation of an invention which concerns a use of human embryos for industrial or commercial purposes is contrary to ‘‘ordre public’’ or morality. Obviously, this brings us back to the question mentioned in the first section of this paper, i.e. how is morality to be determined? As mentioned above, for some time now, the stance of the EPO in relation to matters of morality has been to adopt a utilitarian ‘‘balancing act’’—do the benefits of the invention outweigh its disadvantages? However, the Technical Board of Appeal in the WARF case, which submitted the four questions to the Enlarged Board, stated that it: ‘‘[H]as doubts whether, when it comes to human life, it would be ethically acceptable to make a decision by weighing the interests of human beings who could potentially benefit from the exploitation of the technology against a right, if any, of human embryos (whether or not they can already be qualified as human beings), to get a life and of not being destroyed for the benefit of others.’’29 The Enlarged Board, in its summons to WARF, picked up on this point and appeared to suggest that the balancing act is not appropriate where human dignity—which it 29 Interlocutory decision T-1374/04 of the European Patent Office Technical Board of Appeal, (Munich: European Patent Office, 2006), s.55, available at http://legal.european-patent-office.org/dg3/pdf/ t041374ex1.pdf [Accessed August 18, 2008]. [2008] I.P.Q.: No. 4  2008 Thomson Reuters (Legal) Ltd. and Contributors Sigrid Sterckx 487 identified as being the core issue at stake here—is concerned. Thus, the summons comments: ‘‘Whereas on one line of argument it might be considered that great caution is necessary by the instances of the EPO before themselves deciding that something is contrary to Article 53(a) EPC, on another line of argument the instances of the EPO must be careful to duly take into account what the legislator in Rules [26 to 29] EPC has stated to be contrary to Article 53(a) EPC and the intended purpose, in particular, of preserving human dignity. An argument that there should be a balancing of human dignity against benefits to be achieved, concedes that some benefits outweigh human dignity. What basis is there for this view? If there is a basis for this view for some benefits, does it require there to be immediate concrete benefits, or is a vague hope for hypothetical benefits sufficient?’’30 Here it must be born in mind that Art.1 of the Charter of Fundamental Rights of the European Union,31 helpfully but accidentally brought into the case by WARF’s response to the summons, states that, ‘‘[h]uman dignity is inviolable. It must be respected and protected’’. The question then becomes which of the two main approaches to ethical questions should be taken—either a utilitarian approach of ‘‘weighing up of benefits and disadvantages’’ or a deontological approach, according to which certain things may be morally impermissible, even if they would produce more benefits than disadvantages. WARF advocated the utilitarian approach and in its submissions repeatedly emphasised the therapeutic benefits of hES cell research. The Enlarged Board on the other hand wondered if, whether human dignity should be respected or not, could ever depend on a ‘‘balancing act’’ and, if so, what the nature of the benefits must be in order for them to outweigh human dignity. WARF asserted that the EPO should not consider such questions, as this approach ‘‘would require [EPO] examiners to be moral arbiters’’.32 However, two comments need to be made in this regard: (1) merely deciding on the basis of balancing benefits against disadvantages (without taking human dignity into account) also implies being a moral arbiter; and (2) the EPC requires examiners to be moral arbiters. Article 53(a) EPC is part of the law and it cannot, and should not, be ignored. As Rainer Moufang concludes in his impressive article ‘‘Patenting of Human Genes, Cells and Parts of the Body?—The Ethical Dimensions of Patent Law’’: ‘‘Ethical considerations permeate the entire normative structure of the patent system and play a decisive role in its appropriate development by means of legislation and case law. Patent law also provides adequate space to take into account specific 30 Summons to Oral Proceedings dated March 20, 2008 by the European Patent Office in case G-02/06, s.12, available at http://www.epoline.org/portal/public/registerplus/ [Accessed August 18, 2008] by entering the publication number as EP0770125. 31 Charter of Fundamental Rights of the European Union (2000/C364/01), Official Journal of the European Communities, December 18, 2000, C-364:9. 32 Letter of May 22, 2008 from J A Kemp & Co, the European Patent Attorneys for WARF submitted to the European Patent Office in connection with case G-02/06, s.57, available at http://www.epoline.org/ portal/public/registerplus/[Accessed August 18, 2008] by entering the publication number as EP0770125. [2008] I.P.Q.: No. 4  2008 Thomson Reuters (Legal) Ltd. and Contributors 488 Human Embryonic Cells—the WARF Case bio-ethical arguments. The provision of Art.53(a) EPC constitutes an important gate of entry for overarching moral concepts.’’33 Or to quote the rapporteur for the Enlarged Board in the WARF case, in the summons to WARF: ‘‘The provisions of article 53(a) EPC might thus be considered as a legal norm of higher rank than the provisions of Article 52(1) EPC [the patentability requirements of novelty, inventive step and susceptibility of industrial application], which latter must yield in the case of conflict.’’34 There can be no doubt that the moral assessment prescribed by Art.53(a) EPC must be made. We would suggest that the issue should be analysed both from a utilitarian and from a deontological approach. We cannot provide in-depth analyses here, but we will make some comments as to: (1) what is at stake in both a ‘weighing up’ and a dignity-based approach to the present case; and (2) which conclusions seem to follow from applying these approaches. A balancing approach According to the proponents of hES cell research, the destruction of human embryos in this research can be justified by the resulting therapeutic benefits. If one accepts such an approach, apart from the problem that a strict utilitarian view would also allow the killing of adult human beings if the benefits to be obtained by other human beings would be sufficiently large, another question arises which was aptly formulated by the rapporteur for the Enlarged Board: ‘‘does [this view] require there to be immediate concrete benefits, or is a vague hope for hypothetical benefits sufficient’’?35 As ethicist Søren Holm has explained: ‘‘The benefits that are put into the balance to justify the sacrifice are mainly the therapeutic potential promised by stem cell therapy. . . . If embryos have moral status, [a utilitarian] analysis shows that we should pursue only destructive research (on any kind of human beings) if either (1) this line of research will produce valuable therapeutic results much faster than any of the different non-destructive lines of research, or (2) destructive research will be the only way to produce cures or treatments for certain diseases. . . . [W]e have no strong reasons to believe that any of these two scenarios are likely to be the case and the [utilitarian] 33 R. Moufang, ‘‘Patenting of human genes, cells and parts of the body - the ethical dimensions of patent law’’ (1994) 25 I.I.C. 487, 514. 34 Summons to Oral Proceedings dated March 20, 2008 by the European Patent Office in case G-02/06, s.10, available at http://www.epoline.org/portal/public/registerplus/ [Accessed August 18, 2008] by entering the publication number as EP0770125. 35 Summons to Oral Proceedings dated March 20, 2008 by the European Patent Office in case G-02/06, s.12, available at http://www.epoline.org/portal/public/registerplus/ [Accessed August 18, 2008] by entering the publication number as EP0770125. [2008] I.P.Q.: No. 4  2008 Thomson Reuters (Legal) Ltd. and Contributors Sigrid Sterckx 489 argument therefore at present supports a restriction of stem cell research to non-destructive research.’’36 Moreover, a utilitarian analysis also needs to take into account the balance of benefits over disadvantages in the longer term. What would be the longer term consequences of a situation in which embryos would be treated as objects or as things which are commercialised? In a utilitarian analysis, the disadvantages of instrumentalisation and commercialisation of embryos must be included in the moral assessment—although, in this context, not as actions which may violate moral principles such as human dignity, but as potentially undesirable outcomes which should not be ignored in the balancing act required by utilitarianism and which need to be outweighed by demonstrable benefits in order for the practices in question to be morally permissible. The arguments for taking dignity into account and a dignity-based analysis Since the EPO Technical Board of Appeal decision in case T-356/93,37 the only such decision which has provided a definition of morality, stated that morality refers to conventionally-accepted standards of conduct pertaining to European culture, the Enlarged Board in the WARF case has to consider what are the ‘‘European norms’’ that pertain to research on and use of human embryos. Although, as rightly stated in the ‘‘morality clause’’ of the EPC, legality and morality are not necessarily congruous, since the EU Directive38 on the legal protection of biotechnological inventions and the Charter of Fundamental Rights of the European Union39 are the products of prolonged debate by the representatives of the bulk of the citizens of the EPC states, they must be seen as providing powerful guidance. What does this imply for the argument made by both the Technical Board of Appeal and the Enlarged Board that human dignity is the main issue that needs to be addressed? As to the EU Directive, recital 16 provides that ‘‘patent law must be applied so as to respect the fundamental principles safeguarding the dignity and integrity of the person’’. The European Parliament, in October 2005, adopted a text40 which: ‘‘[I]nsists that the creation of human embryonic stem cells implies the destruction of human embryos and that therefore the patenting of procedures involving human embryonic stem cells or cells that are grown from human embryonic stem cells is a violation,’’ of the EU Directive. 36 S. Holm, ‘‘The ethical case against stem cell research’’ (2003) 12 Cambridge Quarterly of Health Care Ethics 372, 374–375 (emphasis added). 37 Decision T-356/93 of the European Patent Office Technical Board of Appeal, Official Journal of the European Patent Office (1995), p.545, s.6. 38 Directive 98/44 on the legal protection of biotechnological inventions [1998] O.J. L213/13. 39 Charter of Fundamental Rights of the European Union [2000] O.J. C364/9. 40 European Parliament resolution on patents for biotechnological inventions P6 TA(2005)0407 European Parliament, Strasbourg, France, October 26, 2005, para.14. Available at http://www.europarl.europa.eu/sides/getDoc.do?objRefId=102714&language=MT [Accessed August 18, 2008]. [2008] I.P.Q.: No. 4  2008 Thomson Reuters (Legal) Ltd. and Contributors 490 Human Embryonic Cells—the WARF Case The Charter of Fundamental Rights of the European Union, as noted earlier, provides that, ‘‘[h]uman dignity is inviolable. It must be respected and protected’’.41 Accordingly, if the commercial exploitation of Thomson’s invention violates human dignity, then this cannot be ‘‘neutralized’’ by any real or potential benefits it may have. In order to assess whether dignity would indeed be violated in this case, one must take a closer look at the concept of dignity. ‘‘Human dignity’’ is frequently defined as the intrinsic value of human beings which is considered to entitle them to respect. Although this concept is well established in law in several countries, it does not easily lend itself to a practical definition. Nonetheless, this is no reason to brush it aside as vague or unimportant—think of how central the concept of ‘‘invention’’ is to the European Patent Convention, and yet a definition of this concept is not provided in the convention. The idea of human dignity has diverse origins, ranging from classical antiquity to religious teachings to Kant’s moral theory,42 and to more recent national and international declarations such as the Universal Declaration of Human Rights,43 the constitutions of several states, and various declarations on bioethics (e.g. the Council of Europe’s 1997 Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human rights and Biomedicine).44 Hence the concept has several dimensions and can be translated into various moral principles. Thus one dimension—human dignity as represented in some religious views—implies the moral principle of the sanctity of human life at all stages. However, the concept of human dignity has other dimensions which are completely independent of religion. One of these non-religious dimensions implies the principle of noninstrumentalisation/non-commodification of human beings, which was clearly referred to by the Technical Board of Appeal in the WARF case,45 prohibiting uses of human beings as means/objects. Another, equally important, non-religious translation of the concept of human dignity is the principle of the non-commercialisation of the human body and its parts, which forms the basis inter alia of the legal prohibition of organ sales and organ trafficking in the laws of several countries, as well as the basis of Art.21 of the Council of Europe’s Convention on Human Rights and Biomedicine. In its submissions to the Enlarged Board, WARF refers to the principle of non-commercialisation of the human body. WARF reduces this principle to a prohibition of ‘‘sales’’ of human bodies and parts of human bodies: Charter of Fundamental Rights of the European Union [2000] O.J. C364/9. Immanuel Kant’s extremely influential moral theory attempts to ground human dignity on a non-religious foundation. See I. Kant, Foundations of the Metaphysics of Morals (1785), translated from German by Lewis White Beck (Indianapolis: Bobbs-Merrill, 1969), e.g. p.53. 43 Universal declaration of human rights (Geneva: United Nations, 1948), available at http://www.un.org/Overview/rights.html [Accessed August 18, 2008]. 44 Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine: convention on human rights and biomedicine (Oviedo: Council of Europe, 1997), available at http://conventions.coe.int/treaty/en/treaties/html/164.htm [Accessed August 18, 2008]. 45 Interlocutory decision T-1374/04 of the European Patent Office Technical Board of Appeal, (Munich: European Patent Office, 2006), s.55, available at http://legal.european-patent-office.org/dg3/pdf/ t041374ex1.pdf [Accessed August 18, 2008]. 42 41 [2008] I.P.Q.: No. 4  2008 Thomson Reuters (Legal) Ltd. and Contributors Sigrid Sterckx 491 ‘‘The selling of the bodies of people, the selling of organs and tissues, even blood, for financial gain is contrary to the principle of human dignity and is not permissible. The sale of embryos or parts of embryos would likewise be contrary to such principles. This assists in understanding why the sale or industrialisation of embryos is not patentable.’’46 However, such a reduction is incorrect. As Art.3 of the Charter of Fundamental Rights of the European Union—an article to which WARF itself refers in its most recent submissions, in the paragraph preceding the quote above—states: the prohibition does not only concern selling the human body and its parts, but also making them ‘‘a source of financial gain’’. Clearly, something can be made a source of financial gain even if it is not itself being sold. Equally clearly, if WARF’s patent application would be granted, the embryos which are destroyed in the process of obtaining WARF’s claimed cell cultures would be made a source of financial gain. Another non-religious dimension of the concept of ‘‘human dignity’’ is the ‘‘rights’’ dimension. Human dignity is seen by many as the foundation for human rights (in the moral sense of the term ‘‘rights’’, i.e. regardless of whether those rights are legally codified). In this perspective, an action is contrary to human dignity if it violates a person’s basic human rights. This dimension of human dignity is important. Obviously, violations of basic human rights, such as the right to autonomy, may be violations of human dignity. However, reducing the concept of human dignity to the human rights dimension alone is too narrow and too short-sighted. Moral principles can give rise to both rights and obligations. Sometimes the obligations are simply the mirror images of the rights; however there are obligations which exist without a mirror image right, e.g. the obligation to be charitable. The present case lies in that area, since the object of the obligation, the embryo, is not clearly a being possessing rights. A more readily conceptualisable parallel is the human corpse—clearly not the possessor of rights, but also clearly an entity demanding respect and one which should not be instrumentalised or treated as a commercial commodity. Thus, applied to the question of the patentability of hES cells, the absence of human rights of embryos is not a sufficient argument to conclude that concerns or objections based on human dignity do not apply. The possession of moral status, or ‘‘protection-worthiness’’, does not depend on the possession of human rights. Exploitation of an invention concerning a use of human embryos for commercial purposes would thus clearly seem to be a violation of human dignity, since it implies a violation of the principle of non-instrumentalisation of human beings and, more importantly in this context, the principle of the non-commercialisation of the human body and its parts. As the Charter of Fundamental Rights of the European Union suggests, any violation of human dignity would seem, according to European norms, to meet the strict requirement of being contrary to morality which is expressed in Art.53(a) EPC. 46 Letter of May 22, 2008 from J A Kemp & Co, the European Patent Attorneys for WARF submitted to the European Patent Office in connection with case G-02/06, s.37, available at http://www.epoline.org/ portal/public/registerplus/ [Accessed August 18, 2008] by entering the publication number as EP0770125. [2008] I.P.Q.: No. 4  2008 Thomson Reuters (Legal) Ltd. and Contributors 492 Human Embryonic Cells—the WARF Case Why the way the cells are derived matters for the assessment of patentability Unsurprisingly, WARF’s submissions to the EPO showed that they tried to brush aside all the issues discussed in the previous section, by suggesting that the EPO should only look at the claims of the patent application—claims which, as noted earlier, do not recite any uses of embryos, e.g. their destruction, but define the invention as ‘‘a cell culture’’ rather than for example as ‘‘a cell culture made by using embryos’’. However, in order to assess the acceptability of this patent application under the ‘‘morality clause’’, the Enlarged Board should not merely consider what the subject-matter of the application concerns as of this point in the development pipeline of the invention. In WARF’s strategy, it is vital to ‘‘cut off’’ the pipeline/description of the invention at a point later than the stage at which human embryos are destroyed in order to derive hES cells. Using this strategy, WARF seemed to wish to distract the Enlarged Board members’ attention from the core moral issue at stake in this case. However, the fact that the claimed hES cells themselves indeed have no potential to develop into embryos does not imply that there are no moral hurdles. What matters is that the production of the claimed cell cultures requires destruction of embryos which do carry potential and that the grant of a patent would allow WARF to collect royalties on commercial use of these cell cultures. The way in which the claimed cells are made or used must be taken into consideration when determining whether the ‘‘morality clause’’ of the EPC applies. As Rainer Moufang argues: ‘‘[T]he exclusion clause [53(a)] may also apply with respect to inventions, the development of which was decisively characterized by an ethically dubious procedure. . . . [T]he invention should be examined as regards its possibly unethical content according to its dynamics, i.e. in its different stages. Despite the far-reaching consequences of such an argumentation, there are indeed good reasons to take into account the development of an invention.’’47 To conclude our discussion of what is at stake in the assessment of WARF’s application under the ‘‘morality clause’’, a crucial point that needs to be emphasised is that whether the application is excluded by Art.53(a) EPC need not even depend on the question whether human embryos have moral status (and if so, ‘‘how much’’) or on the question whether the destruction of their potential to develop into mature human beings can be ‘‘neutralized’’ or ‘‘outweighed’’ by the benefits of hES cell research. Even if conclusive arguments could be provided as to why hES cell research is morally justified, WARF’s application would still need to be refused under Art.53(a) EPC. Let us, once again, quote EPO Board of Appeal member Rainer Moufang: ‘‘[T]he term ‘exploitation’ employed by the legislature is sufficiently broad so as to exclude from patentability also such inventions, the use of which does not of its own accord generate a conflict with the ordre public. . . . [I]t is conceivable that the elementary conflict with the legal system derives from the intention of commercialization that is necessarily linked to a patent application. In 47 R. Moufang, ‘‘Patenting of human genes, cells and parts of the body—the ethical dimensions of patent law’’ (1994) 25 I.I.C. 487, 504 (footnote omitted). [2008] I.P.Q.: No. 4  2008 Thomson Reuters (Legal) Ltd. and Contributors Sigrid Sterckx 493 such a case the legal system would disapprove not of the innovation itself or of its working in practice, but specifically of the economic exclusionary position afforded by the patent with regard to the particular innovation at issue.48 Patent applications directed to human embryos, to the artificial production or use thereof for research purposes, will necessarily fail in the face of Art. 53(a) EPC. It is true that there are differences between the individual European legal systems with respect to the constitutional guarantees that are accorded to human life before birth. . . . In view of the degradation of human embryos to technical objects, patent applications in this field would nonetheless transcend the boundaries of what can be considered tolerable within the overall European ordre public. Reference to the fact that research on embryos is allowed subject to strict conditions in certain Member States of the EPC does not provide a sufficient counter-argument. The mere intention of commercialization, constituting the background of the patent application, is a violation of morality. As already explained, a broad interpretation of the term ‘exploitation’ in Art.53(a) EPC must be applied: Even if the concrete use of the invention may possibly be justified from an ethical point of view, the sole circumstance that an exclusive right will be granted for it for the purpose of commercialization may violate fundamental ethical principles.’’49 Thus, we must conclude that the answer to question 3 should be ‘‘yes’’ and that the WARF application should be rejected. WARF is also asking the Enlarged Board that the issue as to whether the application falls foul of the ‘‘morality clause’’ be referred to the European Court of Justice (ECJ) despite the fact that the EPC is not an EU law and applies to non-EU countries. Until now, the EPO has not accepted that its cases can be referred to outside courts and it is difficult to see that it would welcome setting such a precedent. In our view, the Enlarged Board of Appeal must find that WARF’s request for a referral to the ECJ must be rejected since the Member States of the EPC are not all EU states—think of the response from the US were the WTO to refer a question relating to TRIPS to the ECJ for final arbitration. The presence of Art.53(a) within the EPC requires the Enlarged Board to be its ultimate interpreter for the EPO. Question 4: Would matters change with scientific developments? The fourth and last question that has been referred to the Enlarged Board is whether it is relevant that after the filing date of WARF’s application hES cells could be obtained without having to recur to a method which necessarily involves the destruction of human embryos. The Enlarged Board, in the summons, not surprisingly indicates that morality is likely to be assessed as of the filing date of the WARF application: Moufang, ‘‘Patenting of human genes, cells and parts of the body’’ (1994) 25 I.I.C. 487, 504. Moufang, ‘‘Patenting of human genes, cells and parts of the body’’ (1994) 25 I.I.C. 487, 507 (footnotes omitted, emphasis added). 49 48 [2008] I.P.Q.: No. 4  2008 Thomson Reuters (Legal) Ltd. and Contributors 494 Human Embryonic Cells—the WARF Case ‘‘On ordinary principles of patent law a claim is assessed by reference to the position at its priority date and the contents of the application as filed.’’50 In our opinion, such an answer is desirable as patent applications in ethically queasy areas will otherwise be prosecuted slowly in order to benefit from any scientific developments that might take place. Patents, as trade-restricting monopolies, should be examined and granted or refused as quickly as possible so as to avoid uncertainty for commercial competitors. ORAL PROCEEDINGS BEFORE THE ENLARGED BOARD OF APPEAL Oral Proceedings before the Enlarged Board of Appeal took place on June 24, 2008 and arguments were put forward by WARF and the President of the EPO. Both conceded that the answers to questions 1 and 4 should be ‘‘yes’’ and ‘‘no’’ respectively and that questions 2 and 3 were closely interlinked. WARF argued that a (utilitarian) balancing act, while not allowed under the Rule in view of its absolute nature was the correct approach to the Article given the lack of a right to life of the embryo,51 and the benefits to humanity of therapeutic stem cell research. The President of the EPO, pointing to the abovementioned Art.1 of the Charter of Fundamental Rights of the European Union and the decision of the European Court of Human Rights in Vo v France,52 suggested that, since human embryos enjoy human dignity and dignity cannot be outweighed in a balancing act, the balancing act could not be applied under the Article where embryos were concerned. The President further argued that the ratio legis of the rule is the principle of non-commercialisation of the human embryo, a principle which, contrary to WARF’s submission, cannot be reduced to a prohibition of sales of embryos or parts of embryos. One member of the Enlarged Board of Appeal pointed out to WARF that its case seemed to be caught by the word ‘‘industrial’’ in Art.57 EPC, under which an invention must be susceptible of industrial application to be patentable. How did this tie in with the exclusion of uses of embryos for industrial and commercial purposes of the rule? WARF indicated that the meaning need not be the same in the two instances, arguing that the ‘‘uses for industrial or commercial purposes’’ of the rule should mean ‘‘as opposed to uses for research and medical purposes’’. Since WARF later argued that the referral to the European Court of Justice that it requested was to ascertain the meaning of an EU instrument by an EU institution rather than to determine the meaning of the EPC, it appears that WARF believed that compatibility with both the rule and Art.57 EPC could be achieved by isolating interpretation of the rule, or more precisely its precursor in Directive 98/44, from interpretation of Art.57 EPC. Summons to Oral Proceedings dated March 20, 2008 by the European Patent Office in case G-02/06, s.13, available at http://www.epoline.org/portal/public/registerplus/ [Accessed August 18, 2008] by entering the publication number as EP0770125. 51 In this context WARF referred to [46] of the decision in Evans v United Kingdom (2006) 43 E.H.R.R. 21. 52 Vo v France (2005) 40 E.H.R.R. 12, in particular at [84] of the decision. 50 [2008] I.P.Q.: No. 4  2008 Thomson Reuters (Legal) Ltd. and Contributors Sigrid Sterckx 495 On the question of a referral to the ECJ, which requires the referring court to be a court of an EU Member State, WARF had relied on an analogy to a reference by the Benelux Court of Justice. In response it was pointed out that all the Benelux states are EU Member States, whereas the EPC is an international treaty for which not all member states are also EU Member States. The Enlarged Board questioned where, in the law it must operate under (the EPC), could it find the authority to refer a question to the ECJ—answer came there none. We must conclude therefore that the rule must be construed in the light, inter alia, of Art.57 EPC to the end that uses for research and therapy, if they have an industrial or commercial aspect, must be excluded by the Rule, and that since the context is that of a patent application they must necessarily have that aspect. Thus, although WARF’s closing request was for questions 2 and 3 to be answered in the negative, we believe that the Board should share our analysis that the answers to these questions must be ‘‘yes’’. The Enlarged Board’s written decision, expected in the coming months, is awaited with great interest. [2008] I.P.Q.: No. 4  2008 Thomson Reuters (Legal) Ltd. and Contributors