Title: Morality, Ordre Public, and European Patents Word Count: 4190 Submitted: 16 May 2017

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1 Title: Morality, Ordre Public, and European Patents Word Count: 4190 Submitted: 16 May 2017 Critically analyse the debate on " ordre public " and morality as grounds for exclusion from patentability using relevant literature and judicial developments in Europe.

2 Table of Contents 1. Introduction 2 2. Jurisdiction and Institutional Influence 3 3. The Subjectivity of Ordre public and morality Morality and Ordre Public under the EPC and Biotech Directive Morality and Ordre Public under Rule 28 and Art.6(2) Conclusion Bibliography 13 Primary 13 Secondary 14 1

3 1. Introduction The infinite points of intersection between morality, public policy, and patents are fraught with debate. Unfortunately, current European law regarding these points of intersection are unclear and allow courts nearly absolute interpretational power. However, when the law defines morality more specifically and provides more guidance to the judiciary, it is apparent that it becomes more effective. The main source of law (and the problem) stems from when the European Patent Organisation ( EPOrg ) introduced Art.53(a) of the EPC disallowing European patents from being granted for inventions that run counter to the ordre 1 public (public policy) or morality when being commercially exploited. R.28 of the Implementing Regulations supplements Art.53(a) EPC (while echoing Art.6 of the Biotech Directive) by specifying certain biotechnological inventions that cannot be granted a European patent due to immorality or public policy grounds. 2 It is in these supplementary provisions where the law provides the courts additional guidance and illustrates an amount of effectiveness. However, this is not the case with the general terms morality and ordre public as they are not defined and are inherently subjective. In addition to these issues, the subjectivity of the law is encouraged by several levels of jurisdictional interpretive possibility. To illustrate the uncertainty in the current law, we must first analyse the varying approaches different jurisdictions have taken when interpreting it. Secondly, we will discuss the reasons why uncertainty is inherent to these morality/public policy provisions. Thirdly, we will demonstrate the benefit of additional guidance surrounding R.28 and other supplementary material. 1 Act Revising the Convention on the Grant of European Patents 2000 ( EPC ) Art.53(a) 2 Implementing Regulations to the European Patent Convention 2000 ( Implementing Regulations ), R.28; Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the Legal Protection of Biotechnological Inventions ( Biotech Directive ) [1998] OJ L 213, Art.6 2

4 2. Jurisdiction and Institutional Influence The EPOrg first introduced the terms ordre public and morality as grounds for 3 exclusion from patentability in Art.53(a) of the EPC1973. In addition, R.23d was introduced to supplement this provision by providing a list of specific types of biotechnological inventions deemed to be immoral or contrary to ordre public any inventions not caught by this list were 4 to be viewed in the light of Art.53(a). In 2000, Art.53 was amended and Rule 28 was provided 5 as a supplementary list for Art.53(a) in the same way as the old Rule 23d. These changes 6 brought the EPC in-line with the TRIPS Agreement (Art.27) and Biotech Directive (Art.6). While all EU Member States have implemented the Biotech Directive into their patent law systems, this does not mean we can disregard interpretations of the EPC by assuming that interpretations of the Directive are the same as of the EPC and thus representative for all of 7 Europe. There are 38 parties to the EPC (including all 28 EU Member States). As such, applicants outside the EU can also apply for a European patent which is potentially applicable in any 8 European state mentioned in their application. In addition, there are several countries within the continent of Europe that are not party to the EU or EPC, but are still members of the World Trade Organisation ( WTO ); thus they are signatories to the TRIPS Agreement and its definition 3 Convention on the Grant of European Patents ( EPC1973 ) Art.53(a) 4 Implementing Regulations to the Convention on the Grant of European Patents 1973, R.23d 5 EPC, Art.53; Implementing Regulations, R.28. The amendments to Art.53 are unlikely to affect the EPO s practice (EPO, OJ SE4/2007 (EPO, 2007) Available at: < May 2017), this history is included for clarity. 6 Annex 1C of the Marrakesh Agreement establishing the World Trade Organization (signed on 15 April 1994) 1869 UNTS 299 ( TRIPS Agreement ), Art.27; Biotech Directive, Art.6 7 Europa, State of Play of the Implementation of Directive 98/44/EC (Europa, 2007) Available at:< May EPO, Member States of the European Patent Organisation (EPO, 2017) Available at: < Accessed 7th April

5 9 of the grounds of morality and ordre public for patent exclusion. This brings us to our first issue it is easy to see that the number of supranational bodies wielding these two terms can confuse applicants and judiciaries. Which definition/interpretation do we follow? In addition to supranational definitions, at the national level, every individual nation can have their own separate interpretations of the grounds of ordre public and morality. 10 This issue of jurisdiction 11 was directly addressed in the case of Cefetra, where the patent in question was filed in the Netherlands. The Netherlands is a party of the WTO, the EPC, the EU, and has its own national patent laws yet the court concluded that EU law (the Biotech Directive) takes precedence over national law and the TRIPS Agreement. 12 With regards to the TRIPS Agreement, this position is not new. The court in Cefetra cited the cases of Dior and Merck Genéricos when explaining that provisions of the TRIPS Agreement cannot supply rights which can be relied upon by virtue of European law and, when there are EU laws present in the sphere in question (morality, public policy, and patents) they will be apply. 15 The court did mention that the relevant EU law will be interpreted in-line with the TRIPS Agreement so as far as possible, but that it has no direct effect on EU law. 16 These conclusions illustrate that when a European patent originates from an EU country which is a member of the WTO, the definitions of morality and ordre public stemming from European law will likely apply. A potential problem exists in that the EPC and Biotech Directive (separate pieces of European law in the same sphere) operate alongside each other, and technically speaking, neither the EPOrg (or European Patent Office) nor the EU are bound to follow the other s definitions. 17 McMahon explains that, on a balance of probabilities, the practical outcome of this potential conflict is that these 9 TRIPS Agreement, Arts.1(3) & 27; WTO, Members and Observers (WTO, 2017) Available at < Accessed April EPO, National law relating to the EPC (EPO, 2017) Available at: < l_law_relating_to_the_epc_17th_edition_en.pdf> pp.8-68, accessed: April C-428/08 Monsanto Technology LLC v Cefetra BV and Others ECLI:EU:C:2010:402, [2011] I ibid paras.63 & Joined Cases C-300/98 and C-392/98 Dior and Others [2000] ECR I-11307, para Case C-431/05 Merck Genéricos Produtos Farmacêuticos [2007] ECR I-7001, para See 13, paras.71 & See 13, para G 0002/06 Use of embryos/warf [2008] ECLI:EP:BA:2008:G , para 7 4

6 European organisations (the EPOrg and EU courts) will most likely adopt the same definitions for political reasons. 18 Therefore, we will work on the assumption that the definitions of both the EPOrg and EU courts are the same but we should keep in mind that the potential for conflict is still possible no matter how small. With regards to potential conflicts between the definitions of morality and ordre public from national and supranational definitions, we can refer to Netherlands v European Parliament. 19 In this case, the court concluded that national definitions of morality and ordre public are assumed to be shared in principle with those under European law because of the time honoured nature of these two terms being in European IP law. 20 Academic critique of this rationale is present and raises the point that regardless of the reasoning in the Netherlands case, the Biotech Directive (the relevant European law in this case) creates even more judicial interpretive uncertainty. 21 That being said, Art.53(a) states that regulations or laws from Contracting States which prohibit forms of commercial 22 exploitation do not reflect what is contrary to ordre public or morality at the European level. This implies that at the very least, the EPC was written with the intention to exclude the interpretations of individual Contracting States. In addition, the fact that the Biotech Directive is an EU Directive means that it is the intention of the EU to harmonize the rules regarding patent exclusion based on morality and ordre public. Considering the direct language from both the EPC and Biotech Directive illustrates that courts should not have an issue with dismissing national law, it is more probable than not that European courts will share interpretations of morality and ordre public exclusions. In conclusion, this issue of conflicting European jurisdictions seems highly complex, but we can make the working assumption that if a nation is a member of the EU or if it is party to 18 McMahon An institutional examination of the implications of the unitary patent package for the morality provisions: a fragmented future too far? (2017) 48(1) IIC 42, pp Case 377/98 Netherlands v European Parliament and Council [2001] ECR I ibid, para It is acknowledged that several academic have identified that regardless of the reasoning behind the verdict in the Netherlands case, the Directive may still create more uncertainty and controversy (See Ho, Splicing Morality and Patent Law: Issues Arising from Mixing Mice and Men (2000) 2 Wash. U. J.L. & POL'y 247, at pp. 252, 255, & 284) 22 EPC, Art.53(a) 5

7 the EPC, the definitions of morality and ordre public would most likely be shared. Though, we must always acknowledge the real potential for conflicting interpretations between national and supranational bodies. However, this conclusion may not last for the 25 European states participating in the EPO s Unitary Patent Package. 23 For these states, yet another supranational jurisdiction will apply to their patents under the EPC which means there is a growing and very real potential for divergent interpretations of morality and ordre public as grounds for exclusion of patentability. 24 As the Unitary Patent Package has not come into force yet, this mere speculation. But, a black swan event is always possible the likelihood of which is increased by 25 the lack of legislative clarity and the subjective nature of morality. 3. The Subjectivity of Ordre public and morality Over the years, European courts have differed drastically in their interpretations of the terms morality and ordre public. This is partially because there is no explicit statutory definition of either term in either the EPC, the Biotech Directive, or the TRIPS Agreement, leaving the terms open for interpretation by the judiciary and patent offices. The only interpretive guidance these two bodies have for these grounds are the EPO s Guidelines for Examination and the supplementary provisions of Rule 28 and Article 6(2). 26 When we analyse the law regarding general claims of morality and ordre public we see this lack of legislative clarity leaves judges in a position where they must fill the gaps in the law with their own moral principles. Secondly, when we analyse claims of morality/ ordre public through the specific biotechnological inventions listed in Rule 28 and Art.6(2), we see that this additional guidance greatly helps the law but issues of clarity remain. 23 Regulation No 1257/2012 of the European Parliament and of the Council of 17 December 2012 Implementing Enhanced Cooperation in the Area of the Creation of Unitary Patent Protection [2012] OJ L361; Council Regulation No 1260/2012 of 17 December 2012 Implementing Enhanced Cooperation in the Area of the Creation of Unitary Patent Protection with Regard to the Applicable Translation Arrangements [2012] OJ L361; Agreement on a Unified Patent Court [2012] OJ C See 18, p See 18, p EPO Guidelines for Examination, (EPO, 2013) Available at: < Accessed May

8 3.1 Morality and Ordre Public under the EPC and Biotech Directive Utilizing Paragraph 4.1 of the Guidelines, courts have adopted an approach to these terms that can only be described as discretionary. 27 The first occasion where Art.53(a) (and the 28 meaning of morality) was discussed was in Onco-mouse. Here, the court concluded that this ground of exclusion would only be used when, after balancing the potential benefits from the invention to mankind versus its potential for animal suffering, human interests are outweighed. 29 We should note that at no point in Onco-mouse does any individual of the Appeals Board explain if these two elements were the limits of morality in the eyes of the court. Later, in the case of Greenpeace 30 the court ruled that the cost/benefit balancing test (from Onco-mouse ) should only be used when an invention would be universally outrageous or public consensus would be overwhelmingly against it. 31 Greenpeace defined morality as a concept which is rooted in the culture inherent in European society and which is related to the belief that some behavior is right and other behavior is wrong. 32 In addition, it defined ordre public as a concept that covers the protection of public security, the physical integrity of persons of society [and] the protection of the environment. 33 Practically speaking, this means that courts will only use this ground if the commercial exploitation of an invention endangers others, the environment, or is wrong to European society. While some might see this development as a narrowing of the law, it is a narrowing of the law in the wrong direction. The court attempts to define morality at a societal level (European society) when realistically, morals range from group to group (and even from person to person) this issue is even more prevalent in societies characterized by social pluralism (like the continent of Europe). 34 To say the entire 27 ibid, Part G, para T-0019/90 Onco-Mouse [1990] ECLI:EP:BA:1990:T ibid, pp T-356/93 Greenpeace Ltd v Plant Genetic Systems/Glutamine Synthetase inhibitors [1995] ECLI:EP:BA:1995:T ibid, pp ibid, p.16, para. 6. The court gives the example of inventions that incite breaches of peace or social order (like terrorism). 33 ibid, pp See generally Bahmueller, Salem Press Encyclopedia (Research Starters, 2017) EBSCOhost Available at: < 7

9 continent of Europe shares one standard of morality is to say the laws from all European countries are shared. This may sound outlandish, but even the extreme opposite opinions from positivist and natural law academics display that law ought to enforce the morals of any given 35 culture. Therefore, it stands to reason that if the court s statement in Greenpeace is true that the concept and understanding of morality is shared in European society then all laws from every European country would share the same moral sentiments and so ought to be the same. This conclusion is absurd, and in Harvard/Transgenic Animals logical approach by concluding that there is no single definition of morality. current law stands per the EPO the court took the same 37 This is where the Compare this to the conclusion of Netherlands v European 39 Parliament : that because ordre public and morality have a long and distinguished history [in] intellectual property rights there is a shared understanding of European morals and ordre public. 40 How can there possibly be a shared understanding of morals across Europe? We live in a society defined by social pluralism; culture varies in every nation within the continent of Europe. 41 The subjective nature of morality defeats the purpose of morality provisions (like this one) which attempt to create a single moral standard for Europe. In the alternative, if the law is not attempting to define a single moral standard (which is true per the court in Harvard/Transgenic Animals ) then it leaves the concept of morality up to judicial interpretation it is an open-textured provision at best. 7a12fa%40sessionmgr4010&hid=4105&bdata=JnNpdGU9ZWRzLWxpdmUmc2NvcGU9c2l0ZQ%3d%3d#AN= &db=ers>Accessed April 23, Raz, The Authority of Law (Oxford University Press, 1979) ch.2; Hobbes, Leviathan (first published 1651, Penguin 1985) T-0315/03 Transgenic animals/harvard [2004] ECLI:EP:BA:2004:T ibid, p.3 38 EPO (2016) Case Law of the Boards of Appeal, I., B. Exceptions to patentability, para (b) Available at: < accessed May See ibid, para See generally: Thornhill, Legal Pluralism: The Many Books on Europe s Many Constitutions (2012) 21(3) Social & Legal Studies pp ; McMillan, Diversity, Standardization and Social Transformation (Routledge, 2011) Part III: Retrieved from: 8

10 In Hart s words, open-textured provisions are a mere legal shell and demand by their express terms to be filled out with the aid of moral principles. 42 Here, the express terms are: inventions deemed to be immoral or contrary to public policy when being commercially exploited will be excluded from patentability. 43 As we have just seen, the law offers zero explanation of morality and courts have been left to conclude that there is no single definition of it in Europe therefore the morality element of these provisions is a mere shell. This lack of clarity also applies to the concept of order public. What constitutes public policy concerns? Is it restricted to the three elements listed in Greenpeace (public security, physical integrity of persons of society, and the protection of the environment)? 44 The truth is that there is no answer to these questions. In Greenpeace, the court ruled out opinion poll evidence (for a representation of public opinion) on the basis that such surveys do not necessarily reflect ordre public or moral norms because survey results can fluctuate within short time periods and that bias is nearly impossible to remove. 45 We must ask ourselves, what constitutes public opinion if not public opinion itself? If we refer to Hart s definition of open-textured provisions, this question forces judges to fill this gap independently these morality/public policy provisions demand judges to supplement the law with their own moral principles or not use this ground of exclusion at all. The Court in Leland Standford 46 seemed to face this exact problem. Here, in response to a patent regarding animal-human chimera, the court admitted that at first glance the invention in question instinctively appears distasteful, if not immoral. 47 Yet the court concluded, as long as a claimed invention has a legitimate use, it cannot be the role of the EPO to act as a moral censor and invoke the provision of Article 53(a) EPC. 48 It continued by stating that in order to refuse a patent on ethical grounds when it is indisputable that the invention has medical benefits it would be presumptuous to interfere in [the] public debate. This position is not new, Relaxin came to the exact same conclusion, 42 Hart, The concept of law (Oxford University Press, 1961) pp Biotech Directive, Art.6; EPC, Art.53; TRIPS Agreement, Art See ibid, pp T-1262/04 Non-invasive Localization/LELAND STANFORD [2012] ECLI:EP:BA:2012:T ibid, p ibid, p ibid 9

11 the court stated, [T]he EPO is not the right institution to decide on fundamental ethical questions. 51 If we set aside the apparent confusion between ethics and morality, we must ask ourselves why the law allows for the exclusion of patentability on the grounds of morality/ ordre public when the EPO admits it cannot utilize it. If the body that grants patents cannot use the patent law, then issues of morality/ ordre public rest on the judiciary to determine what is and is not patentable. As we have just seen, the judiciary has little interpretive guidance when it comes to morality and ordre public yet practically speaking, they are the body determining what patents are excluded under these provisions. As McMahon aptly puts it, under both the EPC and Biotech Directive the adjudicative body called upon to interpret these provisions is forced to act as legislator. 52 Hypothetically speaking, if all humans in Europe were to have the same standard of morality or public policy, then the courts would not have an issue with filling the gaps in the legislation but we previously concluded that a single standard does not exist. As MacCormick illustrates, Autonomy in moral judgment means that each person is responsible for her/his view of what is good and bad, right and wrong and can never be overruled on that issue. This is distinct from the issue of what a public agency or authority may be required by law to do in a given dilemma. 53 To expand, MacCormick is of the opinion that morality is a concept which is inherently subjective and places each individual in their own personal judiciary where they alone determine what is right and what is wrong. This concept is in direct conflict with a law (like the EPC, Biotech Directive, or TRIPS Agreement) which places public agencies or authorities (like the EPO and courts) in a position which they can determine what is right or wrong in lieu of our personal definitions. The result of this conflict can be seen in the hands-off approach courts have taken when addressing claims under these morality provisions. The 50 T-0272/95 Relaxin/HOWARD FLOREY INSTITUTE [1995] ECLI:EP:BA:2002:T ibid, pp See 18 at p MacCormick, Practical reason in law and morality (Oxford University Press, 2009) p

12 practical outcome of this being that claims of general breaches of Article 53(a) and other morality/ ordre public provisions will probably fail as courts do not want to involve themselves. In Bently and Sherman s words, these morality provisions are simply providing lip-service to those who question whether patent law is upholding morality and public policy. 54 However, when we look at recent claims of more specific breaches to the list inventions under Article 6 of the Biotech Directive and the supplementary provision of Rule 28, this is not the case. When provided with more legislative guidance, the judiciary tackles questions regarding these morality provisions head-on. 3.2 Morality and Ordre Public under Rule 28 and Art.6(2) Article 6(2) of the Biotech Directive and R.28 of the EPC 2000, patents cannot be granted for: uses of human embryos for industrial or commercial purposes, processes for cloning human beings, modifying the genetic identity of human beings, or modifying the genetic identity of animals which would likely cause them suffering without a substantial medical benefit to man or animal. 55 The purpose of these provisions was to create a compromise on moral, ethical, environmental, and economic grounds between those who oppose biotech and those who support biotech. 56 There is a substantial amount of judicial and academic debate surrounding the possible interpretations of all of the four types of biotech inventions listed. To illustrate the willingness of courts to engage with the law, one of the most controversial types of inventions will be discussed: the industrial/commercial use of human 57 embryos (Art.6(2)(c)/R.28(c)). 54 Bently & Sherman The Ethics of Patenting: Towards a Transgenic Patent System (1995) 3 Med L Rev 275, p Biotech Directive, Art.6; EPC, R Gitter, Led Astray by the Moral Compass: Incorporating Morality into European Union Biotechnology Patent Law (2001)19 Berkley J International L. 1, p Biotech Directive, Art.6(2)(c); EPC, R.28(c) 11

13 Based on the case law, it appears that any process or invention which (based on the present scientific requirements) requires the destruction of human embryos in any form (indirectly or directly) cannot be patented. 58 The main issue here regards the definition of 59 human embryo specifically that there is no legislative definition. In Brüstle, the court defined a human embryo as any human ovum which is fertilized or is being stimulated by parthenogenesis. 60 At paragraph 34, the court reasons that this definition is adequate because the Biotech Directive illustrates that the EU legislature intends to exclude all patents where human dignity could be effected and so Art.6(2) should be interpreted in a wide sense. biggest issue with this rationale is that the term human dignity is extremely subjective. Once again, the court is attempting to create a standard for a socially plural group of people in this case, all of humankind. In the court s defense, the Biotech Directive explicitly states protecting human dignity as one of its aims. Later, in International Stem Cell Corporation the court did however challenge the broad definition of human embryo provided by Brüstle. In this case, the court ruled that unfertilized ova which in the light of current scientific information cannot develop into a human being The This small example of the development of this exclusion from patentability illustrates the level of engagement and specificity the courts are willing to engage in. Compare this to the courts complete unwillingness to engage in any debate regarding ethics of Relaxin. 65 Some academics believe the provisions under Article 6 will be subject to variation amongst Member States, but the point still stands that at least courts are more open to these specific exceptions. 66 The list of inventions under Art.6 and R.28 are based on the EU and EPO concluding that certain forms of biotechnology are considered immoral in Europe. Whether society believes these inventions are immoral or not is a problem between society and the bodies that govern them. This would be an issue with democracy and is outside 58 See C-34/10 Oliver Brüstle v Greenpeace [2011] ECR I ibid, p ibid, p Biotech Directive, Recital C-364/13 International Stem Cell Corporation v Comp-General of Patents [2014] ECLI:EU:C:2014: ibid, para See See 56, p.18 12

14 of the scope of our discussion. Regardless, Article 6 and Rule 28 illustrate that the inclusion of morality in law is not an issue if the law is specific enough to provide guidance on the topic. 4. Conclusion When we include sweeping and undefined provisions like the exclusion of patentability on the grounds of morality or order public we allow the judiciary carte blanche interpretational power over what society deems appropriate. This issue is exacerbated when we add the factor of several different levels of judicial interpretation into the law. Morality and the law are essentially cousins borne of the same intention to determine what is right and what is wrong in society. Unfortunately, morality is completely subjective. If, as a society, we deem a specific topic to be immoral, then we should include this in the law. However, we cannot allow the courts to dictate what should and should not be patentable based on their personal views of morality just because it might be simpler to draft legislation this way. We do not elect the courts to represent our values, we elect our governments to represent our values. 5. Bibliography Primary Table of Cases: - C-364/13 International Stem Cell Corporation v Comp-General of Patents [2014] ECLI:EU:C:2014: C-34/10 Oliver Brüstle v Greenpeace [2011] ECR I T-1262/04 Non-invasive Localization/LELAND STANFORD [2012] ECLI:EP:BA:2012:T T-0272/95 Relaxin/HOWARD FLOREY INSTITUTE [1995] ECLI:EP:BA:2002:T T-0315/03 Transgenic animals/harvard [2004] ECLI:EP:BA:2004:T T-0019/90 Onco-Mouse [1990] ECLI:EP:BA:1990:T T-356/93 Greenpeace Ltd v Plant Genetic Systems/Glutamine Synthetase inhibitors [1995] ECLI:EP:BA:1995:T Case 377/98 Netherlands v European Parliament and Council [2001] ECR I C-428/08 Monsanto Technology LLC v Cefetra BV and Others ECLI:EU:C:2010:402, [2011] I Joined Cases C-300/98 and C-392/98 Dior and Others [2000] ECR I C-431/05 Merck Genéricos Produtos Farmacêuticos [2007] ECR I G-0002/06 Use of embryos/warf [2008] ECLI:EP:BA:2008:G Table of Legislation, EU Directives/Regulations, Treaties, Coventions - Regulation No 1257/2012 of the European Parliament and of the Council of 17 December 2012 Implementing Enhanced Cooperation in the Area of the Creation of Unitary Patent Protection [2012] OJ L361 - Council Regulation No 1260/2012 of 17 December 2012 Implementing Enhanced Cooperation in the Area of the Creation of Unitary Patent Protection with Regard to the Applicable Translation Arrangements [2012] OJ L361 13

15 - Agreement on a Unified Patent Court [2012] OJ C175 - Act Revising the Convention on the Grant of European Patents Implementing Regulations to the European Patent Convention Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the Legal Protection of Biotechnological Inventions [1998] OJ L Convention on the Grant of European Patents - Implementing Regulations to the Convention on the Grant of European Patents Marrakesh Agreement establishing the World Trade Organization (signed on 15 April 1994) 1869 UNTS 299 Secondary Academic Articles: - Gitter, Led Astray by the Moral Compass: Incorporating Morality into European Union Biotechnology Patent Law (2001)19 Berkley J International L. 1, 13 - Ho, C., Splicing Morality and PatentLaw: Issues Arising from Mixing Mice and Men (2000) 2 Wash. U. J.L. & POL'y McMahon, A., An institutional examination of the implications of the unitary patent package for the morality provisions: a fragmented future too far? (2017) 48(1) IIC 42 - Thornhill, C., Legal Pluralism: The Many Books on Europe s Many Constitutions (2012) 21(3) Social & Legal Studies 413 Books - Raz, J., The Authority of Law (Oxford University Press, 1979) - Thomas, H., Leviathan (first published 1651, Penguin 1985) - McMillan, L., Diversity, Standardization and Social Transformation (Routledge, 2011) - Hart, The concept of law (Oxford University Press, 1961) - MacCormick N Practical reason in law and morality (Oxford University Press, 2009) Websites - Europa, State of Play of the Implementation of Directive 98/44/EC (Europa, 2007) Available at:< May EPO, Member States of the European Patent Organisation (EPO, 2017) Available at: < Accessed 7th April

16 - WTO, Members and Observers (WTO, 2017) Available at < Accessed April EPO, National law relating to the EPC (EPO, 2017) Available at: < /National_law_relating_to_the_EPC_17th_edition_en.pdf> pp.8-68, accessed: April EPO Guidelines for Examination, (EPO, 2013) Available at: < Accessed May Bahmueller, Salem Press Encyclopedia (Research Starters, 2017) EBSCOhost Available at: < e-20923a7a12fa%40sessionmgr4010&hid=4105&bdata=jnnpdgu9zwrzlwxpdmumc2nvcgu9c2l0zq%3 d%3d#an= &db=ers>accessed April 23, EPO (2016) Case Law of the Boards of Appeal, I., B. Exceptions to patentability, para (b) Available at: < accessed May EPO, OJ SE4/2007 (EPO, 2007) Available at: < May

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