歐盟專利法與道德研究

◎　張曦文

歐盟專利法與道德研究

◎張曦文

生物科技通常會受到社會各界的廣泛關注，因為在尖端領域經常會有能引發道德爭議的產品或技術。生物科技發明的特征通常由這項科技所包含的技術特征和該發明所在的社會背景共同塑造。公眾對這些創新通常是贊成的，但如果這些發明遠超人們所能接受的范疇，即使人們會受益匪淺，他們也很難被社會所接受。因此政府開始逐步對這些科技進行規制，以創造一個科學創新發展所必需的并同時能被人類道德觀念所能接受的環境。以往，知識產權的倫理問題多由一個國家對其境內進行規制，在歐盟此問題得以以一個全新的跨境高度進行監管。本文試圖去分析歐盟專利法與道德之間的關系，首先對目前歐盟專利法的道德考量現狀進行了分析，進而對道德考量加入歐盟專利法的利弊進行了衡量，最后引進了一個可能的補充或替代方案。

1.Introduction

Biotechnological science is a subject that always attracts much attention because many of its researches are highly related to moral issues and thus controversial. The features of inventions in biomedical science are shaped by both the underlying knowledge and the social content where such innovations take place.[Brian Salter, ‘Patents and Morality: Governing Human Embryonic Stem Cell Science in Europe’ (2009) KCL p2]The public would show sympathy to those inventions as many benefits are brought by them, while sometimes there would be a different attitude if researches are far beyond what the society could accept regarding the moral content. Therefore, governments started to create regulations in those areas to reconcile the conflicts between the development requirements of both society and science.[ Sheila Jasanoff,States of Knowledge: The Coproduction of Science and Social Order (1st edn, Routledge 2004) p65]

In the past, the way to deal with ethical issues of intellectual properties was mainly limited within the range of a single country by the so-called morality exclusion, and it was rare that those issues had been regulated over the scope of each state. However, now in Europe, Article 53(a) of the European Patent Convention (EPC) regulated that European patents shall not be granted if the commercial exploitation of them would be contrary to morality or ordre public, which would bound all the countries in Europe.[Asa Hellstadius, A Quest for Clarity: Reconstructing Standards for the Patent Law Morality Exclusion (1st edn, Stockholm University 2015) p25] This paper attempts to analyse the relationship between morality and patent law in the European territory. In order to find out whether morality should be embedded in patent law, it is important to have an integrated picture of the European patent law related to morality exclusion. Based on that, this paper makes its point on whether the morality exclusion is necessary. On top of that, this paper is trying to bring an alternative mechanism to deal with the moral matters.

2.What is the moral objection?

It was true that the Article 52(1) European Patent Convention 2000 (EPC) aimed to eliminate the discriminations on technologies in all fields. However, in correspondence European Patent Office (EPO) 2008, it stated that the 53(a) EPC should be considered as a higher legal norm than 52(1)[ Sigrid Sterckx and Julian Cockbain, Exclusions from Patentability: How Far Has the European Patent Office Eroded Bounderies (1st edn, CUP 2012) p319] and in fact, 52(1) was regulated like that. According to 52(1), a patent may be granted only if the invention is new, it involves an inventive step, it is capable of industrial application and it is not excluded by the subject matters in 52(2)(3) and exceptions to patentability in 53.[ European Patent Convention (EPC) [2000] Article 52]The regulation in 53 EPC was that European patents should not be granted if they are contrary to ordre public or morality with the commercial exploitation, surgery or diagnostic methods and varieties or essential biological processes.[ EPC [2000] Article 53]A parallel rule, EPC Rule 28, stipulated that uses of human embryos, processes for animal genetic identity modifications without substantial medical benefits, for human clone, and for human germ line genetic identity modifications should not be patented as well.[ EPC [2000] Rule 28]

Many cases related to morality exclusion in patent law added a lot of different interpretations in various aspects, resulting in complicated or even redundant legislations in this area.Rules, principles and cases concerning morality could generally be separated into animals, plants and human biological materials.

1)Animals

The T19-90 Onco-Mouse case (1990) formed the so-called Harvardmorality test for transgenic animals by weighing ‘the suffering of animals and possible risks to the environment’ against ‘the invention’s usefulness to mankind’. [ Harvard College v BizleyR. Edward [1990] T 0019/90]Then in theT 315/03 Harvard 2003 case, the Technical Board of Appeal (TBA) held that there was no single definition of ‘morality’ in a‘real’ Article 53 (a) EPC objection and the real Article 53 (a) objection should be evaluated at the date of filing or priority date while evidence after that date may also be considered if proved directly related.[Harvard College v British Union for the Abolition of Vivisection [2004] T 0315/03]Besides, Rule 28 (d) EPC should be applied to ensure that any patent should only be granted ifthe suffering of animals is balanced by a medical benefit[ibid]. This socalled ‘Rule’ test was derived from the Biotech Directive, which means Rule 28 (d) and Article 53 (a) should be concurrently applied to every patent.The objective of EPC is to establish a comprehensive patent protection between the contracting states[Proposal for a ‘Regulation of the European Parliament and of the Council’Implementing Enhanced Cooperation in the Area of the Creation of Unitary Patent Protection (2011) para 1.1 〈http:// eur-lex.europa.eu/legal-content/EN/ TXT/?uri=CELEX%3A52011PC0215〉accessed 16 July 2016], so in Michigan State University (2005) the TBA noted that Article 53 (a) should be construed narrowly. The TBA further interpreted the ordre publicas what was formed by the ethically based constitutional or other rules, usually backed up by penal reflecting the basic values prevailing in society and trade.[Hellstadius (n 3) p205] Protected values could include public safety, the integrity of the individual and nowadays certainly also the protection of environment. The TBA also held that there was no single definition of morality and morality should not be a criterion to be determined by the patent authorities. It mentioned that the exploitation of an invention only infringed morality if it was regarded as reprehensible by society in general or at least by the trade concerned.[Michigan State University v Knotgen Anita [2005] T 866/01]In the T 606/03 Artemis (2006) case, the TBA expanded the Harvard T19/90 test applicable to cases where the claimed transgenic animals are likely to suffer. [Astrid Burhoi,‘Moral Exclusions in European Biotechnology Patent Law’(2007) LU p42]In Leland Stanford (2012), it presented that Rule 28 (d) would not apply when there wasn’t genome modification and held that the T 19/90 balancing test and Rule 28 (d) when applied under Article 53 (a) were ‘not wholly identical’.[ Leland Stanford [2012] T 1262/04]

2)Plants

In the Plant Genetic Systems (PGS) (1995)case, the TBA said the T19/90 balancing test could only be conducted where evidence of both advantages and disadvantages existed.[Plant Genetic Systems (PGS)vGreenpeace Ltd [1995] T356/93]Further, the ‘Harvard’ test was only one possible way of assessing patentability under Art 53(a) EPC.It has been interpreted that the concept of ordre public covers protection of public security, physical integrity of individuals and protection of the environment.[Pedro Roffe,Resource Book on TRIPS and Development: An Authoritative and Practical Guide to the TRIPS Agreement(1st edn, CUP 2005) p379] Breach public peace or social order and prejudice to environmentshould be excluded from patentability as being contrary to "ordre public".[ Dan Leskien and Michael Flitner, ‘Intellectual Property Rights and Plant Genetic Resources: Options for a Sui Generis system’(1997) IPGRI p16] Besides, the concept of morality is related 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.[Case Law of the Boards of Appeal〈http://www. epo.org/law-practice/legal-texts/ html/caselaw/2013/e/clr_i_b_2_2_2_ b.htm〉 accessed 17 July 2016]In terms of the purposes of the EPC, the culture concerned should be the culture inherent in European society and civilization.

3)Human biological materials

In Relaxin (1995)[ Relaxin/ Howard Florey Institute [1995] T 272/95], the Opposition Division (OD) established thatan invention involving a human gene would not beuniversally regarded as outrageous.[Andrea Stazi, Biotechnological Inventions and Patentability of Life: The US and European Experience (1st edn, Edward Elgar 2015) p220]It did not add to patenting life because DNA as such was not life but one of the many chemical entities taking part in the biological process. If a woman wants to donate her tissue with consent, there will not be offence to human dignity, and this would not be affected by the exploitation of the claimed molecules. [ Geertrui Overwalle, ‘Policy Levers Tailoring Patent Law to Biotechnology: Comparing U.S. and European Approaches’ (2011) UCILR p450-451] Pending appeal, the Biotech Directive came into force.The TBA (2002) upheld the findings of the OD and the patent was maintained.Article 5(1) of the of Directive 98/44/EC ruled out patents over the human body at any stage of its formation[ Li Jiang, ‘Between Scylla and Charybdis: Patentability and Morality Related to Human Embryonic Stem Cells’ (2015) IPB p67], and Article 6 was the same as Rule 28 which was a sign of developing as to morality jurisprudence in respect to biotechnology.[ Richard Goldberg and Julian Lonbay, Pharmaceutical Medicine, Biotechnology and European Law (1st edn, CUP 2000) p181]Guidelines for Examination in the EPO2015presented that this list (Rule 28) is illustrative and non-exhaustive and is to be seen as giving concrete form to the concept of "ordre public" and "morality" in this technical field.[Guidelines for Examination (EPO, 2015) 〈http://www.epo.org/lawpractice/legal-texts/html/guidelines/ e/g_ii_5_3.htm〉 accessed 17 July 2016] Warren thought T19/90 and PGS are the broader “acceptability” tests whereas Relaxin is classified as an “abhorrence”standard.[Amanda Warren,‘A Mouse in Sheep's Clothing: The Challenge to the Patent Morality Criterion Posed by 'Dolly'’ (1998) EIPR p445]

In Wisconsin Alumni Research Foundation (WARF) (2008), it held that EPO departments have to be considered as judges within the legal order defined by the EPC, and be required to implement the blanket clauses by encapsulating standards of conduct.[Wisconsin Alumni Research Foundation (WARF) [2008] G 0002/06] The role of Enlarged Board of Appeal (EBA) is to assure the uniform application of the EPC. EPO and EBA cannot be considered as legislator. Therefore EBA should limit the scope of its decision. However in this case, EBA clarified that EPO departments must excise their judgement on the question of morality by incorporating higher-ranking norms into patent law.EBA held that the principle governing rule 28(c) as a higher-ranking norm is the principle of respect for human dignity, avoiding instrumentalisation human body[U.S.President's Council on Bioethics,Human Dignity and Bioethics (1st edn, USGPO 2008) p10] and the prohibition of the commercial exploitation of human embryos, which results in that G2/06 is considered as a fundamental step towards the constitutionalisation of EU patent law[Pierre Treichel,‘G2/06 and the Verdict of Immorality’ (2009) IRIPCL p1].It also clarified that whethertechnical teaching is misusing the human embryos in the sense of a commodification has to be judged case-by-case.The decision held that any inventions concerning products which can only be obtained by the use, involving their destruction, of human embryos are unpatentable. This case further stated that the legislature can stipulate and define a genuine European ordre public both in substance and in time. The legislature also can issue an absolute patenting prohibition or define a moral consensus without contravening art 53(a). In addition, Human dignity would exclude the balancing test for transgenic animals.

In Brustle(2010)[ Brüstle v Greenpeace (2010) C-34/10], Court of Justice of the European Union(CJEU) held that any human ovum must, as soon as fertilised, be regarded as a 'human embryo' if that fertilisation is such as to commence the process of development of a human being.[Penny Gilbert and Geoff Lees, ‘Stemming the Tide: No More Patents for Human Embryonic Stem Cells?’ (2010) BSLR p63]The Court quoted the Directive: "Although it seeks to promote investment in the field of biotechnology, use of biological material originating from humans must be consistent with regard for fundamental rights and, in particular, the dignity of the person."

According toOpinion of Advocate General Cruz Villalon 2014 in C-364/13, it was asserted that unfertilised human ova, ‘parthenotes’, were not included in the term ‘human embryos’ in Article 6(2)(c).[Court of Justice of the European Union,‘Advocate General’s Opinion in Case C-364/13 International Stem Cell Corporation v Comptroller General of Patents’ (2014) ]In case C-364/13 (2014) [International Stem Cell Corporation v Comptroller of General Patents [2013] C 364/13], it held that an unfertilised human ovum whose division and further development have been stimulated by parthenogenesis does not constitute a‘human embryo’,within the meaning of that provision, if, in the light of current scientific knowledge, it does not, in itself, have the inherent capacity of developing into a human being, this being a matter for the national court to determine. [Nicola Lucchi, The Impact of Science and Technology on the Rights of the Individual (1st edn, Springer 2016) p146]

Based on the description of Article 53(a) mentioned above, it is apparent that the 53(a) mainly consists of‘commercial exploitation’[Hellstadius (n 3) p375, 377], ‘ordre public’ and‘morality’, and there is a two-stage assessment. The first stage is to evaluate whether the conduct is within the scope of commercial exploitation, where the concept of commercial exploitation would be inevitably considered. Secondly, it needs to assess whether the commercial exploitation would be contrary to the ‘ordre public’ and‘morality’.[Hellstadius (n 3) p397] It is understandable that the boarder of the exclusion within 53(a) would be determined by the meaning or interpretation of these three terms.

4)Commercial exploitation

Traditionally, patent right would be the same as commercial exploitation, but now this would not be the putative principle.[Hellstadius (n 3) p376]If a narrower interpretation is intended, the patent right would not be the same as commercial exploitation, and the scope of commercial exploitation would include the actual commercial exploitation which means the patent right itself is a neutral concept rather than a term containing commercial content. If understood in the traditional way, then the evaluation would be mainly concerning whether the grant of patent right would be contrary to morality or ordre public. While, if understood in the other, then the grant of patent right may not be the focus of the assessment but whether the actual commercial exploitation of the invention on the market would be contrary to morality or ordre publicmatters. Although the EPO case law shows evidence for both of the interpretations, the case law seems to support the narrower interpretation.In recent cases,WARF andBrustle, it was held that the concept of innovation,the scope of subject matter, would affect the concept of commercial exploitation. [Hellstadius (n 3) p380, 382] Besides, the Guidelines for Examination mentioned that the patent should not be denied if the invention can be exploited in a way which does not and would not infringe ordre public and morality.[Guidelines for Examination, (EPO, 2015) 〈http:// www.epo.org/law-practice/legaltexts/html/guidelines/e/g_ii_4_1.htm〉accessed 19 July 2016]On the contrary, the CJEU seems to favour the traditional explanation and identified the morality provision as to allow patents to be refused where there is a threat to ordre public and morality, for example Case C-377/98[ NetherlandsvEuropean Parliament and Council of the European Union[2001]Case C-377/98, para 38].[Hellstadius (n 3) p377]

5)Concept of morality and ordre public

Guidelines for Examination in the EPO 2015mentioned that 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.[ Emanuela, Arezzo and Gustavo Ghidini,Biotechnology and Software Patent Law: A Comparative Review of New Developments (1st edn, Edward Elgar 2011) p316]Although morality and ordre public may be similar in some aspects,the wording of Article 53(a) EPC "ordre public" and morality may form the basis of two separate objections either or both of which canbe raised in a particular case.[Michigan State University v KnotgenAnita[2005]T 866/01]The recent decision from the EBA in WARF relevant to human embryonic stem cells (hESCs) showed a fundamental shift in the EPO’s approach to morality from the balancing approach, which had until then always been taken by EPO, to a deontologicalapproach according to which certain things may be morally impermissible even if they would produce more benefits than disadvantages.[Sigrid and Cockbain (n 4) p243]

Although the ordre public and morality are widely used in international, national and regional legal rules, there is no specific definition in those instruments and the EPO case law provided primary interpretation methodsin the European Union (EU). [Hellstadius (n 3) 397] As interpreted in Michigan State University mentioned above, the ordre public, as what was formed by the ethically based constitutional or other rules, usually backed up by penal reflecting the basic values prevailing in society and trade. Protected values could include public safety, the integrity of the individual and nowadays certainly also the protection of environment[ibid].In PGS,the concept of morality is regarded relating to the belief that some behaviour is right and acceptable whereas other behaviour is wrong[ibid], 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 civilization.

3.Should morality be considered by the patent examiners?

1)Why the moral content should be considered?

A.The moral content inherent in the patent system

Drahos State that the whole patent system is founded based on moral standards, including the creation, operation and interpretation of the system.[Peter Drahos, ‘Biotechnology Patents, Markets and Morality’, (1999) EIPR p441] Patents are a form of property right, and property is a key institution of social and political morality.[Christian Lenk and Nils Hoppe, Ethics and Law of Intellectual Property: Current Problem in Politics, Science and Technology, (1st edn, Routledge 2007) p248] Patent rights authorised people to monopoly all kinds of uses of innovations to make profits, and thus have an inherent moral content. Furthermore, although many critics received, patent law might be regarded as a recognition and extension of Locke’s theory[William Fisher,‘Theories of Intellectual Property’(2001) NELPTPp22][Ellen Paul, Fred Miller and Jeffrey Paul,Natural Rights Individualism and Progressivism in American Political Philosophy (1st edn, CUP 2012) p283], that mixing labour creates value in things that one can claim as property based on a moral entitlement to the fruits of that labour. [Nathan Luscombe,‘Morality in Patent Law’ (2015) NZLSJ] Another point may lie in that the public order and morality are principles recognised internationally and widely in civil law,[ ‘Standards for Morality and Public Order Research’(2009) ICANN p2] and ordre public and morality just extend those principles to patent law which is very logical and demanded as civil law is a higher norm regulation. However, legal scholars and philosophers widely agree that Locke’s labour theory of value fails to justify intellectual property rights.[Paul, Miller and Paul (n 51) p283] Besides, even in civil law context, the moral content is not necessarily considered in each case which is what the current advocators require patent law to do.

B.Thepurposes of patent law

It is noticeable that Article 53(a) EPC is not focused onwhether the grant of patent rights on inventions or even performing the invention is acceptable, but the main concern of 53(a) is the morality of commercially exploiting the invention. Many activities are acceptable where there is no financial reward involved but morally unacceptable when performed at the aim of financial gain, for example organ donation.[Delmonico Commentary,‘What is the system failure?’ (2006) KI pp69-70]Even if the concrete use of the invention may possibly be acceptable, the exclusive right granted in order to commercially exploit it may be beyond what the public could accept.According to Dolder, instrumentalization of the human body, as opposed to parts of it, taking it as an object of technology, was deemed to be a barrier to patentability,therefore making it contrary to morality under Article 53(a) EPC.[Sigrid Sterckx and Julian Cockbain, ‘Assessing the Morality of the Commercial Exploitation of Inventions Concerning Uses of Human Embryos and the Relevance of Moral Complicity’ (2010) SJLTS p88] Moreover, the EPO is empowered by EPC to use morality as exclusion for patentability by interpreting morality, and examiners are qualified to do so[ Taiwo Oriolat,‘Ethical and Legal Issues in Singapore Biomedical Research’(2002) PRLPJA pp505, 517, 527]. Bently[Lionel Bently,‘Sowing Seeds of Doubt on Onco Mouse: Morality and Patentability’ (1994) KCLJ pp190-191], in a different view with Ford[Richard Ford, ‘The morality of biotech patents: differing legal obligations in Europe? (1997) EIPR p317], said that although patent examiners were qualified to assess the technical content in patents rather than ethical, it were those examiners who could understand both the risks and benefits of applications and make further judgement on the morality regarding those inventions. Whereas, Bently may ignore that maybe such a concept stemming from the social content should be defined by the public rather than individuals.

C.Moral exclusion would not stunt researches

Legislation excluding morally controversial subject matter frompatent protection would not stop research into such subject matter from takingplace. [ Peter Yu,Intellectual Property and Information Wealth: Issues and Practices in the Digital Age (1st edn,Praeger 2007) p336]Instead, it would reduce the incentives for conducting immoral researches andkeep certain fruits of such researches in the public domain basically due to two reasons.On one hand, theunderlying activity may be so controversial that the government should notplace its authorisation on it via a patent grant. On the other, those researches may be so socially beneficial thatgovernment should not grant anyone exclusive rights in it.

2)Why morality should not be involved?

A.Ambiguity of morals and relevantconcepts

A main issue pertaining to morality or ethics argument is the vagueness of such term. As in Harvard 2003 case, the TBA held that there is no single definition of ‘morality’ and the implication of morality may be considered at the time of priority date concurrent with at the date of the disputes arising, which makes the assessment being time consuming and able to result in misinterpretation. Moreover, it also clarified that whether technical teaching is misusing the human embryos in the sense of a commodification has to be judged caseby-case in the WARFcase. Then leaving all those hard decisions to individual examiners may not be an ideal way to deal with the moral issues.

B.The potential for redundancy of the morality requirement.

For now, there already are many rules and cases that need to be considered in this area when morality concerned such as Harvard balancing test, Rule test and test advance in PGS, and with the development of biotechnology there would be more and more tests emerging.[Luscombe (n 52)]As a result, the system of morality objection is quite complicated or even redundant.[Hellstadius (n 3) pp27-28] The patent granting processes and litigation processes, not only in EU but in areas all over the world[Ahmer Siddiqui, ‘Report on Patent Backlogs, Inventories and Pendency’ (2014) IPA pp8-9][ UK Intellectual Property Office,‘Patent Backlogs, Inventories and Pendency: International Framework– A Methodological Update for UK analysis’ (2015) p2][Toshiko Takenaka, Patent Law and Theory(1st edn, Edward Elgar 2008) p273], was overwhelmed by the large amount applications filed and the complicated process involved. It then seems that those advocators of remaining morality within consideration in patent law might be too theoretical and ideal.

C.Patent law is not the proper forum for such debate

An appropriate forum for discussingthe patentability of biotechnology should be the legislator. Parliament is equipped to facilitate such a debate, having the mechanisms, such as the ability to initiate referenda, policies and history of practice to hear and take into account these varying opinions. As Bagleyarguedindividuals is not competent enough to decide and resolve the morality issues and the problems of morality and patents should not be dealt with by scientists or individual examiners.[Margo Bagley,‘A Global Controversy: The Role of Morality in Biotechnology Patent Law’(2007)UVSL p339.][ Rebecca Baines, ‘European Patent Law should not Rest on its Morals’ (2015) PF p21] In WARFcase, it was also held that EPO and EBA cannot be considered as legislator.Hoalsosaid that patents examiners were trained to assess the technical merits of inventions, not their moral content.[ Cynthia Ho,‘Splicing Morality and Patent Law: Issues Arising from Mixing Mice and Men’ (2000) p284] Therefore, although examiners could be the one who makes decisions of morality as all the other individuals, they are not the perfect person or agency to do so. It should be the regulator who decides the definition that root in the public belief.[Warren (n 26)pp445-446]

D.Requirement for development of pharma

In the view of others, particularly for utilitarian consequentialists, the Brustle decision is not beneficialin that it makes the European regulatory environment less attractive to leadingedge biotechnology companies and it impedes the prospects of developing stem-cell based therapies for human diseases which are hard to cure (such as Parkinson’s disease which was whatBrustle’s research tried to cure). Patent is a platform for stimulating the development of pharma, which is also clearly reflected by the formation of Doha Declaration[Sigrid Sterckx, ‘Patents and Access to Drugs in Developing Countries: An Ethical Analysis’ (2004) DWB p60]. If morality is not an exclusion that the examiners need to consider, there might be a better environment for the research and development of pharma.

4.Alternative regulatory mechanisms

Thambisetty mentioned that currently, there is a strong single research council, National Institutes of Health (NIH), conducting and supporting medical research in the US, which is able to affect the research trend by leading and funding different researches.[ Lenk and Hoppe(n 49) p261]Although the funding in Europe, almost € 1.7 billion (about $1.9 billion) for 2016[ European Research Council,‘About ERC: Facts and Figures’ 〈https://erc.europa.eu/about-erc/factsand-figures 〉 accessed 19 July 2016], cannot compare to the fund in the U.S., more than 80% of the NIH's annual $28 billion budget for medical research, the European Research Council (ERC) does be able to have some effects on the direction of researches. Therefore, it is recommended to use the public fund as a complementary tool for the regulation to lead biotechnological researches. There is no doubt that the bigger the fund amount, the more influence of guiding would be.

5.Conclusion

The applications of biotechnologies concern, not only, pharmaceuticals, but also the food industry, health and agriculture. Biotechnological inventions are a really important field of investments and, thus a worldwidecompetitive market.To attract investments and encourage innovations on this field, harmonised regulation was necessary in European law to protect such inventions.[Alan Story,‘The Implementation of the Biotechnology Directive (98/44/EC), (2008) KLS p22]

The morality exclusion is regulated by 53(a) EPC and in EU case law could be mainly separated into animals, plants and human biological materials. Regarding animals, there are two main evaluations under 53(a), Rule 28 and the Harvard balancing test. For plants, in PGS, the concept of ordre public and morality were respectively interpreted. In terms of human biological materials, the Relaxin case reaffirmed the concept held in PGSand developed the standard to ‘so abhorrent’, and WARF established that the concept of morality should be defined case-by-case. Concerning the 53(a) itself, the concept of ordre public, morality and commercial exploitation could decide the scope of it. The CJEU deemed that the grant of patent right was the same as grant of commercial exploitation, while the EPO case law interpreted they are different. Ordre public and morality were not normally considered the same concept, with ordre public concerning ethically based constitutional or other rules, usually backed up by penal reflecting the basic values prevailing in society and trade, and morality relating to the belief that some behaviour is right and acceptable whereas other behaviour is wrong, founded on the totality of the accepted norms which are deeply rooted in a particular culture.

Generally,patent law and morality are inextricably intertwined and it will not be easy to give an answer on whether examiners should consider the moral content. The proponent, for considering moral content, argued that the moral content was inherent in patent law, considering moral content by examiners coherent with the aim of patent law and such exclusion would not stunt researched. However, opponentrejected those ideas as the concepts in relation to morality were ambiguous, and far beyond the competency of individuals to deal with, although the examiners could and have the right to consider those issues. They believed that the patent system was already quite complicated and such huge issue should be dealt with by regulators. Some people even though the moral exclusion would stunt the research and development of pharma and thus should not be considered even by patent system. An alternative method was brought into consideration, by using the public fund organisation to lead and control the trend of research in controversial fields.

It seems that with the development of biotechnology, there is nothing could stop the trend of expansive patent right and it is only a matter of time.[ Lenk and Hoppe (n 49) p266]The society demands the process to make progresses no matter current rules, customs and cultures are good or bad, which could be compared to the feminist movement or the civil rights movement. However, the judicial advances are normally under a slow way just as any other significant society reform.