Addressing Significant Societal Needs and Challenges
The first RRI dimension states that responsible research and innovation should contribute to solving societal needs and challenges. In an RRI context, addressing such needs and challenges is usually understood more broadly than simply the creation of economic value [23]. Instead, RRI requires more in terms of addressing our times’ grand challenges, such as climate change, pandemics or an ageing population, or at least that science and technologies that generate risks or uncertainties are justified by their benefits to society.
EPO’s Mission
The EPO describes its mission in the following way: ‘As the Patent Office for Europe, we support innovation, competitiveness and economic growth across Europe through a commitment to high quality and efficient services delivered under the European Patent Convention.’Footnote 4 Especially in light of the economic crisis that has haunted parts of Europe, this is a mandate with robust societal legitimacy, but it is not fully satisfactory in an RRI perspective. However, in addition to generally contributing to economic welfare, the EPO has engaged in some activities related to addressing grand challenges, namely actions targeting climate change. The EPO cooperated with the United Nations Environment Programme and the International Centre for Trade and Sustainable Development on the program ‘Patents and clean energy: bridging the gap between evidence and policy’ [26].Footnote 5 The purpose has been to provide ‘reliable evidence’ as intellectual property rights in the field of climate change technologies have been regarded as ‘a particularly contentious issue’ [26, p. 6]. The EPO also organizes the European Inventor Award, which provides an award to an ‘exceptional contribution to social development, technological progress and economic growth’Footnote 6 and has a certain profile towards environmental and climate technologies.Footnote 7
Patenting Practices
In an RRI perspective, this is relevant, but more interesting is the question of how societal needs are reflected in the core activities, which, in the case of patent offices, means the level of processing patent applications. On this level, the EPO explicitly distances itself from a connection to any positive impacts other than the general macroeconomic assumption that patenting creates economic value and innovation. EPO Guideline G.I.3 states: ‘The EPC does not require explicitly or implicitly that an invention, to be patentable, must entail some technical progress or even any useful effect.’.Footnote 8 EPO Guideline G.II.4.1.3 adds: ‘The EPO has not been vested with the task of taking into account the economic effects of the grant of patents in specific areas of technology and of restricting the field of patentable subject-matter accordingly.’Footnote 9 These guidelines echo the position that a patent is not a positive right to exercise the invention (as there may be other legislation regulating or even prohibiting the actual use of the invention), but a negative right, i.e. a right for an inventor to prevent other actors to exploit his/her invention, for a certain period.Footnote 10 Patent scholars have therefore maintained that assessing the benefits of assumed use of individual patents is not relevant and patent offices are not equipped to take on such a task [27, 28]. Thus, questions related to the impacts (positive or negative) of an invention have no place in the patent system.
One article in the EPC does, however, address the impacts of a patent, namely the article describing the exceptions to patentability (article 53 EPC). Article 53(a) EPC shows that in special cases, a patent may be refused and these cases are related to certain technologies that are seen as inherently controversial: namely ‘inventions the commercial exploitation of which would be contrary to “ordre public” or morality’. The article explains that ‘such exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States’. The EPO guidelines for examination say about article 53(a) EPC: ‘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 [...] This provision is likely to be invoked only in rare and extreme cases.’Footnote 11 Article 53(a) EPC thus does not request any ethical impact assessment but simply gives the EPO a possibility to deny extremely controversial patents. In the Relaxin/Howard Flory Institute case (T0272/95, 1995), the EPO had to decide whether human genetic material was patentable or not. The Opposition Division argued that a ‘fair test’ under article 53(a) would be 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. In this case, where the DNA sequence, which codified the hormone relaxin, was taken from pregnant women and then used in industrial production of the hormone, the Opposition Division (later supported by the Board of Appeal) saw no grounds to reject the patent based on this test. The ‘fair test’ was later incorporated into the EPO Guidelines on article 53(a).
However, a few years earlier, in the decision of the Board of Appeal in the case of the Onco-mouse/Harvard (T19/90, 1990), another test, the so-called Harvard test, was formulated. In this case of a mouse genetically modified for developing cancer, the Board of Appeal held that article 53(a) EPC should be applied by ‘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’. This test, relevant to patent applications where it is clear that the patented animal suffers, requires taking into account the benefits to society of the invention.
As from September 1999, article 53(a) EPC has been supplemented by a rule covering only the biotechnology context, offering additional advice on how to interpret this article in this context. This rule also opens for a certain consideration of benefits of inventions. Based on article 6 of the EU Directive on the legal protection of biotechnological inventions (98/44/EC; hereafter: Biotech Directive), rule 28(1) of the Implementing Regulations to the Convention on the Grant of European Patents specifies that
European patents shall not be granted in respect of biotechnological inventions which, in particular, concern the following:
(a) processes for cloning human beings;
(b) processes for modifying the germ line genetic identity of human beings;
(c) uses of human embryos for industrial or commercial purposes;
(d) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.
Letter (d) shows that in the specific case of inventions that modify the genetic identity of animals (and animals resulting from such processes) and where this modification likely causes suffering, there must be an assessment of benefits to society. These should be substantial but are limited to the medical domain. In contrast to article 53(a) EPC, only animal suffering should be balanced here (i.e. not environmental risks). So how does the EPO perform this balancing act?
In a Board of Appeal decision on another case of transgenic animals (T315/03 Transgenic animals/Harvard, 2006), the Board judged (based on expert statements submitted by the applicant) that substantial medical benefit was provided by a transgenic mouse, but that no evidence had been submitted to prove that other similarly modified mammals would have a similar benefit. Consequently, the Board decided that the patent could only be granted on the mouse.
In the case of Non-invasive localization/Leland Stanford (T1262/04, 2012), the Board of Appeal made a similar judgement on benefit: they referred to three expert statements presented by the inventor that underscored the medical benefits of the invention. The Board then stated: ‘In view of the above, the board concludes that the claimed methods of the invention are at least likely to be of substantial medical benefit to man, thus fulfilling the criterion provided for in rule 28(d) EPC for escaping the patent exclusion. Likewise, when applying the balancing test as developed in T19/90 (supra), the board considers that this likelihood of substantial medical benefit demonstrates the invention’s usefulness to mankind in human cancer research. The board notes in addition that the appellant’s credible assertion that the claimed methods lead to a reduction of the number of experimental animals in cancer research is a further relevant factor in this balancing exercise.’ The Board consequently remitted the case to the department of first instance with the order to grant a patent.
The European patent EP1330552, on selection for the breeding of dairy cows by marker DNA, was granted in 2007 (it was revoked in 2015 by EPO, because of non-compliance of the patent-holder with administrative requirements). The patent was opposed and appealed by Greenpeace related to several provisions in the EPC, including rule 28(d). The opposition and appeal procedures showed that there were strict requirements on Greenpeace to document that the animals suffered. Greenpeace did not have documentation related to the specifics of the case, as studies had not been published on this particular modification. The EPO thus did not find the objections justified and subsequently stated that there was no need to document any benefits to offset the non-documented suffering.
Based on these cases, it seems that in the domain of biotechnological inventions, the EPO accepts suffering of animals if the invention is at least likely to be of substantial medical benefit to man. If suffering is not sufficiently documented, there is no need to document the benefits. In its T1262/04 decision (and referring to T315/03), the Board pointed out that rule 28(d) does not prevent objection based on article 53(a) EPC. This means that even if the application passes the balancing test of rule 28(d), objections can still invoke the more general Harvard test, or the Relaxin ‘fair test’.
Overall, in its patent granting processes, the EPO takes benefits of patents to society into account only in a very limited number of specific cases, i.e. where rule 28 and/or article 53 EPC apply and suffering/harm has been documented. Case law shows that documenting such harm is not straightforward.
Engaging with Stakeholders
Engaging with stakeholders is important in all approaches to RRI. How does the EPO itself define the scope of its stakeholders? According to the EPO, it has many stakeholders, which are listed as ‘staff, users, member states, and the wider public, among other groups’.Footnote 12 This signals a broad approach to inclusion of stakeholders, in line with RRI principles. In this section, we will therefore follow EPO’s distinction between these four stakeholder groups.
Stakeholder engagement in European patenting can be addressed on two levels: the institutional level and the level of the patent granting process. The institutional level is relevant to discuss here because it may affect patent granting practices and will be discussed first.
Engagement with Stakeholders at the Institutional Level
Engagement with Member States and Users
We will first focus on the engagement of the EPO with member states and with users/clients.
The EPO is the executive office of the European Patent Organisation, an intergovernmental organisation that further consists of the Administrative Council (hereafter: AC). According to article 4(3) EPC, the AC acts as the EPO’s supervisory body. The AC is composed of representatives of the 38 member states of the European Patent Organization. They are commonly represented by (the heads of) their national patent offices. Additionally, the European Patent Organisation involves two extension states (Bosnia and Herzegovina, and Montenegro) and four validation states (Moldova, Morocco, Tunisia and Cambodia). These states have an observer status in the AC; the same is true for the EU, the World Intellectual Property Organization (WIPO), the European Union Intellectual Property Office (EUIPO), the Nordic Patent Institute (NPI), BUSINESSEUROPE and the Institute of Professional Representatives before the European Patent Office (epi). The EPO President participates in the AC meetings, as do representatives from the Board of Auditors and the EPO Staff Committee (in which EPO staff is represented).Footnote 13 The AC operates two bodies (which confusingly are called committees: the Technical and Operational Support Committee and the Committee on Patent Law), as well as two committees (the Budget & Finance Committee, and the Select Committee). These bodies/committees have similar compositions as the AC.
In 1992, the EPO European Roundtable on Patent Practice (EUROTAB) was established as a mechanism for national offices in the EPC contracting states and the EPO to exchange views and compare approaches on matters of a practical nature concerning the patent grant procedure, both from a substantive and formal point of view. BUSINESSEUROPE, epi and the International Federation of Inventor’s Associations (IFIA) are also invited to this Roundtable. Earlier, in 1978, the EPO Standing Advisory Committee before the European Patent Office (SACEPO) was established ‘in order to give “interested circles” a say in the development of the European patent system’.Footnote 14 Membership is comprised of representatives from industry (nominated by BUSINESSEUROPE) and the patent profession (nominated by epi), as well as some recognised experts in the field of industrial property law appointed ad personam by the EPO President. Regular meetings are held once per year in Munich and extraordinary meetings and written consultations are also organised whenever an issue of particular importance arises.
Engagement of the EPO with the member states/national patent offices and with its users/clients is thus very well established. The entanglement of national patent offices, EPO, BUSINESSEUROPE and epi, confirms that most patent offices regard the inventors seeking patents as their ‘clients’ or ‘users’ (see Schneider [29], Borras [30] and Drahos [11]) and that the inventorsFootnote 15 have a privileged place in the patent system, both in the national patent systems and in the EPO. This is confirmed by EPO:
Representatives of the legal profession and industry have always had observer status in the Administrative Council of the European Patent Organisation, something which is exceptional for an international organisation. This means that users’ views are heard before legislative, budgetary and technical matters are decided by the Organisation’s member states. […] This approach has facilitated an open and informed debate and has contributed significantly to the development of the European patent system.Footnote 16
On a normative note, given this entanglement, one can however question the way that the EPO and the European Patent Organisation at large deal with the proper division of responsibilities and with governance issues. There hardly seems to be a proper supervisor-supervisee relationship within the European Patent Organisation. The supervisory body (AC) is made up of representatives of national patent offices, which cooperate intensively with the EPO. It is common to elect the EPO President from within the circles of heads of national patent offices. The main exception was Alain Pompidou (EPO President from 2004 to 2007), who was a scientist and politician, without any background in the patent system. The current EPO President, António Campinos, has been executive director of the EUIPO from 2010 to 2018, but before 2010 was head of the Portuguese national patent office (and thus member of the AC). The confusing and blurred use of the acronym EPO (on the website, in documents) for both the European Patent Organization and the European Patent Office does not help to properly demarcate responsibilities.
Another question is whether BUSINESSEUROPE and epi cover the full range of interests from their sectors. BUSINESSEUROPE, the European association of national business associations, also plays an important role as stakeholder in EU decision-making, but in that arena, it is contested for having a de facto privileged status, with early access to institutions such as the European Commission.Footnote 17 Recently, it has been criticised from within the larger European business community for its restrictive position on measures to deal with climate change.Footnote 18epi consists of European patent attorneys with special qualifications (as outlined in article 134–8(b) EPC), who are registered by the EPO; membership of epi is mandatory for registration as a European patent attorney. Overall, the entanglement of the EPO, the AC/national patent offices, BUSINESSEUROPE and epi seems to have many characteristics of a ‘closed shop’.
Engagement with the Wider Public
In contrast, stakeholders that are not considered as users do not have a designated place in the institutional set-up of the European patent system. The coordinator of one of the most important non-industrial stakeholders in the European patent system, the platform of NGOs called No Patents on Seeds! says the following about how the European patent system can be made more responsive to concerns represented by a broader group of stakeholders: ‘The list is long… We do not have an independent court, we do not have any relevant participation of civil society organizations, and we do not have fora for participation. Political governance (such as in the Administrative Council) is performed by people close to the patent world. Everything is missing. Nothing will ensure that civil society has access.’Footnote 19
From 2012 to 2015, the EPO had an Economic and Scientific Advisory Board (ESAB). This board consisted of 11 independent academic experts and practitioners, supported and coordinated by the EPO Chief Economist. Although the ESAB published various relevant reports, it was decided not to continue its activities. One of the few stakeholder events organised by the EPO and documented in the literature appears to be a workshop on the interaction between the EPO and civil society (in 2009, see Parthasarthy and Walker [31, p. 339]). More recently, in May 2018, the EPO organised a conference on patenting and artificial intelligenceFootnote 20, aiming at connecting people from business, academia, the judiciary, policymaking and patent offices. The conference included a session on ethical and social considerations.
Overall, EPO’s engagement with a wider audience (civil society, the public at large) thus seems to be very limited.
Engagement with EPO Staff
Another important stakeholder of the EPO is the Staff Union of the European Patent Office (SUEPO). SUEPO represents the interests of EPO staff in general and those of its members in particular; approximately 50% of EPO staff is members of SUEPO. SUEPO takes particular care to maintain acceptable working conditions for the staff of the EPO. This concerns not only remuneration but also a wide range of everyday aspects of working conditions at the EPO, such as working time, working pressure and ergonomics. SUEPO also claims to represent wider public interests because ‘[…] patenting is a complex issue and citizens must be better informed of the functioning and the relevance of patents’.Footnote 21
EPO’s engagement with SUEPO is problematic, to say the least. Labour relations were largely normal under the Pompidou (2004–2007) and Brimelow (2007–2010) presidencies, even though SUEPO already in 2009 stated that ‘the social climate within the Office has degraded to a level that can only be described as catastrophic’ [32, p. 5]. This situation further deteriorated under the presidency of Benoît Battistelli (2010–2018). An overview of all conflicts since 2010 is beyond the scope of this paper. They are extensively documented on SUEPO’s website, but of course from their perspective. They include the lack of formal recognition of SUEPO by EPO,Footnote 22 dismissal and downgrading of several SUEPO leaders, various other controversial disciplinary proceedings and contested reforms of the EPO career system. These conflicts led to many demonstrations by EPO staff in Munich, starting in December 2014, with the latest in March 2018.
Two institutional factors seem to have contributed to the persistent bad labour relations at EPO, in addition to the management style of Battistelli and his continuous drive for efficiency. First, whereas the employment conditions and rights of civil servants in national public organisations are laid down in national regulations, with national courts having jurisdiction in the case of labour conflicts, the European Patent Organisation, as an international organisation, is not bound by any national labour legislation and does not fall under the jurisdiction of national courts (immunity).Footnote 23 Rules and rights regarding employment have been laid down in an internal codex of Service Regulations,Footnote 24 adopted by the AC, upon recommendations of the EPO President. This means that the EPO, as an employer, can unilaterally determine employment conditions and employee rights. Secondly, based on article 13 EPC, the Administrative Tribunal (AT) of the International Labour Organisation (ILO) is the external instance for resolving individual labour conflicts, but this external procedure is lengthy and deals with individual cases only (not with collective rights such as the right to strike, or general problems such as excessive workload). In the case of dismissal or downgrading of three EPO staff members, originating from late 2015/early 2016, the ILO ruled in June 2018 that the EPO’s disciplinary measures should be fully reversed.Footnote 25
What has the EPO done to improve labour relations, given the high level of conflict? In February 2016, the Board of the AC put pressure on EPO President Battistelli. In a confidential meetingFootnote 26 between the Board and the EPO President, the Board ‘deplored an obvious lack of willingness from the part of the President to embark on an overdue open discussion with the Council on contentious issues—foremost the social dialogue’, with the President disagreeing. Still, this interference and the subsequent AC Resolution of March 2016 urging the EPO President to inter alia reform the disciplinary sanction system at EPO,Footnote 27 triggered a process, which, in October 2016, resulted in the ‘first’Footnote 28 EPO Social Conference. This conference took place in Munich, and during the conference (preliminary drafts) of three recent studies into the EPO’s social and financial situation were discussed, as well as occupational health and working conditions.Footnote 29 The relevance of this Social Conference was however perceived differently by EPO than by some stakeholders, such as SUEPO, which was not invited to participate. Various items on the SUEPO website, as well as another demonstration by EPO staff in Munich in December 2016 and subsequent demonstrations in 2017 and 2018, indicate that the relationship between SUEPO and EPO has not significantly improved as a result of this conference mechanism.
The new EPO President, Campinos, in his letter of motivation for applying for the presidency,Footnote 30 identified the increase of staff engagement at EPO as one of his main challenges. The relevance of that challenge is also shown by the outcomes of an EPO Staff Engagement Survey of March 2019, which among other things showed that only 16% of EPO staff has confidence in EPO senior management.Footnote 31 The survey has been used as input for the recent draft Strategic Plan of April 2019, which lists the fostering of the social dialogue at EPO as one (of the overall 32) key initiatives. This includes re-engagement of the EPO with the unions with the aim to formalise recognition and measures to ensure the responsible use of the internal system of justice.
To conclude this subsection, the observations suggest that, with the exception of the engagement with national patent offices, businesses and patent attorneys, the institutional stakeholder engagement with, and the involvement of citizens by, the EPO is currently at a very low level.
Engagement with Stakeholders at the Patent Processing Level
There are stakeholders and interested parties not only at the institutional level, concerning the EPO in general, but also in many cases of specific patents, and these may interact with the EPO in three different ways.
First, any member of the public can intervene in a patent granting process by filing a third-party observation about the patentability of the invention (art. 115 EPC). No fees are required for the submission of such an observation. Basically, this provides a mechanism by which prior art otherwise undisclosed to the EPO examiners is included in the examination, but as article 115 EPC uses the term ‘patentability’, third-party observations have a broader potential and are not necessarily limited to the issue of novelty. Third-party observations are also communicated to the applicant. The possibility of (pre-grant) third-party observations is used rather infrequently, compared to the number of (post-grant) oppositions and appeals [33]. This may be due to the fact that competitors are not inclined to forewarn the applicant of prior art and will wait until the patent is granted, after which they file an opposition (ibid.). Another reason may be the fact that, in line with the Guidelines,Footnote 32 EPO does not communicate to third parties about what is done with their observations [34]. Kica et al. [35] however show that in the area of human gene patents (where patentability is highly controversial) some particular patent cases evoked a very large number of third-party observations. For example, in the BRCA1 case (EP0705902) on a breast cancer gene, various NGOs, academic societies and research institutes, as well as patient organisations together submitted 150 observations (see also [36]).
Second, any member of the public can file an opposition within 9 months of the EPO’s mention that a patent has been granted (article 99 EPC). If the patent is maintained after an opposition, the complainant can file an appeal within 2 months of the decision (articles 106–108 EPC). If so, the appeal can be assessed in a Technical Board of Appeal or referred to an Enlarged Board of Appeal for more principled cases. Patents are generally opposed by competitors.Footnote 33 Several characteristics of the patent system function as barriers hindering the involvement of other stakeholders:
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It is hard to keep updated on relevant new patents filed for examination. Although these are public, finding the information on EPO’s web service or via the EPO Bulletin often requires expert knowledge. There are also patent database search services, but these require subscription;
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If a patent application of societal interest is found, it may (especially in the fields of emerging science and technologies) be written in a very technical language, making it difficult for stakeholders that are not themselves experts in the field of the patent application at hand to understand the content of the claims
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For oppositions and appeals, there is a fee (currently €785 for an opposition, and €1880 for an appeal), which may prohibit less resourceful and non-organised interested parties to intervene
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Engaging in opposition and appeal requires quite substantial resources, as these procedures will be a matter of interpreting legal texts, requiring legal expertise in addition to the technological expertise
The barriers for engaging in such dialogues are therefore prohibitively high for most non-industrial stakeholders. In spite of these barriers, there are examples of non-industrial stakeholders engaging in opposition and appeal cases. For example, No Patents on Seeds! (in which several NGOs such as Greenpeace cooperate) has been very active in disputing patent cases in the field of biotechnology (especially patents on plants and animals).Footnote 34 No Patents on Seed!’s experience is that ‘it is difficult for civil society organizations to engage in or have an impact in appeal or court procedures, because this usually requires engaging a lawyer, which is expensive for civil society organizations’.Footnote 35
Third, in order to ensure uniform application of the law, or if a point of law of fundamental importance arises, the Boards of Appeal can refer a case to the Enlarged Board of Appeal (article 112(1)(a) EPC). Similarly, the President of the EPO may refer a point of law to the Enlarged Board of Appeal where two Boards of Appeal have given different decisions on that question (article 112(1)(c) EPC). Under article 112 EPC proceedings, third parties can issue written statements concerning the points of law raised in such proceedings (article 10(1) Rules of Procedure of the Enlarged Board of Appeal). Such statements of third parties are known as amicus curiae briefs. The Enlarged Board also has the possibility to explicitly issue requests and to provide further provisions concerning such briefs. The way that the Enlarged Board of Appeal uses these third-party statements has developed over the years. As from 1999, third-party statements were made in seven referral cases involving patents in the field of biotechnology.Footnote 36 In two early cases (G1/98 and G1/04), in which third-party statements were not invited, the number of such statements was limited, and the Enlarged Board of Appeal, in its rulings, gave relatively extended overviews of these statements. In all other cases, third-party statements were invited, and they were made in such large numbers that the Enlarged Board of Appeal appears to be able to deal with them only in a very limited manner. Statements are grouped according to being pro or contra patentability, and in some (but not all) cases, this is followed by a very brief overview of the common denominator of their contents. For example, in G2/06 (Use of embryos/WARF; 2008), the Enlarged Board of Appeal received numerous statements regarding the moral unacceptability of this patent. A considerable number of these were identical, only with different signatures, and appear to be the result of a campaign. Even though Sterckx and Cockbain [37, pp. 286–287] argue that the EPO in this case changed their approach to ethics, from a purely utilitarian approach to considering deontological arguments, the text of the decision does not demonstrate that the (large number of) amicus curiae briefs influenced the EPO considerations.
Generally, statements by third parties in article 112 proceedings may be dealt with as the Enlarged Board sees fit (article 10(2) Rules of Procedure of the Enlarged Board of Appeal). In cases G2/12 (Tomatoes II; 2015) and G2/13 (Broccoli II; 2015), which were dealt with together, the Enlarged Board of Appeal acknowledged the receipt of a large number of third-party statements expressing general objections against patenting the kind of technologies at issue, based upon ethical, economic and social concerns (G2/12, p. 29). But it emphasised (p. 56) that the issues referred to the board relate to questions of law, rather than to economic, social or ethical aspects brought up in some of these amicus curiae letters. In other words, the scope of the input from stakeholders (other than involved parties from industry) and from the public that is seriously considered by EPO is currently very narrow.
Anticipating Potential Problems, Identifying Alternatives and Reflecting on Underlying Values
RRI scholars, such as Stilgoe et al. [19], highlight the need for reflexivity and reflection on values, options and impacts in the research and innovation process. The assumption is that there are values and uncertainties embedded throughout the research and innovation process, and these should be openly discussed. Here, we explore the extent of such open reflection and reflexivity, first at the EPO institutional level and then at the level of the granting of patents.
Reflexivity at the Institutional Level
In the period 2004–2007, under the presidency of Alain Pompidou, the EPO engaged in a scenario process: Scenarios for the Future [38]. Here, more than 100 experts and stakeholders of the patent system were interviewed about their views on challenges and opportunities facing EPO and the European patent system in general. This resulted in four scenarios (with four different dominant drivers): Market Rules (business), Whose Game? (geopolitics), Trees of Knowledge (society) and Blue Skies (technology). The EPO says:
The purpose of scenarios is to examine possible uncertainties that might arise in a complex and turbulent environment. By deploying this methodology, a wider view can be taken and more relevant questions can be asked. This approach encourages a holistic examination of the system and exposes the complex interactions that might impact it. By thinking the unthinkable, and questioning structures that are ordinarily taken as a given, it is possible to better anticipate and adapt to future changes. […] Traditionally, the world of patents has been viewed through the familiar lens of the grey Market Rules scenario. However, the scenario process demonstrates that it is unwise not to take a much wider perspective into account: the other three scenarios reveal further dimensions often overlooked by the IP system. (11).
This scenario process was a laudable initiative from an RRI perspective. According to Elahi and Ramirez [39, p. 205], quoting a key EPO official, ‘[t]he scenarios themselves appeared in countless (external) publications on IP and the so-called “IP5” coalition of five leading patenting offices (EPO, USPTO, the Japanese, Korean, and Chinese patenting offices). Moreover, the scenarios were embraced by Pompidou’s successor, Alison Brimelow, who gave them wider internal as well as external distribution’. This appears to indicate a robust willingness to be reflexive at the institutional level, at least until Brimelow resigned in 2010.
It is currently difficult to document the internal value reflection in the top management of EPO, and as a part of the culture in EPO generally. However, some aspects of the EPO seem to be counterproductive for such reflection. One aspect is that the staff at EPO generally consists of people with scientific or engineering background.Footnote 37 This homogeneity in backgrounds may restrict broad deliberation on values and assumptions unless such deliberation is encouraged in the organisation. Parthasarathy and Walker [31, p. 337] show that there was indeed such encouragement during the 1990s and early 2000s. However, there is evidence that the culture has changed to the disadvantage of reflexivity. According to SUEPO (in 2009, referring to several staff studies), the organisational climate has deteriorated since: ‘All studies found that the present “command and control” style of management is not appropriate for the EPO and conclude that a change is needed towards a more values-based management. The studies propose delegation of authority and “management-by-learning” or “management-by-objectives” as opposed to the current “management-by-instructions” style.’ [32]. Our observations in “Engagement with stakeholders at the institutional level” clearly show that such a change in management style has not occurred.
Another sign of a current lack of willingness to engage in value-based reflection was a high-level EPO ban on attendance of their staff at a workshop on responsiveness in European patenting practices, including a broad range of prominent experts and stakeholders in ethics and patenting, organised as part of the Patent Ethics project, in Munich in 2016. Such withdrawing from open discussion indicates a closed culture in the EPO.
The recent draft Strategic Plan (April 2019) to some extent reflects on (the importance of) values, but here also, the reflection is of a closed nature and limited to EPO corporate values (regarding integrity, respect, and fairness). Referring to interviews with senior UK science policy actors, Macnaghten and Chilvers [40, p. 541] report that ‘closed cultures were seen to create an ethical distance between scientists and societal interests and to lead to the normalisation of ethically sensitive activities’.Footnote 38 This observation about scientific cultures seems relevant also in the EPO context.
Though informative, we cannot draw strong conclusions from these indications that broad organisational reflexivity on values, uncertainties and assumptions does not exist in the EPO. More research is thus needed on this aspect.
Reflexivity at the Patent Processing Level
With regard to the granting of patents, the mandate of the EPO is to apply the articles of the EPC as neutrally and objectively as possible. There should be no open deliberation on assumptions in patent legislation or EPO guidelines, but simple application with high predictability; otherwise, there will be time-consuming opposition and appeals. Even though scholars inspired by science and technoloyg studies (STS) would be quick to point out that this examination and decision-making process is value-laden (see for instance Sideri [41]), such an insight should not be allowed to influence examiners’ processing of concrete applications.
However, for ethically sensitive patent applications, the EPO has initiated a system of labelling so-called sensitive cases (SeCa) [31]. These are cases that might invoke controversy in society and that therefore need to be scrutinised with extra diligence. The EPO official interviewed in this project stated: ‘There is a network of specialized colleagues dealing with SeCa cases. There is lots of internal consultation and there is an active discussion culture on this.’Footnote 39 Parthasarathy [42, p. 112] reports that this extra scrutiny is carried out with internal legal expertise, representatives of the public relations division and higher level management. The mechanism seems to be a matter of risk management by the EPO, rather than a way to open up the discussion with society. A similar point was made earlier by Schneider [12, p. 626] who criticised the lack of involvement in this procedure of people from a wide range of (disciplinary) backgrounds. Moreover, SeCa cases are just a few cases out of thousands of decisions taken every year in the biotechnology field of the EPO, during the search, examination, opposition and appeal phases.Footnote 40 Most of the decisions made on biotechnology patents (or patents in other technology fields) are not subject to such broader discussion in the EPO.
In RRI, it is also important to be aware and reflexive about scientific uncertainty and ambiguity [19]. The scientific uncertainties of emerging science and technologies are an important reason for the need for responsibility in the first place. Some claim that scientific uncertainties are indeed irreducible in many emerging fields [43]; however, for the EPO, reducing uncertainty is considered a core activity: ‘We deal with uncertainty as our daily business; it’s the nature of our job. Our job is to create certainty through examination of the patent application.’Footnote 41 Scientific uncertainties in patenting applications are thus regarded as in principle unproblematic.
The main place for discussion of assumptions and value issues in the EPO is probably in the appeal boards. Here, more principled questions about the interpretation of the EPC are discussed with the parties involved (the patent proprietor and the appellant). Sterckx and Cockbain [37, pp. 243, 297] highlight the WARF appeal case (G2/06 Use of embryos/WARF) as an important example of deliberation about the interpretation of the article on ordre public and morality (article 53(a) EPC). They also mention the G2/07 (Broccoli/PLANT BIOSCIENCE) and G2/08 (Dosage regime/ABBOTT RESPIRATORY) as examples of appeal cases where there has been a willingness to take seriously the value-based restrictions in European patent law. They give the credit for these decisions to the wise leadership of Peter Messerli [37, pp. ix and 322].Footnote 42
The situation appears to have changed after Messerli retired, as there has recently been a lot of controversy about changes in the organisation of the Boards of Appeal. As Smyth [44] presents it: ‘The wider world only noticed the increasingly troubled situation at the EPO when a member of the Boards of Appeal of the EPO was suspended by the President without the prior sanction of the AC, an action that appeared to compromise the judicial independence of the Boards of Appeal. This occurred shortly after a seminal decision of the Enlarged Board of Appeal (EBA), which upheld an objection of suspicion of partiality against its Chairman, on the sole basis of his dual administrative role within the management of the Office. The response of the President, transferring some administrative powers from the EBA Chairman to himself, seemed to make the problem worse rather than better.’ Smyth refers to the events that started with the decision in April 2014 (R19/12) of the Enlarged Board of Appeal to recuse the Vice-President of the EPO from a Petition for Review case. In the set-up of the European Patent Organisation, the judiciary branch (the Boards of Appeal) is part of the EPO and does not have its own legal status. One of the vice-presidents (Vice-President DG3) used to be both the chair of the Enlarged Board of Appeal and the person within EPO senior management that ran the Boards of Appeal, which has raised questions related to the independence of these boards (laid down in article 23 EPC). This was reinforced by the fact that some of the individual labour conflicts discussed in “Engagement with stakeholders at the institutional level” involved Board of Appeal members. In March 2015, the EPO President recommended to the AC the creation of a new position, President of the Boards of Appeal, specifically in charge of managerial and organizational tasks relating to the Boards of Appeal Unit, delegated directly by and under the hierarchical control of the EPO President. The Boards of Appeal President would no longer be member of the EPO team of vice-presidents but would still be chair of the Enlarged Board of Appeal. After consultations, in June 2016, the AC decided to go ahead with this reform (and with the double role of the new President of the Boards of Appeal as manager and as judiciary), but with the President of the Boards of Appeal being responsible to the AC, and hierarchically independent from the EPO President.Footnote 43 This means for example that the President of the Boards of Appeal is in charge of appointment of members of these boards, and not—as previously—the EPO President. The Association of the Members of the Boards of Appeal (AMBA) has been and still seems to be critical of the reform, questioning whether the delegation will really prevent intervention from the part of the EPO President.Footnote 44
Again, the evidence provided here is not sufficient for drawing strong conclusions on the reflexivity within the EPO, but suggests that such reflexivity is not deeply embedded in the organisation and that there are counter-incentives. More studies of the EPO should be conducted to shed light on its organisational culture and working practices.Footnote 45
Responding and Adapting to the Input and Deliberations
The responsiveness dimension of RRI highlights the fact that it is not sufficient to simply organise a stakeholder meeting, to make scenarios or to hold a Social Conference. These actions may well be window dressing if the organisation is not committed to learn from them. Responsiveness involves the openness for discussing topics that stakeholders deem important, it implies the willingness to change and adapt, and it goes beyond mere strategic reaction to events in the organisation’s environment (see also [21]). Related to the topics addressed under the three first dimensions above, we can add some reflections on responsiveness.
With regard to the political level, we can note that there has been certain responsiveness in the European Patent Organisation towards the European Union, as the provisions on patenting in the Biotech Directive were incorporated into the EPC, although this was not legally required by the EPC. The then president of the EPO also responded quickly to the Brüstle decision in the European Court of Justice (ECJ), interpreting Article 6 (2) (c) of the Biotech Directive (denying the patentability of the use of human embryos for industrial and commercial purposes) and promised that it (and similar ECJ decisions) would influence future decisions in the EPO.Footnote 46
From the information reported by Elahi and Ramirez [39, p. 205], the EPO also appears to have been extremely responsive related to the EPO Scenarios project: According to one EPO official interviewed for their study, the Scenarios project encouraged EPO senior officials to address issues such as “global patent warming” (i.e. the surge of patent applications creating a great backlog). Further, it helped the EPO to establish institutional links with the World Economic Forum (WEF), the Organisation for Economic Cooperation and Development (OECD) and the United Nations (for green technology). It was instrumental in EPO’s strategical renewal and in revising its mission statement. The scenario planning effort of the EPO is credited as having supported the coming about of two major institutional innovations: (1) the London Protocol, an optional agreement aiming at reducing the costs relating to the translation of European patents, and (2) the so-called Unitary Patent. As far as the working processes of the EPO are concerned, it enabled the introduction of an internal Raising the Bar program to reduce the number of trivial patents clogging the IP system. It is also credited for accelerating the introduction of an end-to-end digitization program to produce patenting with zero paper emission. If all this is indeed the case, these are impressive results from a scenario process in terms of learning and institutional development. However, there is a lack of evidence on whether this has influenced the ability of EPO staff to engage in more reflexive deliberation on values and assumptions at the patent examination level. From an RRI perspective, this is of greater interest than the impact the scenarios have had on EPO’s business strategies.
With regard to responsiveness towards stakeholders, we have seen that the EPO, in its design, is responsive primarily to patent applicants, patent attorneys and delegations from national patent offices. With regard to involvement of other stakeholders at the level of examining and granting patents, the possibility for third-party observations and the amicus curiae hearing related to the WARF case may be regarded as positive examples, but there is a need for systematic follow-up research on how the EPO responds to such input from non-industrial NGOs and citizens generally.
At the level of examination and granting of patents, the system is in principle designed against responsiveness to society. Because EPO’s mandate is to apply the EPC, no arguments are allowed to influence granting decisions except those that directly concern the existence of prior art and the interpretation of the legal texts (including case law). Patent examiners should in principle not be influenced by public or stakeholder opinion in their interpretation of how the patentability requirements (novelty, inventive step, industrial use) apply to a case. Whether they in practice are immune to such influences would be an important empirical study.
These considerations indicate that the responsiveness to society of the EPO needs much more scrutiny. This indication was also clearly confirmed by the participants in a workshop on responsiveness in European patenting practices organised in Munich, May 2016.Footnote 47