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Experts and Politics in Patent Policy: The Final Report of the Expert Group on the Development and Implications of Patent Law in the Field of Biotechnology and Genetic Engineering of the European Commission, 17 May 2016

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Abstract

The 2016 Report of the “Expert Group on the development and implications of patent law in the field of biotechnology and genetic engineering group” is highly contentious. This opinion provides an overview of its content, discusses its relevance, and projects the future of the reform process of the Directive on Biotechnological Inventions 98/44/EC.

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Notes

  1. Download via the European Commission’s DG Growth Webpage: http://ec.europa.eu/growth/industry/intellectual-property/patents/biotechnological-inventions/; or directly: http://ec.europa.eu/DocsRoom/documents/18604/attachments/1/translations/ (first version uploaded 17 May 2016, last update of the report 16 September 2016).

  2. Commission Decision of 7 November 2012, C (2012) 7686 final.

  3. Article 2 of the Commission Decision reads in full: “to provide the Commission with the necessary legal and technical expertise regarding intellectual property law practice and intellectual property law administration, public and industrial research and development, life sciences including plant and animal breeding, and biotechnology in the context of the application of Directive 98/44/EC, with the exception of ethical issues related to that Directive, which are the mandate of the European Group on Ethics in Science and New Technologies” … [and] “to assist the Commission in its reporting requirements under Article 16, paragraph (c) of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions.”

  4. Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, OJ (30.7.1998) L 213/13.

  5. Prior reports COM(2002) 545 final and COM(2005) 312 final; discussed by Schneider (2010).

  6. Only recital 4 of the Commission Decision of 7 November 2012 (supra note 1) says that the group should assist the Commission in preparing a report on the development and implications of patent law in the field of biotechnology and genetic engineering” (emphasis added by C.G.).

  7. Various Resolutions of the European Parliament had called on the Commission to act; for a summary see Schneider (supra note 5), pp. 602–606.

  8. Programme of the Netherlands Presidency of the Council of the European Union, 1 January 2016–30 June 2016, p. 19. Download: https://english.eu2016.nl/documents/publications/2016/01/07/programme-of-the-netherlands-presidency-of-the-council-of-the-European-Union, published 6 January 2016.

  9. I. Schneider (supra note 5), pp. 601 and 609.

  10. This process resulted, after finalising the IIC review process, into the "Commission Notice on certain articles of Directive 98/44/EC of the European Parliament and of the Council on the legal protection of biotechnological inventions", OJ (8.11.2016) C 411/3.

  11. S. Bostyn, A. Farquharson, R. Jacob, A. Kamperman Sanders, S. Knuth-Lehtola, P. Pereira, P. Puigdomènech, C. Sattler de Sousa e Brito, I. Schneider and J. Taormino.

  12. S. Csörgő, H. Iserentant, C. Then and P. Würtz Lindum.

  13. S. Yeats.

  14. Belgium, Finland, France, Germany, Netherlands, Italy, Portugal, Spain and the United Kingdom, as required by recital 7 and Art. 4(3) of the Commission Decision 7 November 2012 (supra note 1).

  15. EuropaBio (industrial patent policy); European Seed Association (breeders); Flemish Institute of Biotechnology (independent, commercial biotechnological research); No Patents on Seeds! (patent opponent).

  16. This political pressure has built up in the Council of Agricultural Ministers, as recorded by the Luxembourg Presidency: “The impact of a recent decision of the European Patent office (EPO) concerning the patentability of plant traits on the plant breeders' rights regime” was discussed in the Council (Agriculture and Fisheries) on 22 October 2015 (http://data.consilium.europa.eu/doc/document/ST-12943-2015-INIT/en/pdf).

  17. The workshare corresponds to Art. 5(4) Commission Decision 7 November 2012 (supra note 1).

  18. In this area of law, even the presentation of the facts mirror the different worldviews. Therefore, majority and minority opinions need to be read side-by-side to reveal the different perspectives, rationales and assessments of the facts and evidence.

  19. The text assembles the situations of connectivity (e.g. Subreport A: pp. 109 et seq.; Subreport B: Annex B4, EPO-guidelines 2015 after Brüstle: p. 159); Subreport C, pp. 194 et seqq.). The political scientist I. Schneider describes the relation as “co-evolution”, Schneider (supra note 5), pp. 608, 620.

  20. The European Commission chose from about 90 applications.

  21. Yet, over the summer 2016 many mistakes were corrected, a proper front page was installed and a table of contents inserted, the structures of the three annexes became aligned – which provide for the overview of also the dissenting opinions. Yet, there is still an “annex” to an “annex” (p. 255); referencing is not impeccable (footnotes refer, e.g. to A III, meaning A3; footnote No. 113 refers to “alternative strategies […] as shown in Annex I”, but it is B. Annex 1. The text referred to has presumably been inserted into the introduction). Footnote No. 129 is incomplete as to publication years; footnote No. 198 is misleading: the referred authored article in the book edited by C. Geiger is: Krauss and Takenaka (2013). Also unclear are the references to the contributions in the books edited by Lawson and Charnley (eds, 2015) and Kur and Dreier (eds, 2013). Page numbers are missing for the article by G. Van Overwalle in IIC (2011).

  22. Minority opinion held by C. Then as regards part A (pp. 105–120), minority opinion held by S. Csörgő as regards part A (pp. 121–126), minority opinion held by I. Schneider as regards part B (pp. 161–177), minority opinion held by I. Schneider as regards part C (pp. 257–265).

  23. Report, pp. 12, 23.

  24. In short, the EBA in G2/07 required a value decision for an “essentially” biological process and rebutted the patent applicant’s argument that a single technical step in the process renders the process “technical”. The decision aimed at a delineation of the patent and the breeders’ rights system. It secures patentability for processes by which “a trait is introduced into a genome”, and excludes sexual crossing using whole genomes.

  25. These are the famous Tomato and Broccoli II decisions submitted 23 March 2015. Both cases concern molecular marker selection (“smart breeding”), without involving genetic engineering. The legal question was if product protection is available for products which are produced by a process which is itself excluded from patentability under Art. 53(b) EPC. The EBA came to the conclusion that the products remain patentable. The rationale of the decision has remained controversial, see C. Godt, “Good Patent Governance: Norms, Criteria and Procedure”, (forthcoming 2016).

  26. As discussed by the Committee on Agriculture and Rural Development on 13 October 2015 (http://www.europarl.europa.eu/meetdocs/2014_2019/documents/agri/oj/1074/1074951/1074951en.pdf; topic 11); and the Luxembourg Presidency has prepared a note on “The impact of a recent decision of the European Patent office (EPO) concerning the patentability of plant traits on the plant breeders' rights regime”, which was discussed by the Council (Agriculture and Fisheries) on 22 October 2015 (http://data.consilium.europa.eu/doc/document/ST-12943-2015-INIT/en/pdf).

  27. Spelled out in an attached reflection also called "dissenting opinion" by the Chair of the expert group S. Bostyn (Subreport A, Annex A5, pp. 127 et seq.).

  28. Subreport A, Annex A3, pp. 105–120.

  29. Again, for in-depth legal argumentation, one is in better hands with the standard academic literature, e.g. Romandini (2012); Ruster (2015).

  30. C-34/10, CJEU of 18 October 2011, Brüstle, ECR 2011 I, 9821; and C-364/13, CJEU of 18 December 2014, Int’l Stem Cell Corp. (ISCC), published digitally: ECLI:EU:C:2014:2451. For a discussion of these two: Godt (2015).

  31. There is evident tension between the EU and the EPO. While a representative of the EPO was a member of the group, the EPO member did not consent to publishing statistics concerning pending patent applications involving human embryonic stem cells; Report, p. 164.

  32. The minority and majority discuss the same body of scientific evidence, but evaluate its impact on patentablility of new filings in the opposite direction (as evidenced, p. 149, fn. 137). The minority report gives reasons why “the Chung publication” of 2008 cannot be trusted (p. 168), and which impact this evaluation has on claim interpretation (p. 173) [infra 2.2.3]. It is not conveyed why the majority thinks it is able to rely on it. The argumentation could only be retraced if the minutes of the hearing of the scientific expert – the stem cell researcher Prof. Peter Andrews, Professor of Biomedical Science at the University of Sheffield (Report, p. 7) – were public. As conveyed by the minutes of 27 November 2014, several group members had requested the secretariat to prepare a summary report. Obviously, they wanted the arguments to be put on public file. The minutes reveal that the draft report was compiled and sent to Prof. Andrews for approval. Yet, the summary report of the hearing has not been posted on the webpage: http://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupDetail&groupID=2973.

  33. Chung et al. (2008).

  34. Ledford (2015).

  35. C-428/08, CJEU of 6 July 2010, ECR 2010-I, 6765 – Monsanto v. Cefetra.

  36. Godt (2007), pp. 620 (Biopatent Dir.).

  37. Godt, ibid, p. 21, fn. 28.

  38. C-428/08: CJEU’s decision No. 2. The formulation “precludes […] absolute protection” is repeated in the decision several times. To quote Advocate General Mengozzi, in his opinion given at No. 32: “It seems to me that to grant absolute protection to an invention consisting in a DNA sequence, thereby conferring on the patent holder exclusive rights over that sequence, extending to all its possible uses, including those unspecified or unknown at the time when the application was lodged, would be in breach of that fundamental principle, in so far as it would confer on the patent holder a disproportionate level of protection”. In addition, at No. 29, he qualified the protection conferred by the Biopatent Directive as a “purpose-bound” protection.

  39. Which would impose itself for two reasons: (1) the Monsanto case was only on “patent right protection in circumstances such as those of the case in the main proceedings, in which the patented product is contained in the soy meal, where it does not perform the function for which it was patented” (CJEU at No. 33); (2) Advocate General Mengozzi advanced a third definition of “function/purpose”. He says in his opinion given at No. 29: “I consider that […] a DNA sequence must be regarded as protected, even as a self-standing product, only where it performs the function for which it was patented. In other words, it seems to me that Directive 98/44 permits – and, in fact, requires – an interpretation to the effect that […] the protection conferred on DNA sequences is a ‘purpose-bound’ protection”.

  40. Van Overwalle (2011).

  41. The charts are taken from Schneider (supra note 5), pp. 461 et seqq.; see also Godt (supra note 36) p. 620 et seqq.

  42. In depth: Gruss (2011); Uhrich (2010).

  43. Krauss and Takenaka (supra note 21), at p. 265; Gruss (supra note 42); Godt (supra note 36), p. 83.

  44. There is no national case law, as revealed by a European comparative research project, C. Godt, G. Van Overwalle, L. Guibault and D. Beyleveld (eds), Boundaries to Information Property, Cambridge University Press (publication forthcoming). On the reasons thereof one may only speculate. One reason might be that the patent holders have no interest in clarification as this might eventually result in the restriction of EPC patents.

  45. A competitor and potential infringer may not be very interested in national litigation because territoriality of one single state may not outweigh the costs of litigation, because the other 37 EPC member states do still have other jurisdictions. It requires a peculiar business situation in order to make an infringement suit based on the restrictive national statutory language in one of the five member states economically reasonable.

  46. Technically called “Comitology System”, see inter alia Vos (2009).

  47. The European Commission uses the term “expert groups” and distinguishes these from “comitology committees”; see the Commissions explanation of “expert groups” at: http://ec.europa.eu/transparency/regexpert/index.cfm?do=faq.faq&aide=2.

  48. Comitology committees are composed of Member States’ delegates who support the European Commission in formal decision-making, legitimized by the EU legislator, which empowers the Commission to adopt implementing legislation subject to the scrutiny of Member States.

  49. Classically conceptualised as an intended conflict between “truth” and “power”, R. Mayntz, “Speaking Truth to Power: Leitlinien für die Regelungen wissenschaftlicher Politikberatung, der moderne Staat” (dms) – 2(1) Zeitschrift für Public Policy, Recht und Management pp. 5–16, 9: “Der Wissenschaft geht es um wahre Aussagen, der Politik um gestaltendes Handeln. Diese unterschiedlichen Rationalitäten müssen im Beratungsprozess vermittelt werden: Die Qualität der Politikberatung bemisst sich daran, wieweit es gelingt, ein sowohl wissenschaftlich solides wie politisch umsetzbares, kurz ein dem Zweck entsprechend brauchbares Ergebnis zu erzielen.”

  50. See the joint publication of M. Bartl et al., “Knowledge, Law and Power beyond the State”, Amsterdam Law School Legal Studies Research Paper No. 2016-08.

  51. “Formal” work groups are set up by Commission decision. “Informal” work groups are set up by an individual Commission department that has obtained the agreement of the Commissioner and Vice-President responsible and of the Secretariat-General.

  52. The European Commission distinguishes five types (A–E) of expert members: Type A – individuals appointed in a personal capacity, acting independently and expressing their own personal views. Type B – individuals appointed to represent a common interest shared by stakeholder organizations in a particular policy area. They do not represent individual stakeholders, but a particular policy orientation common to different stakeholder organizations. They may be proposed by stakeholder organizations. Type C – organizations in the broad sense of the word including companies, associations, NGOs, trade unions, universities, research institutes, law firms, and consultancies. Type D – Member States’ authorities (national, regional or local). Type E – other public entities, such as authorities from non-EU countries (including candidate countries), EU bodies, offices or agencies, and international organizations.

  53. Being an additional category, most evident with regard to expert committees on ethics, cp. the Federal Belgian Ethics Council representing “the population” (http://www.health.belgium.be/nl/belgisch-raadgevend-comite-voor-bio-ethiek) to the Danish Council of Ethics (http://www.etiskraad.dk/Om-Raadet/Historie.aspx) and the European Group of Ethics (https://ec.europa.eu/research/ege/index.cfm), the latter both representing “experts as experts”.

  54. Qualified as essential element of expert advice, see Mayntz (supra note 49), p. 11.

  55. Recently OECD (2015), “Scientific Advice for Policy Making: The Role and Responsibility of Expert Bodies and Individual Scientists”, OECD Science, Technology and Industry Policy Papers, No. 21, OECD Publishing, Paris. doi:10.1787/5js33l1jcpwb-en; and European Commission, Taking European Knowledge Society Seriously, Report of the Expert Group on Science and Governance to the Science (directed by Brian Wynne), 2015, http://www.ec.europa.eu; academic reflection about the interface has centered around the terms of risk and precaution. A seminal text is Beck (1986); for a primer, see Antonsen and Elmkvist Nilsen (2013).

  56. With regard to the Biopatent Directive, the Commission is complementarily supported by the EGE group, its webpage (supra note 53). For an analysis see Busby et al. (2008).

  57. B. Farrand, “Trading Information for Influence: Forms of Knowledge and the Power of Legitimacy”, in: M. Bartl et al. (eds), (supra note 50), p. 11.

  58. This expectation might not be cogent in all cases.

  59. P. M. Haas, “Introduction: Epistemic Communities and international policy coordination”, 46 International Organization, special edition, “Knowledge, Power, and International Policy”, 1992, pp. 1–35, at p. 3. A seminal work is Holzner and Marx (1979).

  60. B. Farrand (supra note 57), p. 11 observes that “experts” might have “expert knowledge”, but differ with regard to “institutional knowledge, impacting on their ability to be heard”. He distinguishes academics and volunteer staff of NGOs with professional support structures of industry.

  61. http://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupDetail&groupID=2973.

  62. The subgroup on human embryonic stem cells had “the benefit of having invited” one “external” natural scientist Prof. Peter Andrews, University of Sheffield (UK) (report p. 7), as foreseen in Art. 5(7) Commission Decision 7 November 2012 (supra note 1). His expertise was highly valued by the group. Records of the hearing with him were kept (as stated in the minutes of the 8th Meeting of 27 November 2014), but have not been made public.

  63. The European Commission attended the meetings as stipulated in Art. 5(3) Commission Decision 7 November 2012 (supra note 1). Knowledgeable personnel were sent to the group’s meetings, directed by the head of department responsible for IP. This position was held by K. Jorna, until the European Commission was reshaped in Summer 2015 merging former DG Market and DG Enterprise into DG GROW.

  64. Described by Schneider (supra note 5), pp. 194–199.

  65. The installment of expert commissions for strategic reasons is not without precedent. The expert group installed in 2002 to support the Commission in preparing the first Art. 16(c) Report to the Patent Directive 98/44/EC served the function of demonstrating that the Commission was aware of the problem (but it opted not to act formally), Schneider (supra note 5), p. 598. For a thoughtful analysis of “political instrumentalization” of scientific advice see Mayntz (supra note 49), pp. 10 and 14. While she recognizes the underlying problem, she opposes the idea that scientific policy advice should be distinguished from political advice. She aligns the problem with dichotomous opposites, which by their very nature cannot be resolved in one direction only.

  66. “Where possible, unanimity was sought”, Report, p. 11.

  67. P. 28: “Within the Expert Group, agreement could be reached that Headnote 1 and 2 of G2/07 constituted valuable and valid elements of a definition of what is an essentially biological process.” P. 29: “All Experts could agree that natural mutagenesis is a natural process, and that targeted mutagenesis is a technical process.”

  68. On first sight, the Commission’s webpage of the group’s work provides transparency. It posts all agendas and minutes. However, additional documents which were prepared on request by several members are not posted (supra note 32). It is questionable if the non-publication of these documents is in line with good governance norms on expert advice on the side of the advised organization, which shall safeguard against unwarranted instrumentalization of expertise, see Mayntz (supra note 49), p. 12.

  69. No one would expect natural scientists “to consolidate”, or to find “consensus”.

  70. E.g. by creating a time-limited permit for emissions or by a safety measure defined by distance.

  71. C. Sattler de Sousa e Brito, rapporteur for Subreport B on stem cells, was part of the attorney’s team representing Brüstle in the CJEU’s Brüstle proceedings.

  72. J. Taormino reveals on his webpage that he has held various mandates in the EPO’s opposition and appeal procedures on the part of the food and pharmaceutical industry.

  73. Rapporteur for the Subreport A, Hannes Iserentant, e.g. is with the Technology Transfer Institute of the Vlaams Instituut voor Biotechnologie, Ghent. This is a (privatized) TTO, working for the (public) University of Ghent.

  74. Personal communication, 9 June 2016. Van Overwalle’s opinion is based on her membership for many years in the Belgian Advisory Council on Bioethics, the first European Commission's Expert Group on Biotechnological Inventions, the Standing Advisory Committee before the EPO (SACEPO), and the Economic and Scientific Advisory Board (ESAB) of the EPO.

  75. Some of the fundamental beliefs of this “patent epistemic community” are: (1) patentability requirements are conceived of “rules” which have to be interpreted widely, whereas exemptions are technically “exceptions” which are to be interpreted narrowly (disregarding the fact that patents are exceptions to competition, and the legitimation for the exceptions); (2) the patent scope is defined by the wording of the claim (not by concurring human rights, regulations, and circumstances “upstream”); (3) the principle of absolute product protection is valid and may not be questioned; and (4) “conflicts are taken care of by contract autonomy”, and not by statutory licenses.

  76. Schneider (supra note 5), p. 608 (in the original: “parlamentarisches Stimmungsbarometer”).

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Godt, C. Experts and Politics in Patent Policy: The Final Report of the Expert Group on the Development and Implications of Patent Law in the Field of Biotechnology and Genetic Engineering of the European Commission, 17 May 2016. IIC 47, 960–980 (2016). https://doi.org/10.1007/s40319-016-0529-y

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