CA/PL 3/18 Orig.: en Munich, 30.01.2018 SUBJECT: SUBMITTED BY: ADDRESSEES: Update on the patentability of inventions concerning plants and animals under the EPC President of the European Patent Office Committee on Patent Law (for information) SUMMARY In its 152nd meeting on 29 June 2017 the Administrative Council decided to clarify the interpretation of Article 53(b) EPC by way of amendment of Rules 27(b) and 28 EPC in order to exclude from patentability plants and animals exclusively obtained by an essentially biological process. The amendment to the Implementing Regulations was based on a favourable opinion given by the Committee on Patent Law in the 48th meeting in April 2017 and took also account of the Notice of the European Commission from November 2016 related to certain articles in the EU Directive on biotechnological inventions (98/44/EC). In order to provide instructions to examining and opposition divisions for application of the amended practice, the Guidelines for examination were adapted before their entry into force in November 2017. The co-operation with the Community Plant Variety Office continues. CA/PL 3/18
- I - TABLE OF CONTENTS Subject Page I. STRATEGIC/OPERATIONAL 1 II. RECOMMENDATION 1 III. MAJORITY NEEDED 1 IV. CONTEXT 1 V. UPDATES 3 A. AMENDMENT TO THE IMPLEMENTING REGULATION 3 B. ADAPTATION OF THE GUIDELINES FOR EXAMINATION 4 C. EPO/CPVO CO-OPERATION 6 VI. FINANCIAL IMPLICATIONS 7 VII. LEGAL BASIS 7 VIII. DOCUMENTS CITED 7 IX. RECOMMENDATION FOR PUBLICATION 8 CA/PL 3/18
I. STRATEGIC/OPERATIONAL 1. Operational. II. RECOMMENDATION 2. The present document is submitted to the Committee on Patent Law for information. III. MAJORITY NEEDED 3. N/A. IV. CONTEXT 4. Under Article 53(b) EPC European patents shall not be granted in respect of plant or animal varieties or essentially biological processes for the production of plants or animals. The wording of the provision and the wording of Article 4(1) of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions (hereafter "EU Biotechnology Directive") are identical. 5. Pursuant to Rule 27 EPC, in the version of 1 July 2017, biotechnological inventions shall also be patentable if they concern (a) biological material which is isolated from its natural environment or produced by means of a technical process even if it previously occurred in nature, as well as (b) without prejudice to Rule 28, paragraph 2, plants or animals if the technical feasibility of the invention is not confined to a particular plant or animal variety. This provision corresponds to Articles 3(2) and 4(2) of the EU Biotechnology Directive. Under Rule 26(1) EPC the EU Biotechnology Directive shall be used as a supplementary means of interpretation when applying and interpreting the relevant provisions of the EPC. Rules 26-29 EPC were inserted into the EPC in 1999 in order to implement the requirements of the EU Biotechnology Directive in European patent law. 1 6. According to new Rule 28(2) EPC, in the version of 1 July 2017, under Article 53(b), European patents shall not be granted in respect of plants or animals exclusively obtained by means of an essentially biological process. 7. The EPO's Enlarged Board of Appeal gave an interpretation of the exclusion of essentially biological processes within the meaning of Article 53(b) EPC in its combined decisions G 2/07 and G 1/08 of 9 December 2010 2. 1 See Administrative Council document CA/7/99 of 4 May 1999 and the notice dated 1 July 1999 concerning the amendment of the Implementing Regulations to the European Patent Convention, OJ EPO 1999, 573. 2 OJ EPO 2012, 130 and 206. See also document CA/PL 4/17, point 6. CA/PL 3/18 1/8
8. In 2015, before the amendment of Rule 28 EPC, the Enlarged Board of Appeal gave a positive opinion on the allowability of a product claim directed to plants or plant material obtained by an essentially biological process. Patentability was allowed, provided that the application or patent and the invention to which it relates fulfils the formal and substantive requirements of the EPC (see combined decisions G 2/12 and G 2/13 of 25 March 2015 3 ). 9. Following the resolution adopted by the European Parliament in December 2015 4, asking the EU Commission to clarify the patentability of conventional plants under the EU Biotechnology Directive, on 3 November 2016 the EU Commission adopted Notice C/2016/6997 on certain articles of the EU Biotechnology Directive 5 (hereafter "EU Commission Notice"). Based on an analysis of the travaux préparatoires relating to the adoption of the EU Biotechnology Directive, particularly concerning Article 4, as well as on an interpretation of other provisions of the EU Biotechnology Directive, the EU Commission took the view that the EU legislator's intention when adopting the EU Biotechnology Directive was to exclude from patentability products (plants/animals and plant/animal parts) that are obtained by means of essentially biological processes 6. 10. In previous meetings of the Committee on Patent Law the patentability of plantrelated inventions was discussed in the light of both decisions G 2/12 and G 2/13 and of the EU Commission Notice 7. 11. In its 48th meeting on 27 and 28 April 2017 the Committee on Patent Law discussed various options for the way forward on the basis of the analysis prepared by the Office (CA/PL 4/17). The option of amending the EPC Implementing Regulations and the specific wording set out in the Office's analysis benefited broad support. This outcome was reached in the desire to find a balance between legal certainty, clarity and swift action. For the precise wording of the amendment, alternative proposals from the Swiss delegation, which was later withdrawn, as well as from Business Europe (CA/PL 8/17) and epi (CA/PL 9/17) were taken into account in addition to the draft text included in the Office's analysis (point 98 of CA/PL 4/17). The Committee invited the Office to maintain the technical details of points 70-91 of CA/PL 4/17 in the Council document as explanatory notes. The potential for using disclaimers in claims relating to plant patents was to be considered further in the context of the explanatory note. The Committee further invited the Office to adapt the Guidelines for Examination in the EPO to clarify the implementation of the provisions. 3 OJ EPO 2016, A27 and A28. See also document CA/PL 4/17, point 7. 4 P8_TA-PROV(2015)0473: European Parliament Resolution of 17 December 2015 on patents and plant breeder s rights, 2015/2981 (RSP). 5 Official Journal of the EU C 411/3 of 8 November 2016. 6 The EU Commission Notice also addressed other measures, namely compulsory cross-licensing and acces to and deposit of biological material. 7 See documents CA/PL 12/15, CA/PL 3/16, CA/PL 4/16 and CA/PL 18/16 CA/PL 3/18 2/8
12. On this basis the Office submitted a proposal for amendment of the Implementing Regulations to the EPC for decision by the Administrative Council in June (CA/56/17). V. UPDATES A. AMENDMENT TO THE IMPLEMENTING REGULATION 13. On the basis of Articles 33(1)(c) and 35(2) EPC, by decision CA/D 6/17 of 29 June 2017 8 the Administrative Council adopted amendments to Rules 27(b) and 28 EPC in order to exclude from patentability plants and animals exclusively obtained by an essentially biological process 9. The amendment to the Implementing Regulations took account of the EU Commission Notice. By aligning the EPC and the EPO's practice under Article 53(b) EPC with the interpretation of the EU Biotechnology Directive set out in the EU Commission Notice, the amendment safeguards uniformity in harmonised European patent law. At the same time it provides users of the European patent system with more clarity and legal certainty. 14. Amended Rule 27(b) EPC - Patentable biotechnological inventions reads as follows: "Biotechnological inventions shall also be patentable if they concern: (a) Unchanged (b) without prejudice to Rule 28, paragraph 2, plants or animals if the technical feasibility of the invention is not confined to a particular plant or animals variety; (c) Unchanged." 15. New Rule 28(2) EPC - Exceptions to patentability reads as follows: Under Article 53(a), European patents shall not be granted in respect of biotechnological inventions which, in particular, concern the following: (a) Unchanged (b) Unchanged (c) Unchanged (d) Unchanged. (2) Under Article 53(b), European patents shall not be granted in respect of plants or animals exclusively obtained by means of an essentially biological process. 16. The amended Rules entered into force on 1 July 2017. The clarifying nature of the amendment implies that the law has always been in conformity with that interpretation and is thus applicable to European and international applications filed on or after the date of entry into force as well as to pending European patent applications and European patents. This corresponds to the approach taken in the framework of incorporating the EU Biotechnology Directive into the EPC in 1999 10. 8 Cf. Decision of the Administrative Council of 29 June 2017 amending Rules 27 and 28 of the Implementing Regulations to the European Patent Convention (CA/D 6/17), in OJ EPO 2017, A 56. 9 A corresponding exclusion is also present in the national law of certain member states (DE, FR, NL, IT). 10 See T 272/95, point 4 of the Reasons for the Decision. See G 2/07 and G 1/08, OJ EPO 2012, 130 and 206, point 2.4 of the Reasons for the Decision; T 716/91, not published in the OJ EPO, point 2.2 of the CA/PL 3/18 3/8
17. Affected proceedings, which had been stayed ex officio by decision of the President of the EPO on 24 November 2016 11 pending a clarification by the Administrative Council, are gradually resumed and are examined according to the amended Rules 12. B. ADAPTATION OF THE GUIDELINES FOR EXAMINATION 18. The Guidelines for Examination in the EPO are annually updated. The latest edition entered into force on 1 November 2017 and contains instructions to assist examining and opposition divisions in the application of the amended Rules. The new content of the relevant sections in the Guidelines essentially reflect the technical details used as explanatory notes in CA/PL 4/17 (points 70-91). An extraordinary meeting of the SACEPO Working Group Guidelines was scheduled in July 2017 to consult users on the intended text. 19. The exclusion of plants or animals exclusively obtained by means of an essentially biological process according to new Rule 28(2) has been reflected in G-II, 5 (5.2 (ii); 5.3 and 5.4). In section G-II, 5.4 it is clarified that the purpose of Rule 28(2) EPC is to exclude products (plants/animals and plant/animal parts) exclusively obtained by non-technical, i.e. essentially biological, processes. Thus, the exclusion extends to plants and animals exclusively obtained by means of an essentially biological process where no direct technical intervention in the genome of the plants or animals takes place, as the relevant parental plants or animals are merely crossed and the desired offspring is selected for. 20. As discussed in the 48th meeting of the Committee on Patent Law, the term exclusively is used to clarify that a plant or animal originating from a technical process or characterised by a technical intervention in the genome is not covered by the exclusion from patentability even if in addition a non-technical method (crossing and selection) is applied in its production. Therefore the plants or animals produced by a technical process which modifies the genetic characteristics of the plant or animal are patentable. Reasons for the Decision; as well as G 9/93, OJ EPO 1994, 891, point 6.1 of the Reasons for the Decision. 11 Notice from the European Patent Office dated 24 November 2016 concerning the staying of proceedings due to the Commission Notice on certain articles of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, OJ EPO 2016, A104. 12 See Notice from the European Patent Office dated 3 July 2017 concerning the resumption of proceedings following the decision of the Administrative Council of 29 June 2017 to amend Rules 27 and 28 EPC in order to exclude from patentability under Article 53(b) EPC plants and animals exclusively obtained by essentially biological processes, OJ EPO 2017, A 62. CA/PL 3/18 4/8
21. Determining whether a plant or animal is obtained by exclusively biological means entails examining whether there is a change in a heritable characteristic of the claimed organism which is the result of a technical process exceeding mere crossing and selection, i.e. not merely serving to enable or assist the performance of the essentially biological process steps. 22. This implies that, provided the invention is not confined to a particular plant or animal variety (cf. G 1/98 of 20.12.1999 13 ), transgenic plants or animals and technically induced mutants are patentable. Both targeted mutation, e.g. with CRISPR/Cas, and random mutagenesis such as UV-induced mutation are such technical processes. When looking at the offspring of transgenic organisms or mutants, if the mutation or transgene is present in said offspring, it is not produced exclusively by an essentially biological method and is thus patentable. 23. The reference to the general principles governing disclaimers, which has been added in GL, G-II, 5.4 is particularly relevant for claims directed to technically induced mutants. It is envisaged to add a further passage in the Guidelines 2018 with regard to the use of disclaimers in such claims, to exclude plants or animals exclusively obtained by means of an essentially biological process. Account will be taken of the outcome of the proceedings G 1/16, which were pending at the Enlarged Board of Appeal during the drafting of the 2017 edition. 24. Plant or animal propagation material is to be treated in the same manner as the plants or animals themselves. Thus it falls under the exclusion if the technical effect is brought about by an essentially biological process. However the exclusion does not extend to plant or animal parts, which are not propagation material and derived products, such as flour, fatty acids, sugars. These products are treated as chemical products and, provided the general patentability requirements are fulfilled, are patentable. The technicality of a claimed plant or animal product may also lie in a non-heritable physical feature imparted directly to the claimed organism, e.g. a seed coated with a beneficial chemical. 25. Under section G-II, 5.4.2 the exclusion of essentially biological processes for the production of plants or animals is addressed. In a method claim any step of crossing, either implicit or explicit, leads to an objection under Article 53(b) EPC. It has been further clarified that where an essentially biological method contains an additional feature of a technical nature, i.e. the use of genetic molecular markers, the method as a whole remains excluded from patentability (cf. G 1/08, G 2/07), however patent protection is available for any such additional technical steps per se which are performed either before or after the process of crossing and selection. 13 OJ EPO, 2000, 111. CA/PL 3/18 5/8
26. A clarification regarding plants or animals defined by a product-by-process claim has been introduced in F-IV, 4.12, in the sense that the technical method of production of the plant or animal, which imparts a technical feature to a product, may be included in the claims in the form of a product-by-process claims. In this context a reference to the general principles governing disclaimers by which plants and animals excluded from patentability are removed from protection has been added (H-V, 3.5 and 4). 27. Additional examples have been provided to illustrate both excluded subject-matter and patentable subject-matter under the new provisions (G-II, 5.4.2.1). 28. In addition to the Guidelines, examining and opposition divisions are provided with administrative instructions issued under Article 10(2)(a) EPC for the application of amended Rules 27(b) and 28(2) EPC. There particular weight is given to the rigorous assessment of the patentability requirements of novelty (Article 54 EPC) and inventive step (Article 56 EPC). Additionally the examination of reproducibility of the claimed invention without undue burden by the skilled person is underlined. In that assessment account is taken of the public availability of the plant line from which the desired trait is obtainable (Article 83 EPC). The requirement of clarity of the claims (Article 84 EPC) is equally applied in a strict manner. 29. During the revision of the Guidelines for Examination 2018 the relevant passages will be completed and expanded. It is also foreseen to revert to the exclusion of conventional plants/animals, once experience will be gathered with the new provisions, as indicated by the Administrative Council at the June 2017 meeting. C. EPO/CPVO CO-OPERATION 30. On 11 February 2016 the EPO signed an Administrative Arrangement with the EU Community Plant Variety Office (CPVO) to enhance bilateral co-operation, in particular with the aim to strengthen the interinstitutional relationship through the exchange of information and in order to increase transparency. Two bilateral workshops were held (Angers in September 2016 and Munich in March 2017) to increase technical awareness and legal expertise among experts from both organisations and to share knowledge and working practices. 31. In the perspective of improving the use of databases, a project has been developed to integrate CPVO data on plant varieties into the EPO databases. CPVO data is currently not available in a searchable format. It is expected that the availability of CPVO data for EPO examiners will increase transparency and enhance quality of patents in the plant field. The project is ongoing since clarification is still needed on the public availability of the data. In some cases, the information available to the public is not separate from confidential information contained in the relevant documents. CA/PL 3/18 6/8
32. On 29 November 2017 a joint EPO-CPVO public conference was successfully held in Brussels to illustrate the way in which the two offices co-operate to support innovation in the plant sector. Three panel discussions, bringing together policy makers, experts and industry were dedicated respectively to (i) the European Commission's interpretative Notice, (ii) the benefits of IP protection in the plant sector and (iii) transparency and access to innovation. Updates on the patentability of plant-related inventions under the new EPC rules and on latest developments in the plant-variety rights (PVRs) system were also given. 33. During the conference, speakers underlined the complementarity between plantrelated patents and PVRs and stressed the need to find balanced solutions for their coexistence within the current legal framework. In this context the positive effects of the co-operation were pointed out. Transparency was also emphasised, through patent information and PVR documents freely accessible to the public. With regard to the access to protected information both breeders' initiatives, such as the Patent Information and Transparency Online (PINTO) database linking plant varieties to relevant patent information and the industry-led International Licensing Platform (ILP) were highlighted. The conference attracted some 200 participants from industry and academia, the European Commission, European Parliament, legal practice, national patent offices, NGOs and the general public. 34. The co-operation also embraces further opportunities for technical exchanges, such as the participation of EPO staff members to the CPVO meetings and the participation of CPVO staff to EPO training events. 35. It is intended to continue the co-operation with the CPVO in the future with regular information exchanges and expert meetings. Implementation of CPVO data integration is aimed to be finalized in the course of 2018. VI. FINANCIAL IMPLICATIONS 36. N/A. VII. LEGAL BASIS 37. Article 10(2)(c) EPC; Article 33(1) EPC. VIII. DOCUMENTS CITED 38. CA/7/99; CA/PL 12/15; CA/PL 3/16; CA/PL 4/16; CA/PL 18/16, CA/PL 4/17, CA/56/17, CA/D 6/17. CA/PL 3/18 7/8
IX. RECOMMENDATION FOR PUBLICATION 39. Yes. CA/PL 3/18 8/8