- “The Enlarged Board [] abandons the interpretation of Article 53(b) EPC given in decision G 2/12 [sic, G 2/13 is not mentioned] and, in the light of Rule 28(2) EPC, holds that the term essentially biological processes for the production of plants or animals in Article 53(b) EPC is to be understood and applied as extending to products exclusively obtained by means of an essentially biological process or if the claimed process feature defines an essentially biological process” (r.26.8). Therefore, such products are not patentable under Article 53(b) EPC (see below for transitional provisions).
- This leads to the headnote:
- “Taking into account developments after decisions G 2/12 and G 2/13 of the Enlarged Board of Appeal,
- the exception to patentability of essentially biological processes for the production of plants or animals in Article 53(b) EPC has a negative effect on the allowability of
- product claims and product-by-process claims directed to plants, plant material or animals,
- if the claimed product is exclusively obtained by means of an essentially biological process
- or if the claimed process features define an essentially biological process.”
- “This negative effect does not apply to European patents granted before 1 July 2017 and European patent applications which were filed before that date and are still pending.”
- I note that the alternative ground of exclusion from patentability due to process features (recited in a product-by-process claim) defining an essentially biological process is not expressly specified in R.28(2) and reverses G 2/13 hn.2(a). The (only public) underlying document for R.28(2), CA/56/17 appears to be silent about process features.
- The Enlarged Board also extends the prohibition to "plant material" in the headnote, unlike R.28(2) (see the comparison below). The interested reader is referred to CA/56/17, paras. 48, 50 and 64 for the reason why R.28(2) does not mention 'plant material'. The Enlarged Board does not mention that (not patentable) 'plant material' is restricted to propagation material. So perhaps the exception extends to claims directed to
a harvested tomato and totomato paste and tomato juice. Plant material 'such as fruit' is mentioned in G2/12 hn.1. - Before arriving at its decision to overturn G2/12 (and G2/13), “the Enlarged Board concludes that, in view of the clear legislative intent of the Contracting States as represented in the Administrative Council and having regard to Article 31(4) Vienna Convention ["a special meaning shall be given to a term if it is established that the parties so intended"], the introduction of Rule 28(2) EPC allows and indeed calls for a dynamic interpretation of Article 53(b) EPC.”
- The Enlarged Board, however, begins its analysis by rephrasing the questions referred by the President of the Office. The first question is rephrased because the “wording of question 1 is too general and unspecific in that it broaches an institutional topic which reaches well beyond the ultimate object of the referral”.
- The Enlarged Board considers the rephrased question to be admissible: “there are different decisions of two Boards of Appeal on the question whether an amendment to the Implementing Regulations can have an impact on the interpretation of an Article of the EPC” (namely, T 1063/18 implying that such amendment can't have such an impact and T 315/03, r.7.3 stating that “that Article 53(a) EPC contains nothing which precludes or limits its own subsequent interpretation [] by (secondary) legislation”).
- The Enlarged Board decision has the advantage that it avoids a clash with the Contracting States (wisely, in my view). At the same time, the Enlarged Board appears to leave open the question of whether Rule 28(2) EPC is binding on the Enlarged Board.
- “[A]lthough neither the Contracting States, in accordance with Article 172 EPC, nor the Administrative Council, in accordance with Article 33(1)(b) EPC, has formally amended Article 53(b) EPC to extend the scope of the process exclusion to animals, plants and plant material obtained by essentially biological processes, when now interpreting Article 53(b) EPC, the Enlarged Board cannot ignore the Administrative Councils decision to introduce a new paragraph 2 in Rule 28 EPC”. The phrase ‘cannot ignore’ seems to have a different meaning than ‘is bound by’. Indeed the headnote shows that R.28(2) does not preclude the Enlarged Board from declaring more subject-matter non-patentable.
- “As the content of Rule 28(2) EPC does not stand in contradiction to the new interpretation of Article 53(b) EPC given in this opinion, there is no conflict between these provisions.” (emphasis added)
- As to the transitional provision: “For applications, the relevant date is their date of filing or, if priority has been claimed, their priority date.”
- Also interesting is the statement that “[i]rrespective of [the legal status of the Commission's Notice under EU law], as an independent international organisation with its own autonomous legal order, the EPOrg is not directly bound by Union law. It is therefore all the more true that a legally non-binding Notice on the interpretation of the EU Biotech Directive issued by the EU Commission in reaction to decisions of the Enlarged Board on the interpretation of a provision of the EPC, i.e. Article 53(b) EPC, does not form part of EPC law.”
- On the general question of whether exceptions are to be interpreted in a narrow or a broad way: “the Enlarged Board also confirms [...] that the object and purpose of the exception to patentability under Article 53(b) EPC is not sufficiently obvious to answer the question whether or not the clause is to be construed in a narrow or broad way.”
- One Board member of the panel in G3/19 was also a member of the (combined) panel in G 2/12 and G2/13. This member was interestingly enough also the rapporteur in all three cases (link).
- The decision recites “the claimed process features”, but I think that features are not strictly speaking claimed. Subject-matter is claimed, features are recited in a claim. Possibly the headnote should be read as “if the process features of the product-by-process claim define an essentially biological process” (cf. G2/13, hn.2(a)).
- The decision recites “or if the claimed process feature define” (sic) in r.3.3, 'features' in the plural in the headnote and "the claimed process feature defines" r.26.8 but I don't think this any relevance for the substance of the holding.
EPO Headnote
Taking into account developments after decisions G 2/12 and G 2/13 of the Enlarged Board of Appeal, the exception to patentability of essentially biological processes for the production of plants or animals in Article 53(b) EPC has a negative effect on the allowability of product claims and product-by-process claims directed to plants, plant material or animals, if the claimed product is exclusively obtained by means of an essentially biological process or if the claimed process features define an essentially biological process.
This negative effect does not apply to European patents granted before 1 July 2017 and European patent applications which were filed before that date and are still pending.
Comparison G 3/19 vs. Rule 28(2)
Headnote: "plants, plant material or animals, if the claimed product is exclusively obtained by means of an essentially biological process or if the claimed process features define an essentially biological process"
Rule 28(2): "plants or animals exclusively obtained by means of an essentially biological process"Addendum 20.07.2020
The Supreme Court has stated: “The principle that statutes operate only prospectively, while judicial decisions operate retrospectively, is familiar to every law student.” Rivers v. Roadway Express, Inc., 511 U.S. 298, 311-12 (1994). link (with further references and discussion)
EPO G 0003/19 - link
G 3/19 G3/19
SUMMARY OF THE PROCEEDINGS
The referred questions
I. By letter dated 4 April and received on 8 April 2019, the President of the European Patent Office (hereinafter the EPO President) referred the following questions to the Enlarged Board of Appeal (hereinafter the Enlarged Board) under Article 112(1)(b) EPC:
1. Having regard to Article 164(2) EPC, can the meaning and scope of Article 53 EPC be clarified in the Implementing Regulations to the EPC without this clarification being a priori limited by the interpretation of said Article given in an earlier decision of the Boards of Appeal or the Enlarged Board of Appeal?REASONS FOR THE OPINION
2. If the answer to question 1 is yes, is the exclusion from patentability of plants and animals exclusively obtained by means of an essentially biological process pursuant to Rule 28(2) EPC in conformity with Article 53(b) EPC which neither explicitly excludes nor explicitly allows said subject-matter?
The relevant legal provisions
I. Specific reference will be made to the following:
Article 112(1)(b) EPC Decision or opinion of the Enlarged Board of Appeal;
Article 53(b) EPC Exceptions to patentability;
Rule 26(1) and (5) EPC General and definitions, corresponding to Rule 23b(1) and (5) EPC 1973, which was inserted in the Implementing Regulations by decision of the Administrative Council of 16 June 1999 and entered into force on 1 September 1999 (OJ EPO 1999, 437);
Rule 27(b) EPC Patentable biotechnological inventions, as amended by decision of the Administrative Council CA/D 6/17 of 29 June 2017 (OJ EPO 2017, A56) and in force from 1 July 2017;
Rule 28(2) EPC Exceptions to patentability, introduced by decision of the Administrative Council CA/D 6/17 of 29 June 2017 (OJ EPO 2017, A56) and in force from 1 July 2017;
Articles 31 and 32 Vienna Convention on the Law of Treaties of 23 May 1969 (Vienna Convention);
Articles 1 to 4 Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions (EU Biotech Directive, OJ EU 1998 L 213/13; OJ EPO 1999, 101).
[Article 31 General rule of interpretation
1. A treaty shall be interpreted in good faith in accordance with the ordinary meaning to be given to the terms of the treaty in their context and in the light of its object and purpose.
2. The context for the purpose of the interpretation of a treaty shall comprise, in addition to the text, including its preamble and annexes:
(a) any agreement relating to the treaty which was made between all the parties in connexion with the conclusion of the treaty; (b) any instrument which was made by one or more parties in connexion with the conclusion of the treaty and accepted by the other parties as an instrument related to the treaty.
3. There shall be taken into account, together with the context:
(a) any subsequent agreement between the parties regarding the interpretation of the treaty or the application of its provisions; (b) any subsequent practice in the application of the treaty which establishes the agreement of the parties regarding its interpretation; (c) any relevant rules of international law applicable in the relations between the parties.
4. A special meaning shall be given to a term if it is established that the parties so intended.
Article 32 Supplementary means of interpretation
Recourse may be had to supplementary means of interpretation, including the preparatory work of the treaty and the circumstances of its conclusion, in order to confirm the meaning resulting from the application of article 31, or to determine the meaning when the interpretation according to article 31:
(a) leaves the meaning ambiguous or obscure; or (b) leads to a result which is manifestly absurd or unreasonable.]Recourse may be had to supplementary means of interpretation, including the preparatory work of the treaty and the circumstances of its conclusion, in order to confirm the meaning resulting from the application of article 31, or to determine the meaning when the interpretation according to article 31:
Scope and focus of the referral
II. As an initial matter, before the admissibility and substantive issues of the referral are addressed, it is necessary to analyse the scope and focus of the referred questions and the supporting reasoning. Formally speaking, the present referral addresses two issues: first, the scope of the Administrative Councils power to adopt or amend Rules of the Implementing Regulations to give effect to an interpretation of an Article of the EPC which differs from that given in an earlier decision of the Boards of Appeal or the Enlarged Board of Appeal (question 1); secondly, the proper interpretation of Article 53(b) EPC following the adoption of Rule 28(2) EPC, which excludes from patentability plants and animals exclusively obtained by means of an essentially biological process (question 2).