2019 updates to the EPO Guidelines for Examination - the highlights
The updated version of the EPO Guidelines for Examination is now available (here). The new guidelines come into force on 1 November 2019. The guidelines, as the name suggests, are a guide to the current case law and practise of the EPO and are not legally binding (see IPKat herefor a full discussion of legal precedent at the EPO and the role of the guidelines). The 2019 update to the guidelines incorporates some of the significant developments in the established case law of the Boards of Appeal. One key change to the guidelines this year is an update to the assessment of novelty of selection inventions. Other updates include clarification of the definition of “substance or composition” and a new section on the criteria of reasonable expectation in an assessment of obviousness for biotechnology inventions.
However, recent Boards of Appeal decisions have departed from the requirement of a selection to be purposive (e.g. T 261/15). In T 1233/05, the Board of Appeal observed that the requirement for a purposive selection of a claimed sub-range "appears to fall back upon considerations which should be taken into account in the assessment of inventive step rather than in that of novelty" (r. 4.4). The 2019 EPO guidelines have been updated to reflect this position (G-VI-8, and G-VII-12).
Notably however, the updated EPO guidelines do not incorporate the recent Boards of Appeal case law on the novelty of purity selection inventions. For many years the EPO considered an increase in the purity of a compound a special case with respect to novelty. The burden of proof was placed on the applicant to show that the claimed level of purity was never achieved in the prior art. However, in a decision last year (T 1085/13), a Board of Appeal found that previous decision of the Boards were contrary to the principle that novelty can only destroyed by a clear and unambiguous disclosure in the prior art (IPKat post here). With regards to purity inventions, the 2019 guidelines still only indicate that “[a] known compound is not rendered novel merely because it is available with a different degree of purity if the purity can be achieved by conventional means (see T 360/07)” (G-VI-7).
A novel selected sub-range is no longer required to be a “purposive selection”
In a welcome update, the 2019 guidelines have been updated to reflect the recent Boards of Appeal case law on selection inventions. European patent law considers a selection from the prior art as novel under Article 54EPC if: a) the end points of a claimed sub-range or any point falling within the claimed sub-range are not be disclosed in the prior art and b) the end-points of the claimed range are "sufficiently removed" from the individual elements disclosed in the prior art. Historically, the EPO also required the selection to be non-arbitrary or “purposive”. In other words, the selection had to be linked to a technical effect (T 0198/84 (Thiochloroformates) (see r. 7) and T 0279/89 (r. 4.1)).
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| Reviewing the case law |
Notably however, the updated EPO guidelines do not incorporate the recent Boards of Appeal case law on the novelty of purity selection inventions. For many years the EPO considered an increase in the purity of a compound a special case with respect to novelty. The burden of proof was placed on the applicant to show that the claimed level of purity was never achieved in the prior art. However, in a decision last year (T 1085/13), a Board of Appeal found that previous decision of the Boards were contrary to the principle that novelty can only destroyed by a clear and unambiguous disclosure in the prior art (IPKat post here). With regards to purity inventions, the 2019 guidelines still only indicate that “[a] known compound is not rendered novel merely because it is available with a different degree of purity if the purity can be achieved by conventional means (see T 360/07)” (G-VI-7).
How to define a “substance or composition”?
The EPC provides for the patenting of the first or second medical use of a known “substance or composition”. The provision is intended to exclude the patenting of the second medical use of a device. However, "substance or composition" is not defined in the EPC. Determining whether or not something is a substance or composition is not always easy (IPKat: Substance or device - a distinction without a difference?).
The updated guidelines states that guidance on products which can be seen as "substances or compositions" can be found in T 1758/15. The Board in T 1758/15 defined a "substance or composition" as a product that achieves a direct therapeutic effect by a chemical, as opposed to physical, interaction with the body. However, the current case law does not provide guidance on how a physical versus chemical interaction should be determined, for example with respect to products such as tissue scaffolds.
“Reasonable expectation of success” is not equivalent to “a hope to succeed”
A whole new section has been added to the guidelines on obviousness in the biotechnology field (G-VII-13 Inventive step assessment in the field of biotechnology). The section in particular imports Boards of Appeal case law from T 296/93 on the meaning of “reasonable expectation of success” in the context of an obviousness analysis. The updated guidelines emphasize that a reasonable expectation of success “is not to be confused with the ‘hope to succeed’. If researchers are aware when embarking on their research that, in order to reach a technical solution, they will need not only technical skill but also the ability to make the right non-trivial decisions along the way, this cannot be regarded as a "reasonable expectation of success"’ (see also Case Law of the Boards of Appeal, I.D.7.1).
Novelty of a product claim with process features
A new section confirms that a claim may contain both product and process features (F-IV-4.12.1 Product claim with process features). The guidelines also clarify that the same criteria of novelty should be applied to such claims as are applied to product-by-process claims. Particularly, the process features of a product claim with process features are only novel if the product produced by the process is novel [Merpel: is this sentence in contention for the patent tongue-twister of the year?].
The hot chilli pepper of “essentially biological processes”
The European patent community is eagerly awaiting the response of the Enlarged Board of Appeal (EBA) to the EPO president’s referral in G 3/19 (Pepper) (IPKat post: Pepper gets spicy: The EPO President's Referral to the EBA). The nub of the issue is whether the Administrative Council’s amendment of Rule 28(2) EPC (excluding products produced by essentially biological processes from patentability) was lawful given the contradiction of the new Rule with the interpretation of Article 53(b) EPC by the EBA in G 2/12 (Broccoli/Tomato II). Whilst the President’s referral is pending, the guidance that Rule 28(2) EPC excludes products produced by essentially biological processes from patentability remains unchanged in the 2019 guidelines (G-II.5.4). However, as of 4 April 2019, all proceedings before the EPO potentially impacted by the outcome of the referral have been stayed ex officiountil the EBA’s decision on the referral (EPO Notice).
In a minor update, the guidelines on this topic have been updated to explicitly specify that selfing (i.e. self-fertilization) of a transgenic plant should be considered an “essentially biological process”.
The exclusion of computer programs from patentability
The patentability of software is another hot topic at the moment, and subject to its own referral to the EBA (IPKat: The patentability of computer simulated methods - another referral to the Enlarged Board of Appeal). The 2019 guidelines include some updates to the section relating the patentability of artificial intelligence and machine learning. In particular, the guidelines now clarify that “[t]erms such as ‘support vector machine’, ‘reasoning engine’ or ‘neural network’ may, depending on the context, merely refer to abstract models or algorithms and thus do not, on their own, necessarily imply the use of a technical means. This has to be taken into account when examining whether the claimed subject-matter has a technical character as a whole (Art. 52(1), (2) and (3))”.
Final note and question
Attentive readers may have noticed that many of the updates this year are in the form of citations of Boards of Appeal decisions. Case law references from the Boards have in the past been confined to the Case Law of the Boards of Appeal. The Guidelines have previously mostly refrained from referencing Boards of Appeal decisions on which the guidance was based. Why the change? Do readers have any insights?
