EPO Guidelines and Life Science

The updates to the Guidelines for Examination in the European Patent Office (the EPO Guidelines) represent an annual event, anticipated by IP professionals throughout Europe each fall. The Guidelines are updated to reflect significant developments in case law of the Boards of Appeal as well as changes to the EPO’s internal practice. The 2019 update, valid from 1 November 2019, includes several changes that can be expected to influence the drafting and prosecution of patent applications in the field of life science. Below follows a summary of the most important changes.

Inventive step assessment in the field of biotechnology – G-VII, 13

An expectation is more than a hope, explains the EPO in the 2019 Guidelines. More specifically, a «reasonable expectation of success» should not be confused with the «hope to succeed». The clarification in the guidelines that “[i]f 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”» appears to nod to the Board of Appeal (BoA) decision T296/93 and its statement that a reasonable expectation of success “implies the ability of the skilled person to reasonably predict, on the basis of the existing knowledge before the starting of a research project, a successful conclusion to the said project within acceptable time limits”.

This hope-vs-expectation clarification can be found in the 2019 Guidelines’ brand-new section on obviousness in the biotechnology field. The section states that if the skilled person embarks on a project following a teaching of the prior art with a reasonable expectation of success, there is no inventive step. Consequently, from 1 November 2019 it is no longer enough that the skilled person hopes to succeed in order for a modification of the closest prior art to be considered obvious. It is not yet clear if this approach to inventive step analysis could be extended to related fields, but there is no indication in the new section that it is confined to relate only to biotechnology.

Substance or composition – G-VI, 7.1.1

While the EPC allows for patenting of a first or further medical use of a known “substance or composition”, the term “substance or composition» has not been defined in the EPC. Enter T1758/15, followed by the 2019 Guidelines: Under “further medical use”, it is now clarified that “[g]uidance on products which can be seen as «substances or compositions» in this context can be found in T1758/15”.

Decision T1758/15 defines a “substance or composition” as a product that achieves its therapeutic effect by a chemical, rather than physical, interaction with the body. The decision concerns the patentability of a filler material for use in a specific medical method. The board referred to the earlier decision T2003/08, wherein, in the determination regarding a “substance or composition”, it was seen as necessary to establish (a) the means by which the therapeutic effect is achieved and (b) whether that which achieves the therapeutic effect is a chemical entity or composition of chemical entities. In T1758/15, the board argues that the filler is “effective by increasing the distance and occupying a volume, i.e. by a physical effect of the accumulated mass and not due to its chemical constitution”, and thus that “[t]he accumulated mass of the filler material does not […] qualify as a chemical entity or composition of chemical entities in the sense of G 5/83”. The decision further states that “the filler material of the present application is not disclosed as having a relevant radiation-reducing effect on the tissue which can be ascribed to its chemical properties”. I.e., the filler does not achieve therapeutic effect as a chemical entity under point (b). The BoA concluded that the filler material is not a substance or composition in the sense of Art. 54(5) EPC.

So the take-home message is that a “substance or composition” must achieve its therapeutic effect by a chemical interaction with the body. But are things actually clearer? Important to note is that there is a lack of guidance in current case law on how a physical versus chemical interaction should be determined. The distinction between chemical and physical is not always clear-cut – even in T1758/15, the board points out the fact that the filler material indeed is “made up of particular chemical molecules like collagen, which have some influence on the characteristics of the resulting mass”. “Substance or composition” – an update to be continued?

Deletion of part of the claimed subject matter – H-V, 3.3

Patents and applications within the field of life science, perhaps particularly the pharmaceutical field, are known for their many lists. Compounds, formulations, solvents, excipients, administration routes – if you can think of it, there’s probably a pharmaceutical patent with a list that comprises it.

The previous versions of the Guidelines stated, based on T 12/81, that while it was permissible to delete parts of the claimed subject-matter if the corresponding embodiments were originally described, deletions made from more than one list were normally not allowable.

The 2019 update states that alternatives may be deleted from more than one list provided that the deletion “does not result in the creation of new technical information that is not directly and unambiguously derivable from the application as originally filed”. Further, “limitations that do not result in the singling out of a particular combination of specific features but maintain the remaining subject-matter as a generic group which differs from the original group only by its smaller size will normally fulfil the requirements of Article 123(2) EPC”. Notably, the principles also apply to the combination of features from lists in dependent claims.

Selection inventions – G-VI, 8

In an update expected by many, welcomed by some and regarded with scepticism by others, the Guidelines have been updated to drop the criterion of purposive selection, linked to a technical effect (see e.g. T 0198/84 (Thiochloroformates), reasons 7) from the requirements for selection inventions. Hence, the 2019 Guidelines now reflect recent BoA case law (T261/15), and consider a selection invention novel under Art. 54 EPC, provided that the selected sub-range is

– narrow compared to the known range, and

– sufficiently far removed from any specific examples disclosed in the prior art and from the end-points of the known range.

Assessment of purpose or effect is now done solely under the inventive step assessment. This change may be particularly beneficial to applicants in the field of life science, where selection inventions are common, as it appears to make the assessment of novelty less arbitrary, thereby creating greater legal certainty.

(Unusual) parameters – F-IV, 4.11

For life science applicants defining their product claims by parameters related to physical properties of the product, it is worth noticing that this section has been restructured, and now, in line with T849/11 clearly specifies that

“(i) the claims must be clear in themselves when read by the skilled person (not including knowledge derived from the description);

(ii) the method for measuring a parameter (or at least a reference thereto) must appear completely in the claim itself; and

(iii) an applicant who chooses to define the scope of the claim by parameters needs to ensure that the skilled person can easily and unambiguously verify whether they are working inside or outside the scope of the claim.”

A new subsection (F-IV, 4.11.1) is dedicated to unusual parameters, i.e. parameters not commonly used in the field of the invention.

Clarifications regarding file formats when filing sequence listings – A-IV, 5

In a minor, but life science-relevant, amendment, it is clarified that a sequence listing may be in TXT format, and the need for an accompanying statement in accordance with R. 30(1) EPC and WIPO Standard ST.25 has been removed.

The above are, in my opinion, the Guidelines changes that we will notice the most in the life science field – it will, as always, be interesting to see their effects with time. If you would like further information or advice on IP and life science, or just to share your thoughts on the subject, please feel free to contact me.

Written by Hanne Bonge-Hansen