Report of the Committee on Biotechnological Inventions

A. De Clercq (BE), Chair

1. Meetings with attendance of the Biotech Committee

On 16 October 2019 the Committee held its yearly meeting in the epi Secretariat. The Biotech Committee was also partly joined by members of the EPPC group on Pharma.

On 17 October 2019 an ad-hoc delegation of the Biotech Committee met with the DG1 Biotech Directors and other EPO delegates at the EPO in Munich. The meeting was very productive and informative. No official minutes will be prepared at the request of the EPO delegation.

An update was given by the EPO on the EPO and DG1 more particularly the Strategic Plan 2023, the Opposition Practice and experience with OCFD (Opposition & Centralised Formalities Directorates) as well as on Quality including timeliness.

Also, the following general patentability issues in Biotech were discussed:

Plants and animals – updates in view of G3/19
New type of ‘plausibility objections’ in biotech area?
Antibody patenting
Unity of invention in biotech
Amendment and method of treatment language in the description
New rules of proceedings Board of Appeal

2. Patentability of plants and animals – G 3/19

Our committee reported on T 1063/18 in epi information 1/2019- 3/2019. This decision concerns the appeal by the applicant against the decision of the Examining Division to refuse European patent application no. 12 756 468.0 (publication no. EP 2 753 168 A1) for the sole reason that the claimed subject-matter was "found to be within the exception to patentability according to Article 53(b) EPC and Rule 28(2)" (here: plants exclusively obtained by means of an essentially biological process).

The Technical Board of Appeal (TBA) 3.3.04, in an enlarged composition consisting of three technically and two legally qualified members, held that Rule 28(2) EPC (see OJ 2017, A56) is in conflict with Article 53(b) EPC as interpreted by the Enlarged Board of Appeal (EBA) in decisions G 2/12 and G 2/13. In these decisions, the EBA had concluded that the exclusion of essentially biological processes for the production of plants in Article 53(b) EPC did not have a negative effect on the allowability of a product claim directed to plants or plant material.

The following points of law have been referred to the EBA by the President of the EPO in G3/19:

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?
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 epi Biotech Committee together with EPPC prepared an amicus brief in name of epi for G 3/19 which was filed by epi on 30 September 2019. An ad-hoc working group consisting of Ann De Clercq, Simon Wright, Chris Mercer and Heike Vogelsang-Wenke was involved with drafting the amicus brief and our Associate members Jan Desomer and Bart Swinkels also contributed to the discussion as well as many other members of the Biotech Committee. All amicus briefs filed can be found here: https://www.epo.org/law-practice/case-law-appeals/eba/pending/g3-19.html. The Biotech Committee with special thanks to Jan Desomer has summarized these amicus brief in the overview that can be found here: https://patentepi.org/r/info-1904-05. The EPO webpage with G3/19 amicus curiae letters shows 41 entries of which two entries are in fact multiple entries i.e. the written statements filed by 23052 natural persons via Umweltinstitut München e.V. and a statement filed by Christophe Then signed by 49 organizations and 2725 individuals.

The letters can be grouped into:

Emotional letters: driven by the sentiment that there should be no patents on life (No patents on seeds/Julian Cockbain)
“Teleological letters”: breeding germplasm should be freely accessible to ensure food security
Letters by government instance including the Patent Offices: expressing support for the president referral in view of harmonization of patent law.
Legal/Patent-Technical letters
- On admissibility of the referral, the views differ from
  - Clearly inadmissible (FICPI/FEMIPI/ IP Federation/VPP/Croplife and ECPA/CIPA/CNCPI)
    - There is no divergent case law
      - On rule 28(2) EPC there is only T1063/18
    - There is no divergence in the methodology of application of Art 164(2) in earlier decisions re Art 53 (Konig/Rennie Smith/Haedicke/CIPA)
    - There is no divergence by analogy and there are no lacuna in the law to be filled (Konig/Haedicke)
  - Inadmissible or not, but urging the Boards to provide guidance anyhow, in line with G3/08 (epi/Van Woudenberg)
  - EBA should apply some lenience, in view of the importance of the issue (Metzger et al./IPO/Van Woudenberg/European Union)
  - Assumed admissible (Kennington/de Lange/Leconte)
  - Admissible
    - For the reasons the president provided (National instances)
    - There is only one board for biotech – impossible to have divergent case law (Plantum/German Plant Breeders association)
Suggested answers to the questions
- Question 1
  - A distinction should be made between articles that refer to the Implementing Regulations, and ones that do not, like Art 53 (de Lange)
  - Numerous submissions on separation of powers within the EPO, extent of the legislative power of the AC and constitutionality of the EPO (CIPA, Haedicke/Malek/Köning/ de Lange/Leconte)
    - Suggested answer : No – one cannot implement a Rule that conflicts with an article as interpreted by a BOA (various letters)
    - Suggested answer: No – one cannot do that for articles as interpreted by EBA but Yes for an article interpreted by a BOA (IPO)
    - Suggested answer: Yes, Rule 28(2) is lex posterior (Dolder and various of the national instance letters).
Question 2
- Not applicable in view of the no answer to Q1
- No- A rule cannot be used to add exceptions – What is not prohibited by Art 53b is allowed by virtue of Art 52 (Leconte/Konig/…)
- Yes, but with a narrow definition of EBP (Metzger et al)
- Yes, and the definition of EBP should even include smart breeding and mutagenesis (No patents on seeds and the like)

Fritz Dolder has raised partiality of Mr Beckedorf. If picked up by the EBA, they may first have to decide on participation or exclusion of Mr Beckedorf, which would likely delay the issuance of an opinion.

With respect to other publications on G3/19, we refer to:

Heiko Sendrowski in epi Information 2/19 and 3/19

The BoA in T1063/18 may have misjudged the “acte eclairé” status of Art 53b EPC and Art 4 BD. Lenience should be applied in accepting the referral at least with regard to question 1. In the second part there is a plea for referral to CJEU, as this would concern interpretation of the Biotech Directive provisions incorporated in the EPC

Huttenberger in GRUR Int. 2019, 869

A BOA has likely the power to ignore Rule 28(2) EPC in “inter partes” proceedings, but for an “omna erges” effect an EBA decision is required.
The Biotech Committee will keep on following up this topic and provide its comments. It seems that we can expect an opinion by the EBA in 2020.

3. Overview of patentability of plants in the Member States

The Biotech Committee is following further national developments and has prepared an updated overview of the patentability of plants in the member states on basis of reactions of the members in each country and will follow this up further. The information given in the referral document for G3/19 is in our opinion not completely accurate and in many countries the national law has not been amended and there are no immediate changes foreseen (see https://patentepi.org/r/patentability-of-plants).

4. New Rules of Procedure of the Boards of Appeal

There is a general concern about the effect of these rules on the first instance proceedings since the new procedure is more front loaded (in order to reduce the workload and backlog of the Boards of Appeal). This is likely to result in more auxiliary requests and procedural questions in opposition proceedings. DG1 does not completely realise these consequences. There is also a general concern about not remitting.

5. Antibody patenting

A working group from Pharma on antibodies with members from industry exists which meets with the EPO (outside of the remit of the Biotech Committee it appears) and which raises the problems applicants phase towards the EPO. The EPO apparently considers the creation of antibodies as routine and done by nature. This group considers that there is a lack of case law and that antibodies are not covered by the Guidelines. Thus, the examination depends on the examiner. The EPO may need more munition to create case law (either by third party observations and rejection of the applications or by opposition in inter partes proceedings). A suggestion was that the the EPO could publish their internal guidelines.

With regard to patentability, inventive step is a high hurdle for many applicants. In this regard, it is difficult to obtain case law. The EPO needs to be convinced that antibodies should not be treated differently than other molecules. She would not use the term FTO but rather broad and narrow claims.

6. New type of ‘plausibility objections’ in the biotech area?

The pregabalin national court rulings regarding second medical use clearly contradict the EPO’s practice. The EPO will nonetheless be hoped to keep its granting practice. In this specific case, it was questioned whether the experiments proved the plausibility of the substance to relieve pain. Before the EPO, the issues were only novelty and inventive step. The opposition was dismissed. In the national proceedings, the issue was sufficient disclosure. In Hungary, the argument that this was a pioneering second medical use was put forward. In support of this, the EPO’s practice was cited (G IV.7.1), according to which pregabalin for use in the treatment of pain would be allowable even if not plausible for all kinds of pain. The Hungarian patent office allowed the claim but the courts decided to the contrary. This topic was raised with the EPO.

7. Amendment and method of treatment language in the description

At the meeting with the EPO PAOC Directors, it was indicated that in the chemistry field, it is not required that amendments to medical use language in the description are made. It was confirmed at our meeting that this is applied in practice. The question is whether this also applies to biotech. This was discussed at the meeting with the EPO.

8. Joint meeting with EPPC Pharma Group

8.1. Plausibility
Two cases relating to a patent of BMS for a compound (T 0488/16 and T 0950/13) were mentioned wherein the scientific data were only provided during the proceedings. In one case, plausibility was denied, even when on appeal the claim was reduced to a single compound. In the other case, relating to the same compound, plausibility was found. These inconsistent decisions show that we need some information on the criteria applied. On earlier occasions the EPO said that decisions are taken on a case-by-case basis. This is also relevant for the biotech field, even though compounds are defined in a different way.

8.2. Antibody patenting
There was a discussion on the patentability of antibodies as compared with chemicals. The Biotech members explained the problem that the EPO’s practice (of requiring a surprising or unexpected effect) forces applicants to accept very narrow claims which do not provide sufficient protection. There is also the problem of having to provide the scientific data, more particularly there is a timing problem since it takes time to produce the data while it is arbitrary which antibody is chosen. In the US, China and Japan, the patent offices are not that strict.

9. Guidelines for Examination – biotech issues

The Biotech Committee was represented in a discussion of the Guidelines for Examination at the SACEPO Working Party on Guidelines on 22 February 2019. The Biotech Committee also presented its comments on Rule 28(2) EPC and relating disclaimer parts of the Guidelines. The new version of the Guidelines and also the new version of the Case Law book will be studied by the Biotech Committee to spot any changes relating to biotech not previously reported on.

10. Next meeting and questions

The Biotech Committee will continue to deal with all questions relating to biotech and related life sciences inventions as well as topics referred to it by EPPC or other channels. The next committee meeting dates for 2020 have to be set as well as new meeting dates with the EPO.