Report of the Biotech Committee Meeting with EPO directors
A. De Clercq (BE), Chair, S. Wright (GB), Secretary
EPO Internal Re-structuring
Suzanne Herrera gave a presentation with slides about the restructuring of the EPO and the centralised opposition procedure. There has been a reorganisation into 3 sectors: HBC (healthcare, Biotechnology and Chemistry), ICT (Information and Computer Technology) and M&M (Mechanics and Mechatronics). The opposition directorate in HBC has about 273 examiners and 49 formality officers.
DG1 has about 4,500 oppositions per year, but their relatively low frequency eroded legal expertise and there is a need for procedural efficiency, even after training. There was an uneven distribution of cases which led to issues with quality. The EPO wants to improve quality, efficiency and timeliness. So there has been a selection of a pool of specialised Examiners, and 30% of their work will now be oppositions. The Primary Examiners during examination are therefore now unlikely to be on the Opposition Division. At the moment it is probably taking about 22 months to deal with an opposition, but the EPO want to reduce this to about 15 months by 2020. The opposition training has been improved and redesigned.
The search and examination Directorates have now been merged and new teams created with new Team Managers. Each Directorate has its own small team of Formalities Officers. There are therefore bigger units, with greater support for Examiners. They also have Experts with specialist knowledge.
Mr. Schauwecker gave a presentation on UDEC. There has been broad user consultation, with a special consultation meeting in The Hague. Obviously, if cases start go through faster then applicants may need more flexibility, hence the idea of postponed examination. The consideration was to implement it in Q3 of 2018, but in the meantime the Office has decided to allow more time for discussions with users and member states.
Future EPO-EPI meetings
Mr. Stamatopoulos mentioned that there will also be a meeting of the epi with the directors in Chemistry and Pharmacy: as there is significant overlap, he was wondering whether we should combine the meetings in future. He thought there could be a common meeting maybe once a year, perhaps starting with everyone, and then later splitting into two groups (Pharmacy/Chemistry and Biotechnology).
1. Plants and animals - amendments Rule 27 and 28 - amendments Guidelines for Examination:
Mr. Fernandez Branas is the Director of 1120 in charge of this area in Munich. There is still a small number of cases in The Hague with Sönke Holtorf. Proceedings had been stayed in November 2016 on about 185 cases and the new Rules came into effect on 1 July 2017. Examination had been resumed in about 140 cases now. There have been 1 refusal and 2 grants and other applications are awaiting response from applicants. The Guidelines were amended last November 2017. Plants produced by classical mutation techniques or by New Breeding Techniques will not be considered to fall under the exception of Rule 28(2) however a disclaimer will be required. Rule 28(2) EPC is applicable to all new and pending applications. As for plant parts (such as seeds, stem), especially propagation parts, these are patentable (or not) according to whether the plant of origin is patentable (or not), e.g. a seed from a transgenic plant will be regarded patentable under the new Rule 28(2) EPC. The Guidelines are quite clear but will be clarified further in the next edition for example regarding the use of disclaimers. The use of a disclaimer to remove plants produced exclusively by essentially biological processes should be non-problematic after G1/16). Mutant cases are those involving classical mutants (radiation, chemical mutation) and those produced by new breeding techniques (e.g. CRISPR, Zinc finger nucleases, etc.). It is unknown whether certain cases will go to the Boards of Appeal for testing the new Rules.
2. Marker panels
These concern new markers which may be situated in an array; Often such markers are already used in the art for the same purpose and the provision of alternative markers for said purpose is considered obvious unless the applicant can show some surprising effects over the prior art for the claimed panel.
3. New types of plausibility
No new Guidelines. Prior art and application are to be analysed on the same level. Epi can send the EPO examples in case Examiners would be using "plausibility" in a wrong way.
No new developments or Guidelines. There is no real important case which has changed the EPO's practice. It was confirmed that it is not required to have actually made the antibody to a new and inventive target for the antibody to be patentable (in terms of sufficiency).
Claims defined by epitope might be objected to as being unclear (what is an epitope?) as experiments may vary.
5. Deposit of biological material
a) Although the deposit information is often mentioned in the specification, filling in the form correctly does assist the Receiving Office to locate the information which is required by Rule 31 1 (c) EPC.
b) Unfortunately, all Belgian collections are pooled under the 'central' address of the Brussels BCCM. This creates ambiguities between the address mentioned on form RO134 and the address given in the European application. The EPO will usually request clarification by requesting to fill in form RO134 manually. It was mentioned by EPI that problems also arise with the DSM collection. Form RO/134 is designed/maintained by the PCT authority (IB, WIPO in Geneva). The EPO has informed WIPO a long time ago and WIPO needs to act.
6. Summaries of informal interviews
There was an interesting debate over how much information should go on the public file, following an Examiner interview (either in person or by telephone).
The examination timeliness in the biotech area is about 25 months vs the DG1 timeliness of 22 months, but is improving constantly (note this is a median figure, not the average).
The epi made a plea for Examiners not to amend the specification (the Druckexemplar) when issuing the Rule 71(3). We need to be particularly careful about what is said about prior art in the description, one member saying that he simply incorporates, into the description, the abstract for a patent publication and the title for a scientific literature article.
7. Topics from other meetings:
a. Stem cells
Most cases with June 2003 and later filing dates are now allowable. Previously the cut off date had been in 2008 (based on the SBP). The cells sector receives about 400 filings per year (all types of cells and cell culture processes).
b. Sequence listings
The OJ notice on Sequence Listings will be updated in the future.
Examiners may add the alignment on ad hoc basis upon request by the applicant, because the EPO can attach the database results. This is similar to the translations that an Examiner relies upon when citing a document in a non-official language. However it will not be done systematically.
There is nothing new.
d. Medical use claims
There used to be a discrepancy between biotech and PAOC regarding the exact wording of dependent claims (second medical use claims) but this has now been harmonised.
This is only raised in the clearest of cases. The EPO encounters now fewer cases where unity is objected to claims encompassing hundreds of sequences. It is thought also that the practice is more consistent. The average number of cases with Non-Unity is higher in Biotechnology than in other areas across the EPO. EPO receives very few protests cases during the PCT phase.
f. Added matter
A not allowable example of claim amendment was given: it is not allowable to combine claims 2 and 3 when each of dependent claims 2 and 3 were separately dependent upon claim 1. It was noted that in a lot of US originating cases there are no multiple dependencies because that is the US style of drafting (and the US Patent Office objects to multiple dependent claims).
Nothing to report.
7. Any other business
The EPO asked what the growth areas are. The EPO mainly sees growth in bio- and medical informatics and medical devices and for these cases the nature of the first claim may determine the group or Directorate to which the case is assigned. The EPO has already implemented cross-over of technical expertise, and there are now mixed examining divisions for these types of cases (e.g. a BIO expert and a Computer expert).
The EPO will give us the new unit directorate numbers and the indication of the technical area.
The meeting then concluded.