Report of the Committee on Biotechnological Inventions

A. De Clercq (BE), ChairA. De Clercq (BE), Chair
S. Wright (GB), Secretary

The Committee on Biotechnological Inventions met on 5 February. It was the first meeting of the Committee after the epi Council elected its members in the Council Meeting C83, held in Warsaw last 18th November, 2017.

1. Introduction

Everyone on the Committee, including new members, introduced themselves. Ann De Clercq mentioned the Terms of Reference. It was agreed to have associate members, Andreas Oser, Gabriele Leißler-Gerstl, Rafal Witek and Adrian Tombling present at the meeting. Ann De Clercq asked the Committee whether she could stay on as the Chair, and Simon Wright as Secretary. The Committee agreed to let both officers to continue in their respective positions.

2. Comments on previous minutes, reports to council, papers published by epi Biotech Committee

The previous minutes, reports and published papers were approved. We published an overview concerning national laws on plants, but a lot has changed recently, and so this needs updating.

3. Nagoya protocol overview

There is a new section in the German Patents Act (further information can be supplied on request). This requires that biological resources should be mentioned in a patent application: the law passed in 2016. The Committee is looking into the impact of the Nagoya protocol also for other countries.

4. Patentability of plants and animals – amendments to EPC and GLs

The Administrative Council (AC) introduced new amended Rules last June, taking effect from 1 July 2017. The suspension on relevant cases has now been lifted, and these are now being examined. There are amended Guidelines, and since they have been published the new disclaimers decision has issued, suggesting that a disclaimer to deal with the new exclusion regarding plants may be possible. It is still not clear whether plant parts (in particular propagation parts) are patentable or not. The EPO Guidelines suggest they are not patentable, even though that is not what the law says. We also need further clarification on disclaimers, in other words what disclaimer(s) are likely to be allowable, and the exact wording.

5. SPC survey

An epi ad-hoc group, led by the Treasurer, Peter Thomson, has now responded.

6. Guidelines

These are updated every year. There will be a small working group to deal with the biotechnology sections.

7. Topics for meeting with EPO biotech directors on 6 February 2018

The topics as already passed to the EPO in beforehand were briefly discussed.

  1. Plants and animals – amendments Rules 27 and 28 – amendments guidelines for examination: any updates?
  2. Marker panels: more and more examiners request comparative data with prior art markers in order to acknowledge inventive step, even though the prior art is completely silent regarding the potential of the markers used in said panel: new trend to ask for more experimental data?
  3. New type of “plausibility” objections in biotech area: do the examiners have new guidelines in this respect?
    For example, a prior art document which is cited for novelty is said to disclose more than is actually experimentally disclosed therein as it would be plausible that the person skilled in the art could have done more experiments. Also cases wherein the Examiner mentions that it is not plausible that all envisaged embodiments of a claim would work as an objection under inventive step. Should the prior art and the claims under examination not be examined with the same type of plausibility?
  4. Antibodies: any new guidelines for examiners or important case law which they follow?
    Under the heading of ”Antibodies”, we also would be interested to hear the EPO’s reaction, if any, to the US CAFC decision in Amgen v Sanofi from October last year to the effect that claims to antibodies defined solely by their binding to a novel antigen are not valid in the US anymore due to lack of written description. For example, are there any new Board of Appeal cases that deal with this issue, or any discussions about practice changes? Does the established practice of the EPO still stands.
  5. Deposit of Biological material:
    1. Form 1200 (entry into the European phase), item 8, the 2nd paragraph, does not make sense as the deadline expired 16 months from the priority date and the information has already been submitted to the PCT authorities. It is proposed to amend item 8 of Form 1200 in a similar manner as item 9.1.
    2. PCT online request forms do not anymore allow to indicate the correct depositary institution in Belgium.
  6. Although not a topic specifically related to biotech we would like to ask the EPO: could more informative summaries be given of informal interviews so that the reasoning behind the decision can be understood.
  7. Topics to be selected still from the list of topics discussed at our previous meetings with EPO: any updates to be announced by the EPO in any of these areas?
    1. Stem Cells
    2. Sequence Listings and alignments
    3. Pharmacogenomics
    4. Medical use claims (insofar biotech related)
    5. Non-unity (insofar biotech related)
    6. Added Matter – Article 123(2) EPC (insofar biotech related)
    7. Guidelines for Examination (other biotech matters than point 1)
  8. If time: interested to hear about deferring examination, we will however not be able to express our views as these will be expressed by epi delegates at the 9 February consultation and the 20 February CPL meeting.

8. Associate members requests/appointments

The following members have been reappointed or newly appointed as associate member: Bo Hammer Jensen (DK), Caroline Pallard (NL), Hans-Rainer Jaenichen (DE), Andreas Oser (DE), Camila Lidén (SE), Gabrielle Leissler-Gerstl (DE), Jan Desomer (BE), Adrian Tombling (UK), Rafal Witek (PL), Willemijn Gommans (NL).

9. Any other topics

Gabriele Leissler-Gerstl introduced a discussion of the deferred examination. The UDEC paper (user driven early certainty) issued by the EPO was discussed. A draft response had already been prepared by Chris Mercer. The proposal is to delay examination up to three years, on request, once the examination fee has been paid. Third parties however can trigger examination by filing third party observations that are both substantive and non-anonymous. Applicants will still need to file an initial response to the search opinion. The majority of the Committee were in favour of a deferral. A letter was addressed to EPPC in this respect.

10. Next meeting

Most probably in autumn 2018, if possible to be scheduled and timed with a meeting at the EPO.