Minutes of the Meeting of the Committee on Biotechnological Inventions

S. Wright (GB)S. Wright (GB), Secretary

Held on 22 November 2016 in Munich.

1. Minutes

The minutes of the last meeting in 2015 were approved.

The meeting in 2016 did not take place immediately before our annual meeting of EPO Directors since the EPO meeting will take place later, perhaps next spring and probably with a slightly different format. The date has not yet been fixed, but it is likely to be in Munich. SMW is to contact the EPO in order to obtain dates on which the EPO Directors are meeting (probably in Munich).

2. Patentability of Plants

Apparently Austrian law has now also changed, to be similar to the law in France, Germany and Holland whereby plants, that are products of essentially biological processes, are unpatentable. Mr Wright reported on the CPL meeting that was held at the EPO on 21 November 2016. The issue of plant patentability had first been raised at the previous CPL meeting, and following that the EU Commission, under the Dutch Presidency, organised a meeting in Brussels in May. Only a few weeks ago there was an announcement from the EU Commission suggesting that the Biotech Directive should be interpreted to exclude plant products. At the CPL meeting on 21 November the EU (even as observers) gave a short presentation. Most of the national delegates encouraged the EPO to consider changing the law, perhaps by amendment of the implementing regulations. The EPO promised to review the matter, and come up with proposals in the spring of next year.

3. Stem Cells

Not much has happened since the publication of the EU expert group report. The cut-off date for patentability was now 5 June 2003, which is the publication date of the relevant ACT PCT case which refers to (how to obtain hESCs from) parthenotes. There has been a Board of Appeal Decision which referred the case back to the Opposition Division to take account of the EPO's change of practice to the 5 June date.

4. Sequence Listings

Anna Hally will talk to David Brophy (who is in her firm), Secretary of the OCC Committee, about the use of BISSAP. We should perhaps also tell the Directors at an appropriate point in time that we prefer the PatentIn software. WIPO is discussing a new standard 26 in 2017, and this will concern xml formats (and may change the rules on when you can use X to denote more than one amino acid).

5. Medical Use Claims

There was a brief discussion of the Warner Lambert litigation in the UK on the meaning of second medical use claims (there is parallel litigation in many European countries, including Spain, Germany, France, Denmark and Sweden).

6. Added Matter

It was reported anecdotally that Boards of Appeal are hopefully going to interpret Article 123 less strictly.

7. Pharmacogenetics

There has been no progress on this matter since the last meeting.

8. Antibodies

One member suggested that the EPO's practice had become a little bit easier, but we think it very much depends on the Examiner. Many Examiners are insisting on the introduction of sequences in the independent claims. This may be a topic for a presentation at the next meeting with the Directors.

9. Purpose Bound Protection

This was mentioned in connection with the EC Expert Group report.

10. Ariosa vs Sequenom

The epi filed an amicus brief at the Supreme Court, which unfortunately declined to take the case.

Separately, one member had a US case where the US Examiner added a method of treatment step at the end in order to secure allowance of the case.

11. Non-Unity

This is still causing our members problems, in particular if the objection is an "a posteriori" one. This stance can cause considerable difficulties for Applicants when the subject matter fragments according to the EPO Examiner's assessment of the case. In one particular application there was no disunity on the priority application, but one was raised in the later filed PCT application, so there was an inconsistency. Another member reported fewer problems and wondered whether the EPO is finally listening to attorneys' protestations. This, too, might be a useful topic for a presentation to Directors next year, perhaps with some case studies. We wonder whether the situation is worse in Biotech, especially if there are sequences, as the EPO has a tendency to regard each sequence as being a different invention. Several members reported that they had paid additional search fees and simply got the same art cited. One member suggested that we ought to get a refund of the search fee if there is no new art (although it was mentioned that in order to avoid this the EPO would simply just cite another "A" category document).

12. Guidelines for Examination

We had received a question from Francis Leyder, Chair of the UPC, which is being dealt with.

13. Candidate Associate Members

We have had no new requests, but note that Sisko Knuth-Lehtola has retired and has been replaced by Outi Elina Virtaharju.

14. Other Matters

Mr Wright is to contact Aliki Nichogiannopoulou for dates for the next epi-EPO meeting. Mr Wright also explained the changes in the epi Board for the next election term, and that Committees will carry on with the existing membership until the Warsaw Council Meeting in Poland, currently scheduled for 18 November, which would then decide the composition of Committees. This is different from the past where Committee Members had normally been elected in the first Council Meeting of the three year term.

The meeting closed at about 2:30pm.