Report of the Committee on Biotechnological Inventions
A. De Clercq (BE), Chair
This reflects the report to Council at the Athens meeting. Our committee had its last yearly meeting on October 9, 2015 and had a meeting with an ad hoc group of our committee with the EPO Biotech Directors on October 12, 2015. Reports of both meetings have been published in the epi Information (1/2016 and 4/2015). The EPO Biotech Directors have proposed to meet again with a delegation of our committee in spring 2017.
Simon Wright, Ann De Clercq and Tony Tangena attended on May 18th the Symposium "Restoring the balance between patents and plant breeders' rights" (Brussels). Simon Wright attended as observer the CPL meeting on May 12th.
The epi Biotech Committee has prepared an amicus curiae brief in the Arioso vs. Sequenom case (US) This was filed on19 April 2016. A copy of this amicus curiae brief can be find on the epi website under the following link: http://patentepi.com/en/epi-reports/position-papers.html The next Biotech Committee meeting will be held on 22 November 2016.
Below is a summary of some of the most important points discussed by email in our committee in since our last meeting in 2015.
1. Patentability of plants - EBA Decisions G2/12 (“Tomatoes II”) and G2/13 (“Brocolli II”)
We reported on this matter in our published reports in epi Information. We also published on this matter an article “Patentability of Plants” in epi Information 4/2015.
Decisions G2/12 and G2/13 have clarified that product claims or product-by-process claims directed to plants or plant material other than a plant variety are not excluded from patentability under Art. 53 (b) EPC and are allowable if they fulfill the formal and substantive requirements of the EPC. These decisions confirm that exclusions to patentability have to be construed narrowly. The EPO Guidelines for examination were amended in this way.
The EC Expert Group dealing with the EU Biotech Directive 98/44/EC was also discussing this topic and related topics concerning plants. The EU expert group delivered a report including plants recently. We regularly discuss these matters within our committee by email and at our meetings. We favor that all epi members in the group to regularly consult with the Biotech Committee. Due to the fact that this is a very specialized area our committee has associate members that also help a lot to the discussion in this area.
2. Stem Cells
This relates to R. 28 (c) EPC and G2/06. The EPO guidelines currently mention a certain practice of dealing with patentability of stem cells, in particular on the Brüstle case. We reported in our minutes of the meeting with the EPO of October 12th (epi Information 1/2016).
3. Sequence Listings and alignments
As reported for the last council meeting we will reply in writing to the BASF letter (July 2015) that the epi Biotech Committee could not agree to all of the points of BASF. It was considered not useful to submit this kind of letter to the EPO at this moment. BASF can always present letters to the EPO by themselves.
4. Medical use claims
We reported in our minutes of the meeting with the EPO of October 12th (epi Information 1/2016) on this matter. This relates to T1021/11 (June 2015) which confirm that Swiss type and Art. 54(5) type claims can co-exist.
5. Added Matter – Article 123(2) EPC
We reported in our minutes of the meeting with the EPO of October 12th (epi Information 1/2016) on the Guidelines in respect of this matter. The emphasis should be on what the skilled person would understand from the specification.
6. Pharmacogenomics
We reported in our minutes of the meeting with the EPO of October 12th (epi Information 1/2016) on in respect of this matter.
7. Antibodies
We reported in our minutes of the meeting with the EPO of October 12th (epi Information 1/2016) on in respect of this matter.
The EPO cannot gives access to the internal harmonization notes on this matter.
8. Purpose bound protection for genes
Our committee has finalized and published on the epi website an overview of the national laws on protection of nucleic acid sequences with a focus on the question whether countries have a purpose/function limited protection of such nucleic acid sequences. A copy of this report is attached. This overview has also been shared with the EC Expert Group on biotechnological inventions on which a few epi members sit.
Our committee has also prepared a position paper on this matter as discussed at the last Council Meeting (see attached).
Discussion is ongoing at certain levels about purpose bound protection of genes.
9. Non-unity
We reported in our minutes of the meeting with the EPO of October 12th (epi Information 1/2016) on in respect of this matter.
10. Associate members
New associate member requests will be discussed by email and at our next committee meeting.
