Following on from our previous news articles (here, here, here, here) on the current plant patent saga at the EPO and the EPO President's referral of the matter to the Enlarged Board of Appeal (EBA; case G 3/19), there has been recent activity at the European Parliament with one MEP describing the whole issue as a "bureaucratic obstacle". The subsequent passing of a resolution at the European Parliament means that the President of the European Commission will be submitting an amicus curiae brief on the case.
Very interestingly, the European Parliament resolution also extends the issue beyond the EPO, with the statement that it:
"10. Calls on the Commission to engage actively with third countries when negotiating trade and partnership agreements with a view to ensuring the exclusion of essentially biological processes and the products thereof from patentability;"
Ultimately, insofar as the EPO is concerned, this is a clash of politics and law, something that will be very familiar to everybody watching recent events in the UK.
On a more global basis, it seems that this may become an issue in future trade negotiations, with the European Parliament trying to force its position on other countries. Given the approach taken towards gene-edited plants by other countries such as the USA and Japan, this might not be an easy issue to resolve.
SO WHAT HAS BEEN GOING ON?
The deadline for submitting 3rd party observations / amicus curiae on case G 3/19 is 1 October 2019 (OJ EPO 2019, a52). At the time of writing, 12 amicus curiae briefs have been submitted on the case.
The European Parliament Committee on Agriculture and Rural Development (AGRI) met on 4 September and discussed (link - see 09:33:00 onwards) whether the European Commission should submit a written statement to the EBA regarding G3/19.
Amongst the arguments that it would be unethical to patent products of essentially biological processes, there included arguments for a freely available increased genetic resource to combat climate change and claims that genetic resources are a natural heritage, thus the property of citizens.
Significantly, a few misunderstandings came to light when committee members voiced their opinions as to why essentially biological processes for the production of plants should not be patented (essentially biological processes for producing plants are not patentable at the EPO; G 3/19 relates to plant products not processes for producing them). There was also an apparent misunderstanding as to exactly what patents could cover, with members expressing concerns that existing plants could be patented. One member described the whole issue as a "bureaucratic obstacle".
The outcome was a cross-party agreement that it was essential to take a united stand against patenting of plants obtained by essentially biological processes.
In a subsequent question to the European Commission on behalf of the AGRI committee, an overriding concern is stated as being that:
"Barrier-free access to plant material is essential for the innovative capacity of the European plant-breeding sector and farmers, as well as for the genetic variety of our crops and the health of EU citizens."
"internal decision-making rules of the EPO must not undermine democratic political control of European patent law"
and urges the European Commission "to submit an amicus curiae ... reinforcing the conclusions laid down in its Notice of 2016 that the EU legislator’s intention when adopting Directive 98/44/EC was to exclude from patentability products that are obtained through essentially biological processes".
The resolution again shows a fundamental misunderstanding of what the Biotech Directive 98/44/EC says, when it states that "Article 4 thereof, [which] states that products obtained from essentially biological processes shall not be patentable". The simple fact here is that Article 4 of the Biotech Directive does not do that. Instead, it says:
- The following shall not be patentable:
(a) plant and animal varieties;
(b) essentially biological processes for the production of plants or animals.
- Inventions which concern plants or animals shall be patentable if the technical feasibility of the invention is not confined to a particular plant or animal variety.
- Paragraph 1(b) shall be without prejudice to the patentability of inventions which concern a microbiological or other technical process or a product obtained by means of such a process."
The final part of the resolution requires the President of the European Commission to submit the resolution to the EBA by 1 October 2019.
Given the very thorough and detailed nature of Directive 98/44/EC and the clear and simple definition of what the European Parliament resolution says should be unpatentable, it is difficult to reconcile the position stated in the European Parliament resolution with the Biotech Directive and the original legislative intent. If the original legislative intent had been to "exclude from patentability products that are obtained through essentially biological processes" then surely that is exactly what the Directive would have said.
WHAT WILL HAPPEN NEXT?
After the 1 October 2019 date for submitting amicus curiae, the Enlarged Board of Appeal will consider the case. However, there is no fixed timetable for this.
As discussed in our previous articles (links above), the Enlarged Board of Appeal has already ruled on this issue, and so it seems unlikely that it will want to re-consider it, let alone get drawn into EU politics.
If the Enlarged Board of Appel rejects the referral, the matter should be closed and the EPO President should lift the stay on proceedings of affected cases.
For EU politicians, the best way forward would then seem to be to amend the Biotech Directive 98/44/EC. Depending on exactly what EU politicians do, that may however give the EPO President grounds to once again stay proceedings on affected cases.
CONCLUSIONS AND RECOMMENDATIONS
Affected cases are currently stayed (i.e. "on hold") at the EPO. However, when a decision issues on this case (and assuming that the EBA does not change its position) then applicants might wish to put cases on accelerated prosecution to try and obtain granted patents as quickly as possible. That said, an alternative approach would be to hold back to avoid incurring cost while some kind of final resolution is reached at the EU level.
This current case points to a larger fundamental issue, which is that in Europe GMO's such as genetically modified plants are heavily regulated and only a small number of GMO's have obtained marketing authorisations.
The ability to patent plant products (other than a plant variety) obtained using new and inventive plant breeding methods (even if those methods themselves exclusively use classical plant breeding steps) provides the European agri-tech industry with the opportunity to innovate without having to create GMO's and (critically) to be commercially rewarded for those innovations in the form of time-limited patent protection. If that is removed, it could place European agri-tech at a significant disadvantage compared to those outside of Europe, and potentially force innovation away from non-GMO plants to GMO plants.