Hi all, Thank you for all the work you've done. All the exchanges are exciting but also difficult to understand every details. Sorry if my question is inappropriate...
As Katherine mentionned, the point about random mutagenesis is not clear. I understand that No Patents on Seeds puts it in the package of "conventional breeding techniques"/essentially biological process". Did I understand correctly? if yes Why this interpretation?
But: -Random mutagenisis does not, however, fall within the scope of the definition R26 (5). - The example of patent WO2019121603 we mentionned in our report illustrates this because it is a chemical mutagenesis on isolated cells of the plant. However, the french Conseil d'Etat has just made it official that mutagenesis conducted on isolated cells are considered as geneticaly engineering.
I just would like to know if this point is clear to all members or if it is still in discussion, because it seems important to me that there is no misunderstanding about what we are really claiming.
*Christoph :I will read again your answer to Katherine. I also will wait our call conference to get an answer.*
best Anne Charlotte
Le ven. 22 mai 2020 à 11:46, ARCHE NOAH Katherine Dolan < katherine.dolan@arche-noah.at> a écrit :
Hi all,
It is of course important that we agree on a strategy, but I think it is not so important for the letter to the governments.
I would propose that in the letter we outline the issues (contradictions between President’s submission and now valid case law + issue of temporal application of opinion) and suggest we see a really possibility now to fully enforce the exclusion from patentability, but there are different options for the way forward – and we would like to discuss these options with them in a virtual meeting. We could then push for our preferred view in the meetings. It is possibly not such a bad outcome if some states call for an informal clarification and others for a change in the implementing regs, the main goal is that the issue is not “closed” at the meeting in June? The most important thing in my view is we get the letter out asap.
Best
Katherine
*Von:* Npos_2018 [mailto:npos_2018-bounces@testbiotech.de] *Im Auftrag von *Christoph Then *Gesendet:* Mittwoch, 20. Mai 2020 15:25 *An:* npos_2018@testbiotech.de *Betreff:* Re: [Npos_2018] Draft letter to AC and welcome to Gudula
Dear Francois
My answer would be: If my analysis is right, there is no reason for change of the Rules (in regard to the definition of essentially biological process). Therefore, we will not get it. At least it will be very difficult to mobilise governments.
however, we can try if we think it is necessary.
and we have to try, if my analysis is not correct.
In any case, together with Ruth, I will make a collection of case studies (granted patents) showing that there is urgent need for further clarification.
Cheers
Christoph
Am 20.05.20 um 14:07 schrieb francois.meienberg@prospecierara.ch:
Dear Christoph and Katherine
I am following your conversation and arguments.
For me one questions remains : Why should the clarification proposed by Christoph not be included in the Rules ?
This seems to be more certain then just a « statement » - where I do not know the legal standing.
Best
François
*Von:* Npos_2018 npos_2018-bounces@testbiotech.de npos_2018-bounces@testbiotech.de *Im Auftrag von *Christoph Then *Gesendet:* Mittwoch, 20. Mai 2020 09:38 *An:* npos_2018@testbiotech.de *Betreff:* Re: [Npos_2018] Draft letter to AC and welcome to Gudula
Hi Katherine
welcome. please see short comments below. Your question are very helpful.
Lets prepare for phone conference next week.
I think we can sort it out.
Cheers
Christoph
Am 19.05.20 um 21:55 schrieb ARCHE NOAH Katherine Dolan:
Hi Christoph,
Thanks for this explanation, which makes some things clearer but also throws up some questions (I basically need some more information on the points you make – I have looked at the cases you refer to but can’t quite follow your logic, particularly on how we exclude random mutations from patentability by the relying on case law).
*on the case law: I only refer to G1/08 (and G2/07) - I hope I did not
mix up the numbers of the decisions. If you read the headnotes (as quoted in G3/19) point 1 and 2 are very clear. Point 3 is not so clear. But leaves room for our interpretation (please be aware the decision is stating direct insertion of a TRAIT. Random mutation, typically, is not enough to generate a defined TRAIT. see may explanation in the condensed overview) *
*point 4 reads rather problematic. It seems they pick up all of our arguments and says they are not relevant. Further problem: in the text, they also refer to irridation as part of a historical explanation. *
*But you need to read the whole decision to find out, how to interpret. By doing so, at the end, you will find the quote I inserted in may condensed analysis. I think this quote is in line with the EU Commission statement. It is in line with our interpretation. and it is binding. It solves the problems and uncertainties as created by point 3 and 4. However, looking to the examiners decision making, this legal understanding so far is not reflected on the level of examination. This is astonishing. If we raise our demand as suggested, we can sort out these contradictions. Or, in case, we go for further changes of Rules and Laws. *
I would be very keen to have a call (this week?) to discuss some of the details and the next steps so we have a common understanding before the letter is finalised.
*It looks like we have phone conference next week on 26. we can discuss. I also will do further work on the text. So we can manage to send it off next week. we might double check with the schedule of meetings at the EPO, to be right in time. *
On the bigger / more strategic issues:
· I am not a fan of the disclaimer as it is not a binding, transparency rule and still puts the onus on civil society to be alert and check it is being applied fully. But if we can really achieve what we want on the other two points in an easy way, I guess we could live with it, and see how it works in the next year. If it doesn’t work e.g. on the new GMOs we would anyway have to get active again.
*I do not mind, to raise stronger demands (like no absolute product protection under Art 53 b) - we will see if it flies. *
· Regarding the process: You are suggesting that the Admin Council adopts a text that basically replaces the proposal made by the President in 2017 and which will then be reflected in the examination guidelines? Can we check that the Admin Council is able to do this legally? I also wonder strategically if it makes sense to straight away propose this “light” option. On the one hand, I see what you say that they are more likely to be interested in an easy solution. But on the other hand it will be difficult to us to demand a change in the implementing regulations at a later stage if we do not do so now. Again, it is probably better to discuss this together on a call.
*The idea on the process: for each decision to change rules or laws, there are some preparatory documents. These documents are relevant for the interpretation of the decision, they are not binding law as such. But they are binding in case of questions of interpretation. We want the AC to add another preparatory document. Normally this is no problem. And, important to know: The text is already in the examination guidance. I think some further clarification might be needed. But this can be done by the EPO, it is not in the remit of the AC. We just pave the way to get the right decisions on the level of the EPO. Anyway: the text which is legally binding is G1/08. Please read carefully. I might be wrong in my interpretation. It we have to prepare a argumentation which is in contradiction to G1/08, this will be hard task (I already started on it - it might work, but for the moement, I am not convinced that it will work)*
On a separate note the Austrian Ministry called for a change to the Convention in her press release (her team don’t understand the issue yet). I have asked for a meeting but I will hold off on following up until we have agreed on our demands internally: https://www.ots.at/presseaussendung/OTS_20200516_OTS0001/keine-patente-auf-l...
Thanks
Katherine
-----Ursprüngliche Nachricht----- Von: Npos_2018 [mailto:npos_2018-bounces@testbiotech.de npos_2018-bounces@testbiotech.de] Im Auftrag von Christoph Then Gesendet: Dienstag, 19. Mai 2020 17:50 An: npos_2018@testbiotech.de Betreff: Re: [Npos_2018] Draft letter to AC and welcome to Gudula
Dear Katherine
thanks for your comments. I agree that this letter is somehow a change in our communication towards the Members of the AC. But it is not a change in our goals!
I have to admit, when I started to work on this letter, I already had much more arguments and reasoning written down in a longer draft version, before I finally again studied the Decision G1/08 and was happy to find there is a new, smart and more precise way to move the AC. But maybe I should explain. We need a common understanding. So thanks for your question.
In our original response to the 2017 decision we were not fully aware of the obvious contradiction between the President's document and the Decision in G2/07 and G1/08. Therefore, we did not point out these contradictions. But now we should use it. My conclusion: Our position is much stronger than we thought. Also within the current jurisprudence of the EPO, they can not just leave it with this incorrect interpretation of the President.
We should be aware that the decision of G1/07 is already introduced into the examination Guidelines (at least partially). I always was wondering about the strong wording in the Guidelines about fundamental differences between GE and conventional breeding. But I was too stupid and not aware that this is the wording from G1/08. I think at the level of the Technical Board, we might have been made aware that this wording is already quite effective (but this is just some guessing).
Being aware of the facts and findings as summarized, I would like to keep our demand as much as streamlined and easy as possible, to move the delegates to take initiative. Also after our talks with the German ministry, I am sure, we will get most interest and support in our demands if we can show that they can be fulfilled it without changing the Rules or the text of the EPC. So I would like to follow this path.
Would it become legally binding if the AC would adopt the text as proposed? In itself, it would not have a legally binding effect such as a new Rule or change of law. But this is not necessary: We just have to make sure that there is no longer any contradiction between the decision of the AC and (what we think is) the correct interpretation of Rule 28 (2). If my understanding is correct, the desired legal binding effect will simply result from G1/08 and not from the new decision of the AC.
In short: my understanding is that the problem (with the definition) is solved as soon as the AC agrees with us that the text of the President is an incorrect interpretation. If my analysis is not correct, the AC will not follow it and we have to raise stronger demands anyway.
Similarly, the demand that all products and materials needed for breeding are excluded does not seem to by a major problem. I think this demand is supported by all contracting states. There is only a contradiction introduced by the text of former President: It says, that cells still are still patentable. If we get rid to this text, the problem should also disappear.
On the scope of patents, I guess we will have to live with the disclaimer. I see no way to convince the AC to come up with stronger initiatives. But if the proposed text would be adopted, it could support our position. I am not so happy with this situation, but do not think we can go further on the basis of G3/19.
As indicated above, after the decision of the Enlarged Board, the interest of the European governments to get active on this topic might by minor. But nevertheless, I am (for the first time) optimistic we can still reach our goals. Let us go for it.
In addition, what we still could add to the draft letter, is a a change in national law (definition of essentially biological processes and scope of patents). I missed that to add in my draft, but I would like to add.
If needed we also can have a chat on the telephone (or zoom conference).
I think this is a huge opportunity and we should use it asap. But we also should have common understanding of the situation.
Cheers
Christoph
Am 19.05.20 um 15:44 schrieb ARCHE NOAH Katherine Dolan:
Dear Christoph,
Thanks for the draft. I have a couple of questions and based on your
reply I would make some more detailed comments on the letter:
- In my view we are too complementary about the 2017 decision. I am
conscious we should show that we appreciate their efforts, but they did after all ignore our warnings that the proposal didn't go far enough. In Austria we also have the specific situation that we heavily criticised the proposal in 2017 as formally establishing loopholes that were previously informal ( https://www.ots.at/presseaussendung/OTS_20170626_OTS0008/arche-noah-europaei...) and it was this criticism that got Austrian government to vote against it. So it is awkward for us to be too positive now - particularly as we don't want to expect less of the current minister than the minister in 2017, especially as she is a green.
My question - is it ok for you in general if we are less complementary
about the 2017 decision or is this very important for you?
You call on the AC to "adopt and publish a text for clarification". Do
you know what legal binding form this can take? Why are we not aiming for a further change in the Implementing Regulations?
Thanks
Katherine
-----Ursprüngliche Nachricht-----
Von: Npos_2018 [mailto:npos_2018-bounces@testbiotech.de
npos_2018-bounces@testbiotech.de] Im Auftrag
von Christoph Then
Gesendet: Dienstag, 19. Mai 2020 13:26
An: npos_2018@testbiotech.de
Betreff: [Npos_2018] Draft letter to AC and welcome to Gudula
Dear all
welcome to Gudula from Gene ethical Network which replaces Judith which
is on parental leave!
please see attached the draft letter to be sent to the Member States of
the EPO asap. I also will prepare a German version.
I think, after further reading of G2/07 and G1/08, there are very good
chances to sort out the issue the one way or the other. The wording seems to be stronger than I remembered. I included a condensed legal overview which is adding some new elements (after all discussions ...).
Please come back with your comments till Thursday.
Cheers
Christoph
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