Dear all

thanks to Johanna we were also made aware that the new examination guidance is online:

with track changes: https://www.epo.org/law-practice/legal-texts/guidelines/guidelines-preview.h...

final: https://www.epo.org/law-practice/legal-texts/guidelines.html

general overview: https://www.epo.org/law-practice/legal-texts/official-journal/2021/01/a6.htm...

I attach the relevant chapter on patentability with track changes (I guess no German version is available).

it is made clear that rule 28(2) has not be applied to applications filed before July 2017. in this context, also the role of the disclaimer is defined in more detail.

!! on page 51 random mutations are considered:

an very lousy example for patentable inventions was deleted. Very good. Further clarification was added:

A mutant of a plant carrying a heritable exchange in a nucleotide sequence effected by technical means, e.g. UV mutagenesis or CRISPR/Cas *with the proviso that the plant is not exclusively obtained** **by means of an essentially biological process (EBP).*

the second part (now added) of the sentence means that even it mutagenesis is applied, the plant still might be derived from essentially biological processes. This could mean that the patent applicant has to show that the claims are in accordance with G2/07 and G1/08 (direct insertion of a trait) and it is not enough to show that mutagenesis was applied.

To further discuss this issue I would like to give two examples:

in the case of herbicide resistant plants derived from random mutations it might be sufficient to treat them with the herbicide to identify the desired traits (patentable)

in case of plants with resistant to downy mildew it might be necessary to perform (after mutatgenesis) further crossing and selection to derive to the desired (quantitative) trait.

These examples show how these new guidance might become applied. this would mean a step ahead: So far, each application of mutagenesis was sufficient to overcome rule 28 (2). Now only some plants might escape.

But still not all methods for conventional breeding would be excluded.

There is another possibility how this additional half sentence might be used (and made worthless): The EPO could decide to simply demand a disclaimer, leaving it completely open what exactly is patentable or excluded.

!! on page 52, living cells are excluded if derived from relevant plants or animals - this seems to a success of our work.

Summary: Some progress was made. It is hard to say if we have chances to reach better decisions by the Admin Council if we follow our current approach. The alternative would be to say: We now see that based on latest documents, final clarity only can be achieved by a change of law. This also might mean we still could use patents as granted before July 2017 to raise pressure - the debate would no longer just concern rule 28(2). This also might help to move ahead the Admin Council to provide further clarifications.

We have to discuss this next week during our phone call. I also will continue to think about and might have improved analysis next week.

cheers

Christoph