The team is joined by Guest Kats Rosie Burbidge, Stephen Jones, Mathilde Pavis, and Eibhlin Vardy, and by InternKats Verónica Rodríguez Arguijo, Hayleigh Bosher, Tian Lu and Cecilia Sbrolli.

Friday, 11 November 2016

European Commission on Biotech Directive: tomatoes about to be squashed?

This Kat had the pleasure of attending yesterday’s workshop on IP Protection of Biological Inventions organized by VIPS/ACBIS and the University of Basle, featuring presentations by Ursula Kinkeldey (former chair BoA), Ewald Glantschnig (WIPO), Jürgen Meier (Vossius & Partner) and Penny Gilbert (Powell Gilbert).

Ursula Kinkeldey opened the day with reference to the bombshell that is the European Commission’s note on certain articles on Directive 98/44/EC (known to friends and family as the Biotech Directive) adopted on 3 November 2016. By way of background, shortly after its introduction, the Biotech Directive’s content had been implemented verbatim into the Implementing Regulations to the European Patent Convention, according to Dr Kinkeldey because the (second draft of…) the Biotech Directive was substantially guided by the EPO Boards of Appeal case law. Under Article 164(1) EPC the Implementing Regulations are an integral part of the Convention and, hence, are equally binding to the Boards of Appeal of the EPO (Article 23(3) EPC) and to national courts.

In combined cases G 2/12 and G 2/13 (“Tomato II” and “Broccoli II”), the Enlarged Board of Appeal had concluded – taking into account the legislative history of Article 53(b) and Rule 27(b) EPC as well as of Article 4 of Directive 98/44/EC – that Article 53(b) EPC did not preclude the grant of patents on products derived from using essentially biological processes, even if the process used to obtain the product (i.e. selecting and crossing the plants) is essentially biological and thus not patentable (see IPKat post). While one could have come to a different result, the decision is “well-reasoned” (Kinkeldey) and provides legal certainty.

Except that legal certainty just evaporated, because the European Commission, in its interpretative note on the Biotech Directive comes to the conclusion:
The Commission takes the view that the EU legislator's intention when adopting Directive 98/44/EC was to exclude from patentability products (plants/animals and plant/animal parts) that are obtained by means of essentially biological processes.
The Commission argues that the EPO was not bound to take the legislative history of the Biotech Directive into account and thus came to a different conclusion (but it did take it into account…). While admitting that the final wording of the Biotech Directive does not contain a provision on the patentability of products obtained through essentially biological processes, according to the Commission, “having regard to the preparatory work related to the Directive, as summarised above, certain provisions of the Directive are only consistent if plants/animals obtained by essentially biological processes are understood as being excluded from its scope”, referring to Articles 3(2), 4(1) and 4(3) of the Biotech Directive.


Kinkeldey speculated that the interpretative note may be the Commission’s attempt to silence the increasingly vocal plant breeders that consider patents to be encroaching on turf they believe their own without having to amend the Biotech Directive. During the discussion, it was pointed out that since the recent publication of the interpretative note, already a number of proposals to amend the Biotech Directive have been made and the Pandora’s box that is an amendment of the Biotech Directive may be about to be opened.

In the meanwhile, the national courts tasked with the enforcement of European patents are in the unenviable position that they have to decide whether to follow the Enlarged Board of Appeal or the Commission’s interpretative note. Patent proprietors best start biting their nails.

6 comments:

Anonymous said...

"During the discussion, it was pointed out that since the recent publication of the interpretative note, already a number of proposals to amend the Biotech Directive have been made and the Pandora’s box that is an amendment of the Biotech Directive may be about to be opened."

Err no. They clearly fail to get the point what the political significance of coming forward with a "notice" constitutes.

Anonymous said...

As regards "national courts tasked with the enforcement of European patents are in the unenviable position that they have to decide whether to follow the Enlarged Board of Appeal or the Commission’s interpretative note": if national courts have a question on the interpretation of EU law, e.g. the Biotech directive, they can (lower courts) or must (highest court) refer that question to the CJEU.

Anonymous said...

It's easier to confuse the issue than to change the law.

EPO vs EU said...

Well the EU doesn't like dissent and so it will be interesting to see how this pans out. The EPO doesn't have the power or inclination to take on the EU and so will presumably need to look for a way to reverse the G decision. Perhaps there needs to be a mechanism for the EPO to refer questions to the CJEU as a way of preventing this happening again.

Anonymous said...

The Commission certainly had some political goals for issuing its notice with this outcome. The final call, hopefully in all objectivity, will be on the CJEU.

Itzik said...

Don't like the verdict? Change the Law. And if you are unwilling to change the law, suck it up and let the judge do his job.

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