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Friday, 28 July 2017

More on broccoli, tomatoes, and the patentability of a plant or animal obtained by means of an essentially biological process

Further to the IPKat blog post of July 26th ("EPO takes an ‘about turn’ on the patentability of products obtained by essentially biological processes"), Kat friend Florica Rus considers issues raised as a result of these amendments .

As reported, broccoli and tomatoes returned to the patent spotlight as the Administrative Council of the European Patent Office (EPO) amended Rules 27 and 28 of the Implementing Regulation and concluded that products (animals or plants) obtained exclusively from essentially biological process are excluded from patentability. This decision applies to European patent applications filed on or after July 1, 2017, as well as to European patent applications and European patents pending at that time.

To refresh the memories of Kat readers, the decisions (Tomatoes II G 2/12 and Broccoli-II G 2/13) caused a great stir within the public, the breeding industry and EU institutions. In particular, the Tomato/Broccoli II decisions created a divergence between the interpretation of the European Patent Convention (EPC) and the Biotech Directive and it was in conflict with national patent laws (France, Germany, Italy and Netherlands), which precluded from patentability products produced by essentially biological processes.

Against this background, the European Commission (see the Interpretative Notice from November 2016) intervened and took a different view from that of the Enlarged Board of the EPO, concluding that products obtained by essentially biological processes should not receive patent protection. Consequently, the need for harmonization and legal certainty led the EPO to stay ex officio all the proceedings in which the decision depended entirely on the patentability of a plant or animal obtained by an essentially biological process. Following that, on June 29, 2017, the Administrative Council of the EPO amended Rules 27 and 28 of the Implementing Regulation. So, what now?

Amendment of the Rules is welcomed. Even as the impact of these recent developments continue to surface, here are some initial considerations:

1. All the stayed cases will be resumed and even granted patents could be subject to the new Rules, considering the subject-matter of EPO opposition or limitation proceedings or national revocation proceedings. In fact, since 1980, the EPO has granted 180 patents dealing with traditional breeding methods (Patente auf Planzen und Tiere, page 7).

2. The saga of Tomato/Broccoli II will continue to play out, as they are in conflict with these new developments. However, the EPC trumps the Rules when in conflict (Article 164 EPC) and therefore, the EBA is not bound by the Implementing Regulations.

3. As the new Rules are in line with the patent laws in France, Germany, Italy and Netherlands, a decision of the CJEU would probably follow the same interpretation of the process exclusion under article 53 (b) EPC and 4 (1)(b) Biotech Directive.

4. It has been clarified which types of biological material can obtain patent protection as lying outside the exclusion under article 53 (b) EPC (Administrative Council). However, to what extent can patents on native traits be seen as non-technical has yet to be clarified. Considering the degree of innovation in the plant biosciences, there is uncertainty on whether or not to exclude generally from patentability plants with native traits.

5. It remains questionable if the EPO really found the answer to the continuously innovating breeding system and whether it was a good option to avoid defining in a clear-cut fashion between traditional breeding methods (crossing and selection) and breeding methods that involve technical steps in the crossing and selection processes. In other words, it is still open for discussion whether it is the right approach to treat products obtained by a process that involves technical steps even in the crossing and selection processes (See Tomato I/Broccoli I decisions) in the same way as products obtained by purely essentially biological processes (“entirely natural phenomena” Rule 23b (5) EPC), the latter not being patentable.

6. The fear of traditional breeding falling under patentability will still persist. Modern breeding is based on traditional breeding
methods; it is considered predictable and therefore technical. Having this in mind, one can ask whether an identical result cannot be reached upon a repeated breeding process. Is there any difference if this process occurs naturally or is directed by a human? Consequently, there is room to develop best practices for patent examinations and patent drafting.

7. Apparently, small breeders have more freedom to operate without the fear of having traditional breeding put under “patent siege” from big companies.

8. GMOs face in Europe strong and constant opposition. Can it be that after these developments, GMOs will gain more popularity?

In the end, it looks like the current legal changes offer a sensible solution but arguably not a final answer. The implications of Tomato/Broccoli II are far from being totally revealed and breeders will continue to explore the boundaries of Article 53 (b) EPC.

Picture at the middle left by David Monniaux licensed under GNU Free Documentation License

Picture at the lower right by Softeis licensed under GNU Free Documentation License


Anonymous said...

This blog is astounding.

Whilst the legal changes may well be sensible and correct, the means by which that solution has been reached is clearly legally illegitimate and entirely incorrect. The Administrative Council cannot simply overrule the EBA on the basis of a interpretive note from the European Commission. The interpretative note has no legal standing unless and until it is examined by a Court of the European Union.

Regardless of how proper the outcome is, amendment of the Rules cannot and should not be welcomed as it has been achieved by completely bypassing all normal legal procedures. The ends cannot be used to justify the means.

Transgenic said...

To Anonymous of 10:22, it must be kept in mind that after the public reaction to Harvard Oncomouse and the Transgenic Plants case the EPO decided it no longer wanted controversy. It waited for the EU to bring out the Biotech Directive and imported it into the EPC Rules, and the idea was that the EU and CJEU would make the decisions and take the flak for future ethical/bio issues. Therefore the EPO has already given away its authority on these matters to the EU which is why the Administrative Council did what it did, but the problem is the present procedures don't reflect that.

The EPO has to tread very carefully because once the UP and UPC are up and running the EPO will be the next thing the EU will want to encompass. If the EPO had kept to its position to interpret its rules differently from the equivalent language in the Directive it would have given the EU more ammunition for the argument that there can only be one Supreme Appeal Court for patents in Europe. The EPO's days as an independent entity are numbered, and it knows it. For now it must stay subservient to the EU to keep out of trouble, but it know it cannot resist forever.

Tim Roberts said...

The European Commission is entitled to a view on what the Biotech Directive means. But the body with the power to say what it means is the CJEU.

As to whether the change in the Rules is sensible, there may be more than one view. One thing that won't result is increased certainty.

Anonymous said...

To anonymous at 10:22 "The Administrative Council cannot simply overrule the EBA on the basis of a interpretive note from the European Commission."
The Administrative Council has recently lifted the former quasi-automaticity in the renomination of board members for a further five years term, and even dismissed a member in violation of Art 23 EPC. Guess why?

TreatyNotifier said...

-Neil, thanks for the post, but just as a means of clarification: are the boards bound by the implementing regulations to the extent they are NOT inconsistent with the the convention (also in view of article 24 saying the form an integral part of it)

-As for the CJEU, this is indeed a question that is waiting to be asked. However, if EPO (incl the boards) follow the new Rules, then no new patents will be granted, so national judges can only ask such a question with regards to national patents (if those don't follow the EPO line) or already existing EP's. It is likely (but not sure) that those jurisdiction where the EC opinion and the implementng law are already consistent with this reading of the biotech directive will not see a need to make the reference, and it is exactly those jurisdictions that tend to ask a lot of IP questions to CJEU. It could therefore be a long wait until the eventual question is asked...

Neil Wilkof said...

TreatyNotifier, Thanks for your question and I will seek to get Florica to reply.

Anonymous said...

Personally, as a practioner I do not think that this will be a huge problem. The amended rule 28 EPC refers to "essentially biological processes". This weak formulation will result in an outcome that might well be comparable with the situtation regarding the exclusions in Art 52 EPC that however apply only for the exclusions "as such". In practice, programs for computers can be patented quite well as long as there is any interaction with the "outside" and creatvity on the side of the attorney. I expect that a similar approach could be taken with respect to biological processes. That is, try hard and long enought and you will have a T decision that gives you some leeway for arguments in subsequent cases that a claim is not directed to a "essentially" a biological process but merely has some biological features.

That national courts may revoke a patent that is perfectly vaild at the EPO in light of the very same circumstances is also an unfortunate fact of life that however has less consequences in practice than one might think. For example, while it appears that the German Supreme Court has a completely different view with respect to novelty of selections/sub-ranges than the EPO/BOAs, in the end, this hardly ever plays a role.

That the stay of proceedigns of cases "par ordre du mufti" was in my opinion illegal must also be said though.

Anonymous said...

The nuance of "essential" as either 1) "in essence, being" or 2) "requiring" may greatly affect whether the view expressed by anonymous at 14:15 pans out.

The latter nuance eviscerates much more than the first nuance.

Florica said...

Thanks for your comments. There is no doubt that the discussions regarding patents on plants will not end here.

To Treaty Notifier:
If the Boards are consistent with the Convention, having "as a shield" Article 164(2), one could say that they are not bound by the Implementing Regulations and, arguably, no issue can be raised against them. As for Article 24 EPC regarding exclusion and objection of the Board members (I guess you were referring to this provision, I hope not to be wrong), this applies also in case there is a reason for exclusion other than reasons originating from a member itself or from any party of the proceedings. One could think that "other reason" might be not following the amended Rules. Bearing in mind the current situation, in the end, if it will be considered that having a different view than the one in the Amended Rules might trigger exclusion, the case will be treated on a case by case basis. All in all, I am sure that further developments won`t take long ... Hope to have answered to your question.

Regarding a question to the CJEU, it is true that a national patent case can refer to the CJEU. As for the time being, who knows, maybe there is somewhere a national revocation proceeding and in light on the new developments, the national Court will ask for a preliminary ruling.

To Anonymous of 14:15:
I like the comparison with the CII. Their situation can be considered similar to the one of patents on plants, although I think that CII began to have their situation under a more concrete legal layer than the latter. And yes, the creativity of the attorney or "smart claim drafting" could be seen as solutions. As for the reasons which contributed to the stay of the proceedings, there are arguments to run for or against it.

To Anonymous from 10:22:
It is true that there were several others ways to reach a harmonization and to amend the required provisions (e.g. a new Referral to the EBA; revision of the Biotech Directive and the EPC itself and so on). Now, we have to see what`s next and how to deal with/better interpret the new background around plant patents.

Look at things and think said...

For the present:

As there is no judicial review by a national court of a member state of the EU in case of revocation of a patent or refusal of an application, we are bang in the constitutional problems which are to be discussed before the German Constitutional court.

The liability of the member states of the EU might also be at stake with the present amendment of R 27 and 28 EPC, see CIPAs observations.

Another interesting point:

Are the implementing regulations as decided by the Administrative Council always applicable to the Boards of Appeal?

The answer is no, cf. G 6/95, OJ 1996, 649. At the time of this decision, the Praesidium of the BA decided upon the RPBA, which were subsequently enacted by the AC.

With the new structure of the Boards of Appeal, the Praesidium of the Boards having been given the opportunity to comment, the RPBA are decided by the BA Committee, cf R 12c(2)EPC. It means that the Praesidium has just to be heard, but his opinion can be disregarded. I therefore wonder whether a decision like G 6/95 would still be possible.

But the perception of independence of the Boards has been increased....

For the future
And we do not yet have the UPC up and running, and are over the transitional period for opt out.

Once a patent has been granted, the UPC can only take decisions as to infringement and validity, under the control (directly or indirectly) of the CJEU, valid for its member states. It can, at a pinch, decide for member states of the EU which are not member states of the UPC, but it cannot decide for member states of the EPC, which are are neither member states of the EU nor of the the UPC.

Where is the simplification heralded by all the proponents of the UPC?

Why has the UPC not be brought in front of the CJEU?

We really live in interesting times!

Millipede said...

One of the aspects that have so far not been discussed is whether it would be legitimate for the Administrative Council to change the EPC with a retroactive effect: the change in the Rules is not to be applied to alle applications filed after the change, but to all applications and even patents pending before the EPO.

Normally, a change in law will not place a party in a worse situation. What has happened now is comparable by a parliament saying that all new cars should have safety belts, which not only would apply to newly sold cars, but also would apply to cars that have been sold so far and which are still driving on the roads. From now on, cars that are halted by the police and do not have safety belts will be removed from the road.

If this hypothetical car situation would become real, everybody would protest, even if it was felt that having obligatory safety belts was a good idea. Now, since it only affects a minimum number of companies/people apparently such a limitation of rights is gladfully accepted.
From my perspective, I would vote that the EPO (or the European Commission) would compensate holders of these kind of patents (and/or applicants that filed these patents before the change of law) would compensate for loss of patent right (and consequently loss of income).

Alephnull said...

Millipede the vast majority of those cases will have been filed in the knowledge that patentability of products of biological processes was uncertain. They took that risk, and for a small amount of time (between the G decision and the EU notice) things looked good, but surely compensation should not be available in these circumstances.

Anonymous said...

To my mind, this would have been an excellent topic of discussion at a Conference organised under Article 4a EPC. It seems like big legal issues like this where the AC is in danger of acting ultra vires would be the ideal subject for discussion.

EU fan - put the EPO under the CJEU! said...

The whole UPC was the reason for Article 4a EPC to be inserted. To meet, once the political process has evolved a bit more, and discuss the implications for the EPO and whether reforms of the EPC/EPOrg/EPOffice would be necessary.
But some technocrats have preferred to work without political supervision, no matter how much the political representatives wanted to meet to discuss exactly these points.

The EPO did need quite some reforms, but not towards an office for nepotism, increasing the post levels for a small select group of people in the direct vicinity....

Anonymous said...

Anonymous 16:37,
Indeed. We have a Trump-ist act here where a decision is made in haste without regard to the consequences (that's for the little people). EU decisions are applied to non-EU states? Rules are applied retrospectively? Seems equivalent to the Trump no-trans serving tweet - how will it work in practice? Oops. We'll get back to you but we've got immunity so it doesn't matter.

Proof of the pudding said...

Florica - I am interested in your comment regarding the CJEU:
"As the new Rules are in line with the patent laws in France, Germany, Italy and Netherlands, a decision of the CJEU would probably follow the same interpretation of the process exclusion under article 53 (b) EPC and 4 (1)(b) Biotech Directive"

As I understand it, you believe that the CJEU would most likely fall into line with interpretations proffered by certain EU Member States. But why is that? Would that not amount to the tail wagging the dog?

I had understood the CJEU's role to be interpretation of EU legislation. Whilst Member States' interpretations of that legislation might be a "secondary" consideration for the CJEU, do you not think that those ought to be ignored if they conflict with conclusions stemming from primary considerations (including the wording of the relevant provision, as well as its history and purpose)?

The trouble with Directives is that they leave a lot of room for "creative" interpretations by Member States that suit their local needs (or political concerns). To me, this means that Member States' interpretations of Directives ought to be viewed by the CJEU with a healthy dose of scepticism. If that happens in this case, then I think that the CJEU could have a very hard time indeed finding a way to arrive at the same interpretations as in France, Germany, Italy and the Netherlands.

julian cockbain said...

If G-1/98 was wrong, then the new Rules are valid - a hard pill to swallow for some

Proof of the pudding said...

Julian - is anyone seriously suggesting that the ruling in G1/98 is no longer sound law? Unless I missed something, I did not understand even the Commission to be suggesting this.

Also, I don't see what G1/98 has to do with the current rule change. There is quite a difference between "plant not limited to a variety" and "plant not limited to a variety and obtained by means of an essentially biological process". The new rules only attempt to exclude the latter, whereas reversing the ruling in G1/98 would rule out patenting of the former.

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