BREAKING: TBA decides that Rule 28(2) EPC, excluding plant products produced by essentially biological processes from patentability, is void

IPKat has received breaking news that the Technical Board of Appeal (TBA) yesterday decided that recently amended Rule 28(2) EPC is in conflict with Art. 53(b) EPC as interpreted by the Enlarged Board of Appeal in G 2/12 (Broccoli/Tomato II). Further, according to the Art. 164(2) EPC the Articles prevail, thus rending the R. 28 amendment void. 

The case is yet another development in the on-going legal confusion on the issue of whether plant products produced by essential biological processes are patentable. Article 53(c) EPC excludes from patentablity processes for producing plants and animals by essentially natural processes. Rule 28(2) was recently added to extend this exclusion to plant products produced by essentially biological processes. The TBA yesterday ruled that new Rule 28(2) is incompatible with Article 53(b) as previously interpreted by the Enlarged Board of Appeal, and therefore void. 

The decision was issued in oral proceedings yesterday for T 1063/18, an appeal from the Examination Division against an objection under Rule 28(2). Rule 28(2) was amended in a 2017 decision of the Administrative Council (OJ EPO 2017, A56) to exclude plant products produced by essentially biological processes (e.g. natural breeding methods) from patentability. Rule 28(2) relates to Article 53(b), which excludes essentially biological processes for the production of plants or animals from patentability. 


Protecting his tomatoes
Following a long-running legal saga, the Enlarged Board of Appeal (EBoA) decided in Broccoli/Tomatoes I (G 2/07 and G 1/08, IPKat post here), that Article 53(b) EPC excludes from patentability claims directed to an essentially biological process for the production of plants. The follow-up EBoA decisions Broccoli/Tomatoes II (G2/12 and G2/13, IPKat post here) found that the Article 53(b) exclusion should be interpreted narrowly. Particularly, Article 53(b) should not prevent claims directed to plants or plant products produced by essentially biological processes. 

In wake of the Broccoli/Tomatoes II, the European Commission (EC) was asked by the European Parliament to review the Biotech Directive (Directive 98/44/EC). Article 4 of the Biotech Directive mirrors the wording of Article 53(b) EPC, and excludes from patentability essentially biological processes for producing plants and animals, but does not explicitly exclude products produced by such processes. The EC concluded that the intention of the Biotech Directive was to exclude products produced by essentially biological processes from patentability, not just the processes themselves. The EC position was thus at odds with the view of the Enlarged Boards of Appeal in Broccoli/Tomatoes II, but in line with the patent laws in some member states, including France, Germany, Italy and the Netherlands. 

The Administrative Council of the EPO subsequently decided to amend the EPC regulations to reflect the EC's position (IPKat post here). Particularly, Rule 28 of the Implementing Regulations was amended to include the following paragraph:

(2) Under Article 53(b), European patents shall not be granted in respect of plants or animals exclusively obtained by means of an essentially biological process.

The Administrative Council decision was considered a blow for the EU agritech industry, already hampered by arguably the world's most stringent GMO regulations, in the form of the GMO directive (recently ruled by the CJEU also to include gene-edited products, IPKat post here). 

The appeal case decided yesterday, T 1063/18, related to Syngenta's EP patent application EP2753168. The application seeks protection for a pepper plant. The application was rejected by the Examining Division in view of the Rule 28 amendment. Syngenta filed a notice of appeal and statement of grounds in April 2018. The TBA agreed to expedite proceedings in view of the many pending applications to which the issue of new Rule 28 is relevant. Oral Proceedings were held yesterday, 5 December 2018. In view of the nature of the appeal, the EPO also decided to enlarge the number of members on the Board to include 3 technical members and 2 legal members.  Third party observations were filed by  the European See Agency (ESA), urging the board to maintain the rejection in view of Rule 28. Third party observations were also filed in support of Syngenta, for example by Solynta (a potato seed breeding company).

The EPO has not yet issued a statement regarding the decision, and IPKat is therefore indebted to our source and Katfriend Bart van Wezenbeek for information on the outcome of proceedings yesterday at the Board of Appeal, HaarAccording to Bart, the Board found the matter so crystal clear that they did not see the need to refer the question to the Enlarged Board. Particularly, the Board found that Article164(2) EPC stipulates that the Articles have precedence over the rules, and the amendment to Rule 28 is therefore void. The Broccoli/Tomatoes II decisions therefore stand. The case has now be remitted back to the Examining Division, for examination on clarity and inventive step.

Yesterday's decision is an exciting turn of events for the European agritech industry. It seems that the legal uncertainty regarding plant and plant product inventions will continue for some time to come. 

IPKat will, of course, bring you detailed analysis of the published decision once this has been issued.  
BREAKING: TBA decides that Rule 28(2) EPC, excluding plant products produced by essentially biological processes from patentability, is void BREAKING: TBA decides that Rule 28(2) EPC, excluding plant products produced by essentially biological processes from patentability, is void Reviewed by Rose Hughes on Thursday, December 06, 2018 Rating: 5

10 comments:

Anonymous said...

One correction, Solynta filed observations in support of Syngenta's position that the rule was incorrect, as did multiple other parties.

2010-2018 is not over! said...

It was difficult to understand at the time why the then President of the EPO rushed to abide by comments of the Commission and proposed to introduce in the Implementing regulations further amendments to R 27 and 28. If it had been a decision on the CJEU, why not, but even then, there are 38 member states at the EPO and only 28/27 in the European Union. It was a mere position paper of the commission.

One can even be inclined to think, that in its rage against the Boards of Appeal, the then President took every pretext to bash on them. Personal revenge should however not be the motor for changing the rules of a game.

The ball is indeed now again in the court of the AC and it is good so. When the AC decided the amendment, it was the wilful instrument of the then President of the EPO, and, as was said many times, it was the tail wagging the dog. The same can be said about the relocation of the Boards to a suburb of Munich in order "to increase the perception of their independence". That this relocation would not improve the situation of the Boards, should have been more than obvious to anybody thinking straight. But the AC agreed!

I am not sure that the situation will change. It just shows what damage can be made to a system by the wish of destruction and revenge of a single individual supported by a group of people playing the farcical "Yes, Prime Minister".

By the way, it is not the first time that the Boards do not agree on a decision taken by the AC. See G 6/95. On the other hand, when one sees the actual draft RPBA, according to which it will be mandatory for a Board to send an annex with the summons, one can only smile at what happened then.

Rose Hughes said...

Thank you for pointing this out. We have corrected the post.

Canter said...

Well it's an exciting turn of events for patent attorneys also as it's not every day that an EPC rule is declared void.

National courts and the CJEU are bound by the Biotech Directive and so presumably are duty bound to follow the EU's interpretation of this, which is that the products of essentially biological processes are not patentable, and so I suspect claims to them will be declared invalid in any litigation.

Alas, I think this decision brings forward the day when the EU takes control of the EPO on the pretext of harmony, so whilst this little skirmish against the EU Commission has been won, the battle will ultimately be lost.

Cees Mulder said...

On 7 December 2018, the EPO posted a report on its website relating to the decision:
https://www.epo.org/law-practice/case-law-appeals/communications/2018/20181207.html

EPO is not EU and will probably never be said...

Dear Mr Canter,

You seem to forget that the EPC has 38 member states and the EU presently 28 and soon only 27. You might thus have a long time to wait until the EU takes control of the EPO on the pretext of harmony.

If the EU could have taken over the EPO, we would not have to do with the UPC, but EPLA would probably be in place now. However, Opinion C 1/09 came in between.

I do not think that even the children of my grandchildren will see the EU take the control of the EPO!

Canter said...

In response to 'EPO is not EU...', please see http://patentblog.kluweriplaw.com/2018/05/08/eu-bring-unitary-patent-system-control/

Already the economic and academic arguments are being made as can be seen in that article. The EPO is being entrusted with the Unitary Patent, but that will bring the responsibility of harmonising with EU. It does not make sense to have 2 different sets of appeal systems in Europe (The EPO Boards and the CJEU). A single system of control is sensible, and I am sure will come into being at some point.

Proof of the pudding said...

Canter,

I would like to address a number of inaccuracies in (implied) statements in your comment from 7 December.

Firstly, it is the Member States that are bound by the Biotech Directive. The role of the courts is to interpret that legislation, ie to determine the meaning of rules that bind the Member States (and other individuals / entities towards which those rules are directed).

Secondly, only the CJEU is able to provide a binding interpretation of the Biotech Directive. Whilst the views of the Commission and of the Member States may be of interest, they are meaningless if they do not align with the CJEU's interpretation of that Directive.

Thirdly, there has already been national litigation (in the Netherlands) on relevant claims. Contrary to what you asserted would be the inevitable result, those claims were held by the Dutch court not to be excluded from patentability.

Finally, as has already been pointed out, Opinion 1/09 closes the door to the EPO becoming an EU institution. Indeed, it is not 100% clear whether the EPO as it currently stands is compliant with EU law. In this respect, a positive aspect of the Board of Appeal's decision is that it avoided an outcome that would have been a blatant example of non-compliance with EU law (specifically, with Article 267 TFEU, which is essential to preserving the autonomy and supremacy of EU law).

Canter said...

Proof of the Pudding, I completely agree with everything you have written, but I would also point out the broader set of events that happened. The Enlarged Board ruled that products of essentially biological processes were patentable. The EU Commission disagreed. The EPC rules were changed to comply with the Commission's view. This is power politics at play, and a reflection of the hard reality. The EU is an ongoing project which is ever-expanding and patents are something it has an interest in. The EU will ultimately not allow the EPO to dissent in any substantial way. Whilst 'legally' speaking you are correct, I fear that ultimately the EPO will end up being an EU institution at some point because it does not have the power to resist. The EU has recently proposed changes to SPC rights (http://europa.eu/rapid/press-release_IP-18-3907_en.htm). At some point or other it is bound to review patent protection and perhaps how validity is determined, and that will inevitably require the EPO to comply with whatever the EU wants.

Proof of the pudding said...

Canter,

If by "power politics" you mean a breach of democratic norms (including the separation of powers between the executive, legislative and judicial branches), then I agree that this is what is currently in play.

I also agree that the EPO will continue to ensure that, as much as is possible, it acts in accordance with EU law. However, I believe that their compliance on this point will be motivated by self-interest, namely avoiding a situation arising where the CJEU holds the EPC to contravene EU law.

From this perspective, I continue to believe that it is extremely unlikely that the EPO will be converted into an EU institution, as the circumstances are unlikely to arise where the pain caused by such a change (which would almost certainly include restricting membership of the EPO to EU states only) wold be seen as "worth it" by all stakeholders.

The comparison to SPCs is inappropriate. EU-wide SPC protection was created for the first time under EU law. The same is not true for (more or less "harmonised") EU-wide patent protection. We have a well-established (and largely well-functioning) system that exists under international law. The consequences of the EU creating an entire patent system under EU law would therefore be far more profound and unsettling (as well as potentially unpleasant).

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