EPO bows to EU Commission on patentability of products of essentially biological processes

This Kat is grateful to his colleague Andrew Sharples, head of  practice group EIP Life, for preparing this report of recent news from the European Patent Office about the patentability of products of essentially biological processes.  Over to Andy...

The EPO announced on 12 December that it has stayed all examination and opposition proceedings relating to plants and animals obtained by an essentially biological process. This is because of a notice of the European Commission questioning the availability of patents in these fields.

Following the Broccoli and Tomato cases (G2/12 Tomatoes II and G3/12 Broccoli II, discussed on the IPKat here), the Enlarged Board of the EPO ruled that even where an essentially biological process for the production of a plant or animal is not patentable, the resultant animal or plant may itself be patentable. This was on the basis that, effectively, the exclusion under Art. 54(3) EPC was an exclusion of a process, and there was no basis for giving this Article a broader interpretation.

This decision did not go unnoticed by the powers of the EU, and in December 2015, the European Parliament adopted a resolution asking the European Commission to look into the patentability of products of essentially biological processes. This resulted, on 3 November, in the Commission adopting a Notice on certain articles of the Biotech Directive (2016/C 411/03), in which the Commission took a different view from that of the Enlarged Board.

In particular, the Commission found that the preparatory work to the Biotech Directive (Directive 98/44/EC Of The European Parliament And Of The Council)  should have been taken into consideration. Notably, the Commission refers to the Rapporteur's report that

“‘Essentially biological procedures’, i.e. crossing and selection of the whole genome […] do not meet the general conditions for patentability, as they are neither inventive nor reproducible. Breeding is a reiterative process, in which a genetically stable end-product with the required characteristics is attained only after much crossing and selection. This process is so strongly marked by the individuality of the initial and intermediate material that an identical result will not be obtained upon its repetition. Patent protection is not appropriate for such procedures and their products” (Explanatory statement to the ROTHLEY report, 25 June 1997 (A4-0222/97), p. 38, footnote 5)

Certainly the reference to “and their products” seems to support the Commission’s view. However, the Commission’s Notice goes on to state that certain provisions of the Biotech Directive are only consistent if understood as excluding the products of essentially biological process from patentability. To this reader, these aspects of the Commission’s reasoning do not sit well with the fact that there is a specific exclusion in the legislation on plant and animal varieties, and that

“Inventions which concern plants or animals shall be patentable if the technical feasibility of the invention is not confined to a particular plant or animal variety” (Art. 4(2) of the Biotech Directive).

Nevertheless, the Commission has concluded that animals and plants derived from essentially biological processes should not be patentable.

The Commission’s view is not binding on the EPO. It’s not even binding on the EU, as the Notice makes clear, and instead it only provides guidance as to the application of the Directive. Even though  EU law is not binding upon the EPO, the EPO does in practice apply the Biotech Directive, and decisions of the CJEU are certainly persuasive, as was seen in the Brüstle decision, where EPO practice was changed to follow a CJEU decision. Whilst this notice does not have the force of a CJEU decision, it clearly warrants consideration. The EPO Notice states that the effect the Commission’s Notice should have is currently being discussed by the EPO Contracting States.  This is presumably within the forum of the Administrative Council, which has the power to amend the Implementing Regulations of the EPC and hence effectively override G2/12 and G3/12, if it so wishes. This author is not aware of any timescale for this, and in the meantime the EPO has decided to suspend examination and opposition proceedings relating to this subject matter, although searches will continue unaffected. Any communications setting time limits will be withdrawn by the EPO. This is effective immediately. 

EPO bows to EU Commission on patentability of products of essentially biological processes EPO bows to EU Commission on patentability of products of essentially biological processes Reviewed by Darren Smyth on Tuesday, December 20, 2016 Rating: 5


  1. One could argue that there is no provision in the EPC to deny applicants the patent they are entitled to by staying the proceedings and that the EPO is therefore acting "contra legem".

  2. It is outrageous that the EPO is staying proceedings, whilst presumably still collecting renewal fees. I would love to know the legal basis for doing this.

    The staying of opposition proceedings is perhaps even more absurd. This will simply mean that opposed patents will remain valid and enforceable unless and until a national court decides on their validity. If the EPO thinks the patents aren't valid the indefinitely staying opposition proceedings is achieving the exact opposite as it has completely removed an Opponent's opportunity to invalidate a granted European Patent.

  3. I can understand the EPO carrying on with searches for first applications and PCT filings but for other EP application, it does not make sense. If the EU guidance finds its way into the EPC, applicants might wish to withdraw their application and the search fee will only be refunded if the search has not yet started. Further, with publication of the search report, the applicant would be required to respond to the objections raised, for which they would not have the benefit of knowing how the rules were to be changed.

  4. Jurisprudence is not highly esteemed in the EPO These days. The EU-Commission, responsible for the BioT Directive, the model for Rule 26 EPC, can dictate how Article 53b and Rule 26 EPC are to be applied. Separation of Powers?

  5. the evidence, moral argument or even legal basis for "Patent protection is not appropriate for such procedures and their products" appears nowhere. Wish I could say that this surprised me.


  6. The Cat that Walks by HimslefTuesday 20 December 2016 at 18:05:00 GMT

    It would be very interesting to read or watch an interview with the Administrative Council members
    presenting their vision(s) on the implementation of rule of law at the European Patent Office.

    In particular, how the cornerstones of rule of law are seen by the Administrative Council:

    Legality, i.e. legislative powers belonging to a representative body;

    Balance/separation of powers, i.e. balance of legislative, executive, and judicial powers;

    Independent judiciary, i.e. review of decisions and interpretation of law by an independent body.

    The European Patent Office is in charge of taking generally binding decisions for the territory of 38 European countries, which implies adherence to rule of law as a fundamental principle of governance.

  7. Sadly, the problem is not with Tomatoes II but with the EBoA's craven reaction to the Biotech Directive in G-1/98. Correctly decided then, the problem would not have arisen now

  8. The decision by the President of the EPO to stay all the concerned proceedings cannot be appealed before the Boards. One more example of the fundamental lack of accountability of the executive in the European patent system.

  9. The EPO chose to bring itself under the jurisdiction of the EU when it brought the Biotech Directive into the EPC rules. Now it has to stay proceedings to sort this all out. There is no point granting/maintaining patents which are not valid according the Biotech Directive. It's clear that in the long term the Enlarged Board cannot remain independent of the EU, particularly once the UPC is up and running and presumably the CJEU will then be looking at patent cases at lot more regularly as the final appeal court for the UPC.

    We clearly cannot have 2 final patent courts in Europe and this is a good opportunity to start the process of allowing the CJEU to take over the responsibilities of the Enlarged Board.

  10. Why bother about separation of powers? It started with the house-ban of a member of the BA by the president of the EPO a while ago.

    It continued. As the EBA did not abide by the wishes of the AC (and of the president) in this matter, it was relocated to Haar.

    As long as the AC has not amended the Rules, there is no objective reason to stay any proceeding.

    By staying the proceedings, the BA are also touched. Another good way to retaliate.

  11. So, let me get this right.

    Step 1: some "concerned" groups with political clout apply pressure upon the European Commission.

    Step 2: the Commission bows to that pressure and issues a note (based upon questionable legal analysis) interpreting certain legislation.

    Step 3: solely upon the basis of the Commission's note, one of the bodies tasked with "enforcing" that legislation stops following a ruling from the judiciary upon the very point covered by the Commission's note.

    Forgive me, but would I be right in thinking that whoever at the EPO took this action clearly never heard about the concept of separation of powers?

    Of course, this is also another instance in which a decision of the Enlarged Board of Appeal is effectively ignored by the EPO management. How long can this continue? And what will the judges in Karlsruhe make of it?

  12. Shouldn't it be Art 52(3) EPC (patentability) instead of Art 54(3) EPC (novelty)?

  13. There may be some serious Treaty impacts to deny patents in this field of technology ("reproducible" or not)

  14. Well said Proof of the Pudding. But think of the efficiencies which may be gained for the purposes of government. A court gives a view which the government does not or its "friends" do not like. All the government now has to do is to issue a "correcting" note, problem solved. Why limit it to the government; the police, local government, interested bodies, anybody. Indeed why bother with courts at all? I seem to remember when at law school something about the rule of law. If ever I understood it then I certainly do not understand it now.


  15. @Leo:

    Why should a European patent not be granted in a dozen of non-EU member states because of EU law?


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