Following on from my previous report on the EPO Administrative Council’s new Rule 28(2) explicitly excluding products of “essentially biological processes” from patentability, this story has taken some interesting new turns.  New Rule 28(2) was billed as a “clarification” of the meaning of Article 53(b) EPC but in February in a case relating to pepper plants an EPO Technical Board of Appeal (enlarged with legal members) decided that new Rule 28(2) is actually in conflict with Article 53(b) as interpreted by the Enlarged Board of Appeal in the Tomato II and Broccoli II cases.  Now, the President of the EPO has weighed in on the debate as to whether European patents can be obtained for plants that are direct products of essentially biological processes.  The President disagrees with the Board of Appeal in the pepper decision and has referred questions to the Enlarged Board of Appeal to seek final clarification on the matter.

This is a very peculiar situation where the Boards of Appeal and the EPO are in disagreement on an area of patentability and on interpretation of the European Patent Convention.  The Boards of Appeal are independent of the EPO and act as a second instance on decisions from the EPO and as arbiters of how the EPC should be interpreted.  The EPO has now effectively asked the Enlarged Board to overrule two of its earlier decisions and it will be interesting to see how this progresses.

The pepper decision referred to above was T 1063/18 and was an appeal from a decision of refusal of a patent application by the examining division on the sole ground that the claimed invention was in contravention of new Rule 28(2) EPC.  After considering the justifications that the Administrative council used to introduce Rule 28(2) clarifying Article 53(b) and also the earlier Enlarged Board of Appeal decisions interpreting Article 53(b) the Board found no reason to depart from the earlier Enlarged Board decisions so they took the unusual step of deciding that new Rule 28(2) was in fact in conflict with the EPC.  The Board considered that the EPC must prevail over the implementing regulations so allowed the appeal and remitted the case to the examining division to decide on clarity and inventive step.

The President’s recent referral indicates that the EPO are determined to put this issue to bed to prevent further patents being granted to plants and other direct products of essentially biological processes.  The President has asked the Enlarged Board firstly whether the meaning and scope of Article 53 can be clarified in the implementing regulations without the clarification being limited by an earlier interpretation of the article by the Boards of Appeal.  Second, the President has asked that if the answer to the first question is yes, then is new Rule 28(2) in conformity with Article 53(b).  The President has urged the Enlarged Board to answer yes to both questions.

There has been criticism of the legality of the President’s referral as it is not technically a response to conflicting decisions of the Boards of Appeal, which is the usual reason for referrals by the President.  It is also quite surprising that we are seeing the executive branch of an organisation telling the judicial branch how they should be making decisions.  Many are expecting that the Enlarged Board of Appeal will find the referral to be inadmissible but we will keep an eye on this and report in due course.

In the meantime, if you have any concerns about whether your biotechnological invention may be patentable in Europe or elsewhere, then please get in contact with Ross Cummings via or your usual contact in the biotech team at GJE and we will guide you through the legal complexities and implement an IP strategy that works for you.  Regardless of how complex the exclusions from patentability can appear there is almost always a solution that can be put together to enable your company to secure the right IP protection to support incoming investment and commercialisation of your products or services.