Following a proposal from the European Patent Office (EPO), the Administrative Council of the EPO has amended Rules 27 and 28 of the Implementing Regulations to the European Patents Convention (EPC) to exclude animals or plants obtained exclusively from essentially biological process from patentability. The most significant change is an additional paragraph (2) to Rule 28:

“(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 rule change 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.

The decision clarifies practice in the area of plant and animal patents and is intended to bring greater harmonisation in European patent law following a period of uncertainty.

In previous decisions (Tomatoes II G 2/12 and Broccoli-II G 2/13), the Enlarged Board of Appeal of the EPO held that the exclusion from patentability under Article 53(b) to essentially biological processes did not exclude products of essentially biological processes. These decisions were controversial in applying a narrow interpretation of the Biotech Directive and because they were in conflict with national patent laws of several European countries which precluded products produced by essentially biological processes from patentability.

The European Commission reviewed the matter and issued an Interpretative Notice in November 2016 setting out their conclusion that products obtained by essentially biological processes should not receive patent protection.  The EPO then stayed ex officio all pending proceedings in which the decision depended entirely on the patentability of a plant or animal obtained by an essentially biological process whilst the effect of the Commission Notice for the EPO’s examination practice was reviewed. Now that the changes to Rules 27 and 28 have been implemented, the stayed cases will be resumed and examined in accordance with the clarified procedure.

Whilst the rule change is intended to bring clarity and greater certainty, it is not without controversy. Indeed, the legality of the EPO’s decision to change substantive patent law by means of rule changes to the EPC in response to the European Commission’s notice has been questioned. The Chartered Institutes of Patent Attorneys (CIPA) have submitted observations in which they argue that only the Court of Justice of the European Union (CJEU) can provide a definitive ruling on the interpretation of provisions of EU law such as the Biotech Directive. It remains to be seen whether there will be a referral to the CJEU. CIPA’s observations on this issue can be found here.

If you have any questions, do not hesitate to contact one of our patent attorneys.