Recently, the European Patent Office (EPO) changed its regulations, clarifying that plant and animal varieties obtained through essentially biological processes (such as genetically modified plants) will not be considered patentable. The patentability of plant and animal varieties has been a recurring topic of discussion over the years. In making the change, the EPO has departed from its original position that these varieties were patentable, and aligned itself with the view of the European Commission and the European Council. Proceedings concerning this subject matter which had been stayed by the EPO pending the amendment of the rules, will now be gradually resumed.
Patent holders and other parties dealing with this type of patent are advised to carefully consider all potential challenges posed by these developments and reassess their business strategies.
EPO ends its former practice
According to the EU Biotech Directive and the European Patent Convention, a non-EU arrangement, plant and animal varieties, and essentially biological processes for the production of plants or animals, are not patentable. However, neither the directive nor the convention explicitly excludes the patentability of products derived from those processes. In this light, the Enlarged Board of Appeal of the EPO has, in practice, allowed patents on products derived from using essentially biological processes (product-by-process claims).
Spotting this practice, the institutions of the EU have clearly indicated that (i) the EU legislators' intention when adopting the Biotech Directive was to exclude products (plants/animals and plant/animal parts) from patentability if they are obtained by means of essentially biological processes, and (ii) the EPO Enlarged Board of Appeal's decisions are in conflict with the legal provisions of certain EU member states. For more background information, please see our earlier article on this subject.
In response, the EPO (which is itself not a part of the EU) has now decided to amend its rules on the interpretation of the provisions in the Biotech Directive and the European Patent Convention.
Amendments to the EPO rules
The Administrative Council of the EPO has added a second paragraph to Rule 28 of the Implementing Regulations to the European Patent Convention, explicitly stating that European patents will not be granted in respect of plants or animals exclusively obtained by means of an essentially biological process.
The new rules end the earlier EPO practice. They apply with immediate effect to all European patent applications filed on or after 1 July 2017, as well as to European patent applications and European patents pending at that time (which includes opposition proceedings).
This decision at EPO level is a very important step in ending patent protection for plant and animal varieties, and is therefore welcome news for plant and animal breeders. However, the Court of Justice of the European Union has the final say as it concerns the interpretation of the Biotech Directive; see also our previous article describing the possible impact on the market.
While the new rules indeed bring more clarity and legal certainty for the future, a number of uncertainties still remain.
First of all, legal academics are already expressing their concerns regarding the legitimacy of the new EPO practice and its legal impact. By amending its practice, the EPO is effectively altering its interpretation of the Biotech Directive on the basis of non-binding guidelines of EU institutions, which have not yet been confirmed by the EU Court of Justice, which has the final say.
Secondly, although the EPO member states that are also EU member states will most likely align their practices with the new EPO practice, this will not automatically apply to the other, non-EU, EPO member states (Turkey, Norway, Switzerland, Liechtenstein, Iceland, Monaco, San Marino, Albania, Serbia and Macedonia). Those countries may still apply a different regime for their national patents.
Thirdly, it is unclear what impact the amendments will have on existing and currently undisputed European patents on products that are obtained by means of essentially biological processes. If their validity would be questioned later on, e.g. before a national court, the amendment of the rules may, in effect, have an impact on the validity assessment, particularly in those EPO member states that are also members of the EU.
All in all, we recommend that holders of this type of patent, and other parties dealing with those patents, carefully consider all potential challenges connected with the latest developments. More specifically, we advise holders of this type of patent to reassess their business strategies, both with regard to the expected scope of patent protection for certain products in light of these developments, and with regard to the continued payment of renewal fees for existing patents. After all, no one wants to pay for patents that no longer offer protection. We are, of course, available to assist.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.