Blog

Belgium to exclude products obtained from traditional breeding processes from patentability?

29/03/2019
Belgium to exclude products obtained from traditional breeding processes from patentability?
Photo: Shaiith/Shutterstock.com

In the current state of Belgian law, plant and animal varieties as well as essentially biological processes for the production of plants or animals are excluded from patentability (Article XI.5(1) of the Belgian Code of Economic Law – “CEL”). This resonates closely with Article 53(b) of the European Patent Convention (“EPC”) and Article 4(1)(b) of the Biotech Patent Directive[1], both of which stipulate identical exclusions.

However, on February 20th 2019 a legislative proposal was filed in the Belgian federal parliament to broaden this exclusion from patentability to also cover products exclusively obtained from such essentially biological processes. The proposal, which was supplemented by a clarifying amendment on March 19th 2019, follows a long series of events that placed these products under increasing scrutiny from various stakeholders essentially claiming that allowing them to be patented inappropriately limits the amount of germplasm available to breeders.

How it all started

The discussion started off with the decisions from the EPO’s Enlarged Board of Appeal in cases G 2/12 (“Tomato II”) and G 2/13 (“Broccoli II”), where it was held that the exclusion of Article 53(b) EPC only applied to processes involving crossing and selecting, and not to the products resulting therefrom. This view was shared by the District Court of The Hague (in proceedings on the merits) and the Court of Appeal of The Hague (in PI proceedings) in the so-called radish cress case of 2013. However, following an intensive political campaign, the European Commission on 8 November 2016 issued a Notice – officially called the “Commission Notice on certain articles of Directive 98/44/EC of the European Parliament and of the Council on the legal protection of biotechnological inventions” – in which it stated that, despite the wording of the Biotech Patent Directive, the European legislator had always intended for this Directive to exclude from patentability not only the essentially biological process itself, but also the products obtained therefrom. Notwithstanding its non-binding character, the Notice was subsequently picked up by the EPO who, in turn, changed its implementing regulations to introduce a new Rule 28(2) EPC pursuant to which “under Article 53(b) [EPC], European patents shall not be granted in respect of plants or animals exclusively obtained by means of an essentially biological process”. This new rule entered into force on 1 July 2017.

Questions about the legal justification for the Belgian proposal

The current Belgian proposal adduces precisely this Commission Notice and this new Rule 28(2) EPC as a justification to align Belgian law with the Biotech Patent Directive and EPO practice, respectively.  A reference is also made to the national patent laws of other countries, such as the Netherlands and Germany, that already contained similar exclusions.

It remains to be seen whether the current Belgian proposal will turn into law. However, it is questionable, for at least the following reasons, whether the underlying rationale of the proposal as well as its legal basis are sufficiently sound to justify the proposed amendments.

To start with, the proposal presupposes that the 2016 Commission Notice contains the correct interpretation of the Biotech Patent Directive, whereas the content of the Notice has, in our view rightfully, been criticized by several authors.[2] Furthermore, as stated previously, the Notice is not binding, as binding interpretations of EU legislative instruments, such as the Biotech Patent Directive, can only finally be decided by the EU Court of Justice.

Secondly, insofar as the proposal refers to Rule 28(2) EPC, it fails to take into account the EPO Technical Board of Appeal’s decision of 5 December 2018 in case T 1063/18 (dealing with a pepper plant). In that case, it was held that Rule 28(2) EPC is unenforceable because it is in direct contradiction with Article 53(b) EPC as explained by the Enlarged Board of Appeal. In such a scenario, the EPC provides that Article 53(b) should prevail.

Thirdly, the proposal seems problematic in that its explanatory memorandum suggests that the envisaged amendment to the Belgian CEL should not only affect (the validity of) Belgian patents, but also Belgian tiers of European patents. This reasoning goes against the established principle (and Belgian case law) according to which the validity of European patents is exclusively governed by the EPC and not national law, particularly not if the latter differs from the EPC, as would – at least currently - be the case if the proposal is adopted.

Finally and even regardless of whether the proposal is in line with EU law, extending the excluded subject-matter clause to products resulting from essentially biological products risks enacting an unjustified discrimination between the products of traditional plant breeding techniques (essentially biological processes) and other techniques.

[1] Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions.

[2] See e.g. M. KOCK, “The EU Commission Notice on Plants from Essentially Biological Processes: Problem Solved?”, Vol 15 Issue 6 BSLR;  R. AERTS, “The European Commission’s notice on Directive 98/44 and the European Patent Organization’s response: the unpredictable interaction of EU and EPC law”, [2018] JIPLP 800.

Contact


Want to stay tuned?

Subscribe here

follow us on